chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vaccination site induration; Vaccination site erythema; Fatigue; NAUSEATED; Threw up 1 or 2 times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung transplant (Immune suppressive therapy for double lung transplant.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times). At the time of the report, VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative negative (Negative) Negative.         No concomitant and treatment medications were reported. Patient has stated that she does not to fill out any forms or give her mail as she is in a study and looking after her issues.   This case was linked to MOD-2021-019772 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain and discomfort in and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and discomfort in and around the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 026D21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Nitrofurantoin. Spike in A1C level.  Pain and cramps in tendons/ligaments of feet.) on 01-Jan-2017, Hypothyroidism since 01-Jan-2005 and High cholesterol since 01-Jan-2005. Concomitant products included SIMVASTATIN from 01-Jan-2005 to an unknown date for High cholesterol, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Jan-2005 to an unknown date for Hypothyroidism.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain and discomfort in and around the injection site). At the time of the report, VACCINATION SITE PAIN (pain and discomfort in and around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-224090 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid last weekend; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid last weekend) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid last weekend). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid last weekend) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported by the reporter. Patient received first Moderna vaccine on 3-3-2021. Patient received second Moderna vaccine on 4-1-2021.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling
Clinical narrative: swollen arm; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swollen arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    No Medical History information was reported.   In 2019, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (swollen arm) to be probably related.    No treatment information was provided by reporter.  No concomitant medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia, Weight decreased
Clinical narrative: weakness; drug fever; weight loss; This spontaneous case was reported by a physician and describes the occurrence of WEIGHT DECREASED (weight loss), ASTHENIA (weakness) and PYREXIA (drug fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 21-Dec-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a day. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced WEIGHT DECREASED (weight loss). On an unknown date, the patient experienced ASTHENIA (weakness) and PYREXIA (drug fever). At the time of the report, WEIGHT DECREASED (weight loss), ASTHENIA (weakness) and PYREXIA (drug fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Hypoacusis, Oropharyngeal pain, Pain, Tongue erythema
Clinical narrative: sore throat gradually increasing every day; Her gums are sore; Her tongue is turning red; hard at hearing; She has been experiencing pain.; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red), HYPOACUSIS (hard at hearing), PAIN (She has been experiencing pain.) and OROPHARYNGEAL PAIN (sore throat gradually increasing every day) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for an unknown indication.     No Medical History was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Jul-2021, the patient experienced GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red), HYPOACUSIS (hard at hearing) and PAIN (She has been experiencing pain.).   On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat gradually increasing every day). At the time of the report, GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red) and OROPHARYNGEAL PAIN (sore throat gradually increasing every day) had not resolved and HYPOACUSIS (hard at hearing) and PAIN (She has been experiencing pain.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and DOB of the patient added, sore throat gradually increasing every day new event added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Vaccination site swelling; 99.8 degrees concerned; Extreme Fatigue; Body ache, soreness; injection site has redness that is 2 " in diameter; pain at injection site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jul-2021. The most recent information was received on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site has redness that is 2 " in diameter), PYREXIA (99.8 degrees concerned), VACCINATION SITE PAIN (pain at injection site), FATIGUE (Extreme Fatigue) and MYALGIA (Body ache, soreness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (sulfa drugs) and Penicillin allergy.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 08-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site has redness that is 2 " in diameter), FATIGUE (Extreme Fatigue) and MYALGIA (Body ache, soreness). On 10-Jul-2021, the patient experienced PYREXIA (99.8 degrees concerned). On 11-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with PARACETAMOL (TYLENOL) on 07-Jul-2021 for Pain, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 11-Jul-2021 at a dose of 1 dosage form. On 21-Jul-2021, VACCINATION SITE ERYTHEMA (injection site has redness that is 2 " in diameter), PYREXIA (99.8 degrees concerned), VACCINATION SITE PAIN (pain at injection site), FATIGUE (Extreme Fatigue), MYALGIA (Body ache, soreness) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) 99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Allergies to food, and other products Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant Follow up received - Updated the vaccine details like Batch/Lot number and vaccination site, New Events  vaccination site pain, extreme fatigue, Myalgia and Vaccination site swelling added. Outcome updated from unknown to recovered with sequalae.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site swelling; 99.8 degrees concerned; Extreme Fatigue; Body ache, soreness; injection site has redness that is 2 " in diameter; pain at injection site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jul-2021. The most recent information was received on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site has redness that is 2 " in diameter), PYREXIA (99.8 degrees concerned), VACCINATION SITE PAIN (pain at injection site), FATIGUE (Extreme Fatigue) and MYALGIA (Body ache, soreness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (sulfa drugs) and Penicillin allergy.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 08-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site has redness that is 2 " in diameter), FATIGUE (Extreme Fatigue) and MYALGIA (Body ache, soreness). On 10-Jul-2021, the patient experienced PYREXIA (99.8 degrees concerned). On 11-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with PARACETAMOL (TYLENOL) on 07-Jul-2021 for Pain, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 11-Jul-2021 at a dose of 1 dosage form. On 21-Jul-2021, VACCINATION SITE ERYTHEMA (injection site has redness that is 2 " in diameter), PYREXIA (99.8 degrees concerned), VACCINATION SITE PAIN (pain at injection site), FATIGUE (Extreme Fatigue), MYALGIA (Body ache, soreness) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) 99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Allergies to food, and other products Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant Follow up received - Updated the vaccine details like Batch/Lot number and vaccination site, New Events  vaccination site pain, extreme fatigue, Myalgia and Vaccination site swelling added. Outcome updated from unknown to recovered with sequalae.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Limb discomfort, Myalgia
Clinical narrative: felt like his arm was about to kill him; was weak but fine afterwards; soreness was across his shoulder to his neck; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt like his arm was about to kill him), ASTHENIA (was weak but fine afterwards) and MYALGIA (soreness was across his shoulder to his neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (felt like his arm was about to kill him), ASTHENIA (was weak but fine afterwards) and MYALGIA (soreness was across his shoulder to his neck). At the time of the report, LIMB DISCOMFORT (felt like his arm was about to kill him) and MYALGIA (soreness was across his shoulder to his neck) outcome was unknown and ASTHENIA (was weak but fine afterwards) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Headache, Nausea, Vomiting
Clinical narrative: vomiting; head ache; nausea; arthritis pain in my hands; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (head ache), NAUSEA (nausea) and ARTHRITIS (arthritis pain in my hands) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (head ache), NAUSEA (nausea) and ARTHRITIS (arthritis pain in my hands). At the time of the report, VOMITING (vomiting), HEADACHE (head ache), NAUSEA (nausea) and ARTHRITIS (arthritis pain in my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: not feeling well; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 10-Jul-2021, the patient experienced MALAISE (not feeling well) and MYALGIA (body aches). At the time of the report, MALAISE (not feeling well) and MYALGIA (body aches) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We had 11 expired doses given that were expired 13 days prior to doses given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had 11 expired doses given that were expired 13 days prior to doses given) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had 11 expired doses given that were expired 13 days prior to doses given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had 11 expired doses given that were expired 13 days prior to doses given) 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 medication use was unknown Treatment information was unknown
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Fever; sore (arm was sore); achy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (sore (arm was sore)) and PAIN (achy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vitamin D deficiency (low vitamin D level), Hepatic failure (liver failure) and UTI. Concurrent medical conditions included Type 2 diabetes mellitus, Sjogren's, Psoriasis, Neurogenic bladder, Brain lesion, Spinal cord injury (Spinal Lesion), Scarring (Liver Scarring), Paralysis, Hypercoagulability, Hypercholesterolemia and Spinal hemangioma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced PYREXIA (Fever), MYALGIA (sore (arm was sore)) and PAIN (achy). At the time of the report, PYREXIA (Fever), MYALGIA (sore (arm was sore)) and PAIN (achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: moderna vaccine for pregnant mothers; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (moderna vaccine for pregnant mothers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (moderna vaccine for pregnant mothers). At the time of the report, EXPOSURE DURING PREGNANCY (moderna vaccine for pregnant mothers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown  This is a Spontaneous case concerning a female patient of unknown age that reports the probable maternal exposure during or before pregnancy with unknown medical history. The exposure occurred in relation to a dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Upon internal review on 17-Nov-2021, Gender captured, pregnancy type, Birth type and Fetal outcome updated; Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age that reports the probable maternal exposure during or before pregnancy with unknown medical history. The exposure occurred in relation to a dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Pain in extremity, Palpitations
Clinical narrative: Red hard circle on arm/ redness; Sore arm; Hard sore spot; Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021. The most recent information was received on 29-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal), ERYTHEMA (Red hard circle on arm/ redness), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE INDURATION (Hard sore spot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ENALAPRIL MALEATE (VASOTEC [ENALAPRIL MALEATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PALPITATIONS (Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal). On an unknown date, the patient experienced ERYTHEMA (Red hard circle on arm/ redness), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE INDURATION (Hard sore spot). The patient was treated with ALPRAZOLAM (XANAX) for Adverse event, at an unspecified dose and frequency. On 24-Jun-2021, PALPITATIONS (Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal) had resolved. At the time of the report, ERYTHEMA (Red hard circle on arm/ redness) had resolved and PAIN IN EXTREMITY (Sore arm) and INJECTION SITE INDURATION (Hard sore spot) had not resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16 Jul 2021 contains no significant information On 29-Jul-2021: Additional events erythema, pain in extremity and injection site induration were added. Outcome of palpitations was updated from unknown to recovered resolved.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients; 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 PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients) 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 10-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients). At the time of the report, PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on neck, shoulder and arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on neck, shoulder and arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced URTICARIA (Hives on neck, shoulder and arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives on neck, shoulder and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Painful swollen lymph node), LYMPHADENOPATHY (swollen lymph node on the left side of the neck - same side as the injection site /swollen lymph node, 3.5 cm in diameter, on the neck, left side) and VACCINATION SITE SWELLING (Swollen site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The patient's past medical history included Kidney disorder. Concurrent medical conditions included Hypertension. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Swollen site of injection). On 09-Jul-2021, the patient experienced LYMPH NODE PAIN (Painful swollen lymph node) and LYMPHADENOPATHY (swollen lymph node on the left side of the neck - same side as the injection site /swollen lymph node, 3.5 cm in diameter, on the neck, left side). On 12-Jul-2021, VACCINATION SITE SWELLING (Swollen site of injection) had resolved. At the time of the report, LYMPH NODE PAIN (Painful swollen lymph node) and LYMPHADENOPATHY (swollen lymph node on the left side of the neck - same side as the injection site /swollen lymph node, 3.5 cm in diameter, on the neck, left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were  reported.  No treatment information  was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information added on 12JUL2021 contains significant information. New events updated, medical history updated, dosage information updated.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient inadvertently given the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently given the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently given the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently given the Moderna vaccine) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Pain, Vaccination site pain
Clinical narrative: the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.; the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.; felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.; Taken to the emergency room for pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), BREAST PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), PAIN (Taken to the emergency room for pain) and VACCINATION SITE PAIN (felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced PAIN (Taken to the emergency room for pain). On an unknown date, the patient experienced BACK PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), BREAST PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.) and VACCINATION SITE PAIN (felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), BREAST PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), PAIN (Taken to the emergency room for pain) and VACCINATION SITE PAIN (felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication includes Muscle Relaxers and Pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow Up received on 12 july 2021 , updated with new treatment medications( pain killers and muscle relaxants). information about event were updated..
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included WARFARIN, DILTIAZEM, LISINOPRIL and VITAMIN D NOS for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient explained that she thought the person who gave the shot put it too high on her arm.   This case was linked to MOD-2021-253973 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Right arm soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 036C21A) for COVID-19 vaccination.     Concomitant products included WARFARIN, DILTIAZEM, LISINOPRIL and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Right arm soreness). At the time of the report, MYALGIA (Right arm soreness) outcome was unknown.            No treatment medication was reported.    This case was linked to MOD-2021-253962 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Pyrexia
Clinical narrative: want to dig skin until I bleed, Nothing I do stops the itching at all"; chills; headache; low grade fever; began as her head itching which turning into itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (began as her head itching which turning into itching all over body), PRURITUS (want to dig skin until I bleed, Nothing I do stops the itching at all"), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PRURITUS (began as her head itching which turning into itching all over body). On an unknown date, the patient experienced PRURITUS (want to dig skin until I bleed, Nothing I do stops the itching at all"), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever). The patient was treated with CORTISONE at a dose of UNK dosage form, qd. At the time of the report, PRURITUS (began as her head itching which turning into itching all over body), PRURITUS (want to dig skin until I bleed, Nothing I do stops the itching at all"), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications include-blood pressure pill, thyroid medication, a stomach pill for IBS   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow- up document contains No New Information
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Generally didn't feel well; Aches; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (Generally didn't feel well), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient was hospitalized for Covid-19 the last week of May and was treated with monoclonal antibody therapy.). Previously administered products included for an unreported indication: BAMLANIVIMAB and REMDESIVIR.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Generally didn't feel well), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Generally didn't feel well), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: arm warm; arm with a fever; arm red; arm welted up; sore arm; a little sore in the area of injection; arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen), FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red) and URTICARIA (arm welted up) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen). On 12-Jul-2021, the patient experienced VACCINATION SITE PAIN (a little sore in the area of injection). On an unknown date, the patient experienced FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red), URTICARIA (arm welted up) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 09-Jul-2021 at a dose of UNK dosage form. On 11-Jul-2021, PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen) had resolved. At the time of the report, FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red), URTICARIA (arm welted up), MYALGIA (sore arm) and VACCINATION SITE PAIN (a little sore in the area of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        treatment also includes: patient applied warm compresses and a soft massage.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: arm warm; arm with a fever; arm red; arm welted up; sore arm; a little sore in the area of injection; arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen), FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red) and URTICARIA (arm welted up) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen). On 12-Jul-2021, the patient experienced VACCINATION SITE PAIN (a little sore in the area of injection). On an unknown date, the patient experienced FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red), URTICARIA (arm welted up) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 09-Jul-2021 at a dose of UNK dosage form. On 11-Jul-2021, PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen) had resolved. At the time of the report, FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red), URTICARIA (arm welted up), MYALGIA (sore arm) and VACCINATION SITE PAIN (a little sore in the area of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        treatment also includes: patient applied warm compresses and a soft massage.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044821A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On 13-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 24-jul-2021 contains non-significant information.Further Consent denied; Sender's Comments: This report refers to a case of interchange of vaccine products for mRNA-1273 (lot number unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Had a rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RASH (Had a rash). At the time of the report, RASH (Had a rash) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.