chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient felt that the second dose was empty; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient felt that the second dose was empty) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced UNDERDOSE (Patient felt that the second dose was empty). At the time of the report, UNDERDOSE (Patient felt that the second dose was empty) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient believed second dose was not received, but the pharmacist does not agree with the patient. Believes that the patient was confused because two syringes were used during administration of the vaccine. One syringe was used to pull and the other was used to draw. No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.        Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received. NNI.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: feeling really under the weather; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling really under the weather) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   In May 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 1 dosage form. On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced MALAISE (feeling really under the weather). At the time of the report, MALAISE (feeling really under the weather) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Common side effects; 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 COMPLICATION (Common side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Common side effects). At the time of the report, VACCINATION COMPLICATION (Common side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After the first dose in Feb2021, she stopped coughing; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After the first dose in Feb2021, she stopped coughing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Ceclor and Penicillin. Past adverse reactions to the above products included Hives with Ceclor and Penicillin. Concurrent medical conditions included Non-cystic fibrosis bronchiectasis (Coughing stopped for three months after vaccination, then resumed.) since 07-Jan-2017, AFib since 01-Jan-2020 and Sulfonamide allergy (Sulfa drugs (hives)). Concomitant products included ALBUTEROL [SALBUTAMOL] for Bronchiectasis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After the first dose in Feb2021, she stopped coughing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After the first dose in Feb2021, she stopped coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.   This case was linked to MOD-2021-214763 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received. Updated patient demographics, and history. The vaccine administration date, and lot number was added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: CHRONIC FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (CHRONIC FATIGUE) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (CHRONIC FATIGUE). At the time of the report, FATIGUE (CHRONIC FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and patient gender updated to female, reporter's mail added, DOB of patient added, date of vaccine added
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on my clavicle (on the side of injection); 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 LYMPHADENOPATHY (swollen lymph node on my clavicle (on the side of injection)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node on my clavicle (on the side of injection)). At the time of the report, LYMPHADENOPATHY (swollen lymph node on my clavicle (on the side of injection)) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Shaking like a leaf; Appetite lost; Inflammation on neck and hands; sick after both doses/sicker after the second dose; Headache; Fatigue; pyrexia; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and METOPROLOL for an unknown indication.    The patient's past medical history included COVID-19 (For about 7 days) in 2020. Concurrent medical conditions included Atopic dermatitis and Weight increased.   On 23-Apr-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and METOPROLOL (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (pyrexia) and CHILLS (Chills). At the time of the report, TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (pyrexia) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Body temperature: 102 (High) 102 Cel. In 2020, Weight: weight gain (abnormal) Weight gain that worsened.         No treatment medications were provided.   This case was linked to MOD-2021-215394, MOD-2021-215394 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inflammation, Pyrexia, Tremor, Weight
Clinical narrative: Shaking like a leaf; Appetite lost; Inflammation on neck and hands; sick after both doses/sicker after the second dose; Headache; Fatigue; pyrexia; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and METOPROLOL for an unknown indication.    The patient's past medical history included COVID-19 (For about 7 days) in 2020. Concurrent medical conditions included Atopic dermatitis and Weight increased.   On 23-Apr-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and METOPROLOL (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (pyrexia) and CHILLS (Chills). At the time of the report, TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (pyrexia) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Body temperature: 102 (High) 102 Cel. In 2020, Weight: weight gain (abnormal) Weight gain that worsened.         No treatment medications were provided.   This case was linked to MOD-2021-215394, MOD-2021-215394 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine; 2 patients received 1st dose of Moderna that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine) and EXPIRED PRODUCT ADMINISTERED (2 patients received 1st dose of Moderna that was expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine) and EXPIRED PRODUCT ADMINISTERED (2 patients received 1st dose of Moderna that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine) and EXPIRED PRODUCT ADMINISTERED (2 patients received 1st dose of Moderna that was expired) 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.   Concomitant medications were not reported.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: achy; 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 (achy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (achy). At the time of the report, MYALGIA (achy) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a medical assistant and describes the occurrence of VACCINATION COMPLICATION (side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was given out of the 12 hours after the vial is pierced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was given out of the 12 hours after the vial is pierced) 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 EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was given out of the 12 hours after the vial is pierced). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was given out of the 12 hours after the vial is pierced) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; 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 COMPLICATION (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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant was provided no treatment was provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Tremor; decreased appetite; Inflammation; Chills; Pyrexia; Headache; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills) and PYREXIA (Pyrexia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and METOPROLOL for an unknown indication.    The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Weight gain.   On 23-Apr-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and METOPROLOL (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills), PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills), PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         Treatment product details not provided.  Concomitant product details not provided.   This case was linked to MOD-2021-215355, MOD-2021-215355 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pyrexia, Tremor
Clinical narrative: Tremor; decreased appetite; Inflammation; Chills; Pyrexia; Headache; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills) and PYREXIA (Pyrexia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and METOPROLOL for an unknown indication.    The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Weight gain.   On 23-Apr-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and METOPROLOL (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills), PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills), PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         Treatment product details not provided.  Concomitant product details not provided.   This case was linked to MOD-2021-215355, MOD-2021-215355 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccine adverse reaction; 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 COMPLICATION (Vaccine adverse reaction) 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) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccine adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experiencing adverse effect from my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing adverse effect from my 2nd dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experiencing adverse effect from my 2nd dose). At the time of the report, VACCINATION COMPLICATION (experiencing adverse effect from my 2nd dose) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-036787 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache in the back of her heady, headache comes and goes almost everyday, It hurts to sit up. She has to lay down when she has the headache The pt states it feels like something is pressing on the back of her head.; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache in the back of her heady, headache comes and goes almost everyday, It hurts to sit up. She has to lay down when she has the headache The pt states it feels like something is pressing on the back of her head.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced HEADACHE (headache in the back of her heady, headache comes and goes almost everyday, It hurts to sit up. She has to lay down when she has the headache The pt states it feels like something is pressing on the back of her head.). At the time of the report, HEADACHE (headache in the back of her heady, headache comes and goes almost everyday, It hurts to sit up. She has to lay down when she has the headache The pt states it feels like something is pressing on the back of her head.) outcome was unknown.            No Concomitant medication information Was Reported No Treatment information was Reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Myalgia
Clinical narrative: Flu; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) and MYALGIA (Muscle Aches) in a 72-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, received 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 INFLUENZA (Flu) and MYALGIA (Muscle Aches). At the time of the report, INFLUENZA (Flu) and MYALGIA (Muscle Aches) outcome was unknown. Not Provided          No Concomitant  and Treatment medications was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had side effects) in a 70-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had side effects). At the time of the report, VACCINATION COMPLICATION (Had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD-2021-042112 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Liver function test
Clinical narrative: elevated liver enzymes; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (elevated liver enzymes) 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) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (elevated liver enzymes). At the time of the report, HEPATIC ENZYME INCREASED (elevated liver enzymes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: other (High) elevated liver enzymes.         No concomitant medications were reported No treatment medications were reported Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-046164 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukaemia (started clinical trial drug in February 2021) since 2013, Pneumonia fungal and Blood pressure abnormal. Concomitant products included AMLODIPINE for Blood pressure, VALACYCLOVIR [VALACICLOVIR] and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Cancer, FLUCONAZOLE for Pneumonia fungal.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken were clinical trial drug Belumosudial 200 mg BID PO.  No Treatment medications were reported.     This case was linked to MOD-2021-209266, MOD-2021-209266 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-Jun-2021,It contains no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Ear swelling, Neck pain, Swelling, Tinnitus
Clinical narrative: swollen neck; painful neck; shaking; knots in shoulder area, knots in the back of the head; knots by ears; ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), SWELLING (swollen neck), NECK PAIN (painful neck), TREMOR (shaking) and SWELLING (knots in shoulder area, knots in the back of the head) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypercholesterolemia. Concurrent medical conditions included Hypertension, Penicillin allergy, Allergic reaction to analgesics (Allergy to Codeine.) and Allergic reaction to antibiotics (Allergy to Macrolide (Z-Pak).).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TINNITUS (ringing in ears). On 12-Mar-2021, the patient experienced SWELLING (swollen neck), NECK PAIN (painful neck), TREMOR (shaking), SWELLING (knots in shoulder area, knots in the back of the head) and EAR SWELLING (knots by ears). On 12-Mar-2021, TINNITUS (ringing in ears) had resolved. On 17-Mar-2021, SWELLING (swollen neck), NECK PAIN (painful neck), TREMOR (shaking), SWELLING (knots in shoulder area, knots in the back of the head) and EAR SWELLING (knots by ears) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood pressure measurement (125/76-130/80): 189/98 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had periodic episodes of tinnitus approximately twice per year. Concomitant  Medications include Cholesterol medicine and Blood pressure medicine. No treatment medications were provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: swollen neck; painful neck; shaking; knots in shoulder area, knots in the back of the head; knots by ears; ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), SWELLING (swollen neck), NECK PAIN (painful neck), TREMOR (shaking) and SWELLING (knots in shoulder area, knots in the back of the head) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypercholesterolemia. Concurrent medical conditions included Hypertension, Penicillin allergy, Allergic reaction to analgesics (Allergy to Codeine.) and Allergic reaction to antibiotics (Allergy to Macrolide (Z-Pak).).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TINNITUS (ringing in ears). On 12-Mar-2021, the patient experienced SWELLING (swollen neck), NECK PAIN (painful neck), TREMOR (shaking), SWELLING (knots in shoulder area, knots in the back of the head) and EAR SWELLING (knots by ears). On 12-Mar-2021, TINNITUS (ringing in ears) had resolved. On 17-Mar-2021, SWELLING (swollen neck), NECK PAIN (painful neck), TREMOR (shaking), SWELLING (knots in shoulder area, knots in the back of the head) and EAR SWELLING (knots by ears) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood pressure measurement (125/76-130/80): 189/98 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had periodic episodes of tinnitus approximately twice per year. Concomitant  Medications include Cholesterol medicine and Blood pressure medicine. No treatment medications were provided by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Dizziness; Chills; a little headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CHILLS (Chills) and HEADACHE (a little headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043120A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills) and HEADACHE (a little headache). At the time of the report, DIZZINESS (Dizziness), CHILLS (Chills) and HEADACHE (a little headache) had resolved.            It was stated that patient had history of bypasses and he was taking medications for that. The concomitant medications were not provided.   This case was linked to MOD-2021-017956 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received and events reported were resolved, and patient declined further follow up.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Vomiting
Clinical narrative: sweat; Flu like symptoms; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweat) and VOMITING (vomiting) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 10-Mar-2021, the patient experienced HYPERHIDROSIS (sweat) and VOMITING (vomiting). At the time of the report, HYPERHIDROSIS (sweat) and VOMITING (vomiting) outcome was unknown.            Treatment medications were not provided  Action taken with mRNA-1273 in response to the event was not applicable
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter reported that Moderna Covid-19 vials were moved from the freezer to the fridge on 06May2021. The 30 day expiration date was on 05Jun2021.   No concomitant medication details were provided.  No treatment medication details were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: achy joints; can't lift arm straight up; severe left arm pain/body pain; injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm straight up), MYALGIA (severe left arm pain/body pain), VACCINATION SITE PAIN (injection site soreness) and ARTHRALGIA (achy joints) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm straight up), MYALGIA (severe left arm pain/body pain) and VACCINATION SITE PAIN (injection site soreness). On 28-May-2021, the patient experienced ARTHRALGIA (achy joints). On 29-May-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm straight up), MYALGIA (severe left arm pain/body pain), VACCINATION SITE PAIN (injection site soreness) and ARTHRALGIA (achy joints) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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) (unknown route) 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 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that Moderna Covid-19 vials were moved from the freezer to the fridge on 06-May-2021. The 30-day expiration date was on 05-Jun-2021. Patient received their second dose of the Moderna Covid-19 Vaccine on 09-Jun-2021.  Concomitant medication not provided.  Treatment information not provided.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Fatigue
Clinical narrative: Dehydration; Tired; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration) and FATIGUE (Tired) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DEHYDRATION (Dehydration) and FATIGUE (Tired). On 10-Jun-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, DEHYDRATION (Dehydration) and FATIGUE (Tired) had resolved.            Concomitant medications use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received which contains outcome of all events. Event Dehydration was added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Hyperhidrosis, Myalgia, Product dose omission issue
Clinical narrative: Caller stated she missed an email notification on scheduling her second dose.; sweating; hot/cold for 24 hours; pain in left arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING OF BODY TEMPERATURE CHANGE (hot/cold for 24 hours), MYALGIA (pain in left arm), CHILLS (chills) and PRODUCT DOSE OMISSION ISSUE (Caller stated she missed an email notification on scheduling her second dose.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), FEELING OF BODY TEMPERATURE CHANGE (hot/cold for 24 hours), MYALGIA (pain in left arm) and CHILLS (chills). On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller stated she missed an email notification on scheduling her second dose.). On 14-Mar-2021, HYPERHIDROSIS (sweating), FEELING OF BODY TEMPERATURE CHANGE (hot/cold for 24 hours), MYALGIA (pain in left arm) and CHILLS (chills) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller stated she missed an email notification on scheduling her second dose.) 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.   No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Rash
Clinical narrative: Worst Migraine headache; Rash; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine Headache) and RASH (Rash) in a female 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MIGRAINE (Migraine Headache) and RASH (Rash). At the time of the report, MIGRAINE (Migraine Headache) and RASH (Rash) outcome was unknown.            Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.