chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Drug interaction, Swelling face
Clinical narrative: Swelling face (his face swelled up); Face swelled up due to taking Dupixent and getting the covid vaccine while on therapy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen (Batch/Lot number: unknown) at 300 mg 1x/day, second regimen from 04Apr2020 (Batch/Lot number: unknown) to 01Dec2021 at 300 mg and third regimen since 09Oct2022 (ongoing) (Batch/Lot number: unknown) for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious) with onset Oct2022, outcome "unknown", described as "Face swelled up due to taking Dupixent and getting the covid vaccine while on therapy"; SWELLING FACE (non-serious) with onset Oct2022, outcome "unknown", described as "Swelling face (his face swelled up)". The events "swelling face (his face swelled up)" and "face swelled up due to taking dupixent and getting the covid vaccine while on therapy" required emergency room visit. The action taken for dupilumab was dosage not changed.  Additional information: It was reported that patient had Pfizer covid vaccine while on therapy with Dupixent and his face swelled up, he also had missed doses of Dupixent. On unknown dates, consumer had a Pfizer covid vaccine while on therapy; he had Dupixent on a Sunday than had his Pfizer vaccine on a Monday, several days later, his face swelled up. Patient only resumed therapy with Dupixent on 09Oct2022 using the doctor's sample. Treatment for the swelling included going to urgent care and was told that it was due to taking Dupixent and getting the covid vaccine while on therapy; his doctor advised him that he needed to be off Dupixent for 1 month before the covid vaccine and then one month after. Corrective treatment: An unknown corrective Urgent care for the event (his face swelled up). At time of reporting, the outcome was unknown for the event his face swelled up and unknown for the event face swelled up due to taking dupixent and getting the covid vaccine while on therapy. Reporter causality: Related. Company causality: Not reportable.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Influenza, Off label use, Product use issue
Clinical narrative: Patient reported that he got his flu and COVID vaccine and two days later he developed the flu; Patient reported that he got his flu and COVID vaccine and two days later he developed the flu; Patient reported that he got his flu and COVID vaccine and two days later he developed the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US182641.  A 73-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "Patient reported that he got his flu and COVID vaccine and two days later he developed the flu".  Additional information: It was reported that patient got his flu and COVID vaccine and two days later he developed the flu.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: covid symptoms; covid symptoms; Dose1 JANSSEN COVID-19 VACCINE/ BNT162B2 (DOSE 2, (BOOSTER) SINGLE); This is a solicited report received from contactable reporter (Consumer). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4160608 (Company). A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Oct2021 as dose 2, (booster) single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation;  coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1165521), subcutaneous for psoriatic arthropathy, hidradenitis.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "covid symptoms"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Dose1 JANSSEN COVID-19 VACCINE/ BNT162B2 (DOSE 2, (BOOSTER) SINGLE)".  The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccines (BNT162b2, BNT162b2 omi ba.4-5 and BNT162b2) and all events.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: COVID-19/SARS-CoV-2 test positive; COVID-19/SARS-CoV-2 test positive; Vaccine breakthrough infection; COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. Other Case identifier(s): 2022NVX-US-000004137.  A 91-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EM9810), on 04Mar2021 as dose 2, single (Lot number: En6201) and on 02Nov2021 as dose 4 (booster), single (Lot number: 30155BA) for covid-19 immunisation; coviD-19 vaccine prot. subunit (nvx cov 2373)  COVID-19 VACCINE), on 30Mar2021 as dose 3 (booster), single (Lot number: 30155BA) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 30Mar2021, outcome "not recovered", described as  COVID-19 Vaccine"; VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 19Oct2022, outcome "not recovered" and all described as "COVID-19/SARS-CoV-2 test positive"; VACCINE BREAKTHROUGH INFECTION (hospitalization) with onset 19Oct2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive, notes: 19Oct2022 SARS-CoV-2 test, Positive. Case Description: On 24Oct2022, this serious, initial Regulatory Authority Safety Report was received via (Institution name withheld) via Vaccine Adverse Event Reporting System and was received on 07Nov2022. Original reporter type is unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: terrible bilateral hand and joint pain; terrible bilateral hand and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "terrible bilateral hand and joint pain".  Additional information: The patient was having terrible bilateral hand and joint pain, since having Covid shot. The patient was unable to resolve this pain, and needed assistance.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: they administered an old formula of Pfizer covid-19 vaccine booster dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "they administered an old formula of Pfizer covid-19 vaccine booster dose". Additional information: Pharmacist said they have a patient who wanted to get the Pfizer covid-19 vaccine, bivalent but they administered an old formula of Pfizer covid- 19 vaccine booster dose. Caller asked how long they should wait before giving the Pfizer covid-19, Bivalent booster dose to the patient.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experienced six months of joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004151.  A male patient 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: Bnt162b2 (Dose 1, single, Pfizer BioNTech COVID-19 Vaccine (tozinameran), Lot number: unknown), for COVID-19 immunisation.  The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "experienced six months of joint pain".  Additional information: On 07Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine (tozinameran) dose 1, dose 2, and a booster dose for COVID-19 immunisation. It was reported the patient experienced six months of joint pain after the second dose. He experienced adverse reactions again after the Pfizer booster dose. He had joint pains, sickness and it reportedly lasted for a long time. At the time of reporting, the patient still had those joint pains.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: the mRNA vaccines do not work very well for the patient; the mRNA vaccines do not work very well for the patient; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004143.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "It was reported the patient is a liver transplant recipient" (unspecified if ongoing), notes: It was reported the patient is a liver transplant recipient. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "the mRNA vaccines do not work very well for the patient". Clinical course: On 06Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose (booster) for COVID-19 immunisation. It was reported the patient was a liver transplant recipient and the mRNA vaccines did not work very well for the patient because of the medications he takes.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): LRN4778411.  A female patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing), notes: concurrent condition. Concomitant medication(s) included: OCREVUS. The following information was reported: FATIGUE (non-serious) with onset 12Oct2021, outcome "recovered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: brother died behind his vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "brother died behind his vaccination". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: It was reported that, reporter's brother died behind his vaccination , she wanted to speak to a manager or with the CEO . It was mentioned that they knew that the vaccine can cause heart inflammation but they still proceeded with the vaccination. No medical questions addressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: brother died behind his vaccination
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Multiple sclerosis
Clinical narrative: Multiple sclerosis; Dizziness; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): LRN4778449.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS. The following information was reported: DIZZINESS (non-serious) with onset 02Oct2021, outcome "recovered"; MULTIPLE SCLEROSIS (medically significant), outcome "unknown". On 18Mar2021, patient started therapy with Pfizer-BioNTech for COVID-19 prophylaxis (reported as profylaksis). On 02Oct2021, it was reported that patient experienced dizziness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Multiple sclerosis" and the suspect drug BNT162B2 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 drug 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: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: got guillan barre from her flu shot; Initial information received on 17-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an unknown age female patient who got guillan barre from her flu shot after receiving vaccine influenza 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had got guillan barre from her flu shot (guillain-barre syndrome) (unknown latency) following the administration of influenza vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (guillain-barre syndrome).  At time of reporting, the outcome was Unknown for the event guillain-barre syndrome.  Seriousness criteria: Guillain-barre syndrome was assessed as medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had flu while receiving vaccine INFLUENZA 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 VACCINE (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for Prophylactic vaccination (Immunisation)  On an unknown date the patient had flu (influenza) (unknown latency) .  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: caught the flu twice; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Adult and unknown gender patient who had caught the flu twice after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Concomitant medications included Vitamin D not otherwise specified.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) for Flu.  On an unknown date the patient had developed caught the flu twice (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported I have been taking vitamine D for the last 35 years and NO SHOTS, caught the Flu twice. Before that, I got the shots every year and caught the Flu every year.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event caught the flu twice.
Sex: U
Vaccine: FLUX
Symptoms: Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: I got one my lungs filled up with blood clots; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who states that i got one my lungs filled up with blood clots after receiving vaccine influenza 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 vaccine (produced by unknown manufacturer) (formulation, strength, route, dosage, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date the patient developed serious event of i got one my lungs filled up with blood clots (pulmonary embolism) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got one my lungs filled up with blood clots).  At time of reporting, the outcome was Unknown for the event i got one my lungs filled up with blood clots.  Seriousness Criteria : This event was assessed as medically significant. The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 23-Nov-2022: This case involves an unknown age and unknown gender of patient who states that i got one my lungs filled up with blood clots after receiving vaccine influenza vaccine. Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Loss of consciousness
Clinical narrative: pass out a few hours later; Initial information received on 19-Nov-2022 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who passed out a few hours later while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) for prophylactic vaccination.  On an unknown date the patient passed out a few hours later (loss of consciousness) (unknown latency) following the administration of Influenza vaccine.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (loss of consciousness).  At time of reporting, the outcome was Unknown for the event made me pass out a few hours later.  Seriousness criteria: Medically significant for loss of consciousness.; Sender's Comments: Sanofi company comment dated 23-Nov-2022: This case involves an unknown age and unknown gender patient who passed out a few hours later while receiving vaccine Influenza vaccine. Based on information provided, the causal role of company suspect cannot excluded. Case will be re-evaluated post further update on information regarding other underlying disease, risk precipitating factor, concomitant medication, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Impaired quality of life
Clinical narrative: ended up with guillain-barre; she never recovered and her life was very limited with the neurological disease. Big pharma is; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who ended up with guillain-barre; she never recovered and her life was very limited with the neurological disease. big pharma is after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had ended up with guillain-barre; she never recovered and her life was very limited with the neurological disease. big pharma is (guillain-barre syndrome) received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer, lot number not reported in unknown administration site for Immunisation with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Not Recovered / Not Resolved for the event.  Seriousness criteria: medically significant for guillain-barre syndrome.; Sender's Comments: Sanofi company comment dated 23-Nov-2022: This case concerns a patient who has received Influenza vaccine and experienced guillain-barre syndrome. There is no evidence to suggest a causal role of the suspect product hence the event has been assessed as unrelated to the product. There is no pharmacological plausibility of the patient to develop guillain-barre syndrome after receiving Influenza vaccine, hence the benefit risk profile of product is not affected by this report.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: first 2 time's got the flu shot, was sicker than if would have caught it the natural way; Initial information was received on 17-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced first 2 time's got the flu shot, was sicker than if would have caught it the natural way while receiving vaccine influenza 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 suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for Immunization.  On an unknown date the patient developed a non-serious event of first 2 time's got the flu shot, was sicker than if would have caught it the natural way (illness) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Autoimmune disorder, Influenza
Clinical narrative: developed autoimmune problems; started having medical issues including getting the flu often; Initial information received on 18-Nov-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a patient with unknown age and gender who had developed autoimmune problems and started having medical issues including getting the flu often while receiving vaccine influenza 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 unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, form, route was unknown) in unknown administration site for prophylactic vaccination  On an unknown date the patient developed a serious event  developed autoimmune problems (autoimmune disorder) (unknown latency) following the administration of Influenza vaccine . This event was assessed as medically significant.  On an unknown date the patient developed a non-serious started having medical issues including getting the flu often (influenza) (unknown latency) following the administration of Influenza vaccine. Patient told that he never had a flu shot, pneumonia shot, or "C". My younger sister use too get the flu shot (around the 1990's) and she started having medical issues including getting the flu often. She also developed autoimmune problems during the time she was taking the flu shot. She stopped getting the flu shot and many of those medical issues have gone away. She now takes a variety of vitamins and does things to boost her immune system instead of getting the flu shots or pneumonia shots  Action taken: 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.; Sender's Comments: Sanofi Company Comment dated 24-Nov-2022: This case involves a patient with unknown age and gender who had developed autoimmune problems while receiving vaccine influenza vaccine.Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, 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 individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Myocarditis
Clinical narrative: myocarditis; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves Adult and unknown gender patient who had myocarditis while receiving vaccines Covid-19 vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine (manufacturer, route, administration site, dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) for Flu.  On an unknown date, the patient received a dose of suspect covid-19 vaccine not produced by Company (lot number, route, administration site: unknown).  On an unknown date the patient had developed myocarditis (unknown latency) following the administration of influenza vaccine and (unknown latency) following the administration of Covid-19 vaccine.   It was reported "Are y'all adding the Covid shot to it? Because I've gotten my flu shot for years and never had an issue. Was so helpful. Then, I got the flu shot and Covid shot together and got myocarditis. Can I just get the flu shot?"  Action taken: Not applicable for both suspects.  It was not reported if the patient received a corrective treatment for the event (myocarditis).  At time of reporting, the outcome was Unknown for the event myocarditis.  Seriousness criteria: Medically significant.; Sender's Comments: company comment dated 23-Nov-2022: This case involves adult and unknown gender patient who had myocarditis while receiving vaccines influenza vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect product cannot be established in occurrence of the event. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Injury
Clinical narrative: guillain-barre; was vaccine injured from the swine flu shot; Initial information was received on 18-Nov-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a with unknown demographics patient who had guillain-barre and was injured from the Influenza 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 vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient had guillain-barre (guillain-barre syndrome) and injured (injury) (unknown latency) following the administration of Influenza vaccine.  It was reported as: Also my aunt was vaccine injured from the swine flu shot. One of the unfortunate ones that it ended up with Guillain-Barre. She never recovered and her life was very limited with the neurological disease.  Action taken: Not applicable.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the events.  Seriousness criteria: Medically significant for the event guillain-barre.; Sender's Comments: Sanofi company comment dated 23-Nov-2022: This case involves a with unknown demographics patient who had guillain-barre syndrome and was injured from the swine Influenza vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and vaccination date. Case will be reevaluated post further update on concurrent condition during vaccination, underlying diseases excluding alternative etiologies for the reported events, which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: only had one and that was probably years ago, never been so sick in my life; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-HCP.  This case involves an unknown age and unknown gender patient who only had one and that was probably years ago, never been so sick in my life after receiving INFLUENZA 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 influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient only had one and that was probably years ago, never been so sick in my life (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (only had one and that was probably years ago, never been so sick in my life).  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Every year after the flu shot, she was very sick for couple of weeks; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who every year after the flu shot, she was very sick for couple of weeks after receiving vaccine influenza 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 vaccine produced by unknown manufacturer via unknown route in unknown administration site (strength, dose, lot, formulation, frequency, and expiry date: not reported) as prophylactic vaccination.  On an unknown date the patient had every year after the flu shot, she was very sick for couple of weeks (illness) (unknown latency).  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the event (Every year after the flu shot, she was very sick for couple of weeks).  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: But I got the flu type A anyways; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who got the flu type a after receiving influenza 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 vaccine produced by unknown manufacturer (with an unknown strength, formulation, dose, frequency, route, expiry date, batch number, administration site) for prophylactic vaccination.   On an unknown date the patient got the flu type a (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event    Outcome was Unknown for the event but i got the flu type a anyways.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu shot I got the flu; Initial information received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced i got the flu shot i got the flu after receiving  influenza 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 vaccine produced by unknown manufacturer lot number not reported (formulation, expiry date, strength was unknown) via unknown route in unknown administration site for influenza vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency).  It was reported that "we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: 3 weeks after I got the flu shot I got the flu, if you're going to get sick you're going to get sick."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the flu shot I got the flu).  At time of reporting, the outcome was Unknown for the event i got the flu shot i got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: get the shots and get sick; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who reported get the shots and get sick after receiving  influenza vaccine.  The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site (form, strength, batch number, expiry date: unknown) for Prophylactic vaccination. Information for batch and expiry date was requested.  On an unknown date the patient had a non-serious event of get the shots and get sick (illness) (latency: unknown) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: all got the flu that year; Initial information received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who got the flu that year after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient who got the flu that year (influenza) received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Influenza with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (all got the flu that year).  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: i got the flu; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who stated got the flu after receiving influenza 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event i got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: that's had the flu is the person that got a flu shot; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who had the flu is the person that got a flu shot after receiving influenza 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 vaccine (produced by unknown manufacturer) (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that's had the flu is the person that got a flu shot (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (that's had the flu is the person that got a flu shot).  At time of reporting, the outcome was Unknown for the event that's had the flu is the person that got a flu shot.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: i had it last year and was sick all winter; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown age and demographics who experienced i had it last year and was sick all winter after receiving vaccine Influenza 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 vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event i had it last year and was sick all winter (illness) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (i had it last year and was sick all winter).  At time of reporting, the outcome was Unknown for the event i had it last year and was sick all winter.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: terribly sick; Initial information received on 19-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who got terribly sick after receiving vaccine influenza 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for batch number was requested  On an unknown date the patient got terribly sick (illness) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (terribly sick).  At time of reporting, the outcome was Unknown for the event terribly sick.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: The excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees Celsius with no reported adverse event; The vaccines were given post excursion with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an unknown age/gender patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] and tuberculin test [Tubersol] vaccine were given post excursion and the excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees celsius with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, it was reported that the excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees celsius with no reported adverse event (product storage error) for diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and tuberculin test.   On an unknown date, tuberculin test vaccine (lot number - C5994AA, expiry date: 26-Sep-2024) (route, dose, strength, formulation, administration site: unknown) for Immunization and  diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (with lot number: UJ678AAA, expiration date: 09-Sep-2023) (route, dose, strength, formulation, administration site: unknown) for prophylactic vaccination (Immunisation) were given post excursion with no reported adverse event (poor quality product administered)  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  Outcome: Unknown for both the events.  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.