chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: sweats; sore arm; Fever; chills; nausea/ vomiting; nausea/ vomiting; aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 13-Jun-2025, the patient experienced PAIN (aches), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea/ vomiting) and VOMITING (nausea/ vomiting). On an unknown date, the patient experienced HYPERHIDROSIS (sweats). At the time of the report, PAIN (aches), HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea/ vomiting) and VOMITING (nausea/ vomiting) was resolving.      The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medications were reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Hypersensitivity, Hypoxia, Pulmonary function test
Clinical narrative: Shortly after this vaccine (within the week) , the patient had to be put on an inhaler again after 25 years and placed on steroids. This was the first time in 25 years the patient had a respiratory attack.  The patients immune system has been hyper reactive since, easily having respiratory/asthma attacks triggered, despite being put on steroids multiple times. This patient has not had a medical condition prior to this in the time period mentioned above before this vaccine was administered. Recently, she has been really close to calling EMS due to this repository attacks causing hypoxia. All the above is what is promoting this VAERS report, as many adverse effects by these vaccines are underreported.
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: Around 2010, FLM was administered to the child who studying abroad, and the patient developed influenza; A spontaneous report has been received from a other health professional via License Partner. The report concerns a patient of unknown gender (age not provided).  No medical history was reported.   No concomitant products were reported.   The patient started treatment with Flumist Quadrivalent (flumist, influenza virus vaccine polyvalent, q/laiv) UNK, on an unknown date for vaccination.  No malfunction has been reported for the Accuspray Single Dose device.  On an unknown date, the patient experienced around 2010, flm was administered to the child who studying abroad, and the patient developed influenza (preferred term: Influenza).      The outcome of the event(s) of around 2010, flm was administered to the child who studying abroad, and the patient developed influenza was unknown.      The event was considered non-serious.  The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): around 2010, flm was administered to the child who studying abroad, and the patient developed influenza.  The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): around 2010, flm was administered to the child who studying abroad, and the patient developed influenza.      Report received by AstraZeneca via License Partner on 12-JUN-25.   Device Information:  Combination Product Report: Yes  Product As Reported: Flumist Quadrivalent Brand Name: FLUMIST QUADRIVALENT Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller stated patient did not report any symptoms.; patient who is currently 19 years old received their 1st dose of GARDASIL 9 in 2018 and their 2nd dose on 3/27/2025.; This spontaneous report was received from a pharmacist and refers to a 19-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    In 2018, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #, expiration date, dose, frequency, route of administration and anatomical location of vaccine were not reported); on 27-MAR-2025, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), lot #Y018389, expiration date was not reported, but upon internal validation was established as 04-NOV-2026 (dose, route of administration and anatomical location of vaccine were not reported) (inappropriate schedule of drug administration); both doses were administrated for Prophylaxis. The reporter stated that the patient experienced Caller stated patient did not report any symptoms (No adverse event).
Vaccine: DTPPVHBHPB, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025. ROTATEQ and VAXELIS were administered to a patient on 21MAY2025. Limited demographics provided. HCP originally called on; This spontaneous report was received from a Nurse Practitioner and refers to a 6-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-May-2025, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS), dose number 1, (lot # and expiration date were not reported), and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), dose number 1, (lot # and expiration date were not reported) had a temperature excursion of 1.4 degrees Celsius for 18 minutes and was administered to the patient on 21-May-2025 (Product storage error). No adverse event was reported.; Reporter's Comments:
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; one dose of PROQUAD with temperature excursion was inadvertently administered; This spontaneous report was received from an office manager and refers to a identified patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On an unknown date, the patient was inadvertently administered a 0.5 mL dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y006771, expiration date: 24-Sep-2025) for prophylaxis.  The administered dose of the vaccine experienced several temperature excursions as follows: On 09-AUG-2024: -10°C up to 8°C (-9.3C) for 1 hours, 53 minutes; on 29-SEP-2024: -14°C up to -10°C (-13.6C) for 30 minutes; on 16-JUN-2025: -14°C up to -10°C (-14.4C) for 9 minutes.  The patient did not experienced any adverse event.    This is one of two reports received from the same source.; Reporter's Comments: Keywords : MUL
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardiac operation, Immediate post-injection reaction
Clinical narrative: This vaccine sent into immediate afib; This serious case was reported by a consumer via interactive digital media and described the occurrence of atrial fibrillation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced atrial fibrillation (Verbatim: This vaccine sent into immediate afib) (serious criteria GSK medically significant and clinically significant/intervention required). The outcome of the atrial fibrillation was not resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingles vaccine.     The company considered the atrial fibrillation to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2025 This case was reported by a patient via interactive digital media. The patient said that the Shingles vaccine sent him/her into immediate afib (atrial fibrillation).  The patient had no previous heart problems. The patient had to have two surgeries on his/her heart. The patient was still taking heart medications.  The patient stated did not get vaccine. If get a rash go immediately to the physician.; Sender's Comments: Atrial fibrillation is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inflammation
Clinical narrative: Inflammed arm, general inflammation; Headache; This non-serious case was reported by a consumer and described the occurrence of inflammation in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (12 years ago), chickenpox (had chickenpox as a child), asthma and hashimoto's disease. Previously administered products included Shingles vaccine (Received 1st dose of Shingles vaccine in March, with no issues.). Concurrent medical conditions included hypothyroidism and seasonal allergy. Concomitant products included levothyroxine.   On 05-JUN-2025, the patient received the 2nd dose of Shingles vaccine. On 05-JUN-2025, less than a day after receiving Shingles vaccine, the patient experienced inflammation (Verbatim: Inflammed arm, general inflammation) and headache (Verbatim: Headache). The patient was treated with ibuprofen (Advil). The outcome of the inflammation and headache were not resolved.   It was unknown if the reporter considered the inflammation and headache to be related to Shingles vaccine.     It was unknown if the company considered the inflammation and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUN-2025 The patient had inflammed arm, general inflammation and headache. The first vaccine did not have any reaction like this.  The patient had been using ice packs and advil for 4 days to help ease the reaction.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: arm pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 16-MAY-2025, the patient received Bexsero (left arm). On 16-MAY-2025, less than a day after receiving Bexsero, the patient experienced pain in arm (Verbatim: arm pain). The outcome of the pain in arm was resolved.   The reporter considered the pain in arm to be related to Bexsero. It was unknown if the reporter considered the pain in arm to be related to Bexsero Pre-Filled Syringe Device.     The company considered the pain in arm to be related to Bexsero. It was unknown if the company considered the pain in arm to be related to Bexsero Pre-Filled Syringe Device.   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: 09-JUN-2025 The patient experienced expected arm pain after dose.
Age: 70.0
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / Lack of drug effect; shingles on the side of his stomach-a few small red spots / Lack of drug effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 vaccine for prophylaxis.   The patient's past medical history included epstein-barr viremia (Epstein Barre and elevated levels of virus in system, diagnosed when he was child).   On 18-JAN-2022, the patient received the 2nd dose of Shingrix. On 11-OCT-2021, the patient received the 1st dose of Shingrix. On 18-OCT-2021, the patient received COVID-19 vaccine. On an unknown date, more than 2 years after receiving Shingrix and Shingrix and not applicable after receiving COVID-19 vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on the side of his stomach-a few small red spots / Lack of drug effect). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to COVID-19 vaccine.     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, Shingrix and COVID-19 vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2025 The patient self-reported this case for himself. The patient had completed the series for Shingrix with 2 doses. About 7 to 10 days ago in 2025, he was diagnosed with shingles on the side of his stomach (a few small red spots or lack of effect). This diagnosis was made by a dermatologist. The patient was prescribed Valtrex (unknown if generic or brand dispensed, strength not disclosed) to be taken twice daily for 5 days. The patient stated that he was vaccinated with a COVID booster (unknown manufacturer). In 2025, more than 2 years after received COVID-19 vaccine, the patient experienced shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. No further information was obtained or provided.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (concomitant COVID-19 vaccine, h/o epstein-barr viremia and insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: fatigue; headache; drug dose administration interval too long;  This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received first dose on 23 or 24 October 2024).   On 11-JUN-2025, the patient received the 2nd dose of Shingrix (right arm). On 11-JUN-2025, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue), headache (Verbatim: headache) and drug dose administration interval too long (Verbatim: drug dose administration interval too long). Rechallenge with Shingrix was positive. The outcome of the fatigue and headache were not resolved and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the fatigue and headache to be related to Shingrix.     It was unknown if the company considered the fatigue and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2025 Patient received his second dose on 11 JUN 2025.  Patient had the same reaction with both dose one and dose 2.   Patient had fatigue and a headache, these symptoms after the second dose have been persisting for two days. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Allodynia, Herpes zoster, Pain, Scar, Urinary tract infection
Clinical narrative: Urinary tract infection; Shingles; scars; shooting pain; terrible surface pain that a slight touch; Suspected Vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old female 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), urinary tract infection (Verbatim: Urinary tract infection) (serious criteria hospitalization), shingles (Verbatim: Shingles), scar (Verbatim: scars), shooting pain (Verbatim: shooting pain) and allodynia (Verbatim: terrible surface pain that a slight touch). The outcome of the vaccination failure, urinary tract infection, shingles and scar were not reported and the outcome of the shooting pain and allodynia were not resolved.   It was unknown if the reporter considered the vaccination failure, urinary tract infection, shingles, scar, shooting pain and allodynia to be related to Shingles vaccine.     The company considered the vaccination failure and urinary tract infection to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, scar, shooting pain and allodynia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUN-2025 The patient had the vaccines, and still had shingles, on top of a major urinary tract infection that put in the hospital a year and a half ago at the age of 75. On top of scars, the patient was continued to have terrible surface pain that a slight touch, even by her bra, sends shooting pain through her. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Urinary tract infection is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Urinary tract infection; Shingles; scars; shooting pain; terrible surface pain that a slight touch; Suspected Vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old female 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), urinary tract infection (Verbatim: Urinary tract infection) (serious criteria hospitalization), shingles (Verbatim: Shingles), scar (Verbatim: scars), shooting pain (Verbatim: shooting pain) and allodynia (Verbatim: terrible surface pain that a slight touch). The outcome of the vaccination failure, urinary tract infection, shingles and scar were not reported and the outcome of the shooting pain and allodynia were not resolved.   It was unknown if the reporter considered the vaccination failure, urinary tract infection, shingles, scar, shooting pain and allodynia to be related to Shingles vaccine.     The company considered the vaccination failure and urinary tract infection to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, scar, shooting pain and allodynia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUN-2025 The patient had the vaccines, and still had shingles, on top of a major urinary tract infection that put in the hospital a year and a half ago at the age of 75. On top of scars, the patient was continued to have terrible surface pain that a slight touch, even by her bra, sends shooting pain through her. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Urinary tract infection is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: very sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUN-2025 This case was reported by a patient via interactive digital media. The patient's family members who got the 2 shot vaccine and got very sick.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: they hurt but you will get over it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: they hurt but you will get over it). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she took first shingles shots they hurt but will get over it having shingles is horrible it was worth taking the shots.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tiredness; arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes simplex type ii (About 20 years ago, the patient contacted genital herpes). Concomitant products included aciclovir sodium (Acyclovir) and valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness) and pain in arm (Verbatim: arm soreness). The outcome of the tiredness and pain in arm were unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR071843, US2025AMR076294   Additional Information: GSK Receipt Date: 09-JUN-2025 The reporter was the patient. The patient also lives part of the year in another country. The patient received the first of Shingrix in 2018 The only side effects experienced by the patient from any dose of Shingrix were arm soreness and tiredness. About 20 years ago, the patient contacted genital herpes (Herpes Simplex 2).  The patient had taken Valtrex, then went to Acyclovir for suppressive therapy. For tolerance to second dose, refer case US2025AMR076294 For tolerance to third dose, refer case US2025AMR071843; Sender's Comments:  US-GSK-US2025AMR071843:Same patient, 3rd dose US-GSK-US2025AMR076294:Same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tiredness; arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received first dose in 2018, refer case US2025AMR076267). Concurrent medical conditions included herpes simplex (contacted genital herpes). Concomitant products included aciclovir sodium (Acyclovir) and valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness) and pain in arm (Verbatim: arm soreness). Rechallenge with Shingrix was positive. The outcome of the tiredness and pain in arm were unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR071843, US2025AMR076267   Additional Information: GSK Receipt Date: 09-JUN-2025 The reporter was the patient. The patient also lives part of the year in another country. The patient received the second dose of Shingrix in 2018 The only side effects experienced by the patient from any dose of Shingrix were arm soreness and tiredness. About 20 years ago, the patient contacted genital herpes (Herpes Simplex 2).  The patient had taken Valtrex, then went to Acyclovir for suppressive therapy. For tolerance to third dose, refer case US2025AMR071843; Sender's Comments:  US-GSK-US2025AMR076267:Same patient, 1st dose US-GSK-US2025AMR071843:Same patient, 3rd dose
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: the administration of an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: the administration of an expired dose of Havrix). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 12-JUN-2025 An administrative assistant from a healthcare center was called to report the administration of an expired dose of Havrix, which led to an expired vaccine used. She mentioned not having further information about patient data nor date of administration nor dose number.  She stated that more information could be known after talking with her manager. The vaccine administration facility was the same as primary reporter.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: maladministration of the diluent only; maladministration of the diluent only; 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 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB044A, expiry date 31-JUL-2025) for prophylaxis.   On 12-JUN-2025, the patient received Menveo. On 12-JUN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: maladministration of the diluent only) and inappropriate dose of vaccine administered (Verbatim: maladministration of the diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 13-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter A Medical Technician called to report about the maladministration of the diluent only of Menveo vaccine to a patient yesterday which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Medical Technician wanted guidance if they have to revaccinate the patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received her first dose of shingrix on Monday 6/16/25. She called the pharmacy on Wednesday 6/18 stating she had pain at site and throughout arm and had trouble lifting it the first two days after getting it. She also had 2 areas of redness. By Wednesday, she could lift her arm but was still experiencing a great deal of pain. She took some tylenol which helped. Advised to continue tylenol, ice the area, and take an antihistamine.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20, UNK
Symptoms: Crying, Decreased eye contact, Depressed level of consciousness, Developmental regression, Food refusal
Clinical narrative: Relfux/vomit, no longer eating solids, no longer breastfeeding, no longer babbling, eye contact avoidance, moments of being unalert, fever, fussiness, screaming, crying
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20, UNK
Symptoms: Gastrooesophageal reflux disease, Infant irritability, Poor feeding infant, Pyrexia, Screaming
Clinical narrative: Relfux/vomit, no longer eating solids, no longer breastfeeding, no longer babbling, eye contact avoidance, moments of being unalert, fever, fussiness, screaming, crying
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20, UNK
Symptoms: Vomiting
Clinical narrative: Relfux/vomit, no longer eating solids, no longer breastfeeding, no longer babbling, eye contact avoidance, moments of being unalert, fever, fussiness, screaming, crying
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given Bexsero at 14 years old and was not at an increased risk or met special situations to receive early. Dad informed of side effects of vaccine, but did not state patient had any symptoms when talking to physician over phone.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received a 3rd dose of shingrix
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3rd dose of vaccine
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chromaturia, Glucose urine absent, Nitrite urine absent, Protein urine absent, Specific gravity urine normal
Clinical narrative: Patient began having very dark urine less than 24 hours after vaccination. No change with increase in fluids for three days.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Urinary occult blood negative, Urobilinogen urine decreased, White blood cells urine negative, pH urine normal
Clinical narrative: Patient began having very dark urine less than 24 hours after vaccination. No change with increase in fluids for three days.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Timeline reported by patient: 2 pm felt fatigue and dizzy 4 pm stomachache/ pain, nausea 8 pm stomachache pain stopped, face hot, trouble breathing 9 pm fast heartbeat, trouble breathing, attempted albuterol with no effect 10 pm ER: cannot confirm it was vaccine  Confirmed no injection site swelling, itchiness, only slightly soreness  Treatment at ER: Given Prednisone and Diphenhydramine  Discharged with: EPINEPHrine 0.3 mg/0.3 mL injection, Loratadine 10 mg tablet, PredniSONE 50 MG tablet
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Feeling hot, Heart rate increased, Nausea
Clinical narrative: Timeline reported by patient: 2 pm felt fatigue and dizzy 4 pm stomachache/ pain, nausea 8 pm stomachache pain stopped, face hot, trouble breathing 9 pm fast heartbeat, trouble breathing, attempted albuterol with no effect 10 pm ER: cannot confirm it was vaccine  Confirmed no injection site swelling, itchiness, only slightly soreness  Treatment at ER: Given Prednisone and Diphenhydramine  Discharged with: EPINEPHrine 0.3 mg/0.3 mL injection, Loratadine 10 mg tablet, PredniSONE 50 MG tablet
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient said she started to experience redness, swelling, and itchiness in the arm in which she received the vaccination, later in the day after receiving the vaccine. She reported to the pharmacy 5 days later to discuss. She said her symptoms were starting to improve. Pharmacist discussed mitigation measures for what appeared to be a local injection site reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Haematemesis, Head injury, Headache, Mass
Clinical narrative: Pt arriving to office at approx 9am. Pt received vaccines at approx 930am, <5 minutes later syncable episode resulting in pt falling backwards and hitting head.  C/o of headache, small bump to back of head, vomiting x1. + PERRLA, VSS, pale in color, pt reports feeling like "heart is racing" AP-84. Advised to go to ED, mom declining states will go home and monitor pt for 1 hr and then determine if feels ED is appropriate. Concussion protocol reviewed w/ mom and states understanding. Pt leaving office, accompanied by parent, at approx 1040am.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor, Palpitations, Syncope
Clinical narrative: Pt arriving to office at approx 9am. Pt received vaccines at approx 930am, <5 minutes later syncable episode resulting in pt falling backwards and hitting head.  C/o of headache, small bump to back of head, vomiting x1. + PERRLA, VSS, pale in color, pt reports feeling like "heart is racing" AP-84. Advised to go to ED, mom declining states will go home and monitor pt for 1 hr and then determine if feels ED is appropriate. Concussion protocol reviewed w/ mom and states understanding. Pt leaving office, accompanied by parent, at approx 1040am.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Limb discomfort, Sleep disorder
Clinical narrative: Immediately upon injection I felt a lot of pain in and around injection site which was upper left shoulder (6/13/25). Upon returning home my left arm started to feel heavy and very sore from the shoulder down. I messaged the doctor to let her know via MyChart and she told me to go to the ED if symptoms worsened. I put ice on my shoulder and tried to rest it elevated. I also took ibuprofen. I had to physically lift my arm up to get it to move. The pain continued throughout the night and I was not able to sleep on my side due to the pain. The next day (06/14/25) the pain continued from the shoulder down my arm. I tried ice, ibuprofen, and rest again. It didn't really get worse, just didn't get any better. Same thing about not being able to sleep on my side that evening. On 06/15/25-06/17/25, I thought it felt slightly better, but I still needed to lift my arm up at times. On the evening of 06/17/25 I tried sleeping on my left side again but when I awoke the pain began again and lasted through the day on 6/18/25. I messaged the doctor again about the pain, but didn't get a response. After a restless sleep on 6/18/25 I awoke on 6/19/25 (the day I am writing this report) and made an appointment with the doctor because I was in a lot of pain throughout my left shoulder and arm. I also messaged her again explaining why I scheduled the appointment, but asked if there was any other ideas of what to do. She messaged me back and offered to send a referral to Orthopedic Surgery, which I accepted.
Age: 1.75
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a 21 month old who received a QUADRACEL vaccination. QUADRACEL is NOT licensed for below 4 years old. The child did not have any potential side effects or display any untoward symptoms.  Spoke with Sanofi vaccine rep and she stated, "per CDC the Quadracel vaccine inadvertently administered to a child under 4 years of age, the dose may be counted as valid for the DTAP and/or IPV series and does NOT need to be repeated".
Age: 1.67
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash appearing on arms, chest, abdomen, thighs, and legs, with some spots on his back.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Swelling face
Clinical narrative: facial swelling and hand itching 18 hours post dose administration
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Mechanical urticaria, Rash erythematous
Clinical narrative: rash 24 hours after vaccination, red rash that coalesce in pressure zones and it is evanescent. persistent , dermographism positive.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure lasting about 1-2 minutes
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC15, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient received vaccines on 5/30/25 around 10:30am. Per parents, who are both physicians, patient developed a fever on 5/31/25, temperature unknown. Parents gave Tylenol and Motrin as needed. That same night while patient was sleeping, the patient experienced what parents describe as a febrile seizure, which lasted under 2 minutes long. Patient is currently stable, at baseline, with no deficits.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine
Clinical narrative: Approximately 6 weeks after receiving the second Pfizer COVID19 injection, my migraine began to be daily. I have suffered migraines since my teen years but since the vaccine, this new pattern emerged. The pain comes on mid-morning to mid-afternoon every day almost without fail. I have not experienced a completely migraine-free day since the vaccine.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Blood glucose normal, Dizziness, Electrocardiogram normal
Clinical narrative: Upon patient checking out pt began to feel dizzy and became weak, vitals wnl, EKG and Accucheck performed, also wnl, patient sent to the emergency room by EMS
Age: 13.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event reported.  YF-Vax given by IM route instead of subcutaneous.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Haemorrhage, Lip injury, Suture insertion, Syncope
Clinical narrative: After receiving her three vaccines patient had a syncopal event. Patient was seated and soon after the last vaccine she fell forward and to the floor. According to the father patient hit her face and suffered a cut to her lower lip(on the right side). Medical assistant was in the room with parents and soon after likely under 30 seconds, I (MD) was in the room.  Patient was in on the floor and soon after recovered after her syncopal event. Likely lasted under 20 sec. She had small amount of bleeding at the site of injury. Patient was observed and did well in office but was upset. Due to her laceration she was sent to the Peds ER for stitches. Pt did well per ER notes and received 4 stitches.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO adverse effects, child given wrong vaccine
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The normal procedure is to mix the HIB powder with the DTaP-IPV liquid prior to administration of the vaccine. Instead, the HIB powder was mixed with a sterile diluent meant for other vaccines. No Adverse Reactions Occured.
Age: 16.0
Sex: M
Vaccine: MNP
Symptoms: Chest discomfort, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: FEVER, FATIGUE , CHEST DISCOMFORT , arm pain started at the evening of the vaccination. Today 06/19/25 mother states that the child is doing better . afebrile since last evening
Age: 17.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Menquadfi ACWY administered to patient in error. This 2 dose series was already completed. Patient was due for a different type of Menigitis vaccine.  RN obtained and administered wrong vaccine resulting in patient receiving 3rd Menquadfi ACWY vaccine. Mother, who was present in health department with patient and patient were notified immediately after administration error was noted.  No adverse reactons noted.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: pt experienced vaccine associated rash as a side effect of the  vaccine. the pt explained she was experiencing itchiness of the site, it felt hot to touch, and it was getting larger in terms of being inflamed. when examining the site of the reaction, we saw it was swollen and had some signs of blistering.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: pt experienced vaccine associated rash as a side effect of the  vaccine. the pt explained she was experiencing itchiness of the site, it felt hot to touch, and it was getting larger in terms of being inflamed. when examining the site of the reaction, we saw it was swollen and had some signs of blistering.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash, Rash erythematous, Rash vesicular
Clinical narrative: MMR (# 2 - got one early due to international travel), Varicella vaccines given on 6/12. One day prior patient had rhinorrhea, for one day following the vaccine she had diarrhea. Starting  6/17 she developed fever 101-103 improved with iburprofen. At the same time vesicular rash developed on her right hand and since spread to all extremities, trunk, back, and gluteal region. Vesicular, erythematous, umbilicated, varicella- like. It's itchy. Office visit 6/19 and we prescribed zyrtec 2.5mg BID PRN, expectant and symptomatic management at this time. Plan for follow up Monday 6/23 if rash/fever persists.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Injection site warmth
Clinical narrative: The patient had a golf ball size knot at the place of injection, with redness/rash at the site and was hot to the touch. Told the patient she might be experiencing an allergic reaction and she went to the doctor and get doxycycline and prednisone.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired vaccine. Vaccine expired on 06/11/2025, vaccine given on 06/18/2025. Patient didn't experience any adverse events.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Musculoskeletal stiffness, Vomiting
Clinical narrative: When patient in the car after the vaccines given in clinic, patient parent states that patient had a seizure. Her "legs and arms went stiff". Mom gave rescue seizure medication nasally in the car. Patient did have one episode of emesis in the parking lot.  Parent states that she would like to take child home, give her rescue medications and allow her to rest. Advised emergency room if more seizure activity progresses. Continuing to monitor currently with follow up calls.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Chest discomfort, Hypoaesthesia oral, Injection site erythema, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: tingling sensation starting   06/18/2025 in left side of face that moved to mouth/lips then moved to tongue leading to no sensation in mouth about 30 minutes after vaccine administration that continued throughout the night.  on 06/19/2025 redness at the injection site was noted, tingling in tongue, intense pain in left arm. chest tightness that disrupts activities above normal activities of daily living. Patient was given 20ml oral Benadryl in clinic and sent home.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: tingling sensation starting   06/18/2025 in left side of face that moved to mouth/lips then moved to tongue leading to no sensation in mouth about 30 minutes after vaccine administration that continued throughout the night.  on 06/19/2025 redness at the injection site was noted, tingling in tongue, intense pain in left arm. chest tightness that disrupts activities above normal activities of daily living. Patient was given 20ml oral Benadryl in clinic and sent home.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Skin ulcer, Skin warm, Swelling
Clinical narrative: Warmth, redness, swelling, fatigue, skin ulceration, reported via my chart on 6/13/25. Patient was advised to use warm compress, Tylenol, and ibuprofen. If worsens or does not improve needs to be seen. Patient was seen in clinic for further evaluation7 days after receiving vaccine. Physican recommended OTC Hydrocortisone cream and saw improvements to the skin ulceration.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: Patient stated that his doctor told him to get the MMR vaccine. Patient came to the clinic to receive MMR. I gave him the vaccine, but did not realize that the patient was prescribed and taking skyrizi. He came back to the clinic today (6/19/2025) to receive his second dose of the MMR vaccine. He was sent away since he is still taking the skyrizi. He did state that he did not experience any side effect or adverse reactions after receiving the first dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Slight redness, swelling and warmth.   ADvised Ibuprofen and benydryl
Age: 90.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: patient came in and showed pharmacist her arm which was very red to her elbow, hot to touch and itchy. She said it swelled up on Monday after she got and the red was even larger earlier in the week. She had taken benadryl for it . Pharmacist suggested seeing a doctor.
Age: 74.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Cardiac disorder, Death, Thrombosis
Clinical narrative: It was the second shot booster that we started seeing the heart and blood clot problems
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Patient reported to pharmacy on 7th day post vaccine with large red welt on her arm at the injection site and another welt about 3 inches below injection site. Both welts were swollen and warm to the touch. Patient said no itching or pain reported. She said her arm was sore for the first 4 days following injection. Patient was instructed to take antihistamine (Benadryl) and apply cold compress as needed.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient given Bexsero for 2nd dose of Meng B rather then the Trumenba vaccine. Patient will need a 3rd dose of the Bexsero or Trumenba in order to be complete on Meng B series.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Visible than Palpable Red Rash Quarter Size