chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: shortness of breath; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (shortness of breath) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The patient had booster shot on tuesday (01-Feb-2022).  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: since yesterday is with fatigue, like extremely tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (since yesterday is with fatigue, like extremely tired.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced FATIGUE (since yesterday is with fatigue, like extremely tired.). At the time of the report, FATIGUE (since yesterday is with fatigue, like extremely tired.) had not resolved.            Patient was not taking any concomitant medication.  Patient took booster dose in her left arm (non-dominant).   No treatment information was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administrated more than 12 hours after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated more than 12 hours after first puncture) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.    No Medical History information was reported.  On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated more than 12 hours after first puncture). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated more than 12 hours after first puncture) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient had not reported any symptoms after the administration of the vaccine.  No treatment information was provided by the reporter.   Date the vial was initially stored in the refrigerator was 31-Jan-2022; date(s) and time(s) vial was first punctured was 31-Jan-2022 at 9 am; the vaccine was administered in the morning of 01-Feb-2022; the vial was the vial stored in the fridge at correct range temperature post puncture and the vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): as per reporter the nurse took the vial out of the freezer on Friday night and put it on the fridge, which was on appropriate range temperature, then the first puncture was made on 31-Jan-2022 at 9 o'clock.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Not immunocompromised and was given a 3rd full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Not immunocompromised and was given a 3rd full dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 024MZ0A and 012A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and AMLODIPINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Not immunocompromised and was given a 3rd full dose). On 22-Oct-2021, ACCIDENTAL OVERDOSE (Not immunocompromised and was given a 3rd full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-037205, MOD-2021-254142 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Decreased activity, Feeling abnormal, Headache
Clinical narrative: left arm hurts a lot; feels strange; pain in the bones; doesn't want to wake up; headaches; 1st dose on 22Nov2021, 2nd dose 2Feb2022; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015F21A and 940877) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22Nov2021, 2nd dose 2Feb2022). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. On 02-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22Nov2021, 2nd dose 2Feb2022) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Body temperature: normal (normal) normal.         Concomitant medications were not reported.   Event onset of symptoms will be in Feb 2022.  Patient got the second dose in her left arm and told to caregiver that  that her arm hurt a lot, she felt strange and had headaches, pain in the bones, did not want to wake up and her temperature was normal.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: left arm hurts a lot; feels strange; pain in the bones; doesn't want to wake up; headaches; 1st dose on 22Nov2021, 2nd dose 2Feb2022; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015F21A and 940877) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22Nov2021, 2nd dose 2Feb2022). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. On 02-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22Nov2021, 2nd dose 2Feb2022) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Body temperature: normal (normal) normal.         Concomitant medications were not reported.   Event onset of symptoms will be in Feb 2022.  Patient got the second dose in her left arm and told to caregiver that  that her arm hurt a lot, she felt strange and had headaches, pain in the bones, did not want to wake up and her temperature was normal.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia, Skin discolouration
Clinical narrative: Right side of his neck is feeling tense; His right hand pinky; His right hand is starting to tingle; His right hand feel slightly numb; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Right side of his neck is feeling tense), SKIN DISCOLOURATION (His right hand pinky), PARAESTHESIA (His right hand is starting to tingle) and HYPOAESTHESIA (His right hand feel slightly numb) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022T21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (Right side of his neck is feeling tense), SKIN DISCOLOURATION (His right hand pinky), PARAESTHESIA (His right hand is starting to tingle) and HYPOAESTHESIA (His right hand feel slightly numb). At the time of the report, MUSCULOSKELETAL STIFFNESS (Right side of his neck is feeling tense), SKIN DISCOLOURATION (His right hand pinky), PARAESTHESIA (His right hand is starting to tingle) and HYPOAESTHESIA (His right hand feel slightly numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired dose given to patient; We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.  Reporter said excursion was seen with the product which was administered 28 hours and 5 minutes after the vial was punctured and the vial was taken out of the freezer and placed in the refrigerator on 1/26/2022 and  was punctured on 1/27/22 at 10:39 AM and remained at room temperature.       No other additional information was available from the customer.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00621A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  was given to patient.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired vaccine in a 42-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026B21A) for COVID-19 immunization. No medical history reported. On Sep 17, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 17, 2021, patient administered expired vaccine. On Sep 17, 2021, administered expired vaccine: resolved. The vaccine was stored in a freezer. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Rx number was reported.  No treatment medication was reported.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
Sex: U
Vaccine: FLUX
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Collapses on the field; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 31 years old and unknown gender patient who collapses on the field while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event collapses on the field (Loss of consciousness) (unknown latency) following the administration of Influenza Vaccine.   It was reported that goes on and on, and on. It's happening everywhere, and is not normal. 31 years old collapses on the field.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event Outcome : Unknown for the event collapses on the field.  Seriousness criteria : This event(Loss of consciousness) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 06-Feb-2022:This case involves a 31 years old and unknown gender patient who collapses on the field while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: one and only time I took the flu shot I almost died; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves a patient (unknown age, gender) who was receiving vaccine INFLUENZA VACCINE and one and only time patient took the flu shot and almost died.  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.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number not reported) via unknown route in unknown administration site for flu vaccine.  On an unknown date one- and only-time patient took the flu shot and almost died (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Reportedly, one and only time I took the flu shot I almost died. It is unknown if the patient experienced any additional symptoms/events.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (one and only time I took the flu shot I almost died).  At time of reporting, the outcome was Unknown for the event one and only time i took the flu shot i almost died.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case involves a patient (unknown age, gender) who one and only time took the flu shot and almost died, while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and vaccination history, concurrent illnesses and concomitant vaccinations.
Age: 32.0
Sex: U
Vaccine: FLUX
Symptoms: Pericarditis
Clinical narrative: Pericarditis; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 32 year old patient (unknown gender) who experienced pericarditis while receiving vaccine INFLUENZA 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.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (strength, formulation: unknown) produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, pericarditis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Reportedly, 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 goes on and on, and on. it's happening everywhere and is NOT normal!! Event : 32 year old Champion Speed Skater suffered Pericarditis after the vaccine It is unknown if the patient experienced any additional symptoms/events.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Pericarditis).  At time of reporting, the outcome was Unknown for the event pericarditis.; Sender's Comments: Sanofi company comment dated 06-Feb-2022: This case concerns 32 years old patient who experienced pericarditis, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; Initial information received from on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age and unknown gender patient who experienced cardiac arrest while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number , strength, formulation and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious cardiac arrest (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi Company Comment on 06-Feb-2022: This case involves an unknown age and unknown gender patient who experienced cardiac arrest while receiving vaccine INFLUENZA VACCINE. Temporal relationship is unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 40.0
Sex: U
Vaccine: FLUX
Symptoms: Circulatory collapse, Death, Syncope
Clinical narrative: A half marathon runner collapsed during the race and died a little later; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a 40 years old and unknown gender patient who was half marathon runner collapsed during the race and died a little later while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, route, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  It was reported that patient was half marathon runner collapsed during the race and died a little later (circulatory collapse) (unknown latency). This event was assessed as medically significant and was leading to death. At the time of report autopsy details were unknown. The cause of death was reported as Collapse circulatory.  Final diagnosis was (fatal) collapsed.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (collapsed).  At time of reporting, the outcome was Fatal for the event collapsed.; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves 40 years old patient of unknown gender who was half marathon runner collapsed during the race and died a little later (circulatory collapse) with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: A half marathon runner collapsed during the race and died a little later
Age: 90.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered Adacel to a patient today that expired on 09Dec2021 with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 90 years old male patient who administered adacel which was expired on 09dec2021 with no reported adverse event while 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.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5687AA via unknown route in unknown administration site.  On 27-JAN-2022 the patient had adacel that expired on 09dec2021 with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered Adacel to a patient today that expired on 09Dec2021 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered adacel to a patient today that expired on 09dec2021 with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Blood test, Epistaxis, Gingival bleeding, Haemoglobin abnormal
Clinical narrative: Petechial hemorrhage from waist down, bleeding gums and sever nose bleeds, Severe random angioedema.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Petechiae
Clinical narrative: Petechial hemorrhage from waist down, bleeding gums and sever nose bleeds, Severe random angioedema.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Electrocardiogram, General physical condition abnormal
Clinical narrative: Was at home on 12/11/21 and started feeling numbness and tingling on right side traveling to her lips. Seizure. Went to bed. Next day she noticed in the mirror that her face did not look right and watched herself eat. Couldnt open mouth much to eat.  Water ran out of her mouth when she drank it. Felt like she was in the dentists chair. Went to next door neighbor who then took her to ER.  Have never had anything like this happen before.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Seizure, Trismus
Clinical narrative: Was at home on 12/11/21 and started feeling numbness and tingling on right side traveling to her lips. Seizure. Went to bed. Next day she noticed in the mirror that her face did not look right and watched herself eat. Couldnt open mouth much to eat.  Water ran out of her mouth when she drank it. Felt like she was in the dentists chair. Went to next door neighbor who then took her to ER.  Have never had anything like this happen before.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Allergy test, Colonoscopy, Constipation, Diarrhoea
Clinical narrative: Bloating, Diarrhea, Constipation, body aches, fatigue
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Stool analysis
Clinical narrative: Bloating, Diarrhea, Constipation, body aches, fatigue
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry skin, Pain, Pain of skin, Rash, Rash erythematous
Clinical narrative: 5 days after first dose, extremely painful, but not itchy neck rash appeared. 7 days after does entire front and sides of neck, from chin to collar bone was covered in said rash. Bright and dark red, with thick leathery complex. Painful when my neck moved or touched anything. Skin felt like it would rip if I shook head or nodded. Rash went away after 2 weeks through different cocktails of various steroids, creams and natural remedies suggested by my doctor. After my 2nd dose, the same neck rash appeared on day 5 and quickly came back, however this time was much larger and more painful. Took 2 weeks to clear up.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin, Vaccine positive rechallenge
Clinical narrative: 5 days after first dose, extremely painful, but not itchy neck rash appeared. 7 days after does entire front and sides of neck, from chin to collar bone was covered in said rash. Bright and dark red, with thick leathery complex. Painful when my neck moved or touched anything. Skin felt like it would rip if I shook head or nodded. Rash went away after 2 weeks through different cocktails of various steroids, creams and natural remedies suggested by my doctor. After my 2nd dose, the same neck rash appeared on day 5 and quickly came back, however this time was much larger and more painful. Took 2 weeks to clear up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bacterial test negative, Blood creatine phosphokinase normal, Borrelia test negative, C-reactive protein normal
Clinical narrative: 1/28/22 (20 days following receipt of 3rd dose of Pfizer mRNA vaccine) vaccinee abruptly developed lower thoracic-upper lumbar back/spine pain with radiation of pain to both lower extremities, numbness/pins and needles in both lower extremities and antalgic gait
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Differential white blood cell count normal, Full blood count normal, Gait disturbance, Hypoaesthesia
Clinical narrative: 1/28/22 (20 days following receipt of 3rd dose of Pfizer mRNA vaccine) vaccinee abruptly developed lower thoracic-upper lumbar back/spine pain with radiation of pain to both lower extremities, numbness/pins and needles in both lower extremities and antalgic gait
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal normal, Metabolic function test normal, Muscle spasms, Neurological examination abnormal, Pain
Clinical narrative: 1/28/22 (20 days following receipt of 3rd dose of Pfizer mRNA vaccine) vaccinee abruptly developed lower thoracic-upper lumbar back/spine pain with radiation of pain to both lower extremities, numbness/pins and needles in both lower extremities and antalgic gait
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal, Scan with contrast normal, Spinal pain
Clinical narrative: 1/28/22 (20 days following receipt of 3rd dose of Pfizer mRNA vaccine) vaccinee abruptly developed lower thoracic-upper lumbar back/spine pain with radiation of pain to both lower extremities, numbness/pins and needles in both lower extremities and antalgic gait
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Endoscopy abnormal, Eosinophil count increased, Eosinophilic oesophagitis, Eye swelling
Clinical narrative: I received the vaccine on the 19Th and on the 28th night had sever chest pain and had to go to ER. On the same day I started developing skin rashes. I was prescribed Hydrocodone ( Which I have had previously with no allergy) for pain and omeprazole for possible heart burn.  The next day, I went back to the ER with severe drug allergy with swollen lips, eyes and rashes and hives all over my body and had to be given epinephrine. My chest pain continued and upon endoscopy , I was diagnosed with allergic esophagitis , with high eosinophil count in my esophagus. My skin rashes and hives continue to persist even after a month and is very random.   I believe that, given no change in food habits or external stimuli, this could be a delayed onset allergy to the moderna covid vaccine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Rash, Urticaria
Clinical narrative: I received the vaccine on the 19Th and on the 28th night had sever chest pain and had to go to ER. On the same day I started developing skin rashes. I was prescribed Hydrocodone ( Which I have had previously with no allergy) for pain and omeprazole for possible heart burn.  The next day, I went back to the ER with severe drug allergy with swollen lips, eyes and rashes and hives all over my body and had to be given epinephrine. My chest pain continued and upon endoscopy , I was diagnosed with allergic esophagitis , with high eosinophil count in my esophagus. My skin rashes and hives continue to persist even after a month and is very random.   I believe that, given no change in food habits or external stimuli, this could be a delayed onset allergy to the moderna covid vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema, Fatigue, Headache, Injection site induration
Clinical narrative: The morning after I received the Covid vaccine my arm was super sore which was to be expected. But as I?m going about my day, I start to notice the pain was increasing more and more to where it felt like I had a rock or something under my skin. I looked and felt my arm and it was VERY HOT to the touch, super red, and it was the biggest knot ever! Plus my whole upper arm was like a huge hump and extremely swollen. But at the injection site, it felt like a hard medium sized rock was under my skin and when I moved my arm at all or got dressed even, the pain was very extreme. Following the rest of the day, I start noticing that my back and neck began to get sore. I thought nothing of it until it became a nagging pain and I had to sit down and rest and try to relieve the pain. I also have been slightly nauseas and very tired since the day after I received the vaccine. Last thing I noticed was my head pounding. I got such a severe headache that my eyes started to get blurry and they still are. My arm is still very sore as well, but my nausea has subsided for now. It?s only been going on two days post vaccine so we?ll see how long these symptoms last.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: The morning after I received the Covid vaccine my arm was super sore which was to be expected. But as I?m going about my day, I start to notice the pain was increasing more and more to where it felt like I had a rock or something under my skin. I looked and felt my arm and it was VERY HOT to the touch, super red, and it was the biggest knot ever! Plus my whole upper arm was like a huge hump and extremely swollen. But at the injection site, it felt like a hard medium sized rock was under my skin and when I moved my arm at all or got dressed even, the pain was very extreme. Following the rest of the day, I start noticing that my back and neck began to get sore. I thought nothing of it until it became a nagging pain and I had to sit down and rest and try to relieve the pain. I also have been slightly nauseas and very tired since the day after I received the vaccine. Last thing I noticed was my head pounding. I got such a severe headache that my eyes started to get blurry and they still are. My arm is still very sore as well, but my nausea has subsided for now. It?s only been going on two days post vaccine so we?ll see how long these symptoms last.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vision blurred
Clinical narrative: The morning after I received the Covid vaccine my arm was super sore which was to be expected. But as I?m going about my day, I start to notice the pain was increasing more and more to where it felt like I had a rock or something under my skin. I looked and felt my arm and it was VERY HOT to the touch, super red, and it was the biggest knot ever! Plus my whole upper arm was like a huge hump and extremely swollen. But at the injection site, it felt like a hard medium sized rock was under my skin and when I moved my arm at all or got dressed even, the pain was very extreme. Following the rest of the day, I start noticing that my back and neck began to get sore. I thought nothing of it until it became a nagging pain and I had to sit down and rest and try to relieve the pain. I also have been slightly nauseas and very tired since the day after I received the vaccine. Last thing I noticed was my head pounding. I got such a severe headache that my eyes started to get blurry and they still are. My arm is still very sore as well, but my nausea has subsided for now. It?s only been going on two days post vaccine so we?ll see how long these symptoms last.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My menstrual has not came yet its going on 2 days
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Presyncope, Urticaria
Clinical narrative: Patient fell ill and was transported to the ER via ambulance after a presyncopal event on the toilet with diarrhea. She developed hives within 24hrs of this event. Although she has a strong history of environmental allergies, this was her first episode of urticaria.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No further AE's reported; administration of an expired dose of VARlVAX; Temperature: 14°F to 46°F (46 F) max; This spontaneous report was received from a nurse referring to a male patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   Concomitant therapy included sterile diluent (STERILE DILUENT) (lot# S038147).      There was a refrigerator at the place of business in which expired doses of varicella virus vaccine live (oka/merck) (VARIVAX) were stored. Another employee inadvertently took a varicella virus vaccine live (oka/merck) (VARIVAX) dose from this refrigerator which was placed into the refrigerator a year ago and had been in refrigerated temp range since, instead of the freezer where the non expired doses of varicella virus vaccine live (oka/merck) (VARIVAX) was kept. The temperature excursion was 14 Fahrenheit degrees to 46 Fahrenheit degrees (46 Fahrenheit degrees) max for 8760 hours. On 11-JAN-2022, the patient was vaccinated with the improperly stored and expired varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml one time, lot # S000132, expiration date 02-JAN-2021; strength and route of administration were not reported) for prophylaxis (expired product administered, product storage error). No further adverse event (AE) or product quality complaint (PQC) was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Product was adminisered to patient after temperature excursion; This spontaneous report was received from a physician referring to a approximately 4-year-old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On an unknown date in January 2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) once (lot number U022729, expiration date 16-JAN-2023 ; dose, dose number, vaccination scheme, and anatomical location of vaccination were not reported) for prophylaxis.         On 28-JAN-2022, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was administered to patient after temperature excursions. (product storage error). The vaccine was stored for the time frame of 25 minutes in the temperature of 7.4 degree Fahrenheit (F), 20 minutes in the temperature of 6.4 degrees F,15 minutes in the temperature of 5.9 degrees F.  The previous temperature excursion of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was stored at 31.3 degrees F for 28 minutes (min), from 6 degrees F to 14 degrees F (exact temperature was not provided) for 1 hour 15 min and 11 degrees F for 4 hours 6 min. No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.  This is patient (report) number seven, out of seven total.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of shingrix is later than 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and the second dose was received later than 6 months which led to lengthening of vaccination schedule. Consent to follow up was not possible as no contact details were available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in ear, right jaw, and lower lip; numbness lip; This case was reported by a consumer via other manufacturer and described the occurrence of numbness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastroesophageal reflux disease, colitis and bleeding gastric ulcer. Concurrent medical conditions included her2 positive breast cancer. Concomitant products included trastuzumab emtansine (Kadcyla).   On 7th January 2021, the patient received the 1st dose of Shingrix. On 7th January 2021, less than a day after receiving Shingrix, the patient experienced numbness and numb lips. On an unknown date, the outcome of the numbness and numb lips were recovering/resolving.   It was unknown if the reporter considered the numbness and numb lips to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and experienced numbness in right ear, right jaw and right lower lip on the same day. Consent to follow up was not possible as no contact details were available.