chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: MYOCARDITIS (medically significant), outcome "unknown". Clinical course: The caller is inquiring if we have any claims set up for individuals who suffered myocarditis after receiving the Pfizer vaccine. He mentioned that he experienced this after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Hypertension, Nervous system disorder, Tinnitus
Clinical narrative: stroke level blood pressure; stroke level blood pressure; some strange cardiology and neurology issues; some strange cardiology and neurology issues; tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), in 2021 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: CEREBROVASCULAR ACCIDENT (medically significant), HYPERTENSION (medically significant), outcome "unknown" and all described as "stroke level blood pressure"; CARDIAC DISORDER (non-serious), NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown" and all described as "some strange cardiology and neurology issues"; TINNITUS (non-serious), outcome "unknown". The events "stroke level blood pressure", "some strange cardiology and neurology issues" and "tinnitus" required physician office visit. Clinical course: Patient felt very strongly that she was having some strange cardiology and neurology issues since getting her vaccine last year. She received a Pfizer vaccine. She has visited some local physicians that have all dismissed her symptoms as unexplainable and told her there was nothing else to be done. Her symptoms range from stroke level blood pressure to tinnitus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Lymphoma, Malaise
Clinical narrative: lymphoma; wasn't feeling well; anaphylaxis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004047.  A male patient received BNT162b2 (BNT162B2), in Jan2021 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: ANAPHYLACTIC REACTION (medically significant) with onset 2021, outcome "unknown", described as "anaphylaxis"; LYMPHOMA (death, medically significant), outcome "fatal"; MALAISE (non-serious), outcome "unknown", described as "wasn't feeling well". The patient date of death was unknown. Reported cause of death: "The individual contracted lymphoma and died". It was unknown if an autopsy was performed. Clinical course: On 31Oct2022, it was reported that a patient started treatment on an unspecified date in Jan2021 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for COVID-19 immunisation. It was reported the patient got anaphylaxis. "He had a terrible reaction, hard to give any more information because it was back in 2021 and he stopped getting anything after that." The individual contracted lymphoma and died (date of death not queried). The reporter stated that the patient took Pfizer and had a violent reaction. He stayed at the place where he had his shot for about half an hour and was going to drive to a friend's house but wasn't feeling well so ended up going home. The reporter repeated that the patient had a "violent reaction to Pfizer, looking backwards, people thought it was related to PEG. I say anaphylaxis but I should just say violent reaction. It was not medically diagnosed."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: The individual contracted lymphoma and died
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: liver lymphoma; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 62-year-old female patient received BNT162b2 (BNT162B2), 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: LYMPHOMA (medically significant), outcome "unknown", described as "liver lymphoma".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: Test positive for COVID 17Nov2022; Feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 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 and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 14Nov2022, outcome "unknown", described as "Feeling sick"; COVID-19 (non-serious) with onset 17Nov2022, outcome "unknown", described as "Test positive for COVID 17Nov2022". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the updated COVID-19 booster dose on Sunday, 13Nov2022, then the next day, 14Nov2022, started feeling sick but thought that this was only side effect of the vaccine. The patient tested positive for COVID-19 on 17Nov2022. The patient was just wondering of the shot offers protection if the patient was unknowingly infected when received the vaccine.   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: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Photodermatosis, Skin exfoliation
Clinical narrative: dead skin on my face. But I think it was caused by the sun; dead skin on my face. But I think it was caused by the sun; got Covid; got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): MOD22-029530 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Lot number: FE3594) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 029L20A) and on 23Feb2021 as dose 2, single (Lot number: 01M20A) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Vitamin d3; Vitamin c; Zinc. Before the covid shots, the patient has been taking Vitamin pills (Vitamin D3, C, Zinc) and his/her psoriasis has completely disappeared. After Moderna covid-19 vaccine, it just started with patches of bumps on elbows. There was no itching. On 24Feb2021, psoriasis came all the way back. The patient had bumps on buttocks, groin, back of legs and thighs. Never had it there before. The patient also had it on elbows. It's spotty. It was usually on there for a bit, then after a while the dead skin peeled off. After booster dose, the patient had dead skin on face. But patient thought it was caused by the sun. It did not look like psoriasis. The patient had this procedure done by dermatologist regularly. He used liquid nitrogen that he sprayed on face. The patient was going to see dermatologist again next month. The patient got Covid in Aug2022. It was a mild case. Therapeutic measures were taken as a result of skin exfoliation, photodermatosis.The event "dead skin on my face. but i think it was caused by the sun" required physician office visit. Therapeutic measures were taken as a result of skin exfoliation, photodermatosis.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient's husband contracted COVID-19 after initial Comirnaty vaccine series.; Patient's husband contracted COVID-19 after initial Comirnaty vaccine series.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415).  A male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Patient's husband contracted COVID-19 after initial Comirnaty vaccine series.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200106759 same reporter, patient, AE and suspect drug/different dose #;
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: irregular period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30'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, SINGLE, Manufacturer: unknown), for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular period".  Additional information: Late 30s female, otherwise healthy, reported irregular period since second COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Disruptions and irregular period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 40'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: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "Disruptions and irregular period".  Additional information: Healthy female, early 40s experienced disruptions and irregular period after second Pfizer COVID vaccine. Irregular period persisted many months later. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: irregular period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular period".  Additional information: The patient was in her early mid 40s, otherwise healthy female. Experienced irregular period after second COVID vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 202201313623 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A female patient received BNT162b2 (BNT162B2), 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: MIGRAINE (non-serious), outcome "unknown". The event "migraine" required physician office visit. Therapeutic measures were taken as a result of migraine.  Additional information: It was reported that she was being treated by a neurologist. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Malaise
Clinical narrative: flu symptoms (knocked me flat); flu symptoms (knocked me flat); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old 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: INFLUENZA (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "flu symptoms (knocked me flat)".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: C-reactive protein, C-reactive protein increased, Investigation, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; High level of C-Reactive Protein in the blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) 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; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "High level of C-Reactive Protein in the blood". The patient underwent the following laboratory tests and procedures: C-reactive protein: High level, notes: High level of C-Reactive Protein in the blood; labs: no antibodies, notes: The labs show no antibodies from the vaccine. Clinical details: The patient had the series of the vaccine plus 2 boosters. The labs showed no antibodies from the vaccine. The patient developed a condition called Polymyalga rheumatica. High level of C-Reactive Protein in the blood. When patient even received a flu shot had a flare up of the condition.  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: U
Vaccine: COVID19
Symptoms: Feeling hot, Muscular weakness, Paraesthesia, Pruritus
Clinical narrative: Feel a warmth in my upper arm where the vaccine was administered; Itch in the upper arm area and started to get tinglingly down to my fingertips; Itch in the upper arm area and started to get tinglingly down to my fingertips; The strength in my hand has diminished; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 69-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset 2022, outcome "unknown", described as "Feel a warmth in my upper arm where the vaccine was administered"; PARAESTHESIA (non-serious), PRURITUS (non-serious) all with onset 2022, outcome "unknown" and all described as "Itch in the upper arm area and started to get tinglingly down to my fingertips"; MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "unknown", described as "The strength in my hand has diminished".  Clinical course: Patient reported that I received my 3rd booster approximately 7 weeks ago and about a week after I started to feel a warmth in my upper arm where the vaccine was administered. subsequently, I started to itch in the upper arm area and started to get tinglingly down to my fingertips. In the past week, I also noticed that the strength in my hand has diminished. I am 69-year-old, and I am wondering if this possible side effect has been reported to you by other patients.   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: Menstrual disorder
Clinical narrative: Variation in monthly cycle after primary series of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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: MENSTRUAL DISORDER (non-serious), outcome "recovered", described as "Variation in monthly cycle after primary series of vaccine".  Reporter consider event as caused by suspect product.  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: My husband a 51 years old male,healthy died after Pfizer vaccine 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), 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; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "My husband a 51 years old male,healthy died after Pfizer vaccine 4". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. 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.; Reported Cause(s) of Death: My husband a 51 years old male,healthy died after Pfizer vaccine 4
Age: 63.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Depressed mood
Clinical narrative: feeling down; Initial information received on 11-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case is linked to case 2022SA120789(CLUSTER).  This case involves 63 years old female patient who experienced feeling down after receiving COVID-19 vaccine and 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, and COVID-19 vaccine not produced by Sanofi Pasteur (strength, form, dosage, frequency, lot number and expiry date: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was feeling down (depressed mood) (unknown latency) following the administration of vaccines.  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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: have Flu-A; Initial information received on 10-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who experienced have flu-a 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 Flu vaccination.  On an unknown date, the patient developed a non-serious event have flu-a (influenza) (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 (have Flu-A).  At time of reporting, the outcome was Unknown for the event have flu-a.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: aches; sore arm; low grade fever; bad rash all over her arm after receiving fluzone high dose; Initial information received on 11-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/Non-HCP.  This case involves an unknown age female patient who had bad rash all over her arm , sore arm, aches and low grade fever after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  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 quadrival A-B high dose HV vaccine (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date in Nov-2021 the patient had bad rash all over her arm after receiving fluzone high dose (rash) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  On an unknown date the patient had low grade fever (pyrexia), sore arm (pain in extremity) and  aches (pain) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, my cousin informed me late yesterday that last year she had a bad rash all over her arm after receiving Fluzone High Dose. She usually does not have any other issues other than a sore arm, aches, or low grade fever. She is not sure if it was from the vaccine or not but was just wondering if there could be a link.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (bad rash all over her arm after receiving fluzone high dose, sore arm, aches, low grade fever).  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: FLUX
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: cidp; Initial information received on 13-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who experienced CIDP after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In Nov-2012, 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 for Flu (Influenza).  On an unknown date, the patient developed a serious event of CIDP (chronic inflammatory demyelinating polyradiculoneuropathy) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (CIDP).  At time of reporting, the outcome was Unknown for the event CIDP.; Sender's Comments: Sanofi company comment dated 19-Nov-2022: This case involves a patient of unknown age and demographics who experienced CIDP after receiving vaccine Influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; Initial information was received on 13-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 got sick 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 sick (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.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: sick with the flu for 10 days; Initial information received on 13-Nov-2022 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves patient of unknown demographics who experienced sick with the flu for 10 days while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On unknown date in October 2022 (last month), the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination.  On unknown date in 2022, the patient got sick with the flu for 10 days (influenza) at unknown latency following the administration of INFLUENZA VACCINE.  It was reported that "the following potential adverse event has been found on a public post. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Got mine last month and have been sick with the flu for 10 days."   Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event sick with the flu for 10 days.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: the flu shot didn't work; got the flu a month later; Initial information received on 12-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu a month later and the flu shot didn't work 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, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious event of the flu shot didn't work (vaccination failure) (latency: 1 month) following the administration of INFLUENZA VACCINE.   On an unknown date, the patient developed a non-serious event of got the flu a month later (influenza) (latency: 1 month) following the administration of INFLUENZA VACCINE.  It was reported, I got my flu shot and got the flu a month later, the flu shot didn't work, first time I've had the flu in over 20 years.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (got the flu a month later).  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: The event of vaccination failure was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 20-Nov-2022: This case involves an unknown age and unknown gender patient who got the flu a month later and the flu shot didn't work after receiving vaccine INFLUENZA VACCINE. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history would be needed for complete assessment of the case. Based on the data provided, the role of vaccine(s) cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 14-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 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 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 prophylaxis.  On an unknown date the patient developed a non-serious event of flu (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 (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 14-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 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 produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for influenza immunization.  On an unknown date, the patient developed a non-serious event of flu (influenza) (latency: 2 days) following the administration of influenza vaccine.  It was reported, Guess I got my shot late. 2 days after spent over week in bed with flu.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Product dose omission issue
Clinical narrative: patient washed her pieces before realizing that she had missed her last dose of tyvaso; a bit of a headache; Initial information received on 15-Nov-2022 regarding an unsolicited valid non-serious courtesy case received from a Consumer/Non-HCP.  This case involves a 85 years old female patient (50.3 kg) who had a bit of a headache and patient washed her pieces before realizing that she had missed her last dose of tyvaso after receiving influenza vaccine and while treated with treprostinil sodium [tyvaso].  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 Pulmonary arterial hypertension.  Concomitant medications included AMLODIPINE BESILATE.  Patient began therapy with IH Tyvaso (Treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 13-May-2019 for primary pulmonary arterial hypertension. The current dose was reported as 54 µg (9 breaths), four times a day (QID) via inhalation (IH) route.   On 07-Nov-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Influenza immunization.  On 07 Nov 2022 (yesterday), 3 years 5 months and 26 days after initiating Tyvaso, the patient got her flu shot and had a bit of a headache (headache) from that (latency: same day).   On 08 Nov 2022, 3 years 5 months and 27 days after initiating Tyvaso, the patient washed her pieces before realizing that she had missed her last dose of Tyvaso (product dose omission issue)(latency: 1 day) at 20: 30 PM.   The nurse advised her she could open a new ampule and do the last treatment of 9 breaths yet tonight or wait and do the next treatment in the morning.  She decided she would get up about 1 hour early and do the treatment a bit early.  Action taken with treprostinil sodium was unknown and was not applicable with respect to influenza vaccine.   It was not reported if the patient received a corrective treatment for the events (a bit of a headache).  At time of reporting, the outcome was Unknown for 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 guidelines. 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: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 15-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 had flu 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, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Flu. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of flu (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received from on 15-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 had flu after receiving vaccine 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 (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Flu. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious flu (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Got the shot yesterday, sick today; Initial information received on 15-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional) via Social Media.  This case involves an unknown age and unknown gender patient who got the shot yesterday, sick today 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 dose, strength, route) (lot number and expiry date: not reported) in unknown administration site for immunization and  got the shot yesterday, sick today (illness) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got the shot yesterday, sick today).  At time of reporting, the outcome was Unknown for the event got the shot yesterday, sick today.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza like illness
Clinical narrative: very sick for the last 4 days; sure feels like the flu; Initial information received on 15-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an Adult and unknown gender patient who was very sick for the last 4 days and sure felt like 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 (with an unknown strength, form, lot number and expiry date) via subcutaneous route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed very sick for the last 4 days (illness) and sure feels like the flu (influenza like 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 events (sure feels like the flu, very sick for the last 4 days).  At time of reporting, the outcome was Unknown for the event sure feels like the flu and was Unknown for the event very sick for the last 4 days.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got sick everytime the day after; Initial information received on 15-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an patient with unknown age gender who experienced got sick everytime the day after 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 (formulation, strength, dose, route, administration site and lot number not reported) for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick everytime the day after (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.  At time of reporting, the outcome was Unknown for the event got sick everytime the day after.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: fluzone high dose was given intravenously with no reported adverse event; Initial information received on 10-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 68 years old female patient who reported  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was given intravenously with no reported adverse event    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 Osteoporosis.    On 10-Nov-2022, the patient received a 1X  0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (lot number not reported) via intravenously route in unknown administration site for immunization.  On 10-NOV-2022 same day, the patient reported a non-serious event INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (fluzone) high dose was given intravenously with no reported adverse event.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, Medication error, No adverse event, Product use issue
Clinical narrative: given intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 27 years old male patient who had given YELLOW FEVER VACCINE [YF-VAX] intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.  On 14-Nov-2022, the patient received an unknown dose of suspect YELLOW FEVER VACCINE once (strength, formulation lot number and expiry date was unknown) via intramuscular route in the left arm for Immunization.  On 14-Nov-2022 the patient developed a non-serious event of given intramuscularly instead of subcutaneously with no reported adverse event (product use issue)(Latency: same day) following the administration of YELLOW FEVER VACCINE.Reporter wants to know the implications in this situation.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: received a dose of MENACTRA intended as a booster dose, but patient received his last dose in 2021; was behind on vaccinations with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 years old male patient who received a dose of Meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] intended as a booster dose, but patient received his last dose in 2021; was behind on vaccinations with no reported adverse event.  The patient's past vaccination(s) included Menactra on 18-Oct-2021.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Influenza vaccine (Influenza vaccine) for Prophylactic vaccination; and HPV vaccine (HPV vaccine) for prophylactic vaccination.  On 03-Nov-2022, the patient received a 0.25 mL to 2 mL dose for vaccines or 0.1 mL for TB skin test: 0.5ML once, dose 2 (booster dose) of suspect Meningococcal A-C-Y-W135 (D conj) vaccine with standard strength intended as a booster dose, but patient received his last dose in 2021; was behind on vaccinations with no reported adverse event (inappropriate schedule of product administration) (lot U7483AA, expiry date: 20-Oct-2023) via intramuscular route in the right deltoid for immunization with unknown form, .  Action taken: not applicable.  Outcome: Unknown.  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 guidelines. 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.