chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Malaise, Nausea
Clinical narrative: pressure went way up, went to 57/Blood pressure was 57 last night but now 37 or 34/71-62; dizzy/still getting dizzy; nauseous; still don't feel good/Friday I feel terrible but now I can do things; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "pressure went way up, went to 57/Blood pressure was 57 last night but now 37 or 34/71-62"; DIZZINESS (non-serious), outcome "not recovered", described as "dizzy/still getting dizzy"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; MALAISE (non-serious), outcome "unknown", described as "still don't feel good/Friday I feel terrible but now I can do things". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a patient. Caller stated that she received the Pfizer covid-19 vaccine booster on 22Nov, last Tuesday, "I was okay on Wednesday and Thursday but on Friday my pressure went way up, went to 57, dizzy and nauseous. It's lower now but still don't feel good. Is that natural supposed to happen?" She clarified that it was on the night of Thursday when she experienced her side effects, "still getting dizzy, will it go away? does that effect from the vaccines? I'm feeling better but Friday I feel terrible but now I can do things, never had high blood pressure, never one had 'cholesterol' (sounds like not verified). Blood pressure was 57 last night but now 37 or 34/71-62, I feel good then a little while I don't feel good, I can feel my head when I get dizzy, I don't take medication just thyroid (maybe she's referring to thyroid medications)."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Illness, Insomnia, Loss of personal independence in daily activities, Malaise
Clinical narrative: she's feeling sick after receiving the Pfizer covid booster shot; has been ill since/never been so sick in her life; She is sick to her stomach; can't sleep; can't eat; is trying to take of her little dog and can barely get her out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years 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 completed; Unknown manufacturer), for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset Nov2022, outcome "unknown", described as "She is sick to her stomach"; FEEDING DISORDER (non-serious) with onset Nov2022, outcome "unknown", described as "can't eat"; INSOMNIA (non-serious) with onset Nov2022, outcome "unknown", described as "can't sleep"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Nov2022, outcome "unknown", described as "is trying to take of her little dog and can barely get her out"; ILLNESS (non-serious) with onset 16Nov2022, outcome "unknown", described as "has been ill since/never been so sick in her life"; MALAISE (non-serious) with onset 16Nov2022, outcome "unknown", described as "she's feeling sick after receiving the Pfizer covid booster shot".  Additional information: The patient got the Pfizer Covid booster and had been ill since then. She was sick to her stomach, can't sleep, can't eat. She was trying to take of her little dog and could barely get her out. She went across the street to get it and also got other Covid shots. She had never been so sick in her life. It was disgusting and she would never get it again if she knew she was going to be this sick. They should have told her at pharmacy, she never had a problem with the others. She can't sleep and she is at her wits end. The patient wanted to know what medication she can take to make her feel better. She needed a flu shot and was afraid to get it. She was appalled, we have no idea.   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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: she's feeling sick after receiving the Pfizer covid booster shot; has been ill since/never been so sick in her life; She is sick to her stomach; can't sleep; can't eat; is trying to take of her little dog and can barely get her out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years 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 completed; Unknown manufacturer), for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset Nov2022, outcome "unknown", described as "She is sick to her stomach"; FEEDING DISORDER (non-serious) with onset Nov2022, outcome "unknown", described as "can't eat"; INSOMNIA (non-serious) with onset Nov2022, outcome "unknown", described as "can't sleep"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Nov2022, outcome "unknown", described as "is trying to take of her little dog and can barely get her out"; ILLNESS (non-serious) with onset 16Nov2022, outcome "unknown", described as "has been ill since/never been so sick in her life"; MALAISE (non-serious) with onset 16Nov2022, outcome "unknown", described as "she's feeling sick after receiving the Pfizer covid booster shot".  Additional information: The patient got the Pfizer Covid booster and had been ill since then. She was sick to her stomach, can't sleep, can't eat. She was trying to take of her little dog and could barely get her out. She went across the street to get it and also got other Covid shots. She had never been so sick in her life. It was disgusting and she would never get it again if she knew she was going to be this sick. They should have told her at pharmacy, she never had a problem with the others. She can't sleep and she is at her wits end. The patient wanted to know what medication she can take to make her feel better. She needed a flu shot and was afraid to get it. She was appalled, we have no idea.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Vaccination site pain
Clinical narrative: sore injection site (the injection itself didn't hurt, though).; Mild dry cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Mar2021, outcome "recovered", described as "Mild dry cough"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "sore injection site (the injection itself didn't hurt, though).". It was unknown if therapeutic measures were taken as a result of vaccination site pain, cough.  Additional information: It was unknown if any other vaccine in four weeks. It was unknown If covid prior vaccination and if covid tested post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. An elderly patient received BNT162b2 (BNT162B2), on 18Feb2021 at 17:30 as dose 2, single (Lot number: WTEM9509) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "ESRD", start date: 10Feb1996, stop date: 20Sep1998, notes: CAPD; "Renal Tx", start date: 20Sep1998 (ongoing), notes: Still working; "HFPEF" (ongoing), notes: Aortic valve replacement 2011; "Aortic valve replacement", start date: 2011 (unspecified if ongoing), notes: Aortic valve replacement 2011. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1st, Time (24hr): 11:15, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EL9261), administration date: 29Jan2021, for COVID-19 Immunization, reaction(s): "Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots"; TDap (Anatomical Site of Injection: Arm), administration date: 14Jan2021, for Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots".  Additional information: Patient forgotten about the nosebleeds, got after COVID vaccine initial shots. Patient never wrote it down as patient thought he/she could access vsafe to get the dates but patient can't. They lasted less than 24 hours but each time patient had several over the course of a few hours.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200098796 same patient, same drug, different dose/events(2nd dose);
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 at 16:00 as dose 1, single (Lot number: EH9899), in left arm, on 19Jan2021 at 15:00 as dose 2, single (Lot number: EL1283), in left arm and on 06Sep2021 at 17:30 as dose 3 (booster), single (Lot number: FC1180), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "GAD" (unspecified if ongoing), notes: GAD; "CRPS" (unspecified if ongoing), notes: CRPS. Concomitant medication(s) included: SERTRALINE oral, start date: 05Oct2021; PROPRANOLOL oral, start date: 09Feb2016; CLONAZEPAM oral, start date: 16Jun2022; ELIQUIS oral, start date: 11Nov2020; LOSARTAN oral, start date: 15Jul2016; TRAMADOL oral, start date: 20Jul2022; METHOCARBAMOL oral, start date: 20Jul2022; VITAMIN C + ZINC oral, start date: 03Sep2022; ELDERBERRY [SAMBUCUS NIGRA] oral, start date: 01Jan2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a possible contributory role of  subject product BNT162B2 vaccine cannot be excluded for the reported event, based on temporal relationship.. There is  limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a representative. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Nov2022, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset 27Nov2022, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: It was unknown, if patient receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: FK5730), in right arm, on 18Jan2021 as dose 2, single (Lot number: FL1283), in right arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "GERD" (unspecified if ongoing), notes: Other medical history: Arthritis; "seasonal allergies" (unspecified if ongoing), notes: Other medical history: seasonal allergies. Concomitant medication(s) included: MELOXICAM, start date: Jan2018; PRILOSEC [OMEPRAZOLE], start date: Jul2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 02Mar2021 as dose 2, single (Lot number: FL9267), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: B01558A), in left arm and on 05Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: Two mornings later I tested negative and felt fine; (Nov2022) positive, notes: Two mornings after that I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID treatment). No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment).
Sex: U
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection, Nasopharyngitis
Clinical narrative: EBV virus; colds are much more intense and longer; This spontaneous case was reported by a patient and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION (EBV virus) and NASOPHARYNGITIS (colds are much more intense and longer) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION (EBV virus) and NASOPHARYNGITIS (colds are much more intense and longer). At the time of the report, EPSTEIN-BARR VIRUS INFECTION (EBV virus) and NASOPHARYNGITIS (colds are much more intense and longer) outcome was unknown.            Concomitant medication was not provided.  It was reported that since patient had been carrying the EBV virus, patients colds are much more intense and longer. Patient was double vaccinated against covid and recovered. That has a certain reciprocity for patient overall.  Treatment medication information was not provided by the reporter.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series).    Concomitant medications were not reported. On 17-nov-2022 patient received 2nd Monovalent Primary dose was from the same expired vial.                               No treatment information was provided by the reporter.    This case was linked to MOD-2022-680257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live Follow up received contains non -significant information- event verbatim updated.
Sex: U
Vaccine: COVID19
Symptoms: Cholecystectomy, Large intestine polyp, Mass
Clinical narrative: Had emergency gallbladder removed; After having Pfizer vacccine I developed so many lumps, and polyps./ Colon Polyp; After having Pfizer vacccine I developed so many lumps, and polyps.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHOLECYSTECTOMY (medically significant), outcome "unknown", described as "Had emergency gallbladder removed"; LARGE INTESTINE POLYP (intervention required, medically significant), outcome "unknown", described as "After having Pfizer vacccine I developed so many lumps, and polyps./ Colon Polyp"; MASS (non-serious), outcome "unknown", described as "After having Pfizer vacccine I developed so many lumps, and polyps.". Therapeutic measures were taken as a result of cholecystectomy, large intestine polyp.  Clinical course Action Taken was reported as remains live/visible. No more vaccines for patient. After having Pfizer vaccine developed so many lumps, and polyps. Had emergency gallbladder removed as well as colon polyps.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she has had all the vaccines and boosters and she still got the virus four times; she has had all the vaccines and boosters and she still got the virus four times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 92-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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), COVID-19 (medically significant), outcome "not recovered" and all described as "she has had all the vaccines and boosters and she still got the virus four times". The reporter stated that her mother is 92-year-old, and she has had all the vaccines and boosters and she still got the virus four times and got worse after she took another booster. [Note: unknown what vaccine(s) this person received].  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201332944 same patient, different vaccine number/event;
Sex: U
Vaccine: COVID19
Symptoms: Culture, Epistaxis, Full blood count, Investigation, SARS-CoV-2 test
Clinical narrative: Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots; 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), on 29Jan2021 at 11:15 as dose 1, single (Lot number: EL9261) intramuscular, in arm for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 14Jan2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in arm for immunisation. The patient's relevant medical history included: "ESRD", start date: 10Feb1996, stop date: 20Sep1998, notes: Pertinent Details: CAPD; "Renal TX", start date: 20Sep1998 (ongoing), notes: Renal TX , Pertinent details: still working; "HFPEF" (ongoing), notes: HFPEF, Pertinent details: aortic valve replacement 2011. The patient's concomitant medications were not reported.  The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200098796 same patient, same drug, different dose/events(1st dose);
Sex: U
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots; 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), on 29Jan2021 at 11:15 as dose 1, single (Lot number: EL9261) intramuscular, in arm for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 14Jan2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in arm for immunisation. The patient's relevant medical history included: "ESRD", start date: 10Feb1996, stop date: 20Sep1998, notes: Pertinent Details: CAPD; "Renal TX", start date: 20Sep1998 (ongoing), notes: Renal TX , Pertinent details: still working; "HFPEF" (ongoing), notes: HFPEF, Pertinent details: aortic valve replacement 2011. The patient's concomitant medications were not reported.  The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200098796 same patient, same drug, different dose/events(1st dose);
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I didn't felt so well; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't felt so well".  Additional information: It made her think about the effects of the omicron booster since the last shot she got. She didn't felt so well and she did not want to feel sick again in this hard times of her life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her son already received a shot before but still had COVID; her son already received a shot before but still had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "her son already received a shot before but still had COVID". The clinical course was reported as follows: Caller, (Name withheld) was calling about the COVID-19 Vaccine, she mentioned that her son already received a shot before but still had COVID. She is asking if they still need to get another shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flue; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer..  This case involves an unknown  age and gender patient who developed flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 26-Oct-2022, the patient received a  dose of influenza vaccine produced by unknown manufacturer (with unknown formulation, frequency, strength, dose, route, lot number, expiry date and administration site) for influenza and prophylactic vaccination(immunization).  On 07-Nov-2022 the patient developed flu (influenza) (Latency:12 days) following the administration of influenza vaccine .  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: end up in bed for several days are the years that I got the flu shot and every year that I didn't get the flu shot I didn't get sick at all; Initial information received on 24-Nov-2022 regarding an unsolicited valid social media non-serious case received from a Patient   This case involves an unknown age and unknown gender patient who experienced end up in bed for several days are the years that i got the flu shot and every year that i didn't get the flu shot i didn't get sick at all after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events. It was 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(strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date the patient developed a non-serious event end up in bed for several days are the years that i got the flu shot and every year that i didn't get the flu shot i didn't get sick at all (illness) (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.Author/Reporter Comment: The only years that I end up in bed for several days are the years that I got the flu shot and every year that I didn't get the flu shot I didn't get sick at all so no more flu shots and I haven't been sick.  It was 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.  At time of reporting, the outcome was Unknown for the event end up in bed for several days are the years that i got the flu shot and every year that i didn't get the flu shot i didn't get sick at all.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; nitial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-health-care professional.  This case involves an unknown age and unknown gender patient who had flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, Got my flue shot but got the flue anyway.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: wish i hadn't. been sick ever since; Initial information received on 27-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who wish i hadn't. been sick ever since 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, dose, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with non-serious event of wish i hadn't. been sick ever since (illness) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  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: Influenza
Clinical narrative: later got the flu; Initial information was received on 27-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult with unknown gender patient who later got the flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number  and expiration date) for Prophylactic vaccination.  On an unknown date the patient later got the flu (influenza) 2 weeks following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, Medication error
Clinical narrative: got the flu; double doze of flu shot; Initial information received on 26-Nov-2022 regarding an unsolicited valid non-serious social media case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got the flu and had double doze of flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient who got the flu (influenza) (unknown latency) and had double doze of flu shot (extra dose administered) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (got the flu).  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Haemodialysis, Plasmapheresis, Quadriparesis
Clinical narrative: paralyzed from my neck down; five blood dialysis to replace my plasma with fresh; Initial information was received on 26-Nov-2022 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who experienced paralyzed from my neck down, five blood dialysis to replace my plasma with fresh and two months in a rehabilitation facility after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date and month in 1999, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that after being totally paralyzed from my neck down (paralysis) ,five blood dialysis to replace my plasma with fresh(Hemodialysis)(Latency unknown) ,8 days in the hospital ,two months in a rehabilitation facility ,I have decided not to get another one.  Action taken: not applicable.  Corrective treatment: Two months in a rehabilitation facility for paralysis  At time of reporting, the outcome was Unknown for the events.  Seriousness Criteria: Medically significant and hospitalization for event paralysis. Hospitalization for event Hemodialysis; Sender's Comments: Sanofi Company Comment dated 30-Nov-2022: This case involves an unknown age and gender patient who experienced paralyzed from my neck down and five blood dialysis to replace my plasma with fresh after receiving influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of onset latency, past and concomitant medication, hospitalization details, any family history and any relevant medical history of patient precludes comprehensive case assessment.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I know so many people that get the shot and they're the first ones with the flu; Initial information received on 27-Nov-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient and the reporter stated that i know so many people that get the shot and they're the first ones with 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 (strength, form, batch lot number, expiry date: unknown) route in unknown administration site for prophylactic vaccination. Information on batch number and expiry date was requested.  On an unknown date the patient had a non-serious event of  i know so many people that get the shot and they're the first ones with 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.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: received 2nd shot of influenza before the correct time with no reported adverse event; Initial information was received on 28-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 9 months old male patient who received 2nd shot of influenza quadrival a-b vaccine [Fluzone QIV] before the correct time with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor.   On 03-Nov-2022, the patient received a total dose of suspect influenza quadrival a-b vaccine suspension for injection (lot UT7744NA) via intramuscular route in unknown administration site for influenza before the correct time with no reported adverse event (inappropriate schedule of product administration) (latency- same day). The patient did not experience any side effects or symptoms per his mother.   There were no lab data/results available.  Action taken was 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who got the flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for Prophylactic vaccination.  On an unknown date the patient got the flu (influenza) 3 weeks later following the administration of Influenza vaccine.  It was bad.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the flu even though I got the shot; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got the flu even though i got the influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient who got the flu even though i got the shot (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got the flu even though I got the shot).  At time of reporting, the outcome was Unknown for the event got the flu even though i got the shot.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: took the flu the next week and it hit me hard; Initial information received on 28-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient and took the flu the next week and it hit me hard after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient had non serious event  took the flu the next week and it hit me hard (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (took the flu the next week and it hit me hard ).  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 28-Nov-2022 regarding an unsolicited valid Social-Media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date in Oct-2022(last month), the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site as flu shot (Influenza immunisation).  On an unknown date in 2022 the patient developed a non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event flu.