chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Scratch, Urticaria
Clinical narrative: On 2021-11-25 took a hike and got a little bit scratched by some grasses.  Not much tree pollen around, which I know I have been allergic to in the past, and a fair amount of flower pollen.  Started developing worrying-looking viral-shaped redness about the scratches and some itchiness.  On 2021-11-27 took another hike and this time got a bit scratched by some trees instead.  Once again, did not appear to be much tree pollen, and didn't seem to be much pollen at all around on most of the hike.  I started developing the worst, itchiest hives ever.  My skin has rash from wrist , 2-3 inches past where I got scratched, clustered around my scratches and around a tattoo from the previous Friday before the first scratch, inside the elbow, and further up the biceps clustered again around the light scratches.  I also got a few stomach scratches that look similarly worrying, viral.  I note that I have never had hives before unless counting Chicken Pox as a very small child.  This mRNA Pfizer vaccine seems to be sending my immune system into turbo mode!
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event, Angina pectoris, Headache, Pain, Urticaria
Clinical narrative: On 2021-11-25 took a hike and got a little bit scratched by some grasses.  Not much tree pollen around, which I know I have been allergic to in the past, and a fair amount of flower pollen.  Started developing worrying-looking viral-shaped redness about the scratches and some itchiness.  On 2021-11-27 took another hike and this time got a bit scratched by some trees instead.  Once again, did not appear to be much tree pollen, and didn't seem to be much pollen at all around on most of the hike.  I started developing the worst, itchiest hives ever.  My skin has rash from wrist , 2-3 inches past where I got scratched, clustered around my scratches and around a tattoo from the previous Friday before the first scratch, inside the elbow, and further up the biceps clustered again around the light scratches.  I also got a few stomach scratches that look similarly worrying, viral.  I note that I have never had hives before unless counting Chicken Pox as a very small child.  This mRNA Pfizer vaccine seems to be sending my immune system into turbo mode!
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: I was given 0.5 milliliters for my booster shot instead of the standard 0.25 milliliters. I experienced a severe headache, body aches and chills that evening that progressed into the following day.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Incorrect dose administered, Pain
Clinical narrative: I was given 0.5 milliliters for my booster shot instead of the standard 0.25 milliliters. I experienced a severe headache, body aches and chills that evening that progressed into the following day.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product expiration date issue
Clinical narrative: box of vaccines without an expiration date administered to patient; expired vaccine administered; 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 EXPIRATION DATE ISSUE (box of vaccines without an expiration date administered to patient) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In February 2021, the patient experienced PRODUCT EXPIRATION DATE ISSUE (box of vaccines without an expiration date administered to patient) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). In February 2021, PRODUCT EXPIRATION DATE ISSUE (box of vaccines without an expiration date administered to patient) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported.  The vial was good for 30 days once removed from the freezer as long as the refrigerator stayed within temperature range. The expiration date has only come into question recently because individuals who were vaccinated with this lot number after 25-Feb-2021 were applying for the Green Pass.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: follow-up received on 18-Nov-2021 and reporter occupation updated (non significant) On 23-Nov-2021: Non-Significant Follow-up Appended
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nasopharyngitis, Rash, SARS-CoV-2 test
Clinical narrative: delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster; cold; skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms; muscle aches/still achy; in general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold), RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms), MYALGIA (muscle aches/still achy) and FATIGUE (in general fatigue) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Skin reaction (History of skin reactions (hives, etc.)).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold), RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms), MYALGIA (muscle aches/still achy) and FATIGUE (in general fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 milligram; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold) and FATIGUE (in general fatigue) outcome was unknown and RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms) and MYALGIA (muscle aches/still achy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided by the reporter Patient had strep and mono test on 18-Nov-2021, but they were negative. He has a body rash on his trunk and arms. He was prescribed steroid that he took for a couple of days, but it was causing him stomach issues.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up received on 20-NOV-2021 contains no new information On 20-Nov-2021: Follow up information received on 20 Nov 2021 contains event pertaining to first dose and medical history
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response delayed
Clinical narrative: delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster; cold; skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms; muscle aches/still achy; in general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold), RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms), MYALGIA (muscle aches/still achy) and FATIGUE (in general fatigue) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Skin reaction (History of skin reactions (hives, etc.)).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold), RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms), MYALGIA (muscle aches/still achy) and FATIGUE (in general fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 milligram; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, THERAPEUTIC RESPONSE DELAYED (delayed immune response to the Moderna booste/. It started roughly 10-12 days post booster), NASOPHARYNGITIS (cold) and FATIGUE (in general fatigue) outcome was unknown and RASH (skin rashes all ove/ rash comes and goes/ worse on his feet/ on his face/ body rash on his trunk and arms) and MYALGIA (muscle aches/still achy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided by the reporter Patient had strep and mono test on 18-Nov-2021, but they were negative. He has a body rash on his trunk and arms. He was prescribed steroid that he took for a couple of days, but it was causing him stomach issues.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up received on 20-NOV-2021 contains no new information On 20-Nov-2021: Follow up information received on 20 Nov 2021 contains event pertaining to first dose and medical history
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Lip swelling, Pyrexia
Clinical narrative: Difficulty breathing; Swollen lips; Rash all over the body; Chills; Fever of 102/ Fever reduced to 99 in the morning; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body), CHILLS (Chills) and PYREXIA (Fever of 102/ Fever reduced to 99 in the morning) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     The patient's past medical history included Seizure, Stroke in 2013, Heartbeats irregular and Sleep apnea. Concurrent medical conditions included Drug allergy (Keppra). Concomitant products included ZONISAMIDE, OXYBUTYNIN and TOPIRAMATE for an unknown indication.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body), CHILLS (Chills) and PYREXIA (Fever of 102/ Fever reduced to 99 in the morning). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 20-Nov-2021, PYREXIA (Fever of 102/ Fever reduced to 99 in the morning) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 102 (High) High. On 20-Nov-2021, Body temperature: 99 (Low) fever was reduced to 99 in the morning.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      The case was downgrade to non-serious because there no was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.; Sender's Comments: The case was downgrade to non-serious because there no was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Difficulty breathing; Swollen lips; Rash all over the body; Chills; Fever of 102/ Fever reduced to 99 in the morning; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body), CHILLS (Chills) and PYREXIA (Fever of 102/ Fever reduced to 99 in the morning) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     The patient's past medical history included Seizure, Stroke in 2013, Heartbeats irregular and Sleep apnea. Concurrent medical conditions included Drug allergy (Keppra). Concomitant products included ZONISAMIDE, OXYBUTYNIN and TOPIRAMATE for an unknown indication.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body), CHILLS (Chills) and PYREXIA (Fever of 102/ Fever reduced to 99 in the morning). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 20-Nov-2021, PYREXIA (Fever of 102/ Fever reduced to 99 in the morning) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 102 (High) High. On 20-Nov-2021, Body temperature: 99 (Low) fever was reduced to 99 in the morning.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      The case was downgrade to non-serious because there no was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.; Sender's Comments: The case was downgrade to non-serious because there no was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Haemochromatosis, Inappropriate schedule of product administration, Neuropathy peripheral
Clinical narrative: Neuropathy in the feet; Hemochromatosis; 1st dose 21 jan, 2nd dose 26 feb; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in the feet), HAEMOCHROMATOSIS (Hemochromatosis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21 jan, 2nd dose 26 feb) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 032L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21 jan, 2nd dose 26 feb). In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in the feet) and HAEMOCHROMATOSIS (Hemochromatosis). The patient was treated with Manual therapy (Acupuncture using medicines) for Neuropathy peripheral and Manual therapy (Acupuncture using medicines) for Haemochromatosis. On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21 jan, 2nd dose 26 feb) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in the feet) and HAEMOCHROMATOSIS (Hemochromatosis) outcome was unknown.            It was reported that the patient started experiencing events 2 weeks post second dose of vaccine and was treated by a doctor of  medicine for a neuropathy in feet, patient reported that hemochromatosis is when there was excess iron in the feet.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dyspnoea, Fatigue, Nausea, Palpitations
Clinical narrative: shortness of breath [after first dose]; heart seemed to beat a little heavier [after first dose]; tender to the touch/felt like a real soft tissue; nickel-sized bruise/size of a golf ball or lime; injection site turned into a big red dot/had a crown on it/red streak; nauseous; little fatigued after he walked upstairs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime) and VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-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 DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime), VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak), NAUSEA (nauseous) and FATIGUE (little fatigued after he walked upstairs). At the time of the report, DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime), VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak), NAUSEA (nauseous) and FATIGUE (little fatigued after he walked upstairs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-396142, MOD-2021-396143 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema
Clinical narrative: shortness of breath [after first dose]; heart seemed to beat a little heavier [after first dose]; tender to the touch/felt like a real soft tissue; nickel-sized bruise/size of a golf ball or lime; injection site turned into a big red dot/had a crown on it/red streak; nauseous; little fatigued after he walked upstairs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime) and VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-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 DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime), VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak), NAUSEA (nauseous) and FATIGUE (little fatigued after he walked upstairs). At the time of the report, DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime), VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak), NAUSEA (nauseous) and FATIGUE (little fatigued after he walked upstairs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-396142, MOD-2021-396143 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Hallucination
Clinical narrative: severe depression; anxiety; hallucinating after 30-40 minutes; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating after 30-40 minutes) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced HALLUCINATION (hallucinating after 30-40 minutes) (seriousness criterion medically significant). On an unknown date, the patient experienced DEPRESSION (severe depression) and ANXIETY (anxiety). At the time of the report, HALLUCINATION (hallucinating after 30-40 minutes) outcome was unknown and DEPRESSION (severe depression) and ANXIETY (anxiety) had not resolved.            Patient had seeing people go past her window. At store, she saw one of her aunties who passed away. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company Comment : This case concerns a 52-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of hallucination and non serious events of depression and anxiety. The event of hallucination occurred on the same day 30-40 minutes after the second dose of mRNA-1273, while the other events occurred on an unknown date after second dose. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 52-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of hallucination and non serious events of depression and anxiety. The event of hallucination occurred on the same day 30-40 minutes after the second dose of mRNA-1273, while the other events occurred on an unknown date after second dose. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stones; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stones) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Kidney stones) 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.  Treatment information was not provided.  The patient stated that another woman had a kidney stone after receiving the Moderna vaccine. There was another woman that had that a week before that. She knows of 5 total people who had kidney stones from the Moderna.  Company comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced serious unexpected event of nephrolithiasis. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced serious unexpected event of nephrolithiasis. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
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 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-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 and treatment medication was reported.  The reporter wanted to know whether patient should get booster again or any testing done.   This case was linked to MOD-2021-392458 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Brain fog; Extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog) and FATIGUE (Extreme exhaustion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Sleep disorder NOS, VITAMINS NOS for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog) and FATIGUE (Extreme exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse drug reaction, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Adverse drug reaction, at an unspecified dose and frequency and ZINC for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain fog) and FATIGUE (Extreme exhaustion) had resolved.            The patient received booster dose and had extreme exhaustion and brain fog,  a state where she cannot really think fast and clear, which lasted about 10 days.   The patient said that the intensity remained the same, it has not worsened or improved over the past 10 days.  The patient drank lots of fluids and rested.  The patient concomitant medications also included supplements.  During the time of reporting, the patient stated that she haven't had the symptoms evaluated and seeing her primary care physician tomorrow.   This case was linked to MOD-2021-395717, MOD-2021-395928 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site warmth
Clinical narrative: Fatigue; Arm was warm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU (Patient took the flu shot a couple of weeks ago.). Concurrent medical conditions included Arthritis (Patient received cortisone injections arthritis.). Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Fatigue). In February 2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm) and VACCINATION SITE PAIN (Sore arm). The patient was treated with HYDROCORTISONE ACETATE (CORTISONE [HYDROCORTISONE ACETATE]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and AMIKACIN SULFATE (AMICAGEL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Among the treatment they used patient stated that Arnica gel brought some relief to her.   This case was linked to MOD-2021-395766, MOD-2021-395768 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: Disconfort; Egg sized inflammation of the lymph node under the armpit; This spontaneous case was reported by a nurse and describes the occurrence of DISCOMFORT (Disconfort) and LYMPHADENOPATHY (Egg sized inflammation of the lymph node under the armpit) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN for Type 1 diabetes mellitus.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DISCOMFORT (Disconfort) and LYMPHADENOPATHY (Egg sized inflammation of the lymph node under the armpit). The patient was treated with IBUPROFEN for Swelling, at a dose of 400mg during 4 days. At the time of the report, DISCOMFORT (Disconfort) and LYMPHADENOPATHY (Egg sized inflammation of the lymph node under the armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Got COVID after vaccinations; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after vaccinations) and DRUG INEFFECTIVE (Lack of drug effect) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 204M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Got COVID after vaccinations) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Got COVID after vaccinations) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 antibody test: positive (Positive) Patient still had antibodies..         No concomitant medications reported. No treatment medications reported.  It was reported that patient did not experience any symptoms following vaccination. This case concerns a 75 year-old, male patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. Drug ineffective was considered as an additional event. The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 75 year-old, male patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. Drug ineffective was considered as an additional event. The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Nausea
Clinical narrative: After her 1st dose she felt sick to her stomach and in her jowls; The feeling you get around the lymph nodes in your neck when you are about to throw up; The feeling you get around the lymph nodes in your neck when you are about to throw up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (After her 1st dose she felt sick to her stomach and in her jowls), FEELING ABNORMAL (The feeling you get around the lymph nodes in your neck when you are about to throw up) and NAUSEA (The feeling you get around the lymph nodes in your neck when you are about to throw up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (After her 1st dose she felt sick to her stomach and in her jowls), FEELING ABNORMAL (The feeling you get around the lymph nodes in your neck when you are about to throw up) and NAUSEA (The feeling you get around the lymph nodes in your neck when you are about to throw up). At the time of the report, ABDOMINAL DISCOMFORT (After her 1st dose she felt sick to her stomach and in her jowls), FEELING ABNORMAL (The feeling you get around the lymph nodes in your neck when you are about to throw up) and NAUSEA (The feeling you get around the lymph nodes in your neck when you are about to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-396031 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pseudolymphoma
Clinical narrative: Pseudolymphoma; This spontaneous case was reported by a consumer and describes the occurrence of PSEUDOLYMPHOMA (Pseudolymphoma) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSEUDOLYMPHOMA (Pseudolymphoma). At the time of the report, PSEUDOLYMPHOMA (Pseudolymphoma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported  No treatment medication were reported
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Pyrexia, Tremor
Clinical narrative: severe shakes; felt warm/as the day went by he got hotter and hotter; reaction was like a reoccurring malaria; 100.5°F temperature/high fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills). On 11-Apr-2021, TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 100.5f (High) fever.         No concomitant medications were reported. No treatment medications were reported. The shaking and the high fever started and lasted probably 4-6 hour and chills that lasted 4 hours.   This case was linked to MOD-2021-067714, MOD-2021-395970 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: severe shakes; felt warm/as the day went by he got hotter and hotter; reaction was like a reoccurring malaria; 100.5°F temperature/high fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills). On 11-Apr-2021, TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 100.5f (High) fever.         No concomitant medications were reported. No treatment medications were reported. The shaking and the high fever started and lasted probably 4-6 hour and chills that lasted 4 hours.   This case was linked to MOD-2021-067714, MOD-2021-395970 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 78-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chills, Myalgia, Nausea
Clinical narrative: Stomach upset; Back hurts; Neck hurts; Back of her leg hurts; Body aches/felt like every muscle in their body hurts; Typical gastro issue like nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts) and MYALGIA (Body aches/felt like every muscle in their body hurts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (She is a survival of three open heart surgery) and Heart valvular prosthesis user. Concomitant products included FLUDROCORTISONE, VITAMIN D [VITAMIN D NOS], WARFARIN SODIUM (JANTOVEN), PARACETAMOL (TYLENOL [PARACETAMOL]) and LIOTHYRONINE 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 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), MYALGIA (Body aches/felt like every muscle in their body hurts), NAUSEA (Typical gastro issue like nausea) and CHILLS (Chills). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), MYALGIA (Body aches/felt like every muscle in their body hurts), NAUSEA (Typical gastro issue like nausea) and CHILLS (Chills) had resolved.            The patient stated after the 2nd dose within 4 hours, they started having side effects; these side effects were body aches, chills, stomach upset, their back hurts, the back of their leg hurts and felt like every muscle in their body hurts, neck hurts and typical gastro issue like Reportedly, the patient waited for 6 hours before using Tylenol and heat. The patient reported that the symptoms were all gone within a day and a-half and the patient was back to their normal lifestyle.   The patient also reported that they were a survivor of three open heart surgery and had artificial heart valve.   The patient used Heat and Tylenol to alleviate the events.   This case was linked to MOD-2021-395769, MOD-2021-395919 (Patient Link).