chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: inappropriate use due to nurse administered TYPHIM VI to a patient 9 months early with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient with inappropriate use due to nurse administered Typhoid Vi Polysaccharide Vaccine [Typhim Vi]9 months early 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 in March 2024, the patient received a Dose 1 of suspect Typhoid Vi Polysaccharide Vaccine Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On 21-Jul-2025 he/she again received Dose 2 of  same vaccine with an unknown batch number via unknown route in unknown administration site, inappropriate use due to nurse administered typhim vi to a patient 9 months early with no reported adverse event (inappropriate schedule of product administration) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Reportedly, the patient had already gotten the vaccine in Mar-2024 and the nurse administered it yesterday instead of waiting until Mar-2026  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reports that pain was initially dull and deep in the muscle,  it has been getting worse starting first at the injection site and has spread down to the level of the elbow. It is continuous and patient has been unable to pinpoint what exacerbates it. Patient report multiple times per day using bio-freeze which helps for a less than an hour.  As of yesterday patient has picked up gabapentin specifically for this pain.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Chills, Disorientation, Erythema, Fatigue
Clinical narrative: Pt started to have adverse events 3 hours after vaccination including extreme fatigue, fever, and chills. He says he never did take his temperature, but was "extremely hot" and his face was red. He reports becoming extremely disoriented and could not walk or move from bed. He reports that he has no memory from Saturday night to Sunday afternoon. He also reports he could not eat or take any medications from Saturday night to Monday morning.  By day 3 he was feeling "back to normal."
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Gait inability, Mobility decreased, Pyrexia
Clinical narrative: Pt started to have adverse events 3 hours after vaccination including extreme fatigue, fever, and chills. He says he never did take his temperature, but was "extremely hot" and his face was red. He reports becoming extremely disoriented and could not walk or move from bed. He reports that he has no memory from Saturday night to Sunday afternoon. He also reports he could not eat or take any medications from Saturday night to Monday morning.  By day 3 he was feeling "back to normal."
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Injection site pain, Injection site pruritus
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity
Clinical narrative: the patient has been experiencing soreness and pain in her arm after the administration; the patient has been experiencing soreness and pain in her arm after the administration; This spontaneous report was received from a nurse referring to a 12-year-old female patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported. The patient had no known allergies (NKA).  On 30-Jun-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y013565, expiration date: 01-Feb-2027), dose number 1, administered by Intramuscular route (IM) as prophylaxis (dose was not reported).  On 30-Jun-2025 (after the administration), the patient experienced soreness and pain in her arm (pain in extremity, myalgia). The patient had sought medical attention, and she initially started on Naproxen (ALEVE) and then on a methylprednisolone (MEDROL) pack as treatment. At the tine of this report, the patient was still experiencing pain and soreness associated with the vaccination administration. At the reporting time, the patient had not recovered from the events.  The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site mass, Pain, Pain in extremity
Clinical narrative: Made her sick for about 4 or 5 days; It made her feel achy; She had quite a sore arm; She still has a small lump in the area where she received her 20 FEB 2025 vaccine; This case, received on 13-Sep-2024 was assessed as invalid for the following reason: no adverse event.  Additional significant information was received on 20-Jun-2025, from a consumer via contact center (Case No. NOV25-00467). This case has been reassessed as valid based on the follow-up information received. Adverse events were added.  Updated the patient's DOB, patient's race. Added the following in the patient medical history: FIBROMYALGIA, EHLERS DANLOS SYNDROME (HYPERMOBILITY SUBTYPE), CHRONIC NEUTROPHILLIC LEUKOCYTOSIS, and CHRONIC FATIGUE SYNDROME. Updated therapy site to Arm and Vaccine Anatomical Approach Site to Right Arm for both therapies. Updated vaccination facility details of the vaccine received on 13-Sep-2024. Added the new Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) vaccine received on 25-Feb-2025.  Added 2 new events experienced from the mRNA COVID-19 vaccines in the patient past therapy: "She could not tolerate the mRNA COVID-19 vaccines as well" (Adverse event), "Made her feel achy - kind of like when she got an mRNA COVID-19 vaccine" (Pain). Added events experienced with  Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula): on unspecified dates, the patient reported experiencing "Made her sick for about 4 or 5 days" (Illness), "It made her feel achy" (Pain), "She had quite a sore arm" (Pain in extremity), "She still has a small lump in the area where she received her 20 FEB 2025 vaccine" (Injection site mass) on unspecified dates. At the time of reporting, the outcome of the events was unknown.; Sender's Comments: This Female of an unspecified age experienced Illness, Pain, Pain in extremity and Injection site mass after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Illness was reported as non-serious.  The event Pain was reported as non-serious.  The event Pain in extremity was reported as non-serious.  The event Injection site mass was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Illness, Pain, Pain in extremity and Injection site mass is considered Possible.
Vaccine: COVID19, UNK
Symptoms: Intranasal paraesthesia, Mucosal disorder
Clinical narrative: I've noticed a mucosal response having had every combo; Nose tingles during any exposure; My nose tingles during any exposure; This non serious initial spontaneous report was reported by a Consumer via social media monitoring and concerns an individual of unspecified age and sex who experienced I'VE NOTICED A MUCOSAL RESPONSE HAVING HAD EVERY COMBO on an unknown day after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on an unknown date.  At the time of the report, the outcome of the Mucosal disorder was Unknown.  PFIZER BIONTECH COVID-19 VACCINE was also considered suspect.  On 08-May-2025, significant information was received from the consumer via Resolver compliance (Resolver number 00345634). On an unspecified date after vaccination, the consumer experienced "nose tingles during any exposure" (PT: Intranasal paraesthesia). The reporter further informed that it started after the second Novavax shot; a second therapy dose was captured with unknown dates.  At the time of the report, on 08-May-2025, the outcome of Intranasal paraesthesia was unknown.; Sender's Comments: This individual of an unspecified age and sex experienced Mucosal disorder and Intranasal paraesthesia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Mucosal disorder and Intranasal paraesthesia were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Mucosal disorder and Intranasal paraesthesia is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Hyposmia, Influenza virus test, Parosmia, SARS-CoV-2 test, Viral test
Clinical narrative: I can't smell flowers strongly, like my food, I can taste it but I can't really smell it; I started to developed smell, like cigarette smell and I don't smoke/ Lingering smell of smoke, cigarette smoke; I started to developed smell, like cigarette smell and I don't smoke; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via Novavax Medical Information (AE Number: NOV25-00106) and concerns a 60 year-old female who experienced "I STARTED TO DEVELOPED SMELL, LIKE CIGARETTE SMELL AND I DON'T SMOKE" and "I CAN'T SMELL FLOWERS STRONGLY, LIKE MY FOOD, I CAN TASTE IT BUT I CAN'T REALLY SMELL IT" on an unknown date, after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) at unknown latency.  At the time of the report, the outcome of the Parosmia, Hyposmia was Not Recovered/Not Resolved/Ongoing.  On 25-Mar-2025, non-significant information was received from a consumer via a query response - No new information was received. Gitelman's was spelled correctly in the previous version.  On 19-Apr-2025, non-significant information was received from a consumer via a query response - Consent for follow-up was withdrawn. No new information was received.  On 07-May-2025 and 14-May-2025, significant information was received from a consumer via query response and via the Novavax Medical Information (MI No. NOV25-00314) - Lot/Batch number of Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) was reported as 6024MF01A with expiry date of 30-Nov-2024. Updated the event reported term to "I started to developed smell, like cigarette smell and I don't smoke/ Lingering smell of smoke, cigarette smoke". The consumer confirmed that vaccine was administered intramuscularly on her left deltoid.  The event of Parosmia started about two weeks after Novavax vaccine.; Sender's Comments: This 60-year-old female experienced Parosmia and Hyposmia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Parosmia and Hyposmia were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Parosmia and Hyposmia is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Incomplete course of vaccination, Somnolence
Clinical narrative: Just some sleepiness; Had very little side effects in the aftermath of my first dose; She had her first dose, but needs to find a place to get her second dose...Hasn't had any previous COVID-19 vaccines before her Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00196) and concerns a 23-year-old Female who experienced "JUST SOME SLEEPINESS" on an unknown date and "SHE HAD HER FIRST DOSE, BUT NEEDS TO FIND A PLACE TO GET HER SECOND DOSE...HASN'T HAD ANY PREVIOUS COVID-19 VACCINES BEFORE HER NOVAVAX VACCINE" on 28-Oct-2023 after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 28-Oct-2023.  At the time of the report, the outcome of the Somnolence was Unknown and Incomplete course of vaccination was Recovered/Resolved.  On 25-May-2025, significant information was received from a consumer via query response - on an unknown date the patient "had very little side effects in the aftermath of my first dose" after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 28-Oct-2023.  At the time of the report, the outcome of the Adverse event was Unknown.; Sender's Comments: This 23-year-old Female experienced Somnolence, Incomplete course of vaccination, and Adverse event after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The events Somnolence, Incomplete course of vaccination, and Adverse event were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Incomplete course of vaccination, Somnolence, and Adverse event is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Injection site pain
Clinical narrative: After both Novavax vaccines, she had a sore arm at the injection site; For 24h felt less than optimal; Felt less energetic; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00232 and NOV25-00224) and concerns a 67-year-old Female who experienced "AFTER BOTH NOVAVAX VACCINES, SHE HAD A SORE ARM AT THE INJECTION SITE", "FOR 24H FELT LESS THAN OPTIMAL" and "FELT LESS ENERGETIC" on an unspecified dates in 2024 and 2025, after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) first time on unspecified date in October/early November 2024 and second time on 11-Feb-2025.  At the time of the report, the outcome of the Injection site pain, Feeling abnormal, Asthenia was Recovered/Resolved.  A discrepancy was identified in the source document. The events reported were for both doses of the Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) received by the consumer, however, the events are only captured once in this case with the earliest onset date.  On 29-Apr-2025, non-significant information was received from a consumer - No new information received.  On 27-May-2025, significant information was received from a consumer via contact center (MI No. NOV25-00377) - added "She would experience a fever for a week and a half" event experienced with the mRNA vaccines in the patient past therapy.; Sender's Comments: This 67-year-old Female experienced Injection site pain, Feeling abnormal and Asthenia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Injection site pain, Feeling abnormal and Asthenia were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Injection site pain, Feeling abnormal and Asthenia is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Off label use
Clinical narrative: Daughter received the 2024-2025 Novavax vaccine but just one dose; Daughter received the 2024-2025 Novavax vaccine but just one dose; This non-serious initial spontaneous report was reported by a consumer or other non health professional and concerns a female of unspecified age who experienced DAUGHTER RECEIVED THE 2024-2025 NOVAVAX VACCINE BUT JUST ONE DOSE (PT: Incomplete course of vaccination) and DAUGHTER RECEIVED THE 2024-2025 NOVAVAX VACCINE BUT JUST ONE DOSE (PT: Off label use) after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  At the time of the report, the outcome of the Incomplete course of vaccination, Off label use was Recovered/Resolved.; Sender's Comments: This Female of unspecified age experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Incomplete course of vaccination and Off label use were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Off label use
Clinical narrative: I got the one in the last batch in April, but it was only my one shot; I got the one in the last batch in April, but it was only my one shot; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00415) and concerns a female patient of unspecified age who experienced "I got the one in the last batch in April, but it was only my one shot" and "I got the one in the last batch in April, but it was only my one shot" on an unspecified date in Apr-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on the same day.  At the time of the report, the outcome of the Incomplete course of vaccination and Off label use was Recovered/Resolved.; Sender's Comments: This female patient of unspecified age experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Incomplete course of vaccination was reported as non-serious.  The event Off label use was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Off label use
Clinical narrative: I got my last year only got the one dose, didn't get the second; I got my last year only got the one dose, didn't get the second; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00427) and concerns an individual of unspecified age and sex who reported experiencing "I GOT MY LAST YEAR ONLY GOT THE ONE DOSE, DIDN'T GET THE SECOND" (Incomplete course of vaccination) and "I GOT MY LAST YEAR ONLY GOT THE ONE DOSE, DIDN'T GET THE SECOND" (off label use) on an unspecified date in 2024 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) in 2024.  At the time of the report, the outcome of the Incomplete course of vaccination, Off label use was Recovered/Resolved.  A discrepancy was identified in the source document: For the event of Incomplete course of vaccination and Off label use, event onset year was captured as the year of vaccine administration and event cessation was captured to match the event start date with an outcome of recovered/resolved as it is a special situation event.; Sender's Comments: This Female of an unspecified age experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Incomplete course of vaccination and Off label use were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible.
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise, Oral herpes zoster, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; vertigo so bad I passed out; Oral shingles; Vertigo; I get sick or stressed I break out again; I get sick or stressed I break out again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: vertigo so bad I passed out) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: Oral shingles), vertigo (Verbatim: Vertigo), sickness (Verbatim: I get sick or stressed I break out again) and stress (Verbatim: I get sick or stressed I break out again). The outcome of the vaccination failure, passed out, oral herpes zoster, sickness and stress were not reported and the outcome of the vertigo was not resolved.   It was unknown if the reporter considered the vaccination failure, passed out, oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine.     The company considered the vaccination failure and passed out to be unrelated to Shingles vaccine. It was unknown if the company considered the oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the shingle shot, it gave patient oral shingles and vertigo so bad that he/she passed out. 2 years later, the patient still had vertigo issues and when they get sick or stressed it break out again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding oral shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Loss of consciousness is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Suspected vaccination failure; vertigo so bad I passed out; Oral shingles; Vertigo; I get sick or stressed I break out again; I get sick or stressed I break out again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: vertigo so bad I passed out) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: Oral shingles), vertigo (Verbatim: Vertigo), sickness (Verbatim: I get sick or stressed I break out again) and stress (Verbatim: I get sick or stressed I break out again). The outcome of the vaccination failure, passed out, oral herpes zoster, sickness and stress were not reported and the outcome of the vertigo was not resolved.   It was unknown if the reporter considered the vaccination failure, passed out, oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine.     The company considered the vaccination failure and passed out to be unrelated to Shingles vaccine. It was unknown if the company considered the oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the shingle shot, it gave patient oral shingles and vertigo so bad that he/she passed out. 2 years later, the patient still had vertigo issues and when they get sick or stressed it break out again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding oral shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Loss of consciousness is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Borrelia test negative, Impaired work ability, Laboratory test, Malaise, Pain
Clinical narrative: A few months after being vaccinated I became ill and thought it was Lyme disease. After several tests, came back not Lyme or any tick borne illnesses.  Was finally referred to Rheumatology and 3 yrs later was diagnosed with an auto immune disease. lupus. I cannot work any longer, and I am in pain and don?t feel good most days. My life has been ruined by this.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: A few months after being vaccinated I became ill and thought it was Lyme disease. After several tests, came back not Lyme or any tick borne illnesses.  Was finally referred to Rheumatology and 3 yrs later was diagnosed with an auto immune disease. lupus. I cannot work any longer, and I am in pain and don?t feel good most days. My life has been ruined by this.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Depressed level of consciousness, Dyspnoea, Intensive care
Clinical narrative: My friend had covid 19 before her 1st vaccine April 7 2021. She was refused to get but due to her work policy she must to have. Ten days later after the first vaccine, she started having weakness and lethargy symptoms. She went to see doctors with no diagnosis.  When the second vaccine coming , she was very afraid and do not want get the second one. But all the policy ,she had to get it .  Two days later ( 8/15/2022 ) after the second vaccine 08/13/2022, She went to ICU due to difficult breath and coma symptoms. At that time she been diagnosed ALS.  She has motor neuron damaged, her whole body can not move. She had her trachea cut off and on a ventilator to keep her alive.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Mechanical ventilation, Mobility decreased, Motor neurone disease, Tracheostomy
Clinical narrative: My friend had covid 19 before her 1st vaccine April 7 2021. She was refused to get but due to her work policy she must to have. Ten days later after the first vaccine, she started having weakness and lethargy symptoms. She went to see doctors with no diagnosis.  When the second vaccine coming , she was very afraid and do not want get the second one. But all the policy ,she had to get it .  Two days later ( 8/15/2022 ) after the second vaccine 08/13/2022, She went to ICU due to difficult breath and coma symptoms. At that time she been diagnosed ALS.  She has motor neuron damaged, her whole body can not move. She had her trachea cut off and on a ventilator to keep her alive.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient passed away 12/25/2024 with immediate cause listed as Alzheimer's disease. No other information known.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative, Irritability
Clinical narrative: HIVES DEVELOPED  LATE EVENING SAME DAY AS VACCINES GIVEN  AND WERE WORSE BY NEXT MORNING BUT THEN WENT AWAY  NEXT DAY. TEMP AT HOME 104.7 F RECTAL  ON 5-26-25 IN AM  AND PROJECTILE VOMITING, FUSSY AND TACHYCARDIA (PULSE 176), MOTHER GAVE IBUPROFEN,.  WENT TO ER. ZOFRAN PRESCRIBED DX  WAS LIKEY GASTROENTERITIS. HX OF PREMATURE BIRTH 34 WEEKS GESTATION.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Respiratory syncytial virus test negative, Tachycardia, Urticaria, Vomiting projectile
Clinical narrative: HIVES DEVELOPED  LATE EVENING SAME DAY AS VACCINES GIVEN  AND WERE WORSE BY NEXT MORNING BUT THEN WENT AWAY  NEXT DAY. TEMP AT HOME 104.7 F RECTAL  ON 5-26-25 IN AM  AND PROJECTILE VOMITING, FUSSY AND TACHYCARDIA (PULSE 176), MOTHER GAVE IBUPROFEN,.  WENT TO ER. ZOFRAN PRESCRIBED DX  WAS LIKEY GASTROENTERITIS. HX OF PREMATURE BIRTH 34 WEEKS GESTATION.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Cyanosis, Gaze palsy, Generalised tonic-clonic seizure, Hypotonia, Musculoskeletal stiffness
Clinical narrative: Patient received MMR, VRZ, Peumo20, and Hep A vaccines for 12 Months WCC visit with Pediatrician on 07/17/2025 around 08:30am. Patient had no fevers or other symptoms during visit and was discharged. Per mother, around 07:50pm same day, patient started going limp followed by eyes rolling with lip smacking, cyanosis, being unresponsive, and his body stiffened.  Patient had his first-time tonic-clonic seizure lasting around 5 minutes. EMS called and transported to ED. During ED visit, patient had 39.4 Celsius fever, Tylenol given, kept under observation, and discharge home with acetaminophen and ibuprofen. ED F/U w/ Dr. the following day.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Tardive dyskinesia, Unresponsive to stimuli
Clinical narrative: Patient received MMR, VRZ, Peumo20, and Hep A vaccines for 12 Months WCC visit with Pediatrician on 07/17/2025 around 08:30am. Patient had no fevers or other symptoms during visit and was discharged. Per mother, around 07:50pm same day, patient started going limp followed by eyes rolling with lip smacking, cyanosis, being unresponsive, and his body stiffened.  Patient had his first-time tonic-clonic seizure lasting around 5 minutes. EMS called and transported to ED. During ED visit, patient had 39.4 Celsius fever, Tylenol given, kept under observation, and discharge home with acetaminophen and ibuprofen. ED F/U w/ Dr. the following day.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt was administered the Covid vaccine 3 days past the Beyond Use date.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: There were no adverse reactions. The vaccine was diluted twice. Patient was under dosed.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Other Vaccines:  Vaccine Type Brand: priorix; Manufacturer: gsk; LotNumber: 2N795; Route: Sq; BodySite: right arm; Dose: 1; VaxDate: 07/15/2025
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: Systemic: Stroke-Severe
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Systemic: Bell's Palsy-Medium
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Muscle Weakness of left arm-Severe, Systemic: Weakness-Severe, Additional Details: Patient states they have not been able to lift or use arm normally since vaccine, patient states arm is very painful, states they are having extreme muscle pain in arm.
Age: 1.5
Sex: M
Vaccine: PNC20
Symptoms: Blood test, Dehydration, Irritability, Lethargy, Lumbar puncture
Clinical narrative: Mom thinks fussiness and lethargy was due to the vaccine. Pt was also found to be dehydrated at the ER, so likely that is the cause, however mom wanted this incident reported.
Age: 1.5
Sex: M
Vaccine: PNC20
Symptoms: Urine analysis
Clinical narrative: Mom thinks fussiness and lethargy was due to the vaccine. Pt was also found to be dehydrated at the ER, so likely that is the cause, however mom wanted this incident reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Diarrhoea, Expired product administered, Joint swelling
Clinical narrative: Course of events as follows: 2nd Dose:2-25-25 1. A middle aged female Pharmacist with white hair picked up a vial with a small amount of fluid left in it from the counter. It had been sitting on the counter prior to my arrival. *I questioned her as to why it was on the counter instead of in the refrigerator and she advised it was fine and had another dose left in it.  She drew the dose into the needle advised her shift was ending soon and handed it to a tech in  ^trainng" to administer into my arm. 2. Mind you it was 4:30PM in the afernoon and left out on the counter for God only knows how long! 3. I asked her if I should anticipate any side effects from the Vax and she said," No that it was highly unlikely."
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Skin odour abnormal, Vomiting
Clinical narrative: Course of events as follows: 2nd Dose:2-25-25 1. A middle aged female Pharmacist with white hair picked up a vial with a small amount of fluid left in it from the counter. It had been sitting on the counter prior to my arrival. *I questioned her as to why it was on the counter instead of in the refrigerator and she advised it was fine and had another dose left in it.  She drew the dose into the needle advised her shift was ending soon and handed it to a tech in  ^trainng" to administer into my arm. 2. Mind you it was 4:30PM in the afernoon and left out on the counter for God only knows how long! 3. I asked her if I should anticipate any side effects from the Vax and she said," No that it was highly unlikely."
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Chronic sinusitis, Paranasal sinus discomfort, SARS-CoV-2 test positive
Clinical narrative: Chronic sinusitus, chronic sinus pressure, Tinnius, slight brain fog
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Chronic sinusitus, chronic sinus pressure, Tinnius, slight brain fog
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site discomfort, Rash
Clinical narrative: she also noticed redness and a rash; she also noticed redness and a rash; felt "some injection site discomfort" shortly after administration which "seemed typical"; This spontaneous report was received from a consumer and refers to herself, a 58-year-old female patient.   The patient's medical history and concurrent conditions were not reported. Concomitant medications included estrogens conjugated (PREMARIN), progesterone), pregabalin (LYRICA), rosuvastatin .  On 08-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 0.5 mL administered by unknown route (vaccination site, lot # and expiration date were not reported) for pneumococcal conjugate vaccine.  On 08-Jul-2025, the patient felt some injection site discomfort shortly after administration which seemed typical. On 15-jul-2025 (today), she also noticed redness and a rash. The patient reported to a health care professional (HCP) who recommended she took a picture, apply ice, and topical diphenhydramine (BENADRYL). HCP treating the adverse event (AE) provided permission to contact. The patient did have name of administering HCP at the time of the call. No additional AE and no product quality complaint (PQC) was noted. At the reporting time, the patient had not recovered from the reported adverse events.  The causal relationship between the adverse events and the suspect vaccine was not reported.  Lot # is being requested and will be submitted if received.
Vaccine: PNC21
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 2 month old was administered CAPVAXIVE; no adverse event; This spontaneous report was received from a medical assistant referring to a 2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection (lot #Z003579, expiration date: 07-Sep-2026) (168 mcg/ml) administered as prophylaxis (dose, and route of administration were not reported) (Product administered to patient of inappropriate age). No adverse effects were reported (no adverse event).
Sex: F
Vaccine: COVID19, RVX
Symptoms: Allergy to vaccine, Contusion, Rash erythematous
Clinical narrative: Small rash on leg above ankle/rash erythematous/rash is red; Allergy to vaccine; Contusion; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of red rash in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and Dupilumab for nasal polyp.   Concurrent medical conditions included nasal polyp.   On an unknown date, the patient received RSV vaccine and COVID-19 VACCINE. In JUN-2024, the patient received Dupilumab (subcutaneous). On an unknown date, less than 9 months after receiving RSV vaccine and COVID-19 VACCINE and between 3 and 4 months after receiving Dupilumab, the patient experienced red rash (Verbatim: Small rash on leg above ankle/rash erythematous/rash is red), allergy to vaccine (Verbatim: Allergy to vaccine) and contusion (Verbatim: Contusion). The outcome of the red rash, allergy to vaccine and contusion were unknown.   The reporter considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the reporter considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the reporter considered the red rash and contusion to be related to Dupilumab.     The company considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the company considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the company considered the red rash and contusion to be related to Dupilumab.   Additional Information: GSK receipt date: 27-JUN-2025 In 2024 the patient developed a non-serious events 'a reaction that started 5-6 months ago, could be due to RSV vaccine broke out in rash broken blood vessels now appear darker and spreading, small red patch on her leg spread larger to her ankle and knee' (contusion) (rash erythematous) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab,Covid-19 vaccine and RSV vaccine. In 2024 the patient developed a non-serious event 'small rash on leg above ankle' (rash) and 'a new allergy to covid vaccine' (allergy to vaccine) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Covid-19 vaccine. The patient stated that the rash was red but no itching. The patient saw her doctor when the patch was small but has not followed up since.  Corrective treatment was not reported for all events. No additional information was provided.
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient got Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of wrong vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero and did not receive Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient got Bexsero instead of Menquadfi). The outcome of the wrong vaccine administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-JUL-2025 The pharmacist reported that the patient was supposed to get an injection of Menquadfi but got Bexsero instead, which led to, wrong vaccine administered. The reporter mentioned that the patient still wanted to get Menquadfi. The reporter wants to find out if there were any drawbacks to patient getting Menquadfi at these points.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Vaccination failure
Clinical narrative: Vaccination failure; Shingles; Shot stung at 1st; Shot stung at 2nd; This serious case was reported by a consumer via call center representative 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.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), injection site pain (Verbatim: Shot stung at 1st) and injection site pain (Verbatim: Shot stung at 2nd). The outcome of the vaccination failure, shingles, injection site pain and injection site pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and injection site pain to be related to Shingrix. It was unknown if the company considered the shingles and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUL-2025 The patient received both doses of Shingrix vaccine a few years ago. The patient had 6 cases of Shingles since vaccination. Not effective for patient. Shot stung at 1st, but tolerate both well. Hope works better for others. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine (received a COVID-19 vaccine on an unknown date).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be possibly related to Shingrix.   Additional Information: GSK receipt date: 18-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his/her aunty had the COVID vaccine, then six months later received the shingles vaccine. After that, she developed shingles the sickest she had ever been. She went back to the physician and said, did not said the vaccine could give him/her shingles and the physician said, oh yeah, that can occur. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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 vaccine Shingrix
Sex: F
Vaccine: RVX
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient older than 15 weeks of age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Rotavirus vaccine (batch number 3Z34X, expiry date 09-NOV-2026) for prophylaxis.   On 15-JUL-2025, the patient received the 1st dose of Rotavirus vaccine. On 15-JUL-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: patient older than 15 weeks of age). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUL-2025 A health care provider reported that a patient older than 15 weeks of age received Rotarix vaccine which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: underdose; Adult dose to pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number A5DP7, expiry date 11-AUG-2027) for prophylaxis.   On 15-JUL-2025, the patient received Engerix B adult 1 ml. On 15-JUL-2025, an unknown time after receiving Engerix B adult, the patient experienced underdose (Verbatim: underdose) and adult product administered to child (Verbatim: Adult dose to pediatric patient). The outcome of the underdose and adult product administered to child were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUL-2025 The registered nurse gave an adult dose of Engerix-B (1 milliliter) to a 19 year old patient on 15th July 2025 which led to adult product administered to child and underdose.