chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Blood pressure increased, Chest X-ray normal, Electrocardiogram normal, Heart rate increased, Influenza virus test negative
Clinical narrative: tachycardia; she did not feel well; The nurse found the staff member to have an extremely high blood pressure as well as an extremely high pulse, which was in the 150's.; This non-serious case was reported by a consumer via call center representative and described the occurrence of tachycardia in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T74KG, expiry date 30-JUN-2025) for prophylaxis.   Concurrent medical conditions included hypertension.   On 23-OCT-2024 08:30, the patient received Fluarix 2024-2025 season. On 23-OCT-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced tachycardia (Verbatim: tachycardia) and blood pressure high (Verbatim: The nurse found the staff member to have an extremely high blood pressure as well as an extremely high pulse, which was in the 150's.). On 23-OCT-2024 14:00, the patient experienced feeling unwell (Verbatim: she did not feel well). The patient was treated with amlodipine. The outcome of the tachycardia, feeling unwell and blood pressure high were resolved (duration 2 hrs).   The reporter considered the tachycardia, feeling unwell and blood pressure high to be possibly related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the tachycardia, feeling unwell and blood pressure high to be possibly related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-OCT-2024 The reporter reported that the patient had received Fluarix vaccine and on the same day at 14:00 the nurse stating she did not feel well. The nurse found the staff member to had an extremely high blood pressure as well as an extremely high pulse, which was in the 150's. So, the reporter asked they just touching along and they just want to know what to do, go to the hospital or what. The patient did take amlodipine for high blood pressure. The nurse took the staff member to the emergency room, and there an EKG (Electrocardiogram), chest x-ray, lab work, Covid test, and flu test was all reported to be negative. No intervention was required, the symptoms resolved on their own. The staff member states her symptoms lasted about 2 hours in total. The emergency room physician believes this was a reaction to the vaccine. The nurse asked if this had been seen before.
Sex: F
Vaccine: UNK
Symptoms: Malaise, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: tachycardia; she did not feel well; The nurse found the staff member to have an extremely high blood pressure as well as an extremely high pulse, which was in the 150's.; This non-serious case was reported by a consumer via call center representative and described the occurrence of tachycardia in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T74KG, expiry date 30-JUN-2025) for prophylaxis.   Concurrent medical conditions included hypertension.   On 23-OCT-2024 08:30, the patient received Fluarix 2024-2025 season. On 23-OCT-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced tachycardia (Verbatim: tachycardia) and blood pressure high (Verbatim: The nurse found the staff member to have an extremely high blood pressure as well as an extremely high pulse, which was in the 150's.). On 23-OCT-2024 14:00, the patient experienced feeling unwell (Verbatim: she did not feel well). The patient was treated with amlodipine. The outcome of the tachycardia, feeling unwell and blood pressure high were resolved (duration 2 hrs).   The reporter considered the tachycardia, feeling unwell and blood pressure high to be possibly related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the tachycardia, feeling unwell and blood pressure high to be possibly related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-OCT-2024 The reporter reported that the patient had received Fluarix vaccine and on the same day at 14:00 the nurse stating she did not feel well. The nurse found the staff member to had an extremely high blood pressure as well as an extremely high pulse, which was in the 150's. So, the reporter asked they just touching along and they just want to know what to do, go to the hospital or what. The patient did take amlodipine for high blood pressure. The nurse took the staff member to the emergency room, and there an EKG (Electrocardiogram), chest x-ray, lab work, Covid test, and flu test was all reported to be negative. No intervention was required, the symptoms resolved on their own. The staff member states her symptoms lasted about 2 hours in total. The emergency room physician believes this was a reaction to the vaccine. The nurse asked if this had been seen before.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site redness; injection site pain; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a child patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced injection site erythema (Verbatim: injection site redness) and injection site pain (Verbatim: injection site pain). The outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema and injection site pain to be related to Infanrix and Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-OCT-2024 The healthcare professional stated that two of her pediatric patients received Infanrix.  Both children had injection site redness and pain.  The parent's notified the healthcare professional of the effects a few days after vaccination.  It was not reported when the effects began or if they had resolved. Nothing else was reported.  The vaccine administration facility was the same as primary reporter.
Age: 1.58
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Maladministration of TDAP (Boostrix) in a nineteen month old patient; Maladministration of TDAP (Boostrix) instead of DTAP (Infanrix) in a nineteen 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 19-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Boostrix and did not receive Infanrix. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Maladministration of TDAP (Boostrix) in a nineteen month old patient) and wrong vaccine administered (Verbatim: Maladministration of TDAP (Boostrix) instead of DTAP (Infanrix) in a nineteen month old patient). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   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: 23-OCT-2024 The healthcare provider reported that there was maladministration of a tetanus, diphtheria, and pertussis vaccine (Boostrix) instead of diphtheria, tetanus, and pertussis (Infanrix) in a 19 month old patient, which led to inappropriate age at vaccine administration and wrong vaccine administered.  The reporter asked about what to do (advise/guidance) about the maladministration of Boostrix instead of Infanrix
Age: 5.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: The travel HCP called the mother to report the wrong presentation of Menveo was given to boy; Inappropriate age/ travel HCP gave her son (age 5) the One vial presentation of Menveo-pink cap; Pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 5-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21-OCT-2024, the patient received Menveo (intramuscular, unknown thigh). In OCT-2024, an unknown time after receiving Menveo, the patient experienced injection site pain (Verbatim: Pain at injection site). On 21-OCT-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age/ travel HCP gave her son (age 5) the One vial presentation of Menveo-pink cap). On an unknown date, the patient experienced product prescribing error (Verbatim: The travel HCP called the mother to report the wrong presentation of Menveo was given to boy). The outcome of the injection site pain, inappropriate age at vaccine administration and product prescribing error were unknown.   It was unknown if the reporter considered the injection site pain to be related to Menveo.     It was unknown if the company considered the injection site pain to be related to Menveo.   Additional Information: GSK Receipt Date: 24-OCT-2024 The caller (reporter) was the mother of the patient. The caller reported that the travel HCP (healthcare professional) gave her son (patient) who aged 5 years the one vial presentation of Menveo (pink cap), which led to an inappropriate age at vaccine administration. The patient stated there was pain at the injection site.  The travel HCP called the mother to report the wrong presentation of Menveo was given to patient, which led to product prescribing error. The reporter wanted to know next steps. This case had been linked with US2024AMR133267, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR133267:same reporter, other patient
Age: 5.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: The travel HCP called the mother to report the wrong presentation of Menveo was given to both boys; the travel HCP gave her two sons ages 4 and 5 the One vial presentation of Menveo (pink cap), (Inappropriate AGE). Caller also; Pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21-OCT-2024, the patient received Menveo (intramuscular, unknown thigh). In OCT-2024, an unknown time after receiving Menveo, the patient experienced injection site pain (Verbatim: Pain at injection site). On 21-OCT-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: the travel HCP gave her two sons ages 4 and 5 the One vial presentation of Menveo (pink cap), (Inappropriate AGE). Caller also). On an unknown date, the patient experienced product prescribing error (Verbatim: The travel HCP called the mother to report the wrong presentation of Menveo was given to both boys). The outcome of the injection site pain, inappropriate age at vaccine administration and product prescribing error were unknown.   It was unknown if the reporter considered the injection site pain to be related to Menveo.     It was unknown if the company considered the injection site pain to be related to Menveo.   Additional Information: GSK Receipt Date: 24-OCT-2024 The caller (reporter) was the mother of the patient. The caller reported that the travel HCP (healthcare professional) gave her son (patient) who aged 4 years the one vial presentation of Menveo (pink cap), which led to an inappropriate age at vaccine administration. The patient stated there was pain at the injection site.  The travel HCP called the mother to report the wrong presentation of Menveo was given to patient, which led to product prescribing error. The reporter wanted to know next steps. This case had been linked with US2024132447 reported by the same reporter; Sender's Comments:  US-GSK-US2024132447:2N PATIENT
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not go back for the second dose in the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2023 patient received 1st dose of shingrix.).   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: did not go back for the second dose in the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2024 Reporter was a family member who was the patient.  Reporter had limited information and did not want to give her street address. Reporter stated that a family member received the first dose of Shingrix and did not go back for the second dose in the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles after Shingrix; Late 2nd dose/Pharmacist reported that patient (no identifiers available) received the first dose of Shingrix on 2023 and the 2nd dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after Shingrix) and incomplete course of vaccination (Verbatim: Late 2nd dose/Pharmacist reported that patient (no identifiers available) received the first dose of Shingrix on 2023 and the 2nd dose has not been administered yet). The outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2024 The reporter reported that patient (no identifiers available) received the first dose of Shingrix on 2023 and the 2nd dose had not been administered yet.  After the first dose of Shingrix patient got shingles, asked if they should restart the series. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting, the patint did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administering the Second Dose of Shingrix at Less than the Minimum Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included varicella zoster vaccine rge (cho) (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Administering the Second Dose of Shingrix at Less than the Minimum Recommended Interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 24-OCT-2024 The patient got a Shingles shot that was of Shingrix, second dose was administered one month apart and the pharmacist asked that do you have any guidance about that. The reporter did not consent follow-up from the safety department, reactively stating that they want to keep all this information private. No further information was retrieved in this call from the pharmacist´s end (vaccination detail and date, patient demographics).  The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: adult patient accidentally received a pediatric dose of Havrix; adult patient accidentally received a pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 30-year-old male patient who received HAV (Havrix pediatric) (batch number 7YA99, expiry date 30-SEP-2022) and (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   Previously administered products included Havrix (1st dose received on 17th August 2022).   On 18-OCT-2024, the patient received Havrix pediatric. On 18-OCT-2024, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: adult patient accidentally received a pediatric dose of Havrix) and underdose (Verbatim: adult patient accidentally received a pediatric dose of Havrix). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2024 Vaccination manager explained that an adult patient accidentally received a pediatric dose of Havrix on October 18th 2024 which led to adult use of a child product and underdose. Patient received a prior Havrix dose on August 17th 2022.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered in less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 04-DEC-2023, the patient received the 2nd dose of Shingrix. On 04-DEC-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose administered in less than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2024 The pharmacist reported that a patient received first dose of Shingrix on 28-NOV-2023 and 2nd dose on 04-DEC-2023. The reporter mentioned that the patient was fine at the moment.  No other information was provided since caller was in a hurry. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix vaccine earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose receievd late; 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 26-month-old male patient who received HBV (Engerix B) (batch number 95BJ9, expiry date 25-JUL-2026) for prophylaxis.   Previously administered products included Hepatitis B (1st dose received on an unknown date). Concomitant products included PEDIARIX.   On 22-OCT-2024, the patient received the 2nd dose of Engerix B. On 22-OCT-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose receievd late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2024 Pharmacist reported that a 26 month old male patient received first Hepatitis B vaccine at birth, and did not receive a second dose until 18 October 2024, which was Pediarix. The patient was then administered another hepatitis B dose, Engerix-B, on 22 October 2024. The reporter did not know the brand name of the birth dose of Hepatitis B. The patient received 2nd dose of Hepatitis B, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of vaccines before the recommended age; 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 11-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP5, expiry date 09-MAR-2026) for prophylaxis.   Co-suspect products included Hib (Hiberix) (batch number 3PY4Y, expiry date 17-MAR-2026) for prophylaxis and Rota (Rotarix) (batch number LL455, expiry date 11-OCT-2025) for prophylaxis.   On 22-OCT-2024, the patient received the 1st dose of Pediarix, the 1st dose of Hiberix and Rotarix. On 22-OCT-2024, an unknown time after receiving Pediarix, Hiberix and Rotarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of vaccines before the recommended age). The outcome of the inappropriate age at vaccine administration was unknown.   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: 24-OCT-2024 A nurse contacted GSK to report that an 11 year old male patient received a dose of Pediarix and Rotarix on October 22nd 2024 and wanted to know how to proceed with this particular scenario which led to inappropriate age at vaccine administration. They also asked if the dose of Rotarix would be valid or if a new dose had to be administered later on. They consented to receive follow up from GSK's safety team.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: administered Infanrix instead of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa (Infanrix) (batch number H9Y52) for prophylaxis.   On 17-SEP-2020, the patient received Infanrix. On 17-SEP-2020, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: administered Infanrix instead of Kinrix). The outcome of the wrong vaccine administered was unknown.   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: 24-OCT-2024 Nurse Practitioner had just discovered on a patient's vaccination records, that female child received Infanrix instead of a Kinrix vaccine which led to wrong vaccine administered. Patient was missing one IPV dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Neuralgia, Pain
Clinical narrative: pains; neuralgia pains as well; feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds; feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds/also has a shooting pain in her head; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (pains), NEURALGIA (neuralgia pains as well), EAR PAIN (feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds) and HEADACHE (feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds/also has a shooting pain in her head) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced NEURALGIA (neuralgia pains as well), EAR PAIN (feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds) and HEADACHE (feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds/also has a shooting pain in her head). In October 2024, the patient experienced PAIN (pains). At the time of the report, PAIN (pains), NEURALGIA (neuralgia pains as well), EAR PAIN (feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds) and HEADACHE (feels like somebody has thrown a dart through my head , behind right ear and enters right ear and lasts for 2-3 seconds/also has a shooting pain in her head) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  The suspect dosage text was reported as unknown.  The patient received the vaccine around 3 weeks ago and woke up the day after her vaccines with the pains. The patient was feeling the neuralgia pains as well, felt like somebody had thrown a dart through head, behind right ear and entered right ear and lasted for 2-3 seconds, aftershock wear her out, also had a shooting pain in her head. She just wanted to lie down somewhere and still had it.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-777266 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2024: Live non-significant follow-up received included reporter details updated, event verbatim updated and reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-777266:Reporter sister case
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives/His whole chest is red blob by now; This spontaneous case was reported by a patient family member or friend and describes the occurrence of URTICARIA (hives/His whole chest is red blob by now) in a 7-year-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2024, the patient received third dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) 1 dosage form. On 12-Nov-2024,  after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced URTICARIA (hives/His whole chest is red blob by now). At the time of the report, URTICARIA (hives/His whole chest is red blob by now) had not resolved.        For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that no other symptoms to report.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-777330 (E2B Linked Report). This case was linked to MOD-2024-777739 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2024: Live non-significant follow-up received; non-new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-777330:Same reporter different patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia
Clinical narrative: Often it is difficult to walk; past 6 weeks I have endured a lot of muscular pain; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Often it is difficult to walk) and MYALGIA (past 6 weeks I have endured a lot of muscular pain) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Knee replacement (2 knee replacements).  On 01-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Oct-2024, the patient experienced GAIT DISTURBANCE (Often it is difficult to walk) and MYALGIA (past 6 weeks I have endured a lot of muscular pain). At the time of the report, GAIT DISTURBANCE (Often it is difficult to walk) and MYALGIA (past 6 weeks I have endured a lot of muscular pain) had not resolved.      The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.  Concomitant product use was not provided by the reporter.  For the past 6 weeks patient had endured a lot of muscular pain. Patient had 2 knee replacements, and they never hurt, now patient had pain 24/7. Often it was difficult to walk. Patient wished never got this vaccination. Never had any prior side effects with other Moderna vaccinations.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: I pass out; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Nov2024 as dose 1, 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: LOSS OF CONSCIOUSNESS (medically significant) with onset 15Nov2024, outcome "unknown", described as "I pass out". The patient stated, "Well, I do not know if it is related or not, but there have been times in the past, when at night I have to get up and use the bathroom and upon getting up, returning I pass out and this happened last night and I do not know if it is just a coincidence or if it is been part of this vaccine."  Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vertigo, Vomiting
Clinical narrative: vertigo; Severe vomiting; diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Nov2024 at 15:00 as dose 1, single (Lot number: LN0588) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; AMLODIPINE; METOPROLOL; ROSUVASTATIN; TADALAFIL; FLECAINIDE; ELIQUIS. The patient also took other concomitant therapy included "human" (as reported).  The following information was reported: VOMITING (hospitalization) with onset 18Nov2024, outcome "recovering", described as "Severe vomiting"; DIARRHOEA (hospitalization) with onset 18Nov2024, outcome "recovering", described as "diarrhea"; VERTIGO (hospitalization) with onset 18Nov2024, outcome "recovering". The patient was hospitalized for vertigo, vomiting, diarrhoea (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of vertigo, vomiting, diarrhoea included IV treatment for nausea. Other treatment included Meclizine and ondansetron.  Clinical course: Developed vertigo on 18Nov2024 at 12 am. Severe vomiting and diarrhea symptoms as a result. No other vaccine on the same date and in four weeks. No known allergies.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body height, Bone pain, Hypoaesthesia, Lethargy
Clinical narrative: left arm is the sorest and numb/left arm aches all over; lethargic/very lethargic and has no energy; has no energy; bones ache; the site she had it on is very sore and painful; left arm is the sorest and numb; This is a spontaneous report received from a Nurse.  A 91-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Nov2024 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 91 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset Nov2024, outcome "not recovered", described as "bones ache"; HYPOAESTHESIA (non-serious) with onset Nov2024, outcome "not recovered", described as "left arm is the sorest and numb"; VACCINATION SITE PAIN (non-serious) with onset Nov2024, outcome "not recovered", described as "the site she had it on is very sore and painful"; ASTHENIA (non-serious) with onset 18Nov2024, outcome "not recovered", described as "has no energy"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2024, outcome "not recovered", described as "left arm is the sorest and numb/left arm aches all over"; LETHARGY (non-serious) with onset 18Nov2024, outcome "not recovered", described as "lethargic/very lethargic and has no energy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter calling about the shot later clarified as based off the literature given Comirnaty. She mentioned her bones ache, she is lethargic, left arm is the sorest and numb. Caller got the Covid shot yesterday (18Nov2024) and had a lot of side effects, mainly left arm aches all over the place and the site she had it on is very sore and painful. She is very lethargic and has no energy. Trying to figure to out if there is anything she could do to feel better and get over these side effects. In the future she will not bother with getting the covid shot. She knows it is good for a year supposedly. States this is the first time she has really had a side effect from any Pfizer product with this covid business. Probably doesn't even know this happened. Have not recovered completely. It is 11:00 now. It will be 24 hours at 2:30 in the afternoon. Has not recovered from any symptoms yet, symptoms are about the same. Just trying to see what she can do to make her arm feel better and so she is not so lethargic. She does not know what someone can do to feel better sooner, and she knows it will take its course so it will probably take 2-3 days to feel good.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: left arm is the sorest and numb/left arm aches all over; lethargic/very lethargic and has no energy; has no energy; bones ache; the site she had it on is very sore and painful; left arm is the sorest and numb; This is a spontaneous report received from a Nurse.  A 91-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Nov2024 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 91 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset Nov2024, outcome "not recovered", described as "bones ache"; HYPOAESTHESIA (non-serious) with onset Nov2024, outcome "not recovered", described as "left arm is the sorest and numb"; VACCINATION SITE PAIN (non-serious) with onset Nov2024, outcome "not recovered", described as "the site she had it on is very sore and painful"; ASTHENIA (non-serious) with onset 18Nov2024, outcome "not recovered", described as "has no energy"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2024, outcome "not recovered", described as "left arm is the sorest and numb/left arm aches all over"; LETHARGY (non-serious) with onset 18Nov2024, outcome "not recovered", described as "lethargic/very lethargic and has no energy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter calling about the shot later clarified as based off the literature given Comirnaty. She mentioned her bones ache, she is lethargic, left arm is the sorest and numb. Caller got the Covid shot yesterday (18Nov2024) and had a lot of side effects, mainly left arm aches all over the place and the site she had it on is very sore and painful. She is very lethargic and has no energy. Trying to figure to out if there is anything she could do to feel better and get over these side effects. In the future she will not bother with getting the covid shot. She knows it is good for a year supposedly. States this is the first time she has really had a side effect from any Pfizer product with this covid business. Probably doesn't even know this happened. Have not recovered completely. It is 11:00 now. It will be 24 hours at 2:30 in the afternoon. Has not recovered from any symptoms yet, symptoms are about the same. Just trying to see what she can do to make her arm feel better and so she is not so lethargic. She does not know what someone can do to feel better sooner, and she knows it will take its course so it will probably take 2-3 days to feel good.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: left arm is the sorest and numb/left arm aches all over; lethargic/very lethargic and has no energy; has no energy; bones ache; the site she had it on is very sore and painful; left arm is the sorest and numb; This is a spontaneous report received from a Nurse.  A 91-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Nov2024 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 91 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset Nov2024, outcome "not recovered", described as "bones ache"; HYPOAESTHESIA (non-serious) with onset Nov2024, outcome "not recovered", described as "left arm is the sorest and numb"; VACCINATION SITE PAIN (non-serious) with onset Nov2024, outcome "not recovered", described as "the site she had it on is very sore and painful"; ASTHENIA (non-serious) with onset 18Nov2024, outcome "not recovered", described as "has no energy"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2024, outcome "not recovered", described as "left arm is the sorest and numb/left arm aches all over"; LETHARGY (non-serious) with onset 18Nov2024, outcome "not recovered", described as "lethargic/very lethargic and has no energy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter calling about the shot later clarified as based off the literature given Comirnaty. She mentioned her bones ache, she is lethargic, left arm is the sorest and numb. Caller got the Covid shot yesterday (18Nov2024) and had a lot of side effects, mainly left arm aches all over the place and the site she had it on is very sore and painful. She is very lethargic and has no energy. Trying to figure to out if there is anything she could do to feel better and get over these side effects. In the future she will not bother with getting the covid shot. She knows it is good for a year supposedly. States this is the first time she has really had a side effect from any Pfizer product with this covid business. Probably doesn't even know this happened. Have not recovered completely. It is 11:00 now. It will be 24 hours at 2:30 in the afternoon. Has not recovered from any symptoms yet, symptoms are about the same. Just trying to see what she can do to make her arm feel better and so she is not so lethargic. She does not know what someone can do to feel better sooner, and she knows it will take its course so it will probably take 2-3 days to feel good.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: his joints are killing him; This is a spontaneous report received from a Nurse.  A 70-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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPATHY (life threatening), outcome "unknown", described as "his joints are killing him".  Clinical course: She mentioned her son received Comirnaty and his joints are killing him.  She talked to someone earlier and was supposed to get connected to someone else regarding question, but got hung up on.  Confirmed she has already reported these details on herself and son already to the safety department.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event arthropathy and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Cerebrovascular accident, Seizure
Clinical narrative: had a stroke; 3 mini seizures; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS VACCINE), on 30Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 05Nov2024, outcome "unknown", described as "3 mini seizures"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 05Nov2024, outcome "unknown", described as "had a stroke".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Aphthous ulcer, Blood test abnormal, Glossodynia
Clinical narrative: patient reported canker sores in her mouth; patient tongue started hurting; blood test revealed high markers (name unknown); This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Oct2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2024 as dose number unknown, single) for immunisation; COVID-19 vaccine (COVID-19 VACCINE), in Oct2024 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "muscle spasms" (ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD TEST ABNORMAL (non-serious) with onset 2024, outcome "unknown", described as "blood test revealed high markers (name unknown)"; APHTHOUS ULCER (non-serious) with onset Oct2024, outcome "recovered" (2024), described as "patient reported canker sores in her mouth"; GLOSSODYNIA (non-serious) with onset Oct2024, outcome "unknown", described as "patient tongue started hurting". The event "patient reported canker sores in her mouth" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of aphthous ulcer. Additional information: Patient reports seeing her Primary Physician on 31Oct2024, her Primary Physician prescribed magic mouthwash for 5 days. Patient's canker sores resolved.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case initially received on 07-Oct-2024, was reported by a non-health professional and concerns adult female patient.  The patient had no medical history. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 07-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, Dose regimen: Not reported, Dose: 0.5 ml, Route of Administration: Not reported, Site of administration: Not reported, Lot number: not reported and will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 07-Oct-2024, same day of vaccination, the patient experienced Dizziness (outcome: Recovered / Resolved).  Patient experienced DIZZINESS on 07-Oct-2024 after receiving Novavax and Flucelvax on the same day.  Flucelvax (TIV) action taken: Not Applicable  Reporter Assessment: Reporter's assessment: The reporter did not provide a seriousness or causality assessment.; Reporter's Comments: Event assessed as related.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Injection site pain, Malaise, Pyrexia
Clinical narrative: Fever. Began following day, lasted most of the day. Tired, bit dizzy. General malaise. Injection site sore, not worth mentioning if it wasn't for the fever. (Never gotten a fever with any vaccine prior).
Age: 77.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm swell  and red
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Loss of personal independence in daily activities, Malaise, Weight decreased
Clinical narrative: I received high dose flu and COVID vaccine concurrently on 9/28/24.  Was very  ill and tired 9/29 lost 5 pounds in a week. Stopped all DAL. Stayed home for a week. Cancel all plans and medical appointments. Will not have both vaccine concurrently again. You have no place to report that. 71 female, long COVID, with asthma. This happened in May 2021 when recovering from hospitalization case COVID infection of 2020 but  not from the other 7 boosters. Would like to know what changed.  Home TX and rest. Recovered but this 4th health set back of the year.   This was a side effect, short term.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine - previous dose 08/19/2024
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient received duplicate flu shot 8/3/24 and 11/11/24
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Per patient stated she had next day rash on her stomach, looked like clusters with water