chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: Swollen lymph nodes under the arm; Breast cancer; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (Breast cancer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 026A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromuscular dysplasia (Arterial dissection) since January 2013 and Migraine. Concomitant products included WARFARIN for Fibromuscular dysplasia, UBROGEPANT (UBRELVY) for Migraine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 05-Aug-2021, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes under the arm). The patient was treated with Radiotherapy (2 lumpectomies, 21 days radiation) for Breast cancer. In April 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, BREAST CANCER (Breast cancer) and LYMPHADENOPATHY (Swollen lymph nodes under the arm) outcome was unknown.            Patient experienced flu-like symptoms which got recovered after a day or so and she proceeded with living life with no after effects of the vaccine.  Company comment: This spontaneous case reported by consumer concerns a 65-year-old female patient with no relevant medical history who experienced the unexpected serious (medically significant) event of Breast cancer which occurred approximately 4 months after the second dose of mRNA-1273 Vaccine. The patient was treated with Radiotherapy and 2 lumpectomies. Elderly age remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-639559 (Patient Link).; Sender's Comments: This spontaneous case reported by consumer concerns a 65-year-old female patient with no relevant medical history who experienced the unexpected serious (medically significant) event of Breast cancer which occurred approximately 4 months after the second dose of mRNA-1273 Vaccine. The patient was treated with Radiotherapy and 2 lumpectomies. Elderly age remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast cancer, Influenza like illness, Lymphadenopathy
Clinical narrative: Swollen lymph nodes under the arm; Breast cancer; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (Breast cancer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 026A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromuscular dysplasia (Arterial dissection) since January 2013 and Migraine. Concomitant products included WARFARIN for Fibromuscular dysplasia, UBROGEPANT (UBRELVY) for Migraine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 05-Aug-2021, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes under the arm). The patient was treated with Radiotherapy (2 lumpectomies, 21 days radiation) for Breast cancer. In April 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, BREAST CANCER (Breast cancer) and LYMPHADENOPATHY (Swollen lymph nodes under the arm) outcome was unknown.            Patient experienced flu-like symptoms which got recovered after a day or so and she proceeded with living life with no after effects of the vaccine.  Company comment: This spontaneous case reported by consumer concerns a 65-year-old female patient with no relevant medical history who experienced the unexpected serious (medically significant) event of Breast cancer which occurred approximately 4 months after the second dose of mRNA-1273 Vaccine. The patient was treated with Radiotherapy and 2 lumpectomies. Elderly age remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-639559 (Patient Link).; Sender's Comments: This spontaneous case reported by consumer concerns a 65-year-old female patient with no relevant medical history who experienced the unexpected serious (medically significant) event of Breast cancer which occurred approximately 4 months after the second dose of mRNA-1273 Vaccine. The patient was treated with Radiotherapy and 2 lumpectomies. Elderly age remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: sensitive to I guess you would say supernatural events, after I received your shot, and it went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (sensitive to I guess you would say supernatural events, after I received your shot, and it went away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (sensitive to I guess you would say supernatural events, after I received your shot, and it went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (sensitive to I guess you would say supernatural events, after I received your shot, and it went away) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient was very sensitive to supernatural events. After the patient received Moderna shot about a year prior to the date of this report, it went away, which was great. It was not schizophrenia. The patient was ready for any testing which would really help a lot of people.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Accidentally administered vaccines to patients after the temperature excursion occurred; No adverse event; Accidentally administered vaccines to patients after the temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2022 at 2:29 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2022 at 2:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred) and POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred).    No concomitant medication were provided.  It was reported that the temperature logger did not indicate correct temperature. The product was Covid-19 vaccine, orange cap for kids 5 to 11, maroon cap for 6 months to 4 years and gray cap. It was reported that the temperature was not recorded on the logger from 1:45PM until 9PM till yesterday, 31-Aug-2022 and one patient had received one of the vaccines. Later Clarified that vaccine that was administered was the Moderna vaccine not Pfizer. The Pfizer vaccines with orange cap for kids 5 to 11, maroon cap for 6 months to 4 years and gray cap were all involved but were not administered to patients. All those vaccines were located in the same refrigerator.   No treatment details were provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported.   Company comment-This spontaneous case concerns a female patient aged 28 years with no medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred on an unknown date in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination dates nor event onset date was disclosed. Patient had received initial two doses and a booster dose of same vaccine on unknown dates. No further information on risk factors, detailed clinical course, investigations, treatment received was available in the report. Patient took Paxlovid as treatment. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient aged 28 years with no medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred on an unknown date in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination dates nor event onset date was disclosed. Patient had received initial two doses and a booster dose of same vaccine on unknown dates. No further information on risk factors, detailed clinical course, investigations, treatment received was available in the report. Patient took Paxlovid as treatment. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: side effects too awful/terrible side effects; they were sick for two days; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (they were sick for two days) and FEELING ABNORMAL (side effects too awful/terrible side effects) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (they were sick for two days) and FEELING ABNORMAL (side effects too awful/terrible side effects). At the time of the report, ILLNESS (they were sick for two days) had resolved and FEELING ABNORMAL (side effects too awful/terrible side effects) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient received Moderna booster dose.  It was reported that side effects too awful and they would not get another one.   It was reported that side effects are just too much when they received the moderna booster shot.   Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The booster didn't stop me from getting Omicron; Lack of efficacy; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (The booster didn't stop me from getting Omicron) and DRUG INEFFECTIVE (Lack of efficacy) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (The booster didn't stop me from getting Omicron) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (The booster didn't stop me from getting Omicron) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. A survey respondent participated in a qualitative survey. In response to a survey question, respondent stated that the booster didn't stop patient from getting Omicron. It was unknown if the event caused the patient to seek medical care. No treatment drugs were reported. Company comment: This spontaneous case concerns a female patient with unspecified age, with no reported medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (that the booster didn't stop me from getting Omicron) that occurred in context to a dose of mRNA-1273.222 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding medical history and concomitant medication received and treatment details. The event outcome was unknown. Ongoing Covid 19 pandemic could be considered as confounder to the event.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient with unspecified age, with no reported medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (that the booster didn't stop me from getting Omicron) that occurred in context to a dose of mRNA-1273.222 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding medical history and concomitant medication received and treatment details. The event outcome was unknown. Ongoing Covid 19 pandemic could be considered as confounder to the event.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: experienced an adverse reaction (no clarification); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (experienced an adverse reaction (no clarification)) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (experienced an adverse reaction (no clarification)). At the time of the report, IMMUNISATION REACTION (experienced an adverse reaction (no clarification)) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Had an immediate and severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Had an immediate and severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ALLERGY TO VACCINE (Had an immediate and severe allergic reaction). In 2021, ALLERGY TO VACCINE (Had an immediate and severe allergic reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient started treatment of the moderna vaccine a year and a half ago. It was reported that patient had an immediate and severe allergic reaction after Moderna shot and suffered for 2 months. No treatment medications were reported.
Age: 20.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Anaemia, Infusion related hypersensitivity reaction, Psychomotor hyperactivity, Swelling face
Clinical narrative: Made patient hyper; reaction to first infusion for anaemia; Anaemia; A puffy face; Hair thinning; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Made patient hyper), INFUSION RELATED HYPERSENSITIVITY REACTION (reaction to first infusion for anaemia), ANAEMIA (Anaemia), SWELLING FACE (A puffy face) and ALOPECIA (Hair thinning) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Made patient hyper), INFUSION RELATED HYPERSENSITIVITY REACTION (reaction to first infusion for anaemia), ANAEMIA (Anaemia), SWELLING FACE (A puffy face) and ALOPECIA (Hair thinning). At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Made patient hyper), INFUSION RELATED HYPERSENSITIVITY REACTION (reaction to first infusion for anaemia), ANAEMIA (Anaemia) and SWELLING FACE (A puffy face) outcome was unknown and ALOPECIA (Hair thinning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Made patient hyper, reaction to first infusion for anaemia, Anaemia, A puffy face was unknown and Hair thinning was not provided. No treatment details were provided
Sex: M
Vaccine: COVID19, FLUX, UNK
Symptoms: Fatigue, Influenza like illness, Vaccination complication
Clinical narrative: Flu like symptoms; Reactions from flu vaccines; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Reactions from flu vaccines) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Crohn's disease (moderate to severe adult).   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (CF) and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Reactions from flu vaccines) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Reactions from flu vaccines) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication was reported. The primary reporter did not have the lot number information, because the packaging was discarded. It was reported that the patient had an adalimumab (solution for injection in pre-filled pen). It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the events of tired, reactions from flu vaccines and flu like symptoms was not provided with adalimumab (Humira). The reporter causality for the events of tired and flu like symptoms was not provided and probable with event of reactions from flu vaccines with influenza vaccine. No treatment information was reported.
Age: 35.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Covid vaccine issue/fatigue; Sore arm; Redness at injection site; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Covid vaccine issue/fatigue), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concurrent medical conditions included Panuveitis (non-infectious intermediate, posterior and panuveitis).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced FATIGUE (Covid vaccine issue/fatigue), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site). At the time of the report, FATIGUE (Covid vaccine issue/fatigue), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown.     No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 02-Jul-2022, patient took booster dose.  The reporter causality of events with Humira was not provided. No treatment drugs were reported.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am; No adverse event; Vaccine dose given outside the 12hr post puncture time.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.), PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am) and NO ADVERSE EVENT (No adverse event) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies or had any medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient was ever tested positive for COVID-19 or had diagnosis.     On 02-Sep-2022 at 9:42 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Sep-2022 at 9:42 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.), PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.) and PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am).    Concomitant drugs were not reported. It was reported that the patient received full dose. The 1 dose vial was stored in refrigerator post puncture and  was unknown when the vial was initially stored in refrigerator.  The vial was exposed to room temperature for less than an hour and did not undergo any temperature excursion. It was unknown if patient ever seek medical care or if experienced a similar event in the past. Unknown if the symptoms were improved or worsened. Treatment medications were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan, Vaccination site pain
Clinical narrative: lymphadenopathy on neck,Neck lymphadenopathy with measurements of: 9, 8 and 6 mm,Axillary lymphadenopathy with measures 25, 10, 2mm. 2.9,upper left arm lymphadenopathy with measures 2.3,swelling lump in her neck,left external axilla area and 2 other; Felt a lot of pain after receiving the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Felt a lot of pain after receiving the Moderna Covid 19 vaccine) and LYMPHADENOPATHY (lymphadenopathy on neck,Neck lymphadenopathy with measurements of: 9, 8 and 6 mm,Axillary lymphadenopathy with measures 25, 10, 2mm. 2.9,upper left arm lymphadenopathy with measures 2.3,swelling lump in her neck,left external axilla area and 2 other) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 059E21A) for COVID-19 vaccination.     Patient had no allergies.  Patient had never tested positive for COVID.  Concomitant products included LOSARTAN and AMLODIPINE BESILATE for an unknown indication.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Felt a lot of pain after receiving the Moderna Covid 19 vaccine). On 09-Sep-2021, the patient experienced LYMPHADENOPATHY (lymphadenopathy on neck,Neck lymphadenopathy with measurements of: 9, 8 and 6 mm,Axillary lymphadenopathy with measures 25, 10, 2mm. 2.9,upper left arm lymphadenopathy with measures 2.3,swelling lump in her neck,left external axilla area and 2 other). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Felt a lot of pain after receiving the Moderna Covid 19 vaccine) and LYMPHADENOPATHY (lymphadenopathy on neck,Neck lymphadenopathy with measurements of: 9, 8 and 6 mm,Axillary lymphadenopathy with measures 25, 10, 2mm. 2.9,upper left arm lymphadenopathy with measures 2.3,swelling lump in her neck,left external axilla area and 2 other) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Ultrasound scan: found the lymphadenopathy with measurements of: 9, 8 and 6 mm.. On 28-Jan-2022, Ultrasound scan: found a left axillary lymphadenopathy with the measures 25, 10, 2mm. In July 2022, Ultrasound scan: found an upper left arm lymphadenopathy with measures 2.3, 1.2 and 0,6 centimeters and another one of 2.9, 1.6 and 0.6 centimeters.         The patient informed that doctor said she needs surgery, but she did not understand why, she stated she had not gotten any explanation.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Inflammatory marker test, Nail pitting, Onycholysis
Clinical narrative: Inflammatory marker increased; JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS; JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), NAIL PITTING (JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS) and ONYCHOLYSIS (JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Joint pain (7 years) from 01-Jan-2010 to 01-Jan-2017. Concurrent medical conditions included Penicillin allergy and Psoriatic arthritis.   In 2010, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), NAIL PITTING (JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS) and ONYCHOLYSIS (JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS). At the time of the report, INFLAMMATORY MARKER INCREASED (Inflammatory marker increased) had not resolved and NAIL PITTING (JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS) and ONYCHOLYSIS (JOINT PAIN IN MANY AREAS SUCH AS FINGERNAILS/PITTING AND SEPARATION FROM NAIL BED, SHOULDERS, ELBOWS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Inflammatory marker test: Inflammatory marker increased.         No concomitant medication was provided  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   From 01-Jan-2010 to 01-Jan-201, the patient had joint pain in many areas such as fingernails/pitting and separation from nail bed, shoulders, elbows.  The reporter's causality for the event(s) of inflammation level increased and joint pain onset 01-Jan-2010 with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the nail pitting and Onycholysis was not provided.  No treatment details were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation, Cough, Fatigue, Gait disturbance
Clinical narrative: cough that never gone away; sore throat that never gone away; glassy eyes; she has felt ill ever since; she can barely walk; fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week; fatigue; nausea; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since) and GAIT DISTURBANCE (she can barely walk) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number- EN5318, Route of administration- Intramuscular) on 28-Jan-2021, Pfizer (Dose 2, Lot number-  IL9266) on 19-Feb-2021 and FLU [INFLUENZA VACCINE] (7 years ago had similar reaction.). Past adverse reactions to the above products included Adverse reaction with FLU [INFLUENZA VACCINE]; and Sickness with PFIZER BIONTECH COVID-19 VACCINE and Pfizer.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since), GAIT DISTURBANCE (she can barely walk), PYREXIA (fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since), GAIT DISTURBANCE (she can barely walk), PYREXIA (fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 103 degree F for 24 hours and 101 degree F for 2 days. In October 2021, Body temperature fluctuation: Low fluctuation 3 times a week.         Concomitant products were not reported.  Patient neither diagnosed nor tested positive for COVID-19 test. Patient did not have a history of acute and chronic illness at the time of vaccination. No other vaccines was taken within 1 month prior to Moderna COVID-19 vaccine. The event did not cause the patient to seek medical care. It was reported that approximately 112 hours after receiving first booster patient experienced fever. All the symptoms come and go, still ongoing.  No treatment had been taken.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Glassy eyes, Malaise, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: cough that never gone away; sore throat that never gone away; glassy eyes; she has felt ill ever since; she can barely walk; fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week; fatigue; nausea; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since) and GAIT DISTURBANCE (she can barely walk) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number- EN5318, Route of administration- Intramuscular) on 28-Jan-2021, Pfizer (Dose 2, Lot number-  IL9266) on 19-Feb-2021 and FLU [INFLUENZA VACCINE] (7 years ago had similar reaction.). Past adverse reactions to the above products included Adverse reaction with FLU [INFLUENZA VACCINE]; and Sickness with PFIZER BIONTECH COVID-19 VACCINE and Pfizer.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since), GAIT DISTURBANCE (she can barely walk), PYREXIA (fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since), GAIT DISTURBANCE (she can barely walk), PYREXIA (fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 103 degree F for 24 hours and 101 degree F for 2 days. In October 2021, Body temperature fluctuation: Low fluctuation 3 times a week.         Concomitant products were not reported.  Patient neither diagnosed nor tested positive for COVID-19 test. Patient did not have a history of acute and chronic illness at the time of vaccination. No other vaccines was taken within 1 month prior to Moderna COVID-19 vaccine. The event did not cause the patient to seek medical care. It was reported that approximately 112 hours after receiving first booster patient experienced fever. All the symptoms come and go, still ongoing.  No treatment had been taken.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (allergic to some medications as well). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm). In March 2021, FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm) had resolved. The concomitant medication was not reported by reporter. Patient said that patient was on medications for certain pre-existing conditions. Patient said that patient had a tiny bit of sore arm and a little tiredness that lasted no more than 2-5 days after receiving the 2nd dose of the Moderna COVID-19 vaccine. No treatment information was reported. This case was linked to MOD-2022-640751 (Patient Link). Reporter did not allow further contact.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (allergic to some medications as well). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm). In March 2021, FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm) had resolved. The concomitant medication was not reported by reporter. Patient said that patient was on medications for certain pre-existing conditions. Patient said that patient had a tiny bit of sore arm and a little tiredness that lasted no more than 2-5 days after receiving the 2nd dose of the Moderna COVID-19 vaccine. No treatment information was reported. This case was linked to MOD-2022-640751 (Patient Link). Reporter did not allow further contact.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a little more tiredness after one of the boosters; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little more tiredness after one of the boosters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 046B21A, 026A21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to some medications as well).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced FATIGUE (a little more tiredness after one of the boosters). In 2022, FATIGUE (a little more tiredness after one of the boosters) had resolved.    Patient said that patient was on medications for certain pre-existing conditions. Patient also had a little more tiredness after receiving one of the booster doses, possibly the 2nd one. Patient did not remember which booster dose patient experienced this reaction with. Patient said that tiredness lasted for several days after receiving one of the booster doses. Patient , said that these were all expected reactions and Patient didn't even think this needed to be reported. No treatment information was reported. This case was linked to MOD-2022-640736 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: a little more tiredness after one of the boosters; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little more tiredness after one of the boosters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 046B21A, 026A21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to some medications as well).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced FATIGUE (a little more tiredness after one of the boosters). In 2022, FATIGUE (a little more tiredness after one of the boosters) had resolved.    Patient said that patient was on medications for certain pre-existing conditions. Patient also had a little more tiredness after receiving one of the booster doses, possibly the 2nd one. Patient did not remember which booster dose patient experienced this reaction with. Patient said that tiredness lasted for several days after receiving one of the booster doses. Patient , said that these were all expected reactions and Patient didn't even think this needed to be reported. No treatment information was reported. This case was linked to MOD-2022-640736 (Patient Link).   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. There was no reported medical history. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE). At the time of the report, IMMUNISATION REACTION (SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE) outcome was unknown.   Concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.