chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of severe chills for 2 to 3 hours, fatigue and arthralgia (joint pain) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006M20A and 012L20A) for COVID-19 immunization. The patient's past medical history included blood cancer. Concurrent medical conditions included immunocompromised. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 16, 2021, patient experienced severe chills for 2 to 3 hours and fatigue. Feb 16, 2021, patient experienced arthralgia (joint pain). On Feb 16, 2021, severe chills for 2 to 3 hours) resolved. At the time of the report, fatigue and arthralgia (joint pain) outcome: unknown. No concomitant medications or treatment information provided. Reportedly, patient had no adverse reactions after the first Moderna COVID-19 vaccine. This case linked to MOD-2021-375478 (patient link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: soreness in the leg and thigh; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the leg and thigh) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (LOT No. EL1283) on 11-Jan-2021 and PFIZER BIONTECH COVID-19 VACCINE (LOT No. EL9264) on 01-Feb-2021.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY (soreness in the leg and thigh) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the leg and thigh) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral coldness, Vaccination site pain
Clinical narrative: feet were cold like ice cubes; soreness in her joints; soreness in her left arm where she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 031A21A and 866F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine). At the time of the report, PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.    This case was linked to MOD-2021-375486 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: soreness in the arm; started to itch on the side of the site where patient got the shot; started to itch on the side of the site where patient got the shot, and; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE PRURITUS (started to itch on the side of the site where patient got the shot) and VACCINATION SITE ERYTHEMA (started to itch on the side of the site where patient got the shot, and) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PRURITUS (started to itch on the side of the site where patient got the shot) and VACCINATION SITE ERYTHEMA (started to itch on the side of the site where patient got the shot, and). On 23-Oct-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 27-Oct-2021, PAIN IN EXTREMITY (soreness in the arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (started to itch on the side of the site where patient got the shot) had not resolved and VACCINATION SITE ERYTHEMA (started to itch on the side of the site where patient got the shot, and) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported after receiving first shot, patient had soreness in the arm which lasted for about 4 days.  On 5th or 6th day it was started to itch and redness appeared on injection site. Redness gone after 5 day but itching persist.  concomitant medications include vitamins supplements. treatment to the events not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site swelling (has swelling at injection site about the size of a cup) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25mL. On an unknown date, patient had vaccination site swelling (has swelling at injection site about the size of a cup). At the time of the report, vaccination site swelling (has swelling at injection site about the size of a cup) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia
Clinical narrative: Chills; Fatigue; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 006M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia (Blood cancer).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient Date of birth was reported as date in the Source document.  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-375441 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Migraine
Clinical narrative: still feeling under the weather today; Extreme migraine like headache; Profuse Sweating; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Extreme migraine like headache), HYPERHIDROSIS (Profuse Sweating) and MALAISE (still feeling under the weather today) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061EZ1A and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced MIGRAINE (Extreme migraine like headache) and HYPERHIDROSIS (Profuse Sweating). On an unknown date, the patient experienced MALAISE (still feeling under the weather today). At the time of the report, MIGRAINE (Extreme migraine like headache) and HYPERHIDROSIS (Profuse Sweating) outcome was unknown and MALAISE (still feeling under the weather today) had not resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-375450 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral coldness, Vaccination site pain
Clinical narrative: feet were cold like ice cubes; soreness in her joints; soreness in her left arm where she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-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 PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine). At the time of the report, PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-375446 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Flu-like symptoms; They felt sick; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (They felt sick) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (They felt sick). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (They felt sick) outcome was unknown.            Concomitant and treatment medications were not provided.  The patient stated that her friends got the Moderna booster and they both got flu-like symptoms. They felt sick. Patient wanted to know if that's possible. Then the patient changed her mind - she said that she wasn't sure if her friends got the Moderna or another vaccine.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: fly headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (fly headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (fly headache). At the time of the report, HEADACHE (fly headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-375497, MOD-2021-375498 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: for 72 hours after second vaccine arm became sore; for 72 hours after second vaccine arm became swollen; for 72 hours after second vaccine arm became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (for 72 hours after second vaccine arm became sore), VACCINATION SITE SWELLING (for 72 hours after second vaccine arm became swollen) and VACCINATION SITE ERYTHEMA (for 72 hours after second vaccine arm became red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PAIN (for 72 hours after second vaccine arm became sore), VACCINATION SITE SWELLING (for 72 hours after second vaccine arm became swollen) and VACCINATION SITE ERYTHEMA (for 72 hours after second vaccine arm became red). At the time of the report, VACCINATION SITE PAIN (for 72 hours after second vaccine arm became sore), VACCINATION SITE SWELLING (for 72 hours after second vaccine arm became swollen) and VACCINATION SITE ERYTHEMA (for 72 hours after second vaccine arm became red) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; Expired vaccine used; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu (Lot number:3NA4M ,  Route of administration is Intramuscular and first dose.) on 12-Oct-2021. Past adverse reactions to the above products included Adverse event with Flu. Concurrent medical conditions included Asthma since 2001, ADHD since 2011 and GERD since 2010. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for GERD, PHENTERMINE for Weight loss.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and HEADACHE (headache). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. On 27-Oct-2021, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Expired vaccine used; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PAIN IN EXTREMITY (sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021 at 3:39 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. On 27-Oct-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      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 medications was not reported.  Treatment medications was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) 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 24-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No Treatment informations were reported.  This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 2 month 24 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was unknown since no information about the first dose was disclosed. 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 patient (age not provided) with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 2 month 24 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Vaccination site bruising, Vaccination site rash
Clinical narrative: auto immune reaction called "lichen planus"; it looks like a bruise; developed a rash; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN PLANUS (auto immune reaction called "lichen planus"), VACCINATION SITE BRUISING (it looks like a bruise) and VACCINATION SITE RASH (developed 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.   In June 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced LICHEN PLANUS (auto immune reaction called "lichen planus"), VACCINATION SITE BRUISING (it looks like a bruise) and VACCINATION SITE RASH (developed a rash). At the time of the report, LICHEN PLANUS (auto immune reaction called "lichen planus"), VACCINATION SITE BRUISING (it looks like a bruise) and VACCINATION SITE RASH (developed a rash) outcome was unknown.            No Concomitant medication was reported. Patient stated that she was prescribed Protopic which affects t cells and the Moderna vaccine also affects T cells. She explained that 6 months ago after receiving her 2nd Moderna shot, she developed a rash, it looks like a bruise. She stated that it is an auto immune reaction called "lichen planus." Patient stated that she doesn't know if it was related to the vaccine. Treatment medication included Protopic ointment was prescribed, but has not used it yet.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Lost hearing in the left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in the left ear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEAFNESS UNILATERAL (Lost hearing in the left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Lost hearing in the left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) everything done but it is not showing why she death in that ear.         Patient is taking other medication.  Treatment medication was not provided by the reporter.  Company comment: This case concerns a 75 year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Deafness unilateral. The event occurred approximately 4 to 6 weeks after the second dose of Moderna COVID-19 vaccine, exact date not provided. The rechallenge was not applicable since it occurred after the second dose and outcome is unknown. Patient´s advanced age remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-376403 (Patient Link).; Sender's Comments: This case concerns a 75 year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Deafness unilateral. The event occurred approximately 4 to 6 weeks after the second dose of Moderna COVID-19 vaccine, exact date not provided. The rechallenge was not applicable since it occurred after the second dose and outcome is unknown. Patient´s advanced age remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fevers backed off; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fevers backed off) and FATIGUE (Exhaustion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included Long COVID in April 2020.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fevers backed off) and FATIGUE (Exhaustion). The patient was treated with UBIDECARENONE (COQ 10) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] ongoing since an unknown date at an unspecified dose and frequency; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; ECSTASY at an unspecified dose and frequency and MULTIVITAMINS [VITAMINS NOS] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fevers backed off) and FATIGUE (Exhaustion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.  Treatment medications include extra D, supplements and electrolytes. Non drug information includes patient consumes coconut water, protein drink.   This case was linked to MOD-2021-376668 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness on her left arm at the injection site; A bump on her left arm at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on her left arm at the injection site) and VACCINATION SITE SWELLING (A bump on her left arm at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on her left arm at the injection site) and VACCINATION SITE SWELLING (A bump on her left arm at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on her left arm at the injection site) and VACCINATION SITE SWELLING (A bump on her left arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Maternal exposure during breast feeding, Pyrexia
Clinical narrative: sore arm at injection site; achy joints; tiredness; headache; Low grade fever; Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy (Patient recently gave birth. She received first two doses during first trimester.). Concurrent medical conditions included Breast feeding.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever). On 02-Nov-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever) outcome was unknown. Not Provided          No concomitant and treatment medication were provided Patient received first two doses during her first trimester and currently breast feeding.  This case concerns a female patient, of unknown age, with no relevant medical history, who experienced vaccine exposure during breast feeding with associated expected, non-serious events following administration of the third dose of the Moderna COVID-19 Vaccine on 02Nov2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-376688 (Parent-Child Link). This case was linked to MOD-2021-004191 (Patient Link).   See case MOD-2021-376688 for details regarding the child case.; Sender's Comments: This case concerns a female patient, of unknown age, with no relevant medical history, who experienced vaccine exposure during breast feeding with associated expected, non-serious events following administration of the third dose of the Moderna COVID-19 Vaccine on 02Nov2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at injection site; achy joints; tiredness; headache; Low grade fever; Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy (Patient recently gave birth. She received first two doses during first trimester.). Concurrent medical conditions included Breast feeding.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever). On 02-Nov-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever) outcome was unknown. Not Provided          No concomitant and treatment medication were provided Patient received first two doses during her first trimester and currently breast feeding.  This case concerns a female patient, of unknown age, with no relevant medical history, who experienced vaccine exposure during breast feeding with associated expected, non-serious events following administration of the third dose of the Moderna COVID-19 Vaccine on 02Nov2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-376688 (Parent-Child Link). This case was linked to MOD-2021-004191 (Patient Link).   See case MOD-2021-376688 for details regarding the child case.; Sender's Comments: This case concerns a female patient, of unknown age, with no relevant medical history, who experienced vaccine exposure during breast feeding with associated expected, non-serious events following administration of the third dose of the Moderna COVID-19 Vaccine on 02Nov2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Clavicle fracture, Eye contusion, Loss of consciousness, Thrombosis
Clinical narrative: passed out; blood clots; broke their collar bone; black eyes; 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 LOSS OF CONSCIOUSNESS (passed out) and THROMBOSIS (blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified.    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 LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), THROMBOSIS (blood clots) (seriousness criterion medically significant), CLAVICLE FRACTURE (broke their collar bone) and EYE CONTUSION (black eyes). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots), CLAVICLE FRACTURE (broke their collar bone) and EYE CONTUSION (black eyes) outcome was unknown.      No concomitant and treatment medication was reported by patient.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.  Patient reported that 3 friends of her who received Moderna vaccine had serious events after second dose.  This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious events of Loss of consciousness and Thrombosis. The events occurred approximately on an unknown day after the unknown dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid-19 Vaccine in not affected by this report.   This case was linked to MOD-2021-376600, MOD-2021-376153 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious events of Loss of consciousness and Thrombosis. The events occurred approximately on an unknown day after the unknown dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid-19 Vaccine in not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: left arm in pain; cannot move it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm in pain) and MOBILITY DECREASED (cannot move it) 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 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm in pain) and MOBILITY DECREASED (cannot move it). At the time of the report, PAIN IN EXTREMITY (left arm in pain) and MOBILITY DECREASED (cannot move it) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected events of mobility decreased and pain in extremity. The events of mobility decreased and pain in extremity occurrence unknown with respect to the second dose of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under the arm pit injected arm (baseball Size); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node under the arm pit injected arm (baseball Size)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under the arm pit injected arm (baseball Size)). At the time of the report, LYMPHADENOPATHY (Swollen lymph node under the arm pit injected arm (baseball Size)) outcome was unknown.            No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Hot flush
Clinical narrative: hot flashes; bone pain; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), BONE PAIN (bone pain), CHILLS (chills) and HEADACHE (headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced HOT FLUSH (hot flashes), BONE PAIN (bone pain), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (hot flashes), BONE PAIN (bone pain), CHILLS (chills) and HEADACHE (headache) had not resolved.            No concomitant medications provided. The patient experienced hot flashes, chills, headaches, and bones aching.  The symptoms are ongoing.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 8:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided. Client did not have any adverse reaction that was noted. we notified the client and asked them to receive a redosing with un expired vial(lot 037C21A) per our supervisors instructions. All questions and concerns were discussed with the client,
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Re-dosing of moderna vaccine; Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Time of vaccine administered is 10:15am
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient was asked to them to return for redosing with unexpired vial lot 037C21A noted.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypokinesia, Musculoskeletal stiffness, Vaccination complication
Clinical narrative: the problem is still the same; Wednesday was real bad; I can hardly move, could hardly move the fingers; arm real stiff; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (the problem is still the same), FEELING ABNORMAL (Wednesday was real bad), HYPOKINESIA (I can hardly move, could hardly move the fingers) and MUSCULOSKELETAL STIFFNESS (arm real stiff) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced FEELING ABNORMAL (Wednesday was real bad), HYPOKINESIA (I can hardly move, could hardly move the fingers) and MUSCULOSKELETAL STIFFNESS (arm real stiff). On an unknown date, the patient experienced ADVERSE EVENT (the problem is still the same). At the time of the report, ADVERSE EVENT (the problem is still the same) had not resolved and FEELING ABNORMAL (Wednesday was real bad), HYPOKINESIA (I can hardly move, could hardly move the fingers) and MUSCULOSKELETAL STIFFNESS (arm real stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she never received second dose.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Inflammation, Magnetic resonance imaging, Pulmonary mass
Clinical narrative: Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs; Post infectious inflammator; Post infectious inflammator; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY MASS (Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs), INFECTION (Post infectious inflammator) and INFLAMMATION (Post infectious inflammator) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M204) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY MASS (Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs), INFECTION (Post infectious inflammator) and INFLAMMATION (Post infectious inflammator). At the time of the report, PULMONARY MASS (Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs), INFECTION (Post infectious inflammator) and INFLAMMATION (Post infectious inflammator) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Found nodules in a 3.5mm range with opacity, a pattern of something in chest and lungs. Post infectious inflammatory..         Concomitant product use was not provided by the reporter.  On an unknown date, the patient experienced had an MRI done and they found nodules in a 3.5mm range with opacity, a pattern of something in her chest and in her lungs. Post infectious inflammatory.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021; 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 (Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The booster shot that was administered to the patient was expired 30 days ago. The Date the vial was initially stored in the refrigerator 26-OCT-2021.  No concomitant medications reported.  No treatment information was provided.