chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-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 reported. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anger, Blood pressure increased, Chest pain, Cough
Clinical narrative: Her breathing is not the same since the Moderna shot; From time to time her chest is hurting; Her blood pressure is high; loss of sleep; agitation; Cough; short tempered; Headaches; Fatigue; Dose-1  June 2021 and dose-2 September 2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep) and AGITATION (agitation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1  June 2021 and dose-2 September 2021). On an unknown date, the patient experienced DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep), AGITATION (agitation), COUGH (Cough), ANGER (short tempered), HEADACHE (Headaches) and FATIGUE (Fatigue). In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1  June 2021 and dose-2 September 2021) had resolved. At the time of the report, DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep), AGITATION (agitation), COUGH (Cough), ANGER (short tempered), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.            No concomitant treatment was provided. No treatment medication was provided. She had also asked about other potential side effects like: short tempered, agitation, fatigue and loss of sleep. She also asked if the vaccine was not authorized and what about the Pfizer vaccine? Her husband had the Pfizer and then had heart surgery. Does the vaccine change your DNA? How long does it take for it to leave your body? At this point she made the agent hold for some seconds and when she came back she could not hear the agent and hung up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Her breathing is not the same since the Moderna shot; From time to time her chest is hurting; Her blood pressure is high; loss of sleep; agitation; Cough; short tempered; Headaches; Fatigue; Dose-1  June 2021 and dose-2 September 2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep) and AGITATION (agitation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1  June 2021 and dose-2 September 2021). On an unknown date, the patient experienced DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep), AGITATION (agitation), COUGH (Cough), ANGER (short tempered), HEADACHE (Headaches) and FATIGUE (Fatigue). In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1  June 2021 and dose-2 September 2021) had resolved. At the time of the report, DYSPNOEA (Her breathing is not the same since the Moderna shot), CHEST PAIN (From time to time her chest is hurting), BLOOD PRESSURE INCREASED (Her blood pressure is high), INSOMNIA (loss of sleep), AGITATION (agitation), COUGH (Cough), ANGER (short tempered), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.            No concomitant treatment was provided. No treatment medication was provided. She had also asked about other potential side effects like: short tempered, agitation, fatigue and loss of sleep. She also asked if the vaccine was not authorized and what about the Pfizer vaccine? Her husband had the Pfizer and then had heart surgery. Does the vaccine change your DNA? How long does it take for it to leave your body? At this point she made the agent hold for some seconds and when she came back she could not hear the agent and hung up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered beyond the 12 hours use times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered beyond the 12 hours use times) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 vaccination.     Concurrent medical conditions included Herpes simplex and Depression. Concomitant products included HYDROXYZINE, BUSPIRONE and FLUTICASONE for an unknown indication.    On 21-Dec-2021 at 11:05 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021 at 11:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered beyond the 12 hours use times). On 21-Dec-2021 at 11:05 AM, EXPIRED PRODUCT ADMINISTERED (administered beyond the 12 hours use times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A Moderna vial was taken out on 20 Dec 2021 near the end of the day. It was a little less than half full. The person in the morning came in and administered 5 patients beyond the 12 hours use times.  No treatment medications reported.   This case was linked to MOD-2021-430889 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up received contains Patient details, Medical history, Concomitant medications, Suspect product details updated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegic migraine, Tremor
Clinical narrative: "threw her into another hemiplegic migraine" lasted 10 or 11 days; whole body was shaking like her muscles were giving out; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPLEGIC MIGRAINE ("threw her into another hemiplegic migraine" lasted 10 or 11 days) and TREMOR (whole body was shaking like her muscles were giving out) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Solar urticaria, Stomach ulcer with haemorrhage (bleeding stomach ulcers), MTHFR gene mutation (MTHFR(two strains)) and COVID-19 in December 2019. Concurrent medical conditions included Fibromyalgia, Atrial fibrillation, Heart disorder (heart issues), Type 2 diabetes mellitus, Migraine (all types of Migraines (all her life)), Trigeminal neuralgia (hypersensitive trigeminal neuralgia b1, b2, b3), Drug allergy (Haldol), Drug allergy (tramadol), Drug allergy (indomethacin), Latex allergy, Drug allergy (hydrocodone), Allergy to antibiotic (cephalexin), Drug allergy (promethazine), Drug allergy (venlafaxine), Caffeine allergy (coffee), Allergy to plants (lavender) and Allergy (sun). Concomitant products included LEVOTHYROXINE, SIMVASTATIN, VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), PANTOPRAZOLE, DIGOXIN, METOPROLOL, METFORMIN, BUTALBITAL;CAFFEINE;CODEINE;PARACETAMOL, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), 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 01-Apr-2021, the patient experienced HEMIPLEGIC MIGRAINE ("threw her into another hemiplegic migraine" lasted 10 or 11 days) and TREMOR (whole body was shaking like her muscles were giving out). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. In April 2021, HEMIPLEGIC MIGRAINE ("threw her into another hemiplegic migraine" lasted 10 or 11 days) had resolved. At the time of the report, TREMOR (whole body was shaking like her muscles were giving out) outcome was unknown.            Patient is allergic to cillins. Patient stated that she was diagnosed with COVID-19 infection on Nov/Dec 2019 that lasted for 3 months. She reported that she was treated at the hospital and was given oxygen and stated she is still not fully recovered from the infection.   This case was linked to MOD-2021-422331, MOD-2021-422307 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Inappropriate schedule of product administration, Malaise, Tremor
Clinical narrative: Having some shakes feel like throwing up; I feel sick; generally feeling like I have a bad allergy case; chills; vomiting; Had Moderna booster after 2 Pfizer shots initially; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Dec-2021 and was forwarded to Moderna on 22-Dec-2021.    This spontaneous case was reported by a physician and describes the occurrence of TREMOR (Having some shakes feel like throwing up), MALAISE (I feel sick), HYPERSENSITIVITY (generally feeling like I have a bad allergy case), CHILLS (chills) and VOMITING (vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    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 TREMOR (Having some shakes feel like throwing up), MALAISE (I feel sick), HYPERSENSITIVITY (generally feeling like I have a bad allergy case), CHILLS (chills), VOMITING (vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had Moderna booster after 2 Pfizer shots initially). At the time of the report, TREMOR (Having some shakes feel like throwing up), MALAISE (I feel sick), HYPERSENSITIVITY (generally feeling like I have a bad allergy case), CHILLS (chills) and VOMITING (vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had Moderna booster after 2 Pfizer shots initially) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Having some shakes feel like throwing up; I feel sick; generally feeling like I have a bad allergy case; chills; vomiting; Had Moderna booster after 2 Pfizer shots initially; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Dec-2021 and was forwarded to Moderna on 22-Dec-2021.    This spontaneous case was reported by a physician and describes the occurrence of TREMOR (Having some shakes feel like throwing up), MALAISE (I feel sick), HYPERSENSITIVITY (generally feeling like I have a bad allergy case), CHILLS (chills) and VOMITING (vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    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 TREMOR (Having some shakes feel like throwing up), MALAISE (I feel sick), HYPERSENSITIVITY (generally feeling like I have a bad allergy case), CHILLS (chills), VOMITING (vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had Moderna booster after 2 Pfizer shots initially). At the time of the report, TREMOR (Having some shakes feel like throwing up), MALAISE (I feel sick), HYPERSENSITIVITY (generally feeling like I have a bad allergy case), CHILLS (chills) and VOMITING (vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had Moderna booster after 2 Pfizer shots initially) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: My arm was sore at the injection site; My arm was red at the injection site; My arm was swollen at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21B and 043L20RT) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2021-422585 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Taken 4 full doses of Moderna COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Taken 4 full doses of Moderna COVID vaccine) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (Taken 4 full doses of Moderna COVID vaccine). On 20-Dec-2021, EXTRA DOSE ADMINISTERED (Taken 4 full doses of Moderna COVID vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-422785 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic disorder, Blood pressure measurement, Computerised tomogram, Hypertension, Malaise
Clinical narrative: high blood pressure; not feeling well at all; enlarged aorta; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta) in a 73-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta). At the time of the report, HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Blood pressure measurement: high (High) High blood pressure. In December 2021, Computerised tomogram: abnormal (abnormal) enlarged aorta. In December 2021, SARS-CoV-2 test: results pending (Inconclusive) Results pending.         Patient had to go to the emergency room last night, on 20-DEC-2021, because of having issues with high blood pressure, and not feeling well at all. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: high blood pressure; not feeling well at all; enlarged aorta; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta) in a 73-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta). At the time of the report, HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Blood pressure measurement: high (High) High blood pressure. In December 2021, Computerised tomogram: abnormal (abnormal) enlarged aorta. In December 2021, SARS-CoV-2 test: results pending (Inconclusive) Results pending.         Patient had to go to the emergency room last night, on 20-DEC-2021, because of having issues with high blood pressure, and not feeling well at all. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: patient received full 0.5ml dose as booster dose; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (patient received full 0.5ml dose as booster 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced OVERDOSE (patient received full 0.5ml dose as booster dose). At the time of the report, OVERDOSE (patient received full 0.5ml dose as booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.) 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Body has been itchy, on feet and sole, palms and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body has been itchy, on feet and sole, palms and hands) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 012M20A and 029L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, IRBESARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-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 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (Body has been itchy, on feet and sole, palms and hands). The patient was treated with PREDNISONE for Itch, at a dose of 3 pills for 3 days, 2 pills for 3 days, and 1 pill for 2 days. At the time of the report, PRURITUS (Body has been itchy, on feet and sole, palms and hands) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After patient body has been itchy, on feet and sole, palms and hands the patient took prednisone 3 pills, the itch stops. For 6 days, there was no itch. On Day 6, which was at the time of report, the patient took 2 pills (last day of 2 pills), and at night the itch started again.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site warmth
Clinical narrative: hot; very large knot; very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE LYMPHADENOPATHY (very large knot) and VACCINATION SITE PAIN (very sore) 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 VACCINATION SITE WARMTH (hot), VACCINATION SITE LYMPHADENOPATHY (very large knot) and VACCINATION SITE PAIN (very sore). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE LYMPHADENOPATHY (very large knot) and VACCINATION SITE PAIN (very sore) outcome was unknown.            Patient stated that the knot was as big as hand and sticks out a lot.  No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given as eight booster doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given as eight booster 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 an unknown date, the patient received third 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 eight booster doses). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given as eight booster doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unknown reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unknown reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unknown reaction). At the time of the report, VACCINATION COMPLICATION (Unknown reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-422870 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: hearing difficulties; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (hearing difficulties) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013h21r) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 HYPOACUSIS (hearing difficulties). At the time of the report, HYPOACUSIS (hearing difficulties) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.
Age: 34.0
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 (patients received a dose of a vial after 12 hours of initial puncture) in a 34-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 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (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 drug reported. NO Treatment drug reported  Vial puncture on 11 Nov 2021, dose given, kept in refrigerator after puncture.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 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) in a 23-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 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 16-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) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 60.0
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 60-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 concomitants medications was reported.  No treatments medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: is on antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (is on antibiotics) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (is on antibiotics). At the time of the report, VACCINATION COMPLICATION (is on antibiotics) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No Concomitant medication was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; my arm felt like tetanus arm pain/It hurt just to touch it; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (my arm felt like tetanus arm pain/It hurt just to touch it) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (my arm felt like tetanus arm pain/It hurt just to touch it). At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (my arm felt like tetanus arm pain/It hurt just to touch it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-423233, MOD-2021-423238, MOD-2021-423238, MOD-2021-423238 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: administered with a probable minimally under 0.25ml booster dose; They already called the manufacturer of the syringe and they were told that they more or less are able to draw 0.24ml when they use it.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (administered with a probable minimally under 0.25ml booster dose) and SYRINGE ISSUE (They already called the manufacturer of the syringe and they were told that they more or less are able to draw 0.24ml when they use it.) 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) .24 ml. On an unknown date, the patient experienced UNDERDOSE (administered with a probable minimally under 0.25ml booster dose) and SYRINGE ISSUE (They already called the manufacturer of the syringe and they were told that they more or less are able to draw 0.24ml when they use it.). At the time of the report, UNDERDOSE (administered with a probable minimally under 0.25ml booster dose) and SYRINGE ISSUE (They already called the manufacturer of the syringe and they were told that they more or less are able to draw 0.24ml when they use it.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Inappropriate schedule of product administration
Clinical narrative: chest pain; Patient received the first two shots of Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two shots of Pfizer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1. Lot number: ER8729. Expiration date: 20Jul2021) on 09-Apr-2021 and Pfizer (Dose 2.) on 01-May-2021. 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) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two shots of Pfizer). On 22-Dec-2021, the patient experienced CHEST PAIN (chest pain). On 21-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two shots of Pfizer) had resolved. At the time of the report, CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, Heart rate: 110 (High) 110 per second but agent believes it is per minute.         No Concomitant medication was reported.    No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication details were reported.   This case was linked to MOD-2021-423287 (Patient Link).
Age: 59.0
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; Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to 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 (Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture) in a 59-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 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture). On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture) 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.  The vials were being used past the recommended 12 hour post puncture time.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: the antibody test she did in September of 2021 after her 3rd dose showed no antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (the antibody test she did in September of 2021 after her 3rd dose showed no antibodies) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 839902 and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant on 04-Jul-2011.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ANTIBODY TEST NEGATIVE (the antibody test she did in September of 2021 after her 3rd dose showed no antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (the antibody test she did in September of 2021 after her 3rd dose showed no antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: negative (Negative) no antibodies.         Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 83.0
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 (patients received a dose of a vial after 12 hours of initial puncture) in an 83-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 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (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 and treatment medications were reported. Vial punctured 01-Jun-2021 Vial stored in refrigerator once punctured, in freezer prior to puncture (Vial was being used past the recommended 12 hour post puncture time).   This case was linked to MOD-2021-418964 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received booster and is under 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received booster and is under 18 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received 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 (received booster and is under 18 years old). On 21-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received booster and is under 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.~ Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given shots during excursions) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given shots during excursions). On 27-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (given shots during excursions) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.