chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bedridden, Body temperature, Body temperature increased, Chest wall mass
Clinical narrative: HAND GOT LOCKED FOR 3-4 SECONDS; COULD NOT MOVE FINGERS; 3 LINES ABOUT AN INCH LONG POPPING UP UNDER THE SKIN AND THEY FELT HARD ON THE RIGHT SIDE OF CHEST; PAIN THROUGH ALL BODY; SLEPT FOR 24 HOURS; STAYED IN BED ALL DAY; SWEATS; STOMACH PAIN; PAIN AT INJECTION SITE; HEADACHE; TEMPERATURE OF 103-104; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the patient experienced sweats. On 09-JUN-2021, the patient experienced stomach pain. On 09-JUN-2021, the patient experienced pain at injection site. On 09-JUN-2021, the patient experienced headache. On 09-JUN-2021, the patient experienced temperature of 103-104. Laboratory data included: Body temperature (NR: not provided) 103-104. On 10-JUN-2021, the patient experienced stayed in bed all day. On 11-JUN-2021, the patient experienced slept for 24hours. On 17-JUN-2021, the patient experienced pain through all body. On 01-DEC-2021, the patient experienced 3 lines about an inch long popping up under the skin and they felt hard on the right side of chest. On an unspecified date, the patient experienced hand got locked for 3-4 seconds, and could not move fingers. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, stomach pain, pain at injection site, headache, and temperature of 103-104 on 11-JUN-2021, slept for 24 hours, and stayed in bed all day on 12-JUN-2021, and 3 lines about an inch long popping up under the skin and they felt hard on the right side of chest on 01-DEC-2021, had not recovered from pain through all body, and the outcome of hand got locked for 3-4 seconds and could not move fingers was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypersomnia, Injection site pain, Movement disorder
Clinical narrative: HAND GOT LOCKED FOR 3-4 SECONDS; COULD NOT MOVE FINGERS; 3 LINES ABOUT AN INCH LONG POPPING UP UNDER THE SKIN AND THEY FELT HARD ON THE RIGHT SIDE OF CHEST; PAIN THROUGH ALL BODY; SLEPT FOR 24 HOURS; STAYED IN BED ALL DAY; SWEATS; STOMACH PAIN; PAIN AT INJECTION SITE; HEADACHE; TEMPERATURE OF 103-104; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the patient experienced sweats. On 09-JUN-2021, the patient experienced stomach pain. On 09-JUN-2021, the patient experienced pain at injection site. On 09-JUN-2021, the patient experienced headache. On 09-JUN-2021, the patient experienced temperature of 103-104. Laboratory data included: Body temperature (NR: not provided) 103-104. On 10-JUN-2021, the patient experienced stayed in bed all day. On 11-JUN-2021, the patient experienced slept for 24hours. On 17-JUN-2021, the patient experienced pain through all body. On 01-DEC-2021, the patient experienced 3 lines about an inch long popping up under the skin and they felt hard on the right side of chest. On an unspecified date, the patient experienced hand got locked for 3-4 seconds, and could not move fingers. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, stomach pain, pain at injection site, headache, and temperature of 103-104 on 11-JUN-2021, slept for 24 hours, and stayed in bed all day on 12-JUN-2021, and 3 lines about an inch long popping up under the skin and they felt hard on the right side of chest on 01-DEC-2021, had not recovered from pain through all body, and the outcome of hand got locked for 3-4 seconds and could not move fingers was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, SARS-CoV-2 test
Clinical narrative: HAND GOT LOCKED FOR 3-4 SECONDS; COULD NOT MOVE FINGERS; 3 LINES ABOUT AN INCH LONG POPPING UP UNDER THE SKIN AND THEY FELT HARD ON THE RIGHT SIDE OF CHEST; PAIN THROUGH ALL BODY; SLEPT FOR 24 HOURS; STAYED IN BED ALL DAY; SWEATS; STOMACH PAIN; PAIN AT INJECTION SITE; HEADACHE; TEMPERATURE OF 103-104; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the patient experienced sweats. On 09-JUN-2021, the patient experienced stomach pain. On 09-JUN-2021, the patient experienced pain at injection site. On 09-JUN-2021, the patient experienced headache. On 09-JUN-2021, the patient experienced temperature of 103-104. Laboratory data included: Body temperature (NR: not provided) 103-104. On 10-JUN-2021, the patient experienced stayed in bed all day. On 11-JUN-2021, the patient experienced slept for 24hours. On 17-JUN-2021, the patient experienced pain through all body. On 01-DEC-2021, the patient experienced 3 lines about an inch long popping up under the skin and they felt hard on the right side of chest. On an unspecified date, the patient experienced hand got locked for 3-4 seconds, and could not move fingers. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, stomach pain, pain at injection site, headache, and temperature of 103-104 on 11-JUN-2021, slept for 24 hours, and stayed in bed all day on 12-JUN-2021, and 3 lines about an inch long popping up under the skin and they felt hard on the right side of chest on 01-DEC-2021, had not recovered from pain through all body, and the outcome of hand got locked for 3-4 seconds and could not move fingers was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: DIFFICULTY WALKING; PAIN IN ALL JOINTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced difficulty walking, and pain all in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty walking and pain in all joints was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID AND ALL WERE TOTALLY VACCINATED BUT DID NOT HAVE THE BOOSTER; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced got covid and all were totally vaccinated but did not have the booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid and all were totally vaccinated but did not have the booster was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION ERROR; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-DEC-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On DEC-2021, the patient experienced incorrect product storage. On 06-DEC-2021, the patient experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Heart rate, Heart rate increased
Clinical narrative: HEART RACING; HEART RATE OVER 150; POURING SWEAT; SHIVERING; FREEZING COLD; WORST HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: UNKNOWN) dose was not reported, administered on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-DEC-2021, the patient experienced heart racing. On 06-DEC-2021, the patient experienced heart rate over 150. On 06-DEC-2021, the patient experienced pouring sweat. On 06-DEC-2021, the patient experienced shivering. On 06-DEC-2021, the patient experienced freezing cold. On 06-DEC-2021, the patient experienced worst headache. Laboratory data included: Heart rate (NR: not provided) over 150. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worst headache, pouring sweat, shivering, freezing cold, heart racing and heart rate over 150 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Palpitations
Clinical narrative: HEART RACING; HEART RATE OVER 150; POURING SWEAT; SHIVERING; FREEZING COLD; WORST HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: UNKNOWN) dose was not reported, administered on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-DEC-2021, the patient experienced heart racing. On 06-DEC-2021, the patient experienced heart rate over 150. On 06-DEC-2021, the patient experienced pouring sweat. On 06-DEC-2021, the patient experienced shivering. On 06-DEC-2021, the patient experienced freezing cold. On 06-DEC-2021, the patient experienced worst headache. Laboratory data included: Heart rate (NR: not provided) over 150. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worst headache, pouring sweat, shivering, freezing cold, heart racing and heart rate over 150 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: STRUGGLING FROM VACCINE DAMAGE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced struggling from vaccine damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of struggling from vaccine damage was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient via a company representative concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution and suspension for suspension for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date to 01-JUN-2021 for moderate to severe chronic plaque psoriasis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On JUN-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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 04-Dec-2021, the patient experienced PYREXIA (Fever). On 06-Dec-2021, PYREXIA (Fever) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient stated that after first 2 shots she had no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by a respiratory therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    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 (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported.  Treatment details were not given.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received). At the time of the report, PRODUCT STORAGE ERROR (patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Reporter details updated.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19 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 COVID-19 (COVID19 after vaccination). At the time of the report, COVID-19 (COVID19 after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant and treatment medications were reported. The patient reported COVID-19 before September vaccine and was about to have a hip replacememt surgery and Flu shot. Company Comment : This spontaneous case concerns a patient with an unknown age and gender  with no reported medical  history, who experienced non-serious , unexpected , AESI event of Covid 19 which occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received: Non-Significant information.; Sender's Comments: This spontaneous case concerns a patient with an unknown age and gender  with no reported medical  history, who experienced non-serious , unexpected , AESI event of Covid 19 which occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Gait disturbance, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: collapsed unconscious; collapsed unconscious; some shaking; sweating; walking difficulty; disoriented; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed unconscious) and SYNCOPE (collapsed unconscious) 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.     No Medical History information was reported.   On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (collapsed unconscious) (seriousness criterion medically significant), SYNCOPE (collapsed unconscious) (seriousness criterion medically significant), TREMOR (some shaking), HYPERHIDROSIS (sweating), GAIT DISTURBANCE (walking difficulty), CONFUSIONAL STATE (disoriented) and VOMITING (Vomiting). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed unconscious), SYNCOPE (collapsed unconscious), TREMOR (some shaking), HYPERHIDROSIS (sweating), GAIT DISTURBANCE (walking difficulty), CONFUSIONAL STATE (disoriented) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Company Comment : This case concerns a patient of an unknown age and gender, with no details on relevant medical history, who experienced the unexpected serious events of LOSS OF CONSCIOUSNESS and SYNCOPE. The events occurred after a dose of mRNA- 1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no details on relevant medical history, who experienced the unexpected serious events of LOSS OF CONSCIOUSNESS and SYNCOPE. The events occurred after a dose of mRNA- 1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: collapsed unconscious; collapsed unconscious; some shaking; sweating; walking difficulty; disoriented; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed unconscious) and SYNCOPE (collapsed unconscious) 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.     No Medical History information was reported.   On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (collapsed unconscious) (seriousness criterion medically significant), SYNCOPE (collapsed unconscious) (seriousness criterion medically significant), TREMOR (some shaking), HYPERHIDROSIS (sweating), GAIT DISTURBANCE (walking difficulty), CONFUSIONAL STATE (disoriented) and VOMITING (Vomiting). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed unconscious), SYNCOPE (collapsed unconscious), TREMOR (some shaking), HYPERHIDROSIS (sweating), GAIT DISTURBANCE (walking difficulty), CONFUSIONAL STATE (disoriented) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Company Comment : This case concerns a patient of an unknown age and gender, with no details on relevant medical history, who experienced the unexpected serious events of LOSS OF CONSCIOUSNESS and SYNCOPE. The events occurred after a dose of mRNA- 1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no details on relevant medical history, who experienced the unexpected serious events of LOSS OF CONSCIOUSNESS and SYNCOPE. The events occurred after a dose of mRNA- 1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: Expired 2nd dose given; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019F21A) for COVID-19 vaccination.     The patient's past medical history included Hypokalemia and Osteoarthritis. Previously administered products included for Product used for unknown indication: fluzone (Manufacturer is given as BSK. Lot number: 3P3T4 Route: Intramuscular Body site: Right arm deltoid Start date: 09-Nov-2021). Past adverse reactions to the above products included No adverse event with fluzone. Concurrent medical conditions included Allergy (Codeine allergy), Allergy (Erythromycin allergy), Allergy (Augmentin allergy), Allergy (Cephalexin allergy), Type 2 diabetes mellitus, Cirrhosis of liver, COPD, Hyperlipidemia, Depression, Anemia, Adhesive tape allergy, Chronic kidney disease, Thrombocytopenia and GERD (Gastrooesophageal reflux disease with esophagitis). Concomitant products included MIRTAZAPINE (REMERON) for Depression, OMEPRAZOLE for GERD, SIMVASTATIN for Hyperlipidemia, ALPRAZOLAM for Panic disorder, METFORMIN for Type 2 diabetes mellitus, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), FUROSEMIDE, PROPRANOLOL HCL, SPIRONOLACTONE, ONDANSETRON, LORATADINE, POTASSIUM CHLORIDE and LISINOPRIL for an unknown indication.   On 25-Oct-2021 at 4:57 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2020, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Med history: Hypertensive CKD, atherosclerosis of native artery of bilat lower extremities, Moderate episode of recurrent major depressive disorder, Panic disorder without agoraphobia, cirrhosis of liver not due to alcohol. Concomitant medications included: Gentle iron 0.4milligram for anemia. No treatment drug details was reported. The vial moved to refrigerator: 29-Nov-2021. The vaccine was kept frozen with temperature monitored and excursions. The vial was set out one hour prior given to patient. There have been no side effects noted.   This case was linked to MOD-2021-399872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: follow-up received on 01-DEC-2021 contains significant information which includes added hcp, medical history, drug information and event added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Thyroid cancer and Blood pressure abnormal.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced URTICARIA (developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at a dose of UNK, prn; ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency and OMALIZUMAB (XOLAIR) for Adverse event, at a dose of UNK, qmo. At the time of the report, URTICARIA (developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs) had not resolved.            He had thyroid cancer years ago, he changed thyroid medication from one brand to synthroid in the event that would be the cause of his reaction and also was taking blood pressure medicine but quitted it because of this too.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product contamination physical
Clinical narrative: Patients received vaccine with silver metal particles; Poor quality vaccine adminstered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine adminstered) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 015M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine adminstered). On 30-Nov-2021, PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine adminstered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No Concomitant medication was reported.  No patient reported having side effects   This case was linked to MOD-2021-403142, MOD-2021-403143, MOD-2021-403144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up received contains patient details, vaccine information updated.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling abnormal, Heart rate, Heart rate increased, Memory impairment
Clinical narrative: heart issue; brain fogginess; couldn't remember were she is; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart issue), FEELING ABNORMAL (brain fogginess), MEMORY IMPAIRMENT (couldn't remember were she is) and HEART RATE INCREASED (fast heart beat) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart issue), FEELING ABNORMAL (brain fogginess), MEMORY IMPAIRMENT (couldn't remember were she is) and HEART RATE INCREASED (fast heart beat). At the time of the report, CARDIAC DISORDER (heart issue), FEELING ABNORMAL (brain fogginess), MEMORY IMPAIRMENT (couldn't remember were she is) and HEART RATE INCREASED (fast heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) fast heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported  Patient got the first dose of the Moderna covid19 vaccine 6 weeks ago.   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product quality issue
Clinical narrative: Received dose from vial that had black particulates in previous syringe; Received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Particulate was thin,slightly smudged and broke apart when lightly touched it with the end of a pen. Concomitant products were not provided. Treatment medication were not reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product quality issue
Clinical narrative: Received dose from vial that had black particulates in previous syringe; Received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash pruritic
Clinical narrative: finger and toes are itching and burning right at the top; finger and toes are itching and burning right at the top; a rash at the ends of the finger and toes and both itch.; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (finger and toes are itching and burning right at the top), BURNING SENSATION (finger and toes are itching and burning right at the top) and RASH PRURITIC (a rash at the ends of the finger and toes and both itch.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 045b21a and 048a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PRURITUS (finger and toes are itching and burning right at the top), BURNING SENSATION (finger and toes are itching and burning right at the top) and RASH PRURITIC (a rash at the ends of the finger and toes and both itch.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (finger and toes are itching and burning right at the top), BURNING SENSATION (finger and toes are itching and burning right at the top) and RASH PRURITIC (a rash at the ends of the finger and toes and both itch.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Vaccination site discolouration, Vaccination site induration
Clinical narrative: the site  is discolored/ injection area on the arm got hard and black; the injection area on the arm got hard  and black; nerves in their hand  are bad; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerves in their hand  are bad), VACCINATION SITE DISCOLOURATION (the site  is discolored/ injection area on the arm got hard and black) and VACCINATION SITE INDURATION (the injection area on the arm got hard  and black) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced NERVE INJURY (nerves in their hand  are bad). On 05-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (the site  is discolored/ injection area on the arm got hard and black) and VACCINATION SITE INDURATION (the injection area on the arm got hard  and black). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, VACCINATION SITE INDURATION (the injection area on the arm got hard  and black) had resolved. At the time of the report, NERVE INJURY (nerves in their hand  are bad) and VACCINATION SITE DISCOLOURATION (the site  is discolored/ injection area on the arm got hard and black) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient went to the doctor on 2nd December 2021 and the doctor recommended them to not take the second dose. No concomitant medication were given.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Sick to their stomach; breaking up in a sweat; body rash on their trunk, mainly on their stomach and the top of their legs; nausea and fever; Weird headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat), RASH (body rash on their trunk, mainly on their stomach and the top of their legs), PYREXIA (nausea and fever) and HEADACHE (Weird headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced PYREXIA (nausea and fever), HEADACHE (Weird headache) and NAUSEA (nausea). On 03-Dec-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat) and RASH (body rash on their trunk, mainly on their stomach and the top of their legs). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat) and RASH (body rash on their trunk, mainly on their stomach and the top of their legs) had not resolved and PYREXIA (nausea and fever), HEADACHE (Weird headache) and NAUSEA (nausea) outcome was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Sick to their stomach; breaking up in a sweat; body rash on their trunk, mainly on their stomach and the top of their legs; nausea and fever; Weird headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat), RASH (body rash on their trunk, mainly on their stomach and the top of their legs), PYREXIA (nausea and fever) and HEADACHE (Weird headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced PYREXIA (nausea and fever), HEADACHE (Weird headache) and NAUSEA (nausea). On 03-Dec-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat) and RASH (body rash on their trunk, mainly on their stomach and the top of their legs). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Sick to their stomach), HYPERHIDROSIS (breaking up in a sweat) and RASH (body rash on their trunk, mainly on their stomach and the top of their legs) had not resolved and PYREXIA (nausea and fever), HEADACHE (Weird headache) and NAUSEA (nausea) outcome was unknown.