chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 81 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309858, 20220309987, 20220310363, 20220310590, 20220310306, 20220310548 and 20220310631.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309858, 20220309972, 20220310363, 20220310590, 20220310306, 20220310548 and 20220310631.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 3:06 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. HCP called to ask about a box of vials that they received on 7JAN2022. There is one vial who was been administered after 30 days on fridge (30 days were on 6FEB2022). The LOT NUMBER of that vial was 022J21A and they administered a Moderna COVID-19 vaccine to 5 patients. HCP stated that she don´t have the Personal information of those patients. The vaccines were administered in the pharmacy: 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses) and 2 patients on 9FEB2022 ( 1 booster and 1 primary dose ). The expiration date of the vial affected is 24APR2022. On 10FEB2022 the patients received the vaccine one hours after first puncture and on 9FEB2022 the patients received the vaccine almost 3 hours since the first punctured. HCP stated that there is no temperature excursion during the administration of that vial ( the vials were in the fridge).   This case was linked to MOD-2022-480636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow up received contains Non significant information. Fax no. updated. On 01-Mar-2022: Report type changed from invalid to spontaneous, drug start date and details, patient and reporter details and event start date updated.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Received partial dose; Syringe leakage; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received partial dose) and SYRINGE ISSUE (Syringe leakage) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 INCORRECT DOSE ADMINISTERED (Received partial dose) and SYRINGE ISSUE (Syringe leakage). At the time of the report, INCORRECT DOSE ADMINISTERED (Received partial dose) and SYRINGE ISSUE (Syringe leakage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects) 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) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (side effects). At the time of the report, ADVERSE REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product temperature excursion issue
Clinical narrative: 12 patients received the vaccine that underwent a temperature excursion; 12 patient doses administered from one vial (instead of the standard 10 doses); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (12 patients received the vaccine that underwent a temperature excursion) and INCORRECT DOSE ADMINISTERED (12 patient doses administered from one vial (instead of the standard 10 doses)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Dec-2020, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (12 patients received the vaccine that underwent a temperature excursion) and INCORRECT DOSE ADMINISTERED (12 patient doses administered from one vial (instead of the standard 10 doses)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (12 patients received the vaccine that underwent a temperature excursion) outcome was unknown and INCORRECT DOSE ADMINISTERED (12 patient doses administered from one vial (instead of the standard 10 doses)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event) 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) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Unproperly thawed vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Unproperly thawed vaccine administered) 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 PRODUCT ADMINISTRATION ERROR (Unproperly thawed vaccine administered). At the time of the report, PRODUCT ADMINISTRATION ERROR (Unproperly thawed vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Diarrhoea, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: swollen lymph nodes; fever; chills; nausea; diarrhea; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), DIARRHOEA (diarrhea) and LYMPHADENOPATHY (swollen lymph nodes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), DIARRHOEA (diarrhea) and LYMPHADENOPATHY (swollen lymph nodes). On 27-Mar-2021, PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), DIARRHOEA (diarrhea) and LYMPHADENOPATHY (swollen lymph nodes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Neurological symptom, Tinnitus
Clinical narrative: neurological problems; shingles; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological problems), HERPES ZOSTER (shingles) and TINNITUS (tinnitus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurological problems), HERPES ZOSTER (shingles) and TINNITUS (tinnitus). At the time of the report, NEUROLOGICAL SYMPTOM (neurological problems), HERPES ZOSTER (shingles) and TINNITUS (tinnitus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient reports she was on social media and had seen so many people post about having neurological issues like Tinnitus and Shingles after receiving the vaccine.  No specific information on the brand of vaccine.  No information was provided that the patient experienced these symptoms herself.    Concomitant medications were not reported.   Treatment information if any was not provided.   This case was linked.   Reporter did not allow further contact; Sender's Comments:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue after the second shot; 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 FATIGUE (fatigue after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue after the second shot). At the time of the report, FATIGUE (fatigue after the second shot) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: the injection site is swollen; the injection site is itcy; the injection site is red.; 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 VACCINATION SITE SWELLING (the injection site is swollen), VACCINATION SITE PRURITUS (the injection site is itcy) and VACCINATION SITE ERYTHEMA (the injection site is red.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (the injection site is swollen), VACCINATION SITE PRURITUS (the injection site is itcy) and VACCINATION SITE ERYTHEMA (the injection site is red.). At the time of the report, VACCINATION SITE SWELLING (the injection site is swollen), VACCINATION SITE PRURITUS (the injection site is itcy) and VACCINATION SITE ERYTHEMA (the injection site is red.) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication not provided.  Concomitant medication not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: having allergies and took vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of ALLERGY TO VACCINE (having allergies and took vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy multiple.    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 ALLERGY TO VACCINE (having allergies and took vaccine). At the time of the report, ALLERGY TO VACCINE (having allergies and took vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       He reports that the pharmacist noticed that people in general who had allergies at baseline and who had received any sort of vaccine were also coming in for more allergy support medications.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: maybe swollen lymph nodes around neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (maybe swollen lymph nodes around neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (maybe swollen lymph nodes around neck). At the time of the report, LYMPHADENOPATHY (maybe swollen lymph nodes around neck) outcome was unknown.            Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Vaccination site swelling
Clinical narrative: the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before; immediate swelling in the area; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before) and VACCINATION SITE SWELLING (immediate swelling in the area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history provided by the reporter.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PAROSMIA (the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before) and VACCINATION SITE SWELLING (immediate swelling in the area). At the time of the report, PAROSMIA (the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before) and VACCINATION SITE SWELLING (immediate swelling in the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other concomitant medication  provided by the reporter The Treatment information was not provided.   This case was linked to MOD-2021-147695 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram, Erythema, Fatigue, Joint swelling
Clinical narrative: Swelling in left shoulder near neck; Dry heaves; Arm had swelling; Arm had redness; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in left shoulder near neck), RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid operation (partial thyroid removal) in 2000. Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, LEVOTHYROXINE for Thyroid operation, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Vitamin supplementation, CALCIUM (ALGAE CALCIUM), MONASCUS PURPUREUS (RED YEAST RICE) and UBIDECARENONE (CO Q10) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness), PYREXIA (Fever) and FATIGUE (Tired). On an unknown date, the patient experienced JOINT SWELLING (Swelling in left shoulder near neck). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swelling in left shoulder near neck) had not resolved and RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness), PYREXIA (Fever) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 101.1 - 101.9 (High) 101 -109. On an unknown date, Body temperature: below 100 (normal) below 100. On an unknown date, Computerised tomogram: negative for lipoma (normal) Results were negative for signs of Lipoma.         Vaccine was administered via an injection to the patient.  Patient took concomitant medication algae cal plus, for bone strength and red yeast rice with Co Q10 for cardio health. Patient had consulted the doctor for the event swelling in the left shoulder and underwent CAT scan.   This case was linked to MOD-2021-012679 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Retching
Clinical narrative: Swelling in left shoulder near neck; Dry heaves; Arm had swelling; Arm had redness; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in left shoulder near neck), RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid operation (partial thyroid removal) in 2000. Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, LEVOTHYROXINE for Thyroid operation, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Vitamin supplementation, CALCIUM (ALGAE CALCIUM), MONASCUS PURPUREUS (RED YEAST RICE) and UBIDECARENONE (CO Q10) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness), PYREXIA (Fever) and FATIGUE (Tired). On an unknown date, the patient experienced JOINT SWELLING (Swelling in left shoulder near neck). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swelling in left shoulder near neck) had not resolved and RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness), PYREXIA (Fever) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 101.1 - 101.9 (High) 101 -109. On an unknown date, Body temperature: below 100 (normal) below 100. On an unknown date, Computerised tomogram: negative for lipoma (normal) Results were negative for signs of Lipoma.         Vaccine was administered via an injection to the patient.  Patient took concomitant medication algae cal plus, for bone strength and red yeast rice with Co Q10 for cardio health. Patient had consulted the doctor for the event swelling in the left shoulder and underwent CAT scan.   This case was linked to MOD-2021-012679 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Headache, Influenza like illness
Clinical narrative: taste loss; loss of smell; dizzy; runny nose; headache; flu like symptoms; fever; Vaccination site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), RHINORRHOEA (runny nose), HEADACHE (headache) and AGEUSIA (taste loss) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and VACCINATION SITE PAIN (Vaccination site pain). On 29-Jun-2021, the patient experienced RHINORRHOEA (runny nose) and HEADACHE (headache). On 02-Jul-2021, the patient experienced AGEUSIA (taste loss), ANOSMIA (loss of smell) and DIZZINESS (dizzy). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), RHINORRHOEA (runny nose), HEADACHE (headache), AGEUSIA (taste loss), ANOSMIA (loss of smell), DIZZINESS (dizzy) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, SARS-CoV-1 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-248049 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-1 test, Vaccination site pain
Clinical narrative: taste loss; loss of smell; dizzy; runny nose; headache; flu like symptoms; fever; Vaccination site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), RHINORRHOEA (runny nose), HEADACHE (headache) and AGEUSIA (taste loss) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and VACCINATION SITE PAIN (Vaccination site pain). On 29-Jun-2021, the patient experienced RHINORRHOEA (runny nose) and HEADACHE (headache). On 02-Jul-2021, the patient experienced AGEUSIA (taste loss), ANOSMIA (loss of smell) and DIZZINESS (dizzy). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), RHINORRHOEA (runny nose), HEADACHE (headache), AGEUSIA (taste loss), ANOSMIA (loss of smell), DIZZINESS (dizzy) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, SARS-CoV-1 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-248049 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Condition aggravated, Dizziness, Nausea, Product dose omission issue
Clinical narrative: dizzy; temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8; has a fatty liver and that now is even more sensible to fats; patient hasn't received the second dose and it has been more than a month; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BODY TEMPERATURE DECREASED (temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8), CONDITION AGGRAVATED (has a fatty liver and that now is even more sensible to fats), PRODUCT DOSE OMISSION ISSUE (patient hasn't received the second dose and it has been more than a month) and NAUSEA (nauseated) 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 09-Apr-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 DIZZINESS (dizzy), BODY TEMPERATURE DECREASED (temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8), CONDITION AGGRAVATED (has a fatty liver and that now is even more sensible to fats), PRODUCT DOSE OMISSION ISSUE (patient hasn't received the second dose and it has been more than a month) and NAUSEA (nauseated). At the time of the report, DIZZINESS (dizzy), BODY TEMPERATURE DECREASED (temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8) and NAUSEA (nauseated) outcome was unknown, CONDITION AGGRAVATED (has a fatty liver and that now is even more sensible to fats) had not resolved and PRODUCT DOSE OMISSION ISSUE (patient hasn't received the second dose and it has been more than a month) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment: For the temperature a pill that was recommended (doesn't remember the name).  Concomitant medication was not provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial was stored at room temperature for over 12 hours; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-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-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) outcome was unknown and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) 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. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: myalgia; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia) and PYREXIA (fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced MYALGIA (myalgia) and PYREXIA (fever). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (myalgia) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Fever 101.3 degrees F   This case was linked to MOD-2021-250232 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: Inappropriate Schedule of Vaccine administered; second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) had resolved.        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.   Concomitant medication use was unknown Treatment information was unknown
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received doses from an expire vial) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperglycemia since 31-May-2018, Hypercholesterolemia since 31-May-2018 and Hypertension since 11-Jun-2009.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-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 EXPIRED PRODUCT ADMINISTERED (patient received doses from an expire vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received doses from an expire vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has a current condition og Benign hyperstension. Patient had no known allergies. Concomitant medication and treatment drug were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow-up added as case change from invalid to valid, patients demographics added and all current condition added. Action taken updated from unknown to not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Vaccination site reaction
Clinical narrative: sharp pain in the right kidney; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (sharp pain in the right kidney) and VACCINATION SITE REACTION (covid arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (sharp pain in the right kidney) and VACCINATION SITE REACTION (covid arm). At the time of the report, RENAL PAIN (sharp pain in the right kidney) and VACCINATION SITE REACTION (covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arm soreness; 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 MYALGIA (arm soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced MYALGIA (arm soreness). At the time of the report, MYALGIA (arm soreness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details ere provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Feeling abnormal, Heart rate decreased
Clinical narrative: heart was racing; like no sense of orientation or distance or depth; muscle pain; feels like I just ran a marathon; dizziness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), DISORIENTATION (like no sense of orientation or distance or depth), MYALGIA (muscle pain), FEELING ABNORMAL (feels like I just ran a marathon) and DIZZINESS (dizziness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004D21A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced PALPITATIONS (heart was racing), DISORIENTATION (like no sense of orientation or distance or depth), MYALGIA (muscle pain), FEELING ABNORMAL (feels like I just ran a marathon), DIZZINESS (dizziness) and FATIGUE (tiredness). At the time of the report, PALPITATIONS (heart was racing), DISORIENTATION (like no sense of orientation or distance or depth), MYALGIA (muscle pain), FEELING ABNORMAL (feels like I just ran a marathon), DIZZINESS (dizziness) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Heart rate decreased: (abnormal) unknown. On 12-Jul-2021, Heart rate increased: (abnormal) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Palpitations
Clinical narrative: heart was racing; like no sense of orientation or distance or depth; muscle pain; feels like I just ran a marathon; dizziness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), DISORIENTATION (like no sense of orientation or distance or depth), MYALGIA (muscle pain), FEELING ABNORMAL (feels like I just ran a marathon) and DIZZINESS (dizziness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004D21A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced PALPITATIONS (heart was racing), DISORIENTATION (like no sense of orientation or distance or depth), MYALGIA (muscle pain), FEELING ABNORMAL (feels like I just ran a marathon), DIZZINESS (dizziness) and FATIGUE (tiredness). At the time of the report, PALPITATIONS (heart was racing), DISORIENTATION (like no sense of orientation or distance or depth), MYALGIA (muscle pain), FEELING ABNORMAL (feels like I just ran a marathon), DIZZINESS (dizziness) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Heart rate decreased: (abnormal) unknown. On 12-Jul-2021, Heart rate increased: (abnormal) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Histamine intolerance, Scar, Urticaria
Clinical narrative: similar effects/hives/full body chronic hives; similar effects/dizzy; Scarring; Histamine intolerance; 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 URTICARIA (similar effects/hives/full body chronic hives), DIZZINESS (similar effects/dizzy), SCAR (Scarring) and HISTAMINE INTOLERANCE (Histamine intolerance) 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 URTICARIA (similar effects/hives/full body chronic hives), DIZZINESS (similar effects/dizzy), SCAR (Scarring) and HISTAMINE INTOLERANCE (Histamine intolerance). At the time of the report, URTICARIA (similar effects/hives/full body chronic hives) and DIZZINESS (similar effects/dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: left arm hurt; 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 MYALGIA (left arm hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MYALGIA (left arm hurt). In January 2021, MYALGIA (left arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication was provided. no medical history and concomitant medication was provided. 2nd dose was taken on Jan 2021. exact date not provided.   This case was linked to MOD-2021-256638 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding mother; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding mother) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding mother). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding mother) 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.   This case was linked to MOD-2021-256695 (Parent-Child Link).   See case MOD-2021-256695 for details regarding the Parent case.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time; doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time) and EXPIRED PRODUCT ADMINISTERED (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a) 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 10-Jul-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 PRODUCT STORAGE ERROR (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time) and EXPIRED PRODUCT ADMINISTERED (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a). At the time of the report, PRODUCT STORAGE ERROR (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time) and EXPIRED PRODUCT ADMINISTERED (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drugs included no treatment drugs included