chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left arm went numb and hand went numb for 6 hours.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left arm went numb and hand went numb for 6 hours.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden thrombophilia since 02-May-2017, Homocystinaemia (MTHR blood disorders) and Clot blood (6 blood clots in the past). Concomitant products included APIXABAN (ELIQUIS) from 02-May-2017 to an unknown date for an unknown indication.    On 11-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 9:00 PM, the patient experienced HYPOAESTHESIA (Left arm went numb and hand went numb for 6 hours.). On 12-Mar-2021, HYPOAESTHESIA (Left arm went numb and hand went numb for 6 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-174517 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19) outcome was unknown and DRUG INEFFECTIVE (lack of efficacy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. He also mentions that he just had a Regeneron Infusion  . He wants to know how long he will be contagious for? How long does he have to quarantine?  Company Comment: This a drug ineffective report. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. No further information is expected since there is no consent for safety follow up.; Sender's Comments: This a drug ineffective report. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. No further information is expected since there is no consent for safety follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: My upper arm, where the vaccine was administered yesterday, is red and pretty swollen; is more swollen now than it was earlier; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (My upper arm, where the vaccine was administered yesterday, is red and pretty swollen) and VACCINATION SITE SWELLING (is more swollen now than it was earlier) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (My upper arm, where the vaccine was administered yesterday, is red and pretty swollen) and VACCINATION SITE SWELLING (is more swollen now than it was earlier). At the time of the report, VACCINATION SITE ERYTHEMA (My upper arm, where the vaccine was administered yesterday, is red and pretty swollen) and VACCINATION SITE SWELLING (is more swollen now than it was earlier) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: A week after the 1st dose he had a HSV-2 outbreak; This spontaneous case was reported by a non-health professional and describes the occurrence of HERPES SIMPLEX (A week after the 1st dose he had a HSV-2 outbreak) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     The patient's past medical history included HSV infection.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HERPES SIMPLEX (A week after the 1st dose he had a HSV-2 outbreak). The patient was treated with ACYCLOVIR [ACICLOVIR] for HSV infection, at an unspecified dose and frequency. At the time of the report, HERPES SIMPLEX (A week after the 1st dose he had a HSV-2 outbreak) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The treatment history was not reported. The concomitant medication was not reported. Before getting the vaccine patient used to have 1-2 outbreaks a year and Patients had needed Acyclovir which didn't use before.   This case was linked to MOD-2021-293081 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Myalgia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: A little tired; Arm was sore; COVID-19 positive test; Drug ineffective; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive test), DRUG INEFFECTIVE (Drug ineffective), FATIGUE (A little tired) and MYALGIA (Arm was sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included CLL.   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 20-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive test) and DRUG INEFFECTIVE (Drug ineffective). On an unknown date, the patient experienced FATIGUE (A little tired) and MYALGIA (Arm was sore). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive test), DRUG INEFFECTIVE (Drug ineffective), FATIGUE (A little tired) and MYALGIA (Arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient tested positive for covid after getting two doses of vaccine. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.  Company Comment: Based on the mechanism of action of mRNA-1273, the event COVID-19 Positive test is assessed as not related to mRNA-1273, however, based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event COVID-19 Positive test is assessed as not related to mRNA-1273, however, based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: reactions to the second shot; lymph node swelling; 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 VACCINATION COMPLICATION (reactions to the second shot) and LYMPHADENOPATHY (lymph node swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reactions to the second shot) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, VACCINATION COMPLICATION (reactions to the second shot) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Unevaluable event
Clinical narrative: Patient had non related COVID19 health conditions; not receiving 2nd dose/patient couldn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Patient had non related COVID19 health conditions) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose/patient couldn't receive the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 UNEVALUABLE EVENT (Patient had non related COVID19 health conditions) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose/patient couldn't receive the 2nd dose). At the time of the report, UNEVALUABLE EVENT (Patient had non related COVID19 health conditions) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose/patient couldn't receive the 2nd dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling cold, Hot flush, Insomnia
Clinical narrative: Couldn't eat all day, hot and cold flashes; Hot flash; cold flashes; barely slept last night.; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Couldn't eat all day, hot and cold flashes), HOT FLUSH (Hot flash), FEELING COLD (cold flashes) and INSOMNIA (barely slept last night.) 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 FEEDING DISORDER (Couldn't eat all day, hot and cold flashes), HOT FLUSH (Hot flash), FEELING COLD (cold flashes) and INSOMNIA (barely slept last night.). At the time of the report, FEEDING DISORDER (Couldn't eat all day, hot and cold flashes), HOT FLUSH (Hot flash), FEELING COLD (cold flashes) and INSOMNIA (barely slept last night.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       . No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were pulled from vials that were involved in temperature excursion; Doses were pulled from vials that were involved in temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Doses were pulled from vials that were involved in temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Doses were pulled from vials that were involved in temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Doses were pulled from vials that were involved in temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Doses were pulled from vials that were involved in temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Doses were pulled from vials that were involved in temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Doses were pulled from vials that were involved in temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. On Sep17-2021 our fridge that held one open partial box of MODERNA compressor died, fridge temperature went to a maximum of 57.28 degree's when the MODERNA vaccines were removed and placed in another approved vaccine fridge. Total time of out of temperature range was 2 hours and 15.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Upon follow-up receipt: 2nd dose number added. On 30-Sep-2021: Non Significant follow up
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: injection site pain; headache; body aches - could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), HEADACHE (headache) and MYALGIA (body aches - could barely walk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (injection site pain), HEADACHE (headache) and MYALGIA (body aches - could barely walk). In April 2021, INJECTION SITE PAIN (injection site pain), HEADACHE (headache) and MYALGIA (body aches - could barely walk) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported  No treatment medication was reported   This case was linked to MOD-2021-325840 (Patient Link).   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: little sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (little sick) in a 50-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 first 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. On an unknown date, the patient experienced ILLNESS (little sick). At the time of the report, ILLNESS (little sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-325371 (Patient Link).; Sender's Comments: This case concerns a 50-year-old female patient with no relevant medical history, who experienced the unexpected event of Illness. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The case is initially reported as serious however based on available information and medical judgement, the case is non serious as the outcome of the event is not hospitalization.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyskinesia, Dysstasia, Gait disturbance
Clinical narrative: Jerking/started jerking all over; could not stand; Legs felt like rubber bands.  No strength; Chills; Very, very bad headache; Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk; Legs just buckled/legs felt like rubber bands; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), DYSKINESIA (Jerking/started jerking all over), CHILLS (Chills) and HEADACHE (Very, very bad headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LISINOPRIL, ATENOLOL, ATORVASTATIN, FISH OIL and CALCIUM for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), CHILLS (Chills) and HEADACHE (Very, very bad headache). On 15-May-2021, the patient experienced DYSKINESIA (Jerking/started jerking all over). 15-May-2021, the patient experienced DYSSTASIA (could not stand) and ASTHENIA (Legs felt like rubber bands.  No strength). On 15-May-2021, DYSKINESIA (Jerking/started jerking all over) had resolved. On 16-May-2021, GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), CHILLS (Chills), HEADACHE (Very, very bad headache), DYSSTASIA (could not stand) and ASTHENIA (Legs felt like rubber bands.  No strength) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-325697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up was received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: Jerking/started jerking all over; could not stand; Legs felt like rubber bands.  No strength; Chills; Very, very bad headache; Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk; Legs just buckled/legs felt like rubber bands; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), DYSKINESIA (Jerking/started jerking all over), CHILLS (Chills) and HEADACHE (Very, very bad headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LISINOPRIL, ATENOLOL, ATORVASTATIN, FISH OIL and CALCIUM for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), CHILLS (Chills) and HEADACHE (Very, very bad headache). On 15-May-2021, the patient experienced DYSKINESIA (Jerking/started jerking all over). 15-May-2021, the patient experienced DYSSTASIA (could not stand) and ASTHENIA (Legs felt like rubber bands.  No strength). On 15-May-2021, DYSKINESIA (Jerking/started jerking all over) had resolved. On 16-May-2021, GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), CHILLS (Chills), HEADACHE (Very, very bad headache), DYSSTASIA (could not stand) and ASTHENIA (Legs felt like rubber bands.  No strength) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-325697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up was received.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered from a vial that was more than 30 days on the fridge; vial that spent more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) and PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge). On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-326226, MOD-2021-326421, MOD-2021-326307, MOD-2021-326468, MOD-2021-326218, MOD-2021-326226, MOD-2021-326383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Patient demographic details, Vaccine facility information and suspected drug ROA was updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Extraskeletal ossification, Myalgia, Myositis, Vaginal haemorrhage
Clinical narrative: Autoimmune disease due to the vaccine; Feminine bleeding; Myositis ossificans; Massive inflammation in her quad muscle.; Very painful in the quad; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disease due to the vaccine), VAGINAL HAEMORRHAGE (Feminine bleeding), MYOSITIS OSSIFICANS (Myositis ossificans), MYOSITIS (Massive inflammation in her quad muscle.) and MYALGIA (Very painful in the quad) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 040A21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN (NEURONTIN), MONTELUKAST SODIUM (SINGULAIR) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disease due to the vaccine), VAGINAL HAEMORRHAGE (Feminine bleeding), MYOSITIS OSSIFICANS (Myositis ossificans), MYOSITIS (Massive inflammation in her quad muscle.) and MYALGIA (Very painful in the quad). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disease due to the vaccine), VAGINAL HAEMORRHAGE (Feminine bleeding), MYOSITIS OSSIFICANS (Myositis ossificans), MYOSITIS (Massive inflammation in her quad muscle.) and MYALGIA (Very painful in the quad) outcome was unknown.            Concomitant medication also included inflammatory drug and Neurontin at night. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.  One of the possible diagnosis was myositis ossificans and it was localized and would go away but would take 46 weeks. The worst version their doctors said was it might be autoimmune disease due to the vaccine and the doctor thinks it was unlikely, but it might be a potentially related. The patient also reported that they had feminine bleeding, which they no longer had at their age. Reportedly, all the symptoms started post 2-3 weeks after getting the vaccine and the two things happened at the same time.; Sender's Comments: This case concerns a 62 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of  Autoimmune disorder. The event occurred an unknown number of days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event of Autoimmune disorder based on medical judgement and review of source document that does not support seriousness criteria.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscular weakness
Clinical narrative: It took all the strength from her leg; major flare up; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (It took all the strength from her leg) and CONDITION AGGRAVATED (major flare up) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced CONDITION AGGRAVATED (major flare up). On 28-Aug-2021, the patient experienced MUSCULAR WEAKNESS (It took all the strength from her leg). At the time of the report, MUSCULAR WEAKNESS (It took all the strength from her leg) and CONDITION AGGRAVATED (major flare up) had resolved. Not Provided          The patient experienced a bad reaction from the Moderna Covid vaccine clarified as a major flare up describe as that morning she could not get out of bed, and it took all the strength from her legs, and she had to crawl out of bed. No concomitant medications information was reported. No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: sore arm for 24 hours after the second dose; experienced for 24 hours chills after the Moderna's second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm for 24 hours after the second dose) and CHILLS (experienced for 24 hours chills after the Moderna's second dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Hypercholesteraemia (No recent change in status of chronic condition) since 08-Jan-2005. Concomitant products included ATORVASTATIN from 08-Jan-2005 to an unknown date for an unknown indication.   On 29-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm for 24 hours after the second dose) and CHILLS (experienced for 24 hours chills after the Moderna's second dose). On 25-Feb-2021, VACCINATION SITE PAIN (sore arm for 24 hours after the second dose) and CHILLS (experienced for 24 hours chills after the Moderna's second dose) had resolved.            No treatment details were reported. Patient did not have any acute illness at the time  of vaccination and up to one month before. Patient was not sure if the flu shot was behaving like a booster, or if it was not fully effective because it might  reacted with the Moderna vaccine, or if the second set of chills from the flu shot means nothing important. patient  received the high dose flu shot Fluzone HD QUAD 2021-22 PFS shot and experienced chills for 4 hours (9pm 21sep21-1am 22sep21), the onset was 12 hours after shot.  also has a little sore arm, vaccine was administered in the wrong part of the arm and it bled a little. He have never in the past had chills after the flu shot (left arm).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up was received and added additional reporter, patient race, ethnicity, height and weight. Patient lab test and current condition was added. Updated  suspect dose time, and added cosuspect as Fluzone and concomitant dose, frequency and start date was updated. Event outcome and intensity was updated for chills after flushot. On 27-Sep-2021: Non-Significant Follow up-Document attachment consists of no new information
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Decreased appetite, Dysphagia, Pyrexia, Sigmoidoscopy
Clinical narrative: Appetite decreased; lost 11 pounds; food does not go down; Little Vomiting, he upchucked; He felt warm like feverish that was only for a couple of hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds), DYSPHAGIA (food does not go down), VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Throat cancer (cancer survivor), Esophageal cancer (cancer survivor) and Pacemaker insertion (cardiac). Concurrent medical conditions included Atrial fibrillation and Hypoglycemia. Concomitant products included LEVOTHYROXINE, APIXABAN (ELIQUIS), METOPROLOL, COLECALCIFEROL (VITAMINE D3), BETACAROTENE (BETA CAROTENE), OMEPRAZOLE, TAMSULOSIN, DIGOXIN, FAMOTIDINE, ACYCLOVIR [ACICLOVIR], ROSUVASTATIN, ERYTHROMYCIN and SUCRALFATE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds), DYSPHAGIA (food does not go down), VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours). At the time of the report, DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds) and DYSPHAGIA (food does not go down) outcome was unknown and VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) no cancer found. On an unknown date, Sigmoidoscopy: normal (normal) no cancer found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included centrum silver, stool softner two per day and iron pill three times a week.  Treatment details was not reported by the reporter.  Reporter stated that doctor suggested for her husband to get tested for Covid   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received contains no new information
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Appetite decreased; lost 11 pounds; food does not go down; Little Vomiting, he upchucked; He felt warm like feverish that was only for a couple of hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds), DYSPHAGIA (food does not go down), VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Throat cancer (cancer survivor), Esophageal cancer (cancer survivor) and Pacemaker insertion (cardiac). Concurrent medical conditions included Atrial fibrillation and Hypoglycemia. Concomitant products included LEVOTHYROXINE, APIXABAN (ELIQUIS), METOPROLOL, COLECALCIFEROL (VITAMINE D3), BETACAROTENE (BETA CAROTENE), OMEPRAZOLE, TAMSULOSIN, DIGOXIN, FAMOTIDINE, ACYCLOVIR [ACICLOVIR], ROSUVASTATIN, ERYTHROMYCIN and SUCRALFATE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds), DYSPHAGIA (food does not go down), VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours). At the time of the report, DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds) and DYSPHAGIA (food does not go down) outcome was unknown and VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) no cancer found. On an unknown date, Sigmoidoscopy: normal (normal) no cancer found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included centrum silver, stool softner two per day and iron pill three times a week.  Treatment details was not reported by the reporter.  Reporter stated that doctor suggested for her husband to get tested for Covid   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received contains no new information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cognitive disorder, Confusional state, Memory impairment, White blood cell count
Clinical narrative: She can't remember what her last name was, she was very removed from the reality of the world.; Confused state after third shot; lost cognitive faculties; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (She can't remember what her last name was, she was very removed from the reality of the world.), CONFUSIONAL STATE (Confused state after third shot) and COGNITIVE DISORDER (lost cognitive faculties) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 030M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Arthritis. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID, CALCIUM, DILTIAZEM, DULOXETINE, GABAPENTIN, LETROZOLE, LEVOTHYROXINE, MODAFINIL, MELATONIN, INSULIN ASPART (NOVOLOG), OLMESARTAN MEDOXOMIL (BENICAR), OMEPRAZOLE, OXYCODONE, INSULIN GLARGINE (TOUJEO), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), LIRAGLUTIDE (VICTOZA), RIVAROXABAN (XARELTO) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced MEMORY IMPAIRMENT (She can't remember what her last name was, she was very removed from the reality of the world.) and CONFUSIONAL STATE (Confused state after third shot). 01-Sep-2021, the patient experienced COGNITIVE DISORDER (lost cognitive faculties). On 01-Sep-2021, MEMORY IMPAIRMENT (She can't remember what her last name was, she was very removed from the reality of the world.), CONFUSIONAL STATE (Confused state after third shot) and COGNITIVE DISORDER (lost cognitive faculties) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood test: normal (normal) normal. In September 2021, White blood cell count: high (High) Slightly high which returned to normal the following day..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant also included over-the-counter fiber supplement. No Treatment medications were provided by reporter.    This case was linked to MOD-2021-329105 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: updated medical history, outcome of all events to recovered and added new event (cognitive disturbance).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Sleep apnoea syndrome, Snoring
Clinical narrative: Sleep apnea diagnosis; Not sleeping; Snoring all his life; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP APNOEA SYNDROME (Sleep apnea diagnosis), INSOMNIA (Not sleeping), SNORING (Snoring all his life) and FATIGUE (Tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea and Sleep apnea on 02-Jul-2021. Concurrent medical conditions included Hypertension (High Blood Pressure), Cholesterolosis NOS and Restless leg syndrome. Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]) for Cholesterolosis NOS, LOSARTAN and MELOXICAM for Hypertension, ROPINIROLE for Restless leg syndrome.   On 09-Sep-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2020, 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 SLEEP APNOEA SYNDROME (Sleep apnea diagnosis), INSOMNIA (Not sleeping), SNORING (Snoring all his life) and FATIGUE (Tired). The patient was treated with Surgery for Sleep apnoea syndrome. At the time of the report, SLEEP APNOEA SYNDROME (Sleep apnea diagnosis), SNORING (Snoring all his life) and FATIGUE (Tired) had resolved and INSOMNIA (Not sleeping) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received a surgery in 02-JULY-2021 for sleep apnea. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Significant follow up. Relevant medical history added. Outcome of events has been updated.Product indication for concomitant medication MELOXICAM has been updated
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Illness, Influenza like illness, Mobility decreased, Pain
Clinical narrative: COVID Arm; Very ill; flu like symptoms; unable to move my arm; pain when moving arm; Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing), VACCINATION SITE REACTION (COVID Arm), ILLNESS (Very ill), INFLUENZA LIKE ILLNESS (flu like symptoms) and MOBILITY DECREASED (unable to move my arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (alergy to codine).    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EPISTAXIS (Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID Arm), ILLNESS (Very ill), INFLUENZA LIKE ILLNESS (flu like symptoms), MOBILITY DECREASED (unable to move my arm) and PAIN (pain when moving arm). At the time of the report, EPISTAXIS (Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing) had not resolved, VACCINATION SITE REACTION (COVID Arm) had resolved and ILLNESS (Very ill), INFLUENZA LIKE ILLNESS (flu like symptoms), MOBILITY DECREASED (unable to move my arm) and PAIN (pain when moving arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow-up received events and outcome were  added.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID Arm; Very ill; flu like symptoms; unable to move my arm; pain when moving arm; Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing), VACCINATION SITE REACTION (COVID Arm), ILLNESS (Very ill), INFLUENZA LIKE ILLNESS (flu like symptoms) and MOBILITY DECREASED (unable to move my arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (alergy to codine).    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EPISTAXIS (Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID Arm), ILLNESS (Very ill), INFLUENZA LIKE ILLNESS (flu like symptoms), MOBILITY DECREASED (unable to move my arm) and PAIN (pain when moving arm). At the time of the report, EPISTAXIS (Today is experiencing a really bad bloody nose on the left nose straw for over 25 minutes now and it is ongoing) had not resolved, VACCINATION SITE REACTION (COVID Arm) had resolved and ILLNESS (Very ill), INFLUENZA LIKE ILLNESS (flu like symptoms), MOBILITY DECREASED (unable to move my arm) and PAIN (pain when moving arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow-up received events and outcome were  added.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product administered to patient of inappropriate age (received first dose of Moderna COVID-19 vaccine under 18 years of age) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006D21A) for COVID-19  immunization. No medical history reported. On Sep 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 23, 2021, patient experienced product administered to patient of inappropriate age (received first dose of Moderna COVID-19 vaccine under 18 years of age). On Sep 23, 2021,  product administered to patient of inappropriate age (received first dose of Moderna COVID-19 vaccine under 18 years of age) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medication or treatment information reported. No adverse reactions following vaccination as per the nurse. The nurse stated patient waited 15 minutes after vaccination and he was fine. This case linked to MOD-2021-330210 (patient link).