chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Oral herpes, Pruritus, Rash
Clinical narrative: Bells palsy; fever blisters; got rash and pruritus all over the trunk; rash and itching all over the trunk; This spontaneous case was reported by a physician and describes the occurrence of BELL'S PALSY (Bells palsy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), DULOXETINE, FOLIC ACID, VITAMIN A NOS, BALOFLOXACIN, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) and AMLODIPINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (rash and itching all over the trunk) and RASH (got rash and pruritus all over the trunk). On 28-Feb-2021, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant) and ORAL HERPES (fever blisters). The patient was treated with PREDNISONE for Adverse event, at a dose of 15 milligram and VALACYCLOVIR [VALACICLOVIR] for Adverse event, at a dose of 1 gram. On 27-Feb-2021, PRURITUS (rash and itching all over the trunk) and RASH (got rash and pruritus all over the trunk) had resolved. At the time of the report, BELL'S PALSY (Bells palsy) and ORAL HERPES (fever blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment : This case concerns a  77 year-old female subject, who experienced the unexpected event  of  BELL´S PALSY The event occurred three days after the first dose of mRNA-1273. The event was considered related to the product per the reporter's physician. The benefit-risk relationship of drug Spikevax mRNA-1273 is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Upon internal review on 17-Sep-2021, case was unlocked to get company comment from MSAand removed event of facial paralysis , added new event rash; Sender's Comments: This case concerns a  77 year-old female subject, who experienced the unexpected event  of  BELL´S PALSY The event occurred three days after the first dose of mRNA-1273. The event was considered related to the product per the reporter's physician. The benefit-risk relationship of drug Spikevax mRNA-1273 is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Possible side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Possible side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Possible side effect). At the time of the report, VACCINATION COMPLICATION (Possible side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vials were stored in the refrigerator on 03May2021, and administered on 24Sep2021/ administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vials were stored in the refrigerator on 03May2021, and administered on 24Sep2021/ administration of vaccine past 30 days in the fridge) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vials were stored in the refrigerator on 03May2021, and administered on 24Sep2021/ administration of vaccine past 30 days in the fridge). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The vials were stored in the refrigerator on 03May2021, and administered on 24Sep2021/ administration of vaccine past 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-335024, MOD-2021-348962 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up include 1st and 2nd dose administration dates were added. On 11-Oct-2021: Updated Dose 1 and 2 date of administration. Added lot number for dose 1.Updated expire date.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Received expired second dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 037f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-347607 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow up received contains non significant information (reporter information) but in initial version missed to captured dose 1 details and event inappropriate scheduled of vaccine administered hence updated in FU.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 dose administered beyond the use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered beyond the use by date) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included SIMVASTATIN for Hyperlipidaemia.   On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021 at 10:57 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered beyond the use by date). On 07-Oct-2021 at 10:57 AM, EXPIRED PRODUCT ADMINISTERED (1 dose administered beyond the use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  This dose administered past beyond use date was the patient's 2nd dose. 2nd dose Use By Expiration 06-Oct-2021 by 2:45 pm.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow-up document contains no new information. On 14-Oct-2021: Follow up received on 14-Oct-2021, which contains significant information: patient demographics, suspect drug details, medical history and concomitant medication added.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: follow up received on 14-oct-21 contain no new information
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: it has only been 19 days between the first and the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has only been 19 days between the first and the second dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has only been 19 days between the first and the second dose). On 31-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has only been 19 days between the first and the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Significant follow up updated reporter information, patient information, dose 2 information added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pigmentation disorder
Clinical narrative: Weakness; micro and lipochrome  values that usually are around 1 increased to 3 and 2 respectively; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and PIGMENTATION DISORDER (micro and lipochrome  values that usually are around 1 increased to 3 and 2 respectively) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thalassemia minor. Concomitant products included LOSARTAN for Hypertension, ATENOLOL for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 ASTHENIA (Weakness) and PIGMENTATION DISORDER (micro and lipochrome  values that usually are around 1 increased to 3 and 2 respectively). At the time of the report, ASTHENIA (Weakness) and PIGMENTATION DISORDER (micro and lipochrome  values that usually are around 1 increased to 3 and 2 respectively) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Lab data- blood work was performed. Micro and lipochrome values were increased to 3 and 2 respectively   This case was linked to MOD-2021-347566 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired third dose) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031L21a and 031L21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired third dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Reporter contact information was updated   This case was linked to MOD-2021-346406, MOD-2021-346331, MOD-2021-346347, MOD-2021-346608, MOD-2021-346268, MOD-2021-346421, MOD-2021-347067, MOD-2021-347112, MOD-2021-347368, MOD-2021-346981, MOD-2021-347368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Non-Significant follow up appended-Email ID updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of decreased appetite (does not want to eat today) and nausea (queasy) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 050E21A) for COVID-19 immunization. No medical information reported. On Sep 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 11, 2021, patient had decreased appetite (does not want to eat today) and nausea (queasy). At the time of the report, decreased appetite (does not want to eat today) and nausea (queasy) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (I have had a dull headache ever since) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-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 HEADACHE (I have had a dull headache ever since). At the time of the report, HEADACHE (I have had a dull headache ever since) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that it was unknown about immunocompromised status of patient. No concomitant and treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose, after 12 hours of first puncture.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose, after 12 hours of first puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose, after 12 hours of first puncture.) had resolved.        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-2021-348276 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received and reporters details updated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 10-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-348333 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus/Ringing in ears; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus/Ringing in ears) 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 TINNITUS (Tinnitus/Ringing in ears). At the time of the report, TINNITUS (Tinnitus/Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided. Patient also received Pfizer COVID-19 vaccine.   This case was linked to MOD-2021-348408.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: No new information.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure inadequately controlled, Blood pressure measurement, Tachycardia
Clinical narrative: She has uncontrollable blood pressure; Tachycardic; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INADEQUATELY CONTROLLED (She has uncontrollable blood pressure) and TACHYCARDIA (Tachycardic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030421A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Diabetic and Hypertension. Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN DEGLUDEC (TRESIBA), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), ATORVASTATIN, OMEPRAZOLE, BUPROPION, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INADEQUATELY CONTROLLED (She has uncontrollable blood pressure) and TACHYCARDIA (Tachycardic). At the time of the report, BLOOD PRESSURE INADEQUATELY CONTROLLED (She has uncontrollable blood pressure) and TACHYCARDIA (Tachycardic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.         No treatment details were reported.  Other concomitant drugs include Fomasipian by mouth once daily, Vitamin DQ once a week 1.25mg capsule. Patient stated that when she lost weight her blood pressure got better.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2, Headache, Myalgia, Nasal congestion
Clinical narrative: was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure; chills; Fever; Headache; body aches; Cold symptoms; congestion ST; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure), CHILLS (chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), CHILLS (chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure). At the time of the report, NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure), CHILLS (chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure; chills; Fever; Headache; body aches; Cold symptoms; congestion ST; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure), CHILLS (chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), CHILLS (chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure). At the time of the report, NASOPHARYNGITIS (Cold symptoms), NASAL CONGESTION (congestion ST), EXPOSURE TO SARS-COV-2 (was exposed from her family who has symptoms of COVID as well (not tested) most likely exposure), CHILLS (chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; mild headache; little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache) and FATIGUE (little tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included UTI. Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract infection, LORATADINE (CLARITIN [LORATADINE]), MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], LEVOTHYROXINE, ZINC, COLECALCIFEROL (VITAMIN D3), AMLODIPINE, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) and PANTOPRAZOLE for an unknown indication.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache) and FATIGUE (little tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg twice a day and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache) and FATIGUE (little tired) had resolved.        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 had a sore arm, was a little tired, mild headache for about a week.   This case was linked to MOD-2021-348139 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Left atrial enlargement, Vaccination site pain
Clinical narrative: enlarged upper left atrium; little soreness where the shot was; This spontaneous case was reported by a consumer and describes the occurrence of LEFT ATRIAL ENLARGEMENT (enlarged upper left atrium) and VACCINATION SITE PAIN (little soreness where the shot was) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, INSULIN GLARGINE (LANTUS) and ATENOLOL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 LEFT ATRIAL ENLARGEMENT (enlarged upper left atrium) and VACCINATION SITE PAIN (little soreness where the shot was). At the time of the report, LEFT ATRIAL ENLARGEMENT (enlarged upper left atrium) and VACCINATION SITE PAIN (little soreness where the shot was) outcome was unknown.            Concomitant Medications include Novalab. Treatment Medications include Blood thinner
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased
Clinical narrative: could not function a 100% after first and second dose; exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore; This spontaneous case was reported by an other health care professional and describes the occurrence of MOBILITY DECREASED (could not function a 100% after first and second dose) and FATIGUE (exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Radiation injury NOS. Concomitant products included LOSARTAN for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (could not function a 100% after first and second dose) and FATIGUE (exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (could not function a 100% after first and second dose) and FATIGUE (exhausting tiredness after first and second dose/after dinner she had to go straight to bed after first and second dose/she still does not feel fully recovered but is not tired anymore) had resolved.        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.   This case was linked to MOD-2021-348231, MOD-2021-348232 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: 10-12 hours of nausea after the third dose; 10-12 hours of headache after the third dose; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (10-12 hours of nausea after the third dose) and HEADACHE (10-12 hours of headache after the third dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Radiation exposure. Concomitant products included LOSARTAN for an unknown indication.  On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced NAUSEA (10-12 hours of nausea after the third dose) and HEADACHE (10-12 hours of headache after the third dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 09-Oct-2021, NAUSEA (10-12 hours of nausea after the third dose) and HEADACHE (10-12 hours of headache after the third dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-348194, MOD-2021-348231 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given a moderna shot 24 hours after it was opened; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given a moderna shot 24 hours after it was opened) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given a moderna shot 24 hours after it was opened). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given a moderna shot 24 hours after it was opened) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-347918 (Patient Link).   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered >12 hours post puncture; Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours). On 11-Oct-2021 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 11-Oct-2021, PRODUCT STORAGE ERROR (Dose administered from a vial that was punctured and stored at room temperature beyond 12 hours) had resolved. On 11-Oct-2021 at 12:00 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in refrigerator on 02-Oct-2021 and the vial was first punctured on 10-Oct-2021. Post puncture vial was stored in room temperature for 30 hours.  No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-348407 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Secretion discharge
Clinical narrative: spitting up mucus; did not get the second dose due to the itching; itching from her toes to her head; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching from her toes to her head), SECRETION DISCHARGE (spitting up mucus) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose due to the itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching from her toes to her head). On an unknown date, the patient experienced SECRETION DISCHARGE (spitting up mucus) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose due to the itching). At the time of the report, PRURITUS (itching from her toes to her head) and SECRETION DISCHARGE (spitting up mucus) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get the second dose due to the itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  As treatment for the events patient used a sugar/coffee scrub shower gel once. Patient did not get the second dose due to the itching.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Fatigue; Under left armpit it feels a knot and looks swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Under left armpit it feels a knot and looks swollen), PYREXIA (Fever) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012A21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Under left armpit it feels a knot and looks swollen). On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Under left armpit it feels a knot and looks swollen), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Patient has been given third dose as the patient was on immune suppressive medication.   This case was linked to MOD-2021-348370 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow- up received contains batch number of suspect drug, reporter address and updated start date of second dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Hypoaesthesia, Paraesthesia, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (numbness and tingling in my fingers), BURNING SENSATION (and burning in finger tips), PARAESTHESIA (tingling in her fingers), HEADACHE (headaches) and VACCINATION SITE PAIN (soreness at injection site/ pain in left upper deltoid, at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced HYPOAESTHESIA (numbness and tingling in my fingers), BURNING SENSATION (and burning in finger tips), PARAESTHESIA (tingling in her fingers), HEADACHE (headaches), VACCINATION SITE PAIN (soreness at injection site/ pain in left upper deltoid, at the injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness and tingling in my fingers), BURNING SENSATION (and burning in finger tips), PARAESTHESIA (tingling in her fingers) and HEADACHE (headaches) had not resolved and VACCINATION SITE PAIN (soreness at injection site/ pain in left upper deltoid, at the injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment included shaking out hands for numbness and tingling where patient feels it as a circulation problem.   This case was linked to MOD-2021-348391 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (numbness and tingling in my fingers), BURNING SENSATION (and burning in finger tips), PARAESTHESIA (tingling in her fingers), HEADACHE (headaches) and VACCINATION SITE PAIN (soreness at injection site/ pain in left upper deltoid, at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced HYPOAESTHESIA (numbness and tingling in my fingers), BURNING SENSATION (and burning in finger tips), PARAESTHESIA (tingling in her fingers), HEADACHE (headaches), VACCINATION SITE PAIN (soreness at injection site/ pain in left upper deltoid, at the injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness and tingling in my fingers), BURNING SENSATION (and burning in finger tips), PARAESTHESIA (tingling in her fingers) and HEADACHE (headaches) had not resolved and VACCINATION SITE PAIN (soreness at injection site/ pain in left upper deltoid, at the injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment included shaking out hands for numbness and tingling where patient feels it as a circulation problem.   This case was linked to MOD-2021-348391 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Dyspnoea, Eye pain, Fatigue
Clinical narrative: Not feeling well/not expecting to feel the way he feels; Tired; Confused (meaning he could not put thoughts together); Moody; Throat swelled up; Could not breath; Started to sweat; Eyes hurts; Joint hurts; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)), MOOD SWINGS (Moody), PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started to sweat) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE, LOSARTAN and SPIRONOLACTONE for an unknown indication.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started to sweat), EYE PAIN (Eyes hurts) and ARTHRALGIA (Joint hurts). On 04-Oct-2021, the patient experienced CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)), MOOD SWINGS (Moody) and FATIGUE (Tired). On an unknown date, the patient experienced MALAISE (Not feeling well/not expecting to feel the way he feels). At the time of the report, CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)) and MOOD SWINGS (Moody) was resolving and PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started to sweat), EYE PAIN (Eyes hurts), MALAISE (Not feeling well/not expecting to feel the way he feels), ARTHRALGIA (Joint hurts) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three days after vaccination patient noted that his thyroid medication was not working.  No treatment information was reported.