chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a 51-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced THROMBOSIS (blood clot) (seriousness criteria death and medically significant). The patient died in December 2020. The reported cause of death was blood clot. An autopsy was performed.            No concomitant drug details were reported. No treatment details were reported.  Company comment: This is a spontaneous case concerning a 51-year-old male patient with no medical history reported, who experienced unexpected, fatal  event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The patient died in December 2020. The reported cause of death was blood clot. An autopsy was performed. No information about the first dose was disclosed. Clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 51-year-old male patient with no medical history reported, who experienced unexpected, fatal  event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The patient died in December 2020. The reported cause of death was blood clot. An autopsy was performed. No information about the first dose was disclosed. Clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Blood clot
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Peripheral swelling
Clinical narrative: Arm was blistering; Had a reaction, looked like it was swollen; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Arm was blistering) and PERIPHERAL SWELLING (Had a reaction, looked like it was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia. Concomitant products included SIMVASTATIN for Cholesterol, ALPRAZOLAM and TRAZODONE for Insomnia, NORTRIPTYLINE for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Arm was blistering) (seriousness criterion hospitalization) and PERIPHERAL SWELLING (Had a reaction, looked like it was swollen) (seriousness criterion hospitalization). The patient was treated with BETAMETHASONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, BLISTER (Arm was blistering) and PERIPHERAL SWELLING (Had a reaction, looked like it was swollen) outcome was unknown.            After the second dose, the patient ended up in the emergency room as arm was spreading looked like it was blistering.  Patient went to hospital and took all kind of tests. Patient was having a reaction, it was swollen.  Company comment: This is a spontaneous case concerning a 58 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, events of Peripheral swelling and blister. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events occurred after the second dose and outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-410058, MOD-2021-033090 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 58 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, events of Peripheral swelling and blister. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events occurred after the second dose and outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: Feeling pretty tough; Joint pain; Headache; Chills; Fever; Felt a little rough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling pretty tough), FEELING ABNORMAL (Felt a little rough), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9939904, 012A21A and 017821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced FEELING ABNORMAL (Felt a little rough) and MYALGIA (Body aches). On 14-Dec-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 15-Dec-2021, the patient experienced FEELING ABNORMAL (Feeling pretty tough). 15-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Feeling pretty tough), FEELING ABNORMAL (Felt a little rough), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2021-413784 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling pretty tough; Joint pain; Headache; Chills; Fever; Felt a little rough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling pretty tough), FEELING ABNORMAL (Felt a little rough), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9939904, 012A21A and 017821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced FEELING ABNORMAL (Felt a little rough) and MYALGIA (Body aches). On 14-Dec-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 15-Dec-2021, the patient experienced FEELING ABNORMAL (Feeling pretty tough). 15-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Feeling pretty tough), FEELING ABNORMAL (Felt a little rough), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2021-413784 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Product packaging quantity issue
Clinical narrative: can only draw 9 full doses from each vial, always a little short of the tenth dose; Doses administered from vials that were underfilled (PC); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PACKAGING QUANTITY ISSUE (can only draw 9 full doses from each vial, always a little short of the tenth dose) and ACCIDENTAL UNDERDOSE (Doses administered from vials that were underfilled (PC)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 PRODUCT PACKAGING QUANTITY ISSUE (can only draw 9 full doses from each vial, always a little short of the tenth dose) and ACCIDENTAL UNDERDOSE (Doses administered from vials that were underfilled (PC)). At the time of the report, PRODUCT PACKAGING QUANTITY ISSUE (can only draw 9 full doses from each vial, always a little short of the tenth dose) and ACCIDENTAL UNDERDOSE (Doses administered from vials that were underfilled (PC)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Report receipt from QC is on 07-JAN-2021. PCID number is 5845. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) antibody test was done on patient and antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not report any adverse events or symptoms. No concomitant medication and treatment information was reported.  Analysis of the vial(s) associated with your storage excursion is complete. The vaccine administered on or after July 31, 2021 from lot number 037C21A likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   This case was linked to MOD-2021-415889 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Significant followup received: Dose number of suspect drug was updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination complication
Clinical narrative: she got COVID; Side effects; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (she got COVID) and VACCINATION COMPLICATION (Side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (she got COVID) and VACCINATION COMPLICATION (Side effects). At the time of the report, COVID-19 (she got COVID) and VACCINATION COMPLICATION (Side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested for COVID and was tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided. Patient got first vaccine and a week later was got side effects so got tested for COVID and patient was tested positive.  Company comment: This case concerns a female patient, unknown age, with no medical history reported, who experienced the non-serious unexpected events of Covid-19 (AESI) and vaccination complication on unknown date after the first dose of mRNA 1273 Covid-19 vaccine. The patient was said to be having side effects after the vaccine. A week after the vaccine, she got tested for Covid and was positive.  The patient's Covid-19 infection may be a confounder to the side effects that patient was having after the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no medical history reported, who experienced the non-serious unexpected events of Covid-19 (AESI) and vaccination complication on unknown date after the first dose of mRNA 1273 Covid-19 vaccine. The patient was said to be having side effects after the vaccine. A week after the vaccine, she got tested for Covid and was positive.  The patient's Covid-19 infection may be a confounder to the side effects that patient was having after the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the forearm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the forearm after first dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congenital heart disease NOS.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on the forearm after first dose). At the time of the report, RASH (Rash on the forearm after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2021-416284 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; unauthorized age received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Patient mistakenly given both doses of the vaccine.  No concomitant and treatment information were reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: got a booster dose yesterday instead of a third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (got a booster dose yesterday instead of a third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (got a booster dose yesterday instead of a third dose). On 15-Dec-2021, ACCIDENTAL UNDERDOSE (got a booster dose yesterday instead of a third dose) had resolved.            Patient who was severe immunocompromised got a booster dose instead of a third dose. No concomitant medication were provided. No treatment information were given.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Has a big red arm; Itchy arm; Very swollen arm the size of a small egg; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Has a big red arm), PRURITUS (Itchy arm) and PERIPHERAL SWELLING (Very swollen arm the size of a small egg) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 029A21A and 031L20A) for COVID-19 vaccination.     Previously administered products included for H1N1 influenza immunisation: Flu shot (Received about 6 to 7 years ago.Patient missed a day of work after the flu shot.Patient still gets the regular flu vaccine in a high dose.). Past adverse reactions to the above products included Vaccination adverse reaction with Flu shot. Concurrent medical conditions included Cold sores, Fibromyalgia and Chronic pain. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Chronic pain, LYSINE for Cold sores, DULOXETINE and GABAPENTIN for Fibromyalgia, MULTIVITAMIN [VITAMINS NOS], CALCIUM, MAGNESIUM and COLISTIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In December 2021, the patient experienced ERYTHEMA (Has a big red arm), PRURITUS (Itchy arm) and PERIPHERAL SWELLING (Very swollen arm the size of a small egg). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Itchy, at a dose of Lotion and Manual therapy (Putting ice on it) for Peripheral swelling. At the time of the report, ERYTHEMA (Has a big red arm), PRURITUS (Itchy arm) and PERIPHERAL SWELLING (Very swollen arm the size of a small egg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Advil P M which the patient took as treatment medication didn't worked for her and the Aveeno lotion helped a little but not for long. The patient stated that She got a mild case of COVID-19 in November so she got monoclonal antibodies and since she got COVID-19 her blood pressure is running higher than usual so she was put on lisinopril. She has been putting ice in the arm where the reaction occurred.   This case was linked to MOD-2021-416077 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Wrong technique in product usage process
Clinical narrative: punctured the vials 21 times yesterday and gave that dose to a patient; punctured the vials 21 times yesterday and gave that dose to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (punctured the vials 21 times yesterday and gave that dose to a patient) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (punctured the vials 21 times yesterday and gave that dose to a patient) 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 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (punctured the vials 21 times yesterday and gave that dose to a patient) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (punctured the vials 21 times yesterday and gave that dose to a patient). On 15-Dec-2021, PRODUCT ADMINISTRATION ERROR (punctured the vials 21 times yesterday and gave that dose to a patient) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (punctured the vials 21 times yesterday and gave that dose to a patient) 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: She also stated that she had 20 chills in one hour; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She also stated that she had 20 chills in one hour) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 028H21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   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 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (She also stated that she had 20 chills in one hour). At the time of the report, CHILLS (She also stated that she had 20 chills in one hour) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-416093 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Off label use, Pain in extremity, Pyrexia
Clinical narrative: delayed interval between 1st and 2nd dose; sore arm right arm; chills; fever of 101.7 degrees Fahrenheit; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (delayed interval between 1st and 2nd dose), PAIN IN EXTREMITY (sore arm right arm), CHILLS (chills) and PYREXIA (fever of 101.7 degrees Fahrenheit) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 047C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient reported it had resolved.) from 14-Sep-2021 to 2021. Concurrent medical conditions included Kidney failure (He has a history of stage 4 kidney failure). Concomitant products included ATORVASTATIN, GLIPIZIDE, ALLOPURINOL, CHLORTALIDONE (CHLORTHALIDONE), SODIUM BICARBONATE and IXEKIZUMAB (TALTZ) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm right arm), CHILLS (chills) and PYREXIA (fever of 101.7 degrees Fahrenheit). On 16-Dec-2021, the patient experienced OFF LABEL USE (delayed interval between 1st and 2nd dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. On 16-Dec-2021, OFF LABEL USE (delayed interval between 1st and 2nd dose) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm right arm), CHILLS (chills) and PYREXIA (fever of 101.7 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.7 degrees fahrenheit (High) 101.7 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had a history of stage 4 kidney failure and was advised 90 days to get his second dose of the Moderna COVID-19 vaccine. Patient suffered a sore arm at the injection site and received second dose greater than 35 days after first dose.   This case was linked to MOD-2021-416102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Follow-up received on 16-Dec-2021 included updated start date of suspect product, dose 2 information along with treatment drug information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Like a gout attack; Soreness all over; Sweats; Chills with fever/ Fevers; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Like a gout attack), PAIN (Soreness all over), HYPERHIDROSIS (Sweats) and PYREXIA (Chills with fever/ Fevers) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GOUT (Like a gout attack), PAIN (Soreness all over), HYPERHIDROSIS (Sweats) and PYREXIA (Chills with fever/ Fevers). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 2 tablets. On 05-May-2021, GOUT (Like a gout attack), PAIN (Soreness all over), HYPERHIDROSIS (Sweats) and PYREXIA (Chills with fever/ Fevers) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-416215 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 039B21A and 031B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.            Patient weight was 268 lbs.  No medical history was provided by the reporter. No treatment medication were reported.   This case was linked to MOD-2021-416195 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick and had to stay in bed for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick and had to stay in bed for 24 hours) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301420) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick and had to stay in bed for 24 hours). At the time of the report, ILLNESS (sick and had to stay in bed for 24 hours) had resolved.      No concomitant medications provided. No treatment medications provided. Patient stated that they are healthy and not immunocompromised.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms after second dose; Shaking after second dose; Small fever after second dose; Chills after second dose; Second dose administered 8 to 9 weeks after the first dose; Mild headache that lasted 36 hours after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose), TREMOR (Shaking after second dose), PYREXIA (Small fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Mild headache that lasted 36 hours after second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congenital heart disease NOS.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 8 to 9 weeks after the first dose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose), TREMOR (Shaking after second dose), PYREXIA (Small fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Mild headache that lasted 36 hours after second dose). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 8 to 9 weeks after the first dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose), TREMOR (Shaking after second dose), PYREXIA (Small fever after second dose) and CHILLS (Chills after second dose) outcome was unknown and HEADACHE (Mild headache that lasted 36 hours after second dose) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-416038 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Flu like symptoms after second dose; Shaking after second dose; Small fever after second dose; Chills after second dose; Second dose administered 8 to 9 weeks after the first dose; Mild headache that lasted 36 hours after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose), TREMOR (Shaking after second dose), PYREXIA (Small fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Mild headache that lasted 36 hours after second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congenital heart disease NOS.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 8 to 9 weeks after the first dose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose), TREMOR (Shaking after second dose), PYREXIA (Small fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Mild headache that lasted 36 hours after second dose). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 8 to 9 weeks after the first dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose), TREMOR (Shaking after second dose), PYREXIA (Small fever after second dose) and CHILLS (Chills after second dose) outcome was unknown and HEADACHE (Mild headache that lasted 36 hours after second dose) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-416038 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: missed second dose; tested Positive for Covid19 5 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested Positive for Covid19 5 days after first dose) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested Positive for Covid19 5 days after first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, COVID-19 (tested Positive for Covid19 5 days after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient received the antibodies 7 days after the first dose, it has been just about 90 days after the antibody treatment. No concomitant medications were reported.  Company Comment: This case of Product dose omission issue, concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected event of COVID-19. The patient tested positive for COVID-19, 5 days after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was resolved. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case of Product dose omission issue, concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected event of COVID-19. The patient tested positive for COVID-19, 5 days after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was resolved. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 antibody test, Vitamin D, Vitamin D increased
Clinical narrative: Antibodies were 243 units which was considered low; Vitamin D numbers were higher than normal for her - 112; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST (Antibodies were 243 units which was considered low) and VITAMIN D INCREASED (Vitamin D numbers were higher than normal for her - 112) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 032L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Nodule. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced SARS-COV-2 ANTIBODY TEST (Antibodies were 243 units which was considered low) and VITAMIN D INCREASED (Vitamin D numbers were higher than normal for her - 112). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, SARS-COV-2 ANTIBODY TEST (Antibodies were 243 units which was considered low) and VITAMIN D INCREASED (Vitamin D numbers were higher than normal for her - 112) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Blood test: 243 (Low) COVID antibodies. Her results were 243 units which was considered low.. On 06-Dec-2021, Vitamin D: 112 (High) Vitamin D numbers were higher than normal for her but she explained that she also had been taking Vitamin D for years. Her numbers were 112..         Due to antibodies were low patient had concern of taking another booster vaccine.   This case was linked to MOD-2021-415132 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Headache, Lymphadenopathy, Malaise
Clinical narrative: very very sick; uncontrollable shaking; very very weak; cough not bad; low grade fever; vomiting; lymph node under the left arm is the size of a soft ball; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad) and PYREXIA (low grade fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 013L20A and 066M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad), PYREXIA (low grade fever), VOMITING (vomiting), LYMPHADENOPATHY (lymph node under the left arm is the size of a soft ball) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad), PYREXIA (low grade fever), VOMITING (vomiting), LYMPHADENOPATHY (lymph node under the left arm is the size of a soft ball) and HEADACHE (headache) had not resolved.            No concomitant medication details was reported. She Started off with tylenol for the first two days and called the pharmacist and told her to put ice packs on it and to took Advil.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: very very sick; uncontrollable shaking; very very weak; cough not bad; low grade fever; vomiting; lymph node under the left arm is the size of a soft ball; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad) and PYREXIA (low grade fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 013L20A and 066M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad), PYREXIA (low grade fever), VOMITING (vomiting), LYMPHADENOPATHY (lymph node under the left arm is the size of a soft ball) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad), PYREXIA (low grade fever), VOMITING (vomiting), LYMPHADENOPATHY (lymph node under the left arm is the size of a soft ball) and HEADACHE (headache) had not resolved.            No concomitant medication details was reported. She Started off with tylenol for the first two days and called the pharmacist and told her to put ice packs on it and to took Advil.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Product dose omission issue, Rash, Urticaria
Clinical narrative: Hives; Sunburn feeling on stomach; Rash all over body; Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), DYSPEPSIA (Sunburn feeling on stomach), RASH (Rash all over body) and PRODUCT DOSE OMISSION ISSUE (Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Sulfonamide allergy (Allergy to sulfa) and Drug allergy (Allergy to lexapro).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so). On an unknown date, the patient experienced URTICARIA (Hives), DYSPEPSIA (Sunburn feeling on stomach) and RASH (Rash all over body). At the time of the report, URTICARIA (Hives), DYSPEPSIA (Sunburn feeling on stomach) and RASH (Rash all over body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  HCP was contacted, caller first was advised to not get second shot and later HCP said is not sure and it might be better to receive second shot.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: can hardly move his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (can hardly move his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can hardly move his arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (can hardly move his arm) outcome was unknown.            No concomitant medications reported. No treatment medication was reported.  Patient mentioned their son had a third dose of the vaccine and can hardly move his arm even after a month. Also added their son had covid-19 after the second dose of the vaccine and before this third dose. He was in hospital and received a drug cocktail, and went home after 2 days.   This case was linked to MOD-2021-419252, MOD-2021-418444, MOD-2021-419308, MOD-2021-418432, MOD-2021-418640 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Uterine leiomyoma
Clinical narrative: Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of UTERINE LEIOMYOMA (Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UTERINE LEIOMYOMA (Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 vaccine). The patient was treated with Surgery (Uterine fibroid removal surgery) for Uterine leiomyoma. At the time of the report, UTERINE LEIOMYOMA (Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 vaccine) outcome was unknown.            No concomitant medication was reported by the reporter.  Patient took booster dose on 15 Dec 2021.   Reporter did not allow further contact