chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Hypoaesthesia
Clinical narrative: doesn't feel the same anymore/ feels off; a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off; legs went numb/feet went numb; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (doesn't feel the same anymore/ feels off), DYSGEUSIA (a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off) and HYPOAESTHESIA (legs went numb/feet went numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, CD9D21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Drug allergy.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 16-Feb-2022, the patient experienced DYSGEUSIA (a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off). 16-Feb-2022, the patient experienced HYPOAESTHESIA (legs went numb/feet went numb). On an unknown date, the patient experienced FEELING ABNORMAL (doesn't feel the same anymore/ feels off). The patient was treated with IBUPROFEN at a dose of 1 dosage form once a day and PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form once a day. At the time of the report, FEELING ABNORMAL (doesn't feel the same anymore/ feels off) and HYPOAESTHESIA (legs went numb/feet went numb) outcome was unknown and DYSGEUSIA (a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off) had resolved.            No concomitant medication were provided.   Patient reported that she had her wisdom teeth out in high school and was healthy prior to getting the Moderna vaccines.  No treatment medication were provided.   This case was linked to MOD-2022-508581, MOD-2022-508700 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given >35 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days from 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. CD9D21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulpha drugs) and Drug allergy (Allergy to Opioids).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days from 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days from 1st dose) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-508581, MOD-2022-508605 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Hepatic mass, Positron emission tomogram, Pulmonary mass
Clinical narrative: Many more lymph nodes and lung nodules than before; Many more lymph nodes and lung nodules than before and now it is in liver too; Enlargment in breast mass; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Enlargment in breast mass), PULMONARY MASS (Many more lymph nodes and lung nodules than before) and HEPATIC MASS (Many more lymph nodes and lung nodules than before and now it is in liver too) 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 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BREAST MASS (Enlargment in breast mass). On 16-Feb-2022, the patient experienced PULMONARY MASS (Many more lymph nodes and lung nodules than before) and HEPATIC MASS (Many more lymph nodes and lung nodules than before and now it is in liver too). At the time of the report, BREAST MASS (Enlargment in breast mass), PULMONARY MASS (Many more lymph nodes and lung nodules than before) and HEPATIC MASS (Many more lymph nodes and lung nodules than before and now it is in liver too) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2022, Positron emission tomogram: abnormal (abnormal) Not only the breast mass had greatly enlarged but there were many more lymph nodes and lung nodules than before and now it was in liver too..         No concomitant product was provided.  It was reported that this time results were much worse than before.  The patient was quite clear that the booster shots were certainly not safe for her and had resulted in her and now dealing with a fatal disease.  No treatment information was provided.   This case was linked to MOD-2022-508678 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was inadvertently administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was inadvertently administered from an expired vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was inadvertently administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was inadvertently administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  2 patients had administered from expired vaccines (beyond use by date). HCP does not have that information but states the Use by date was on 07 Mar 2022. Date(s) of administration of vaccine, 1st patient on 07 Mar 2022 at 2:30 pm and 2nd patient on 09 Mar 2022 at 11:30 am. The vial did not undergo any temperature excursions.  No treatment details were provided.   This case was linked to MOD-2022-508368 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I took both vaccination with very few side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I took both vaccination with very few side effect) in a 47-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I took both vaccination with very few side effect). At the time of the report, VACCINATION COMPLICATION (I took both vaccination with very few side effect) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2022-508849, MOD-2022-508853 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I took both vaccination with very few side effect) in a 47-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I took both vaccination with very few side effect). At the time of the report, VACCINATION COMPLICATION (I took both vaccination with very few side effect) outcome was unknown. No concomitant drug reported. No treatment information was provided by the reporter. Patient want to take legal action, as patient reported suffered alot after booster dose. This case was linked to MOD-2022-508838, MOD-2022-508853 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040D21A, 014M20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Blood pressure) and Tachycardia. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, PROPRANOLOL for Hypertension and Tachycardia, DUTASTERIDE for an unknown indication.   On 27-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 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose) outcome was unknown.            The patient took DUTASTERIDE for Prostate.  No treatment details were reported.
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Blood test, Endoscopy abnormal, Ulcer, Viral infection
Clinical narrative: Endoscopy indicates ulcer with a perplexing virus probably auto immune. Getting blood tests today
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C1A and 204C21I) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose) outcome was unknown.            Patient was not an immunocompromised patient  No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the patient would like to know when would it be appropriate for him to receive the booster
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Mammogram
Clinical narrative: armpit had a little ball now "that hurts", which became bigger like a grape and wanted to know if it was a reaction to the vaccine; a little ball in the armpit that hurts; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (armpit had a little ball now "that hurts", which became bigger like a grape and wanted to know if it was a reaction to the vaccine) and AXILLARY PAIN (a little ball in the armpit that hurts) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 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 AXILLARY MASS (armpit had a little ball now "that hurts", which became bigger like a grape and wanted to know if it was a reaction to the vaccine) and AXILLARY PAIN (a little ball in the armpit that hurts). At the time of the report, AXILLARY MASS (armpit had a little ball now "that hurts", which became bigger like a grape and wanted to know if it was a reaction to the vaccine) and AXILLARY PAIN (a little ball in the armpit that hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: result not provided result not provided (Had one month ago).         No concomitant medication were provided. No treatment details were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022; A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 5:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator. Date the vial was initially stored in the refrigerator on 07 Feb 2022 at 10:31am. The vial did not undergo any temperature excursion.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Immunocompromised patient received a Booster dose instead of a Third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Immunocompromised patient received a Booster dose instead of a Third dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 010A21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Immunosuppression in February 2022. Concurrent medical conditions included Cancer (NOS).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (Immunocompromised patient received a Booster dose instead of a Third dose). At the time of the report, UNDERDOSE (Immunocompromised patient received a Booster dose instead of a Third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies and never tested positive for Covid-19.  She received Pneumonia and Shingles vaccine but HCP could not confirm the date of administration. No treatment medications were reported. Patient experienced no symptoms after the Booster dose.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Male patient received a dose of vaccine that had been punctured from for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Male patient received a dose of vaccine that had been punctured from for more than 12 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 10:05 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022 at 10:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Male patient received a dose of vaccine that had been punctured from for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Male patient received a dose of vaccine that had been punctured from for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had received booster dose. No concomitant medication information was reported. Pharmacy store manager stated that the vial was initially stored in the refrigerator 07-Mar-2022 placed into freezer. They took it out of the freezer and stored in refrigerator on 09-Mar-2022 at 8:30pm and date and time vial was first punctured on 10-March-2022 at 10:25 am. Administration time was at: 10:05am. The vial left out over night on the night of the 10-Mar-2022. The vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature was about 24 hours. No treatment information was reported.   This case was linked to MOD-2022-509154 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: her whole body is sore & aching, and hurting real bad/ Muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (her whole body is sore & aching, and hurting real bad/ Muscle pain) and ARTHRALGIA (joint pain) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 028K21A and 067T21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (her whole body is sore & aching, and hurting real bad/ Muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MYALGIA (her whole body is sore & aching, and hurting real bad/ Muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medication were provided
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: After puncturing vial was kept for more than 12 hours and administered.; Female patient received a dose of vaccine that had been punctured from for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Female patient received a dose of vaccine that had been punctured from for more than 12 hours) and PRODUCT STORAGE ERROR (After puncturing vial was kept for more than 12 hours and administered.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Female patient received a dose of vaccine that had been punctured from for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (After puncturing vial was kept for more than 12 hours and administered.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Female patient received a dose of vaccine that had been punctured from for more than 12 hours) and PRODUCT STORAGE ERROR (After puncturing vial was kept for more than 12 hours and administered.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a store manager  No Concomitant information was reported.  Reporter  stated that the vial was initially placed into freezer on 07-MAR-2022.They took it out of the freezer and stored in refrigerator on 09-Mar-2022 at 8:30pm.The vial was first punctured on 10-March-2022 at 10:25 am. The vial was left out over night on the night of the 10-Mar-2022. The vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature was about 24 hours.Administration time was between 2 -10:10 am.   No Treatment information was reported.   This case was linked to MOD-2022-509148 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: Injuries; This spontaneous case was reported by a consumer and describes the occurrence of INJURY (Injuries) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJURY (Injuries). At the time of the report, INJURY (Injuries) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: Not being able to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Not being able to walk) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0041c21a and 043b21a) for COVID-19 vaccination.     Concurrent medical conditions included Spinal cord compression (Compressed vertebra).   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-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 GAIT INABILITY (Not being able to walk). At the time of the report, GAIT INABILITY (Not being able to walk) outcome was unknown.            Patient was using many concomitant medications. Patient was unable to walk since March . Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Productive cough
Clinical narrative: productive cough; first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (productive cough) and PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     The patient's past medical history included Productive cough. Concurrent medical conditions included Reaction to food colouring, COPD (Started 20 years ago, changes across the board because of the lung infection), Serratia marcescens infection (bacterial lung infection started 7 years ago, slight changes due to environmental problems), Irritable bowel syndrome (Started 10 years ago), Diarrhea (December 2020 phase change (from constipation to diarrhea).) since December 2020 and Drug allergy (some ingredients used in antibiotics called sulfa additives). Concomitant products included ALBUTEROL [SALBUTAMOL], IPRATROPIUM BROMIDE (ATROVENT), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MACROGOL 3350 (MIRALAX) and PREDNISONE for an unknown indication.    On 12-Dec-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 PRODUCTIVE COUGH (productive cough) and PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). At the time of the report, PRODUCTIVE COUGH (productive cough) had not resolved and PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was using prednisone around August-September 2021. In December 2020 phase change (from constipation to diarrhea), he was using 4 or more laxatives in high doses each night. Then he stopped using all those medications, including vitamins.  Patient reported the people who gave him the first shot told him they would  be in contact with him in 30 days to give him the second shot. However, those people stopped and another business took on their work. There was a time lapse between his first shot and then at the time of reporting.  For the adverse event productive cough  patient did not seek medical care.Treatment information was not provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hypoaesthesia, Immunisation reaction, Myalgia
Clinical narrative: Weakness; All the other things; Tingling in fingertips- both hands; Numbness in fingertips- both hands; Fever of 101.5 Degrees Fahrenheit; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), VACCINATION COMPLICATION (All the other things), PARAESTHESIA (Tingling in fingertips- both hands), HYPOAESTHESIA (Numbness in fingertips- both hands) and PYREXIA (Fever of 101.5 Degrees Fahrenheit) in a 42-year-old male patient 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Mar-2022 at 9:00 AM, the patient experienced ASTHENIA (Weakness), VACCINATION COMPLICATION (All the other things), PARAESTHESIA (Tingling in fingertips- both hands), HYPOAESTHESIA (Numbness in fingertips- both hands), PYREXIA (Fever of 101.5 Degrees Fahrenheit), CHILLS (Chills) and MYALGIA (Body Aches). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing from March 2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), VACCINATION COMPLICATION (All the other things), PARAESTHESIA (Tingling in fingertips- both hands), HYPOAESTHESIA (Numbness in fingertips- both hands), PYREXIA (Fever of 101.5 Degrees Fahrenheit), CHILLS (Chills) and MYALGIA (Body Aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.5 degrees fahrenheit (High) 101.5 Degrees Fahrenheit.         Patient had no known allergies, never tested positive for COVID, No known acute and chronic illnesses at the time of vaccination.  No concomitant medications were reported  Patient stated that all events were worsened.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Weakness; All the other things; Tingling in fingertips- both hands; Numbness in fingertips- both hands; Fever of 101.5 Degrees Fahrenheit; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), VACCINATION COMPLICATION (All the other things), PARAESTHESIA (Tingling in fingertips- both hands), HYPOAESTHESIA (Numbness in fingertips- both hands) and PYREXIA (Fever of 101.5 Degrees Fahrenheit) in a 42-year-old male patient 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Mar-2022 at 9:00 AM, the patient experienced ASTHENIA (Weakness), VACCINATION COMPLICATION (All the other things), PARAESTHESIA (Tingling in fingertips- both hands), HYPOAESTHESIA (Numbness in fingertips- both hands), PYREXIA (Fever of 101.5 Degrees Fahrenheit), CHILLS (Chills) and MYALGIA (Body Aches). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing from March 2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), VACCINATION COMPLICATION (All the other things), PARAESTHESIA (Tingling in fingertips- both hands), HYPOAESTHESIA (Numbness in fingertips- both hands), PYREXIA (Fever of 101.5 Degrees Fahrenheit), CHILLS (Chills) and MYALGIA (Body Aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.5 degrees fahrenheit (High) 101.5 Degrees Fahrenheit.         Patient had no known allergies, never tested positive for COVID, No known acute and chronic illnesses at the time of vaccination.  No concomitant medications were reported  Patient stated that all events were worsened.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave out Covid vaccine to a 17 year old and gave Moderna) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave out Covid vaccine to a 17 year old and gave Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave out Covid vaccine to a 17 year old and gave Moderna) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Reporter was director of nursing. No concomitant medications information was reported. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2022: Follow-up received contains no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Now is receiving breast cancer therapy; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST CANCER (Now is receiving breast cancer therapy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced BREAST CANCER (Now is receiving breast cancer therapy) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Now is receiving breast cancer therapy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received therapy for breast cancer.  No concomitant medications were provided.  It was reported that patient received the primary series of the Moderna Covid-19 Vaccine on Jan 2021 and Feb 2021 and the patient wasn´t immunocompromised at the moment of vaccination. but now receiving breast cancer therapy at the time of report and  also reports that patient wants to receive an additional dose of the vaccine.  Additional information regarding adverse event was not available at the time of report.  Company Comment:  This is a spontaneous case concerning a 68-year-old female with a medical history of 2 doses of mRNA-1273 in January and February 2021 who experienced the serious (medically significant), unexpected event of breast cancer at an unknown time and in an unknown relationship to the 2 doses of RNA-1273. Testing was not reported. Treatment is reported as chemotherapy. The outcome is probably ongoing as the patient is reported still being treated. Confounders are that the patient may have had the breast cancer before the vaccine and it is unlikely a cancer advanced enough to be detected could have been caused by the vaccine in such a short time period. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female with a medical history of 2 doses of mRNA-1273 in January and February 2021 who experienced the serious (medically significant), unexpected event of breast cancer at an unknown time and in an unknown relationship to the 2 doses of RNA-1273. Testing was not reported. Treatment is reported as chemotherapy. The outcome is probably ongoing as the patient is reported still being treated. Confounders are that the patient may have had the breast cancer before the vaccine and it is unlikely a cancer advanced enough to be detected could have been caused by the vaccine in such a short time period. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The patient immunocompromised got booster dose instead of third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (The patient immunocompromised got booster dose instead of third dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Nov-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. On 19-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (The patient immunocompromised got booster dose instead of third dose). At the time of the report, INCORRECT DOSE ADMINISTERED (The patient immunocompromised got booster dose instead of third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site reaction
Clinical narrative: Bad side effects/in bed for 2 days after; Arm pain; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad side effects/in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (9 months ago). Concurrent medical conditions included Asthma and Hypercholesterolemia. Concomitant products included ATORVASTATIN for Cholesterol.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Bad side effects/in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, VACCINATION SITE REACTION (Bad side effects/in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2022-509431 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: getting hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (getting hives all over the body) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076H21A, 021B21A-1 and 007C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL, B-COMPLEX, MULTIVITAMINS [VITAMINS NOS] and MAGNESIUM for an unknown indication.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, the patient experienced URTICARIA (getting hives all over the body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (getting hives all over the body) had not resolved.            The patient's allergist told the patient to take Zyrtec. It had been 2 months since then and the patient still had the hives. The hives pop up and then go away.  The patient had no history of testing positive for COVID-19 and had taken the booster dose.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received 0.25ml Moderna booster 3 months after J&J vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml Moderna booster 3 months after J&J vaccine) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine in August 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Immunocompromised.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml Moderna booster 3 months after J&J vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml Moderna booster 3 months after J&J vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient was immunocompromised and the pharmacist was wanted to know when it would be possible for the patient to received the second booster dose from Moderna.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Infection
Clinical narrative: Infection; worsening illness/may be chronic; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFECTION (Infection) and ILLNESS (worsening illness/may be chronic) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Infection) and ILLNESS (worsening illness/may be chronic). At the time of the report, INFECTION (Infection) and ILLNESS (worsening illness/may be chronic) had resolved. Not Provided          After vaccination patient's husband unintentionally passed infection to her that lasted weeks instead of days.  No concomitant medication were reported.  No treatment medication were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm pain; Headache; Fatigue; Was in bed for 2 days after; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (9 months ago). Concurrent medical conditions included Asthma (taking steroids for asthma) and Hypercholesterolaemia. Concomitant products included ATORVASTATIN for Hypercholesterolaemia.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BEDRIDDEN (Was in bed for 2 days after). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, BEDRIDDEN (Was in bed for 2 days after) had resolved and PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications included steroids for asthma.  At the time patient got his vaccines, he was taking steroids for asthma. So, his doctor said he should be fine to get his third full dose, but he never got it. He reports that with the first two doses, he had bad side effects.  Treatment information was not provided   This case was linked to MOD-2022-509348 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt the injection needle pinch his arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt the injection needle pinch his arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (felt the injection needle pinch his arm.). At the time of the report, VACCINATION SITE PAIN (felt the injection needle pinch his arm.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided.  The patient received the vaccine in his left arm shoulder deltoid muscle.  No treatment medication was provided.   This case was linked to MOD-2022-509786, MOD-2022-509820.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt the injection needle pinch his arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt the injection needle pinch his arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (felt the injection needle pinch his arm.). At the time of the report, VACCINATION SITE PAIN (felt the injection needle pinch his arm.) outcome was unknown.            No Concomitant information was reported. No Treatment information was reported.   This case was linked to MOD-2022-509755, MOD-2022-509820 (Patient Link).