chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain of skin, Pruritus
Clinical narrative: A LITTLE BIT DEPRESSED; PAINFUL SKIN; HAS NOT HAD GOOD SLEEP AT NIGHT; ATOPIC DERMATITIS; ITCHY LIKE CRAZY; DRY SKIN PATCHES; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, and propranolol for blood pressure.  On APR-2021, the patient experienced atopic dermatitis. On APR-2021, the patient experienced itchy like crazy. On APR-2021, the patient experienced dry skin patches. Laboratory data included: Blood test (NR: not provided) Normal, and Skin biopsy (NR: not provided) atopic dermatitis. On MAY-2021, the patient experienced has not had good sleep at night, and painful skin. On an unspecified date, the patient experienced a little bit depressed. Treatment medications (dates unspecified) included: triamcinolone, diphenhydramine hydrochloride, pramocaine hydrochloride, prednisone, dupilumab, and hydroxyzine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atopic dermatitis, itchy like crazy, dry skin patches, painful skin, and a little bit depressed, and the outcome of has not had good sleep at night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: STIFF NECK; BODY ACHES; FEVER OF 100.5; POUNDING HEADACHE; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-DEC-2021, the patient experienced stiff neck, body aches, fever of 100.5, and pounding headache. Laboratory data included: Body temperature (NR: not provided) fever of 100.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 100.5, pounding headache, body aches and stiff neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Headache, Pyrexia
Clinical narrative: running another temperature/another fever/100 F; Felt hot/felt hot again/took a nap; Low grade fever of 99.6 F; Pretty wiped out; A little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot/felt hot again/took a nap), FATIGUE (Pretty wiped out), PYREXIA (Low grade fever of 99.6 F), HEADACHE (A little bit of a headache) and PYREXIA (running another temperature/another fever/100 F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 028L20A or 025L20A and 041F20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-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. In December 2021, the patient experienced HEADACHE (A little bit of a headache). On 27-Dec-2021, the patient experienced FATIGUE (Pretty wiped out). On 28-Dec-2021, the patient experienced FEELING HOT (Felt hot/felt hot again/took a nap) and PYREXIA (Low grade fever of 99.6 F). On 29-Dec-2021, the patient experienced PYREXIA (running another temperature/another fever/100 F). On 28-Dec-2021, FEELING HOT (Felt hot/felt hot again/took a nap) and PYREXIA (Low grade fever of 99.6 F) had resolved. At the time of the report, FATIGUE (Pretty wiped out), HEADACHE (A little bit of a headache) and PYREXIA (running another temperature/another fever/100 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Body temperature: low grade fever of 99.6 degrees fahrenheit (High) low grade fever of 99.6 degrees Fahrenheit. On 29-Dec-2021, Body temperature: 100 degrees fahrenheit (High) 100 degrees Fahrenheit.         No relevant concomitant medications were provided. No treatment information was provided.  On 28 Dec 2021, before patient went to work, she had a low grade fever of 99.6 degrees Fahrenheit. She felt hot, took a nap, and felt hot again. She works in a hospital, so when she got to work, it had resolved. Throughout her shift, she was checking it. On 29 Dec 2021 she was running another temperature, another fever. It was 100 degrees Fahrenheit. She felt hot.   This case was linked to MOD-2021-432498 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: really bad reaction - dose 2; could not walk - dose 2, could not go upstairs - dose; fever of 103°F - dose 2; chills - dose 2; fatigue for two days - dose 2; muscle pain - dose 2; headache - dose 2; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2) and FATIGUE (fatigue for two days - dose 2) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2), FATIGUE (fatigue for two days - dose 2), MYALGIA (muscle pain - dose 2) and HEADACHE (headache - dose 2). At the time of the report, VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2) and MYALGIA (muscle pain - dose 2) outcome was unknown and FATIGUE (fatigue for two days - dose 2) and HEADACHE (headache - dose 2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) The result was 103 fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking concomitant medication that did not want to disclose. No treatment medications were provided.   This case was linked to MOD-2021-433504, MOD-2021-433560 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination complication
Clinical narrative: really bad reaction - dose 2; could not walk - dose 2, could not go upstairs - dose; fever of 103°F - dose 2; chills - dose 2; fatigue for two days - dose 2; muscle pain - dose 2; headache - dose 2; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2) and FATIGUE (fatigue for two days - dose 2) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2), FATIGUE (fatigue for two days - dose 2), MYALGIA (muscle pain - dose 2) and HEADACHE (headache - dose 2). At the time of the report, VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2) and MYALGIA (muscle pain - dose 2) outcome was unknown and FATIGUE (fatigue for two days - dose 2) and HEADACHE (headache - dose 2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) The result was 103 fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking concomitant medication that did not want to disclose. No treatment medications were provided.   This case was linked to MOD-2021-433504, MOD-2021-433560 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation down her armpit) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059h21a and 003b21a) for COVID-19 vaccination. Concurrent medical conditions included Hemorrhoids. Concomitant products included DIOSMIN (DAFLON [DIOSMIN]) for Hemorrhoids.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced INFLAMMATION (inflammation down her armpit) and PYREXIA (fever). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1000 mg. At the time of the report, INFLAMMATION (inflammation down her armpit) and PYREXIA (fever) outcome was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Vaccination complication
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (got sick from the vaccine/ Half a dose put down/ in bed for two days), FEELING ABNORMAL (Patient felt that it was going to kill her) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not walk her dog) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012L20A and 016M20A) for COVID-19 vaccination. Concomitant products included INTERFERON for Leukemia, METOPROLOL, AIRBORNE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 29-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 VACCINATION COMPLICATION (got sick from the vaccine/ Half a dose put down/ in bed for two days), FEELING ABNORMAL (Patient felt that it was going to kill her) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not walk her dog). At the time of the report, VACCINATION COMPLICATION (got sick from the vaccine/ Half a dose put down/ in bed for two days), FEELING ABNORMAL (Patient felt that it was going to kill her) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not walk her dog) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No medical history was provided by the reporter.No treatment medication was reported.Concomitant medications included Centrum, TUMS, Cranberry Supplement with ongoing status.The patient stated that her family had immune issues and genetic issues. She further stated that, she and her brother got sick from the vaccine. She felt it was going to kill her. She couldn't walk her dog. Half a dose put her down so she doesn't know if she should stick with Moderna. She herself and her brother were in bed for two days. This case was linked to MOD-2021-434808 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue
Clinical narrative: Received a full third dose of the Moderna vaccine although they were not immunocompromised; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and ACCIDENTAL OVERDOSE (Received a full third dose of the Moderna vaccine although they were not immunocompromised) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (Tiredness). On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full third dose of the Moderna vaccine although they were not immunocompromised). On 01-Sep-2021, ACCIDENTAL OVERDOSE (Received a full third dose of the Moderna vaccine although they were not immunocompromised) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-434069 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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.   No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-435187, MOD-2021-435192 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph node; Low-grade fever/100.6 fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Low-grade fever/100.6 fever) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Low-grade fever/100.6 fever). At the time of the report, LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Low-grade fever/100.6 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6 fever.         The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-435190 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Bad diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (LOT: GR8734) on 09-Apr-2021 and Pfizer (LOT: ER8735) on 30-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIARRHOEA (Bad diarrhea). At the time of the report, DIARRHOEA (Bad diarrhea) outcome was unknown.            Patient took no treatment medications but she drank some amount of water.  The reporter states that sometimes the patient take Miralax, and it catches up to her sometimes and are hoping that the diarrhea is from the Miralax.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021; got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) and INCORRECT DOSE ADMINISTERED (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) and INCORRECT DOSE ADMINISTERED (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021). On 05-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) and INCORRECT DOSE ADMINISTERED (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Soliloquy
Clinical narrative: some peculiar side effects which are not normal; talking to voices in my head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (some peculiar side effects which are not normal) and SOLILOQUY (talking to voices in my head) 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 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (some peculiar side effects which are not normal) and SOLILOQUY (talking to voices in my head). At the time of the report, FEELING ABNORMAL (some peculiar side effects which are not normal) and SOLILOQUY (talking to voices in my head) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. The patient heard voices of people that had personal vendetta against him. The patient had never experienced anything like this before receiving the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Immune compromised and have had both vaccines and a booster; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Immune compromised and have had both vaccines and a booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In August 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INCORRECT DOSE ADMINISTERED (Immune compromised and have had both vaccines and a booster). In August 2021, INCORRECT DOSE ADMINISTERED (Immune compromised and have had both vaccines and a booster) had resolved.            No concomitant medications were provided. No treatment medications were reported.  The patient have had both vaccines and a booster.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose that was left out of the 12 hour post punctured mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose that was left out of the 12 hour post punctured mark) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 013A21A and 028I20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose that was left out of the 12 hour post punctured mark). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose that was left out of the 12 hour post punctured mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-435921 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: she has "a little flu" ("Gripilla").; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (she has "a little flu" ("Gripilla").) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included Catheterisation cardiac and Surgery.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA (she has "a little flu" ("Gripilla").). At the time of the report, INFLUENZA (she has "a little flu" ("Gripilla").) outcome was unknown.            Patient was still on antibiotics, but she doesn't have a diagnosis.  Treatment medication was unknown. Lot number couldn't be gathered appropriately, it was said 7D21A or 7021A.    This case was linked to MOD-2021-435613 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Diarrhoea, Hypoaesthesia, Vaccination site pain
Clinical narrative: Numbness in legs after 2nd shot; On & off burning sensation injection site continued after 2nd shot; Diarrhea continued after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea continued after 2nd shot), HYPOAESTHESIA (Numbness in legs after 2nd shot) and VACCINATION SITE PAIN (On & off burning sensation injection site continued after 2nd shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B231A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced DIARRHOEA (Diarrhea continued after 2nd shot) and VACCINATION SITE PAIN (On & off burning sensation injection site continued after 2nd shot). In May 2021, the patient experienced HYPOAESTHESIA (Numbness in legs after 2nd shot). The patient was treated with TINIDAZOLE for Diarrhea, at an unspecified dose and frequency. On 30-Dec-2021, VACCINATION SITE PAIN (On & off burning sensation injection site continued after 2nd shot) had resolved. At the time of the report, DIARRHOEA (Diarrhea continued after 2nd shot) and HYPOAESTHESIA (Numbness in legs after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Antibody test: 705 (High) very high antibody count.         Patient reported  that patient  has not had it for a while but does not remember the date of the last episode. Patient visited 2  doctors and both prescribed antibiotics tinidazole. No concomitant medications information was reported.   This case was linked to MOD-2021-435671 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported .  The vial was punctured the previous day, on 28 Dec 2021, and used for up to 17 hours post puncture.No patients have reported any side effects from this dose.  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that the vial was punctured on 28-DEC-2021 and used for up to 17 hours post puncture.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; Initial information received on 23-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves patient of unknown demographics who had gbs (Guillain-Barre syndrome) 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 an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, frequency, route, administration site, batch and expiry date was unknown) as prophylactic vaccination.  It was reported that patient had one in over 20 yrs. since then patient had developed GBS (Guillain-Barre syndrome, onset and latency: unknown) and patient doctor told to never get another one, so he/she learned to take better care of himself/herself eat real whole foods keep his/her D3 levels between 50-70. Patient rarely eat sugar and had remained flu free  Action taken: Drug withdrawn  Corrective treatment: not reported  Outcome: unknown  Seriousness criteria: medically significant for Guillain-Barre syndrome; Sender's Comments: Sanofi company comment dated 24-Dec-2021: This case involves patient of unknown demographics with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, 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.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Malaise
Clinical narrative: sick with who knows what, can't get a test; Initial information received on 27-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sick with who knows what, can't get a test while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunization.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "sick with who knows what, can't get a test" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick with who knows what, can't get a test).  At time of reporting, the outcome was Unknown for the event sick with who knows what, can't get a test.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect route of product administration, Limb injury
Clinical narrative: This case involves Adult and unknown gender patient who experienced got shoulder injury and flu shot put in wrong place while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "got shoulder injury" (limb injury) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious flu shot put in wrong place (product administered at inappropriate site) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (Got Shoulder injury, flu shot put in wrong place). At time of reporting, the outcome was Unknown for the event got shoulder injury and was Unknown for the event flu shot put in wrong place. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: This case involves an unknown age female patient who experienced got sick and flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "several years ago. got sick, went to doctor. Diagnosed with flu. No I cannot have it, I took the shot. they said it is only good for 60 days or so". Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (got sick, flu). At time of reporting, the outcome was Unknown for the event got sick and was Unknown for the event flu.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion due to the product not being refrigerated upon receipt. Caller reporting IPOL at a high of 68F for 75 hours with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demographics who had temperature excursion due to the product not being refrigerated upon receipt. caller reporting ipol at a high of 68f for 75 hours with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  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 Primary dose of suspect IPV (VERO) (of unknown dose, formulation) lot U1C571M in unknown administration site.  On an unknown date the patient developed a non-serious event temperature excursion due to the product not being refrigerated upon receipt. caller reporting ipol at a high of 68f for 75 hours with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion due to the product not being refrigerated upon receipt. Caller reporting IPOL at a high of 68F for 75 hours with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion due to the product not being refrigerated upon receipt. caller reporting ipol at a high of 68f for 75 hours with no reported adverse event.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This case involves a 20 months old male patient who experienced administered pentacel to a patient without reconstituting it with no reported adverse event. while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); HEPATITIS A VACCINE (HEPATITIS A VACCINE); and INFLUENZA VACCINE (INFLUENZA VACCINE). On 28-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U7013AA via intramuscular route in unknown administration site for prophylactic vaccination. On 28-DEC-2021 the patient developed a non-serious administered pentacel to a patient without reconstituting it with no reported adverse event. (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (administered PENTACEL to a patient without reconstituting it with no reported adverse event.). At time of reporting, the outcome was Unknown for the event administered pentacel to a patient without reconstituting it 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. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: Extreme body inflammation.  Every joint is painful. It has lasted a month
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives all over body
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient called and stated she had numbness from her right ear to her mouth along with numbness of her right tongue. She also stated she was starting to feel tingling in her right side extremities.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Onset on same day as vaccination.  Entire riht side of body affected.  Hip, arm, shoulder, neck, ears are all bothered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Injection site erythema, Lymphadenopathy
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Lymph Node Swelling-Severe, Additional Details: chest pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Headache, Lethargy, Lymphadenopathy, Menstrual disorder
Clinical narrative: Day of the 1st dose (several hours later): very painful arm soreness Morning after the 1st dose: incapacitating headache, lethargic, arm soreness, lymph node/gland swelling in the armpit, mostly on the same side as the arm I received the shot in. Side effects lasted into the next day as well.  2 1/2 weeks after 1st dose: menstruation occurred 3 days early (I?m very regular with 28 day cycles) and I had unusually tender breasts beforehand.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Day of the 1st dose (several hours later): very painful arm soreness Morning after the 1st dose: incapacitating headache, lethargic, arm soreness, lymph node/gland swelling in the armpit, mostly on the same side as the arm I received the shot in. Side effects lasted into the next day as well.  2 1/2 weeks after 1st dose: menstruation occurred 3 days early (I?m very regular with 28 day cycles) and I had unusually tender breasts beforehand.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling, Urticaria
Clinical narrative: Swollen puffy eyes and some hives on trunk
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Ear, nose and throat examination, Tinnitus
Clinical narrative: The next morning  I got Tinnitus and it is still with me. I went to a doctor and there is no treatment.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunodeficiency, Intensive care, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted.  COVID infection breakthrough with inpatient hospital stay in ICU.  Immunocompetent
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted.   COVID infection breakthrough with inpatient hospital stay on general medical unit
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypertension, Incorrect dose administered
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Error: Wrong Dose of Vaccine - Too Low-
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Error: Wrong Dose of Vaccine - Too Low-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted.   COVID infection breakthrough.   Inpatient admit to a general medical unit. LOT NUMBERS OF VACCINES NOT LISTED in Vaccine registry
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Numbness, tingling, shooting electrical pains down left arm. Lasted few minutes and then stopped. Lasted hours with second vaccine and involved both arms.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna booster shot, when only Pfizer booster is currently authorized for 16 y/o.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Intensive care, Tracheostomy, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated with J&J, not boosted.   COVID infection breakthrough and admit to inpatient ICU.  Chronic trach.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Angiogram cerebral, Anticoagulant therapy, Blindness, Cerebrovascular accident
Clinical narrative: CVA occipital  lobe presenting with visual loss.  She recovered fully .  Symptoms occured suddenly   21 days post vaccination.   Stroke confirmed on  brain MRI. Treated with heparin.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Magnetic resonance imaging head abnormal, Neurological symptom
Clinical narrative: CVA occipital  lobe presenting with visual loss.  She recovered fully .  Symptoms occured suddenly   21 days post vaccination.   Stroke confirmed on  brain MRI. Treated with heparin.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Gianotti-Crosti syndrome, Metabolic function test, Rash, Red blood cell sedimentation rate
Clinical narrative: Skin Rash after Peds Pfizer and DX with Gianotti crosti Rash. Went to ER on 12-24-21
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Skin Rash after Peds Pfizer and DX with Gianotti crosti Rash. Went to ER on 12-24-21
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and sore lymph nodes (under both arm pits).  Soreness started to lessen within a few days, however while less sore, there is still noticeable mild soreness 4 weeks later
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Respiratory failure
Clinical narrative: Received 2 doses Pfizer vaccine Feb and March 2021, no booster; admitted Dec 2021 for hypoxic respiratory failure 2/2 covid19 pneumonia. Discharged home next day.