chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: Thick mucus draining on the back of their throat,it was terrible; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Thick mucus draining on the back of their throat,it was terrible) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 11J20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LORAZEPAM, ATENOLOL, VENLAFAXINE, ESOMEPRAZOLE MAGNESIUM, FAMOTIDINE, ATORVASTATIN, MELOXICAM and ESTRADIOL for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SECRETION DISCHARGE (Thick mucus draining on the back of their throat,it was terrible). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SECRETION DISCHARGE (Thick mucus draining on the back of their throat,it was terrible) had not resolved.            Relevant concomitant medications included Bupropion XL. Treatment medication included common allergy medication.   This case was linked to MOD-2021-388022 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Back pain
Clinical narrative: bottom of her back is hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (bottom of her back is hurting) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013721A, 027L20A and 031L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE for an unknown indication.    Concurrent medical conditions included Epilepsy.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient received dose of PNEUMOCOCCAL VACCINE (unknown route) 1 dosage form. In November 2021, the patient experienced BACK PAIN (bottom of her back is hurting). The patient was treated with IBUPROFEN for Low back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (bottom of her back is hurting) outcome was unknown.            Concomitant medications of the patient include seizure medications.  On 16-Nov-2021, the patient used heating pad as treatment.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Her arm is all red; Feels like a ball; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm is all red) and PERIPHERAL SWELLING (Feels like a ball) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 040A21A and 030M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ERYTHEMA (Her arm is all red) and PERIPHERAL SWELLING (Feels like a ball). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Her arm is all red) and PERIPHERAL SWELLING (Feels like a ball) outcome was unknown.            Patient declined to give details of concomitant medications that she takes.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received booster dose from an expired vial of the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received booster dose from an expired vial of the Moderna COVID19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnsons & Johnsons COVID-19 vaccine (1st dose and Lot - 1805031) on 18-Mar-2021.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster dose from an expired vial of the Moderna COVID19 vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received booster dose from an expired vial of the Moderna COVID19 vaccine) had resolved.            The patient received first dose of Johnson's & Johnsons' COVID19 vaccine on 18-Mar-2021 (lot: 1805031).  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: receiving booster dose from a expired vial; Inappropriate schedule of vaccine administration; 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 EXPIRED PRODUCT ADMINISTERED (receiving booster dose from a expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. # 047c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving booster dose from a expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On 15-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving booster dose from a expired vial) outcome was unknown.            No concomitant medications are provided. No treatment medications are provided 2 patients received on 15Nov2021 a booster dose from an expired vial of the Moderna COVID19 vaccine original J/J lot number Moderna COVID19 vaccine expired   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Non significant follow up received
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a full dose as a booster/full dose and not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full dose as a booster/full dose and not immunocompromised) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received a full dose as a booster/full dose and not immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (Received a full dose as a booster/full dose and not immunocompromised) had resolved.            No Concomitant product use was reported. No treatment information was provided. Company comments includes This is a case of Accidental Overdose that concerns a 71-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up information received included patient's age and medical history. Added patient's age and updated type 2 diabetes as patient medical history.; Sender's Comments: This is a case of Accidental Overdose that concerns a 71-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Pain in extremity
Clinical narrative: Shortness of breath/I also felt short of breath; Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath; It felt like I was going to pass out; I had a sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Shortness of breath/I also felt short of breath), CHEST PAIN (Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath), DIZZINESS (It felt like I was going to pass out) and PAIN IN EXTREMITY (I had a sore arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021 at 4:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 16-Nov-2021, the patient experienced DYSPNOEA (Shortness of breath/I also felt short of breath), CHEST PAIN (Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath) and DIZZINESS (It felt like I was going to pass out). At the time of the report, DYSPNOEA (Shortness of breath/I also felt short of breath), CHEST PAIN (Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath), DIZZINESS (It felt like I was going to pass out) and PAIN IN EXTREMITY (I had a sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitants were not provided.  Treatment was not given.  Patient have these events sometimes, it is not uncommon for patient when patient  go up stairs or something like that.   This case was linked to MOD-2021-388374 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received included product details and additional event.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Lyme disease
Clinical narrative: Tick bite; Diagnosed with Lyme disease post Tick bites; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (Diagnosed with Lyme disease post Tick bites) and ARTHROPOD BITE (Tick bite) in a 79-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 10-Mar-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 LYME DISEASE (Diagnosed with Lyme disease post Tick bites) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHROPOD BITE (Tick bite) (seriousness criterion medically significant). The patient was treated with DOXYCYCLINE for Lyme disease, at an unspecified dose and frequency and TINIDAZOLE for Lyme disease, at an unspecified dose and frequency. At the time of the report, LYME DISEASE (Diagnosed with Lyme disease post Tick bites) and ARTHROPOD BITE (Tick bite) outcome was unknown.            Concomitant medications were not reported.  It was reported that she was diagnosed by Lyme disease in Apr-2021 post tick bites and She was on lyme disease treatment with Doxycycline and Tinidazole. She stated that the package insert for tinidazole warns not to take any vaccination. She has been off tinidazole for two weeks because she would like to get the booster Moderna shot.  Company comment: This case concerns a 79 year old female with no reported medical history , who experienced Serious ( medically significant ) unexpected events of Lyme disease and Arthropod  Bite  which occurred approximately 1 month after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , The patient was treated with Doxycline and Tinidazole and the outcome of the events was unknown. The re-challenge for this case is not applicable since the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report; Sender's Comments: This case concerns a 79 year old female with no reported medical history , who experienced Serious ( medically significant ) unexpected events of Lyme disease and Arthropod  Bite  which occurred approximately 1 month after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , The patient was treated with Doxycline and Tinidazole and the outcome of the events was unknown. The re-challenge for this case is not applicable since the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Feeling weak a day or so; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak a day or so) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Pain. Concomitant products included AMLODIPINE for Blood pressure, PRAVASTATIN for Cholesterol, MELOXICAM for Pain.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced ASTHENIA (Feeling weak a day or so). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Feeling weak a day or so) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-388204, MOD-2021-388272 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash, Rash pruritic, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Moderna rash; got a red,raised,itchy rash; itchy rash; got a red, raised, itchy rash; Felt awful; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Felt awful), RASH (Moderna rash), VACCINATION SITE SWELLING (got a red,raised,itchy rash), RASH PRURITIC (itchy rash) and VACCINATION SITE ERYTHEMA (got a red, raised, itchy rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) and MAGNESIUM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt awful). On 14-Mar-2021, the patient experienced RASH (Moderna rash), VACCINATION SITE SWELLING (got a red,raised,itchy rash), RASH PRURITIC (itchy rash) and VACCINATION SITE ERYTHEMA (got a red, raised, itchy rash). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. On 14-Mar-2021, FEELING ABNORMAL (Felt awful) had resolved. In March 2021, RASH (Moderna rash), VACCINATION SITE SWELLING (got a red,raised,itchy rash), RASH PRURITIC (itchy rash) and VACCINATION SITE ERYTHEMA (got a red, raised, itchy rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient  called  the event as a Moderna rash.   Lot number of the second Moderna COVID-19 vaccination was provided  only 003.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) 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 EXPIRED PRODUCT ADMINISTERED (received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021) had resolved.            No concomitant medications were reported. No treatment was reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported   This case was linked to MOD-2021-388396, MOD-2021-388405, MOD-2021-388405 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site swelling
Clinical narrative: Sore left armpit; swollen left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of AXILLARY PAIN (Sore left armpit) and VACCINATION SITE SWELLING (swollen left arm) 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-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced AXILLARY PAIN (Sore left armpit) and VACCINATION SITE SWELLING (swollen left arm). At the time of the report, AXILLARY PAIN (Sore left armpit) and VACCINATION SITE SWELLING (swollen left arm) had not 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3-4 doses administered past published expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3-4 doses administered past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3-4 doses administered past published expiry). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3-4 doses administered past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.  A nurse accidentally administered 3-4 doses of  expired Moderna COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Non significant information received
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with EPINEPHRINE for Difficulty breathing, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ONE) at an unspecified dose and frequency. On 19-Mar-2021, DYSPNOEA (Difficulty breathing) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she has been receiving Prolia Injections every 6 months for the past 4 years. Her next Prolia injection is due on Thursday 18-NOV-2021 and Pulmonologist gave her an antihistamine Benadryl prior to vaccination and watched her after vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Myoclonic epilepsy
Clinical narrative: myoclonic seizure lasted approximately 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of MYOCLONIC EPILEPSY (myoclonic seizure lasted approximately 15 minutes) 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-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MYOCLONIC EPILEPSY (myoclonic seizure lasted approximately 15 minutes) (seriousness criterion medically significant). At the time of the report, MYOCLONIC EPILEPSY (myoclonic seizure lasted approximately 15 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.  company's comment: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious event of myoclonic seizure. The event myoclonic seizure exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious event of myoclonic seizure. The event myoclonic seizure exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Chills, Fatigue, Feeling cold
Clinical narrative: Her heart was going fast(almost anxiety); Felt cold; Felt pain at the top part of her left breast; Felt pain on her left arm; Whole side of the left chest area hurts; Area where injection was done hurts; Lymph nodes on the left side of her breast were swollen; Felt super tired; Had the chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Her heart was going fast(almost anxiety)), FEELING COLD (Felt cold), BREAST PAIN (Felt pain at the top part of her left breast), PAIN IN EXTREMITY (Felt pain on her left arm) and CHEST PAIN (Whole side of the left chest area hurts) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 010M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. In November 2021, the patient experienced BREAST PAIN (Felt pain at the top part of her left breast), PAIN IN EXTREMITY (Felt pain on her left arm), CHEST PAIN (Whole side of the left chest area hurts), INJECTION SITE PAIN (Area where injection was done hurts), LYMPHADENOPATHY (Lymph nodes on the left side of her breast were swollen), FATIGUE (Felt super tired) and CHILLS (Had the chills). On 16-Nov-2021, the patient experienced PALPITATIONS (Her heart was going fast(almost anxiety)) and FEELING COLD (Felt cold). At the time of the report, PALPITATIONS (Her heart was going fast(almost anxiety)) had resolved and FEELING COLD (Felt cold), BREAST PAIN (Felt pain at the top part of her left breast), PAIN IN EXTREMITY (Felt pain on her left arm), CHEST PAIN (Whole side of the left chest area hurts), INJECTION SITE PAIN (Area where injection was done hurts), LYMPHADENOPATHY (Lymph nodes on the left side of her breast were swollen), FATIGUE (Felt super tired) and CHILLS (Had the chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) done 3 times COVID-19 test, but all turned out to be negative.         No concomitant medication information was reported.  Patient reported that she felt so sick in Dec 2020 and had done COVID-19 test three times which all turned to be negative, but she thinks that she had COVID-19 that time. Treatment medications included experimental flu drug.   This case was linked to MOD-2021-388558, MOD-2021-388542 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Pain in extremity, Palpitations, SARS-CoV-2 test
Clinical narrative: Her heart was going fast(almost anxiety); Felt cold; Felt pain at the top part of her left breast; Felt pain on her left arm; Whole side of the left chest area hurts; Area where injection was done hurts; Lymph nodes on the left side of her breast were swollen; Felt super tired; Had the chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Her heart was going fast(almost anxiety)), FEELING COLD (Felt cold), BREAST PAIN (Felt pain at the top part of her left breast), PAIN IN EXTREMITY (Felt pain on her left arm) and CHEST PAIN (Whole side of the left chest area hurts) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 010M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. In November 2021, the patient experienced BREAST PAIN (Felt pain at the top part of her left breast), PAIN IN EXTREMITY (Felt pain on her left arm), CHEST PAIN (Whole side of the left chest area hurts), INJECTION SITE PAIN (Area where injection was done hurts), LYMPHADENOPATHY (Lymph nodes on the left side of her breast were swollen), FATIGUE (Felt super tired) and CHILLS (Had the chills). On 16-Nov-2021, the patient experienced PALPITATIONS (Her heart was going fast(almost anxiety)) and FEELING COLD (Felt cold). At the time of the report, PALPITATIONS (Her heart was going fast(almost anxiety)) had resolved and FEELING COLD (Felt cold), BREAST PAIN (Felt pain at the top part of her left breast), PAIN IN EXTREMITY (Felt pain on her left arm), CHEST PAIN (Whole side of the left chest area hurts), INJECTION SITE PAIN (Area where injection was done hurts), LYMPHADENOPATHY (Lymph nodes on the left side of her breast were swollen), FATIGUE (Felt super tired) and CHILLS (Had the chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) done 3 times COVID-19 test, but all turned out to be negative.         No concomitant medication information was reported.  Patient reported that she felt so sick in Dec 2020 and had done COVID-19 test three times which all turned to be negative, but she thinks that she had COVID-19 that time. Treatment medications included experimental flu drug.   This case was linked to MOD-2021-388558, MOD-2021-388542 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, 002A21A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-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 HEADACHE (Headache after second dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included cholesterol pill.   This case was linked to MOD-2021-388603 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: heavy menstrual bleeding; This spontaneous case was reported by a nurse and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy menstrual bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy menstrual bleeding). At the time of the report, HEAVY MENSTRUAL BLEEDING (heavy menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details was not reported.  Treatment details was not provided by the reporter. This case concerns  a female with unknown age, with no reported medical history , who experienced Non-serious , unexpected event of Heavy menstrual bleeding which occurred on an unknown date, with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event  is unknown and the details of the doses are also unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report; Sender's Comments: This case concerns  a female with unknown age, with no reported medical history , who experienced Non-serious , unexpected event of Heavy menstrual bleeding which occurred on an unknown date, with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event  is unknown and the details of the doses are also unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin swelling
Clinical narrative: skin looks swelled up; skin looks red; Rash on her face/rash on her cheeks/under her eyes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (skin looks swelled up), ERYTHEMA (skin looks red) and RASH (Rash on her face/rash on her cheeks/under her eyes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced SKIN SWELLING (skin looks swelled up), ERYTHEMA (skin looks red) and RASH (Rash on her face/rash on her cheeks/under her eyes). At the time of the report, SKIN SWELLING (skin looks swelled up), ERYTHEMA (skin looks red) and RASH (Rash on her face/rash on her cheeks/under her eyes) outcome was unknown.            Concomitant medication included cholesterol pill but patient stopped taking it about one week ago.   No treatment medications were reported.  After the first dose she did not experience any side effect.   This case was linked to MOD-2021-388581 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 010A21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Joint pain (Joint sore), Joint stiffness (Joint stuff) and Arthritis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better). On 30-Oct-2021, THERAPEUTIC RESPONSE UNEXPECTED (He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better) had resolved.            No concomitant medications are provided.  It was reported that patient before it was used to be really joint sore and stuff, but it cleared up and it was not sore anymore. It was a whole lot better. He believed that he have (or had) arthritis and that was not there anymore. He said that he could felt it a little bit but nothing like it was before.    No treatment medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: follow-up  received contains No new information.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Got accidentally vaccinated with Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got accidentally vaccinated with Moderna booster) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got accidentally vaccinated with Moderna booster). On 15-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got accidentally vaccinated with Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No side effects were reported at the time of report.  Company comment- This case concerns a 8-year-old, male patient, with no known medical history, who experienced the non-serious event of product administered to a patient of inappropriate age. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was supposed to get a Pfizer vaccine but was given Moderna booster by pharmacist. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 8-year-old, male patient, with no known medical history, who experienced the non-serious event of product administered to a patient of inappropriate age. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was supposed to get a Pfizer vaccine but was given Moderna booster by pharmacist. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report adverse event; 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 VACCINATION COMPLICATION (Report adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (Report adverse event). At the time of the report, VACCINATION COMPLICATION (Report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Secretion discharge
Clinical narrative: Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster; Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster) and CONDITION AGGRAVATED (Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 028L20A and 11J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Arthritis and Blood pressure. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-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 SECRETION DISCHARGE (Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster) and CONDITION AGGRAVATED (Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SECRETION DISCHARGE (Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster) and CONDITION AGGRAVATED (Thick mucus draining on the back of their throat/it was terrible/never truly went away/Fleur up again after the booster) had not resolved.            Patient was treated  common allergy medication  and took dose pack cortisone .   This case was linked to MOD-2021-388573 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of booster shot which was more than 18 hr in fridge; Administration of booster shot which was more than 18 hr in fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. No Medical History information was reported.On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received 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 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were reported. This case was linked to MOD-2021-388723, MOD-2021-385958 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 15 year old) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment drug details were reported.