chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; immune system was compromised; I got shingles; had covid; nothing helps the nerve pain; had 3 shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), immunocompromised (Verbatim: immune system was compromised) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles), covid-19 (Verbatim: had covid), post herpetic neuralgia (Verbatim: nothing helps the nerve pain) and extra dose administered (Verbatim: had 3 shingles vaccine). The outcome of the vaccination failure, immunocompromised, covid-19 and post herpetic neuralgia were not reported and the outcome of the shingles was resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure, immunocompromised, shingles, covid-19 and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and immunocompromised to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, covid-19 and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by a patient via interactive digital media. The patient had 3 shingles vaccines.  The patient reported to had Covid and then got shingles.  The doctor stated that his/her immune system was compromised.  The pain was extremely painful and nothing helped the nerve pain.  The patient stated hopefully he/she would not get them again.  The patient had them in the same place as the woman above. The patient received 3 doses of Shingles vaccine, which led to extra dose administered. 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 the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Immunodeficiency  is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: make me hurt/achy; Tired; just got my 2nd shot. already had the first single shingle shot a few years ago; 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.   Previously administered products included Shingles vaccine (received 1st shot a few years ago).   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 pain (Verbatim: make me hurt/achy), tiredness (Verbatim: Tired) and drug dose administration interval too long (Verbatim: just got my 2nd shot. already had the first single shingle shot a few years ago). The outcome of the pain and tiredness were not reported and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the pain and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the pain and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2025 This case was reported by a patient via interactive digital media. The patient just got his/her 2nd shot and did it make me hurt, tired and achy. The patient hoped it kept him/her from getting shingles though and already had the first Shingle shot a few years ago. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: on her head and forehead; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female 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 shingles (Verbatim: on her head and forehead). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The reporter said that they did not always work and he/she thought may sometimes trigger the disease, 2 out of 3 friends that took the vaccine got shingles shortly after.  One a light case the other more severe on her head and forehead.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: did not feel well; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a 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 feeling unwell (Verbatim: did not feel well). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by a consumer via interactive digital media. A lady in line had said that make sure you get it on a day when you have nothing planned for the next couple of days. She had not felt well but had not asked for specifics.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; i have a mild case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i have a mild case of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date : 30-APR-2025 This case was reported by a patient via interactive digital media. He/she have had the 2 shingle shots, appox 4 years ago, now his/her doctor was told he/she had a mild case of shingles, he/she was 69 years old. 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 the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; 7 years after the shingrex vaccine, i for shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 7 years after the shingrex vaccine, i for shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via (Chatbot) interactive digital media. The reporter reported that 7 years after the Shingrix vaccine, the patient had shingles. The patient asked could he/she got a booster. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The patient had a short bout of shingles last year in 2024. The patient had the Shingles shot several years ago so, with medication from an ER (emergency) nurse (the patient did not know it was shingles he/she had) it cleared within a week and did not experience any pain.  She said a person could still get shingles even after having the shot, but it was not as severe. Further patient stated make sure you get the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had them 8 times since; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them 8 times since). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 The case was received from the patient via interactive digital media.  The patient got the shot, worst mistake ever and have had them 8 times since. The patient stated that do not put it in your body. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 71.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered/Twinrix expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 71-year-old female patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   On 29-APR-2025, the patient received Twinrix. On 29-APR-2025, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered/Twinrix expired dose). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-APR-2025 The reporter reported regarding Twinrix vaccine, and was wondering if had this specific date of point about administration after the posted expiration date on the box, like was it percentage less effective. The healthcare professional confirmed that a patient received a Twinrix expired dose which led to Expired vaccine administered.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; 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 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 422GF, expiry date 24-FEB-2025) for prophylaxis.   On 29-APR-2025, the patient received Rotarix lyophilized formulation. On 29-APR-2025, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-APR-2025 The reporter reported that they had gave a rotavirus vaccine on the day of reporting and did not realize that it actually expired on February 24th, which led to expired vaccine used.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: administration of the lyophilized component of Menveo with sterile water diluent; administration of the lyophilized component of Menveo with sterile water diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   Previously administered products included Menveo (received first dose of Menveo on an unknown date).   On 30-APR-2025, the patient received the 2nd dose of Menveo. On 30-APR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: administration of the lyophilized component of Menveo with sterile water diluent) and inappropriate dose of vaccine administered (Verbatim: administration of the lyophilized component of Menveo with sterile water diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 30-APR-2025 The pharmacist reported about the administration of the lyophilized component of Menveo with sterile water diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  They mentioned the dose was administered on the day of reporting and being the second dose. The Vaccine Administration Facility was the same as Primary Reporter
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: she may have only given the diluent; she may have only given the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 7HG2A, expiry date 01-JAN-2026) for prophylaxis.   On 21-MAR-2025, the patient received Priorix. On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: she may have only given the diluent) and inappropriate dose of vaccine administered (Verbatim: she may have only given the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 01-MAY-2025 The pharmacist reported that a nurse said she gave Priorix but thought she may have only given the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early dose since HCP was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 mo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 2g3S9, expiry date 30-SEP-2027) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 01-MAY-2025, the patient received the 2nd dose of Bexsero. On 01-MAY-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: early dose since HCP was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 mo). The outcome of the drug dose administration interval too short 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: 01-MAY-2025 The reporter reported that she had a patient that was given his first dose on 28th February 2025 and the second dose was actually administered on 01st May 2025, she was not informed of the change to dosing schedule for Bexsero and was following the old schedule. Note to PV-I am submitting as early dose since healthcare professional was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 months) which led to shortening of vaccination schedule.
Sex: F
Vaccine: RSV
Symptoms: Headache, Nasal congestion
Clinical narrative: severe headache; nasal congestion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of headache in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number E75E5, expiry date 05-NOV-2025) for prophylaxis.   On 30-APR-2025, the patient received Arexvy. On 01-MAY-2025, 1 days after receiving Arexvy, the patient experienced headache (Verbatim: severe headache) and nasal congestion (Verbatim: nasal congestion). The outcome of the headache and nasal congestion were not resolved.   It was unknown if the reporter considered the headache and nasal congestion to be related to Arexvy.     It was unknown if the company considered the headache and nasal congestion to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAY-2025 A pharmacy manager called to report that a patient who received Arexvy yesterday (day before reporting) was experiencing severe headache and nasal congestion one day after getting vaccine. Patient had to go to urgent care to check out this.  Reporter wanted to know do GlaxoSmithKline have any information of this adverse reactions in their database.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past; tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past; This spontaneous case was reported by a physician assistant and describes the occurrence of DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UT7695NA) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna. Past adverse reactions to the above products included No adverse effect with Moderna.   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past). At the time of the report, DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was not allergic to any previous vaccination, medications, food or other products and had no other diagnosed illness/medical history/chronic health conditions.  The patient did not receive any other vaccine on the same date as suspect vaccine. Patient was not taking any other medications within 2 weeks prior to the event onset nor received any other vaccines within 4 weeks prior to the first dose administration of the suspect vaccine. Event did not require emergency room visit nor physician's office visit.  Infection from COVID occurred over a year after vaccination.  There was no predisposing factor, and no culture analysis was performed and also no other relevant test(s) performed.  No treatment was received for the adverse event.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Wife died from the Covid 19 vaccine called Moderna after two days that she got it; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Wife died from the Covid 19 vaccine called Moderna after two days that she got it) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            This case was created for reporter's wife.  No concomitant medications were reported.  It was reported that the reporter had a friend and his wife who died from the Moderna Covid-19 vaccine. The caller was asked if there was an adverse event that happened regarding flu shot, and the reporter asked if Pfizer or manufacturer of the shot be financially liable for the damages incurred from an adverse event or not. The reporter had lots of questions regarding Covid vaccine, he never got it and never got sick but reported that everybody that he knew who got the vaccine always became sick. The reporter did not mention the brand of Covid vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-785516 (E2B Linked Report).; Reporter's Comments: Company Comments. The time between vaccination and the patient`s death is unknown. Tozinameran remained co-suspect product. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785516:Master case (Caller's friend case); Reported Cause(s) of Death: wife died from the Covid 19 vaccine called Moderna after two days that she got it
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Inappropriate schedule of product administration, Postural orthostatic tachycardia syndrome, Thyroid disorder, Tinnitus
Clinical narrative: cidp; tinnitus; vertigo; pots; lost my thyroid; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 045A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) (seriousness criterion medically significant), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication was reported.  Patient administered dose on 20-Apr-2021 of batches (031A21A or 045A21A).  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: cidp; tinnitus; vertigo; pots; lost my thyroid; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 045A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) (seriousness criterion medically significant), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication was reported.  Patient administered dose on 20-Apr-2021 of batches (031A21A or 045A21A).  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Eye disorder, Swelling, Vaccination site pain
Clinical narrative: walk slowly because here on left of my back has a some sort of swelling.; having eye problem; pain on my right arm on that very spot where vaccine was administered into my body/I have been having pain on the spot all my arm, my right arm has been hurting, and I can hardly lift it; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9702), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "walk slowly because here on left of my back has a some sort of swelling."; EYE DISORDER (non-serious), outcome "unknown", described as "having eye problem"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain on my right arm on that very spot where vaccine was administered into my body/I have been having pain on the spot all my arm, my right arm has been hurting, and I can hardly lift it". Therapeutic measures were taken as a result of eye disorder.  Additional information: Patient got this COVID Vaccine (Clarified as Pfizer COVID-19 Vaccine) back in October and since then he had been pain on the spot where he got the, where he was vaccinated on his right arm. It had been hurting him all the time. He receive the COVID Vaccine in October last year and ever since he had been having pain on the spot all his arm, his right arm had been hurting, and he can hardly lift it, and he went back to pharmacy to complain to them. Well, he thought it would go away but it did not. He walk slowly because here on left of  his back had a some sort of swelling. He did not know if that was responsible for it? His back, on the right side is somewhat swollen. He said In past 2 weeks, no. He did not go to any blood work in the past, he also had been having eye problem. So, that one he had been going to the eye doctor for it. He do take medication, the eye medication they gave him eye drop. He always having the problem though.
Sex: F
Vaccine: COVID19
Symptoms: Intracranial aneurysm
Clinical narrative: Brain aneurysm; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "dementia" (unspecified if ongoing), notes: was in a nursing home and suffering with maybe like dementia (Intent: History); "in a nursing home" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTRACRANIAL ANEURYSM (death, medically significant), outcome "fatal", described as "Brain aneurysm". The patient date of death was unknown. Reported cause of death: "Brain aneurysm". It was not reported if an autopsy was performed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500093770 same reporter/suspect vaccine/event; different patient;US-PFIZER INC-202500093769 same reporter/suspect vaccine; different patient/event;; Reported Cause(s) of Death: Brain aneurysm
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: Diplopia; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 at 08:30 as dose 2, single (Lot number: EW0172) at the age of 46 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Contrast dye" (unspecified if ongoing), notes: Known allergies: Contrast dye. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DIPLOPIA (disability) with onset 10Aug2024, outcome "not recovered". Therapeutic measures were taken as a result of diplopia.
Vaccine: RSV
Symptoms: Drug ineffective, Foetal exposure during pregnancy, Respiratory syncytial virus infection, Term baby
Clinical narrative: Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.; Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.; This is a spontaneous report received from a Physician from a sales representative.  An infant patient born to a mother who, while pregnant received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant), outcome "unknown" and all described as "Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.". The patient was hospitalized for drug ineffective, respiratory syncytial virus infection (start date: 2024). It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection.  Clinical course: It was reported that 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (respiratory syncytial virus infection) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500094055 same product/event, different patient;
Vaccine: RSV
Symptoms: Drug ineffective, Foetal exposure during pregnancy, Respiratory syncytial virus infection, Term baby
Clinical narrative: Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms' who had received the RSV maternal vaccine at 35-36 weeks gestation.; Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms' who had received the RSV maternal vaccine at 35-36 weeks gestation.; This is a spontaneous report received from a Physician from a sales representative.  An infant patient born to a mother who, while pregnant received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) other for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization), outcome "unknown" and all described as "Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms' who had received the RSV maternal vaccine at 35-36 weeks gestation.". It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection.  Clinical course: It was reported that 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with ABRYSVO in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202500093960 same product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Oral lichen planus
Clinical narrative: got Oral Lichen Planus after 3 vaccinations; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019096 (BioNTech).  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: ORAL LICHEN PLANUS (non-serious), outcome "unknown", described as "got Oral Lichen Planus after 3 vaccinations".  Additional information: Reporter's brother (patient) got Oral Lichen Planus after 3 vaccinations. Asked to find a cure for this disease.
Vaccine: MMR
Symptoms: Device connection issue, Underdose
Clinical narrative: No additional AE; Patient only received a partial dose.; when administering MMR II and the needle attached to the luer lock on the diluent pre-filled syringe was loose; The nurse reports leaking occurred through the threaded part of the needle; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 15-Apr-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (lot #Y015834 was verified to be a valid number, expiration date: 20-Sep-2026) (product quantity: 1 vial) diluted with sterile diluent (BAXTER STERILE DILUENT) (product quantity: 1 prefilled syringe) (lot # and expiration date were not reported) (dose, scheme, strength, formulation injection site and route of administration were not provided). It was reported that when administering Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) the needle attached to the luer lock on the diluent pre-filled syringe was loose (device connection issue). The nurse reported that leaking occurred through the threaded part of the needle and the needle was twisted on tight (needle issue). Patient only received a partial dose (incorrect dose administered). Product has been discarded and is not available for return. Pictures are not available. No additional adverse event was reported.
Vaccine: COVID19
Symptoms: Lymphatic system neoplasm, Wound
Clinical narrative: tumor in my lymph node; an open wound; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WOUND (non-serious) with onset 2021, outcome "not recovered", described as "an open wound"; LYMPHATIC SYSTEM NEOPLASM (medically significant) with onset 2021, outcome "not recovered", described as "tumor in my lymph node". Clinical course: Patient got the COVID vaccine shot from Pfizer in 2021. It caused an open wound, and a tumor in the lymph node. Patient have had this for 4 years now and finally decided it was enough.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Participant received Covid-19 injection at 1531 on 5/2/25, participant was observed for 15 minutes. After obnservation period, participant went and got up to walk and stated, "I feel lightheaded, and I have a left numb arm, but the lightheadedness started earlier in the day".  RN offered snacks, water, and Gatorade to participant. RN performed vitals on participant, all within normal limits  (BP: 130/90, HR 98, 96% oxygen saturation on room air, 97.8 temporal temperature.) Participant stated "my numb arm and lightheadendness has resolved" about ten minutes after vitals were taken and participant left building.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient complained of soreness and redness on arm. Was warm and tender to the touch. Redness was swelling. Also described headache like/shingle pain. She had no issues with the first shot.  Advised to contact Dr if it got worse. Counseled on icing it and taking Benadryl. Patient was already taking ibuprofen for the swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient complained of soreness and redness on arm. Was warm and tender to the touch. Redness was swelling. Also described headache like/shingle pain. She had no issues with the first shot.  Advised to contact Dr if it got worse. Counseled on icing it and taking Benadryl. Patient was already taking ibuprofen for the swelling.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, PNC13, RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: This is not adverse reaction event. HAVRIX was administered by 11/04/2024, the Hep-A vaccine expired by 11/02/2024. It's administered 2 days later after expired. And we already report to GSK and authority on 11/05/2024. But report in VAERS, because it reported by GSK, so we report it again. We already followed the results from GSK and authority. This is duplicated report. There is no adverse reaction by vaccination and no treatment at all. Informed to patient's parents right a way.
Age: 55.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient developed SIRVA and experienced pain in shoulder and arm and could not move his arm
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Rash
Clinical narrative: rash whole body
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: patient complaining of swelling and inflammation and bruising at the injection site that was going away and a week later she is experiencing pain and swelling again and noticed that the arm below the injection site is getting bruised again.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery thrombosis, Myocardial infarction
Clinical narrative: Heart attack with blood clot.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Brain fog, Confusional state, Derealisation, Dizziness
Clinical narrative: Approximately an hour after receiving the vaccine, I experienced a stabbing (ice pick) headache and have experienced the same headache daily since the vaccine (aprox. 3 1/2 years). I have never experienced this type of headache in my life prior to the vaccine.  The intensity of the headache varies but has been consistent and persistent since receiving the vaccine on 10/21/2021. Other symptoms include, dizziness, brain fog, confusion, memory loss, feelings of derealization, fatigue, body aches, hand eye coordination difficulties and my reaction time and awareness of my surroundings have been impaired dramatically.