chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired vaccine administered to a patient) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 032B21A) for COVID-19 immunization. No medical history reported. On Sep 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 30, 2021, patient administered expired product (expired vaccine administered to a patient). On Sep 30, 2021, administered expired product (expired vaccine administered to a patient) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. Originally when the reporter looked-up the expiration date for the Moderna COVID-19 vaccine, it stated it was good until Oct 5, 2021. After administration when the reporter looked-up the expiration date, the website stated the vaccine expired on Sep 24, 2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: severe pain from her waist down to her thigh; felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 023M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-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 PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy). At the time of the report, PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  It was reported that patient was not aware if she was eligible for booster dose or not.   This case was linked to MOD-2021-338524 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: severe pain from her waist down to her thigh; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy). At the time of the report, PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy) outcome was unknown.            After the third dose patient was in severe pain from her waist down to her thigh and felt dizzy. No concomitant and treatment medication were provided.   This case was linked to MOD-2021-338542, MOD-2021-338524.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). In September 2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Feeling abnormal, Nasopharyngitis
Clinical narrative: kind of bad; thought she was coming down with a cold; very confused; fatigue/tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Multiple sclerosis.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness) 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 relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Influenza like illness
Clinical narrative: He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.; He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.). At the time of the report, INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) outcome was unknown and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The treatment information was not provided.   This case was linked to MOD-2021-337484, MOD-2021-337912, MOD-2021-338264, MOD-2021-338266, MOD-2021-338267, MOD-2021-338271, MOD-2021-338277, MOD-2021-338292, MOD-2021-338347, MOD-2021-338355, MOD-2021-338366, MOD-2021-338372, MOD-2021-338375, MOD-2021-338417, MOD-2021-338458, MOD-2021-338530, MOD-2021-338534, MOD-2021-338564, MOD-2021-338578, MOD-2021-338581, MOD-2021-338604, MOD-2021-338607, MOD-2021-338817, MOD-2021-338604 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported.   This case was linked to MOD-2021-338604 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They received an expired dose; 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 EXPIRED PRODUCT ADMINISTERED (They received an expired dose) 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 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They received an expired dose) had resolved. Not Provided          No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Osteoarthritis, Pain in extremity
Clinical narrative: Osteoarthritis; Arthralgias in their fingers/arthralgias in the hand; Had more arm pain for longer hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had more arm pain for longer hours), OSTEOARTHRITIS (Osteoarthritis) and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included LORAZEPAM for Anxiety and Insomnia, ROSUVASTATIN and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Had more arm pain for longer hours). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis) and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand). At the time of the report, PAIN IN EXTREMITY (Had more arm pain for longer hours) and OSTEOARTHRITIS (Osteoarthritis) outcome was unknown and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient might have had some COPD that flared up, the patient thinks that might not be due to the shot. No treatment information was reported.   This case was linked to MOD-2021-338672, MOD-2021-338621 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight arm pain for few hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight arm pain for few hours) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis NOS. Concomitant products included LORAZEPAM for Insomnia and Anxiety, ROSUVASTATIN CALCIUM (ROSUVASTATIN [ROSUVASTATIN CALCIUM]) and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (slight arm pain for few hours). At the time of the report, PAIN IN EXTREMITY (slight arm pain for few hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided   This case was linked to MOD-2021-338621, MOD-2021-338659 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: blood sugar went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar went up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L201A, 016M201A and 040C21A) for COVID-19 vaccination.     The patient's past medical history included Laser therapy (18 eye laser treatments) and Keratectomy. Concurrent medical conditions included Type 1 diabetes mellitus, Cancer, COPD and Arthritis. Concomitant products included INSULIN for Blood sugar increased.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-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 BLOOD GLUCOSE INCREASED (blood sugar went up). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar went up) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment drugs were reported.  The patient had to take an extra dose that time and adjust the dose of the insulin for a few days before it got controlled.  On 15-Feb-2021,The patient received second dose and  03-Sep-2021, received third dose of Moderna vaccine.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042120A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 040821A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased and Overweight (Slightly).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate). On 24-Aug-2021, OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate) had resolved.            Concomitant medication details were not provided. Treatment details were not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at shot site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy to codeine.), Drug allergy (allergy to Quinalones), Drug allergy (allergy to sulfa drugs), Drug allergy (allergy to muscle relaxants), Rheumatoid arthritis, Hypothyroidism, Arteriosclerosis, Chronic fatigue and Hypertension. Concomitant products included ENALAPRIL from 10-Feb-2005 to an unknown date, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 12-Mar-2015 to an unknown date, APIXABAN (ELIQUIS) from 15-Jan-2020 to an unknown date, DILTIAZEM (CARDIZEM [DILTIAZEM]) from 15-Jan-2020 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 20-Feb-2019 to an unknown date for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at shot site). In May 2021, VACCINATION SITE PAIN (Soreness at shot site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-029776 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular, Polymenorrhoea
Clinical narrative: Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination; Periods are heavier; Periods are more painful; Extremely irregular, worse than when i was teenager; I have gotten my menstrual cycle 4 times since Moderna's vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Menopausal symptoms, Hot flashes and Mood swings. Concomitant products included ESTROVEN for Menopausal symptoms.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination). At the time of the report, MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination) outcome was unknown.            No treatment medications were provided. The periods were heavier, more painful and extremely irregular, worse than when i was an teenager. Had been Menopausal seven months prior to this vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) 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 provided.   This case was linked to MOD-2021-338604, MOD-2021-338616 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna; Heavy periods; Painful periods; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESTROVEN for an unknown indication.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods). At the time of the report, MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided  Patient reported that it is now September 2021 and she has gotten her menstrual cycle 4 times since Moderna vaccination
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough covid infection despite the fact that I was fully vaccinated; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated). At the time of the report, COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Additional information received included reporter information, patient details, route of administration, vaccine indication, and  lab data.; Sender's Comments: This case concerns a 54-year-old male patient with no relevant medical history reported,  who experienced non serious unexpected event of special interest  CVODI-19. The event occurred approximately a month after the second dose of Spikevax. Rechallenge was not applicable since the event occurred after the second dose.  The benefit-risk relationship of drug is not affected by this report. Lack of efficacy not reported since there are no exact dates of vaccine administration provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: My entire family of 5 ended up getting COVID; had first vaccine in July, has not yet had her second as of yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet) 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.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet). At the time of the report, COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.; Sender's Comments: This case concerns a female with unknown age , with no reported medical history, who experience the unexpected events of Covid 19 and Product dose omission issue . These events occurred on  an unknown date after vaccination with the first doe of mRNA- 1273 (Moderna). The rechallenge is not applicable since there is no report yet of a  2nd dose. The benefit -risk relationship of mRNA-1273( Moderna ) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Funkiness; She had a little reaction of a fever for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Funkiness) and PYREXIA (She had a little reaction of a fever for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   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 FEELING ABNORMAL (Funkiness) and PYREXIA (She had a little reaction of a fever for 24 hours). At the time of the report, FEELING ABNORMAL (Funkiness) outcome was unknown and PYREXIA (She had a little reaction of a fever for 24 hours) had resolved.            Its been past 7 months of her first vaccination. Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-339365 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concurrent medical conditions included Autoimmune disorder NOS. Concomitant products included ATENOLOL (TENORMIN) for an unknown indication.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself). In 2021, EXPIRED PRODUCT ADMINISTERED (second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Medical conditions includes Cardiac.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Off label use
Clinical narrative: has a lump under his left arm in the arm pit area; he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (has a lump under his left arm in the arm pit area) and OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 011J20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised). On an unknown date, the patient experienced AXILLARY MASS (has a lump under his left arm in the arm pit area). On 29-Sep-2021, OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised) had resolved. At the time of the report, AXILLARY MASS (has a lump under his left arm in the arm pit area) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days) and PAIN IN EXTREMITY (Very sore arm for a week) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Radiation therapy (Did radiation for Rosai-Dorfman Disease in July and August.).  Concurrent medical conditions included Rosai-Dorfman syndrome (A histiocytosis disease, which is a non malignant blood cancer, but it is not present in the blood stream.) and Diabetic. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week), PYREXIA (Slight fever) and HEADACHE (Bad headache for a day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week) and HEADACHE (Bad headache for a day) had resolved and PYREXIA (Slight fever) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-339411 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site movement impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days) and PAIN IN EXTREMITY (Very sore arm for a week) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Radiation therapy (Did radiation for Rosai-Dorfman Disease in July and August.).  Concurrent medical conditions included Rosai-Dorfman syndrome (A histiocytosis disease, which is a non malignant blood cancer, but it is not present in the blood stream.) and Diabetic. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week), PYREXIA (Slight fever) and HEADACHE (Bad headache for a day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week) and HEADACHE (Bad headache for a day) had resolved and PYREXIA (Slight fever) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-339411 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L0A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included L-THYROXINE [LEVOTHYROXINE] and ALENDRONATE SODIUM for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 09-Jan-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported by reporter.   This case was linked to MOD-2021-339522, MOD-2021-322828 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a  74-year-old, female patient with no relevant medical history, who experienced the expected event of vaccination site pain. The event occurred during the same day after the first dose of Moderna COVID-19 Vaccine. The rechallenge was negative since the event did not re-occur after the administration of the remaining doses of the vaccine. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered to patients; 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 (Expired vaccine was administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to patients). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: sore left injection site arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A nurse gave a 16 year old a Vaxelis vaccine.; This non-serious spontaneous safety report was received by a partner on 15-SEP-2021 and forwarded to the agency on 16-SEP-2021 from a nurse The causal relationship between Vaxelis and the reported event: A nurse gave a 16 year old a Vaxelis vaccine was assessed as not applicable due to the nature of the event.  Further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Glycosylated haemoglobin, Glycosylated haemoglobin increased
Clinical narrative: Cannot extend arm outward or upward without cringing in pain; Cannot extend arm outward or upward without cringing in pain; Muscle in arm that took injection aches; Inflammation like the vaccine "flipped a switch" triggering re-emergence of sciatica & heightened arthritic pain in toes, ankles and fingers; Worst seasonal allergies ever; acute sinus infection; urinary tract infection; Elevated HA1C; Extreme muscular ache & burning; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731) via an unspecified route of administration, administered in arm left on13Apr2021 at 01:30 PM (age at vaccination 58 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included diagnosed with type 2 diabetes 3 month after vaccine, nonalcoholic fatty liver since 2005, seasonal allergies, arthritis, and allergic to penicillin & sulfa drugs. Concomitant medications included atorvastatin (ATORVASTATIN); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); azelastine (AZELASTINE) nasal all taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination. No other vaccine in four weeks. On 14Apr2021 at 01:30 PM the patient experienced Extreme muscular ache & burning, joint pain, chills & nausea, 2 incidents each lasting 4-5 hours, both day after shot. Chills & nausea continued for 35 days until relief came with sinus infection medication. Muscle in arm that took injection aches 3 months later (Jul2021) cannot extend arm outward or upward without cringing in pain. Inflammation like the vaccine flipped a switch triggering reemergence of sciatica & heightened arthritic pain in toes, ankles and fingers. Worst seasonal allergies ever - culminated in acute sinus infection & urinary tract infection from antibiotic. Elevated HA1C not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). The patient visits Doctor or other healthcare professional office/clinic. No treatment was received for the events. No covid was tested post vaccination. The patient underwent lab tests and procedures which included glycosylated haemoglobin: elevated on Not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). Therapeutic measures were taken as a result of nausea. The outcome of the event nausea was recovered 19May2021 and other events not recovered.  No follow-up attempts are needed. No further information is expected.