chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Arthralgia
Clinical narrative: JOINT ACHES FOR 3-4 DAYS; This spontaneous report received from a patient via a social media and by a company representative concerned an 86 year old of an unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 3 dose of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 3 dose of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1). The patient received booster vaccine of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered in arm (Unspecified) for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The patient received non-company suspect vaccine included: influenza vaccine (Flu shot) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported, administered in arm (Unspecified) for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced joint aches for 3-4 days (Dose number in series: 2). It was reported that "I am 86 and had a flu shot in one arm and a 4th booster covid in the other. Only had joint aches for 3 - 4 days". The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient recovered from joint aches for 3-4 days. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Heavy menstrual bleeding, Impaired work ability, Memory impairment
Clinical narrative: MEMORY ISSUES; CAN NOT SEEM TO GET JOB DONE WITHOUT HESITATION/COULD NOT RETURN TO WORK TILL MARCH; DRAINED; CAUGHT COVID; MENSTRUATION NON STOP TILL FEB (FEBRUARY); This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's pre-existing medical conditions included: Patient work at a clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On DEC-2021, the patient experienced menstruation non stop till feb (february). On JAN-2022, the patient experienced caught covid. On an unspecified date, the patient experienced memory issues, can not seem to get job done without hesitation/could not return to work till march, and drained. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from menstruation non stop till feb (february) on FEB-2022, and the outcome of drained, caught covid, memory issues and can not seem to get job done without hesitation/could not return to work till march was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Headache, Nasal congestion, Nausea
Clinical narrative: Congestion; No appetite; Bodyaches; Headache; Nausea; Fever; tested positive for COVID-19; pain at my injection site for 2 days; A spontaneous report was received from a Health Care Professional (reporting on self), concerning a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tested positive for COVID-19, pain at my injection site for 2 days, Congestion/ Nasal congestion, Headache, Nausea, Fever, Bodyaches and No appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J02A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 31-Dec-2020, the patient had experienced pain at the injection site. The patient had recovered from the pain at the injection site on 01-Jan-2021.  On 17-Jan-2021, the patient had tested positive for COVID-19,   On 18-Ja-2021, the patient experienced congestion, headache, nausea, fever (100.8°F), body aches and no appetite.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the event of pain at my injection site for 2 days was recovered on 01-Jan-2021. Outcome of the events of COVID-19, Congestion/ Nasal congestion, Headache, Nausea, Fever, Bodyaches and No appetite was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain), a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, for the other events (nasal congestion, decreased appetite, pain, headache, nausea, pyrexia) concurrent COVID-19 may remain as confounder. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Congestion; No appetite; Bodyaches; Headache; Nausea; Fever; tested positive for COVID-19; pain at my injection site for 2 days; A spontaneous report was received from a Health Care Professional (reporting on self), concerning a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tested positive for COVID-19, pain at my injection site for 2 days, Congestion/ Nasal congestion, Headache, Nausea, Fever, Bodyaches and No appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J02A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 31-Dec-2020, the patient had experienced pain at the injection site. The patient had recovered from the pain at the injection site on 01-Jan-2021.  On 17-Jan-2021, the patient had tested positive for COVID-19,   On 18-Ja-2021, the patient experienced congestion, headache, nausea, fever (100.8°F), body aches and no appetite.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the event of pain at my injection site for 2 days was recovered on 01-Jan-2021. Outcome of the events of COVID-19, Congestion/ Nasal congestion, Headache, Nausea, Fever, Bodyaches and No appetite was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain), a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, for the other events (nasal congestion, decreased appetite, pain, headache, nausea, pyrexia) concurrent COVID-19 may remain as confounder. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: classic covid pneumonia; positive covid PCR; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive covid PCR) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive covid PCR) (seriousness criterion hospitalization). The patient was hospitalized on 26-Jan-2021 due to COVID-19 PNEUMONIA and SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (positive covid PCR) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: (Negative) Negative. On an unknown date, Blood immunoglobulin M: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field.; Reporter's Comments: This case concerns a male patient, an infectious disease MD, who experienced a serious event of COVID-19 pneumonia and SARS-Cov-2 test positive after receiving first dose of mRNA-1273 (Lot# 039K20A). Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Monoplegia, Nausea, Speech disorder
Clinical narrative: Right arm went totally dead; Speech started to become flared; Dizziness; She felt funny and slipped from the bed to the floor; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of MONOPLEGIA (Right arm went totally dead) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MONOPLEGIA (Right arm went totally dead) (seriousness criterion medically significant), SPEECH DISORDER (Speech started to become flared), DIZZINESS (Dizziness), FALL (She felt funny and slipped from the bed to the floor) and NAUSEA (Nausea). On 22-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, MONOPLEGIA (Right arm went totally dead), SPEECH DISORDER (Speech started to become flared), DIZZINESS (Dizziness) and FALL (She felt funny and slipped from the bed to the floor) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported.  Treatment information was not provided.  Company Comment: This case concerns a 83-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the unlisted events of dizziness, arm went totally dead/ monoplegia, speech disorder, fall, and the listed event of nausea, approximately 9 days after administration of the first dose of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: This case concerns a 83-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the unlisted events of dizziness, arm went totally dead/ monoplegia, speech disorder, fall, and the listed event of nausea, approximately 9 days after administration of the first dose of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: looks like Cellulitis; Injection Site Warm to the touch; A little discomfort in the left arm; Erythema 5cm diameter around Injection Site; Red 5cm diameter around Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of CELLULITIS (looks like Cellulitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced CELLULITIS (looks like Cellulitis) (seriousness criterion medically significant), INJECTION SITE WARMTH (Injection Site Warm to the touch), INJECTION SITE DISCOMFORT (A little discomfort in the left arm), INJECTION SITE ERYTHEMA (Erythema 5cm diameter around Injection Site) and INJECTION SITE ERYTHEMA (Red 5cm diameter around Injection Site). At the time of the report, CELLULITIS (looks like Cellulitis), INJECTION SITE WARMTH (Injection Site Warm to the touch), INJECTION SITE DISCOMFORT (A little discomfort in the left arm), INJECTION SITE ERYTHEMA (Erythema 5cm diameter around Injection Site) and INJECTION SITE ERYTHEMA (Red 5cm diameter around Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INJECTION SITE WARMTH (Injection Site Warm to the touch), INJECTION SITE DISCOMFORT (A little discomfort in the left arm), INJECTION SITE ERYTHEMA (Erythema 5cm diameter around Injection Site) and INJECTION SITE ERYTHEMA (Red 5cm diameter around Injection Site) to be possibly related. No further causality assessment was provided for CELLULITIS (looks like Cellulitis).    Treatment details: Benadryl and Second Generation Cephalosporin Antibiotic.  No concomitant medication was reported.  Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cerebral haemorrhage, Fall, Headache, Myalgia
Clinical narrative: brain bleed; serious fall; Stomach ache; Arm ache; Headaches; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (brain bleed) and FALL (serious fall) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm ache), HEADACHE (Headaches) and MYALGIA (Muscle ache). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (brain bleed) (seriousness criteria hospitalization and medically significant) and FALL (serious fall) (seriousness criterion hospitalization). At the time of the report, CEREBRAL HAEMORRHAGE (brain bleed), FALL (serious fall), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm ache), HEADACHE (Headaches) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details was reported. No concomitant medication was reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's elderly age is a risk factor for fall which could have lead to the cerebral hemorrhage. No further information is available.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received wherein brain bleed and fall events were added and case upgraded to serious On 16-Jul-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's elderly age is a risk factor for fall which could have lead to the cerebral hemorrhage. No further information is available.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: brain bleed; serious fall; Stomach ache; Arm ache; Headaches; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (brain bleed) and FALL (serious fall) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm ache), HEADACHE (Headaches) and MYALGIA (Muscle ache). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (brain bleed) (seriousness criteria hospitalization and medically significant) and FALL (serious fall) (seriousness criterion hospitalization). At the time of the report, CEREBRAL HAEMORRHAGE (brain bleed), FALL (serious fall), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm ache), HEADACHE (Headaches) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details was reported. No concomitant medication was reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's elderly age is a risk factor for fall which could have lead to the cerebral hemorrhage. No further information is available.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received wherein brain bleed and fall events were added and case upgraded to serious On 16-Jul-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's elderly age is a risk factor for fall which could have lead to the cerebral hemorrhage. No further information is available.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chills, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; fatigue; fever; chills; COVID-19 Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 Pneumonia), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 Pneumonia) (seriousness criteria hospitalization and medically significant). On 26-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criteria hospitalization and medically significant), FATIGUE (fatigue) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization) and CHILLS (chills) (seriousness criterion hospitalization). The patient was hospitalized on 15-Feb-2021 due to CHILLS, COVID-19 PNEUMONIA, FATIGUE, OROPHARYNGEAL PAIN and PYREXIA. At the time of the report, COVID-19 PNEUMONIA (COVID-19 Pneumonia), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, COVID-19 pneumonia: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Reporter's Comments: Covid 19 Pneumonia is unlikely to be due to Moderna Covid 19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Brain oedema, Fatigue, Feeling abnormal, Headache
Clinical narrative: Experienced angina; She felt like her brain was swollen; Severe nerve pain (sciatic); felt like she was dying; Soreness; Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Experienced angina) and BRAIN OEDEMA (She felt like her brain was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatica (on and off for 30years), Penicillin allergy (Penicillin) and Latex allergy (Latex). Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Feb-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 an unknown date, the patient experienced ANGINA PECTORIS (Experienced angina) (seriousness criterion medically significant), BRAIN OEDEMA (She felt like her brain was swollen) (seriousness criterion medically significant), NEURALGIA (Severe nerve pain (sciatic)), FEELING ABNORMAL (felt like she was dying), MYALGIA (Soreness), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ANGINA PECTORIS (Experienced angina), BRAIN OEDEMA (She felt like her brain was swollen), NEURALGIA (Severe nerve pain (sciatic)), FEELING ABNORMAL (felt like she was dying), MYALGIA (Soreness), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No laboratory provided by the reporter Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information included : Additional events were added. On 24-Jun-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Pyrexia
Clinical narrative: Experienced angina; She felt like her brain was swollen; Severe nerve pain (sciatic); felt like she was dying; Soreness; Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Experienced angina) and BRAIN OEDEMA (She felt like her brain was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatica (on and off for 30years), Penicillin allergy (Penicillin) and Latex allergy (Latex). Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Feb-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 an unknown date, the patient experienced ANGINA PECTORIS (Experienced angina) (seriousness criterion medically significant), BRAIN OEDEMA (She felt like her brain was swollen) (seriousness criterion medically significant), NEURALGIA (Severe nerve pain (sciatic)), FEELING ABNORMAL (felt like she was dying), MYALGIA (Soreness), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ANGINA PECTORIS (Experienced angina), BRAIN OEDEMA (She felt like her brain was swollen), NEURALGIA (Severe nerve pain (sciatic)), FEELING ABNORMAL (felt like she was dying), MYALGIA (Soreness), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No laboratory provided by the reporter Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information included : Additional events were added. On 24-Jun-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness, Dyspnoea
Clinical narrative: Fast heart beat; lightheadedness; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (Fast heart beat) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent insertion NOS (Patient had a stent inserted in him 9 months ago.) in May 2020. Concomitant products included TICAGRELOR (BRILINTA) from 12-May-2020 to an unknown date and ACETYLSALICYLIC ACID (ASPRIN) from 12-May-2020 to an unknown date for Anticoagulant therapy, PRAVASTATIN from 12-Sep-2014 to an unknown date for Cholesterol, METFORMIN from 12-Jan-2008 to an unknown date for Diabetes, ALLOPURINOL from 12-Mar-1999 to an unknown date for Gout.   On 30-Dec-2020 at 5:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced DIZZINESS (lightheadedness) and DYSPNOEA (Shortness of breath). On 04-Jan-2021 at 5:00 PM, the patient experienced ARRHYTHMIA (Fast heart beat) (seriousness criterion medically significant). On 05-Jan-2021, ARRHYTHMIA (Fast heart beat) had resolved. At the time of the report, DIZZINESS (lightheadedness) and DYSPNOEA (Shortness of breath) outcome was unknown.            On 02/25/21, patient visited his cardiologist who suggested that he should have a LINQ monitor (ILR) implant proceedure performed to record his heart beat function to mitigate a stroke risk. On 03/23/21 his cardiologist performed his LINQ monitor implant.  Patient have had only two episodes. Both occurred in a similar period after each Moderna covid vaccine. Patient have not had such physical experience before the vaccines and since. In the absence of any other circumstances (mitigating or otherwise) he believe that those two episodes were most likely a reaction to the vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-025272.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Upgrading from NS to Serious. Dizziness and shortness of breadth, events were added. Event Tachycardia coding was changed too Arrhythmia. On 30-Apr-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field. On 02-Jun-2021: Reporter needs clarification on having two cases for two doses, believes they are duplicates On 02-Jun-2021: Non Significant Follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: triggered auto-immune psoriatic arthritis; warm to touch; quarter size red mark at the injection site; itches once in a while; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (triggered auto-immune psoriatic arthritis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TRIAMCINOLONE, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), OMEPRAZOLE and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PSORIATIC ARTHROPATHY (triggered auto-immune psoriatic arthritis) (seriousness criterion medically significant), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (quarter size red mark at the injection site) and VACCINATION SITE PRURITUS (itches once in a while). At the time of the report, PSORIATIC ARTHROPATHY (triggered auto-immune psoriatic arthritis), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (quarter size red mark at the injection site) and VACCINATION SITE PRURITUS (itches once in a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Loss of personal independence in daily activities
Clinical narrative: Her mother is legally blind with vision that is like "looking through a straw" due to glaucoma progression/After the second dose caller reports that her mother can no longer see anything; Needs help for everything, has not been able to get around the house or feed herself; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Her mother is legally blind with vision that is like "looking through a straw" due to glaucoma progression/After the second dose caller reports that her mother can no longer see anything) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B12A and 025B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma (She was blind with vision due to glaucoma progression. Patient had not seen any eye doctor or taken any eye medication  in the last five years.) since an unknown date and Glaucoma.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced BLINDNESS (Her mother is legally blind with vision that is like "looking through a straw" due to glaucoma progression/After the second dose caller reports that her mother can no longer see anything) (seriousness criterion medically significant) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Needs help for everything, has not been able to get around the house or feed herself). At the time of the report, BLINDNESS (Her mother is legally blind with vision that is like "looking through a straw" due to glaucoma progression/After the second dose caller reports that her mother can no longer see anything) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Needs help for everything, has not been able to get around the house or feed herself) had not resolved.            No concomitant medications was reported Treatment information was not provided  Action taken with mRNA-1273 in response to the event was not applicable  Very limited information regarding this event has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Lip swelling
Clinical narrative: Face was drooping like bell's palsy; Swollen Lips; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Face was drooping like bell's palsy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Swollen lips (thought was due to working as a land scraper (had happened previously)). Concurrent medical conditions included Milk allergy (had ice cream around the same time as the first dose).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced BELL'S PALSY (Face was drooping like bell's palsy) (seriousness criterion medically significant) and LIP SWELLING (Swollen Lips). At the time of the report, BELL'S PALSY (Face was drooping like bell's palsy) and LIP SWELLING (Swollen Lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LIP SWELLING (Swollen Lips) to be unlikely related. No further causality assessment was provided for BELL'S PALSY (Face was drooping like bell's palsy).    Concomitant medications were not provided.   The patient took second dose of Moderna vaccine with no adverse effects.   Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field. On 30-Jul-2021: Follow-up contains patient's other relevant history and second dose details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram, Pyrexia
Clinical narrative: bleeding on the left side of his brain that later spilled to the right side of his brain; Felt hot like he had a fever; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (bleeding on the left side of his brain that later spilled to the right side of his brain) and PYREXIA (Felt hot like he had a fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (bleeding on the left side of his brain that later spilled to the right side of his brain) (seriousness criteria death and medically significant) and PYREXIA (Felt hot like he had a fever) (seriousness criterion death). The patient died on 24-Apr-2021. The reported cause of death was bleeding in brain. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Computerised tomogram: bleeding on the left side of his brain that later spilled to the right side of his brain.         Very limited information regarding these events have been provided at this time. Patient's age can be a confounding factor to the events. No further information is expected.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field. On 27-May-2021: Suspect product lot number updated.; Sender's Comments: Very limited information regarding these events have been provided at this time. Patient's age can be a confounding factor to the events. No further information is expected.; Reported Cause(s) of Death: Bleeding in brain
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: had a seizure after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (had a seizure after the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (had a seizure after the second shot) (seriousness criterion medically significant). At the time of the report, SEIZURE (had a seizure after the second shot) outcome was unknown.            No concomitant medications were reported. No treatment details were provided. The adverse event was submitted via chat box mentioning about a person who experienced seizure after 2nd shot and questioned about the side effects.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Loss of consciousness
Clinical narrative: Passed out; Heart felt like it was shifting gears, Heart felt like it was skipping a beat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and EXTRASYSTOLES (Heart felt like it was shifting gears, Heart felt like it was skipping a beat) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant) and EXTRASYSTOLES (Heart felt like it was shifting gears, Heart felt like it was skipping a beat) (seriousness criterion hospitalization). The patient was hospitalized from 14-Jun-2021 to 15-Jun-2021 due to EXTRASYSTOLES and LOSS OF CONSCIOUSNESS. On 15-Jun-2021, LOSS OF CONSCIOUSNESS (Passed out) and EXTRASYSTOLES (Heart felt like it was shifting gears, Heart felt like it was skipping a beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis worse) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Back pain. Concurrent medical conditions included Pollen allergy and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) and FAMPRIDINE (AMPYRA) for an unknown indication. On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple sclerosis worse) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis worse) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. The patient's concomitant medication included Balance of nature veggies, balance of nature fruits. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Moderna COVID-19 Vaccine administered as part of the primary series to a 17 year old patient that previously received 2 shots from the primary series and 1 booster all three of them from Pfizer; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna COVID-19 Vaccine administered as part of the primary series to a 17 year old patient that previously received 2 shots from the primary series and 1 booster all three of them from Pfizer) and NO ADVERSE EVENT (No adverse event) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     Patient never had COVID + test or diagnosis.  Patient did not have acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, Lot number: 31130BA,Expiration date: Dec2021) on 23-Sep-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, Lot number:31076BD, Expiration date: Jan2022) on 15-Oct-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster dose, Lot no: FL3205 and Expiration date:Feb2022) on 21-Feb-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 13-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna COVID-19 Vaccine administered as part of the primary series to a 17 year old patient that previously received 2 shots from the primary series and 1 booster all three of them from Pfizer). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna COVID-19 Vaccine administered as part of the primary series to a 17 year old patient that previously received 2 shots from the primary series and 1 booster all three of them from Pfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna COVID-19 Vaccine administered as part of the primary series to a 17 year old patient that previously received 2 shots from the primary series and 1 booster all three of them from Pfizer).    No concomitant medications were reported. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. No treatment medications were reported.