chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Muscle spasms, Nausea, Oropharyngeal pain, Pain
Clinical narrative: SORE THROAT; LEFT SIDE OF BODY WAS SORE AND ACHY (UNDER THE ARM, BREAST AND BACK); MUSCLE SPASM ON THE BACK OF RIBCAGE AND KNEE; FEVER; NAUSEA; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 120 pounds, and height was 62 inches. The patient's past medical history included anterior cruciate ligament surgery of the knee, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: Unknown) dose was not reported, administered on 26-JUL-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced sore throat. On 27-JUL-2021, the subject experienced left side of body was sore and achy (under the arm, breast and back). On 27-JUL-2021, the subject experienced muscle spasm on the back of ribcage and knee. On 27-JUL-2021, the subject experienced fever. On 27-JUL-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of sore throat, nausea, left side of body was sore and achy (under the arm, breast and back) and muscle spasm on the back of ribcage and knee was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE THROAT; LEFT SIDE OF BODY WAS SORE AND ACHY (UNDER THE ARM, BREAST AND BACK); MUSCLE SPASM ON THE BACK OF RIBCAGE AND KNEE; FEVER; NAUSEA; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 120 pounds, and height was 62 inches. The patient's past medical history included anterior cruciate ligament surgery of the knee, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: Unknown) dose was not reported, administered on 26-JUL-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced sore throat. On 27-JUL-2021, the subject experienced left side of body was sore and achy (under the arm, breast and back). On 27-JUL-2021, the subject experienced muscle spasm on the back of ribcage and knee. On 27-JUL-2021, the subject experienced fever. On 27-JUL-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of sore throat, nausea, left side of body was sore and achy (under the arm, breast and back) and muscle spasm on the back of ribcage and knee was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: CHILLS; STOMACH MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and stomach muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and stomach muscle pain was not reported. This report was non-serious. The case is associated with Product Quality Complaint number: 90000187552.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Hypoaesthesia, Vomiting
Clinical narrative: UPPER LEFT THIGH FELT (FELT LIKE ITS ASLEEP, BUT NOT  TINGLING AND NO PAIN),  RANGES FROM HER KNEE TO "BUTT AREA" ON THE  SIDE OF THE LEG; THREW UP AT NIGHT; SWEATING; FELT PRETTY BAD; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was 106 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies and had no drug abuse or illicit use. the patient did not have any past medical history and was not receiving any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced threw up at night. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced felt pretty bad. On 28-JUL-2021, the subject experienced upper left thigh felt (felt like its asleep, but not tingling and no pain), ranges from her knee to "butt area" on the side of the leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up at night, sweating, and felt pretty bad on 10-APR-2021, and had not recovered from upper left thigh felt (felt like its asleep, but not tingling and no pain), ranges from her knee to "butt area" on the side of the leg. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product container issue
Clinical narrative: TWO BROKEN VIALS; POTENTIAL ADMINISTRATION ERROR FROM ONE CRACKED VIAL; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 04-AUG-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced two broken vials. On 28-JUL-2021, the subject experienced potential administration error from one cracked vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two broken vials and potential administration error from one cracked vial was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: FEELING TIRED; LOW ENERGY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, treatment medications included: paracetamol. On 24-JUL-2021, the subject experienced feeling tired. On 24-JUL-2021, the subject experienced low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and low energy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Headache, Pain, Vomiting
Clinical narrative: VOMITING; FELT LIKE COULD NOT BREATHE; PAIN IN LOWER BACK; PAIN IN ENTIRE BODY; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced vomiting. On 28-JUL-2021, the subject experienced felt like could not breathe. On 28-JUL-2021, the subject experienced pain in lower back. On 28-JUL-2021, the subject experienced pain in entire body. On 28-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, felt like could not breathe, pain in lower back, and headache, and the outcome of pain in entire body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Pain in extremity
Clinical narrative: ARM HURTS LIKE HELL; MILD SHORT LIVED HEADACHE; MINOR CHEST TIGHTNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-JUL-2021, the subject experienced minor chest tightness. On 27-JUL-2021, the subject experienced mild short lived headache. On 28-JUL-2021, the subject experienced arm hurts like hell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor chest tightness, mild short lived headache and arm hurts like hell was not reported. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: REALLY SICK; FEVER; HEADACHE; VACCINE ADMINISTERED TO PERSON WHOSE AGE IS 17; This spontaneous report received from a parent concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 28-JUL-2021, the subject experienced vaccine administered to person whose age is 17. On 29-JUL-2021, the subject experienced really sick. On 29-JUL-2021, the subject experienced fever. On 29-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and really sick, and the outcome of vaccine administered to person whose age is 17 was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Mobility decreased, Myalgia, Product dose omission issue
Clinical narrative: Receiving her second dose past 36 days; sore arm; Loss of mobility (left arm); No range of motion (left arm)/could not use her arm for 4 weeks; Tenderiness; thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) and MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm). On 27-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) (seriousness criterion disability), MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) (seriousness criterion disability) and TENDERNESS (Tenderiness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Receiving her second dose past 36 days) and MYALGIA (sore arm). On 26-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm) had resolved. On 15-Mar-2021, INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) and MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) had resolved. At the time of the report, TENDERNESS (Tenderiness) and MYALGIA (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Receiving her second dose past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.  It was reported that the patient will be receiving the second dose on 27 Jul 2021.  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-Jul-2021: Address, New events were 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Receiving her second dose past 36 days; sore arm; Loss of mobility (left arm); No range of motion (left arm)/could not use her arm for 4 weeks; Tenderiness; thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) and MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm). On 27-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) (seriousness criterion disability), MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) (seriousness criterion disability) and TENDERNESS (Tenderiness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Receiving her second dose past 36 days) and MYALGIA (sore arm). On 26-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm) had resolved. On 15-Mar-2021, INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) and MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) had resolved. At the time of the report, TENDERNESS (Tenderiness) and MYALGIA (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Receiving her second dose past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.  It was reported that the patient will be receiving the second dose on 27 Jul 2021.  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-Jul-2021: Address, New events were 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Yellow skin
Clinical narrative: I have a small tumor on pancreas; dark urine; Blond stools; yellowing skin; hilar cholangio carcinoma; small tumor on my liver; Persistent itching all over body/Itching moves; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGIOCARCINOMA (hilar cholangio carcinoma) and HEPATIC NEOPLASM (small tumor on my liver) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic leukemia, Bile duct cancer and Liver spots (Spot on liver).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (Persistent itching all over body/Itching moves). On an unknown date, the patient experienced CHOLANGIOCARCINOMA (hilar cholangio carcinoma) (seriousness criterion medically significant), HEPATIC NEOPLASM (small tumor on my liver) (seriousness criterion medically significant), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, CHOLANGIOCARCINOMA (hilar cholangio carcinoma), HEPATIC NEOPLASM (small tumor on my liver), PRURITUS (Persistent itching all over body/Itching moves), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin) outcome was unknown.            No concomitant medication reported.  Treatment included, anti-histamines couple of times a day and  steroids prescribed by the doctor was reported  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine.   This case was linked to MOD21-035148 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up document contains new events.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine. MOD21-035148:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Heart rate
Clinical narrative: Anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Misoprostol on 01-Jan-2016 and Amoxicillin on 01-Jan-2019. Past adverse reactions to the above products included Anaphylaxis with Amoxicillin and Misoprostol. Concurrent medical conditions included Cystitis interstitial since 01-Jan-2004.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 13-Apr-2021 to 20-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form. On 13-Apr-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Heart rate: high (High) Fast heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had allergic side effect ongoing after vaccination for 1-2 weeks. In addition, the patient had allergic side effects to the Vitamin D3 supplement (SOB and tachycardia) and the Macrobid (anaphylaxis) which was after the moderna 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.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received from initial reporter: Patient demographics, medical history, and treatment medications were added. Events dyspnea, palpitations, dizziness, tremor, Blood Pressure fluctuation were deleted and subsumed under anaphylactic reaction. This case was upgraded from non-serious to serious due to the addition of new anaphylactic reaction.; 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, COVID19
Symptoms: Blood test, Illness, Syncope
Clinical narrative: fainted three minutes after the first shot; Doctor got really sick after the second shot of the Moderna Vaccine; 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 SYNCOPE (fainted three minutes after the first shot) 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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 100 mcg. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 60 mcg. On an unknown date, the patient experienced SYNCOPE (fainted three minutes after the first shot) (seriousness criterion medically significant) and ILLNESS (Doctor got really sick after the second shot of the Moderna Vaccine). At the time of the report, SYNCOPE (fainted three minutes after the first shot) and ILLNESS (Doctor got really sick after the second shot of the Moderna Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Blood test: igg antibodies present (normal) IgG antibodies were present.         Concomitant medications were not provided.  Treatment information was not provided.  Patient stated that she never got sick as she never took second shot. She stated Moderna dose was too high and she should had to robust protection with moderna vaccine as she read it was 80% effective. Patient was asking advise.  This case concerns an adult patient of unknown age and gender with a serious unexpected event of syncope, and nonserious illness. Syncope latency 3 minutes after first 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.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received contains, New event and Co-suspect drug added. Lab details added conservatively as per the SD.; Sender's Comments: This case concerns an adult patient of unknown age and gender with a serious unexpected event of syncope, and nonserious illness. Syncope latency 3 minutes after first 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fluid retention
Clinical narrative: Atrial fibrillation; Water rentention; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 69-year-old male 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 01-Apr-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 25-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and FLUID RETENTION (Water rentention). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and FLUID RETENTION (Water rentention) outcome was unknown.            The concomitant medications were not reported. The 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. 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 events, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (heart inflammation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (heart inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (heart inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immune thrombocytopenia, Platelet count, SARS-CoV-2 antibody test
Clinical narrative: The platelet count exhibited marked decrease after dose 2.; Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) in a 72-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.      Concurrent medical conditions included Immune thrombocytopenia. Concomitant products included ELTROMBOPAG for Immune thrombocytopenia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses). The patient was treated with ELTROMBOPAG for Adverse event, at a dose of 50 milligram once a day and ELTROMBOPAG for Adverse event, at a dose of 75 milligram once a day. At the time of the report, IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: Three days after taking dose 2 of vaccine the platelet count fell to 27 x 10^9/L (86%decrease) prompting an increase in eltrombopag to 75 mg daily and 205 10^9/L (Inconclusive) In response to 3 doses of eltrombopag, the platelet count increased to 205 x 10^9/L. In 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) to be possibly related.    The eltrombopag daily dose was adjusted to compensate for dynamic platelet destruction   This case was linked to MOD-2021-263889, MOD-2021-263965, MOD-2021-263970 (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. Chronic Immune Thrombocytopenia could be potentially confounders/co-suspects for the events.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. No laboratory data was provided. No treatment information was provided.  Very limited information regarding  this event has been provided at this time. No further information  is expected at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding  this event has been provided at this time. No further information  is expected at this time.; Reported Cause(s) of Death: unknown cause of death
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anything; hard for her to breath; Could hardly walk; Arm pain; Not like herself; felt wipe out; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (heart became inflamed) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDITIS (heart became inflamed) (seriousness criterion medically significant), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated). On 07-Apr-2021, MYOCARDITIS (heart became inflamed), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated) had resolved.            Treatment medication were not reported. Concomitant products were not provided.  After the second dose, the patient felt wiped out, weak, couldn't do anything, which was described as "not like herself". At the same time, the patient couldn't lay down.  These symptoms lasted for about five weeks.  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.; 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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myocarditis, Nausea, Pain in extremity, Pneumonitis
Clinical narrative: heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anything; hard for her to breath; Could hardly walk; Arm pain; Not like herself; felt wipe out; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (heart became inflamed) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDITIS (heart became inflamed) (seriousness criterion medically significant), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated). On 07-Apr-2021, MYOCARDITIS (heart became inflamed), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated) had resolved.            Treatment medication were not reported. Concomitant products were not provided.  After the second dose, the patient felt wiped out, weak, couldn't do anything, which was described as "not like herself". At the same time, the patient couldn't lay down.  These symptoms lasted for about five weeks.  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.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Chest discomfort, Fatigue, Neuralgia
Clinical narrative: Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.; She is experiencing enough pain to give someone a Heart Attack/Chest congestion; Periodic neurologic pain; Totally out of it; Knees hurt; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Family history included Guillain-Barre syndrome.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) (seriousness criterion medically significant), CHEST DISCOMFORT (She is experiencing enough pain to give someone a Heart Attack/Chest congestion), NEURALGIA (Periodic neurologic pain), SOMNOLENCE (Totally out of it), ARTHRALGIA (Knees hurt) and FATIGUE (Exhausted). At the time of the report, ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.), CHEST DISCOMFORT (She is experiencing enough pain to give someone a Heart Attack/Chest congestion), NEURALGIA (Periodic neurologic pain), SOMNOLENCE (Totally out of it), ARTHRALGIA (Knees hurt) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Patient was diagnosed with COVID back in JAN-2021.         The concomitant medication included was non specified blood pressure medication. No treatment information was provided by reporter.  Company comments:Very limited information regarding these events have been provided at this time. Further information has been requested.   This case was linked to MOD-2021-267517 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.; She is experiencing enough pain to give someone a Heart Attack/Chest congestion; Periodic neurologic pain; Totally out of it; Knees hurt; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Family history included Guillain-Barre syndrome.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) (seriousness criterion medically significant), CHEST DISCOMFORT (She is experiencing enough pain to give someone a Heart Attack/Chest congestion), NEURALGIA (Periodic neurologic pain), SOMNOLENCE (Totally out of it), ARTHRALGIA (Knees hurt) and FATIGUE (Exhausted). At the time of the report, ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.), CHEST DISCOMFORT (She is experiencing enough pain to give someone a Heart Attack/Chest congestion), NEURALGIA (Periodic neurologic pain), SOMNOLENCE (Totally out of it), ARTHRALGIA (Knees hurt) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Patient was diagnosed with COVID back in JAN-2021.         The concomitant medication included was non specified blood pressure medication. No treatment information was provided by reporter.  Company comments:Very limited information regarding these events have been provided at this time. Further information has been requested.   This case was linked to MOD-2021-267517 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Epilepsy, Generalised tonic-clonic seizure, Mouth haemorrhage, Seizure
Clinical narrative: tonic-clonic seizures; Husband is now an epileptic; started convulsing; stop breathing; lots of blood coming out of his mouth; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (started convulsing), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 036B26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendectomy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (started convulsing) (seriousness criterion medically significant), DYSPNOEA (stop breathing) and MOUTH HAEMORRHAGE (lots of blood coming out of his mouth). On 22-Jul-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) (seriousness criterion medically significant) and EPILEPSY (Husband is now an epileptic) (seriousness criterion medically significant). At the time of the report, SEIZURE (started convulsing), DYSPNOEA (stop breathing), MOUTH HAEMORRHAGE (lots of blood coming out of his mouth), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) outcome was unknown.            Weeks after taking his second dose of the Moderna COVID-19 vaccine, on 24May2021, the patient started having convulsions, stopped breathing and his wife had to bring him to the hospital. Also started having lots of blood coming out of his mouth, at the hospital they said he could have bitten himself when having convulsions but they could not find signs of that. On 22Jul2021 the same thing happened, he started having convulsions, but there was no blood coming out of his mouth this time. The patient is now an epileptic and wife thinks he is screwed and she's scared that she may loose him. They said they're tonic-clonic seizures.   Patient did not take any medications prior to this.  Concomitant medications information not reported. Treatment information not 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. However, more information is required for further assessment.; 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. However, more information is required for further assessment.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passing out) 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 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (passing out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passing out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment details not provided.; 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.