chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: No smell; no taste for a bit; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (No smell), AGEUSIA (no taste for a bit) and FEELING ABNORMAL (lousy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (No smell), AGEUSIA (no taste for a bit) and FEELING ABNORMAL (lousy). At the time of the report, ANOSMIA (No smell), AGEUSIA (no taste for a bit) and FEELING ABNORMAL (lousy) outcome was unknown.            No Concomitant medication was reported.  No treatment medications were reported.; Sender's Comments: This is a spontaneous case concerning a 81-year-old female patient with no relevant medical history reported, who experienced AESI, non serious, unexpected events of Anosmia and Ageusia. The events occurred unknown days after the second dose of mRNA-1273.    No information about the first dose was disclosed. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5mL booster dose,Got the whole dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5mL booster dose,Got the whole dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Immunocompromised.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 27-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5mL booster dose,Got the whole dose). On 27-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5mL booster dose,Got the whole dose) had resolved.            Concomitant information was not provided. Treatment information was not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) 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) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-369020 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: left arm shoulder deltoid muscle. had a sore left arm; tired; under the weather; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm shoulder deltoid muscle. had a sore left arm), FATIGUE (tired) and MALAISE (under the weather) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm shoulder deltoid muscle. had a sore left arm), FATIGUE (tired) and MALAISE (under the weather). At the time of the report, VACCINATION SITE PAIN (left arm shoulder deltoid muscle. had a sore left arm), FATIGUE (tired) and MALAISE (under the weather) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-369222, MOD-2021-369381 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: under the weather; had a sore left injection site arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site arm) and FATIGUE (tired) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site arm) and FATIGUE (tired). At the time of the report, MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site arm) and FATIGUE (tired) 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.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369380, MOD-2021-369222 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Pain in extremity, Vaccination site induration, Vaccination site swelling
Clinical narrative: Soft lump underneath my arm; pain [in arm]; hard for me to sleep on my right side; a lot of pain underneath my arm; 2 inches by 2 inches/3 inches by 2 inches now; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Soft lump underneath my arm), PAIN IN EXTREMITY (pain [in arm]), VACCINATION SITE INDURATION (hard for me to sleep on my right side), AXILLARY PAIN (a lot of pain underneath my arm) and VACCINATION SITE SWELLING (2 inches by 2 inches/3 inches by 2 inches now) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-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 (Soft lump underneath my arm), PAIN IN EXTREMITY (pain [in arm]), VACCINATION SITE INDURATION (hard for me to sleep on my right side), AXILLARY PAIN (a lot of pain underneath my arm) and VACCINATION SITE SWELLING (2 inches by 2 inches/3 inches by 2 inches now). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of UNK, bid. At the time of the report, AXILLARY MASS (Soft lump underneath my arm), PAIN IN EXTREMITY (pain [in arm]) and AXILLARY PAIN (a lot of pain underneath my arm) outcome was unknown and VACCINATION SITE INDURATION (hard for me to sleep on my right side) and VACCINATION SITE SWELLING (2 inches by 2 inches/3 inches by 2 inches now) had not resolved.            No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up document received. Contact details of primary reporter updated, new reporter information added. New events added. Conmed added.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading; Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading; It is still hot; Didn't feel good; Headache; Diarrhea; Fatigue; Felt like throwing up; 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 SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading), FEELING HOT (It is still hot), FEELING ABNORMAL (Didn't feel good) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading), FEELING HOT (It is still hot), FEELING ABNORMAL (Didn't feel good), HEADACHE (Headache), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and NAUSEA (Felt like throwing up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading) and FEELING HOT (It is still hot) had not resolved and FEELING ABNORMAL (Didn't feel good), HEADACHE (Headache), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and NAUSEA (Felt like throwing up) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information included Allergy pill and ice.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Swelling
Clinical narrative: Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading; Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading; It is still hot; Didn't feel good; Headache; Diarrhea; Fatigue; Felt like throwing up; 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 SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading), FEELING HOT (It is still hot), FEELING ABNORMAL (Didn't feel good) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading), FEELING HOT (It is still hot), FEELING ABNORMAL (Didn't feel good), HEADACHE (Headache), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and NAUSEA (Felt like throwing up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading) and FEELING HOT (It is still hot) had not resolved and FEELING ABNORMAL (Didn't feel good), HEADACHE (Headache), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and NAUSEA (Felt like throwing up) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information included Allergy pill and ice.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin reaction, Vaccination complication, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: minor reaction to the Moderna booster vaccine; had a minor skin reaction about 24 hours after the vaccine; Rash; It is red; broke out in hives pretty bad all around that area in their top of their arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (minor reaction to the Moderna booster vaccine), SKIN REACTION (had a minor skin reaction about 24 hours after the vaccine), RASH (Rash), VACCINATION SITE ERYTHEMA (It is red) and VACCINATION SITE URTICARIA (broke out in hives pretty bad all around that area in their top of their arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (minor reaction to the Moderna booster vaccine), SKIN REACTION (had a minor skin reaction about 24 hours after the vaccine), RASH (Rash), VACCINATION SITE ERYTHEMA (It is red) and VACCINATION SITE URTICARIA (broke out in hives pretty bad all around that area in their top of their arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (minor reaction to the Moderna booster vaccine), SKIN REACTION (had a minor skin reaction about 24 hours after the vaccine), RASH (Rash) and VACCINATION SITE ERYTHEMA (It is red) outcome was unknown and VACCINATION SITE URTICARIA (broke out in hives pretty bad all around that area in their top of their arm) had resolved.            No concomitant medications were provided.  Reporter claim that the clinic didn't clean their arm before giving vaccine with anything and they administered the vaccine in a second degree bum scar spot, also stated that they had no reaction after the first two doses of the Moderna Covid-19 Vaccine.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The vial was initially stored in the refrigerator on 20-Apr-2021. HCP said that none of the patients experienced side effects so was not sure if should send the form anyways. Also mentioned that there were 14 patients instead of 18 because of some duplicates   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: HCP confirmed that there were 14 patients instead of 18 because of some duplicates.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Since then she has been experiencing side effects; Hot fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Since then she has been experiencing side effects) and PYREXIA (Hot fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced VACCINATION COMPLICATION (Since then she has been experiencing side effects). On an unknown date, the patient experienced PYREXIA (Hot fever). At the time of the report, VACCINATION COMPLICATION (Since then she has been experiencing side effects) outcome was unknown and PYREXIA (Hot fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: believes they give her the wrong dosage for the booster; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (believes they give her the wrong dosage for the booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (believes they give her the wrong dosage for the booster). On 29-Oct-2021, INCORRECT DOSE ADMINISTERED (believes they give her the wrong dosage for the booster) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: has a big knot in it; left arm started itching; has redness of a long oval; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (has a big knot in it), VACCINATION SITE PRURITUS (left arm started itching) and VACCINATION SITE ERYTHEMA (has redness of a long oval) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 02113A and 16M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE MASS (has a big knot in it), VACCINATION SITE PRURITUS (left arm started itching) and VACCINATION SITE ERYTHEMA (has redness of a long oval). At the time of the report, VACCINATION SITE MASS (has a big knot in it), VACCINATION SITE PRURITUS (left arm started itching) and VACCINATION SITE ERYTHEMA (has redness of a long oval) outcome was unknown.            She had a hard time making out the1st lot  No concomitant medications were reported  No treatment information was provided
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Arm is tight where they got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm is tight where they got the shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included CALCIUM and VITAMINS NOS for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE INDURATION (Arm is tight where they got the shot). At the time of the report, VACCINATION SITE INDURATION (Arm is tight where they got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were not reported.    This case was linked to MOD-2021-369498, MOD-2021-369479 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ARTHROPATHY (Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine). The patient was treated with CORTISONE on 22-Oct-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHROPATHY (Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine) outcome was unknown.            Concomitant medications were not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: another patient received a dose from the same vial (lot # 006C21A; expiration date 10Oct2021); This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (another patient received a dose from the same vial (lot # 006C21A; expiration date 10Oct2021)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (another patient received a dose from the same vial (lot # 006C21A; expiration date 10Oct2021)). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (another patient received a dose from the same vial (lot # 006C21A; expiration date 10Oct2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication reported. No Concomitant medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea
Clinical narrative: got really sick; bad headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), HEADACHE (bad headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, ILLNESS (got really sick), HEADACHE (bad headache) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-370027, MOD-2021-370043 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the Moderna vaccine (6 months stored in the refrigerator); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine (6 months stored in the refrigerator)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine (6 months stored in the refrigerator)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine (6 months stored in the refrigerator)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. Dose administered after 30-day use by date or after manufacturer date of expiry.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: i slept most of the day; very bad chills; Headache; Muscle aches; loss of appetite; Dizziness; overt weakness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), ASTHENIA (overt weakness), SOMNOLENCE (i slept most of the day) and CHILLS (very bad chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu. Concurrent medical conditions included Factor V Leiden mutation since April 2007. Concomitant products included CALCIUM from 01-Jan-2015 to an unknown date, MAGNESIUM from 01-Jan-2016 to an unknown date and POTASSIUM from 01-Jan-2018 to an unknown date for an unknown indication.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced SOMNOLENCE (i slept most of the day). In September 2021, the patient experienced DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), ASTHENIA (overt weakness), CHILLS (very bad chills), HEADACHE (Headache) and MYALGIA (Muscle aches). On 08-Sep-2021, CHILLS (very bad chills) had resolved. At the time of the report, DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), HEADACHE (Headache) and MYALGIA (Muscle aches) outcome was unknown and ASTHENIA (overt weakness) and SOMNOLENCE (i slept most of the day) had resolved.            no treatment medication were reported.   This case was linked to MOD-2021-322614 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Somnolence
Clinical narrative: i slept most of the day; very bad chills; Headache; Muscle aches; loss of appetite; Dizziness; overt weakness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), ASTHENIA (overt weakness), SOMNOLENCE (i slept most of the day) and CHILLS (very bad chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu. Concurrent medical conditions included Factor V Leiden mutation since April 2007. Concomitant products included CALCIUM from 01-Jan-2015 to an unknown date, MAGNESIUM from 01-Jan-2016 to an unknown date and POTASSIUM from 01-Jan-2018 to an unknown date for an unknown indication.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced SOMNOLENCE (i slept most of the day). In September 2021, the patient experienced DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), ASTHENIA (overt weakness), CHILLS (very bad chills), HEADACHE (Headache) and MYALGIA (Muscle aches). On 08-Sep-2021, CHILLS (very bad chills) had resolved. At the time of the report, DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), HEADACHE (Headache) and MYALGIA (Muscle aches) outcome was unknown and ASTHENIA (overt weakness) and SOMNOLENCE (i slept most of the day) had resolved.            no treatment medication were reported.   This case was linked to MOD-2021-322614 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: arm became hot to the touch around the injection site; arm became hard around the injection site; arm became itchy around the injection site; arm became "red" around the injection site; painful around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm became hot to the touch around the injection site), VACCINATION SITE INDURATION (arm became hard around the injection site), VACCINATION SITE PRURITUS (arm became itchy around the injection site), VACCINATION SITE ERYTHEMA (arm became "red" around the injection site) and VACCINATION SITE PAIN (painful around the injection site) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE WARMTH (arm became hot to the touch around the injection site), VACCINATION SITE INDURATION (arm became hard around the injection site), VACCINATION SITE PRURITUS (arm became itchy around the injection site), VACCINATION SITE ERYTHEMA (arm became "red" around the injection site) and VACCINATION SITE PAIN (painful around the injection site). At the time of the report, VACCINATION SITE WARMTH (arm became hot to the touch around the injection site), VACCINATION SITE INDURATION (arm became hard around the injection site), VACCINATION SITE PRURITUS (arm became itchy around the injection site), VACCINATION SITE ERYTHEMA (arm became "red" around the injection site) and VACCINATION SITE PAIN (painful around the injection site) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper
Clinical narrative: really bad stomach ache; abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad stomach ache) and ABDOMINAL PAIN (abdominal pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 047A21A and 006M20A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included ATORVASTATIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (really bad stomach ache) and ABDOMINAL PAIN (abdominal pain). The patient was treated with FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (really bad stomach ache) and ABDOMINAL PAIN (abdominal pain) outcome was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Burning sensation, Joint swelling, Limb discomfort
Clinical narrative: she has inflammation in her legs; leg burn; ankle swelling; her legs won't stop burning in her legs from her thighs down to her feet; she has arthritis, and her left leg is worse than her right leg and she has to use a cane and cannot stand.; This is a spontaneous report from a Pfizer-sponsored program.  A 59-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 27Mar2021 (At the age of 59 years) as DOSE 1, single, via an unspecified route of administration, patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), administered in Arm Left on 17Apr2021 (At the age of 59 years) as DOSE 2, single, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced that her legs won't stop burning from her thighs down to her feet and there is tenderness and burning in her feet. Also she had Ankle swelling. Patient did not had any problems walking before that and went to the orthopedist and was told she had arthritis and her left leg was worse than her right leg and she had to use a cane and cannot stand. On 07Jun2021 they gave her the Cortisol steroids. Patient stated that she can't put pressure on her left leg and on 06Jul2021 had the steroid injection Cortisol and had that in both the right and left knee and they said it was inflammation and took x-rays and determined it was not a cartilage issue. Recently on 13Jun2021 went to the vascular HCP for the same thing and she had no blood clots in her legs but had a burning sensation in her legs. The patient underwent lab tests and procedures which included x-ray on unspecified date, X-rays showed inflammation. The outcome of the events were unknown.   No Follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate irregular, Hypersensitivity, Peripheral swelling
Clinical narrative: It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; I have irregular heart beat, My heart is slow.; This is a spontaneous report from a contactable consumer or other non hcp.  A 42 years old male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 10Sep2021 as dose 1, single for covid-19 immunisation. Medical history included thyroid hormone replacement therapy, Thyroid, blood pressure measurement. Concomitant medication(s) included metformin; levothyroxine (LEVOTHYROXINE). It was reported that, the patient experienced it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area, it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area on an unspecified date with outcome of unknown, it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area, have irregular heartbeat, my heart is slow on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: increased heart rate: irregular.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (25Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; It caused me to have rash, My feet is swollen, Allergic reactions in my abdominal area.; I have irregular heart beat, My heart is slow.; This is a spontaneous report from a contactable consumer or other non hcp.  A 42 years old male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 10Sep2021 as dose 1, single for covid-19 immunisation. Medical history included thyroid hormone replacement therapy, Thyroid, blood pressure measurement. Concomitant medication(s) included metformin; levothyroxine (LEVOTHYROXINE). It was reported that, the patient experienced it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area, it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area on an unspecified date with outcome of unknown, it caused me to have rash, my feet is swollen, allergic reactions in my abdominal area, have irregular heartbeat, my heart is slow on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: increased heart rate: irregular.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (25Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough
Clinical narrative: cough. I always had it but it's worse now; heaviness in the chest a little bit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 18Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced cough. i always had it but it's worse now, heaviness in the chest a little bit. It was reported that "patient have a cough. patient always had it but it's worse now. Patient also experiencing heaviness in the chest a little bit. Reports wants to know if these symptoms are related to Pfizer COVID-19 vaccine. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph node the size of a softball under her armpit/swollen lymph node on her collarbone the size of a softball; swelling under her armpit and chest; This is a spontaneous report from a contactable consumer female patient (Daughter) that:  A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF2587), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swollen lymph node the size of a softball under her armpit/swollen lymph node on her collarbone the size of a softball and swelling under her armpit and chest. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Throat swelling; my entire body was itchy; certain parts like my head, neck, face, breast ares had hives like bumps; Hives (full body aching); the spot where I got the shot started to itch; tight throat; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3185), via intramuscular route, administered in left arm on 19Sep2021 at 14:10 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included ongoing asthma, allergies, ongoing anxiety, PCOS (polycystic ovarian syndrome) from an unknown date to 2018, hysterectomy, ongoing insomnia and known allergy with PNC. Concomitant medications included HYDROXYZINE for anxiety and insomnia from 2020 and ongoing, ALBUTEROL [SALBUTAMOL SULFATE] for asthma, diphenhydramine hydrochloride (BENADRYL) for allergies and paracetamol (TYLENOL). The patient previously took prednisone, vertex, Bactrim and experienced allergies. Prior vaccinations within four weeks were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for COVID-19. On 19Sep2021 at 14:11, the patient reported that the spot where she got the shot started to itch. On 19Sep2021 at 14:15, the patient experienced certain parts like head, neck, face, breast areas had hive like bumps and hives (full body aching). By bedtime (11pm) on 19Sep2021, her whole upper body got small pink hives and was very itchy, without relief, she also began experience a tight throat and has to use her inhaler and benedryl. On 19Sep2021 at 23:00, the patient reported that her entire body was itchy. By the next morning, 20Sep2021 her full body was itching uncontrollably. On 20Sep2021, the patient experienced throat swelling (minor). She could not get relief, so she called her doctors office to make an appointment, her primary doctor was full, so the office had she seen by doctor colleague. The doctor said she was having severe allergic reaction and to not get the 2nd shot. She increased the hydroxyzine to 100 mg every 3 hrs as well as benedryl every six. Doctor told her to go right to the ER if her throat swelled anymore and if it dot difficult to breathe. Adverse events required physician office visit. Relevant tests were not done. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. Therapeutic measures were taken as a result of the events which included treatment with hydroxyzine 100 mg every 3 hours as well as benadryl every six. No treatment was received for the event (the spot where I got the shot started to itch). The outcome of the event (tight throat and throat swelling) was unknown, event (Hives (full body aching)) was recovered on an unspecified date in 2021 and other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Irritability
Clinical narrative: injection site pain; sore arm; chills; headache; light fever/slight fever; dry cough; tiredness; he had swelling at the injection; just irritating; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (BNT162B2), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2021 (at the age of 64-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included pneumonia (he has a history of pneumonia and will be getting his shot in 24November2021), covid-19 from 2020 to an unknown date (he tested positive for COVID last year, it was mild and resolved after 2-3 weeks). The patient's concomitant medications were not reported. It was reported that on an unspecified, the patient experienced injection site pain, sore arm, chills, headache, light fever/slight fever, dry cough, tiredness, he had swelling at the injection, just irritating. It was reported that, patient got his flu shot last month. his HCP emphasized the importance of getting the flu shot and ever since he has been getting flu and pneumonia shot and hasn't been getting sick every year. After the second shot, he had a sore arm, and a few other symptoms like, chills, bad headache, slight fever, and dry cough, similar to getting a flu shot. The outcome of event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain; sore arm; chills; headache; light fever/slight fever; dry cough; tiredness; he had swelling at the injection; just irritating; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (BNT162B2), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2021 (at the age of 64-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included pneumonia (he has a history of pneumonia and will be getting his shot in 24November2021), covid-19 from 2020 to an unknown date (he tested positive for COVID last year, it was mild and resolved after 2-3 weeks). The patient's concomitant medications were not reported. It was reported that on an unspecified, the patient experienced injection site pain, sore arm, chills, headache, light fever/slight fever, dry cough, tiredness, he had swelling at the injection, just irritating. It was reported that, patient got his flu shot last month. his HCP emphasized the importance of getting the flu shot and ever since he has been getting flu and pneumonia shot and hasn't been getting sick every year. After the second shot, he had a sore arm, and a few other symptoms like, chills, bad headache, slight fever, and dry cough, similar to getting a flu shot. The outcome of event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.