chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine that was kept for more than 30 days in the refrigerator was administered; Vaccine that was kept for more than 30 days in the refrigerator was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was kept for more than 30 days in the refrigerator was administered) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.    No Medical History information was reported.  On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was kept for more than 30 days in the refrigerator was administered) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vaccine that was kept for more than 30 days in the refrigerator was administered) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   There was no information on previous doses for the patient. Date the vial was initially stored in the refrigerator was 29-Dec-21 and the vial did not undergo any temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients; Received booster dose from a vial stored more than 30 days in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster dose from a vial stored more than 30 days in refrigerator) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster dose from a vial stored more than 30 days in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients). On 29-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received booster dose from a vial stored more than 30 days in refrigerator) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered to 4 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported No information on previous doses for patient reported Date of vial was initially stored in the refrigerator reported as 29-Dec-2021 It was reported that vial had not undergo any temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received booster dose from a vial stored >30 days in refrigerator; Vaccine that was kept for more than 30 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received booster dose from a vial stored >30 days in refrigerator) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster dose from a vial stored >30 days in refrigerator) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator). On 29-Jan-2022, EXPIRED PRODUCT ADMINISTERED (received booster dose from a vial stored >30 days in refrigerator) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no information on previous doses for the patient. Date the vial was initially stored in the refrigerator was 29-Dec-21 and the vial did not undergo any temperature excursions.  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-467833 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received booster dose from a vial stored >30 days in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received booster dose from a vial stored >30 days in refrigerator) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster dose from a vial stored >30 days in refrigerator). On 29-Jan-2022, EXPIRED PRODUCT ADMINISTERED (received booster dose from a vial stored >30 days in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: your vax gave my wife 32% of her body psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (your vax gave my wife 32% of her body psoriasis) 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 PSORIASIS (your vax gave my wife 32% of her body psoriasis). At the time of the report, PSORIASIS (your vax gave my wife 32% of her body psoriasis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced 32% of her body with psoriasis, started the day of the shot and hadn't stopped. No concomitant medications were reported. No treatment medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered in less than 25 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered in less than 25 days) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Wellbutrin), Allergy to antibiotic (Amoxicillin), Allergy to antibiotic (Doxycycline), Iodine allergy and Allergy to antibiotic (Erythromycin).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Mar-2021 at 9:01 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered in less than 25 days). On 21-Mar-2021 at 9:01 AM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered in less than 25 days) had resolved. Not Provided      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 provided.   This case was linked to MOD-2022-457591 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (developed shingles from the Moderna COVID-19 vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced herpes zoster (developed shingles from the Moderna COVID-19 vaccine). At the time of the report, herpes zoster (developed shingles from the Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2022-468516 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm was swollen for a month; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen for a month) 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 01-Feb-2022, the patient experienced PERIPHERAL SWELLING (arm was swollen for a month). At the time of the report, PERIPHERAL SWELLING (arm was swollen for a month) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided. It was reported that the patient did the Moderna Covid-19 vaccine, arm was swollen for a month. The patient was not doing the booster.     Reporter did not allow further contact
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: after the initial vaccine he contracted CoVid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (after the initial vaccine he contracted CoVid) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Idiopathic thrombocytopenic purpura (deficiency from 4-16 years old.) and IgG subclass deficiency (IgG deficiency from 4-16 years old.).    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (after the initial vaccine he contracted CoVid). At the time of the report, COVID-19 (after the initial vaccine he contracted CoVid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.  It was reported that the patient received COVID vaccine almost 4 weeks ago. A week after the initial vaccine he contracted COVID. He was scheduled for his second dose and he saw information that indicated that he should wait so he did not get sick again. Patient reported that when he asked the Dr he said he could come 3/10/22 so he thought he should ask directly with conflicting information.  Company comment: This spontaneous case concerns a 26-year-old male patient with a relevant medical history of IgG subclass deficiency, who experienced the unexpected non serious AESI of COVID-19, approximately 1 week after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course. Previous history of IgG subclass deficiency might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Updated Reporter's details, Information about date of vaccine administration added; Sender's Comments: This spontaneous case concerns a 26-year-old male patient with a relevant medical history of IgG subclass deficiency, who experienced the unexpected non serious AESI of COVID-19, approximately 1 week after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course. Previous history of IgG subclass deficiency might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine > 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine > 12 hours after first puncture) 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 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine > 12 hours after first puncture). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine > 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unauthorized aged group received vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized aged group received vaccine) in a 17-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized aged group received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized aged group received vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 1805020) for COVID-19 vaccination.     Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.   On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Patient had not reported any symptoms since receiving that dose of the vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Swelling face
Clinical narrative: Swollen Right Cheek after booster; Hard Nodule on the Right Cheek and the right corner of the lips after booster; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen Right Cheek after booster) and NODULE (Hard Nodule on the Right Cheek and the right corner of the lips after booster) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 036A21A and 012N20A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Cosmetic Fillers in the cheek (Juviderm)  5 years ago) and Dermal filler injection (Cosmetic Fillers in lip) in June 2021.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced SWELLING FACE (Swollen Right Cheek after booster) and NODULE (Hard Nodule on the Right Cheek and the right corner of the lips after booster). On 12-Jan-2022, SWELLING FACE (Swollen Right Cheek after booster) and NODULE (Hard Nodule on the Right Cheek and the right corner of the lips after booster) had resolved.            No concomitant medications were reported.  It was reported that their were no side effects after the first and second shot.  About 3 weeks after the booster, the patient started having swollen right cheek, hard nodule on the right cheek and the right corner of the lips.  Dermatologist told her about the drug interaction of Moderna COVID-19 vaccine with the dermal fillers and prescribed Steroids (unspecified).  Swollen Right Cheek after booster/Swelling on her cheekbone went down after using the steroid after booster.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Feeling abnormal, Pyrexia, SARS-CoV-2 test
Clinical narrative: brain is foggy/can't think; fatigue every single day; having fever/fever of unknown origin/running a fever for 2 months now; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain is foggy/can't think), PYREXIA (having fever/fever of unknown origin/running a fever for 2 months now) and FATIGUE (fatigue every single day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 013L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (having fever/fever of unknown origin/running a fever for 2 months now). On an unknown date, the patient experienced FEELING ABNORMAL (brain is foggy/can't think) and FATIGUE (fatigue every single day). At the time of the report, FEELING ABNORMAL (brain is foggy/can't think) and FATIGUE (fatigue every single day) outcome was unknown and PYREXIA (having fever/fever of unknown origin/running a fever for 2 months now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything came back fine. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient has been tested 5x for COVID and all came out negative.   No concomitant medication information provided.  consumer was not sure if she was given the 3rd or the booster dose. She says she was not categorized as immunocompromised but she was sensitive to medication and in general prone to getting sick.  No treatment medication information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Paraesthesia oral, Product dose omission issue, Swollen tongue
Clinical narrative: Did not receive 2nd dose; Tingling in her tongue; Swelling of tongue; Itching and rash on arm at injection site; Itching and rash on arm at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (Tingling in her tongue), SWOLLEN TONGUE (Swelling of tongue), INJECTION SITE RASH (Itching and rash on arm at injection site), INJECTION SITE PRURITUS (Itching and rash on arm at injection site) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Clotting disorder.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INJECTION SITE RASH (Itching and rash on arm at injection site) and INJECTION SITE PRURITUS (Itching and rash on arm at injection site). On 19-Apr-2021, the patient experienced PARAESTHESIA ORAL (Tingling in her tongue) and SWOLLEN TONGUE (Swelling of tongue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). At the time of the report, PARAESTHESIA ORAL (Tingling in her tongue), SWOLLEN TONGUE (Swelling of tongue), INJECTION SITE RASH (Itching and rash on arm at injection site) and INJECTION SITE PRURITUS (Itching and rash on arm at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) 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.   No concomitant medication reported No treatment medication reported It was reported that the patient said 10 days later she still had swelling and itching and rash on the arm at the injection site. Patient went to her family doctor who said she should switch to Pfizer for the 2nd dose of the vaccine. She was also advised to not get the Johnson and Johnson vaccine because of a history of clotting. However, she did not received any vaccine for her second dose, and it had been about 10 months since her first dose of the Moderna COVID-19 vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson (Batch/Lot number: Unknown. Expiration date: 23Jun2021. Route: A shot in her left arm (non-dominant) and she did not confirm that it was an intramuscular injection.) on 10-Apr-2021. Past adverse reactions to the above products included No adverse reaction with Johnson & Johnson. Concurrent medical conditions included Menopause (Patient was in menopause, and has been in menopause for a year and a half.).    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half). On 12-Jan-2022, POSTMENOPAUSAL HAEMORRHAGE (Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half) had resolved.            No concomitant medications were provided by reporter. On Wednesday she started to have signs of her period cycle for seven days. The period started light and then heavy and then it ended. Patient took Moderna Booster dose but does not confirm that it was an intramuscular injection. No treatment medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) 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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2022-468520, MOD-2022-468523, MOD-2022-468125 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A vial was in the fridge for more than 30 days and was given to a client; Vial was in the fridge for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vial was in the fridge for more than 30 days and was given to a client) and PRODUCT STORAGE ERROR (Vial was in the fridge for more than 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vial was in the fridge for more than 30 days and was given to a client) and PRODUCT STORAGE ERROR (Vial was in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A vial was in the fridge for more than 30 days and was given to a client) and PRODUCT STORAGE ERROR (Vial was in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow-up information received contains no new information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Groin pain, Lymphadenopathy, Musculoskeletal discomfort, X-ray
Clinical narrative: Shooting severe pain that went up to his right groin; Fluid on his right groin; Enlarged lymph nodes on the left groin area; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Shooting severe pain that went up to his right groin), MUSCULOSKELETAL DISCOMFORT (Fluid on his right groin) and LYMPHADENOPATHY (Enlarged lymph nodes on the left groin area) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 12M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes on the left groin area). In January 2022, the patient experienced GROIN PAIN (Shooting severe pain that went up to his right groin) and MUSCULOSKELETAL DISCOMFORT (Fluid on his right groin). At the time of the report, GROIN PAIN (Shooting severe pain that went up to his right groin) and MUSCULOSKELETAL DISCOMFORT (Fluid on his right groin) had not resolved and LYMPHADENOPATHY (Enlarged lymph nodes on the left groin area) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Specialist stated that they were lymph nodes and it came from the booster shot and they will go away.         No concomitant medications were provided. Treatment information includes Anti-Inflammatory for the pain.  Patient stated that the doctor recommended draining the fluid but not at the moment because it was not large enough.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose of Moderna given to pediatric patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna given to pediatric patient) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna given to pediatric patient). On 06-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna given to pediatric patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. It was reported pediatric patient received the 1st dose of Moderna vaccine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient was given .25ml for third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient was given .25ml for third dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 31-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient was given .25ml for third dose). On 31-Aug-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient was given .25ml for third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up was received and contains no new information.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of product administered to patient of inappropriate age (16-year-old/unauthorized age group received Moderna COVID-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Jan 18, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 18, 2022, patient experienced product administered to patient of inappropriate age (16-year-old/unauthorized age group received Moderna COVID-19 vaccine). On Jan 18, 2022, product administered to patient of inappropriate age (16-year-old/unauthorized age group received Moderna COVID-19 vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a fever for like 1 day; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (had a fever for like 1 day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025S20A) for COVID-19 vaccination.     The patient's past medical history included Coronavirus infection (had coronavirus at the end of October 2020) in October 2020. Concurrent medical conditions included Hyperthyroidism (Her Thyroid T3 was elevated). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hyperthyroidism.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (had a fever for like 1 day). In 2021, PYREXIA (had a fever for like 1 day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported Her Thyroid T3 was elevated but the doctor said that's normal since she takes Synthroid.  The treatment information was unknown.   This case was linked to MOD-2022-468527, MOD-2022-468597 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Fatigue, Influenza like illness, Palpitations
Clinical narrative: back pain; heart palpitations; flu like symptoms; skin sensation; anxiety; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation) and ANXIETY (anxiety) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperparathyroidism, Blood pressure high and High cholesterol.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-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 BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation), ANXIETY (anxiety) and FATIGUE (fatigue). At the time of the report, BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation), ANXIETY (anxiety) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Skin sensitisation
Clinical narrative: back pain; heart palpitations; flu like symptoms; skin sensation; anxiety; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation) and ANXIETY (anxiety) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperparathyroidism, Blood pressure high and High cholesterol.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-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 BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation), ANXIETY (anxiety) and FATIGUE (fatigue). At the time of the report, BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation), ANXIETY (anxiety) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Mild flu like symptoms) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The patient's past medical history included Stroke on 12-May-2012, Heart attack on 30-Mar-2020 and CPAP (sleep apnea) since an unknown date.Concurrent medical conditions included Crohn's disease since 1990, Sleep apnea (necessities nighty use of a CPAP machine), Blood pressure high (currently under control), Immunocompromised, Vitamin B1 deficiency, Chest pain, AFib, Prostatic disorder and Blood cholesterol abnormal. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, METOPROLOL for Atrial fibrillation, THIAMINE for Beri beri, ATORVASTATINE [ATORVASTATIN] for Blood cholesterol abnormal, ISOSORBIDE for Chest pain, TERAZOSIN for Prostatic disorder.On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Mild flu like symptoms). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Mild flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided   This case was linked to MOD-2022-468837, MOD-2022-468891 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up received and reporter information, patient demographics, medical history, concomitant medications and new events were added. The event of VACCINATION COMPLICATION  was amended to sore arm and mild flu like symptoms.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered booster to 14 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered booster to 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered booster to 14 year old). On 31-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered booster to 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: After first dose he was weak the first day and then was fine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (After first dose he was weak the first day and then was fine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METFORMIN, AMLODIPINE and ATORVASTATIN for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced ASTHENIA (After first dose he was weak the first day and then was fine). At the time of the report, ASTHENIA (After first dose he was weak the first day and then was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It mentioned that the patient consumed concomitant medications for high blood pressure.  No treatment medications were reported.   This case was linked to MOD-2022-468644 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Feeling cold, Vaccination site induration, Vaccination site pain
Clinical narrative: feeling cold along her back; left arm injection site is very hard; left arm injection site is painful; thinks that she received 2.5ml for a booster dose of the Moderna COVID-19 vaccine instead of the 0.25ml for her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold along her back), VACCINATION SITE INDURATION (left arm injection site is very hard), VACCINATION SITE PAIN (left arm injection site is painful) and ACCIDENTAL OVERDOSE (thinks that she received 2.5ml for a booster dose of the Moderna COVID-19 vaccine instead of the 0.25ml for her booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 milliliter. On an unknown date, the patient experienced FEELING COLD (feeling cold along her back), VACCINATION SITE INDURATION (left arm injection site is very hard), VACCINATION SITE PAIN (left arm injection site is painful) and ACCIDENTAL OVERDOSE (thinks that she received 2.5ml for a booster dose of the Moderna COVID-19 vaccine instead of the 0.25ml for her booster dose). At the time of the report, FEELING COLD (feeling cold along her back), VACCINATION SITE INDURATION (left arm injection site is very hard) and VACCINATION SITE PAIN (left arm injection site is painful) outcome was unknown and ACCIDENTAL OVERDOSE (thinks that she received 2.5ml for a booster dose of the Moderna COVID-19 vaccine instead of the 0.25ml for her booster dose) had resolved.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient had refused to provider her date of birth or age and also refused to provide an e-mail address.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up document contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling cold, Headache, Influenza virus test
Clinical narrative: 102 fever; aches,pain; chills; headache; very very cold; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache) and FEELING COLD (very very cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Two knee replacements). Concurrent medical conditions included Osteoarthritis. Concomitant products included MELOXICAM for Osteoarthritis.    On 15-Mar-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 PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache), FEELING COLD (very very cold) and DISCOMFORT (uncomfortable). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at a dose of Extra strength and DOXYCYCLINE for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache), FEELING COLD (very very cold) and DISCOMFORT (uncomfortable) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-1 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative. On an unknown date, X-ray limb: not measured not measured.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient put herself on doxycycline treatment for one week, All Those events lasted for a day and a half.   This case was linked to MOD-2021-023532, MOD-2022-468649 (Patient Link).