chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: slight polyethylene glycol allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21AA, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20211150020.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Muscle spasms, Pyrexia, Skin lesion
Clinical narrative: LEG CRAMPS IN BOTH LEGS WHEN SITTING/LAYING IN BED; CHILLS; FEVER; SKIN LESION POPPED UP ON ANKLE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's disease, and other pre-existing medical conditions included: Patient has a skin condition called something like annular granular .Patient was unsure of the name. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the patient experienced skin lesion popped up on ankle. On an unspecified date, the patient experienced leg cramps in both legs when sitting/laying in bed, chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99-101 degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps in both legs when sitting/laying in bed, chills, and fever, and was recovering from skin lesion popped up on ankle. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Malaise, Pain in extremity, SARS-CoV-2 test
Clinical narrative: FEELS HOT/COLD; ARM SORENESS; NOT FEELING 100 PERCENT; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: UNKNOWN) dose was not reported, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced feels hot/cold. On 21-NOV-2021, the patient experienced arm soreness. On 21-NOV-2021, the patient experienced not feeling 100 percent. On 21-NOV-2021, the patient experienced headache. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feels hot/cold, and arm soreness, and the outcome of not feeling 100 percent was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 20-DEC-2021) dose was not reported, administered on 22-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced incorrect product storage. On 22-NOV-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain
Clinical narrative: ACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced ache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from fatigue, and had not recovered from ache. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHES; CHILLS; This spontaneous report received from a consumer via a company representative concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Paraesthesia, Tremor
Clinical narrative: SHAKING; DIZZINESS; DIFFICULTY BREATHING; TINGLING AT OPPOSITE ARM OF THE INJECTION SITE; NAUSEA; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-NOV-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-NOV-2021, the patient experienced shaking. On 20-NOV-2021, the patient experienced dizziness. On 20-NOV-2021, the patient experienced difficulty breathing. On 20-NOV-2021, the patient experienced tingling at opposite arm of the injection site. On 20-NOV-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling at opposite arm of the injection site, nausea, shaking, dizziness, and difficulty breathing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired and fatigued; tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of FATIGUE (tired and fatigued) and the second episode of FATIGUE (tired and fatigued) 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 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced the first episode of FATIGUE (tired and fatigued) and the second episode of FATIGUE (tired and fatigued). At the time of the report, last episode of FATIGUE (tired and fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-387049 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up was received, updated reporters phone number. On 15-Nov-2021: Follow-up was received contains no new information. On 15-Nov-2021: Follow-up was received contains no new information.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Product administered to patient of inappropriate age, Vaccination site pain, Wrong product administered
Clinical narrative: 12 year old received full dose of moderna covid-19 vaccine 100 mcg; wrong vaccine administered; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS for an unknown indication.    On 05-Nov-2021 at 7:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 05-Nov-2021 at 7:55 AM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered). On 05-Nov-2021 at 7:55 AM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) had resolved. In November 2021, VACCINATION SITE PAIN (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) to be related. No further causality assessment was provided for VACCINATION SITE PAIN (sore arm).    No treatment information was provided. No concomitant medication was provided. The vaccine clinic was supposed to give the Pfizer vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2021: Significant follow-up-event updated
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Pyrexia, Speech disorder, Tremor
Clinical narrative: body tremors that are affecting her speech/"Tremors started again 30 minutes ago and I just got home 5 minutes ago"; I can't really walk; body tremors that are affecting her speech; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (body tremors that are affecting her speech/"Tremors started again 30 minutes ago and I just got home 5 minutes ago"), GAIT DISTURBANCE (I can't really walk), SPEECH DISORDER (body tremors that are affecting her speech), PAIN (body aches) and PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder. Concomitant products included LAMOTRIGINE (LAMICTAL) and ASENAPINE MALEATE (SAPHRIS) for Bipolar disorder, MULTIVITAMIN & MINERAL for an unknown indication.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (body tremors that are affecting her speech/"Tremors started again 30 minutes ago and I just got home 5 minutes ago"). In November 2021, the patient experienced GAIT DISTURBANCE (I can't really walk), SPEECH DISORDER (body tremors that are affecting her speech), PAIN (body aches) and PYREXIA (fever). The patient was treated with LORAZEPAM (ATIVAN) for Tremor, at a dose of 1 dosage form. At the time of the report, TREMOR (body tremors that are affecting her speech/"Tremors started again 30 minutes ago and I just got home 5 minutes ago"), GAIT DISTURBANCE (I can't really walk), SPEECH DISORDER (body tremors that are affecting her speech), PAIN (body aches) and PYREXIA (fever) outcome was unknown.            This case was linked to MOD-2021-386577 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Myasthenia gravis, Skin warm, Tremor
Clinical narrative: myasthenia gravis/ it's symptoms flared up; Had uncontrollable shakes; She was burning up; Her skin was so hot; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (myasthenia gravis/ it's symptoms flared up) and TREMOR (Had uncontrollable shakes) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0SZM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myasthenia gravis (a neuromuscular condition).   On 16-Mar-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 16-Mar-2021, the patient experienced MYASTHENIA GRAVIS (myasthenia gravis/ it's symptoms flared up) (seriousness criterion medically significant), BURNING SENSATION (She was burning up), SKIN WARM (Her skin was so hot), TREMOR (Had uncontrollable shakes) (seriousness criterion medically significant) and ASTHENIA (Weakness). At the time of the report, MYASTHENIA GRAVIS (myasthenia gravis/ it's symptoms flared up), BURNING SENSATION (She was burning up), SKIN WARM (Her skin was so hot), TREMOR (Had uncontrollable shakes) and ASTHENIA (Weakness) had resolved.            No relevant concomitant medications were reported. Patient reported that She took no treatment and just went to bed.  Company Comment: This case concerns a 81 year old female patient, with medical history of Myasthenia gravis who experienced serious unexpected event of Myasthenia gravis aggravated  after second dose of mRNA-1273. The event occurred the same day after vaccination. The re-challenge is unknown since event outcome is recovered and event occurred after second dose. Patient's previous diagnosis of myasthenia gravis is a contributing factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 81 year old female patient, with medical history of Myasthenia gravis who experienced serious unexpected event of Myasthenia gravis aggravated  after second dose of mRNA-1273. The event occurred the same day after vaccination. The re-challenge is unknown since event outcome is recovered and event occurred after second dose. Patient's previous diagnosis of myasthenia gravis is a contributing factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15-year-old received Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old received Moderna COVID-19 vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03621A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old received Moderna COVID-19 vaccine). On 12-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old received Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine administer after puncturing more than 20 times; 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 ADMINISTRATION ERROR (Vaccine administer after puncturing more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administer after puncturing more than 20 times). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administer after puncturing more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was reported by the reporter.  Pharmacist stated that they had 14 vials of Moderna COVID-19 vaccine that was punctured more 20 times in order to administer the dose to the patient. The vial did not undergo any temperature excursion.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Musculoskeletal chest pain, Myalgia, Vaccination complication
Clinical narrative: Severe pain in the muscle in his chest after first shot; Severe discomfort in the muscle in his chest after first shot; he had the pain; Received Pfizer COVID-19 shot for the 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Severe pain in the muscle in his chest after first shot), CHEST DISCOMFORT (Severe discomfort in the muscle in his chest after first shot), VACCINATION COMPLICATION (Received Pfizer COVID-19 shot for the 2nd dose) and MYALGIA (he had the pain) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION COMPLICATION (Received Pfizer COVID-19 shot for the 2nd dose). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Severe pain in the muscle in his chest after first shot), CHEST DISCOMFORT (Severe discomfort in the muscle in his chest after first shot) and MYALGIA (he had the pain). On 12-Nov-2021, VACCINATION COMPLICATION (Received Pfizer COVID-19 shot for the 2nd dose) had resolved. At the time of the report, MUSCULOSKELETAL CHEST PAIN (Severe pain in the muscle in his chest after first shot), CHEST DISCOMFORT (Severe discomfort in the muscle in his chest after first shot) and MYALGIA (he had the pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.  Nurse states that they gave patient Pfizer COVID-19 vaccine as the second dose and he tolerated it well.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received on 17-NOV-2021 contains significant information: event added
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: fatigued; fever; chills; beginning of rash at injection site; beginning of swelling at injection site; The patient says that his injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (The patient says that his injection site arm hurt) and VACCINATION SITE RASH (beginning of rash at injection site) in a male 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.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (The patient says that his injection site arm hurt). On 13-Nov-2021, the patient experienced FATIGUE (fatigued), PYREXIA (fever), CHILLS (chills), VACCINATION SITE RASH (beginning of rash at injection site) and VACCINATION SITE SWELLING (beginning of swelling at injection site). At the time of the report, FATIGUE (fatigued), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (The patient says that his injection site arm hurt), VACCINATION SITE RASH (beginning of rash at injection site) and VACCINATION SITE SWELLING (beginning of swelling at injection site) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-387040 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non Significant follow-up added On 15-Nov-2021: Non Significant follow-up added
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: fatigued; fever; chills; beginning of rash at injection site; beginning of swelling at injection site; The patient says that his injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (The patient says that his injection site arm hurt) and VACCINATION SITE RASH (beginning of rash at injection site) in a male 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.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (The patient says that his injection site arm hurt). On 13-Nov-2021, the patient experienced FATIGUE (fatigued), PYREXIA (fever), CHILLS (chills), VACCINATION SITE RASH (beginning of rash at injection site) and VACCINATION SITE SWELLING (beginning of swelling at injection site). At the time of the report, FATIGUE (fatigued), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (The patient says that his injection site arm hurt), VACCINATION SITE RASH (beginning of rash at injection site) and VACCINATION SITE SWELLING (beginning of swelling at injection site) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-387040 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non Significant follow-up added On 15-Nov-2021: Non Significant follow-up added
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: less energy; aches,  pains in joints; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (less energy) and ARTHRALGIA (aches,  pains in joints) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) (Acid reflux) and Osteochondritis. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced ASTHENIA (less energy) and ARTHRALGIA (aches,  pains in joints). At the time of the report, ASTHENIA (less energy) and ARTHRALGIA (aches,  pains in joints) outcome was unknown.            No treatment information were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: follow up received on 18-Nov-2021 contains NNI.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache/It's starting over, even more so everywhere.; Aches/It's starting over, even more so everywhere.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/It's starting over, even more so everywhere.) and MYALGIA (Aches/It's starting over, even more so everywhere.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included NAPROXEN SODIUM (ALEVE) and IBUPROFEN for Arthritis.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache/It's starting over, even more so everywhere.) and MYALGIA (Aches/It's starting over, even more so everywhere.). At the time of the report, HEADACHE (Headache/It's starting over, even more so everywhere.) and MYALGIA (Aches/It's starting over, even more so everywhere.) had not resolved.            No concomitant drug information provided.   This case was linked to MOD-2021-387079, MOD-2021-387075 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received the full dose instead of the booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received the full dose instead of the booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 040A2H and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (stage 3 leukemia Col stage 0). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient received the full dose instead of the booster). On 12-Nov-2021, ACCIDENTAL OVERDOSE (Patient received the full dose instead of the booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported. Patient reports she goes to an oncologist and it is just being watched and no treatment.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15-NOV-2021 Updated Medical history Stage. On 18-Nov-2021: Follow-up received on 19-NOV-2021 Updated Email address
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: He states that the low grade fevers have been up to 99F & 100F & they come & go; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He states that the low grade fevers have been up to 99F & 100F & they come & go) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (He states that the low grade fevers have been up to 99F & 100F & they come & go). At the time of the report, PYREXIA (He states that the low grade fevers have been up to 99F & 100F & they come & go) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f and 100f (Low) the low grade fevers have been up to 99F & 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-glomerular basement membrane disease, Antineutrophil cytoplasmic antibody
Clinical narrative: concurrent antineutrophil cytoplasmic autoantibody; antiglomerular basement membrane glomerulonephritis; This literature-non-study case was reported in a literature article and describes the occurrence of ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Concurrent anti-GBM nephritis and ANCA-mediated glomerulonephritis after second dose of SARS-CoV-2 mRNA vaccination. Kidney Int Rep.     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, the patient experienced ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) (seriousness criterion medically significant) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) (seriousness criterion medically significant). At the time of the report, ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) to be possibly related.    Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Company Comment: This literature-non-study case concerns a 23-year-old male patient with no relevant medical history, who experienced serious unexpected events of antineutrophil cytoplasmic antibody and anti-glomerular basement membrane disease. The events occurred unspecified time after the second dose of the Moderna COVID-19 vaccine. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This literature-non-study case concerns a 23-year-old male patient with no relevant medical history, who experienced serious unexpected events of antineutrophil cytoplasmic antibody and anti-glomerular basement membrane disease. The events occurred unspecified time after the second dose of the Moderna COVID-19 vaccine. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was excursion from the freezer; There was an excursion from their freezer/they were administered to 118 patients.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 11-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Embolia cutis medicamentosa
Clinical narrative: Nicolau syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Nicolau syndrome after glatiramer acetate injection in close proximity to administration of SARS-CoV-2 mRNA vaccine. Neurol Neuroimmunol Neuroinflamm    Concomitant products included GLATIRAMER ACETATE for an unknown indication.   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 EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) (seriousness criterion medically significant). At the time of the report, EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) to be possibly related.    Nicolau Syndrome After Glatiramer Acetate Injection in Close Proximity to Administration of SARS-CoV-2 mRNA Vaccine  Company Comment: This literature case report concerns a 59 year-old female whose medical history is not available, who experienced the unexpected serious event of Embolia cutis medicamentosa (reported as the LLT: Nicolau syndrome). The event occurred after the second dose of an mRNA vaccine administration whose brand is not provided. Conservatively the case is considered valid. The administration of Glatiramer Acetate Injection in close proximity to mRNA vaccine is a confounder/co-suspect for the event.  The benefit-risk relationship of mRNA1273 vaccine is not affected by this report   Reporter did not allow further contact; Sender's Comments: This literature case report concerns a 59 year-old female whose medical history is not available, who experienced the unexpected serious event of Embolia cutis medicamentosa (reported as the LLT: Nicolau syndrome). The event occurred after the second dose of an mRNA vaccine administration whose brand is not provided. Conservatively the case is considered valid. The administration of Glatiramer Acetate Injection in close proximity to mRNA vaccine is a confounder/co-suspect for the event.  The benefit-risk relationship of mRNA1273 vaccine is not affected by this report
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Minimal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minimal side effects) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Minimal side effects). At the time of the report, VACCINATION COMPLICATION (Minimal side effects) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-383001 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), MELATONIN and L-THEANINE for Sleep difficult, VITAMIN D [VITAMIN D NOS], FISH OIL (OMEGA3 JACK) and MAGNESIUM for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications were not provided by reporter.   This case was linked to MOD-2021-392118 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Decreased interest, Fatigue, Inappropriate schedule of product administration
Clinical narrative: along with the fatigue I had no interest in reading and she used to like reading a lot; The patient received second dose of vaccine beyond 35 days (first dose on 14-Jan-2021 and second dose on 25-Feb-2021); 3 months of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED INTEREST (along with the fatigue I had no interest in reading and she used to like reading a lot), FATIGUE (3 months of fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received second dose of vaccine beyond 35 days (first dose on 14-Jan-2021 and second dose on 25-Feb-2021)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), MELATONIN and L-THEANINE for Sleep disorder, VITAMIN D [VITAMIN D NOS], OMEGA-3 [OMEGA-3 NOS] and MAGNESIUM for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received second dose of vaccine beyond 35 days (first dose on 14-Jan-2021 and second dose on 25-Feb-2021)). On an unknown date, the patient experienced DECREASED INTEREST (along with the fatigue I had no interest in reading and she used to like reading a lot) and FATIGUE (3 months of fatigue). On 25-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received second dose of vaccine beyond 35 days (first dose on 14-Jan-2021 and second dose on 25-Feb-2021)) had resolved. At the time of the report, DECREASED INTEREST (along with the fatigue I had no interest in reading and she used to like reading a lot) outcome was unknown and FATIGUE (3 months of fatigue) had resolved.            The patient received the 2nd dose in her left arm (not dominant one).  The patient did not take any treatment medication.   This case was linked to MOD-2021-392097 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Prostatic disorder NOS.    On 04-Mar-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 ARTHRALGIA (Joint pain) (seriousness criterion disability). At the time of the report, ARTHRALGIA (Joint pain) 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.   At the time of the vaccination patient was received high blood pressure medication and a prostate medication as a concomitant medication. Treatment product was not provided by the reporter  This is a spontaneous case concerning a 65 years old, male patient with  no clinical history who experienced the unexpected event of ARTHRALGIA The event occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-387057 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65 years old, male patient with  no clinical history who experienced the unexpected event of ARTHRALGIA The event occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.