chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Immunisation, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'Congenital anomaly/birth defect'; Sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'Congenital anomaly/birth defect'; dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A fetus patient was exposed to bnt162b2 (Pfizer-BioNTech COVID-19), transplacental, administration date 22Dec2021 00:15 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The mother of the patient was 37 years old at the time of vaccination. Date of last menstrual period of the mother: 04Nov2021. The mother was 6 weeks pregnant at the time of exposure to bnt162b2. The mother was 7 weeks pregnant at the event onset. The mother is expected to deliver a baby(s) on 11Aug2022. The mother's relevant medical history and concomitant medications were not reported. The mother's vaccination history included: Bnt162b2 (Dose Number: 02, Vaccine Administration date: 02Jun2021, Lot no.: EW0178, Anatomical Site: Arm left), administration date: 02Jun2021, for Covid-19 immunization, reaction(s): "gestational period:7, 1st dose:12May2021,2nd dose:02Jun2021"; Bnt162b2 (Dose Number: 01, Vaccine Administration date: 12May2021, Lot no.: EW0183), administration date: 12May2021, for Covid-19 immunization, reaction(s): "gestational period:7, 1st dose:12May2021,2nd dose:02Jun2021". The following information was reported: IMMUNISATION (death, congenital anomaly) with onset 22Dec2021 00:15, outcome "fatal", described as "dose received: 3"; MATERNAL EXPOSURE DURING PREGNANCY (death, congenital anomaly), CONGENITAL ANOMALY (death, congenital anomaly) all with onset 25Dec2021, outcome "fatal" and all described as "Sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'Congenital anomaly/birth defect'". The events "dose received: 3", "sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'congenital anomaly/birth defect'" and "sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'congenital anomaly/birth defect'" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of congenital anomaly. The patient date of death was 25Dec2021. The reported cause of death was abortion spontaneous. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200029132 mother case; Reported Cause(s) of Death: Miscarriage
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: positive for covid19; had vaccine.; positive for covid19; had vaccine.; I have been sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose number unknown, single 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), SARS-COV-2 TEST POSITIVE (medically significant), outcome "unknown" and all described as "positive for covid19; had vaccine."; ILLNESS (non-serious), outcome "unknown", described as "I have been sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive: had vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: mild, positive local reactions; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a patient of unknown demographics who experienced mild, positive local reactions, while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE 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 VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed mild, positive local reactions (local reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that they needed to skin test a patient to the flu vaccine that they suspected had egg allergy. they used one of our doctors and her nurse as controls who they knew were not allergic to egg. They both had mild, positive local reactions -they were brain storming what we may have done wrong and also were looking into what the differences were between >65 quadrivalent and regular quadrivalent vaccines. The doctor was also asking what the inactive ingredients were.    Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (mild, positive local reactions).  At time of reporting, the outcome was Unknown for the event mild, positive local reactions.
Sex: U
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: mild, positive local reactions; Initial information received on 04-Jan-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who experienced mild, positive local reactions while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE 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 VACCINE (formulation: suspension for injection, strength, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious mild, positive local reactions (localized skin reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported"We needed to skin test a patient to the flu vaccine that we suspected had egg allergy. We used one of our doctors and her nurse as controls who we know are not allergic to egg. They both had mild, positive local reactions-We are brain storming what we may have done wrong and also are looking into what the differences are between >65 quadrivalent and regular quadrivalent vaccines. The doctor is also asking what the inactive ingredients are. This case has been created for Nurse Separate case has been created for unknown number of people for positive skin test."  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event non-serious mild, positive local reactions  At time of reporting, the outcome was Unknown for the event non-serious mild, positive local reactions
Sex: U
Vaccine: FLUX
Symptoms: H1N1 influenza
Clinical narrative: variant of h1n1; Initial information received on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who had variant of h1n1 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 lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious variant of h1n1 (h1n1 influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (variant of h1n1).  At time of reporting, the outcome was Unknown for the event variant of h1n1.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Flu shots make me sick every time; Initial information received on 31-Dec-2021 regarding an unsolicited valid  non-serious case received from a patient.  This case involves Adult and unknown gender patient who take flu shots make sick every time 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 (unknown manufacturer, lot number, formulation, strength, not reported via unknown route in unknown administration site, expiry date) for prophylactic vaccination.  On an unknown date in 1970 ,the patient developed a non-serious event "flu shots make me sick every time "(illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu shots make me sick every time).  At time of reporting, the outcome was Unknown for the event flu shots make me sick every time.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 31-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics 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 an unknown dose of suspect INFLUENZA VACCINE (with an route, strength) produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported"Never had the flu until I got a flu shot. Not about to do that again. It is unknown if the patient experienced any additional symptoms/events."  Action taken with INFLUENZA VACCINE (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: Illness
Clinical narrative: got the flu shot, got so ill that would rather suffer through the flu; Initial information received on 30-Dec-2021 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 shot, got so ill that would rather suffer through the 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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; formulation: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got the flu shot, got so ill that would rather suffer through the flu" (illness) (unknown latency).  There were no lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot, got so ill that would rather suffer through the flu).  At time of reporting, the outcome was Unknown for the event got the flu shot, got so ill that would rather suffer through the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an unknown age and unknown gender patient who experienced got my flu shot in october and still caught the 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "got my flu shot in October and still caught the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. I got my flu shot in October and till caught the flu Comment". Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got my flu shot in October and still caught the flu). At time of reporting, the outcome was Unknown for the event got my flu shot in October and still caught the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient of unknown demographics who got 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 an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation, strength, frequency) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported" I got mine, a month later I got the flu. Sometimes I swear they shoot you up with water." Action taken with INFLUENZA VACCINE (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: Inflammation
Clinical narrative: flare of inflammation go through several body parts; condition aggravated; Initial information received on 03-Jan-2022 regarding an unsolicited valid non-serious social media case received from a patient.   This case involves an unknown age and unknown gender patient who had flare of inflammation go through several body parts while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In OCT-2021, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route in unknown administration site (dose, formulation, strength, lot number and expiry date: not reported) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "flare of inflammation go through several body parts" (inflammation) with symptom condition aggravated (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "When I worked in health care, all the staff got their jab so we could protect our residents. I hadn't had a flu shot for a few years & then decided to get one in October of 2021, because Covid is still hanging around. I had a flare of inflammation go through several body parts. Had never had a reaction from a flu vaccine before."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flare of inflammation go through several body parts).  At time of reporting, the outcome was Unknown for the event flare of inflammation go through several body parts.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: I got sick every time I got a flu shot so no more for me; Initial information received on 04-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient).  This case involves an adult patient of unknown age and gender who developed illness (I got sick every time I got a flu shot so no more for me) while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation, strength) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "i got sick every time i got a flu shot so no more for me" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got sick every time I got a flu shot so no more for me).  At time of reporting, the outcome was Unknown for the event i got sick every time i got a flu shot so no more for me.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: get sick maybe once ever three years; Initial information received on 03-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who reported get sick maybe once ever three years, while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 1992, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "get sick maybe once ever three years" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" got the flu shot in 1992. It was a terrible. I had an adverse reaction to it and will never get another one. Fortunately I only get sick maybe once ever three years, maybe."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (get sick maybe once ever three years).  At time of reporting, the outcome was Unknown for the event get sick maybe once ever three years.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: This case involves an unknown age and unknown gender patient who experienced got sick from them 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 (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation). On an unknown date the patient developed a non-serious event "got sick from them (illness)" (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I have had mine and got sick from them I am getting booster monday and not looking forward to it." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got sick from them). At time of reporting, the outcome was Unknown for the event got sick from them.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received from on 05-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non health care professional).  This case involves Adult and unknown gender patient who experienced got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 1975, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu).  At time of reporting, the outcome was Unknown for the event got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: I got sick; Initial information received on 12-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient).  This case involves a patient of unknown demographics 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 an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation, strength) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "i got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported "got a flu shot 1 time in my life 30 years ago and I got sick as fuck! from that shot! I never had flu be for that shot and I never had flu 30 years after that shot! So I'm good thanks."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got sick).  At time of reporting, the outcome was Unknown for the event i got sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: took it twice got the flu twice; Initial information received on 05-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who stated took it twice got the flu twice 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 two unknown doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; strength; formulation: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "took it twice got the flu twice" (influenza) (unknown latency).  It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (took it twice got the flu twice).  At time of reporting, the outcome was Unknown for the event took it twice got the flu twice.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Rhinorrhoea
Clinical narrative: nose to run; Miserable; Initial information received on 03-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from the patient.  This case involves an unknown age and unknown gender patient who experienced nose to run and miserable 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 (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious "nose to run (rhinorrhoea)" (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious "miserable (feeling abnormal)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My last shot caused my nose to run for 3 months. That was 4 years ago this year. I was so miserable. Only time it didn't run was when I was asleep. I had to hold a Kleenex under my nose to drive. Since then. I have not had the flu or a runny nose. It stirred up a hystaming. I suffered. I'm sorry about that. But wasn't my fault."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (nose to run, Miserable).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event nose to run and was Recovered / Resolved on an unknown date for the event miserable.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Got sick from it; Initial information received on 05-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got sick from it 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 lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious got sick from it (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got sick from it).  At time of reporting, the outcome was Unknown for the event got sick from it.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Got sick for 2 weeks; Initial information received on 04-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient f unknown demographics who got sick for 2 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 lot number not reported via unknown route for influenza immunization.  On an unknown date, the patient developed a non-serious got sick for 2 weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got sick for 2 weeks).  At time of reporting, the outcome was Unknown for the event got sick for 2 weeks.
Age: 94.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: shingles; Initial information received on 05-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer son.  This case involves 94 years old male patient who had shingles 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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; strength; formulation: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "shingles" (herpes zoster) (unknown latency).  It was reported "My dad got his flu shot and came down with a nasty case of shingles which I read is not uncommon."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (shingles).  At time of reporting, the outcome was Unknown for the event shingles.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult 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 produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (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: Adverse reaction
Clinical narrative: got the flu every season anyway; bad reaction; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves unknown age and gender patient who got the flu every season anyway and bad reaction while receiving vaccine influenza vaccine (Flu 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 and expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu every season anyway (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious bad reaction (adverse reaction) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, stopped getting flu shot 15 years ago (approximately 2007) after a bad reaction. Always got the flu every season anyway. Since I stopped getting the vaccine, I haven't gotten the flu since. Before getting vaccinated every year only had the flu twice. Crazy! Not against vaccines, but now feel the flu vac is more about making money than anything else.  Action taken: INFLUENZA VACCINE was discontinued due to bad reaction and not applicable for event influenza.  It was not reported if the patient received a corrective treatment for the events (got the flu every season anyway, bad reaction).  At time of reporting, the outcome was Unknown for the event got the flu every season anyway and was Unknown for the event bad reaction.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot for years always got the flu anyway; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported got the flu shot for years always got the flu anyway 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination .  On an unknown date the patient developed a non-serious event "got the flu shot for years always got the flu anyway" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "got the flu shot for years always got the flu anyway It is unknown if the patient experienced any additional symptoms/events".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot for years always got the flu anyway).  At time of reporting, the outcome was Unknown for the event got the flu shot for years always got the flu anyway.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got mine the 20th and got diagnosed with a different flu on the 22nd; Initial information received on 06-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp via global digital media.  This case involves Adult of an unknown gender patient who reported i got mine the 20th and got diagnosed with a different flu on the 22nd ,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 (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event " i got mine the 20th and got diagnosed with a different flu on the 22nd" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got mine the 20th and got diagnosed with a different flu on the 22nd).  At time of reporting, the outcome was Unknown for the event i got mine the 20th and got diagnosed with a different flu on the 22nd.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 05-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult of 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 (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event" flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"got the flu shot got the flu."  Action taken with INFLUENZA VACCINE (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: Ill-defined disorder
Clinical narrative: got mind and it almost kill me; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who got mind and it almost kill him/her 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 an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a serious event "got mind and it almost kill me" (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got mind and it almost kill me).  At time of reporting, the outcome was Unknown for the event got mind and it almost kill me.; Sender's Comments: Sanofi Company Comment dated 13-Jan-2022. This case involves a patient of unknown demographics who got mind and it almost kill him/her while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Sex: U
Vaccine: FLUX
Symptoms: Cerebral haemorrhage
Clinical narrative: brain bleed; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics whose brain bleed 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, injection (strength, dose, route, frequency: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient had brain bleed (cerebral haemorrhage) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient haven't had the flue sense 1990.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (brain bleed).  At time of reporting, the outcome was Unknown for the event brain bleed.; Sender's Comments: Sanofi Company Comment dated 13-Jan-2022. This case involves a patient of unknown demographics whose brain bleed while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed  Further information regarding therapy details, time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.    This case involves Adult male 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was reported, "the only time I got the flu was when I got the flu shot! Same with hubby so no coincidence there!! Never again. Plus my mother & her sister for years would get the flu shot, only ones that ended up with dementia! Sorry no! Nothing beats your immune system, learn what to take to stay healthy!!"  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (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 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult 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 (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (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.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Malaise
Clinical narrative: Covid symptoms; Initial information received on 03-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 years old female patient who had covid symptoms while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jan-2021, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  On 03-JAN-2022 the patient developed a non-serious covid symptoms (covid-19) 1 year following the administration of RABIES (HDC) VACCINE.  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the event (Covid symptoms).  At time of reporting, the outcome was Unknown for the event covid symptoms.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis allergic, Pruritus, Rash
Clinical narrative: had severe itching that started from her extremities (hands and legs), and finished with an allergic rash all over her body; had severe itching that started from her extremities (hands and legs), and finished with an allergic rash all over her body; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious courtesy case received from a pharmacist.  This case involves a 54 years old female patient who had severe itching that started from her extremities (hands and legs), and finished with an allergic rash all over her body, while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included METHOTREXATE (OTREXUP) for Rheumatoid arthritis.  On 08-Dec-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route in unknown administration site for vaccination.  On 24-DEC-2021 the patient developed a non-serious had severe itching that started from her extremities (hands and legs) and finished with an allergic rash all over her body (rash,pruritus) 16 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Pruritus and Rash.  At time of reporting, the outcome was Unknown for the events
Sex: M
Vaccine: DTAPIPVHIB, HEP, RVX
Symptoms: Product preparation error
Clinical narrative: one of the children did not receive the ACT-HIB portion of the vaccine, with no reported adverse event; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious case was received from the health professional.  This case involves a 5 months old male patient who did not receive the act-hib portion of the vaccine, with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), and family history were not provided.  Concomitant medications included rotavirus vaccine (Rotavirus Vaccine) for prophylactic vaccination; and hepatitis b vaccine (Hepatitis B Vaccine) for prophylactic vaccination.  On 15-Dec-2021, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Strength : 0.5 ML; form, dosage: unknown; lot/batch number: UJ569ABA) via intramuscular route in unknown administration site for immunization.  On 15-DEC-2021 the patient developed a non-serious event 'one of the children did not receive the act-hib portion of the vaccine, with no reported adverse event' (product preparation error) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It is reported 'Caller reporting that two children received the PENTACEL vaccine on 15Dec2021 but one of the children did not receive the ACT-HIB portion of the vaccine. Caller stated they do not know which one of the patient did not receive the ACT-HIB portion. Caller is wanting to find out what to do'.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event one of the children did not receive the act-hib portion of the vaccine, with no reported adverse 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.