chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: CHILLS; FEVER; HEADACHE; FATIGUE; MUSCLE ACHINESS; This spontaneous report received from a patient concerned a female 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-OCT-2021, the patient experienced chills. On 30-OCT-2021, the patient experienced fever. On 30-OCT-2021, the patient experienced headache. On 30-OCT-2021, the patient experienced fatigue. On 30-OCT-2021, the patient experienced muscle achiness. Laboratory data included: Body temperature (NR: not provided) 100.4-100.6 F. On 01-NOV-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, headache, and muscle achiness, and had not recovered from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: CHILLS; FEVER; HEADACHE; FATIGUE; MUSCLE ACHINESS; This spontaneous report received from a patient concerned a female 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-OCT-2021, the patient experienced chills. On 30-OCT-2021, the patient experienced fever. On 30-OCT-2021, the patient experienced headache. On 30-OCT-2021, the patient experienced fatigue. On 30-OCT-2021, the patient experienced muscle achiness. Laboratory data included: Body temperature (NR: not provided) 100.4-100.6 F. On 01-NOV-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, headache, and muscle achiness, and had not recovered from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: VACCINE ALMOST KILLED; This spontaneous report received from a consumer concerned a female 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: 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 vaccine almost killed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine almost killed was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) 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 by reporter. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received 2 different vaccines; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received 2 different vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 080C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Sputnik COVID-19 vaccine (lot I-450321) on 28-Apr-2021. Past adverse reactions to the above products included No adverse event with Sputnik COVID-19 vaccine.    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received 2 different vaccines). On 02-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Received 2 different vaccines) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up information included about outcome of both doses of vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Muscular weakness, Pyrexia, Vaccination site pain
Clinical narrative: Her legs are not wobbly but they do not feel strong; She feels warm; Where she got the inoculation (arm) is sore; 102 fever/ She feels feverish; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Her legs are not wobbly but they do not feel strong), FEELING HOT (She feels warm), VACCINATION SITE PAIN (Where she got the inoculation (arm) is sore) and PYREXIA (102 fever/ She feels feverish) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 032L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Her legs are not wobbly but they do not feel strong), FEELING HOT (She feels warm), VACCINATION SITE PAIN (Where she got the inoculation (arm) is sore) and PYREXIA (102 fever/ She feels feverish). At the time of the report, MUSCULAR WEAKNESS (Her legs are not wobbly but they do not feel strong), FEELING HOT (She feels warm), VACCINATION SITE PAIN (Where she got the inoculation (arm) is sore) and PYREXIA (102 fever/ She feels feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 102 (High) 102 fever.         The patient was taking Diabetic medication. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Myalgia, Nasopharyngitis
Clinical narrative: Hot; Cold; Muscle aches; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot), NASOPHARYNGITIS (Cold), MYALGIA (Muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) 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-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced FEELING HOT (Hot), NASOPHARYNGITIS (Cold), MYALGIA (Muscle aches), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FEELING HOT (Hot), NASOPHARYNGITIS (Cold), MYALGIA (Muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Body temperature, Off label use, Pyrexia
Clinical narrative: Accidental overdose; Patient also stated that not immunocompromised; Developed a fever of 103.0 F; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Accidental overdose), OFF LABEL USE (Patient also stated that not immunocompromised) and PYREXIA (Developed a fever of 103.0 F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidental overdose), OFF LABEL USE (Patient also stated that not immunocompromised) and PYREXIA (Developed a fever of 103.0 F). On 22-Oct-2021, ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Patient also stated that not immunocompromised) had resolved. At the time of the report, PYREXIA (Developed a fever of 103.0 F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2021, Body temperature: (High) Fever of 103.0F..         No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-363280 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-Up information received: Events (incorrect dose administered and off label use) added and Email Id updated.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Fatigue, Insomnia, Pyrexia
Clinical narrative: Some mild chest pain; I felt a little fatigue; Fever; I could not sleep; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I could not sleep), DECREASED APPETITE (Loss of appetite), CHEST PAIN (Some mild chest pain), FATIGUE (I felt a little fatigue) and PYREXIA (Fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 027A21A and 044B21A) for COVID-19 vaccination.     The patient's past medical history included Suspected COVID-19 (Maybe (several tests yielded negative results)).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced INSOMNIA (I could not sleep), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever). 22-Oct-2021, the patient experienced FATIGUE (I felt a little fatigue). On 23-Oct-2021, the patient experienced CHEST PAIN (Some mild chest pain). At the time of the report, INSOMNIA (I could not sleep), DECREASED APPETITE (Loss of appetite), CHEST PAIN (Some mild chest pain), FATIGUE (I felt a little fatigue) and PYREXIA (Fever) had resolved.            Treatment medication was not provided. Concomitant medication was not provided.  On 23-Oct-2021, the patient started having some mild chest pain, but did not saw the physician, or anything like that.  On 25-Oct-2021, the patient still had the chest pain, but was much better now. And all the other side effects were a lot better. Whenever the patient get a viral infection, the patient did not felt like eating at all.   This case was linked to MOD-2021-363021, MOD-2021-363022 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received contains no significant information. On 27-Oct-2021: upon follow up receipt: Event outcome was updated(recovering-recovered) and narrative was generated accordingly.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information provided by the reporter .
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pegnant during booster dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pegnant during booster dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in June 2021 and the estimated date of delivery was 23-Mar-2022. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pegnant during booster dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second trimester of the pregnancy.  On 25-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pegnant during booster dose) 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 information was provided.  This case concerns a 30-year-old, female patient with no known medical history, who experienced the non-serious event of Maternal exposure during pregnancy. The patient received the third dose of vaccine approximately at 18 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 30-year-old, female patient with no known medical history, who experienced the non-serious event of Maternal exposure during pregnancy. The patient received the third dose of vaccine approximately at 18 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I felt a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt a little fatigue) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 ( "Maybe" (several tests yielded negative results)  ).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (I felt a little fatigue). At the time of the report, FATIGUE (I felt a little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported by reporter.  Patient reported that he might had history of COVID 19 (Several tests yielded negative results).  Patient informed that he was fine and not to worry. He informed that he was just anxious the previous day.  No treatment medication reported by reporter.   This case was linked to MOD-2021-363021, MOD-2021-362956 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up information received contains No New Information. On 27-Oct-2021: Follow up information received on 28-OCT-2021 and contains NNI
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm swelled up twice the size size of my palm; Achy; Tired; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), VACCINATION SITE SWELLING (Arm swelled up twice the size size of my palm), VACCINATION SITE PAIN (Sore left arm) and FATIGUE (Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 025J202A and 041L20A) 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) (Intramuscular) 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 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm). On 24-Oct-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired). On 25-Oct-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelled up twice the size size of my palm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), VACCINATION SITE PAIN (Sore left arm) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE SWELLING (Arm swelled up twice the size size of my palm) had not resolved.            No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received doses from vials that had been in the refrigerator past the 30 day use by date; 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 (Received doses from vials that had been in the refrigerator past the 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had been in the refrigerator past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had been in the refrigerator past the 30 day use by date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported. It was reported that, dosage administered on 13-Oct-2021, 14-Oct-2021 and 19-Oct-2021 from lot 020F21A.   This case was linked to MOD-2021-364962, MOD-2021-364355, MOD-2021-364754, MOD-2021-364515, MOD-2021-364819, MOD-2021-364949, MOD-2021-364896, MOD-2021-365131, MOD-2021-364840, MOD-2021-364950, MOD-2021-365067, MOD-2021-364825, MOD-2021-365177, MOD-2021-365189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow Up received and added information in narrative
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Fever of 101.1 F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.1 F) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Oct-1900, the patient experienced HEADACHE (Headache). On 23-Oct-2021, the patient experienced PYREXIA (Fever of 101.1 F). At the time of the report, PYREXIA (Fever of 101.1 F) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 101.1 f (High) Fever of 101.1 F.         No concomitant medications reported.  No treatment reported.   This case was linked to MOD-2021-362942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up  information received and contact information updated. On 28-Oct-2021: Follow up information received- email id updated
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Peripheral swelling, Swelling, Urticaria
Clinical narrative: Left side of his body the side where he got the injection got itchy and it never stops itching; Also has bumps; bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over; bumps on my legs are getting worse and worse; hives are getting bigger and bigger; sore arm; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), CONDITION AGGRAVATED (bumps on my legs are getting worse and worse), URTICARIA (hives are getting bigger and bigger), PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), CONDITION AGGRAVATED (bumps on my legs are getting worse and worse), URTICARIA (hives are getting bigger and bigger), PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen arm). On 23-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Left side of his body the side where he got the injection got itchy and it never stops itching) and VACCINATION SITE SWELLING (Also has bumps). At the time of the report, SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (Left side of his body the side where he got the injection got itchy and it never stops itching) and VACCINATION SITE SWELLING (Also has bumps) outcome was unknown and CONDITION AGGRAVATED (bumps on my legs are getting worse and worse) and URTICARIA (hives are getting bigger and bigger) had not resolved.      Patient reported concomitant medications as Diabetes medication,High blood pressure medication,Around 30 different medications (did not want to share all). No treatment medications were provided .   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up  received contains concomitant medications, New events added and anatomical location, patient date of birth updated
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Left side of his body the side where he got the injection got itchy and it never stops itching; Also has bumps; bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over; bumps on my legs are getting worse and worse; hives are getting bigger and bigger; sore arm; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), CONDITION AGGRAVATED (bumps on my legs are getting worse and worse), URTICARIA (hives are getting bigger and bigger), PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), CONDITION AGGRAVATED (bumps on my legs are getting worse and worse), URTICARIA (hives are getting bigger and bigger), PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen arm). On 23-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Left side of his body the side where he got the injection got itchy and it never stops itching) and VACCINATION SITE SWELLING (Also has bumps). At the time of the report, SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (Left side of his body the side where he got the injection got itchy and it never stops itching) and VACCINATION SITE SWELLING (Also has bumps) outcome was unknown and CONDITION AGGRAVATED (bumps on my legs are getting worse and worse) and URTICARIA (hives are getting bigger and bigger) had not resolved.      Patient reported concomitant medications as Diabetes medication,High blood pressure medication,Around 30 different medications (did not want to share all). No treatment medications were provided .   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up  received contains concomitant medications, New events added and anatomical location, patient date of birth updated
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Vaccination complication
Clinical narrative: Heart palpitations; Other reactions; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions). At the time of the report, PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-363332 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up document contains non-significant information: updated email id.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Vaccination complication
Clinical narrative: Heart palpitations; Other reactions; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions). At the time of the report, PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) outcome was unknown.            Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-363323 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contained: Added reporter details - Email id;
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 048B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. The vial was initially stored in the refrigerator on 22-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up contains significant information of dose 1 and dose 2 information  and patient demographics updated. On 27-Oct-2021: Follow up received on 28-Oct-2021 contains alternative phone number for reporter, report's address and facility details
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Influenza, Pain in extremity, Pyrexia, Vaccination site discomfort
Clinical narrative: Arm was hurting the day; Lots of discomfort in the arm where she received the shot; Felt like having the flu for a couple of days; Fever; To the point she cannot even lift her arm; It's getting worse each day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting the day), CONDITION AGGRAVATED (It's getting worse each day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot), MOBILITY DECREASED (To the point she cannot even lift her arm) and INFLUENZA (Felt like having the flu for a couple of days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 01FE21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting the day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot) and PYREXIA (Fever). 11-Oct-2021, the patient experienced INFLUENZA (Felt like having the flu for a couple of days). In October 2021, the patient experienced CONDITION AGGRAVATED (It's getting worse each day) and MOBILITY DECREASED (To the point she cannot even lift her arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-Oct-2021, INFLUENZA (Felt like having the flu for a couple of days) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was hurting the day), CONDITION AGGRAVATED (It's getting worse each day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot) and MOBILITY DECREASED (To the point she cannot even lift her arm) had not resolved and PYREXIA (Fever) outcome was unknown.            Concomitant products included blood pressure medication for an unknown indication and inhaler for autoimmune system disease.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: Arm was hurting the day; Lots of discomfort in the arm where she received the shot; Felt like having the flu for a couple of days; Fever; To the point she cannot even lift her arm; It's getting worse each day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting the day), CONDITION AGGRAVATED (It's getting worse each day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot), MOBILITY DECREASED (To the point she cannot even lift her arm) and INFLUENZA (Felt like having the flu for a couple of days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 01FE21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting the day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot) and PYREXIA (Fever). 11-Oct-2021, the patient experienced INFLUENZA (Felt like having the flu for a couple of days). In October 2021, the patient experienced CONDITION AGGRAVATED (It's getting worse each day) and MOBILITY DECREASED (To the point she cannot even lift her arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-Oct-2021, INFLUENZA (Felt like having the flu for a couple of days) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was hurting the day), CONDITION AGGRAVATED (It's getting worse each day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot) and MOBILITY DECREASED (To the point she cannot even lift her arm) had not resolved and PYREXIA (Fever) outcome was unknown.            Concomitant products included blood pressure medication for an unknown indication and inhaler for autoimmune system disease.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. The patient is not immunocompromised.   This case was linked to MOD-2021-363403, MOD-2021-363338 (Patient Link).
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received the first dose of the J&J vaccine as first dose,received a booster dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received the first dose of the J&J vaccine as first dose,received a booster dose of Moderna) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F211A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 22-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received the first dose of the J&J vaccine as first dose,received a booster dose of Moderna). On 22-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Received the first dose of the J&J vaccine as first dose,received a booster dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient received the first dose of the J&J vaccine as first dose, Lot: 1805029, received on 13March2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: had a 24 hours reaction to the second dose; rundown; tired; low grade fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), MALAISE (rundown), FATIGUE (tired), PYREXIA (low grade fever) and MYALGIA (body aches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 012L20A and 017F21A/012F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), MALAISE (rundown), FATIGUE (tired), PYREXIA (low grade fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 03-Mar-2021, VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), MALAISE (rundown), FATIGUE (tired), PYREXIA (low grade fever) and MYALGIA (body aches) had resolved.            Concomitant medication includes high blood pressure medication.   This case was linked to MOD-2021-363444, MOD-2021-363015 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Local soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Local soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (PCN-Pain meds), Depression and Hypothyroidism. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) from 02-Jan-2012 to an unknown date for Depression, THYROID for Hypothyroidism.   On 14-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. In February 2021, the patient experienced MYALGIA (Local soreness). At the time of the report, MYALGIA (Local soreness) outcome was unknown.            No treatments information was provided.   This case was linked to MOD-2021-363387, MOD-2021-305281 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tremor in her leg/tremors felt above the knee; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremor in her leg/tremors felt above the knee) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. In March 2021, the patient experienced TREMOR (Tremor in her leg/tremors felt above the knee). The patient was treated with GABAPENTIN for Adverse event, at a dose of 100 milligram once a day. At the time of the report, TREMOR (Tremor in her leg/tremors felt above the knee) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The patient stated after 2-3 weeks after getting the vaccine, started experiencing tremor in her leg, tremors felt above the knee, felt like it was a poison.   This case was linked to MOD-2021-363548 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of BONE PAIN (Deep long bone pain/His long bones were extraordinarily painful), CHILLS (Shaking chills) and PYREXIA (Fever of 101 F) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 041L20A and 025J2-02A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced BONE PAIN (Deep long bone pain/His long bones were extraordinarily painful), CHILLS (Shaking chills) and PYREXIA (Fever of 101 F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Deep long bone pain/His long bones were extraordinarily painful), CHILLS (Shaking chills) and PYREXIA (Fever of 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101 (High) 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Patient received half dose booster shot.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Underdose, Vaccination site haemorrhage
Clinical narrative: bleeding at the injection site; he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster; The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), UNDERDOSE (he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster) and EXTRA DOSE ADMINISTERED (The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), UNDERDOSE (he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster) and EXTRA DOSE ADMINISTERED (The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm). On 25-Oct-2021, EXTRA DOSE ADMINISTERED (The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding at the injection site) and UNDERDOSE (he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was not immunocompromised.   Concomitant medication of the patient was not reported.  The reporter mentioned that it was at least six months following the first two doses of the Moderna COVID-19 vaccine of the patient (the exact dates not available at this time).   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received on 26-OCT-2021. New events, patient details and vaccination details were added. Event description was updated.