chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Pyrexia, Thrombosis, Vertigo
Clinical narrative: vertigo; Migraine type headaches; Flu like symptoms; Fever; Blood clot in right upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and THROMBOSIS (Blood clot in right upper arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot in right upper arm) (seriousness criterion medically significant), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was hospitalized on 28-Feb-2021 due to VERTIGO. At the time of the report, VERTIGO (vertigo), THROMBOSIS (Blood clot in right upper arm), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. No corrective treatment was provided.  28-Feb-2021, he was hospitalized for vertigo for 3 days.   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. Very limited information regarding these events have been provided at this time.  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. Very limited information regarding these events have been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Throat tightness
Clinical narrative: anaphylaxis; throat tightening; chills; 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 ANAPHYLACTIC REACTION (anaphylaxis) 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 was provided by the reporter.  Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.   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 ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant), THROAT TIGHTNESS (throat tightening) and CHILLS (chills). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis), THROAT TIGHTNESS (throat tightening) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion hospitalization). At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia) requiring hospitalization , meds and platelet infusion 4 days following the Moderna vaccine with no details regarding presenting symptoms, platelet count, treatment outcome.     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.  This case was linked to MOD-2021-096593, US-MODERNATX, INC.-MOD-2021-096593 (Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. MOD-2021-096593:Same Literature article (11 patients) US-MODERNATX, INC.-MOD-2021-096593:Same literature article (37-yo male)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Haematemesis, Malaise, Nausea
Clinical narrative: black diarrhea; Stomach pain on left side under ribs, felt a lot of pressure; vomiting with blood; general malaise; fever; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (vomiting with blood) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031A21R) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (general malaise), PYREXIA (fever) and NAUSEA (nausea). On 15-Mar-2021, the patient experienced HAEMATEMESIS (vomiting with blood) (seriousness criterion medically significant), DIARRHOEA (black diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain on left side under ribs, felt a lot of pressure). At the time of the report, HAEMATEMESIS (vomiting with blood), MALAISE (general malaise), DIARRHOEA (black diarrhea), ABDOMINAL PAIN UPPER (Stomach pain on left side under ribs, felt a lot of pressure), PYREXIA (fever) and NAUSEA (nausea) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.  Concomitant product use was not provided by the reporter. Treatment medications included Nexium and ondansetron.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: black diarrhea; Stomach pain on left side under ribs, felt a lot of pressure; vomiting with blood; general malaise; fever; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (vomiting with blood) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031A21R) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (general malaise), PYREXIA (fever) and NAUSEA (nausea). On 15-Mar-2021, the patient experienced HAEMATEMESIS (vomiting with blood) (seriousness criterion medically significant), DIARRHOEA (black diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain on left side under ribs, felt a lot of pressure). At the time of the report, HAEMATEMESIS (vomiting with blood), MALAISE (general malaise), DIARRHOEA (black diarrhea), ABDOMINAL PAIN UPPER (Stomach pain on left side under ribs, felt a lot of pressure), PYREXIA (fever) and NAUSEA (nausea) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.  Concomitant product use was not provided by the reporter. Treatment medications included Nexium and ondansetron.  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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Lip swelling, Oropharyngeal discomfort
Clinical narrative: mild anaphylactic reaction; Throat felt funny; Throat felt swollen; couldn't breath properly; coughing; wheezing; lip got swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (mild anaphylactic reaction) in a 33-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 Drug allergy (Allergic to sulfa) and Asthma.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 28-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (mild anaphylactic reaction) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen). At the time of the report, ANAPHYLACTIC REACTION (mild anaphylactic reaction), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen) was resolving.            No relevant concomitant medications were provided.  She used inhalers and other at home treatment and thought her Asthma is acting up. She went to her Doctor who told her that she might had the mild anaphylactic reaction from the Vaccine. He gave her prednisone and diphenhydramine to use and she is feeling much better now.  Action taken with mRNA in respect to the events was not applicable.   This case was linked to MOD-2021-100620 (E2B Linked Report).; Sender's Comments:  MOD-2021-100620:dose 1 case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Wheezing
Clinical narrative: mild anaphylactic reaction; Throat felt funny; Throat felt swollen; couldn't breath properly; coughing; wheezing; lip got swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (mild anaphylactic reaction) in a 33-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 Drug allergy (Allergic to sulfa) and Asthma.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 28-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (mild anaphylactic reaction) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen). At the time of the report, ANAPHYLACTIC REACTION (mild anaphylactic reaction), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen) was resolving.            No relevant concomitant medications were provided.  She used inhalers and other at home treatment and thought her Asthma is acting up. She went to her Doctor who told her that she might had the mild anaphylactic reaction from the Vaccine. He gave her prednisone and diphenhydramine to use and she is feeling much better now.  Action taken with mRNA in respect to the events was not applicable.   This case was linked to MOD-2021-100620 (E2B Linked Report).; Sender's Comments:  MOD-2021-100620:dose 1 case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history has been provided.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced COVID-19 (Positive COVID-19) (seriousness criteria hospitalization, medically significant and intervention required). The patient was hospitalized on 16-Apr-2021 due to COVID-19. At the time of the report, COVID-19 (Positive COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test positive: Positive.     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.   The patient was administered monoclonal antibodies on 16-Apr-2021 as a treatment of the event. The reporter stated the patient has recovered and inquired if it is advisable to give the second dose of the vaccine. His clarification request was promptly answered by an agent, confirming the second dose is safe to administer if the patient has recovered completely. It was further specified that the second dose should be given within the recommended interval and no later. Concomitant medications have not been specified.; Sender's Comments: 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: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Hallucination, Headache, Loss of consciousness, Pain in extremity
Clinical narrative: Passed out; Hallucination; Chest tightness; Sore arm; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and HALLUCINATION (Hallucination) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), HALLUCINATION (Hallucination) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest tightness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HALLUCINATION (Hallucination), CHEST DISCOMFORT (Chest tightness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown. Patient was hospitalized due to vehicular accident          Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  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.; 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.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B218) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Hypertension, VITAMIN D3, VITAMIN B COMPLEX and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three days after the shot on 13-Apr-2021, the patient experienced tenderness and rash on the left armpit and arm that turned to hives and bump the next day on 14-Apr-2021 and blister the day after and on 15-Apr-2021 with some new blisters on his chest. Ten days later on 23-Apr-2021, he was diagnosed with shingles by health care provider and he continued to have itchy blisters and a few extra blisters on his back. He got treatment anti-viral agents, 500mg Famciclovir, Benadryl and Hydrocortisone. He asked if this shot might cause shingles and asked if he could still get his second dose given the anti-viral medications and current conditions.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: Chills; Weakness; Headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), ASTHENIA (Weakness) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), ASTHENIA (Weakness) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, CHILLS (Chills), ASTHENIA (Weakness) and HEADACHE (Headache) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient received 1st dose of Moderna vaccine on 06-Apr-2021 and on 07-Apr-2021 started having chills, weakness, headache everyday. His father went to doctor twice and doctor gave him IV but no medication and told him these are side effects from vaccine and could not do anything. The patient's son did not have vaccination card so he did not provide information about lot number.The physician gave him intravenous fluid but no medication and told him these are side effects from Moderna vaccine and can not do anything.  The concomitant medications were 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.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Computerised tomogram, Gastritis, Haematemesis
Clinical narrative: inflamed stomach; Hurts to breath under left breast by the rib; MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad; continued vomiting; Once she eats, she starts vomiting blood; Feels thirsty too; weak legs; stomach pain left side; chills; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Once she eats, she starts vomiting blood) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21R and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain left side), CHILLS (chills) and PYREXIA (fever). On 15-Apr-2021, the patient experienced HAEMATEMESIS (Once she eats, she starts vomiting blood) (seriousness criterion medically significant), THIRST (Feels thirsty too) and MUSCULAR WEAKNESS (weak legs). On 29-Apr-2021, the patient experienced GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad) and VOMITING (continued vomiting). At the time of the report, HAEMATEMESIS (Once she eats, she starts vomiting blood) had not resolved and ABDOMINAL PAIN UPPER (stomach pain left side), THIRST (Feels thirsty too), MUSCULAR WEAKNESS (weak legs), GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad), VOMITING (continued vomiting), CHILLS (chills) and PYREXIA (fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Computerised tomogram: abnormal (abnormal) CT scan showed inflamed stomach.  The action taken with mRNA-1273 in response to the event was not applicable.  Treatment for the events included Nexium and ondansetron.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Painful respiration, Pyrexia, Thirst, Vaccination complication
Clinical narrative: inflamed stomach; Hurts to breath under left breast by the rib; MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad; continued vomiting; Once she eats, she starts vomiting blood; Feels thirsty too; weak legs; stomach pain left side; chills; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Once she eats, she starts vomiting blood) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21R and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain left side), CHILLS (chills) and PYREXIA (fever). On 15-Apr-2021, the patient experienced HAEMATEMESIS (Once she eats, she starts vomiting blood) (seriousness criterion medically significant), THIRST (Feels thirsty too) and MUSCULAR WEAKNESS (weak legs). On 29-Apr-2021, the patient experienced GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad) and VOMITING (continued vomiting). At the time of the report, HAEMATEMESIS (Once she eats, she starts vomiting blood) had not resolved and ABDOMINAL PAIN UPPER (stomach pain left side), THIRST (Feels thirsty too), MUSCULAR WEAKNESS (weak legs), GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad), VOMITING (continued vomiting), CHILLS (chills) and PYREXIA (fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Computerised tomogram: abnormal (abnormal) CT scan showed inflamed stomach.  The action taken with mRNA-1273 in response to the event was not applicable.  Treatment for the events included Nexium and ondansetron.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: inflamed stomach; Hurts to breath under left breast by the rib; MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad; continued vomiting; Once she eats, she starts vomiting blood; Feels thirsty too; weak legs; stomach pain left side; chills; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Once she eats, she starts vomiting blood) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21R and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain left side), CHILLS (chills) and PYREXIA (fever). On 15-Apr-2021, the patient experienced HAEMATEMESIS (Once she eats, she starts vomiting blood) (seriousness criterion medically significant), THIRST (Feels thirsty too) and MUSCULAR WEAKNESS (weak legs). On 29-Apr-2021, the patient experienced GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad) and VOMITING (continued vomiting). At the time of the report, HAEMATEMESIS (Once she eats, she starts vomiting blood) had not resolved and ABDOMINAL PAIN UPPER (stomach pain left side), THIRST (Feels thirsty too), MUSCULAR WEAKNESS (weak legs), GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad), VOMITING (continued vomiting), CHILLS (chills) and PYREXIA (fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Computerised tomogram: abnormal (abnormal) CT scan showed inflamed stomach.  The action taken with mRNA-1273 in response to the event was not applicable.  Treatment for the events included Nexium and ondansetron.  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling abnormal, Headache, Morbid thoughts, Suicidal ideation
Clinical narrative: Abdominal pain; Monster headache; Arm sore at injection site; Suicidal ideation; Felt unstable/sitting on the couch like a zombie; Morbid thinking; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Suicidal ideation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder, Vasculitis and Depression.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking). On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site). On 30-Apr-2021, SUICIDAL IDEATION (Suicidal ideation), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of these events included water and Anacin.  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.   Reporter did not allow further contact; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Abdominal pain; Monster headache; Arm sore at injection site; Suicidal ideation; Felt unstable/sitting on the couch like a zombie; Morbid thinking; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Suicidal ideation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder, Vasculitis and Depression.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking). On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site). On 30-Apr-2021, SUICIDAL IDEATION (Suicidal ideation), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of these events included water and Anacin.  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.   Reporter did not allow further contact; 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: F
Vaccine: COVID19
Symptoms: Back injury, Confusional state, Feeling abnormal, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: lost consciousness and blacked out; In the process of her fall, she also hurt her back; felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted; bit confused; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness and blacked out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced BACK INJURY (In the process of her fall, she also hurt her back), FEELING ABNORMAL (felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted) and CONFUSIONAL STATE (bit confused). On 23-Mar-2021 at 5:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness and blacked out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness and blacked out), BACK INJURY (In the process of her fall, she also hurt her back), FEELING ABNORMAL (felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted) and CONFUSIONAL STATE (bit confused) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: covid19 (Positive) diagnosis of COVID19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took Ibuprofen to relieve the pain after the fall. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  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
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cystitis, Neurogenic bladder, Neuropathy peripheral, Rheumatoid arthritis, Skin papilloma
Clinical narrative: Rheumatoid arthritis flare up in left shoulder; Spinal cord injury; Neurogenic bladder; Right foot with neuropathy, Neuropathy of right foot; Area periodically develope warts; Bladder infection; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder), SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection, Urostomy and Catheter placement. Concurrent medical conditions included Foot infection (with Humira) since February 2021, Sulfonamide allergy and Latex allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, METHOTREXATE for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) (seriousness criterion medically significant), SPINAL CORD INJURY (Spinal cord injury) (seriousness criterion medically significant), NEUROGENIC BLADDER (Neurogenic bladder) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot) (seriousness criterion medically significant), SKIN PAPILLOMA (Area periodically develope warts) (seriousness criterion medically significant) and CYSTITIS (Bladder infection) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) was resolving and SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) outcome was unknown.        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.   The patient experienced bladder infection in 2021.  The patient was treated with Nitrofurantoin started approximately on 01 Mar 2021.  Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal cord injury
Clinical narrative: Rheumatoid arthritis flare up in left shoulder; Spinal cord injury; Neurogenic bladder; Right foot with neuropathy, Neuropathy of right foot; Area periodically develope warts; Bladder infection; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder), SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection, Urostomy and Catheter placement. Concurrent medical conditions included Foot infection (with Humira) since February 2021, Sulfonamide allergy and Latex allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, METHOTREXATE for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) (seriousness criterion medically significant), SPINAL CORD INJURY (Spinal cord injury) (seriousness criterion medically significant), NEUROGENIC BLADDER (Neurogenic bladder) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot) (seriousness criterion medically significant), SKIN PAPILLOMA (Area periodically develope warts) (seriousness criterion medically significant) and CYSTITIS (Bladder infection) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) was resolving and SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) outcome was unknown.        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.   The patient experienced bladder infection in 2021.  The patient was treated with Nitrofurantoin started approximately on 01 Mar 2021.  Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: took the COVID test and it was positive; Did not get second dose after 36 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (took the COVID test and it was positive) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon operation. Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE in April 2021. Concurrent medical conditions included Diabetes, Gastritis, Vertigo, Depression and Thyroid disorder.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (took the COVID test and it was positive) (seriousness criterion hospitalization). On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose after 36 days). The patient was hospitalized on 22-Mar-2021 due to COVID-19. On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose after 36 days) had resolved. At the time of the report, COVID-19 (took the COVID test and it was positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unknown medications for diabetes, gastritis, vertigo, depression and thyroid disorder.  No treatment information was provided.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 with lot # 006B21A with an associated AE. 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: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 with lot # 006B21A with an associated AE. 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: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hip arthroplasty, Rash
Clinical narrative: neck rash; hip replacement; This spontaneous case was reported by a physician and describes the occurrence of HIP ARTHROPLASTY (hip replacement) in a 55-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On 15-Dec-2020, the patient experienced HIP ARTHROPLASTY (hip replacement) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (neck rash). At the time of the report, HIP ARTHROPLASTY (hip replacement) had resolved and RASH (neck rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   there is no reasonable possibility that the events of hip replacement surgery, after First dose of covid vaccine developed rash around neck and after second dose of covid vaccine patient was fatigue are related to humira (adalimumab); 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.