chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, Off label use
Clinical narrative: Because of her inability to maintain antibodies she is re-vaccinated with Meningococcal vaccines; This non-serious case was reported by a physician via sales rep and described the occurrence of off label use in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included dialysis (The patient also undergoes dialysis for treatment of this syndrome) and henoch-schonlein purpura. Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Menveo and Bexsero. On an unknown date, an unknown time after receiving Menveo and Bexsero, the patient experienced off label use (Verbatim: Because of her inability to maintain antibodies she is re-vaccinated with Meningococcal vaccines). The outcome of the off label use 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 : 08-APR-2025 Adult Female had an autoimmune syndrome.  The syndrome ends in Purpura (possibly Henoch-Schonlein purpura).  Over time her therapy to treat the syndrome had decreased her immune system's ability to maintain antibodies.  The patient also undergoes dialysis for treatment of this syndrome.  Because of her inability to maintain antibodies she was re-vaccinated with Meningococcal vaccines (unknown if Menveo or Bexsero or both) every 2 to 4 years which led to off label use.
Age: 0.17
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage administration (2 month 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 2-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number JT347, expiry date 30-SEP-2025) for prophylaxis.   On 19-MAR-2025, the patient received Menveo. On 19-MAR-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration (2 month old patient)). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 07-APR-2025 The other health professional reported that since in the audit just found a male two month old patient was administered a Menveo 1 vial vaccine which led to inappropriate age at vaccine administration.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Maladministration of Priorix intramuscular; 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 an unspecified number of patients who received MMR (Priorix) 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: Maladministration of Priorix intramuscular). 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: 07-APR-2025 Pharmacist reported that she and several colleagues administer Priorix IM instead of SC to adult patients, which led to subcutaneous injection formulation administered by other route. No further information provided. Did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: powder portion was drowning up with normal saline; powder portion was drowning up with normal saline; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis.   On 01-APR-2025, the patient received Menveo. On 01-APR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: powder portion was drowning up with normal saline) and inappropriate dose of vaccine administered (Verbatim: powder portion was drowning up with normal saline). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 07-APR-2025 Other HCP reported that they received a box with 2 vials presentation (Menveo), one the powder one the liquid, and when drowning up to give to a patient, powder portion was drowning up with normal saline and the liquid was completely not given. Menveo reconstituted with normal saline instead of the supplied CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient that received one dose of Shingrix in 2018/ did not receive 2nd dose; 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received one dose in 2018).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient that received one dose of Shingrix in 2018/ did not receive 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 08-APR-2025 The reporter reported that he/she had a patient that received one dose of Shingrix in 2018. The reporter wanted to know did the series need to be restarted since so much time has elapsed for the second shot. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: would they have to restart the dose or will they still proceed getting their 2nd dose; 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 1st dose on 01-JAN-2021).   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:  would they have to restart the dose or will they still proceed getting their 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 09-APR-2025 The health care professional reported that a patient had her 1st (Shingrix) dose in 2021, would they have to restart the dose or will they still proceed getting their 2nd dose. At the beginning of the call, HCP mentioned that this was about Shingrix only mentioned 2021 as the vaccination date for 1st dose, but she did not  have the specific date (reporter set this as 01-01-2021 due to the system did not allow only the year). Health care professional mentioned that the patient is not immunocompromised. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: A 60 years old female patient received a dose of Priorix via IM instead of subcutaneous.; 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 60-year-old female patient who received MMR (Priorix) (batch number 955E2, 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 60 years old female patient received a dose of Priorix via IM instead of subcutaneous.). 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: 10-APR-2025 The reporter called to report that a patient received Priorix IM instead of SQ and asked if it was ok, which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B- Pediatric dose administered to an adult patient; Engerix-B- Pediatric dose administered to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 59-year-old male patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis.   On 11-APR-2025, the patient received the 1st dose of Engerix B pediatric. On 11-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B- Pediatric dose administered to an adult patient) and accidental underdose (Verbatim: Engerix-B- Pediatric dose administered to an adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable.   Additional Information: GSK Receipt Date: 11-APR-2025 Nurse reported that on 11th April 2025, an adult male patient had erroneously received the first dose of Engerix-B pediatric, which led to Adult use of a child product and Accidental underdose.
Age: 79.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix intramuscularly instead of subcutaneously administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 79-year-old female patient who received MMR (Priorix) (batch number J942L, expiry date 08-NOV-2026) for prophylaxis.   On 11-APR-2025, the patient received Priorix (intramuscular). On 11-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix intramuscularly instead of subcutaneously administration). 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: 11-APR-2025 Pharmacy Technician wanted to know how to proceed after giving Priorix intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (contracted Covid-19) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: spikevax NOS (in the previous years.). Past adverse reactions to the above products included No adverse effect with spikevax NOS.    In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient and their spouse both have received Spikevax in November 2024 as well as in the previous years. They both contracted Covid-19.  It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided. Reporter causality was not reported.  This case contains information for the 2nd patient out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2025-784847 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784847:Patient 2 of 2
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (contracted Covid-19) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS.    In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) outcome was unknown.            The concomitant medication was not reported.  Patient and her spouse both had received Spikevax in November 2024 as well as in the previous years. It was unknown if the patient experienced any additional symptoms/events. The treatment drug information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-784855 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784855:Patient 1 of 2
Age: 64.0
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Pfizer's shot / had COVID / It did not work; got Pfizer's shot / had COVID / It did not work; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Feb2025 as dose 1, 0.3 ml single (Lot number: LM2216) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; LISINOPRIL. The patient also took other concomitant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "got Pfizer's shot / had COVID / It did not work". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) COVID; (10Apr2025) still had COVID; (05Apr2025) COVID. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The clinical course was reported as follows: Patient got the Pfizer's shot and now had COVID. I did not work. No blood work, patient did go to complete care to get checked for see if she/he had COVID. The patient was told that she/he had COVID and patient checked it the home test and she/he had COVID. Then the patient did one in the morning of 10Apr2025 which was five days later and still had COVID.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I've had two. We use Pfizer/ both got Covid; I've had two. We use Pfizer/ both got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've had two. We use Pfizer/ both got Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: We never got the virus until this week; We never got the virus until this week; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 66-year-old female patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "We never got the virus until this week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The husband reported that they got Covid last week. They got the medicine today from the doctor's prescription, Pax Covid. Both got the Pfizer vaccine when it first came out. And had all the vaccines until the pandemic was over. They never got the virus until this week. Fortunately they had the medicine, and they had the testing and everything was already in place and got the medication easily.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500044564 same reporter/drug/event different patient;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: she had Covid; she had Covid; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 09Apr2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Mar2025 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation, reaction(s): "No adverse effect". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Mar2025, outcome "recovering" and all described as "she had Covid". Therapeutic measures were taken as a result of covid-19. Clinical details: the patient had a letter from Pfizer due to a reaction from a Covid Vaccine. She got a reaction to Covid Vaccine in Mar2025; she had on the 2nd, her last one. She's had everyone, which she was ok. And then, two weeks after that, she had Covid. The patient stated she is doing better. She was taking Paxlovid. It got rid of all her symptoms, its like a heavy duty drug. She's fully vaxxed too. She's just glad the Paxlovid worked for her right away.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: pulsitile tinnitus; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Apr2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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  NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "pulsitile tinnitus".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I keep getting Covid, even though I took six of the Pfizer vaccines; I keep getting Covid, even though I took six of the Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2022 (unspecified if ongoing), notes: COVID three times already, once in 2022 and Mar2024, Apr2024. The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 3, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 4, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 5, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "I keep getting Covid, even though I took six of the Pfizer vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient stated, "I just signed up for assistance to the patient assistance program to obtain Paxlovid 'cause I keep getting Covid, even though I took six of the Pfizer vaccines, I keep getting Covid. This is my third time for the year." When asked if the patient had taken Paxlovid before, the patient stated, "Yes, this is going to be my third time. Actually the fourth, this is going to be the fourth" When asked when the first time was that the patient took Paxlovid, the patient said, "2022 I had it in Mar of this year, and then Apr of this year, and now Jul2024. I took this (inaudible) two shots, I took four booster shots, but the thing is I would sneeze a lot and headache and runny nose."
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19/I have had all covid 19 vacciantions and boosters; Covid-19/I have had all covid 19 vacciantions and boosters; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (VACUNA COVID-19 JANSSEN), in Dec2020 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "cholesterol increased" (unspecified if ongoing); "Blood pressure increased" (unspecified if ongoing); "seasonal allergies" (ongoing), notes: Still having allergy symptoms due to seasonal allergies. Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased; LISINOPRIL taken for blood pressure increased; VITAMIN B12 [COBAMAMIDE]; CLARITIN [LORATADINE] taken for seasonal allergy. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19/I have had all covid 19 vacciantions and boosters". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking any other medications within 2 weeks prior to the event onset. The patient is not allergic to any previous vaccination, medications, food or other products. There are no any other diagnosed illnesses / medical history / chronic health conditions to report. Have had all Covid 19 vaccinations and boosters. Even participated in clinical Trial of J& J vaccine in Dec2020. Had avoided getting Covid for 4+ years even when my wife had it twice.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I've had the Pfizer vaccine/ this is my second bout with Covid; I've had the Pfizer vaccine/ this is my second bout with Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (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 "unknown" and all described as "I've had the Pfizer vaccine/ this is my second bout with Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient mentioned she had really good luck. She has had the Pfizer vaccine and this is her second bout with Covid so this will be the second time taking the medicine.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He's had three shots. We use Pfizer/ both got Covid; He's had three shots. We use Pfizer/ both got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 63-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer patient" (ongoing); "very low immune system" (ongoing); "Covid-19", start date: 2023 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "He's had three shots. We use Pfizer/ both got Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: We never got the virus until this week; We never got the virus until this week; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "recovered" and all described as "We never got the virus until this week". The patient underwent the following laboratory tests and procedures: Investigation NOS: Unknown results, notes: they had the testing and everything was already in place. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The reporter stated that they got Covid last week. They got the medicine today from the doctor's prescription, Pax Covid. Both got the Pfizer vaccine when it first came out. And had all the vaccines until the pandemic was over. They never got the virus until this week. Fortunately they had the medicine, and they had the testing and everything was already in place and got the medication easily.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500079122 same reporter/drug/event different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective
Clinical narrative: positive for Covid and prescribed Paxlovid/pneumonia; positive for Covid and prescribed Paxlovid; pneumonia; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: Bnt162b2 (Primary Immunization series complete.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: COVID-19 PNEUMONIA (medically significant) with onset 01Apr2024, outcome "unknown", described as "pneumonia"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "positive for Covid and prescribed Paxlovid/pneumonia"; COVID-19 (medically significant), outcome "unknown", described as "positive for Covid and prescribed Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, covid-19 pneumonia. Clinical course: It was clarified that the patient and her husband are both positive for Covid and both prescribed Paxlovid. The patient have a sinus infection and pneumonia and so she's on day 11 now (12Apr2024). On 12Apr2024 is 11 days ago with the pneumonia, sinus infection and so the patient was done antibiotics and steroids and all that kind of stuff. So, she don't need it (Paxlovid) at this point. She think it's too late for her. The patient had Paxlovid before and it made such a difference. The patient stated that she thinks that she and her husband have had it (Paxlovid) one other time. And they've had all the Pfizer vaccines too.
Sex: M
Vaccine: MEN
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: injection site reaction and it began spreading; it hurt really bad; Initial information received on 04-Apr-2025 regarding an unsolicited valid  non-serious case received from a patient's relative.  This case involves an Adolescent male patient (154.94 cm and 61.82 kg) who had injection site reaction and it began spreading and it hurt really bad while receiving vaccine MENINGOCOCCAL VACCINE and while treated with DUPILUMAB [DUPIXENT] delivered via dupilumab prefilled syringe.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergies: johnson grass 1:20 vial.  Concomitant medications included Levocetirizine dihydrochloride (Levocetirizine dihydrochloride).  On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 200mg/1.14ml) at a dose 200 mg QOW subcutaneous for undefined delivered via dupilumab prefilled syringe. On 31-Mar-2025, the patient received a  dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious event "injection site reaction and it began spreading" (injection site reaction) (unknown latency) following the first dose intake (batch number: 4L240Z and expiry date on 31-Mar-2027) of DUPILUMAB  and (with unknown batch number and expiry date) of MENINGOCOCCAL VACCINE .  On an unknown date the patient developed a non-serious event "it hurt really bad" (injection site pain) (unknown latency) following the first dose intake (batch number: 4L240Z and expiry date on 31-Mar-2027) of DUPILUMAB and (with unknown batch number and expiry date) of MENINGOCOCCAL VACCINE .  It was reported "meningococcal vaccine was taken on 31-Mar and patient did not respond well per mother. patient had injection site reaction and it began spreading. it was getting better. patient told his mom it hurt really bad".  Action taken with DUPILUMAB: Unknown for both the events. Action taken with MENINGOCOCCAL VACCINE: Not applicable for both the events.  Corrective treatment: Not reported for both the events.  Outcome: Recovering / Resolving for the event injection site reaction and Unknown for the event injection site pain.
Sex: F
Vaccine: DTAP
Symptoms: Liquid product physical issue
Clinical narrative: deteriorated vaccine administered with no reported adverse event; Initial information received on 06-Apr-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional  This case involves an unknown age female patient who had deteriorated DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a deteriorated dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5281AA, Expiry: 05-Oct-2019) via unknown route in unknown administration site for prophylactic vaccination as white particles were noticed to be floating in the vials when administering (poor quality product administered) (latency: same day).  It was reported, before this issue was identified 5 vials was already administered to 5 patients. Reporter also asked, I would like to have the following Lot's checked. Concerning as my daughter received the same lot. Can a few batches be contaminated, while others are ok and the Lot's: C5281AA, C5307AA & C5367AA.  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Expired product administered
Clinical narrative: expired YF-Vax was administered with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 years old female patient to whom expired yellow fever vaccine [YF-VAX] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Apr-2025, the patient was administered an expired dose of suspect yellow fever vaccine (Solution for injection) (expiry date: 31-Mar-2025) strength; lot number not reported) via unknown route in unknown administration site for Immunisation with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 19.0
Sex: F
Vaccine: MEN, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: had a "vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II administered this mixture to patient, with no reported adverse event; had a "vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II administered this mixture to patient, with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to US-SA-2025SA105763 (Cluster case).   This case involves a 19 years old female patient who experienced a vaccine mix-up" and that the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was beside the diluent for MMR-II/mistakenly combined the menquadfi with the MMR-II and the patient was administered this mixture, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Apr-2025, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7852AB , Expiry: 31-Oct-2025) (Strength: Standard) via intramuscular route in the left arm as immunization which was mistakenly mixed with MMR-II as diluent, the menquadfi was beside the diluent for MMR-II with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day).  Reportedly, they said that these patients did not need MENQUADFI. Pharmacist said that patients did not report any adverse events.   Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA105763:patient 2
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol was given post excursion to one patient with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom received IPV (Vero) [Ipol] was given post excursion to one patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, in Apr-2025 ,the patient received a unknown dose of suspect IPV (Vero) Suspension for injection (strength: unknown, expiry date: 31-Oct-2026 and lot X1C891M) via unknown route in unknown administration site as prophylactic vaccination (immunization) and  was given post excursion to one patient with no reported adverse event (poor quality product administered) (same day latency).  Reportedly: Max/low temperature reached: 10 MINS 8.8C Reason: Unknown, Human error: No, the extended stability data cover the excursion all except for the open IPOL. The caller reported that the excursion took place on 04Apr2025; that they were made are of the incident after the vaccine was administered; that there is no more information available for this report due to the caller's computer was down at the time of the call.  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: acthib was diluted with sterile water instead of 0.4% sod chloride and given to a patient with no reported adverse event; Initial information received on 14-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient who was given experienced HIB (PRP/T) VACCINE [ACT-HIB] which was diluted with sterile water instead of 0.4% sodium chloride with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was given unknown dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site for immunization which was diluted with sterile water instead of 0.4% sodium chloride with no reported adverse event (product preparation error) (same day: latency).  Action taken: Not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient only received one of the two vials they were supposed to with no adverse event; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old female patient who received only one of the two vials for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)], they were supposed to with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) and pneumococcal vaccine, both for Immunisation.  On 04-Apr-2025, the patient received only one of the two vials for Dose 4 of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection of standard strength with lot UK110A and expiry date 31-Aug-2025 via intramuscular route in the left vastus lateralis for Immunization they were supposed to with no adverse event (single component of a two-component product administered) (Latency same day).  Reportedly, reporter stated that it is possible that instead of reconstituting the 2 vials together, only one was reconstituted with sterile water and administered  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle disorder, Pain in extremity, Rheumatoid factor
Clinical narrative: Sore hand joints, then sore feet, then sore legs, sore hips, loss of muscular control from waist down
Vaccine: VARZOS
Symptoms: Paralysis
Clinical narrative: I know someone who took it and was paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (Verbatim: I know someone who took it and was paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was resolved.   It was unknown if the reporter considered the paralysis to be related to Shingles vaccine.     The company considered the paralysis to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The reporter knew someone who took it and was paralyzed. They had a long journey to recover from vaccine injury. The patient had to have lots of therapy and had to learn to walk again. This case was linked with US2025AMR045208 from the same reporter.; Sender's Comments: Paralysis is a  listed event which is considered related to a GSK vaccine Shingles vaccine US-GSK-US2025AMR045208:Same reporter
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Myalgia
Clinical narrative: he began experiencing dizziness; Muscle pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure, benign prostatic hyperplasia and anticoagulant therapy. Concomitant products included nebivolol, morniflumate (Flomax), aspirin, acetylcysteine (N Acetyl Cystein) and collagen.   On 02-APR-2025, the patient received Shingrix (intramuscular, left deltoid). On 02-APR-2025, less than a day after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain). On 04-APR-2025, the patient experienced dizziness (Verbatim: he began experiencing dizziness). The outcome of the dizziness was not resolved and the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the dizziness and muscle pain to be related to Shingrix.     It was unknown if the company considered the dizziness and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2025 The patient self-reported this case for himself. The patient received his Shingrix vaccine in his left deltoid.  He states that two days later he began experiencing dizziness, which was worse when he was lying flat.  The patient had seen his primary care physician who performed the Epley maneuver and administered a steroid shot.  He also saw a chiropractor and received a neck adjustment.  The patient stated that there has been no improvement.  He also reported muscle pain which began the day of the vaccination and went away within a couple of days.