chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 2, single (Lot number: N9581) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTTS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 12Jan2021, when the patient was 77-year-old, for Covid-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious), COUGH (non-serious), FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Feb2021, outcome "unknown" and all described as "1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs".  Additional information: Relevant past drug history: Name of Drug as Reported: Unk. Reaction: Allergy. Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19:Yes. List of any other medications the patient received within 2 weeks of vaccination is MULTIVIT, LOSARTAN.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201380992 same patient and different drug dose/events.;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Mild Flu like; Headache; Cough; Fatigue; Sore Arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTTS" (unspecified if ongoing), notes: POTTS. Concomitant medication(s) included: LOSARTAN. The following information was reported: COUGH (non-serious) with onset Jan2021, outcome "unknown"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset Jan2021, outcome "unknown", described as "Mild Flu like"; PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "Sore Arm".  Additional Information: Patient Experienced 1st -5th doses mild flu like, HA, SL Cough, Fatigue, Sore Arm 48 Hrs.Other medications in two weeks was Multivit, losartan. Yes, other vaccine in four weeks, Other vaccine 4 weeks product was Pfizer. Yes, COVID tested post vaccination and no prior vaccination. Sender's Comments: Linked Report(s) : PFIZER INC-202201380992 same patient and different drug dose/events.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 at 13:15 as dose 1, single (Batch/Lot number: unknown), in left arm 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), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: On 16Dec2022 the patient was treated with Paxlovid for treatment of COVID-19  and Date of last administration was on 17Dec2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm 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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medication in 2 weeks. The patient received Paxlovid from 02Dec2022 to 06Dec2022 for the treatment of event. Treatment stop on 06Dec2022. The patient did not have any no known allergy.  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 available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Allergic to Cephalosporin anitbotics" (unspecified if ongoing); "ITP" (unspecified if ongoing), notes: IVIG medical treatment for ITP; "IVIG medical treatment" (unspecified if ongoing), notes: IVIG medical treatment for ITP. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: I first tested positive for covid; (Dec2022) Negative, notes: testing negative; (Dec2022) Positive, notes: started getting symptoms again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment was started on 05Dec2022 and treatment was stopped on 10Dec2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, Malaise, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; not feeling well; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-ABBVIE-4185114.  A 56-year-old patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg (40mg/0.4ml, 40mg cf)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE; PAXLOVID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid" and "not feeling well" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical information: Solicited report by a consumer of a adult person with events of and non-serious covid, and not feeling well with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date, the patient experienced not feeling well, covid. Pfizer/ BioNTech was also considered suspect.  Assessment results: HUMIRA 40MG/0.4ML-COVID-19, feeling unwell, non-health care professional, not related. Pfizer/BioNTech-COVID-19, feeling unwell, non-health care professional, not reported.  Causalities: The reporter's causality for the event(s) of covid with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of covid and not feeling well with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  The reporter's causality for the event(s) of not feeling well with Adalimumab Solution for Injection was Not Provided.    Opinion was that the causality for the event(s) of covid and not feeling well with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.   Opinion was that the causality for the event(s) of covid and not feeling well with Adalimumab Solution for Injection was Not Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the reported events vaccination failure, covid-19 and malaise are possibly related to the suspect.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dialysis, Dizziness, Drug ineffective
Clinical narrative: experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.; experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.; she needs to go on dialysis 3 days a week; Cold; Tiredness; Headache; Muscle Pain; Joint Pain; weak when trying to get up; not feeling well; she feels dizzy for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots."; DIALYSIS (medically significant), outcome "unknown", described as "she needs to go on dialysis 3 days a week"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle Pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint Pain"; DIZZINESS (non-serious), outcome "unknown", described as "she feels dizzy for a week"; ASTHENIA (non-serious), outcome "unknown", described as "weak when trying to get up"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Clinical information: Caller stated that she is not feeling well after getting all the Pfizer COVID-19 Vaccine Shots. She stated that she needs to go on dialysis 3 days a week and she is experiencing Cold, Tiredness, Headache, Muscle Pain, Joint Pain, and she feels dizzy for a week and she is weak when trying to get up. Submitted Manual AE Form because the caller experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nasopharyngitis
Clinical narrative: experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.; experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.; she needs to go on dialysis 3 days a week; Cold; Tiredness; Headache; Muscle Pain; Joint Pain; weak when trying to get up; not feeling well; she feels dizzy for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots."; DIALYSIS (medically significant), outcome "unknown", described as "she needs to go on dialysis 3 days a week"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle Pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint Pain"; DIZZINESS (non-serious), outcome "unknown", described as "she feels dizzy for a week"; ASTHENIA (non-serious), outcome "unknown", described as "weak when trying to get up"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Clinical information: Caller stated that she is not feeling well after getting all the Pfizer COVID-19 Vaccine Shots. She stated that she needs to go on dialysis 3 days a week and she is experiencing Cold, Tiredness, Headache, Muscle Pain, Joint Pain, and she feels dizzy for a week and she is weak when trying to get up. Submitted Manual AE Form because the caller experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.; experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.; she needs to go on dialysis 3 days a week; Cold; Tiredness; Headache; Muscle Pain; Joint Pain; weak when trying to get up; not feeling well; she feels dizzy for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots."; DIALYSIS (medically significant), outcome "unknown", described as "she needs to go on dialysis 3 days a week"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle Pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint Pain"; DIZZINESS (non-serious), outcome "unknown", described as "she feels dizzy for a week"; ASTHENIA (non-serious), outcome "unknown", described as "weak when trying to get up"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Clinical information: Caller stated that she is not feeling well after getting all the Pfizer COVID-19 Vaccine Shots. She stated that she needs to go on dialysis 3 days a week and she is experiencing Cold, Tiredness, Headache, Muscle Pain, Joint Pain, and she feels dizzy for a week and she is weak when trying to get up. Submitted Manual AE Form because the caller experienced symptoms of having COVID-19 after getting all the Pfizer COVID-19 Vaccine Shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Malaise
Clinical narrative: Rapid increase in body temp to 102 degrees; Uncontrollable shivering; Malaise; Fatigue; 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), 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: BODY TEMPERATURE INCREASED (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered", described as "Rapid increase in body temp to 102 degrees"; CHILLS (non-serious), 12 hrs after the suspect product(s) administration, outcome "unknown", described as "Uncontrollable shivering"; MALAISE (non-serious), 12 hrs after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 12 hours after the bi-valent booster, patient experienced a rapid increase in body temperature to 102 degrees, uncontrollable shivering and malaise for approximately 4 hours. That was followed by a normalized body temperature, but continued malaise and fatigue for the next 12 hours.  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.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Paraesthesia
Clinical narrative: Paresthesias("brain zaps"); Dose 1, dose 2: Moderna; dose 3: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2021-158733 (Moderna).  A 47-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing); "Hypertension", start date: 2022 (unspecified if ongoing), notes: Newly diagnosed, gradual onset; "hyperlipidemia" (ongoing); "OCD", start date: 1989 (ongoing), notes: OCD; "Sleep" (ongoing), notes: sleep. Concomitant medication(s) included: ATORVASTATIN oral taken for hyperlipidaemia (ongoing); MELATONIN oral taken for sleep disorder (ongoing); PAROXETINE oral taken for obsessive-compulsive disorder (ongoing); QUETIAPINE oral, stop date: 2021. Vaccination history included: coviD-19/mrna-1273 (DOSE 1, SINGLE; Lot number: 009C21A; Anatomical location: Left arm; Time of administration:11:00; Route of administration:Intramuscular), administration date: 20Apr2021, for COVID-19 immunization, reaction(s): "Brain zaps (paresthesias)"; coviD-19/mrna-1273 (DOSE 2, SINGLE; Lot number: 041C21A; Anatomical location: right arm; Time of administration:06:10; Route of administration:Intramuscular), administration date: 19May2021, for COVID-19 immunization, reaction(s): "Brain zaps (paresthesias)". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "Dose 1, dose 2: Moderna; dose 3: Pfizer"; PARAESTHESIA (non-serious), outcome "unknown", described as "Paresthesias("brain zaps")". The event "paresthesias("brain zaps")" required physician office visit.  Additional information: It was reported that allergies to medications, food and other products were unknown. Acute illness at the time of vaccination and up to one month before was none. The symptom was nearly identical to that caused by withdrawal if a dose of paroxetine was skipped. but actually took more than the prescribed dose (to try to make the symptoms go away). Moreover, the patient experienced mild paresthesias (brain zaps) after taking the Pfizer booster in Dec2021; moderate symptoms after taking the bi-valent booster on 14Sep2022 and intolerably severe brain zaps paresthesias on 02Nov2022, the day of onset of a cold-like illness. Patient had not associated such symptoms with the onset of cold or the flu prior to receiving a coronavirus vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic response unexpected
Clinical narrative: gave me some relief from my cancer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 74-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; sirolimus (SIROLIMUS). The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Patient was in remission from her cancer. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "gave me some relief from my cancer". The action taken for sirolimus was unknown.  Additional information: The patient noted that the vaccine gave some relief from cancer, which was elaborated as worked on the whole immune system, not otherwise specified.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: felt flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. 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. 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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "felt flu like symptoms".  Additional information: Had the COVID Booster and felt flu like symptoms the next day. 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: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: did not get Covid until after I had both initial doses of the [Pfizer] vaccine.; did not get Covid until after I had both initial doses of the [Pfizer] vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "did not get Covid until after I had both initial doses of the [Pfizer] vaccine.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I did not get Covid until after I had both initial doses of the [Pfizer] vaccine.  Clinical information: patient was still not comfortable getting the booster. patient took care of family members with Covid and did not get the virus. patient did not get Covid until after patient had both initial doses of the [Pfizer] vaccine. So, for patient personally, didn't think the vaccine did any good at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Generalised bullous fixed drug eruption
Clinical narrative: Generalized fixed drug eruption; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERALISED BULLOUS FIXED DRUG ERUPTION (medically significant), outcome "unknown", described as "Generalized fixed drug eruption".; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event Generalized bullous fixed drug eruption and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, DTAP, FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: protocol is for pregnant women at their facility to receive flu vaccines, Covid vaccines and TDAP with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received  from a other health professional.  This case involves an unknown age female patient who was exposed to vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, COVID-19 VACCINE and INFLUENZA VACCINE in context of protocol is for pregnant women at their facility to receive flu vaccines, covid vaccines and tdap with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported.  The estimated due date was not reported.  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 suspect Influenza vaccine for Immunization,covid-19 vaccine, Diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number, route, administration site and expiry date: not reported) for prophylactic vaccination    On an unknown date the patient developed a non-serious event protocol is for pregnant women at their facility to receive flu vaccines, covid vaccines and tdap with no reported adverse event (exposure during pregnancy) (Latency- Same day) following the administration of influenza vaccine,covid-19 vaccine, diphtheria and tetanus and acellular pertussis vaccine.  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for the event   Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu I had the flu shot 3months before I got the flu; Initial information received on 12-Dec-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 i had the flu shot 3months before i got the 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 suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for flu (influenza vaccination).  On an unknown date the patient diagnosed with a non-serious event of flu i had the flu shot 3months before i got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown
Sex: U
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: it hurts; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated it hurts after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had a non-serious event of it hurts (vaccination site pain) (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.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu very bad; Initial information received on 13-Dec-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 still got the flu very bad after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 suspect Influenza vaccine(strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic Vaccination.   On an unknown date the patient developed a non-serious event still got the flu very bad (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported Was the company suspect product inappropriately used as per local authorization? Unknown Is Sanofi authorized to communicate with the patient's / your healthcare provider?   Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu very bad).  At time of reporting, the outcome was Unknown for the event still got the flu very bad.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the flu shot and guess what, I got the flu; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated got the flu shot and guess what, i got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer unknown at this time (strength, form, batch lot, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of got the flu shot and guess what, i got the 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.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: Pneumonia; Flu; Initial information received on 13-Dec-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 had pneumonia and flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient had serious event pneumonia  (unknown latency)  This event was assessed as medically significant.  On an unknown date the patient had non-serious event flu (influenza) (unknown latency).  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events; Sender's Comments: Sanofi Company Comment dated on 19-DEC-2022: This case involves an unknown age and unknown gender patient who had pneumonia and flu after receiving vaccine INFLUENZA VACCINE.  Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: very ill; Initial information received  on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who got very ill after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for flu.   On an unknown date, the patient got very ill (illness) (latency: unknown) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (very ill).  At time of reporting, the outcome was Unknown for the event very ill.
Age: 77.0
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick as a dog; Initial information received on 12-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 77-year-old and unknown gender patient who got sick as a dog 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 suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of got sick as a dog (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, Never Again, I'm 77 going on 78. It is unknown if the patient experienced any additional symptoms/events. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (got sick as a dog).  At time of reporting, the outcome was Unknown for the event got sick as a dog.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Tested positive for type A flu; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-helath care professional.  This case involves an adult patient of unknown age and gender who had tested positive for type a 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(unknown form, route, strength, lot number and expiry date) in unknown administration site for Flu(Influenza). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of tested positive for type a 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  we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I got my flu shot in October. Tested positive for type A flu today."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Tested positive for type A flu).  At time of reporting, the outcome was Unknown for the event tested positive for type a flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: get the flu shot every year got the flu now . its nasty; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who get the flu shot every year, got the flu now 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 (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On 10-Dec-2022 the patient had a non-serious event of get the flu shot every year got the flu now, its nasty (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (get the flu shot every year got the flu now . its nasty).  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  outcome: Unknown
Age: 0.17
Sex: F
Vaccine: FLUX, MMR, PNC13, RV1, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: child received too many vaccines. The infant was scheduled to receive VAXELIS, PREVNAR 13, and ROTARIX. However, the infant also received MMR, VARICELLA, and a Flu shot which were not scheduled with no reported adverse event; Initial information on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 2 months old female patient who was administered too many vaccines. the infant was scheduled to receive Diphtheria/Tetanus/5 AC PERT/IPV/HIB(OMPC)/HEP B vaccine (Vaxelis), PREVNAR 13, and ROTARIX. however, the infant also received MMR, VARICELLA vaccine, live and Influenza vaccine which were not scheduled with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 AC PERT/IPV/HIB(OMPC)/HEP B (VAXELIS) vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of suspect Rotarix, MMR, Prevnar 13 and Varicella vaccine, live not produced by Sanofi Pasteur (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On 12-Dec-2022, the patient received too many vaccines. the infant was scheduled to receive Diphtheria/Tetanus/5 AC PERT/IPV/HIB(OMPC)/HEP B vaccine (Vaxelis), PREVNAR 13, and ROTARIX. However, the infant also received MMR, VARICELLA vaccine, live and Influenza vaccine which were not scheduled with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  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.   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: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: ADACEL that were administered in August were administered in error again yesterday with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case is linked to case 2022SA507244(CLUSTER).  This case involves a 13 years old male patient who experienced adacel that were administered in august were administered in error again yesterday with no reported adverse event after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE,HEPATITIS B VACCINE (and VARICELLA ZOSTER VACCINE for Prophylactic vaccination.  On 16-Aug-2022 he also received a (series-1)dose of the suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE(Dose-0.5mL)(Frequency-Total)( Strength = STANDARD) (Batch/lot number-U7283AA) via intramuscular route in the right deltoid for Immunization.  On 12-Dec-2022, the patient received a (series-2)dose of Same suspect(Dose-0.5mL)(Frequency-Total)(Strength = STANDARD) via intramuscular route in right deltoid for Immunization  (Batch Number/Lot Number, Expiry date: Unknown)  On 12-DEC-2022 the patient developed a non-serious event Adacel that were administered in august were administered in error again yesterday with no reported adverse event (inappropriate schedule of product administration)(Latency- 3 months 27 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  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.