chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Interchange of vaccine products, Myalgia, Neck pain, Vaccination complication
Clinical narrative: neck ache is ridiculously bad; more symptoms; neurological disorder that affects her balance; Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad; Received both doses of Pfizer COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache is ridiculously bad), VACCINATION COMPLICATION (more symptoms), BALANCE DISORDER (neurological disorder that affects her balance), MYALGIA (Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad) and INTERCHANGE OF VACCINE PRODUCTS (Received both doses of Pfizer COVID-19 vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (Both doses of the Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received both doses of Pfizer COVID-19 vaccine). On an unknown date, the patient experienced NECK PAIN (neck ache is ridiculously bad), VACCINATION COMPLICATION (more symptoms), BALANCE DISORDER (neurological disorder that affects her balance) and MYALGIA (Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad). On 05-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Received both doses of Pfizer COVID-19 vaccine) had resolved. At the time of the report, NECK PAIN (neck ache is ridiculously bad) and MYALGIA (Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad) had not resolved and VACCINATION COMPLICATION (more symptoms) and BALANCE DISORDER (neurological disorder that affects her balance) outcome was unknown.            No concomitant products were reported.  Patient took muscle relaxers as a prescription and they did nothing to help, she also used cream and all sorts of stuff but it does not help. This neck ache was ridiculously bad. This muscle aches have been hell.   Patient took some Ibuprofen and cannabis oil, use a heating pad and rest.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains no new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Illness, Rash, SARS-CoV-2 test
Clinical narrative: Felt really sick; Coughed; Wheezed; Lungs were really tight; Rashes on the entire left arm; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Felt really sick), COUGH (Coughed), WHEEZING (Wheezed), CHEST DISCOMFORT (Lungs were really tight) and RASH (Rashes on the entire left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 041B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (rested at home for 1 to 2 weeks.) from December 2020 to January 2021. Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, NAPROXEN for Fibromyalgia.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ILLNESS (Felt really sick) and RASH (Rashes on the entire left arm). 22-Oct-2021, the patient experienced COUGH (Coughed), WHEEZING (Wheezed) and CHEST DISCOMFORT (Lungs were really tight). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and DEXAMETHASONE at a dose of 1 mg twice a day. On 29-Oct-2021, ILLNESS (Felt really sick) had resolved. At the time of the report, COUGH (Coughed), WHEEZING (Wheezed) and CHEST DISCOMFORT (Lungs were really tight) had resolved and RASH (Rashes on the entire left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included topical Anti-rash Cream and Albuterol/budesonide nebulizer twice a day.  Patient stated it has been 2 weeks since she had seen the doctor and still had to use regular nebulizer twice daily. Symptoms including lethargy and body aches .Took Tylenol for the body ache.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Felt really sick; Coughed; Wheezed; Lungs were really tight; Rashes on the entire left arm; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Felt really sick), COUGH (Coughed), WHEEZING (Wheezed), CHEST DISCOMFORT (Lungs were really tight) and RASH (Rashes on the entire left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 041B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (rested at home for 1 to 2 weeks.) from December 2020 to January 2021. Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, NAPROXEN for Fibromyalgia.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ILLNESS (Felt really sick) and RASH (Rashes on the entire left arm). 22-Oct-2021, the patient experienced COUGH (Coughed), WHEEZING (Wheezed) and CHEST DISCOMFORT (Lungs were really tight). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and DEXAMETHASONE at a dose of 1 mg twice a day. On 29-Oct-2021, ILLNESS (Felt really sick) had resolved. At the time of the report, COUGH (Coughed), WHEEZING (Wheezed) and CHEST DISCOMFORT (Lungs were really tight) had resolved and RASH (Rashes on the entire left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included topical Anti-rash Cream and Albuterol/budesonide nebulizer twice a day.  Patient stated it has been 2 weeks since she had seen the doctor and still had to use regular nebulizer twice daily. Symptoms including lethargy and body aches .Took Tylenol for the body ache.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site warm and hot to touch; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm and hot to touch) and VACCINATION SITE ERYTHEMA (Injection site red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm and hot to touch) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE WARMTH (Injection site warm and hot to touch) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved.            No concomitant medications were provided. No treatment medications were provided. It was more pronounced when patient woke up on (09Nov2021).  This case concerns a 77-year-old female patient with no relevant medical history, who experienced the unexpected event of Vaccination Site Warmth and expected event of Vaccination Site Erythema. The events occurred on the same day after receiving the third dose of mRNA-1273 Vaccine. The event Vaccination Site Erythema is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-380108 (Patient Link).; Sender's Comments: This case concerns a 77-year-old female patient with no relevant medical history, who experienced the unexpected event of Vaccination Site Warmth and expected event of Vaccination Site Erythema. The events occurred on the same day after receiving the third dose of mRNA-1273 Vaccine. The event Vaccination Site Erythema is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Vaccination complication
Clinical narrative: little bit slowed down-he has a lay back personality; received a booster dose of a batch that was reported to be no good; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (little bit slowed down-he has a lay back personality) and POOR QUALITY PRODUCT ADMINISTERED (received a booster dose of a batch that was reported to be no good) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 025B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol (Under control). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol.   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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received a booster dose of a batch that was reported to be no good). On an unknown date, the patient experienced VACCINATION COMPLICATION (little bit slowed down-he has a lay back personality). On 30-Oct-2021, POOR QUALITY PRODUCT ADMINISTERED (received a booster dose of a batch that was reported to be no good) had resolved. At the time of the report, VACCINATION COMPLICATION (little bit slowed down-he has a lay back personality) outcome was unknown.            No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 09-NOV-2021 and contains non significant information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure abnormal, Blood triglycerides, Dyspepsia, Flatulence
Clinical narrative: blood pressure issues; burning in the stomach; has a lot of gas in the stomach; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLOOD PRESSURE ABNORMAL (blood pressure issues), DYSPEPSIA (burning in the stomach) and FLATULENCE (has a lot of gas in the stomach) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-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 BLOOD PRESSURE ABNORMAL (blood pressure issues), DYSPEPSIA (burning in the stomach) and FLATULENCE (has a lot of gas in the stomach). At the time of the report, BLOOD PRESSURE ABNORMAL (blood pressure issues) and DYSPEPSIA (burning in the stomach) had not resolved and FLATULENCE (has a lot of gas in the stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: 140 - 230 (High) 140 to 230 something. On an unknown date, Blood triglycerides: high (High) borderline to be consider diabetic..         Patient had a previous blood test showed that their cholesterol and sugar triglyceride levels were good (this was a month ago). No concomitant and no treatment information was provided .   This case was linked to MOD-2021-380122 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Significant Follow-up received contain patients  lab text  information . Event was added, 'Has a lot of gas in the stomach'.; Sender's Comments: This case concerns a 58-year-old, male patient, with no disclosed medical history, who experienced the non-serious, unexpected events of blood pressure abnormal, dyspepsia and flatulence. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. On unknown date, patient had blood tests, blood cholesterol and blood triglycerides done, which were high, borderline, no treatment was mentioned. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the Moderna Covid-19 vaccine which has been exposed to more than 72 hours at room temperature and at the same time expired (06Nov2021) to a patient on 08Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose given 05Feb2021; 2nd dose given 15Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 05Feb2021; 2nd dose given 15Mar2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 05Feb2021; 2nd dose given 15Mar2021). On 15-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 05Feb2021; 2nd dose given 15Mar2021) had resolved.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-379996 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5mL for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5mL for booster dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 038K20A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Type 2 diabetes mellitus (Type-2 diabetes), Hyperlipidemia and Drug dependence (nicotine dependent). Concomitant products included METFORMIN, ATORVASTATIN, SILDENAFIL CITRATE (VIAGRA), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), OMEPRAZOLE, VARENICLINE TARTRATE (CHANTIX) and MONTELUKAST for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5mL for booster dose). On 08-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5mL for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nicotine replacement was taken as concomitant medication. No treatment medications were reported.  Confirmed with caller no adverse effect was observed with all 3 doses. The patient was observed for 30 minutes after the booster dose, no abnormalities observed during the observation period.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: minor reaction to the first dose of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (minor reaction to the first dose of the vaccine.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (minor reaction to the first dose of the vaccine.). At the time of the report, VACCINATION COMPLICATION (minor reaction to the first dose of the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-380069 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: Had dentist yesterday and had 2 teeth pulled/dental extraction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Nov-2021 and was forwarded to Moderna on 09-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TOOTH EXTRACTION (Had dentist yesterday and had 2 teeth pulled/dental extraction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH EXTRACTION (Had dentist yesterday and had 2 teeth pulled/dental extraction). The patient was treated with PROCAINE (NOVOCAINE [PROCAINE]) for Adverse event, at a dose of Unknown. At the time of the report, TOOTH EXTRACTION (Had dentist yesterday and had 2 teeth pulled/dental extraction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Patient had visited dentist and had her 2 teeth pulled. She didn't receive her 2nd shot of the Moderna COVID 19 Vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt a tiny bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt a tiny bit) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) and PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On 20-Jan-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 VACCINATION SITE PAIN (Arm hurt a tiny bit). At the time of the report, VACCINATION SITE PAIN (Arm hurt a tiny bit) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After the first dose they hardly had anything, their arm hurt a tiny bit.  Treatment medication was not reported.   This case was linked to MOD-2021-380167, MOD-2021-378552 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant ringing in the ears since obtaining the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of   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. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given.  No treatment medication was given.  Company Comment: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected event of tinnitus. The event tinnitus exact occurrence unknown but stated that the event occurred since the unknown dose number of mRNA-1273 vaccine administration. 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 unknown age and gender with no relevant medical history, who experienced the unexpected event of tinnitus. The event tinnitus exact occurrence unknown but stated that the event occurred since the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy
Clinical narrative: Lethargic after first shot; Bad Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic after first shot) and CHILLS (Bad Chills after first shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dental abscess (Had dental abscess and visited the dentist.).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced LETHARGY (Lethargic after first shot) and CHILLS (Bad Chills after first shot). The patient was treated with AMOXICILLIN ongoing since an unknown date for Dental abscess, at a dose of 500 mg. On 18-Jan-2021, LETHARGY (Lethargic after first shot) and CHILLS (Bad Chills after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication  was provided by the reporter.  Patient had a history of dental problems that started way prior to the vaccination and added that dental problems have nothing to do with the vaccine. Also had a dental abscess and visited the dentist. Patient had a dental appointment on 10-NOV-2021, and has been using Amoxicillin 500mg for 1 week and will continue another week. Patient visited the pharmacy to get a booster dose of Moderna on Sunday. The Pharmacist told to wait because Amox500 may interfere with the vaccine efficacy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Vaccination site movement impairment
Clinical narrative: could not lift their arm after the second dose; felt a little off for a day and a half,; headache; achy joints, not bad,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT, FEELING ABNORMAL, HEADACHE, and ARTHRALGIA in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 939905, and 029L20A) for COVID-19 vaccination.     Concomitant products included EXCEDRIN ASPIRIN FREE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-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 experienced VACCINATION SITE MOVEMENT IMPAIRMENT, FEELING ABNORMAL, HEADACHE, and ARTHRALGIA. The patient was treated with TYLENOL 8 HOUR for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT, FEELING ABNORMAL, HEADACHE, and ARTHRALGIA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Vaccination Site Movement Impairment, and expected events of Headache and Arthralgia. The events on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events on second dose did not happen on the first dose. The events headache and arthralgia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-380153, MOD-2021-378552 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 012M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgery to address the wart). Concurrent medical conditions included Wart (on her nose for 10 years).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster) was resolving.            Patient took anti wart medication.  Treatment information was not provided.   This case was linked to MOD-2021-379605 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CICLOSPORIN (RESTASIS), VITAMINS NOS and METOPROLOL for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported stated that patient took Acupressure therapy as treatment.    This case was linked to MOD-2021-380501, MOD-2021-380502 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Inappropriate schedule of product administration, Nausea
Clinical narrative: Delayed 2nd Moderna vaccine administration; diarrhea; Over 100F high fever; Vomiting; extreme fatigue; Nausea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (Over 100F high fever), VOMITING (Vomiting), FATIGUE (extreme fatigue) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048S21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (Over 100F high fever), VOMITING (Vomiting), FATIGUE (extreme fatigue) and NAUSEA (Nausea). On 20-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed 2nd Moderna vaccine administration). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. In 2021, PYREXIA (Over 100F high fever) and FATIGUE (extreme fatigue) had resolved. On 20-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed 2nd Moderna vaccine administration) had resolved. At the time of the report, DIARRHOEA (diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-276490 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Delayed 2nd Moderna vaccine administration; diarrhea; Over 100F high fever; Vomiting; extreme fatigue; Nausea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (Over 100F high fever), VOMITING (Vomiting), FATIGUE (extreme fatigue) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048S21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (Over 100F high fever), VOMITING (Vomiting), FATIGUE (extreme fatigue) and NAUSEA (Nausea). On 20-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed 2nd Moderna vaccine administration). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. In 2021, PYREXIA (Over 100F high fever) and FATIGUE (extreme fatigue) had resolved. On 20-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed 2nd Moderna vaccine administration) had resolved. At the time of the report, DIARRHOEA (diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-276490 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: bruise; discoloration (green/yellow) enlarged to about a third of my upper arm; vaccine running down on the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Nov-2021 and was forwarded to Moderna on 09-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise), ACCIDENTAL UNDERDOSE (vaccine running down on the arm) and VACCINATION SITE DISCOLOURATION (discoloration (green/yellow) enlarged to about a third of my upper arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (vaccine running down on the arm). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruise) and VACCINATION SITE DISCOLOURATION (discoloration (green/yellow) enlarged to about a third of my upper arm). On 25-Oct-2021, ACCIDENTAL UNDERDOSE (vaccine running down on the arm) had resolved. At the time of the report, VACCINATION SITE BRUISING (bruise) and VACCINATION SITE DISCOLOURATION (discoloration (green/yellow) enlarged to about a third of my upper arm) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Non-Significant Follow-up Append.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Nausea
Clinical narrative: Weakness; Chills; Achiness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills), MYALGIA (Achiness) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ASTHENIA (Weakness), CHILLS (Chills), MYALGIA (Achiness) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Weakness), CHILLS (Chills), MYALGIA (Achiness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The reporter's house cleaning lady felt sick on Saturday and Sunday.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: is having bad side effects from booster; she is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (is having bad side effects from booster) and VACCINATION COMPLICATION (she is not feeling well) 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 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (is having bad side effects from booster). November 2021, the patient experienced VACCINATION COMPLICATION (she is not feeling well). At the time of the report, VACCINATION COMPLICATION (is having bad side effects from booster) and VACCINATION COMPLICATION (she is not feeling well) had not resolved.            No concomitant medication was provided  Treatment medication was not provided by the reporter  It was stated that She asked is it true that you are not supposed to take pain killers.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Vaccination site pain
Clinical narrative: sore left arm; strange metal taste in her mouth/sugary things may trigger metallic taste/metal taste comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (strange metal taste in her mouth/sugary things may trigger metallic taste/metal taste comes and goes) and VACCINATION SITE PAIN (sore left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included Tooth restoration in 2021 and Dental fillings in 2021. Concomitant products included SIMVASTATIN for Cholesterol, LATANOPROST for Glaucoma.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). In 2021, the patient experienced DYSGEUSIA (strange metal taste in her mouth/sugary things may trigger metallic taste/metal taste comes and goes). At the time of the report, DYSGEUSIA (strange metal taste in her mouth/sugary things may trigger metallic taste/metal taste comes and goes) and VACCINATION SITE PAIN (sore left arm) outcome was unknown.            No treatment medications were provided.  Patient stated had dental work in the summer of 2021 (new tooth implant). Patient also reported having another procedure done involving a filling or crown work prior to the dental work done in the Summer 2021. The patient stated she has no known drug or food allergies. The patient mentioned concerned to get the Moderna booster dose.   This case was linked to MOD-2021-380468 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. Did the vial undergo any temperature excursions?: No This case concerns a female patient of unknown age with no relevant medical history, who experienced the event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fractured finger.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis). At the time of the report, ARTHRITIS (Arthritis) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. The patient stated that the index finger on the right hand was froze, cannot bend it and stated that the doctors told him it was due to arthritis and he broke the fingers 3-4 times while playing sports.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with relevant medical history of broken fingers3-4 times while playing sports, who experienced non-serious unexpected event of special interest (AESI) arthritis. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Reportedly, the patient could not bend his fingers without pain and the index finger on the right hand was frozen without the ability to bend it. The doctor told him it was due to arthritis and prior history of broken fingers multiple times while playing sports. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  Patient's advanced age and history of fractured fingers are possible confounders. The benefit-risk relationship of drug is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm (1st dose)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Tooth restoration (new tooth implant) in 2021 and Dental fillings in 2021. Concurrent medical conditions included Glaucoma and Blood cholesterol. Concomitant products included SIMVASTATIN for Cholesterol, LATANOPROST (LATANOPROST 1A PHARMA) for Glaucoma.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm (1st dose)). At the time of the report, PAIN IN EXTREMITY (sore left arm (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment information was reported.  Patient has no known drug or food allergies   This case was linked to MOD-2021-380388 (Patient Link).