chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymph node pain, Pain in jaw, Tongue blistering, Tongue disorder
Clinical narrative: 3 days later my tongue had large bumps and blisters/I still have them; 3 days later my tongue had large bumps and blisters/I still have them; My jaw hurts and my lymph nodes hurt; My jaw hurts and my lymph nodes hurt; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Oct2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 11Oct2024 at 15:00 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Bivalve molusks allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TONGUE DISORDER (non-serious), TONGUE BLISTERING (non-serious) all with onset 15Oct2024 at 04:00, outcome "not recovered" and all described as "3 days later my tongue had large bumps and blisters/I still have them"; PAIN IN JAW (non-serious), LYMPH NODE PAIN (non-serious) all with onset 15Oct2024 at 04:00, outcome "not recovered" and all described as "My jaw hurts and my lymph nodes hurt". It was unknown if therapeutic measures were taken as a result of tongue disorder, tongue blistering, pain in jaw, lymph node pain.  Additional information: It was reported that 3 days later her tongue had large bumps and blisters. She still had them. Her jaw hurts and her lymph nodes hurt. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which they are reporting. The patient was not taking any other medications within 2 weeks of the event starting. No Hospitalization prolonged. Vaccine was administered at hospital facility.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, warm, & swollen left arm that lasted until 01Aug2024; Red, warm, & swollen left arm that lasted until 01Aug2024; Red, warm, & swollen left arm that lasted until 01Aug2024; This is a spontaneous report received from a Physician from a sales representative.  A 68-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Jul2024 as dose number unknown, single (Lot number: HP7364) at the age of 68 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 2024, outcome "recovered" (01Aug2024) and all described as "Red, warm, & swollen left arm that lasted until 01Aug2024"; PERIPHERAL SWELLING (non-serious), outcome "recovered" (01Aug2024), described as "Red, warm, & swollen left arm that lasted until 01Aug2024".  Additional information: The patient experienced allergy for unknown drug. The patient had not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient had not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. It was unknown that the patient taking any other medications within 2 weeks of the event starting.
Age: 27.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Vaccination site reaction
Clinical narrative: Within 24 hours following administration, experienced mild injection site reaction; general fatigue; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 06Nov2024 as dose number unknown, single) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 07Nov2024, outcome "recovering", described as "Within 24 hours following administration, experienced mild injection site reaction"; FATIGUE (non-serious) with onset 07Nov2024, outcome "recovering", described as "general fatigue"; HEADACHE (non-serious) with onset 07Nov2024, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site reaction, fatigue, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting. Patient had no allergy. It was reported that within 24 hours following administration, experienced mild injection site reaction. Further, felt general fatigue, headache.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), on 06Nov2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2024, outcome "unknown", described as "pain at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.  Additional information: Patient received co administration of the flu shot and Comirnaty and had zero side effects other than pain at the injection site.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Redness, swelling, induration, and rash, in a 3-4 cm round size at injection site; Redness, swelling, induration, and rash, in a 3-4 cm round size at injection site; Redness, swelling, induration, and rash, in a 3-4 cm round size at injection site; Redness, swelling, induration, and rash, in a 3-4 cm round size at injection site; pain at injection site; This is a spontaneous report received from an Other HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Nov2024 as dose 1, single (Lot number: Lm2210) at the age of 52 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (TRIVALENT INFLUENZA VACCINE), on 05Nov2024 as dose 1, single (Lot number: 9P74A), in left arm for immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "tree nut allergy" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 01Apr2024; PROGESTERONE, start date: 01Apr2024; ALLEGRA D [FEXOFENADINE HYDROCHLORIDE;PSEUDOEPHEDRINE HYDROCHLORIDE]. The following information was reported: VACCINATION SITE INDURATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 06Nov2024 at 07:00, outcome "not recovered" and all described as "Redness, swelling, induration, and rash, in a 3-4 cm round size at injection site"; VACCINATION SITE PAIN (non-serious) with onset 06Nov2024 at 07:00, outcome "not recovered", described as "pain at injection site". Therapeutic measures were not taken as a result of vaccination site induration, vaccination site erythema, vaccination site swelling, vaccination site rash, vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the suspect vaccine. The patient was taking other medications within 2 weeks of the onset of the event. The patient was not hospitalized due to any event.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, C-reactive protein, Red blood cell sedimentation rate
Clinical narrative: Diagnosed with ANCA Vasculitis; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 02Jul2021 as dose 1, single (Lot number: EW0180) at the age of 46 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid issues/Hashimotos" (unspecified if ongoing); "Thyroid issues/Hashimotos" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (prolonged hospitalization, disability, life threatening) with onset 04Jul2021, outcome "recovered with sequelae", described as "Diagnosed with ANCA Vasculitis". The patient prolonged hospitalization for anti-neutrophil cytoplasmic antibody positive vasculitis (hospitalization duration: 7 day(s)). The event "diagnosed with anca vasculitis" required emergency room visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated; Red blood cell sedimentation rate: Elevated. Therapeutic measures were taken as a result of anti-neutrophil cytoplasmic antibody positive vasculitis. Clinical course: The patient did not receive other vaccine on same date, in four weeks, and in two weeks. The patient started to cough up blood 2-3 days post vaccine. Flu like symptoms, and moderate to severe muscle and joint pain. Elevated sed rate/CRP in labs. Symptoms continued for months until he ended up in the ER due to difficulty breathing and severe disabling pain. Diagnosed with ANCA Vasculitis. The adverse event resulted in Hospitalization, Prolongation of existing hospitalization (treatment received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for 7 days and recovered with lasting effects. He received treatment was for severe ANCA vasculitis. Patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am fully vaccinated with current booster/Diagnosed with COVID/milder COVID symptoms (sneezing, coughing and sore throat); I am fully vaccinated with current booster/Diagnosed with COVID/milder COVID symptoms (sneezing, coughing and sore throat); This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) 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 included: "Healthy 68 year old female with the exception of Melanoma surgery in 2010.", start date: 2010 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Nov2024 at 08:00, outcome "not recovered" and all described as "I am fully vaccinated with current booster/Diagnosed with COVID/milder COVID symptoms (sneezing, coughing and sore throat)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Nov2024) Negative; (05Nov2024) Negative; (08Nov2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Nausea, Vertigo positional
Clinical narrative: Severe positional vertigo; nausea; This is a spontaneous report received from a Nurse.  A 51-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Nov2024 as dose 1, single (Lot number: LM2210, Expiration Date: 07Apr2025) at the age of 51 years, in right arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 04Nov2024 as dose 1, single (Lot number: F9X4P), in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Lactose allergy" (unspecified if ongoing). Concomitant medication(s) included: ZEPBOUND, start date: 01Apr2024; FLU VACCINE VII taken for immunisation, on 04Nov2024 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VERTIGO POSITIONAL (non-serious) with onset 06Nov2024 at 05:00, outcome "recovering", described as "Severe positional vertigo"; NAUSEA (non-serious) with onset 06Nov2024 at 05:00, outcome "recovering". Therapeutic measures were taken as a result of vertigo positional, nausea.  Additional information: It was reported that the patient was taking other medications within 2 weeks of the event starting. Patient was taking unknown medication for the events of Severe positional vertigo and nausea. Hospitalization Prolonged was reported as No for the events.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a Consumer or other non HCP.  A male patient in his 70's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered", described as "Stroke". Clinical course: Caller, sakes rep for Pfizer, It was reported that patient, her husband, when he had second primary dose, did not knew which Covid vaccine it was, patient had stroke, reporter thought from Covid vaccine. Reporter had 3 friends that had different issues, breathing and heart attack. That was all the reporter gave. Reporter was receptionist, reporting regarding her husband and 2 other friends. Clarified by caller, reporter would be calling in to report this, as well, to provide all of the details regarding her husband. The only thing caller knew was, patient, the reporter's husband, was in his 70's, was a male, stroke happened soon after the vaccine, thought it was 3 years ago and clarified, reporter thought it was after second vaccine, second dose when the vaccine first came out. All she was told, it was soon after the vaccine and stated that patient did completely got better from the stroke.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400298510 Same reporter/vaccine, different patient/event;US-PFIZER INC-202400298511 Same reporter/vaccine, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: she has atrophy in that muscle; This is a spontaneous report received from a Pharmacist.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE ATROPHY (non-serious), outcome "unknown", described as "she has atrophy in that muscle".  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: patient is running is very high fever like he is saying like 103 or sometimes 104; This is a spontaneous report received from a Pharmacist.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HP7365, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (medically significant), outcome "unknown", described as "patient is running is very high fever like he is saying like 103 or sometimes 104". The patient underwent the following laboratory tests and procedures: Body temperature: 103, notes: patient is running is very high fever like he is saying like 103 or sometimes 104; 104, notes: patient is running is very high fever like he is saying like 103 or sometimes 104. Therapeutic measures were taken as a result of pyrexia.  Additional information: The reporter stated, "I am calling from a pharmacy. I am pharmacist myself too. So, this is more about drug side effect question. I administered Prevnar 20 on the 7th and patient is running is very high fever like he is saying like 103 or sometimes 104, is that okay? You know he can keep on taking the Tylenol? I never seen that high temperature before."; Sender's Comments: As there is limited information in the case provided, the causal association between the event pyrexia and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) 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.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: got infected and developed COVID-19; got infected and developed COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Nurse from medical information team.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Sep2022 as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "latex allergy", start date: 2014 (unspecified if ongoing), notes: about 10 years ago. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Aug2023, outcome "recovered" and all described as "got infected and developed COVID-19". Clinical course: The Consumer reported that she has been fully vaccinated since 2021 with Pfizer's COVID 19 vaccines, except for 2022, when she received a dose of the Moderna vaccine. The Consumer reported that when she got infected and developed COVID-19 like symptoms, she had fever, cough, loss of taste and smell. Stated she got COVID-19 on 26Aug2023 between dose 6 and 7. She thinks that the symptoms lasted 5-7 days, fever, tired, cough and whatever. She did lose sense of taste and smell for 4-5 months.; Sender's Comments: Based on the information provided , temporal association and the administration  of the suspect drug a possible contributory role of the suspect drug in triggering the onset of   the events Interchange of vaccine products, Drug ineffective , COVID-19  cannot be excluded.,Linked Report(s) : US-PFIZER INC-202400297861 same reporter/patient, different events/dose;US-PFIZER INC-202400298948 same reporter/patient, different events/dose;US-PFIZER INC-202400298946 same reporter/patient, different events/dose;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: got infected and developed COVID-19; got infected and developed COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Nurse from medical information team.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Sep2022 as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "latex allergy", start date: 2014 (unspecified if ongoing), notes: about 10 years ago. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Aug2023, outcome "recovered" and all described as "got infected and developed COVID-19". Clinical course: The Consumer reported that she has been fully vaccinated since 2021 with Pfizer's COVID 19 vaccines, except for 2022, when she received a dose of the Moderna vaccine. The Consumer reported that when she got infected and developed COVID-19 like symptoms, she had fever, cough, loss of taste and smell. Stated she got COVID-19 on 26Aug2023 between dose 6 and 7. She thinks that the symptoms lasted 5-7 days, fever, tired, cough and whatever. She did lose sense of taste and smell for 4-5 months.; Sender's Comments: Based on the information provided , temporal association and the administration  of the suspect drug a possible contributory role of the suspect drug in triggering the onset of   the events Interchange of vaccine products, Drug ineffective , COVID-19  cannot be excluded.,Linked Report(s) : US-PFIZER INC-202400297861 same reporter/patient, different events/dose;US-PFIZER INC-202400298948 same reporter/patient, different events/dose;US-PFIZER INC-202400298946 same reporter/patient, different events/dose;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Vaccination site pain
Clinical narrative: Pain in the injection site; sore arm; Chills; Feels a little blah and needs to lay down; This is a spontaneous report received from a consumer from medical information team.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; intramuscular in right arm), administration date: 10Jan2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "Pain in the injection site; sore arm", "Chills", "Feels a little blah". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Feels a little blah and needs to lay down"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain in the injection site; sore arm".  Additional Information: The patient has been fully vaccinated since 2021 with Pfizer's COVID-19 vaccines. The patient had never had symptoms with the administration of the Comirnaty vaccine outside of the expected symptoms like pain in the injection site. The patient had no previous investigations. With the Pfizer COVID-19 vaccine, she gets a sore arm, chills, and feels a little blah and needs to lay down for a little and then feels fine. All have been like that except the later vaccine, she didn't feel anything until she woke up in the middle of the night. She usually gets her vaccine during the day and then lays down for a couple of hours and feels good. The events were considered non-serious.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400298947 Same patient and product; different dose and event;US-PFIZER INC-202400297861 Same patient and product; different dose and event;US-PFIZER INC-202400298946 Same patient and product; different dose and event;US-PFIZER INC-202400299017 Same patient and product; different dose and event;US-PFIZER INC-202400298948 Same patient and product; different dose and event;US-PFIZER INC-202400299015 Same patient and product; different dose and event;US-PFIZER INC-202400299016 Same patient and product; different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema
Clinical narrative: on the area she received the vaccination the red spot has grown 100 times bigger than what it was; feeling nauseous; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Nov2024 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: NAUSEA (non-serious) with onset Nov2024, outcome "unknown", described as "feeling nauseous"; VACCINATION SITE ERYTHEMA (non-serious) with onset Nov2024, outcome "unknown", described as "on the area she received the vaccination the red spot has grown 100 times bigger than what it was".  Additional information: Patinet mentioned she went and got the Covid vaccine on Tuesday (05Nov2024) and on the area she received the vaccination the red spot had grown 100 times bigger than what it was and had also been feeling nauseous.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Nausea, Somnolence
Clinical narrative: Somnolence; Fatigue; Injection Site Pain; Nausea; Initial information received on 16-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/ non healthcare professional.  This case involves a 39 years old female patient who experienced somnolence, fatigue, injection site pain and nausea, after receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Oct-2024, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date in Oct-2024 the patient developed somnolence, fatigue, injection site pain (vaccination site pain) and nausea (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  Action taken : not applicable.  It was not reported if the patient received corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Circulatory collapse, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: difficulty walking; collapsed twice; falling down; Guillain Barre syndrome; Initial information received on 05-Nov-2024 regarding an unsolicited valid courtesy serious case received from unknown.  This case involves a 70-year-old male patient who had difficulty walking, collapsed twice, falling and guillain barre syndrome after receiving Tozinameran (Comirnaty) and influenza USP trival A-B high dose subvirion vaccine [fluzone high dose].  The patient's past medical history included Basal cell carcinoma.  The patient's past medical treatment(s), vaccination(s) and  family history was not provided.  At the time of the event, the patient had ongoing Hyperlipidemia and Systemic lupus erythematosus.  Concomitant medications included Losartan potassium (Losartan) for Hypertension; Hydroxychloroquine sulfate (Hydroxychloroquine) for Systemic lupus erythematosus; and atorvastatin for Hyperlipidemia.  On 30-Aug-2024, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (unknown strength) with lot U8489CA and expiry date 30-Jun-2025 via unknown route in unknown administration site and Dose 1 of suspect Tozinameran (Comirnaty) (unknown strength, formulation) not produced by Sanofi Pasteur lot LM2215 and expiry date 31-Mar-2025 via intramuscular route in unknown administration site all for prophylactic vaccination (immunization).  On 03-Sep-2024 the patient developed difficulty walking (gait disturbance), collapsed twice (circulatory collapse), falling down (fall) and guillain barre syndrome (Latency 4 days) following the administration of influenza USP trival A-B high dose subvirion vaccine and Tozinameran.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events.  Seriousness criteria: The patient was hospitalized for these events and was medically significant for circulatory collapse, Guillain-Barre syndrome .; Sender's Comments: Sanofi company comment dated 11-Nov-2024: This case involves a 70-year-old male patient who had difficulty walking, collapsed twice, falling and guillain barre syndrome after receiving Tozinameran (Comirnaty) and influenza USP trival A-B high dose subvirion vaccine [fluzone high dose]. Further information regarding allergic history and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to non-viable product being administered due to a temperature with no reported adverse event; Initial information received on 31-OCT-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient who received INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV] as inappropriate use due to non-viable product being administered due to a temperature with no reported adverse event while receiving vaccine  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 dose of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE  solution for injection (lot TFAA2409, expiry:31-MAY-2025) via unknown route in unknown administration site for prophylactic vaccination inappropriate use due to non-viable product being administered due to a temperature with no reported adverse event (poor quality product administered) (unknown latency).  Reportedly, caller said the patient received the stability report, but she wanted to know how soon a patient can do the re-vaccination after a possible non viable dose.   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.
Sex: F
Vaccine: DTP, FLUX, RVX
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: bit of soreness; at 36 weeks I believe you may have to do them all so baby will get antibodies before birth; Initial information received on 31-Oct-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who had bit of soreness and at 36 weeks she believes doctor may have to do them all so baby will get antibodies before birth after receiving vaccines RSV vaccine, influenza vaccine and diphtheria, tetanus and NOS (Not otherwise specifed) pertussis vaccine. The reported at 36 weeks I believe you may have to do them all so baby will get antibodies before birth with no adverse event occurred at 36 Weeks of pregnancy The reported bit of soreness occurred at 36 Weeks of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.   On an unknown date, the patient received unknown dose of suspect diphtheria, tetanus and NOS pertussis vaccine (unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site, unknown dose of influenza vaccine (unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site and unknown dose of RSV vaccine (unknown strength, formulation, lot and expiry date) not produced by Sanofi Pasteur via unknown route in unknown administration site.  On an unknown date the patient developed bit of soreness (injection site pain) (unknown latency) following the administration of diphtheria, tetanus and NOS pertussis vaccine, influenza vaccine and RSV vaccine.  On an unknown date at 36 weeks patient believe Doctor may have to do them all vaccines so baby will get antibodies before birth (maternal exposure during pregnancy) (unknown latency)  Information on the batch number could not be requested corresponding to the one at time of event occurrence.  Reportedly, patient stated that I got the flu and tdap weeks be for the RSV. Dr said to space the out but at 36 weeks I believe you may have to do them all so baby will get antibodies before birth. I did have any crazy symptoms after having the shots tho. Just bit of soreness after the RSV.   Relevant prenatal testing after exposure not involved.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.   Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: U
Vaccine: DTP
Symptoms: Fatigue
Clinical narrative: Tdap just made me tired the next day; flu I felt nothing from; RSV was the worst of the 4 but still nothing I could not handle; Initial information received on 31-Oct-2024 regarding an unsolicited valid non-serious case received from patient.  This case involves an unknown age and gender patient who said DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. just made me tired the next day, flu i felt nothing from and RSV was the worst of the 4 but still nothing i could not handle.  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 dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (unknown strength, dosage, formulation, expiry, lot number and route) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed  flu I felt nothing from (influenza), TDAP just made me tired the next day (fatigue) and rsv was the worst of the 4 but still nothing i could not handle (respiratory syncytial virus infection) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, The patient got all 3 and the COVID booster. No issue with any of them.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was unknown for all the events.
Sex: U
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: made my arm sore; Initial information received on 30-Oct-2024 regarding an unsolicited valid Social Media non-serious courtesy case received from a consumer/ Non-Healthcare Professional.  This case involves an unknown age /gender patient who experienced made arm sore after receiving diphtheria, tetanus and acellular pertussis vaccine.  The patient's past vaccination(s) included Influenza vaccine, COVID and RSV (Respiratory Syncytial Virus) with tired for a day and then felt better. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization).   On an unknown date the patient developed arm sore as hell (pain in extremity) (unknown latency) following the administration of diphtheria, tetanus and acellular pertussis vaccine.  There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Reportedly, patient had strong reactions to flu and covid too. It could have also been because toddler didn't let sleep through the night.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (made my arm sore).  At time of reporting, the outcome was Unknown for the event made my arm sore.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: products were administered post excursion with no reported AE; Initial information received on 14-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and gender patient who administered HIB (PRP/T) VACCINE [ActHIB] post excursion 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 dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (unknown strength, dosage, expiry, lot number and route) in unknown administration site for prophylactic vaccination was administered post excursion with no reported adverse event (poor quality product administered) (unknown latency).   Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, refrigerator malfunction Max/Low Temperature reached: (negative)-1.9 Celsius duration out of labelled range: below 2 C 1 hour and 33 minutes below 0C for 35 minutes. No Human Error.    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.
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities, Paralysis
Clinical narrative: couldn't walk; couldn't walk, dress or bathe myself; Guillain Barre Syndrome; paralyzed from the neck down; Initial information received on 04-Nov-2024 regarding an unsolicited valid serious Courtesy case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who had guillain barre syndrome and paralyzed from the neck down after receiving vaccines tozinameran (Comirnaty) and influenza USP trival A-B high dose subvirion vaccine [fluzone high dose].  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 Systemic lupus erythematosus in Jun-2005.  concomitant medications included hydroxychloroquine for systemic lupus erythematosus; atorvastatin for cardiac disorder; mirabegron (myrbetriq) for hypertonic bladder, prednisone for systemic lupus erythematosus; and losartan for renal disorder.  On 30-Aug-2024, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength, lot and expiry date) via intramuscular route in the right deltoid and Unknown dose of tozinameran (unknown strength, formulation, lot and expiry date) not produced by Sanofi Pasteur via intramuscular route in the left shoulder both for Prophylactic vaccination (immunization).  On an unknown date the patient couldn't walk (gait inability) and couldn't walk, dress or bathe myself (loss of personal independence in daily activities) (unknown latency) following the administration of influenza USP trival A-B high dose subvirion vaccine and tozinameran.  On 03-Sep-2024 the patient developed guillain barre syndrome and paralyzed from the neck down (paralysis)   (Latency 4 days) following the administration of influenza USP trival A-B high dose subvirion vaccine and tozinameran.   Information on the batch number was cannot be requested corresponding to the one at time of event occurrence.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness criteria: These events were assessed as medically significant and was leading to disability. The patient was hospitalized for this event during 11 days. from 2024 (hospitalization during 11 days).; Sender's Comments: Sanofi company comment dated 13-Nov-2024: This case involves an unknown age male patient who had guillain barre syndrome and paralyzed from the neck down after receiving vaccines tozinameran (Comirnaty) and influenza USP trival A-B high dose subvirion vaccine [fluzone high dose]. Further information regarding allergic history and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 14 year patient received FLUBLOK with no reported adverse event; Initial information received on 30-OCT-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient received INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant: no other vaccines.   On 25-OCT-2024, the patient received 0.5ml (Standard) dose of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE  (once) (lot TFAA2408, expiry: 31-MAY-2025) via intramuscular route in unknown administration site for immunization with no reported adverse event (product administered to patient of inappropriate age).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, 4 patients younger than 18 have received FLUBLOK over the course of the month of October. No adverse events reported. All patients received FLUBLOK only, no other vaccines.   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-2024SA325942:
Age: 10.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: reconstitution portion of the vaccine was given but not the liquid with no reported AE; Initial information received on 16-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 month old male patient who while vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] from which the reconstitution portion of the vaccine was given but not the liquid with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (menigococcal protein), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Vaxelis) for immunization.  On 16-Oct-2024, the patient received a  dose 3 of suspectDiphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, powder and suspension for suspension for injection (lot number: UJ982AA) (unknown expiry date) which the reconstitution portion of the vaccine was given but not the liquid with no reported adverse event (single component of a two-component product administered) (latency same day) in intramuscular route in unknown administration site for immunization.  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.