chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Pulmonary fibrosis, Vaccination failure
Clinical narrative: Have pulmonary fibrosis; Have caught covid; I am fully vaccinated have been for over a month, have caught covid; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY FIBROSIS (Have pulmonary fibrosis) in a patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY FIBROSIS (Have pulmonary fibrosis) (seriousness criterion medically significant), COVID-19 (Have caught covid) and VACCINATION FAILURE (I am fully vaccinated have been for over a month, have caught covid). At the time of the report, PULMONARY FIBROSIS (Have pulmonary fibrosis), COVID-19 (Have caught covid) and VACCINATION FAILURE (I am fully vaccinated have been for over a month, have caught covid) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.  For the event Pulmonary fibrosis, based on the current available information; although the use of the product and the start date of the event was more than 30 days apart, a causal relationship cannot be excluded. Nevertheless, the event COVID-19 could a potential confounder /co-suspect for this event.  For the event lack of efficacy of the product and COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: For the event Pulmonary fibrosis, based on the current available information; although the use of the product and the start date of the event was more than 30 days apart, a causal relationship cannot be excluded. Nevertheless, the event COVID-19 could a potential confounder /co-suspect for this event.  For the event lack of efficacy of the product and COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Thrombosis
Clinical narrative: blood clotting.; pain in right leg and knee; pain in right leg and knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clotting.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included ADHD, Anxiety, Inflammatory arthritis and Blood pressure high. Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Anxiety, SULFASALAZINE for Arthritis, PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure high, PREDNISONE for Inflammatory arthritis.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee). On 11-Jun-2021, the patient experienced THROMBOSIS (blood clotting.) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clotting.), PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee) had not resolved.        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.   Patient visited ER due to pain the leg and knee and was diagnosed with blood clotting.  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 16-Jun-2021: Added Reporter information(address, contact details), patient demographic information, medical history. Added vaccine batch number, route of administration, concomitant medication information. Start dates of the events pain in extremity and arthralgia added.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Insomnia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsions), DYSPNOEA (couldn't breathe) and OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache). On 12-Jun-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criteria medically significant and intervention required), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) (seriousness criteria medically significant and intervention required), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted). On an unknown date, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant) and VACCINATION SITE REACTION (She is still having an injection site reaction.). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Jun-2021, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) had resolved. At the time of the report, SEIZURE (Convulsions), DYSPNOEA (couldn't breathe), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted) outcome was unknown and VACCINATION SITE REACTION (She is still having an injection site reaction.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient went to emergency room and they gave her Benadryl she had convulsions, and she never had an issue with Benadryl. They then gave her steroids that helped with her symptoms of throat closing and breathing. She was still having an injection site reaction.  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.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain in extremity, Seizure, Vaccination site reaction, Vaccination site scar
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsions), DYSPNOEA (couldn't breathe) and OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache). On 12-Jun-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criteria medically significant and intervention required), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) (seriousness criteria medically significant and intervention required), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted). On an unknown date, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant) and VACCINATION SITE REACTION (She is still having an injection site reaction.). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Jun-2021, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) had resolved. At the time of the report, SEIZURE (Convulsions), DYSPNOEA (couldn't breathe), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted) outcome was unknown and VACCINATION SITE REACTION (She is still having an injection site reaction.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient went to emergency room and they gave her Benadryl she had convulsions, and she never had an issue with Benadryl. They then gave her steroids that helped with her symptoms of throat closing and breathing. She was still having an injection site reaction.  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.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsions), DYSPNOEA (couldn't breathe) and OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache). On 12-Jun-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criteria medically significant and intervention required), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) (seriousness criteria medically significant and intervention required), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted). On an unknown date, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant) and VACCINATION SITE REACTION (She is still having an injection site reaction.). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Jun-2021, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) had resolved. At the time of the report, SEIZURE (Convulsions), DYSPNOEA (couldn't breathe), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted) outcome was unknown and VACCINATION SITE REACTION (She is still having an injection site reaction.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient went to emergency room and they gave her Benadryl she had convulsions, and she never had an issue with Benadryl. They then gave her steroids that helped with her symptoms of throat closing and breathing. She was still having an injection site reaction.  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.; 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: Hospitalized during vaccination process; Missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Hospitalized during vaccination process) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalized during vaccination process) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, HOSPITALISATION (Hospitalized during vaccination process) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        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.   Concomitant medication was not provided. No Treatment information was provided.  Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Loss of consciousness
Clinical narrative: Passed out; Dizzy; Sweating; Pain in arm; aches; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). 15-May-2021, the patient experienced DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain in arm), MYALGIA (aches), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 17-May-2021, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain in arm), MYALGIA (aches), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. Not Provided.        Concomitant medication use was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-083017 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Passed out; Dizzy; Sweating; Pain in arm; aches; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). 15-May-2021, the patient experienced DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain in arm), MYALGIA (aches), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 17-May-2021, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain in arm), MYALGIA (aches), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. Not Provided.        Concomitant medication use was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-083017 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Product dose omission issue
Clinical narrative: Pregnancy resulted in a miscarriage; Did not receive 2nd dose; Found out she was pregnant after receiving 1st dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) 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.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) had resolved and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that the patient received first shot and then found out she was pregnant.  The pregnancy resulted in a miscarriage and patient wanted to knowif she should now get her 2nd shot, or restart the vaccination series.    This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.   Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial spasm, Loss of consciousness, Muscle spasms, Muscle twitching, Myalgia
Clinical narrative: Blackout; Muscle twitching; Tingling; Cramps legs; Facial spasm; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011321A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia). At the time of the report, LOSS OF CONSCIOUSNESS (Blackout), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia) outcome was unknown.            Concomitant product use was not provided.  At the time of the report, the patient is awaiting results of a magnetic resonance imaging test.  Treatment information was not provided.  This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on 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.; Sender's Comments: This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on 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.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Blackout; Muscle twitching; Tingling; Cramps legs; Facial spasm; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011321A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia). At the time of the report, LOSS OF CONSCIOUSNESS (Blackout), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia) outcome was unknown.            Concomitant product use was not provided.  At the time of the report, the patient is awaiting results of a magnetic resonance imaging test.  Treatment information was not provided.  This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on 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.; Sender's Comments: This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on 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.
Sex: U
Vaccine: COVID19
Symptoms: Product contamination, Pyrexia, Septic shock
Clinical narrative: Fatal fevers; Septic shock; Product contamination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fatal fevers), SEPTIC SHOCK (Septic shock) and PRODUCT CONTAMINATION (Product contamination) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fatal fevers) (seriousness criterion death), SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION (Product contamination) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided.  104 Patients received the vaccine.  Treatment information was not provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Plenty of blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Plenty of blood clots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Plenty of blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Plenty of blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. No Treatment information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear infection, Middle ear effusion
Clinical narrative: hearing loss/deafness; Fluid in middle ear; Ear infection; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (hearing loss/deafness) in a male 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.     Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DEAFNESS (hearing loss/deafness) (seriousness criterion medically significant), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection). The patient was treated with PREDNISONE at a dose of 40 mg once a day. At the time of the report, DEAFNESS (hearing loss/deafness), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient had 60% hearing loss/deafness due to fluid buildup and infection in ears that developed shortly after his first Moderna vaccine after 14-Apr-2021.  Patient developed same symptoms shortly after second vaccine on 15-May-1021.  Both times the patient was treated with a 5-day course of Prednisone 40 mg PO QD, and events resolved.  Action taken with mRNA-1273 in response to the event was not applicable.  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.; 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
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue
Clinical narrative: stroke; always tired; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and FATIGUE (always tired). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) and FATIGUE (always tired) outcome was unknown.            Concomitant product use was not provided by the reporter.   The patient had stroke 3 months after taking the 2nd shot.  Treatment information was not provided.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   Company Comment   Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Vaccination site pain
Clinical narrative: Blood in stool; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 VACCINATION SITE PAIN (pain at the injection site). On 17-Jun-2021, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant). On 15-Jun-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced pain at the injection site the day he received the vaccine and stopped the following day (15 Jun 2021). Patient also noticed blood in his stools on 17 Jun 2021. Consumer did not take any medications to treat his symptoms and is not taking any concurrent medications. No further treatment information was provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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.; 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Vertigo
Clinical narrative: Zero to no hearing in her left ear; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Zero to no hearing in her left ear) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hearing disability (Hearing issues, but not to the point of deafness/lost of hearing.) and Ear tube insertion.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Zero to no hearing in her left ear) (seriousness criterion medically significant) and VERTIGO (Vertigo). The patient was treated with PREDNISONE ongoing since an unknown date for Hearing loss, at an unspecified dose and frequency. At the time of the report, DEAFNESS UNILATERAL (Zero to no hearing in her left ear) and VERTIGO (Vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Acoustic stimulation tests: profound hearing loss (Positive) Profound hearing loss.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product used was provided by the reporter.  Around 22-Apr-2021, the patient started experiencing vertigo and went to the doctor. A hearing test was performed because she had zero to no hearing in her left ear. Hearing test indicated profound hearing loss. The doctor thinks the vaccine caused her hearing loss. They told her to get a COVID and antibody test because the virus might have caused the hearing loss. The patient had therapy for her ears and she regained her hearing back a little bit, but she will still have to get hearing aids.   Treatment information included prednisone and hearing aids.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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 17-Jun-2021: Follow-up received on 17-Jun-2021 included no new information.; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Loss of consciousness
Clinical narrative: She had a non traumatic intracerebral hemorrhage; Never regained consciousness after the stroke/unresponsiveness; Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) and CEREBROVASCULAR ACCIDENT (Stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus on 21-Jan-2021.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) (seriousness criteria death, hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 21-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medications include unspecified medications for diabetes and low pressure.   Reporter further explained the event  as non traumatic intracerebral hemorrhage. Patient was hospitalized for some days and died one or two days after coming back to home.  The treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Company Comment Very limited information regarding this events has been provided at this time.   Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Headache, Nausea, Vomiting
Clinical narrative: Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred  on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  In about a period of two weeks, the ultrasound indicated that the baby's heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage.  Date of last menstrual period and estimated due date were not provided.  No treatment was given.  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-2021-226308 (Parent-Child Link).   See case MOD-2021-226308 for details regarding the child case.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neuralgia
Clinical narrative: Nerve pain down the arm; Lymph node swelled up like hard mass. Its still their I can feel it.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain down the arm) and LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) (seriousness criterion medically significant). On 23-Mar-2021, the patient experienced NEURALGIA (Nerve pain down the arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Nerve pain, at a dose of 1 dosage form. On 17-Jun-2021, NEURALGIA (Nerve pain down the arm) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) outcome was unknown.            Laboratory data included Ultrasound Biopsy. No Concomitant medication details was provided. No treatment medication details was provided. Patient will be getting  surgery scheduled in July to remove his lymph nodes (supraclavicular lymph node removal left side of the collar bone).  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-2021-226030 (Patient Link).; 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.
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Visual impairment
Clinical narrative: lost her eye sight for around 5 mins; Impaired vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) 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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Impaired vision). At the time of the report, BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) had resolved and VISUAL IMPAIRMENT (Impaired vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided. Treatment information was not provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment   Very limited information regarding the date of vaccine administration and the start dates of the events have been provided. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Additional information received patient demographics, dose details and event updated.; Sender's Comments: Very limited information regarding the date of vaccine administration and the start dates of the events have been provided. Further information has been requested.