chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; PAIN; CRAMPING; DIZZINESS; SWELLING JOINTS; WEAKNESS; EXTREME FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-AUG-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced pain, cramping, swelling joints, extreme fatigue, and headaches that went away four days after, and patient also experienced dizziness, weakness and fatigue that lasted for about a month. On 25-DEC-2021, the patient experienced headaches, cough, itchy throat and weakness (suspected clinical vaccination failure, and suspected covid-19 infection). On 20-JAN-2022, the patient tested positive (twice) for a covid-19 using an antigen rapid test (BinaxNOW).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain, cramping, swelling joints, and headaches on 05-SEP-2021, and dizziness, weakness, and extreme fatigue, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213333.; Sender's Comments: V0: 20220139800-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via Social media concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reported stated "my brother was injected on Thursday and was dead by Sunday. Don't go thinking its all good. You have been duped". On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220141974-COVID-19 VACCINE AD26.COV2.S- Dead. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Horrible horrible headache; Temperature of 103; Chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Horrible horrible headache), PYREXIA (Temperature of 103) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 041L20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral amyloid angiopathy since July 2021.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Horrible horrible headache), PYREXIA (Temperature of 103) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Horrible horrible headache), PYREXIA (Temperature of 103) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The patient took some Tylenol to alleviate the symptoms and they stopped the morning of 3rd day. The patient explains that her condition, Cerebral Amyloid Angiopathy, is something that happens in brain where it causes to have stroke, the blood vessels in brain will be weak and cause blood to lay around in brain and eventually causes stroke. The reporter added that she was 2/3rds there and will eventually have a stroke It was reported that the AEs were worse after booster dose and that the symptoms stopped the morning of the third day.   This case was linked to MOD-2022-456441, MOD-2021-016657 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrooesophageal reflux disease, Oesophagitis, Pruritus, Rash
Clinical narrative: He also has Diarrhea for the last 5 days; Rash after booster; Swollen esophagus after booster; Acid reflux after booster; Itchy all over body, mainly in the bottom of feet and hands and groin area after booster; Hives after booster; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster) and DIARRHOEA (He also has Diarrhea for the last 5 days) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 01DM20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster) and RASH (Rash after booster). On 15-Jan-2022, the patient experienced DIARRHOEA (He also has Diarrhea for the last 5 days). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Oesophageal inflammation, at a dose of UNK, prn. At the time of the report, OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster), DIARRHOEA (He also has Diarrhea for the last 5 days) and RASH (Rash after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had visited the doctor and was given a Steroid shot and pack treatment. And was also prescribed with Zyrtec, Benadryl liquid PRN for esophagus.  Concomitant medication information was not reported
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: He also has Diarrhea for the last 5 days; Rash after booster; Swollen esophagus after booster; Acid reflux after booster; Itchy all over body, mainly in the bottom of feet and hands and groin area after booster; Hives after booster; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster) and DIARRHOEA (He also has Diarrhea for the last 5 days) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 01DM20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster) and RASH (Rash after booster). On 15-Jan-2022, the patient experienced DIARRHOEA (He also has Diarrhea for the last 5 days). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Oesophageal inflammation, at a dose of UNK, prn. At the time of the report, OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster), DIARRHOEA (He also has Diarrhea for the last 5 days) and RASH (Rash after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had visited the doctor and was given a Steroid shot and pack treatment. And was also prescribed with Zyrtec, Benadryl liquid PRN for esophagus.  Concomitant medication information was not reported
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack ( heart attack (10019250), Myocardial infarction (10028596)); This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack ( heart attack (10019250), Myocardial infarction (10028596))) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 17-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack ( heart attack (10019250), Myocardial infarction (10028596))) (seriousness criteria death and medically significant). The patient died on 18-Dec-2021. The reported cause of death was heart attack ( heart attack(10019250), myocardial infarction (10028596)). It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDIAL INFARCTION (Heart attack ( heart attack (10019250), Myocardial infarction (10028596))) to have an unknown relationship.    No concomitant medication were provided.  Patient received JANSSEN COVID-19 vaccine as their 1st dose vaccine.  No treatment information were reported.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, serious AESI of myocardial infarction. The event, which resulted in a fatal outcome, occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. On 18Dec2021, the patient experienced a heart attack and died. No further details were provided. It is unknown if an autopsy was performed. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, serious AESI of myocardial infarction. The event, which resulted in a fatal outcome, occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. On 18Dec2021, the patient experienced a heart attack and died. No further details were provided. It is unknown if an autopsy was performed. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Heart attack ( heart attack(10019250), Myocardial infarction (10028596))
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm a little warm but it didn't hurt that bad after the first dose) and FEELING HOT (the arm a little warm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A, 023C21A and 084J21A) for COVID-19 vaccination. Concurrent medical conditions included Heart disorder (diagnosed about 20 years ago.) and Diabetes (diagnosed about 20 years ago.).Concomitant products included METFORMIN for Diabetes, VITAMIN D3 for an unknown indication.On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (the arm a little warm but it didn't hurt that bad after the first dose) and FEELING HOT (the arm a little warm). At the time of the report, PAIN IN EXTREMITY (the arm a little warm but it didn't hurt that bad after the first dose) and FEELING HOT (the arm a little warm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The patient's additional concomitant medication included a lot of vitamins (D3 and others) and unspecified medication for heart. No treatment drugs were reported.This case was linked to MOD-2022-457665 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 045B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.  The vial was stored in refrigerator on 05-Jan-2022 and administered on 06-Jan-2022. the vial did not undergo any temperature excursion
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose) on 26-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (Second dose) on 27-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  It was reported that, on 06-Jan-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 Doses administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 012M20A and 025A21A) for COVID-19 vaccination.     Concomitant products included COLCHICINE, DENOSUMAB (PROLIA), FESOTERODINE FUMARATE (TOVIAZ), LISINOPRIL, OMEPRAZOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX), RIVAROXABAN (XARELTO), HYDROCODONE, PARACETAMOL (TYLENOL [PARACETAMOL]) and METOPROLOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12(US) hours post puncture). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12(US) hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by the reporter.  No treatment medication was reported.  Date the vial initially stored in the refrigerator was 14 Jan 2022 Date and time vial first punctured was 19Jan2022, 8:40am The vial did not undergo any temperature excursions. The vial was stored in fridge post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was only for drawing doses.   This case was linked to MOD-2022-458470, MOD-2022-458516 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had a reaction to the first dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the first dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had a reaction to the first dose). At the time of the report, VACCINATION COMPLICATION (had a reaction to the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: the spot where I was injected keeps getting bigger and bigger; more pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (the spot where I was injected keeps getting bigger and bigger) and VACCINATION SITE PAIN (more pain) 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.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2022, the patient experienced VACCINATION SITE SWELLING (the spot where I was injected keeps getting bigger and bigger) and VACCINATION SITE PAIN (more pain). At the time of the report, VACCINATION SITE SWELLING (the spot where I was injected keeps getting bigger and bigger) and VACCINATION SITE PAIN (more pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   I had my booster shot on friday and since then the spot where I was injected keeps getting bigger and bigger with more pain, is that normal? AE submitted. Consent for follow up accepted.  No concomitant products were reported. No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: extremely suck after the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (extremely suck after the booster) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (extremely suck after the booster). At the time of the report, VACCINATION COMPLICATION (extremely suck after the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: FLUX
Symptoms: Blindness, Intensive care, Paralysis
Clinical narrative: completely paralyzed; ended up blind; Initial information was received on 14-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a female patient of unknown demographics who was completely paralyzed and ended up blind 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 formulation, strength, dosage, lot number and expiration date via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the patient got the flu shot and 3 days later she was completely paralyzed (Paralysis) and stayed in ICU on an unknown date. It was reported that on an unknown date after unknown latency, the patient ended up blind (Blindness). It is unknown if the patient experienced any additional symptoms/events. These events were assessed as medically significant. The patient was hospitalized for these events on an unknown date.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (completely paralyzed, ended up blind).  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: Sanofi company comment 23-Jan-2022: This case involves a female patient who was completely paralyzed and ended up blind after being vaccinated with Influenza vaccine. On the basis of the reported information a significant temporal relationship can be established . However, additional information regarding patient medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Haemorrhage, Thrombosis, Uterine dilation and curettage
Clinical narrative: Bleeding large clots.  Occurred at the time of implantation and placenta attached abnormally.  Genetics came back normal and miscarried .  During D&C, lost 2L of blood
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: Bad menstrual cycles, heavier flow, more days per flow, getting it all different times sometimes 2 weeks apart and sometimes having for 2 weeks.  all messed up
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The Moderna vaccine was given to this patient who was not 18 years of age when vaccine was done.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Confusional state, Dysphagia
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Injection site erythema, Mouth swelling, Pruritus
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Swollen tongue, Tachycardia, Throat tightness
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This patient was given a Modera vaccine prior to her 18th birthday.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Pt stated that her throat stated to swell up about 12 minutes after vaccination. Called 911. I also gave epipen one dose. Pt declined 911 services. she never lost consiousness. watched pt for 30 more mintues and she stated she was ok to leave.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Limb injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Pt admitted to hospital for Covid related diagnosis.  Pt received Covid vaccination
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Admit to the hospital with covid related diagnosis.  Had Covid Vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long. We have recommended to the patient to get revaccinated.
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Admit with Covid related diagnosis.  Had Covid vaccine
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: admit to hospital with covid related diagnosis.  Had Covid Vaccine
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: admit to hospital with covid related diagnosis.  Had Covid Vaccine.
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Admit to hospital with Covid related diagnosis.  Had Covid Vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient states got booster morning of 1/20 and starting breaking out in hives on torso and extremities by evening.  Has continued to break out in hives, but controlled by taking OTC Benedryl.   Seen at Health Services on morning of 1/24.  No other possible cause has been found.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Computerised tomogram, Electrocardiogram, Headache, Laboratory test
Clinical narrative: 72 hours post vaccination I had head pain, vision change, and unregulated blood pressure that sent me to the E.R. I have since been on two blood pressure medications and my blood pressure is still not regulated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: 72 hours post vaccination I had head pain, vision change, and unregulated blood pressure that sent me to the E.R. I have since been on two blood pressure medications and my blood pressure is still not regulated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper, Coagulopathy, Computerised tomogram abnormal, Exposure to SARS-CoV-2
Clinical narrative: Possible severe adverse event.  Patient stated he got the Pfizer COVID-19 vaccination in October and believes he may have had COVID-19 infection around the holidays (he was symptomatic after direct exposure but was never tested.)  Symptoms resolved however on 1/24 patient presented to the ER at the Hospital with epigastric and lower abdominal pain and a low POX.  Workup revealed extensive clotting  burden, including bilateral massive pulmonary emboli with saddle embolus, a splenic infarct, a kidney infarct and clot in his SMA.  No history of clotting issues and no known family hx of blood disorders.  No other obvious risk factors.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Mesenteric artery thrombosis, Oxygen saturation decreased, Pulmonary embolism, Renal infarct
Clinical narrative: Possible severe adverse event.  Patient stated he got the Pfizer COVID-19 vaccination in October and believes he may have had COVID-19 infection around the holidays (he was symptomatic after direct exposure but was never tested.)  Symptoms resolved however on 1/24 patient presented to the ER at the Hospital with epigastric and lower abdominal pain and a low POX.  Workup revealed extensive clotting  burden, including bilateral massive pulmonary emboli with saddle embolus, a splenic infarct, a kidney infarct and clot in his SMA.  No history of clotting issues and no known family hx of blood disorders.  No other obvious risk factors.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Splenic infarction
Clinical narrative: Possible severe adverse event.  Patient stated he got the Pfizer COVID-19 vaccination in October and believes he may have had COVID-19 infection around the holidays (he was symptomatic after direct exposure but was never tested.)  Symptoms resolved however on 1/24 patient presented to the ER at the Hospital with epigastric and lower abdominal pain and a low POX.  Workup revealed extensive clotting  burden, including bilateral massive pulmonary emboli with saddle embolus, a splenic infarct, a kidney infarct and clot in his SMA.  No history of clotting issues and no known family hx of blood disorders.  No other obvious risk factors.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haematuria, Pain in extremity
Clinical narrative: Sudden onset after usual slight arm pain, feeling tired, of intermittent gross hematuria which continued for 48 hours. No treatment. May or may not be causally related. Have had similar events 5 years and 2 years ago. Work up showed only varicosities peri prostatic. No infections at the time.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Syncope
Clinical narrative: Pt admitted for Syncope/COVID 19, not requiring o2 or tx at this time
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Fibrin D dimer increased, Haemoglobin decreased, Hypoxia
Clinical narrative: Patient is fully vaccinated and boosted on 10/22/2021.  Hospitalized on 12/20/2021 and tested + for COVID on this date. Admission diagnoses:  COVID 19, acute respiratory failure, hyoxia, sepsis, elevated troponin, bilateral pneymonia, altered mental status. Labs:  hg 6.9 requiring blood transfusions. low Platetlets 123. elevated D dimer 1,656. Treatment: Lovenox, antibiotcs, remdesivir, barcitinitb and decadron. Patient discharged
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Platelet count decreased, Pneumonia, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient is fully vaccinated and boosted on 10/22/2021.  Hospitalized on 12/20/2021 and tested + for COVID on this date. Admission diagnoses:  COVID 19, acute respiratory failure, hyoxia, sepsis, elevated troponin, bilateral pneymonia, altered mental status. Labs:  hg 6.9 requiring blood transfusions. low Platetlets 123. elevated D dimer 1,656. Treatment: Lovenox, antibiotcs, remdesivir, barcitinitb and decadron. Patient discharged
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion, Troponin increased
Clinical narrative: Patient is fully vaccinated and boosted on 10/22/2021.  Hospitalized on 12/20/2021 and tested + for COVID on this date. Admission diagnoses:  COVID 19, acute respiratory failure, hyoxia, sepsis, elevated troponin, bilateral pneymonia, altered mental status. Labs:  hg 6.9 requiring blood transfusions. low Platetlets 123. elevated D dimer 1,656. Treatment: Lovenox, antibiotcs, remdesivir, barcitinitb and decadron. Patient discharged
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID test
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: Pain in the right side of my chest.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Angiogram pulmonary abnormal, Asthenia, Blood gases abnormal, COVID-19
Clinical narrative: Patient arrives via EMS with complaint of shortness of breath and fever that started yesterday.  Patient is on 3 and half liters nasal cannula at baseline, home health nurse has turned off the oxygen.  Upon EMS arrival patient was 82%, she was placed on 6 L nasal cannula with improvement of her pulse ox.  Patient complains of worsening cough and fever since yesterday.  Patient feels more short of breath, unable to move or exert herself secondary to the dyspnea and overwhelming weakness.  Patient also complains of pain to her right lower extremity with a skin tear where she actually dropped an oxygen tank onto her leg.  Patient can planes of generalized body aches, rates it 5 out of 10, radiates throughout her whole body, started yesterday with fever.  Patient has a cough that is nonproductive.  Patient just finished a course of outpatient antibiotics for pneumonia, has a PICC line in her right upper extremity.  Patient denies chest pain, nausea, vomiting, diarrhea or constipation.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Central venous catheterisation, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Patient arrives via EMS with complaint of shortness of breath and fever that started yesterday.  Patient is on 3 and half liters nasal cannula at baseline, home health nurse has turned off the oxygen.  Upon EMS arrival patient was 82%, she was placed on 6 L nasal cannula with improvement of her pulse ox.  Patient complains of worsening cough and fever since yesterday.  Patient feels more short of breath, unable to move or exert herself secondary to the dyspnea and overwhelming weakness.  Patient also complains of pain to her right lower extremity with a skin tear where she actually dropped an oxygen tank onto her leg.  Patient can planes of generalized body aches, rates it 5 out of 10, radiates throughout her whole body, started yesterday with fever.  Patient has a cough that is nonproductive.  Patient just finished a course of outpatient antibiotics for pneumonia, has a PICC line in her right upper extremity.  Patient denies chest pain, nausea, vomiting, diarrhea or constipation.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Hepatic enzyme, Hypercapnia, Hypophagia, Hypoxia
Clinical narrative: Patient arrives via EMS with complaint of shortness of breath and fever that started yesterday.  Patient is on 3 and half liters nasal cannula at baseline, home health nurse has turned off the oxygen.  Upon EMS arrival patient was 82%, she was placed on 6 L nasal cannula with improvement of her pulse ox.  Patient complains of worsening cough and fever since yesterday.  Patient feels more short of breath, unable to move or exert herself secondary to the dyspnea and overwhelming weakness.  Patient also complains of pain to her right lower extremity with a skin tear where she actually dropped an oxygen tank onto her leg.  Patient can planes of generalized body aches, rates it 5 out of 10, radiates throughout her whole body, started yesterday with fever.  Patient has a cough that is nonproductive.  Patient just finished a course of outpatient antibiotics for pneumonia, has a PICC line in her right upper extremity.  Patient denies chest pain, nausea, vomiting, diarrhea or constipation.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Increased viscosity of bronchial secretion, International normalised ratio increased, Limb injury, Lung disorder, Malaise
Clinical narrative: Patient arrives via EMS with complaint of shortness of breath and fever that started yesterday.  Patient is on 3 and half liters nasal cannula at baseline, home health nurse has turned off the oxygen.  Upon EMS arrival patient was 82%, she was placed on 6 L nasal cannula with improvement of her pulse ox.  Patient complains of worsening cough and fever since yesterday.  Patient feels more short of breath, unable to move or exert herself secondary to the dyspnea and overwhelming weakness.  Patient also complains of pain to her right lower extremity with a skin tear where she actually dropped an oxygen tank onto her leg.  Patient can planes of generalized body aches, rates it 5 out of 10, radiates throughout her whole body, started yesterday with fever.  Patient has a cough that is nonproductive.  Patient just finished a course of outpatient antibiotics for pneumonia, has a PICC line in her right upper extremity.  Patient denies chest pain, nausea, vomiting, diarrhea or constipation.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Pneumonia, Productive cough
Clinical narrative: Patient arrives via EMS with complaint of shortness of breath and fever that started yesterday.  Patient is on 3 and half liters nasal cannula at baseline, home health nurse has turned off the oxygen.  Upon EMS arrival patient was 82%, she was placed on 6 L nasal cannula with improvement of her pulse ox.  Patient complains of worsening cough and fever since yesterday.  Patient feels more short of breath, unable to move or exert herself secondary to the dyspnea and overwhelming weakness.  Patient also complains of pain to her right lower extremity with a skin tear where she actually dropped an oxygen tank onto her leg.  Patient can planes of generalized body aches, rates it 5 out of 10, radiates throughout her whole body, started yesterday with fever.  Patient has a cough that is nonproductive.  Patient just finished a course of outpatient antibiotics for pneumonia, has a PICC line in her right upper extremity.  Patient denies chest pain, nausea, vomiting, diarrhea or constipation.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Renal function test normal, Respiratory failure, SARS-CoV-2 test positive, Skin laceration
Clinical narrative: Patient arrives via EMS with complaint of shortness of breath and fever that started yesterday.  Patient is on 3 and half liters nasal cannula at baseline, home health nurse has turned off the oxygen.  Upon EMS arrival patient was 82%, she was placed on 6 L nasal cannula with improvement of her pulse ox.  Patient complains of worsening cough and fever since yesterday.  Patient feels more short of breath, unable to move or exert herself secondary to the dyspnea and overwhelming weakness.  Patient also complains of pain to her right lower extremity with a skin tear where she actually dropped an oxygen tank onto her leg.  Patient can planes of generalized body aches, rates it 5 out of 10, radiates throughout her whole body, started yesterday with fever.  Patient has a cough that is nonproductive.  Patient just finished a course of outpatient antibiotics for pneumonia, has a PICC line in her right upper extremity.  Patient denies chest pain, nausea, vomiting, diarrhea or constipation.