chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant product use was not provided by the reporter.No treatment information provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Chest pain, Electrocardiogram, Pain
Clinical narrative: Ongoing chest pain for about a week starting about two weeks post first Pfizer shot. Went to cardiologist and diagnosed with pericardial effusion. Pain self-resolved, but still some intermittent pain.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Physical examination, Troponin
Clinical narrative: Ongoing chest pain for about a week starting about two weeks post first Pfizer shot. Went to cardiologist and diagnosed with pericardial effusion. Pain self-resolved, but still some intermittent pain.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Muscle disorder, Muscle twitching, Muscular weakness
Clinical narrative: Twitching and other significant muscle fasciculations. Muscle weakness and feelings of muscles being "off".
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Formication, Inflammation, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts), PRURITUS (itching/scratching) and RASH MACULAR (skin spots were red/skin spots were dark pink) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 043B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts), PRURITUS (itching/scratching), RASH MACULAR (skin spots were red/skin spots were dark pink), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (redness) and INFLAMMATION (inflammatory response/histamine reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (had reactions). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), PRURITUS (itching/scratching), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (redness), INFLAMMATION (inflammatory response/histamine reaction) and VACCINATION COMPLICATION (had reactions) outcome was unknown and SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts) and RASH MACULAR (skin spots were red/skin spots were dark pink) had not resolved.    No concomitant medications were reported by the reporter.Most recent FOLLOW-UP information incorporated above includes:On 22-Nov-2021: follow up received and vaccination details updated , new events added , event outcome updated. On 22-Nov-2021: follow up received and new event added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin discolouration, Urticaria, Vaccination complication
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts), PRURITUS (itching/scratching) and RASH MACULAR (skin spots were red/skin spots were dark pink) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 043B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts), PRURITUS (itching/scratching), RASH MACULAR (skin spots were red/skin spots were dark pink), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (redness) and INFLAMMATION (inflammatory response/histamine reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (had reactions). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), PRURITUS (itching/scratching), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (redness), INFLAMMATION (inflammatory response/histamine reaction) and VACCINATION COMPLICATION (had reactions) outcome was unknown and SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts) and RASH MACULAR (skin spots were red/skin spots were dark pink) had not resolved.    No concomitant medications were reported by the reporter.Most recent FOLLOW-UP information incorporated above includes:On 22-Nov-2021: follow up received and vaccination details updated , new events added , event outcome updated. On 22-Nov-2021: follow up received and new event added.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: There was a man I knew that didn't take his 2nd dose of the Moderna Covid-19 vaccine who died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (There was a man I knew that didn't take his 2nd dose of the Moderna Covid-19 vaccine who died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 22-Nov-2021 The patient died on 22-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported  Company Comment: This is a fatal case that concerns a male patient of an unknown age, with no relevant medical history reported, who experienced the unexpected fatal event of DEATH. He died on 22-Nov-2021, after an unknown time interval after the dose of the mRNA-1273. The cause of death was not reported. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-395669.; Sender's Comments: This is a fatal case that concerns a male patient of an unknown age, with no relevant medical history reported, who experienced the unexpected fatal event of DEATH. He died on 22-Nov-2021, after an unknown time interval after the dose of the mRNA-1273. The cause of death was not reported. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received the expired vaccine) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.  No Medical History information was reported.On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received the expired vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient Received the expired vaccine) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant informations were reported. No Treatment informations were reported.total nine doses were administered from one vial. The vial was initially stored in the refrigerator on 11-NOV-2021. The vial was fist puncture on 18-NOV-2021 at 10 hours. The vial was store in the fridge post puncture and no vial undergone any temperature excursions.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A, 031A21A and 058F21A) for COVID-19 vaccination. No Medical History information was reported.On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 09-May-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. It was reported that to help with the symptoms she laid down and rested.No concomitant medications were mentioned.No treatment details were reported.This case was linked to MOD-2021-395956 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Rash, Thunderclap headache
Clinical narrative: red blotchy rash all over his back; Worst headache of his life, a "thunder cloud headache"; This spontaneous case was reported by a consumer and describes the occurrence of THUNDERCLAP HEADACHE (Worst headache of his life, a "thunder cloud headache") and RASH (red blotchy rash all over his back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     Concurrent medical conditions included Pain in foot (It was reported patient  had pain to his foot from the vaccine but caller stated that he never had pain in his foot from the vaccine. He said it has been ongoing for years from neuropathy).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THUNDERCLAP HEADACHE (Worst headache of his life, a "thunder cloud headache"). On 22-Apr-2021, the patient experienced RASH (red blotchy rash all over his back). At the time of the report, THUNDERCLAP HEADACHE (Worst headache of his life, a "thunder cloud headache") and RASH (red blotchy rash all over his back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Computerised tomogram: normal (normal) normal.         No concomitant medications information was reported. No treatment medications were provided   This case was linked to MOD-2021-085673 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant follow-up appended medical history added; Sender's Comments:  MOD-2021-085673:2nd Dose Case
Sex: U
Vaccine: PPV
Symptoms: Influenza
Clinical narrative: flu; This spontaneous report has been received from a lawyer, for zoster vaccine live (ZOSTAVAX) (MARRS # 2108USA004563), concerning a patient of unknow age and gender. The patient's medical history included smoking user and chickenpox.    On an unspecified date in 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknow) (dose, unit, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient got a really bad flu. The outcome of the ebvent was unknown. The event was considered to be related to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknow).; Sender's Comments:  US-009507513-2108USA004563:
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dysarthria, Furuncle, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUL-2021, the patient experienced loss of bladder control. On 15-JUL-2021, the patient experienced slurred speech. On 15-JUL-2021, the patient experienced occasional loss of balance. On 15-JUL-2021, the patient experienced sharp pain sensation in feet. On 15-JUL-2021, the patient experienced tingling sensation in feet. On 19-NOV-2021, the patient experienced boils on lower extremities. On 19-NOV-2021, the patient experienced red splotches on torso. Treatment medications (dates unspecified) included: syzygium aromaticum oil.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from loss of bladder control, slurred speech, tingling sensation in feet, occasional loss of balance, red splotches on torso, boils on lower extremities, and sharp pain sensation in feet.This report was non-serious. Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Urinary incontinence
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUL-2021, the patient experienced loss of bladder control. On 15-JUL-2021, the patient experienced slurred speech. On 15-JUL-2021, the patient experienced occasional loss of balance. On 15-JUL-2021, the patient experienced sharp pain sensation in feet. On 15-JUL-2021, the patient experienced tingling sensation in feet. On 19-NOV-2021, the patient experienced boils on lower extremities. On 19-NOV-2021, the patient experienced red splotches on torso. Treatment medications (dates unspecified) included: syzygium aromaticum oil.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from loss of bladder control, slurred speech, tingling sensation in feet, occasional loss of balance, red splotches on torso, boils on lower extremities, and sharp pain sensation in feet.This report was non-serious. Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Guillain-Barre syndrome, Thrombosis with thrombocytopenia syndrome
Clinical narrative: POTENTIALLY FATAL SIDE EFFECTS; THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME; GUILLAIN-BARRE SYNDROME; This spontaneous report was received from literature: Parents are not so sure THERE'S NO HARM IN COVID-19 [VACCINE] TRYING. This report concerned multiple patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that there were 47 patients experienced blood clots - thrombosis with thrombocytopenia syndrome (TTS), a rare and serious adverse event, after the administration of the JANSSEN COVID VACCINE. It also reported that some people who received the JANSSEN COVID VACCINE had Guillain-Barre Syndrome (GBS), a rare disorder where the body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis. Most people recovered completely from GBS (Guillain-Barre Syndrome), but some had permanent nerve damage. A former journalist, started looking for vaccine studies after her appointment to receive the J&J/Janssen dose was cancelled in the spring when reports about potentially fatal side effects appeared (that suspension was eventually lifted by the healthcare authorities). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of potentially fatal side effects on an unspecified date, and the outcome of thrombosis with thrombocytopenia syndrome and guillain-barre syndrome was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0 : 20211154358-COVID-19 VACCINE AD26.COV2.S -thrombosis with thrombocytopenia syndrome and guillain-barre syndrome. This event(s) is labeled per Regulatory Authority and is therefore considered potentially related.  20211154358-COVID-19 VACCINE AD26.COV2.S -potentially fatal side effects. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, (dose number in series 1), one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, patient had a break through case of Covid (suspected covid 19) even though was vaccinated and suspected clinical vaccination failure. The patient took immunosuppressants. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the suspected covid 19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.; Sender's Comments: V0: 20211157677- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Dose number series was 1. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain Barre syndrome 8 days after the vaccine. The patient also enquired "This cytokine storm, when read about it, appears to be a rush of super inflammation. For people already having inflammatory or autoimmune disorders, that was very dangerous". The patient also questioned if there was "any connection between guillain barre syndrome and rheumatoid arthritis". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211161448- COVID-19 VACCINE AD26.COV2.S- Guillain-Barre syndrome. This event is labeled per RSI and is therefore considered potentially related.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Head discomfort, Headache, Pain in extremity
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 45 year old of unspecified sex.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-NOV-2021, the patient experienced stomach pain. On 19-NOV-2021, the patient experienced left arm felt hot compared with rest of the body. On 19-NOV-2021, the patient experienced pressure in head. On 19-NOV-2021, the patient experienced left arm soreness. On 19-NOV-2021, the patient experienced headache.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the stomach pain, headache, left arm felt hot compared with rest of the body, left arm soreness and pressure in head was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Erythema nodosum, Laboratory test, Physical examination
Clinical narrative: Erythema nodosum; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA NODOSUM (Erythema nodosum) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA NODOSUM (Erythema nodosum) (seriousness criterion hospitalization). At the time of the report, ERYTHEMA NODOSUM (Erythema nodosum) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 23.5 mg/l 23.5 mg/L. On an unknown date, Laboratory test: negative (Negative) negative ANA, rheumatoid factor, ESR, thyroid panel, upper respiratory viral panel including SARS-CoV-2.. On an unknown date, Physical examination: abnormal (abnormal) examination was benign other than multiple, tender, non-blanchable 6-8 cm erythematous nodules present on the bilateral calves and shins..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA NODOSUM (Erythema nodosum) to be possibly related.    Prior to emergency department presentation, patient had been seeing her primary care physician for her ongoing symptoms. Her vital signs in the emergency department were stable. She had progressively worsening lower extremity rash. The rash started 7 days after the second administered dose of the SARS-CoV-2 vaccine (Moderna series).  She was discharged from the ED and continued supportive care with nonsteroidal anti-inflammatory drugs.  Concomitant product and treatment medication use was not provided by the reporter.  This case concerns a 44 year-old, female patient with no relevant medical history, who experienced the serious (due to hospitalization) unexpected event of Erythema nodosum. The event occurred approximately 7 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 44 year-old, female patient with no relevant medical history, who experienced the serious (due to hospitalization) unexpected event of Erythema nodosum. The event occurred approximately 7 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant and treatment medications were reported by reporter.Most recent FOLLOW-UP information incorporated above includes:On 19-Nov-2021: Follow Up received on 19-Nov-2021 (Second reporter Information is updated.)
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Skin test
Clinical narrative: Angioedema; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:    Concurrent medical conditions included Allergy to vaccine (Flu vaccine).    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 ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Angioedema) to be possibly related.    No concomitant information were reported. Patient was treated with steroids and antihistamines  This is a literature case concerning a  20 -year-old male patient with medical history of allergy to flu vaccine , who experienced the serious unexpected event of  angioedema  3 hours  after  receiving the first  dose of  mRNA-1273. Patient was treated with steroids and antihistamines. An expanded skin allergy testing (included PEG, methylprednisolone acetate, methylprednisolone sodium, triamcinolone acetonide, and polysorbate 20) was negative. The benefit-risk relationship of MRNA-1273 is not affected by this report.   This case was linked to MOD-2021-394131 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a literature case concerning a  20 -year-old male patient with medical history of allergy to flu vaccine , who experienced the serious unexpected event of  angioedema  3 hours  after  receiving the first  dose of  mRNA-1273. Patient was treated with steroids and antihistamines. An expanded skin allergy testing (included PEG, methylprednisolone acetate, methylprednisolone sodium, triamcinolone acetonide, and polysorbate 20) was negative. The benefit-risk relationship of MRNA-1273 is not affected by this report.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Throat irritation, Wheezing
Clinical narrative: Angioedema; Wheezing; throat pruritus; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema), WHEEZING (Wheezing) and THROAT IRRITATION (throat pruritus) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), WHEEZING (Wheezing) (seriousness criterion medically significant) and THROAT IRRITATION (throat pruritus) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema), WHEEZING (Wheezing) and THROAT IRRITATION (throat pruritus) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Angioedema), WHEEZING (Wheezing) and THROAT IRRITATION (throat pruritus) to be possibly related.    Laboratory test included Polyethylene glycol and polysorbate skin testing with results not provided until FTA is available  Company Comment: This literature case concerns a 22-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Angioedema, Wheezing and Throat irritation. A Polyethylene glycol and polysorbate skin testing was also reported (no results available). The events occurred at an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was unknown since the events outcome was unknown and no information about other doses was available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-394128 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This literature case concerns a 22-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Angioedema, Wheezing and Throat irritation. A Polyethylene glycol and polysorbate skin testing was also reported (no results available). The events occurred at an unknown date after a dose of mRNA-1273 vaccine. The rechallenge was unknown since the events outcome was unknown and no information about other doses was available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) 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 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) 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 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medication details were provided. No Treatment medication details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I knew 2 girls that didn't take their 2nd dose & died.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (I knew 2 girls that didn't take their 2nd dose & died.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. No treatment medications were reported.  Company's comment: This is a spontaneous report concerning a female patient of unknown age and medical history. The reporter mentions that knew the patient and that she hadn't taken the second dose of the vaccine and died. The date of vaccination and manufacturer were not reported, nor was cause of death. No further information was disclosed. A query was raised requesting any information that can be provided to further elucidate this case.   This case was linked to MOD-2021-395669 (Patient Link).; Sender's Comments: This is a spontaneous report concerning a female patient of unknown age and medical history. The reporter mentions that knew the patient and that she hadn't taken the second dose of the vaccine and died. The date of vaccination and manufacturer were not reported, nor was cause of death. No further information was disclosed. A query was raised requesting any information that can be provided to further elucidate this case.; Reported Cause(s) of Death: Unknown cause of death
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a half dose for the 2nd dose of the Moderna COVID-19 vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.No Medical History information was reported.On 22-Nov-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received a half dose for the 2nd dose of the Moderna COVID-19 vaccine). On 22-Nov-2021, ACCIDENTAL UNDERDOSE (Received a half dose for the 2nd dose of the Moderna COVID-19 vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications was reported.No treatment drug details was reported.This case was linked to MOD-2021-395761 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL was administered to 1 patient more than 12hours post puncture) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. Concomitant products included SILDENAFIL for an unknown indication.On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL was administered to 1 patient more than 12hours post puncture). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL was administered to 1 patient more than 12hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.  No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The vial was initially stored in the refrigerator was 11-NOV-2021. The vial was first punctured was 18-NOV-2021 at 10 am. Date of administration of vaccine was 19-NOV-2021.Concomitant medications was not provided by the reporter.Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-395956, MOD-2021-395951 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Accidental overdose
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (I have had a bad stomache for over a week now) and ACCIDENTAL OVERDOSE (I was mistakingly given double booster dose - 0.5ml) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (I have had a bad stomache for over a week now) and ACCIDENTAL OVERDOSE (I was mistakingly given double booster dose - 0.5ml). At the time of the report, ABDOMINAL PAIN UPPER (I have had a bad stomache for over a week now) outcome was unknown and ACCIDENTAL OVERDOSE (I was mistakingly given double booster dose - 0.5ml) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant and treatment information were reported by the reporter.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Cold sweat, Feeling cold
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in bed for the past 2 days), FEELING COLD (feeling cold) and COLD SWEAT (cold sweats.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced BEDRIDDEN (in bed for the past 2 days), FEELING COLD (feeling cold) and COLD SWEAT (cold sweats.). At the time of the report, BEDRIDDEN (in bed for the past 2 days), FEELING COLD (feeling cold) and COLD SWEAT (cold sweats.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: arm started hurting him and it's still hurting him; painful under certain conditions; cannot scratch his back or do other certain things because the arm hurts for minutes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting him and it's still hurting him), PAIN (painful under certain conditions) and LIMB DISCOMFORT (cannot scratch his back or do other certain things because the arm hurts for minutes) 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. In February 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 PAIN IN EXTREMITY (arm started hurting him and it's still hurting him), PAIN (painful under certain conditions) and LIMB DISCOMFORT (cannot scratch his back or do other certain things because the arm hurts for minutes). At the time of the report, PAIN IN EXTREMITY (arm started hurting him and it's still hurting him), PAIN (painful under certain conditions) and LIMB DISCOMFORT (cannot scratch his back or do other certain things because the arm hurts for minutes) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.