chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: very hot; really sick; red; arm is still swollen; itching; chills/freezing; horrible body aches on legs; pretty high fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), ILLNESS (really sick), PERIPHERAL SWELLING (arm is still swollen), PRURITUS (itching) and CHILLS (chills/freezing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 95?905, 010M20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING HOT (very hot), ILLNESS (really sick), PERIPHERAL SWELLING (arm is still swollen), PRURITUS (itching), CHILLS (chills/freezing), MYALGIA (horrible body aches on legs), PYREXIA (pretty high fever) and ERYTHEMA (red). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (very hot), ILLNESS (really sick), PRURITUS (itching), CHILLS (chills/freezing), MYALGIA (horrible body aches on legs), PYREXIA (pretty high fever) and ERYTHEMA (red) outcome was unknown and PERIPHERAL SWELLING (arm is still swollen) had not resolved.            no concomitant medications are provided by the reporter. Patient took Advil and it did not bring the fever down and Tylenol.   This case was linked to MOD-2021-375561 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: HCP really shook and administered the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ERROR (HCP really shook and administered the vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (HCP really shook and administered the vaccine). At the time of the report, PRODUCT PREPARATION ERROR (HCP really shook and administered the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 99 F after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 99 F after 2nd shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever 99 F after 2nd shot). On 20-Apr-2021, PYREXIA (Fever 99 F after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Body temperature: 99 (High) Fever 99 F after 2nd shot.         No Concomitant product use was reported. No treatment information was provided.  After the second dose, the patient's temperature went up to a maximum of 99F and he did not had a fever.   This case was linked to MOD-2021-375559, MOD-2021-374581 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: received an expired vaccine; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) and VACCINATION SITE PAIN (sore arm) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) and VACCINATION SITE PAIN (sore arm). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) had resolved. On 27-Oct-2021, VACCINATION SITE PAIN (sore arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   No Treatment information was reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Body aches; fever; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu (Route was Intramuscular and Injection site was Left deltoid and the lot number was 52772.) on 19-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu.    On 26-Oct-2021 at 1:08 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021 at 1:08 AM, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-2021, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. It was reported that no treatment was needed for the patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm is very, very sore now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm is very, very sore now) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION SITE PAIN (My arm is very, very sore now). At the time of the report, VACCINATION SITE PAIN (My arm is very, very sore now) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: their heartrate increases due to the vaccine; 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 HEART RATE INCREASED (their heartrate increases due to the vaccine) 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 HEART RATE INCREASED (their heartrate increases due to the vaccine). At the time of the report, HEART RATE INCREASED (their heartrate increases due to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Heart rate was spike on day 2 and usually subsides by day 6.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts.    On 26-Oct-2021 at 11:08 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021 at 11:08 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021 at 11:08 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was stated that, the patient never diagnosed with or tested positive for COVID-19. She did not have any acute illness at the time of vaccination and up to one month before. She also did not have any chronic or long-standing health conditions. She had not taken any prescription, over-the-counter medications, dietary supplement or herbal remedies at the time of vaccination. She did not experienced the similar event in the past and there was no other potential cause to the event.  Patient did not receive any treatment for the event No concomitant medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm hurts and is very unbearable; hard to drive; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts and is very unbearable) and MOBILITY DECREASED (hard to drive) 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 PAIN IN EXTREMITY (arm hurts and is very unbearable) and MOBILITY DECREASED (hard to drive). At the time of the report, PAIN IN EXTREMITY (arm hurts and is very unbearable) and MOBILITY DECREASED (hard to drive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient complained about still having side effects from the Moderna vaccine and wanted to be involved in the program for compensation.  No concomitant medications were reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: Chest pain; Difficulty breathing; Diarrhea; Headache; very tired and lost not knowing what to do; feeling very sick; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), ILLNESS (feeling very sick) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0409D8A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure abnormal.   On 03-Nov-2021 at 2:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (feeling very sick). 2021, the patient experienced FATIGUE (very tired and lost not knowing what to do). On 03-Nov-2021 at 7:00 AM, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), ILLNESS (feeling very sick), HEADACHE (Headache) and FATIGUE (very tired and lost not knowing what to do) had not resolved.            No treatment medication has been provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Chest pain; Difficulty breathing; Diarrhea; Headache; very tired and lost not knowing what to do; feeling very sick; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), ILLNESS (feeling very sick) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0409D8A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure abnormal.   On 03-Nov-2021 at 2:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (feeling very sick). 2021, the patient experienced FATIGUE (very tired and lost not knowing what to do). On 03-Nov-2021 at 7:00 AM, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), ILLNESS (feeling very sick), HEADACHE (Headache) and FATIGUE (very tired and lost not knowing what to do) had not resolved.            No treatment medication has been provided.
Sex: U
Vaccine: COVID19
Symptoms: Carditis, Loss of consciousness, Renal disorder, Thrombosis
Clinical narrative: passed out; blood clots; heart inflammation; kidney troubles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots) and CARDITIS (heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), THROMBOSIS (blood clots) (seriousness criterion medically significant), CARDITIS (heart inflammation) (seriousness criterion medically significant) and RENAL DISORDER (kidney troubles). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots), CARDITIS (heart inflammation) and RENAL DISORDER (kidney troubles) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported. No lab data reported.   This case was linked to MOD-2021-376600 (Patient Link).; Sender's Comments: This case concerns patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected serious events of loss of consciousness, thrombosis (AESI) and carditis. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the second dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Multiple excursions that have occurred; Multiple excursions that have occurred; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Multiple excursions that have occurred) and POOR QUALITY PRODUCT ADMINISTERED (Multiple excursions that have occurred) 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 PRODUCT STORAGE ERROR (Multiple excursions that have occurred) and POOR QUALITY PRODUCT ADMINISTERED (Multiple excursions that have occurred). At the time of the report, PRODUCT STORAGE ERROR (Multiple excursions that have occurred) and POOR QUALITY PRODUCT ADMINISTERED (Multiple excursions that have occurred) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not specified
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Arthralgia, Pyrexia
Clinical narrative: joint pains,joint aches; Patient had a mild Fever; patient received his primary series of  the Pfizer Covid-19 vaccine/I received my Moderna full dose vaccine for my third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (patient received his primary series of  the Pfizer Covid-19 vaccine/I received my Moderna full dose vaccine for my third dose), ARTHRALGIA (joint pains,joint aches) and PYREXIA (Patient had a mild Fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (First Pfizer vaccination) on 02-Apr-2021 and Pfizer COVID-19 vaccine (second Pfizer dose) on 23-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concurrent medical conditions included Cancer. Concomitant products included RITUXIMAB (RITUXAN) for an unknown indication.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (patient received his primary series of  the Pfizer Covid-19 vaccine/I received my Moderna full dose vaccine for my third dose). On an unknown date, the patient experienced ARTHRALGIA (joint pains,joint aches) and PYREXIA (Patient had a mild Fever). On 08-Oct-2021, ACCIDENTAL OVERDOSE (patient received his primary series of  the Pfizer Covid-19 vaccine/I received my Moderna full dose vaccine for my third dose) had resolved. At the time of the report, ARTHRALGIA (joint pains,joint aches) and PYREXIA (Patient had a mild Fever) outcome was unknown.            No treatment medications were reported.  Patient were reported as he is a cancer patient and taken a medication called Rituxan. Patient received the Pfizer vaccine for my first two doses of Covid-19 vaccine. Patient did not received any antibodies after the Pfizer vaccination series. No adverse events were reported for after Pfizer vaccination.   Patient were reported that received Moderna full dose vaccine for third dose and patient did develop antibodies after receiving the Moderna Covid-19 vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered after published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after published expiry date) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after published expiry date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (dose administered after published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took first dose with no side effects were reported. No concomitant and treatment information were reported by the reporter
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Vaccination complication
Clinical narrative: Dose was not stored at the manufacturers recommended temperature; Minor side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor side effects) and PRODUCT STORAGE ERROR (Dose was not stored at the manufacturers recommended temperature) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   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) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Dose was not stored at the manufacturers recommended temperature). In April 2021, the patient experienced VACCINATION COMPLICATION (Minor side effects). On 12-Apr-2021, PRODUCT STORAGE ERROR (Dose was not stored at the manufacturers recommended temperature) had resolved. At the time of the report, VACCINATION COMPLICATION (Minor side effects) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that she was told that it would be her choice whether to get a third dose or not. Therefore, she did not get the third dose and was now being told she was technically not vaccinated (she was a (Privacy) worker and needs to be fully vaccinated).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After the 1st dose she was tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (After the 1st dose she was tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had Covid in March of 2020, loss smell & taste, had a fever, and aches & pains) in March 2020. Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (After the 1st dose she was tired). At the time of the report, FATIGUE (After the 1st dose she was tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-375104, MOD-2021-375073 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: dizziness/she feels tired around 4:00 pm; Her energy level continued to feel low; little more tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, ASTHENIA, and FATIGUE in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS, ASTHENIA, and FATIGUE. At the time of the report, DIZZINESS, ASTHENIA, and FATIGUE outcome was unknown.            No concomitant medication was reported. Treatment include extra D supplements   This case was linked to MOD-2021-376428, MOD-2021-376700 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021 at 10:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Patient received the booster dose, where error dose administered with expired vials. although there was no adverse event reported.  later the facility requested the patient to receive re-dose of Moderna with an unexpired vials.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the Moderna booster and was by error administered a dose from an expired vial (Lot 038C21A). Patient did not have an adverse reaction that was noted. Reporter notified and asked them  to return to receive a re-dosing of the Moderna booster with an un expired vial(Lot 037C21A) , per our supervisors instructions.  No concomitant medications were reported. No treatment information were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: By error administered a dose from an Expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (By error administered a dose from an Expired vial) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (By error administered a dose from an Expired vial). On 28-Oct-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (By error administered a dose from an Expired vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medication was provided.  Client came to receive their Moderna booster and was by error administered a dose from an expired vial Lot number: 038C21A. Client did not have any adverse reaction. They had notified the client and asked them to return to receive a re-dosing of their Moderna booster with an unexpired vial with Lot number: 037C21A as per their supervision instructions. All questions and concerns were discussed with the client.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccination center attempted to notify the client and asked them to receive a re-dosing of their Moderna booster with an unexpired vial (037C21A) but they were unable to het through the client and a message was left on their phone.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. client asked them to return for redosing with unexpired vial lot 037C21A. Noted
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster dose was administered by error from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose was administered by error from expired vial) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose was administered by error from expired vial). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose was administered by error from expired vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknow if the patient was diagnosed with or tested positive for COVID-19. It was also unknown if she had any acute illness at the time of vaccination and up to one month before or any chronic or long-standing health conditions. It was also unknown if she had taken any prescription, over-the-counter medications, dietary supplement or herbal remedies at the time of vaccination.  It was stated that, she had come in to receive her Moderna booster dose and was by error administered a dose from expired vial. She did not have any adverse reaction that was noted. She was notified and told what happed. She was informed that team would be in touch with further instructions once a final decision was made on whether or not to redose, per the supervisors instructions.   No concomitant medication reported. No treatment information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, VITAMIN D, VITAMIN E, VITAMIN C, and ASPIRIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN. The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Headache, Nasal congestion
Clinical narrative: L arm where I had received the booster shot was sore; mentally spacey; Nasal congestion; Woke up in the middle of the night and I was chilled; strong headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (L arm where I had received the booster shot was sore), CONFUSIONAL STATE (mentally spacey), NASAL CONGESTION (Nasal congestion), CHILLS (Woke up in the middle of the night and I was chilled) and HEADACHE (strong headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Darvocet).    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (L arm where I had received the booster shot was sore), CONFUSIONAL STATE (mentally spacey), NASAL CONGESTION (Nasal congestion), CHILLS (Woke up in the middle of the night and I was chilled), HEADACHE (strong headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (L arm where I had received the booster shot was sore), NASAL CONGESTION (Nasal congestion) and CHILLS (Woke up in the middle of the night and I was chilled) outcome was unknown, CONFUSIONAL STATE (mentally spacey) and FATIGUE (fatigue) had not resolved and HEADACHE (strong headache) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-329230 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: L arm where I had received the booster shot was sore; mentally spacey; Nasal congestion; Woke up in the middle of the night and I was chilled; strong headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (L arm where I had received the booster shot was sore), CONFUSIONAL STATE (mentally spacey), NASAL CONGESTION (Nasal congestion), CHILLS (Woke up in the middle of the night and I was chilled) and HEADACHE (strong headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Darvocet).    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (L arm where I had received the booster shot was sore), CONFUSIONAL STATE (mentally spacey), NASAL CONGESTION (Nasal congestion), CHILLS (Woke up in the middle of the night and I was chilled), HEADACHE (strong headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (L arm where I had received the booster shot was sore), NASAL CONGESTION (Nasal congestion) and CHILLS (Woke up in the middle of the night and I was chilled) outcome was unknown, CONFUSIONAL STATE (mentally spacey) and FATIGUE (fatigue) had not resolved and HEADACHE (strong headache) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-329230 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received a booster dose of 0.5ml, a full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5ml, a full dose.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 031M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5ml, a full dose.). On 05-Nov-2021, ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5ml, a full dose.) had resolved.            It was reported that the patient received booster dose because she had some medical issues.  No concomitant medications were reported. No treatment medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: miserable; aching on her joints; headache; chills; fever of 101.2F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 011A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 5:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F). At the time of the report, FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 101.2 (High) 101.2F.         No relevant concomitant medications were reported. Treatment information was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: miserable; aching on her joints; headache; chills; fever of 101.2F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 011A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 5:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F). At the time of the report, FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 101.2 (High) 101.2F.         No relevant concomitant medications were reported. Treatment information was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: light headed; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) and HEADACHE (bad headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received 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 05-Nov-2021, the patient experienced DIZZINESS (light headed) and HEADACHE (bad headache). At the time of the report, DIZZINESS (light headed) and HEADACHE (bad headache) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was unknown.  Caller stated got the booster dose from the Moderna vaccine in the morning along with their spouse. Patient had a bad headache in afternoon for a little while and was light headed.  Patient got the first 2 doses of the Moderna vaccine as well.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue
Clinical narrative: Stomach gurgling; Diarrhea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach gurgling), DIARRHOEA (Diarrhea) and FATIGUE (Tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Heart disease, unspecified.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach gurgling), DIARRHOEA (Diarrhea) and FATIGUE (Tiredness). At the time of the report, ABDOMINAL DISCOMFORT (Stomach gurgling), DIARRHOEA (Diarrhea) and FATIGUE (Tiredness) outcome was unknown.      No concomitant medication were given.  No treatment information were given.   This case was linked to MOD-2021-376900 (Patient Link).