chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for 2-3 days) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 2-3 days). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for 2-3 days) 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received included no new information.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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 medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Appendix disorder, Pain in extremity
Clinical narrative: sore arm; why i was part of the may be 1% whose appendix hot infected; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and APPENDIX DISORDER (why i was part of the may be 1% whose appendix hot infected) 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 PAIN IN EXTREMITY (sore arm) and APPENDIX DISORDER (why i was part of the may be 1% whose appendix hot infected). At the time of the report, PAIN IN EXTREMITY (sore arm) and APPENDIX DISORDER (why i was part of the may be 1% whose appendix hot infected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received include new event information.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination complication
Clinical narrative: side effects; 16-year old vaccinated; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old vaccinated) in a 16-year-old patient of an unknown 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old vaccinated). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller refused to provide any specific adverse events details and stated reports were provided. No concomitant medications were reported. No treatment details were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacist gave a 17 year old a booster shot today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist gave a 17 year old a booster shot today) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (The patient got the first two shots as Pfizer.) and Pfizer (The patient got the first two shots as Pfizer.). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist gave a 17 year old a booster shot today). On 21-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist gave a 17 year old a booster shot today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Migraine, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose on 21Sep2021), MIGRAINE (migraine), PAIN IN EXTREMITY (right arm pain), TREMOR (mild tremors) and PYREXIA (fevering) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 027A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (Nov/Dec 2019 that lasted for 3 months. Treated with oxygen and stated she is still not fully recovered from the infection.) in November 2019. Concurrent medical conditions included Drug allergy (Allergy to Haldol), Drug allergy (Allergy to tramadol), Drug allergy (Allergy to indomethacin), Latex allergy (latex), Drug allergy (Allergy to cillin), Drug allergy (Allergy to hydrocodone), Drug allergy (Allergy to cephalexin), Drug allergy (Allergy to promethazine), Drug allergy (Allergy to venlafaxine), Food allergy (Allergy to coffee), Allergy (Allergy to lavender), Allergy (Allergy to the sun), Atrial fibrillation, Type 2 diabetes mellitus, Migraine (all types of Migraines), Trigeminal neuralgia (b1, b2, b3.), Solar urticaria, Ulcer bleeding gastric, MTHFR gene mutation (two strains) and Fibromyalgia. Concomitant products included LEVOTHYROXINE, SIMVASTATIN, VITAMIN D [VITAMIN D NOS], FISH OIL (OMEGA 3 [FISH OIL]), PANTOPRAZOLE, DIGOXIN, METOPROLOL, METFORMIN, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), IBUPROFEN, PARACETAMOL (TYLENOL [PARACETAMOL]), MECLIZINE [MECLOZINE], POTASSIUM, FUROSEMIDE and GLYCERYL TRINITRATE (NITROSTAT) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose on 21Sep2021), MIGRAINE (migraine), PAIN IN EXTREMITY (right arm pain), TREMOR (mild tremors), PYREXIA (fevering), MYALGIA (severe achiness lasted about 3 to 5 days total) and HEADACHE (a sore head). In September 2021, MIGRAINE (migraine), PAIN IN EXTREMITY (right arm pain), PYREXIA (fevering), MYALGIA (severe achiness lasted about 3 to 5 days total) and HEADACHE (a sore head) had resolved. On 21-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose on 21Sep2021) had resolved. At the time of the report, TREMOR (mild tremors) outcome was unknown. No Treatment information was provided. Concomitant information include Butalbital/ Caffeine/ APAP/Codeine. This case was linked to MOD-2021-422324, MOD-2021-422307 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose on 21Sep2021), MIGRAINE (migraine), PAIN IN EXTREMITY (right arm pain), TREMOR (mild tremors) and PYREXIA (fevering) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 027A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (Nov/Dec 2019 that lasted for 3 months. Treated with oxygen and stated she is still not fully recovered from the infection.) in November 2019. Concurrent medical conditions included Drug allergy (Allergy to Haldol), Drug allergy (Allergy to tramadol), Drug allergy (Allergy to indomethacin), Latex allergy (latex), Drug allergy (Allergy to cillin), Drug allergy (Allergy to hydrocodone), Drug allergy (Allergy to cephalexin), Drug allergy (Allergy to promethazine), Drug allergy (Allergy to venlafaxine), Food allergy (Allergy to coffee), Allergy (Allergy to lavender), Allergy (Allergy to the sun), Atrial fibrillation, Type 2 diabetes mellitus, Migraine (all types of Migraines), Trigeminal neuralgia (b1, b2, b3.), Solar urticaria, Ulcer bleeding gastric, MTHFR gene mutation (two strains) and Fibromyalgia. Concomitant products included LEVOTHYROXINE, SIMVASTATIN, VITAMIN D [VITAMIN D NOS], FISH OIL (OMEGA 3 [FISH OIL]), PANTOPRAZOLE, DIGOXIN, METOPROLOL, METFORMIN, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), IBUPROFEN, PARACETAMOL (TYLENOL [PARACETAMOL]), MECLIZINE [MECLOZINE], POTASSIUM, FUROSEMIDE and GLYCERYL TRINITRATE (NITROSTAT) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose on 21Sep2021), MIGRAINE (migraine), PAIN IN EXTREMITY (right arm pain), TREMOR (mild tremors), PYREXIA (fevering), MYALGIA (severe achiness lasted about 3 to 5 days total) and HEADACHE (a sore head). In September 2021, MIGRAINE (migraine), PAIN IN EXTREMITY (right arm pain), PYREXIA (fevering), MYALGIA (severe achiness lasted about 3 to 5 days total) and HEADACHE (a sore head) had resolved. On 21-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose on 21Sep2021) had resolved. At the time of the report, TREMOR (mild tremors) outcome was unknown. No Treatment information was provided. Concomitant information include Butalbital/ Caffeine/ APAP/Codeine. This case was linked to MOD-2021-422324, MOD-2021-422307 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine was given on 18Nov2021, as two second doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was given on 18Nov2021, as two second doses) 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 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was given on 18Nov2021, as two second doses). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine was given on 18Nov2021, as two second doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.   Reporter did not allow further contact
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysphonia, Pyrexia, Rhinorrhoea
Clinical narrative: nose is running (nothing bad, but more than usual); Hoarse throat; 99.7° temperature yesterday (21Dec2021) and 99.8° today (22Dec2021); This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose is running (nothing bad, but more than usual)), DYSPHONIA (Hoarse throat) and PYREXIA (99.7° temperature yesterday (21Dec2021) and 99.8° today (22Dec2021)) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 016C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (hospitalized/needed rehab) in March 2020. Concurrent medical conditions included Stroke since August 2020.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced PYREXIA (99.7° temperature yesterday (21Dec2021) and 99.8° today (22Dec2021)). On an unknown date, the patient experienced RHINORRHOEA (nose is running (nothing bad, but more than usual)) and DYSPHONIA (Hoarse throat). At the time of the report, RHINORRHOEA (nose is running (nothing bad, but more than usual)), DYSPHONIA (Hoarse throat) and PYREXIA (99.7° temperature yesterday (21Dec2021) and 99.8° today (22Dec2021)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, Body temperature: 99.7 (High) 99.7 degree temperature. On 22-Dec-2021, Body temperature: 99.8 (High) 99.8 degree.         No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Almost all newspapers note that the booster is 50 micrograms, My booster was not that; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Almost all newspapers note that the booster is 50 micrograms, My booster was not that) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Almost all newspapers note that the booster is 50 micrograms, My booster was not that). At the time of the report, INCORRECT DOSE ADMINISTERED (Almost all newspapers note that the booster is 50 micrograms, My booster was not that) 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Illness, Rash, Rash erythematous
Clinical narrative: hives; large red itchy patches all over the body; getting sick; large red itchy patches all over the body; large red itchy patches all over the body; allergic reactions; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body) and RASH (large red itchy patches all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body), RASH (large red itchy patches all over the body), HYPERSENSITIVITY (allergic reactions) and FATIGUE (Very tired). At the time of the report, URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body), RASH (large red itchy patches all over the body), HYPERSENSITIVITY (allergic reactions) and FATIGUE (Very tired) outcome was unknown.            Patient had allergic reaction to the vaccine. No concomitant medications and no treatment medications were reported..   This case was linked to MOD-2021-094421 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: hives; large red itchy patches all over the body; getting sick; large red itchy patches all over the body; large red itchy patches all over the body; allergic reactions; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body) and RASH (large red itchy patches all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body), RASH (large red itchy patches all over the body), HYPERSENSITIVITY (allergic reactions) and FATIGUE (Very tired). At the time of the report, URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body), RASH (large red itchy patches all over the body), HYPERSENSITIVITY (allergic reactions) and FATIGUE (Very tired) outcome was unknown.            Patient had allergic reaction to the vaccine. No concomitant medications and no treatment medications were reported..   This case was linked to MOD-2021-094421 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Wound
Clinical narrative: healing a wound in the hand; She had adverse reaction to the main vaccination; This spontaneous case was reported by a consumer and describes the occurrence of WOUND (healing a wound in the hand) and VACCINATION COMPLICATION (She had adverse reaction to the main vaccination) 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 WOUND (healing a wound in the hand) and VACCINATION COMPLICATION (She had adverse reaction to the main vaccination). At the time of the report, WOUND (healing a wound in the hand) and VACCINATION COMPLICATION (She had adverse reaction to the main vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after second dose/ How long do side effects last after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after second dose/ How long do side effects last after second 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 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 VACCINATION COMPLICATION (side effects after second dose/ How long do side effects last after second dose). At the time of the report, VACCINATION COMPLICATION (side effects after second dose/ How long do side effects last after second dose) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test abnormal, Drug interaction
Clinical narrative: Blood thinner (Warfarin), results high with a reading of 3.1; Medication vaccine interaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLOOD TEST ABNORMAL (Blood thinner (Warfarin), results high with a reading of 3.1) and DRUG INTERACTION (Medication vaccine interaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product WARFARIN for Anticoagulant therapy.    No Medical History information was reported.   On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started WARFARIN (unknown route) at an unspecified dose. On 15-Jan-2021, the patient experienced BLOOD TEST ABNORMAL (Blood thinner (Warfarin), results high with a reading of 3.1). In January 2021, the patient experienced DRUG INTERACTION (Medication vaccine interaction). At the time of the report, BLOOD TEST ABNORMAL (Blood thinner (Warfarin), results high with a reading of 3.1) and DRUG INTERACTION (Medication vaccine interaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood test: 3.1 (High) high with a reading of 3.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: husband had adverse events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (husband had adverse events) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (husband had adverse events). At the time of the report, VACCINATION COMPLICATION (husband had adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided. She mentioned that her husband had adverse events before but did not want to report the adverse events and did not provide any information about her husband.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received a half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received a half dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Immunocompromised.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a half dose). On 08-Dec-2021, ACCIDENTAL UNDERDOSE (received a half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body ache; Headache; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache) 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 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache) had not 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt three days after vaccination) 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 PAIN IN EXTREMITY (arm hurt three days after vaccination). At the time of the report, PAIN IN EXTREMITY (arm hurt three days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (her doctor prescribed prednisone after having a surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 SURGERY (her doctor prescribed prednisone after having a surgery). The patient was treated with PREDNISONE for Surgery, at an unspecified dose and frequency. At the time of the report, SURGERY (her doctor prescribed prednisone after having a surgery) had resolved. Concomitant medication of the patient was not reported. The patient reported no side effects. The patient already had two prednisone doses and read that she should not take prednisone with the vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna booster given to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (2nd dose - 15May2021 lot number EW087) and Pfizer (1st dose - 24Apr2021 lot number EW0171). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 22-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to a 16 year old). On 22-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to a 16 year old) 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.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Rash, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmness at the injection site), COUGH (bad cough which she believes has nothing to do with the vaccine), RASH (rash) and PYREXIA (fever is from after getting the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergic asthma (The patient being around her home with all the air pollutants.). On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the injection site), COUGH (bad cough which she believes has nothing to do with the vaccine), RASH (rash) and PYREXIA (fever is from after getting the second dose). At the time of the report, VACCINATION SITE WARMTH (warmness at the injection site), COUGH (bad cough which she believes has nothing to do with the vaccine), RASH (rash) and PYREXIA (fever is from after getting the second dose) outcome was unknown. Treatment medication use was not provided by the reporter. The concomitant medication included steroid inhaler for allergy induced asthma. Reporter did not allow further contact.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter states that he thinks the patient got full dose instead of a booster dose and the administrating pharmacist states she got a booster dose. This case was linked to MOD-2021-422964 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine was given as four first doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as four first doses) 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-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as four first doses). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as four first doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Discuss adverse effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Discuss adverse effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Discuss adverse effects). At the time of the report, VACCINATION COMPLICATION (Discuss adverse effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the Moderna booster 4 months instead of 6 months after the 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 22-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a J & J vaccine in March and received a Moderna Booster about 2 weeks ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination J & J vaccine in March 2021. Past adverse reactions to the above products included No adverse event with J & J vaccine.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (gave me a 25 mcg dose instead of 50 to 100 mcg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a J & J vaccine in March and received a Moderna Booster about 2 weeks ago). In December 2021, ACCIDENTAL UNDERDOSE (gave me a 25 mcg dose instead of 50 to 100 mcg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a J & J vaccine in March and received a Moderna Booster about 2 weeks ago) 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 was provided.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment details were reported.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Vial was punctured on  11-Nov-21, dose was given, kept in refrigerator after puncture. It was reported that there were two vials that were punctured and used some time between June and 5 -November , but reporter can't back track those dates, they were written on the vials themselves, which were disposed of. It just came to their attention that the vials were being used past the recommended 12 hour post puncture time. No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2021-418964 (Patient Link).
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the vial puncture on 11/11/21, dose given, kept in refrigerator after puncture
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial punctured on 11-Nov-2021, dose given and kept in refrigerator after puncture.  No treatment information was provided by the reporter.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      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.  Patient vial was punctured on 01-Jun-2021, stored in refrigerator once punctured and was in freezer prior to puncture.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Vial punctured 01-Jun-2021. Vial stored in refrigerator once punctured, in freezer prior to puncture.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Necrotising retinitis
Clinical narrative: Retinal necrosis; This spontaneous case was reported by a health care professional and describes the occurrence of NECROTISING RETINITIS (Retinal necrosis) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NECROTISING RETINITIS (Retinal necrosis) (seriousness criterion medically significant). At the time of the report, NECROTISING RETINITIS (Retinal necrosis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Concomitant  medications  for the eyes but did not provide details and also received treatment medications for his symptoms.   Company comment: This spontaneous case concerns a 74-year-old male patient, with unknown medical history, who experienced the serious (medically significant) unexpected event of NECROSITING RETINITIS. The event occurred on an unknown date after the second dose. The rechallenge is not applicable since limited information about dosing and outcome of the event has been provided. There is limited information available for reviewing, but the event has been considered serious since it has had an impact on patient's vision and a query was sent to obtain further information. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-411495 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old male patient, with unknown medical history, who experienced the serious (medically significant) unexpected event of NECROSITING RETINITIS. The event occurred on an unknown date after the second dose. The rechallenge is not applicable since limited information about dosing and outcome of the event has been provided. There is limited information available for reviewing, but the event has been considered serious since it has had an impact on patient's vision and a query was sent to obtain further information. The benefit-risk relationship of mRNA-1273 is not affected by this report.