chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th September 2022).   On 02-OCT-2024, the patient received the 2nd dose of Shingrix. On 02-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt date: 31-MAR-2025 The patient who came to get Shingrix shots on 25th September 2022 and 2nd October 2024 (2 years apart)  wanted to get a 3rd dose. The reporter consented to follow up. The lot and expiration date of 2nd dose not available during call. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: administer a Bexsero vaccine instead of a Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number 88G34, expiry date 30-SEP-2027) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 10-MAR-2025, the patient received the 1st dose of Bexsero. On an unknown date, the patient received Menveo. On 10-MAR-2025, an unknown time after receiving Bexsero and not applicable after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: administer a Bexsero vaccine instead of a Menveo). 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: 31-MAR-2025 The registered nurse called and mentioned to administer a Bexsero vaccine instead of a Menveo to a patient which led to, wrong vaccine administered. The nurse explained that the Bexsero vaccine was approved for patients between 10 to 25 years old, but as this was an inadvertent administration. The vaccine administration facility was the same as primary reporter.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: AE Priorix - Administration of only the diluent.; AE Priorix - Administration of only the diluent.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 64-year-old female patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis.   On 28-FEB-2025, the patient received Priorix. On 28-FEB-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: AE Priorix - Administration of only the diluent.) and inappropriate preparation of medication (Verbatim: AE Priorix - Administration of only the diluent.). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication 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: 31-MAR-2025 The nurse reported that the two patients that likely received an incomplete Priorix dose, but they could not confirm which patient received only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered  The nurse thought they should revaccinate both patients but one of them would receive an extra dose. The nurse asked for information about a patient receiving an extra dose of Priorix or if they could check titers prior to revaccination and asked what was the recommendation in that situation. This case is linked with US2025038563, reported by same reporter.; Sender's Comments:  US-GSK-US2025038563:Same reporter/Different Patient
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: patient received only the diluent portion; patient received only the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis.   On 13-MAR-2025, the patient received Priorix. On 13-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent portion). 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: 31-MAR-2025 The nurse reported that the two patients that likely received an incomplete Priorix dose, but they could not confirm which patient received only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered  The nurse thought they should revaccinate both patients but one of them will receive an extra dose. The nurse asked for information about a patient receiving an extra dose of Priorix or if they could check titers prior to revaccination and asked what was the recommendation in that situation. This case is linked with US2025038566, reported by same reporter.; Sender's Comments:  US-GSK-US2025038566:Same reporter/Different Patient
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: A patient received Priorix via IM instead of SC; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A patient received Priorix via IM instead of SC). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-MAR-2025 The pharmacist called to report that a patient received Priorix via IM (intramuscular) instead of SC (subcutaneous), which led to subcutaneous injection formulation administered by other route. The reporter wanted to know do they need to repeat the dose.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: accidentally administered only the adjuvant portion of Shingrix; received only the adjuvant portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ534, expiry date 23-OCT-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 31-MAR-2025 A practice administrator called to report that they accidentally administered only the adjuvant portion of Shingrix to a patient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter wanted to know was it ok for the patient, any side effect they should consider or do they need to revaccinate.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B, it was expired back in July 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis.   On 31-MAR-2025, the patient received Engerix B. On 31-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B, it was expired back in July 2024). 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: 31-MAR-2025 On 31-Mar-2025 a Registered pharmacist called and reported that a patient of mine received a vaccine Engerix-B, it was expired back in July 2024, which led to expired vaccine used. Reporter was wondering if had information on extended expiration on that, or what the revaccination guidelines were for this particular accident. The Vaccine Administration Facility is the same as Primary Reporter. The patient received the vaccine on the day of reporting, 31-Mar-2025.
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling in fingertips; This non-serious case was reported by a physician via call center representative and described the occurrence of tingling of extremity in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: tingling in fingertips). The outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.     It was unknown if the company considered the tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt Date:31-MAR-2025 The reporter asked regarding tingling in fingertips after the first Shingrix vaccine. The reporter asked any data around this and if second dose still be received.
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient; they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient; 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 patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient) and inappropriate dose of vaccine administered (Verbatim: they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 01-APR-2025 The pharmacist reported that they reconstituted a Hiberix vaccine with sterile water rather than saline and then administered it to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked was there any harm to the patient and asked the vaccine needed to be repeated.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a 3 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis.   On 01-APR-2025, the patient received the 1st dose of Kinrix. On 01-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 3 year old patient). 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: 01-APR-2025 The clinic manager reported that they had a patient on the day of reporting and he was a 3 year old, little boy and they gave him Kinrix the IPV and DTAP which led to, inappropriate age at vaccine administration. The reporter stated that they know the vaccine was recommended for 4 year and above so, they just wanted to get the recommendations on that.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix vaccine was administer to a 9 months male baby; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (IPV).   On 11-MAR-2025, the patient received Kinrix. On 11-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine was administer to a 9 months male baby). 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: 02-APR-2025 The nurse reported that the patient received Kinrix vaccine and was administered to a 9 months old patient and with this last vaccine the patient had 3 Dtap and 3 IPV doses The Vaccine Administration Facility was the same as Primary Reporter. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 14-year-old female patient who received MMR (Priorix) (batch number 2JX7Y) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient.). The outcome of the incorrect storage of drug 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: 02-APR-2025 Other HCP reported that the Priorix vaccines were exposed to a temperature of minus 23.5 degree celsius. Vaccine stored outside recommended conditions and administered to patient, which led to incorrect storage of drug. Reporter had received a new MMR vaccine with a different brand that was not supposed to be frozen and accidentally gave to patient the MMR. It was reported that administered vaccine was Priorix. This case is linked with US2025039710 reported by same reporter.; Sender's Comments:  US-GSK-US2025039710:SAME REPORTER
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix vaccine 13 months ago with batch number 274YD and expiry date 15 September 2025).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed the second dose of Shingrix ). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 02-APR-2025 The physician assistant reported that a 73 years old female patient missed the second dose of Shingrix, it had been almost 13 months since dose 1. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: HEPA, HEPAB
Symptoms: Interchange of vaccine products
Clinical narrative: Interchangeability; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a adult patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included Hepatitis a vaccine for prophylaxis.   In FEB-2025, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 1st dose of Hepatitis a vaccine. In FEB-2025, an unknown time after receiving Twinrix, the patient experienced interchange of vaccine products (Verbatim: Interchangeability). The outcome of the interchange of vaccine products 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: 04-APR-2025 The pharmacist stated that an adult patient (unknown specific age) received what it seems to be first dose of Hepatitis A vaccine (unknown brand name or lot number) on 2017 (unknown specific date), and on February 2025 (not specific date) the patient got first dose of Twinrix, which led to interchange of vaccine products.  Since pharmacist was calling on behalf of another facility, they did not have patient demographics or additional details of the scenario.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a dose of Shingrix in 2018 and has not received another dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Shingrix in 2018 and has not received another dose yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 The pharmacist reported that a patient received a dose of Shingrix in 2018 and had not received another dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix in September 2023 and hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in SEP-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix in September 2023 and hasn't received a second dose yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 The pharmacist reported that a patient received 1st dose of Shingrix in September 2023 and had not received second dose yet. The Vaccine Administration Facility is the same as Primary Reporter Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Wrong Route of Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number TY7MZ) for prophylaxis.   On 03-APR-2025, the patient received the 1st dose of Shingrix. On 03-APR-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong Route of Administration). The outcome of the intramuscular formulation administered by other route was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 The registered nurse reported that the patient given Shingrix with subcutaneous route by accident and wanted to know if there was any protocol for this, which led to intramuscular formulation administered by other route.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Tinnitus
Clinical narrative: STARTING DECEMBER 2024, RINGING IN THE EARS WHEN TRYING TO LAY DOWN TO SLEEP; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (STARTING DECEMBER 2024, RINGING IN THE EARS WHEN TRYING TO LAY DOWN TO SLEEP) in a 71-year-old male patient who received mRNA-1345 (mRESVIA) for Lower respiratory tract infection.     Previously administered products included for COVID-19 prophylaxis: moderna covid-19 vaccine on 01-Apr-2021 and moderna covid-19 vaccine on 27-Sep-2021. Past adverse reactions to the above products included No adverse effect with moderna covid-19 vaccine and moderna covid-19 vaccine.    On 17-Oct-2024, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) 1 dosage form. On 01-Dec-2024,  after starting mRNA-1345 (mRESVIA), the patient experienced TINNITUS (STARTING DECEMBER 2024, RINGING IN THE EARS WHEN TRYING TO LAY DOWN TO SLEEP). At the time of the report, TINNITUS (STARTING DECEMBER 2024, RINGING IN THE EARS WHEN TRYING TO LAY DOWN TO SLEEP) had not resolved.        The action taken with mRNA-1345 (mRESVIA) (Intramuscular use) was unknown.   For mRNA-1345 (mRESVIA) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   This case was linked to MOD-2025-783373 (Patient Link).
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: A kid died from myocarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (A kid died from myocarditis) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (A kid died from myocarditis) (seriousness criteria death and medically significant). The reported cause of death was died from myocarditis. It is unknown if an autopsy was performed. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Company comment:  Reportedly, it was stated that the patient died from myocarditis after vaccination, however, no additional details regarding medical history of the patient, clinical course of the event, treatment details, as well as temporal relationship between vaccination and the event of myocarditis were provided. It remained unknown if an autopsy was performed. The benefit-risk relationship of the product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-307118 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2025: Live non-significant follow up received: reference numbers were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-307118:Master case; Reported Cause(s) of Death: Died from myocarditis
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Anxiety, Asthenia, Balance disorder
Clinical narrative: Off balance -Fall down; Crying; Runny nose; High anxiety; Vertigo; Weakness; No smell; No Appetite; No taste; Coughing; vomit; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety) and VERTIGO (Vertigo) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 4, Batch no: GH9702) on 08-Nov-2022, Morphine and codeine. Past adverse reactions to the above products included No adverse effect with Pfizer; and Sickness with Morphine and codeine. Concurrent medical conditions included Drug allergy (Codeine made patient sick), Drug allergy (Morphine made patient sick), COVID-19 since 05-Jan-2020, High cholesterol since 10-Jun-1969, Post-traumatic stress disorder since 30-Nov-1970, Thyroid disorder since 15-Jun-1965, Stomach ache and Constipation. Concomitant products included Docusate sodium (Colace) from 01-Jan-2020 to an unknown date for Constipation, Calcium carbonate (Tums) from 01-Jan-2020 to an unknown date for Stomach ache.    On 21-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit). At the time of the report, BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure up.         The events cause the patient to seek medical care. No other factors that could had led to the adverse event. The patient experienced similar events in past.  No treatment information was reported.   This case was linked to MOD-2025-782752 (Patient Link).; Reporter's Comments: Previously given Pfizer vaccination (unknown indication) can be contributing factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cough, Crying, Decreased appetite, Rhinorrhoea
Clinical narrative: Off balance -Fall down; Crying; Runny nose; High anxiety; Vertigo; Weakness; No smell; No Appetite; No taste; Coughing; vomit; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety) and VERTIGO (Vertigo) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 4, Batch no: GH9702) on 08-Nov-2022, Morphine and codeine. Past adverse reactions to the above products included No adverse effect with Pfizer; and Sickness with Morphine and codeine. Concurrent medical conditions included Drug allergy (Codeine made patient sick), Drug allergy (Morphine made patient sick), COVID-19 since 05-Jan-2020, High cholesterol since 10-Jun-1969, Post-traumatic stress disorder since 30-Nov-1970, Thyroid disorder since 15-Jun-1965, Stomach ache and Constipation. Concomitant products included Docusate sodium (Colace) from 01-Jan-2020 to an unknown date for Constipation, Calcium carbonate (Tums) from 01-Jan-2020 to an unknown date for Stomach ache.    On 21-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit). At the time of the report, BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure up.         The events cause the patient to seek medical care. No other factors that could had led to the adverse event. The patient experienced similar events in past.  No treatment information was reported.   This case was linked to MOD-2025-782752 (Patient Link).; Reporter's Comments: Previously given Pfizer vaccination (unknown indication) can be contributing factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Off balance -Fall down; Crying; Runny nose; High anxiety; Vertigo; Weakness; No smell; No Appetite; No taste; Coughing; vomit; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety) and VERTIGO (Vertigo) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 4, Batch no: GH9702) on 08-Nov-2022, Morphine and codeine. Past adverse reactions to the above products included No adverse effect with Pfizer; and Sickness with Morphine and codeine. Concurrent medical conditions included Drug allergy (Codeine made patient sick), Drug allergy (Morphine made patient sick), COVID-19 since 05-Jan-2020, High cholesterol since 10-Jun-1969, Post-traumatic stress disorder since 30-Nov-1970, Thyroid disorder since 15-Jun-1965, Stomach ache and Constipation. Concomitant products included Docusate sodium (Colace) from 01-Jan-2020 to an unknown date for Constipation, Calcium carbonate (Tums) from 01-Jan-2020 to an unknown date for Stomach ache.    On 21-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit). At the time of the report, BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure up.         The events cause the patient to seek medical care. No other factors that could had led to the adverse event. The patient experienced similar events in past.  No treatment information was reported.   This case was linked to MOD-2025-782752 (Patient Link).; Reporter's Comments: Previously given Pfizer vaccination (unknown indication) can be contributing factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Upper limb fracture
Clinical narrative: a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna; broke my arm; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna) and UPPER LIMB FRACTURE (broke my arm) 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) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna) and UPPER LIMB FRACTURE (broke my arm). At the time of the report, IMMUNISATION REACTION (a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna) and UPPER LIMB FRACTURE (broke my arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported. Date of administration reported as 2020, 2021, and 2022 in years.  It was reported that so if wanted to believe that it's, that it was dangerous, then they went for research that. And if wanted to believe in the power of whatever, getting immunized and was doing what's best for country, and then making that into some sort of judgment on somebody's Character for personality, testing and 23 and testing, those were all the side effects of that. It was also added "That was a side effect of Moderna and Johnson and Johnson and Pfizer. That's also an ethical and compliance concern, Patient stated she had "numerous vaccines. that's a really negative side effect. Patient broke arm and patient wanted to learn how to write with left hand. She added, "she didn't go with Johnson Johnson. It was unknown if the patient experienced any additional symptoms/events No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2025: Significant follow-up information received. New event (Arm fracture) added, and reference numbers added. On 25-Mar-2025: Non-significant information received new information received. On 25-Mar-2025: Non-significant information received new information received. On 25-Mar-2025: Non-significant information received new information received. On 25-Mar-2025: Significant follow-up information received: reference numbers added, and narrative was updated.
Vaccine: COVID19
Symptoms: Complement analysis, Flow cytometry, Immune-mediated adverse reaction
Clinical narrative: Unexpected immunological response; This spontaneous case was reported by a patient and describes the occurrence of IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Kidney transplant (First kidney transplant. Currently being evaluated for a second transplant).   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) (seriousness criterion medically significant). At the time of the report, IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Complement analysis: Positive. On an unknown date, Flow cytometry: Positive.         Concomitant medication was not reported. Patient had received three doses of Moderna Covid-19 vaccine. After vaccination, CDC (Complement-Dependent Cytotoxicity) and Flow Crossmatch tests returned positive results. The patient had been evaluated for 2nd kidney transplant, but this unexpected immunological response had raised serious concerns and significantly impacted patient's health and quality of life. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Past medical history of Kidney transplant is a confounder for the event. The benefit -risk relationship of product is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Loss of consciousness, Pain
Clinical narrative: leaving her too weak to stand for several minutes; chills; passed out the following morning/weak; body aches; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out the following morning/weak) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 04-Oct-2024, the patient experienced LOSS OF CONSCIOUSNESS (passed out the following morning/weak) (seriousness criterion medically significant), PAIN (body aches) and CHILLS (chills). On an unknown date, the patient experienced DYSSTASIA (leaving her too weak to stand for several minutes). At the time of the report, LOSS OF CONSCIOUSNESS (passed out the following morning/weak), PAIN (body aches), DYSSTASIA (leaving her too weak to stand for several minutes) and CHILLS (chills) outcome was unknown.       No concomitant medications were reported.  Patient received all recommended doses and confirmed no other vaccines were received in the past four weeks. The doctor advised not to get another dose in April (appointment already scheduled) unless the formula had been updated. Patient was unsure of full vaccination history but had received all recommended doses. No lot number was provided. Patient was inquired whether can take Pfizer vaccine instead of moderna vaccine since experienced severe side effects with the last dose of modern vaccine.  It is unknown if the patient experienced any additional symptoms/events.  Reporter causality was not reported.  No treatment medications were reported.   Reporter did not allow further contact; Reporter's Comments: The age is a contributor for the events. The benefit -risk relationship of product is not affected by this report.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. 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-202500069078 same reporter/events, different patient;US-PFIZER INC-202500069065 same reporter/events, different patient;US-PFIZER INC-202500069064 same reporter/events, different patient;US-PFIZER INC-202500069066 same reporter/events, different patient;US-PFIZER INC-202500069067 same reporter/events, different patient;US-PFIZER INC-202500069039 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: Broken vial or broken injection of Prevnar 20; Received a broken vial in a shipment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LK6653, Expiration Date: 30Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Broken vial or broken injection of Prevnar 20; Received a broken vial in a shipment".  Additional information: The reporter stated that they received some broken vial or broken injection of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein). They wanted to know if they can get replacement. The vaccine was not given to patients. NDC Number: 00005-2000-10  The reporter considered "broken vial or broken injection of prevnar 20; received a broken vial in a shipment" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "broken vial or broken injection of prevnar 20; received a broken vial in a shipment" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Follow-up (07Apr2025): This is a follow-up report from product quality group providing investigation results. Updated information: narrative
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: Debilitated by COVID-19 before; Debilitated by COVID-19 before; Severe long COVID-19 and had an acute infection right now; Long COVID-19; This is a spontaneous report received from a consumer, Program ID.  A 39-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Primary immune deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Debilitated by COVID-19 before"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "not recovered", described as "Long COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Severe long COVID-19 and had an acute infection right now".  The patient had COVID-19 before and is very sick. The patient needs nirmatrelvir/ritonavir (PAXLOVID) and also has other medical issues. During an inbound call for financial assistance, the patient had a prescription for nirmatrelvir/ritonavir (PAXLOVID). The patient had very severe long COVID-19 and had an acute infection right now. The patient had very severe primary immune deficiency. The patient had been so debilitated by COVID-19 before. The patient asked if it is five days that's covered. The patient's doctor said that she could only write 5 days at a time cause some people with long COVID-19 they find nirmatrelvir/ritonavir helps them a lot, so they take it for 5 days and then they take it for 5 more days. The patient asked if the company knows anything about the vaccine injuries from the COVID-19 vaccine. The patient didn't know that nirmatrelvir/ritonavir was made by Pfizer and had a really severe reaction to the COVID-19 vaccine, so the patient was just curious.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. 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-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer
Vaccine: COVID19
Symptoms: Death, Death
Clinical narrative: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. 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-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer