chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: confused; extremely weak; cold and clammy; barely could move arm; banged head on cabinet; overwhelming nausea; lost consciousness; arm hurt a little bit/throbbing pain; Felt fatigued; A spontaneous report was received from a consumer, who was also a 73-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurt a little bit/throbbing pain, felt fatigued, confused, overwhelming nausea, lost consciousness, banged her head on the cabinet, extremely weak, cold and clammy and barely could move arm .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, the patient received the first of the two planned doses of mRNA-1273 (batch# 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On the night of 13 Feb 20212, the patient experienced arm hurt a little bit and she felt fatigued.  In the early morning of 14 Feb 2021, the patient went to the bathroom.  On her way to the bathroom,  she felt confused and had overwhelming nausea.  She lost consciousness and banged her head on the cabinet.  Within second, she regained consciousness but felt extremely weak.  She could not recall how she got back to her bed.  The patient said she was cold and clammy at that time and she never got back to sleep.  During the day on 14 Feb 2021, the patient felt a throbbing pain on the arm where she got the injection.  She was not sure whether that was due to the injection or due to her fall when she lost consciousness.  She could barely move the arm.  Then she took a nap in the afternoon and was able to recover from her lack of sleep that night.    Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown (although her doctor advised her not to get the second dose given the reaction she had).  The outcome of the events was resolved on 15 Feb 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Additional information has been requested.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Deep vein thrombosis, Dyspnoea, Fibrin D dimer
Clinical narrative: Pulmonary embolism in her lungs; DVT in her leg; Chest pain in her right chest; Breathing was labored; Breaking out in hives; Chills; Dull Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, breathing was labored, pulmonary embolism in lungs, DVT in leg, chills, dull headache, heartbeat is up and stayed up , D-dimer levels were high and breaking out in hives, and shortness of breath.  Relevant  medical history included  cancer involving lungs . Relevant concomitant medication was not reported.  On 13 FEB 2021, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 FEB 2021, the patient experienced chills, headache, and heart rate increased.  On 27 FEB 2021, the patient experienced chest pain, dyspnea, urticaria, pulmonary embolism, deep vein thrombosis,  for which she  required hospitalization.  Relevant laboratory investigations included increased D-dimer.  Treatment for the events included Heparin and  oral blood thinner.  Action taken with mRNA-1273 in response to the events was unknown.  On 16 FEB 2021, the outcome of the event's chills, headache was considered as resolved. At the  time of this report, the outcome of the event's chest pain, dyspnoea, pulmonary embolism, deep vein thrombosis, heart rate increased, fibrin D dimer increased and urticaria were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the events Pulmonary embolism, DVT,  is Unlikely related to mRNA-1273 and a very limited information regarding these events has been provided.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pulmonary embolism, Urticaria
Clinical narrative: Pulmonary embolism in her lungs; DVT in her leg; Chest pain in her right chest; Breathing was labored; Breaking out in hives; Chills; Dull Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, breathing was labored, pulmonary embolism in lungs, DVT in leg, chills, dull headache, heartbeat is up and stayed up , D-dimer levels were high and breaking out in hives, and shortness of breath.  Relevant  medical history included  cancer involving lungs . Relevant concomitant medication was not reported.  On 13 FEB 2021, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 FEB 2021, the patient experienced chills, headache, and heart rate increased.  On 27 FEB 2021, the patient experienced chest pain, dyspnea, urticaria, pulmonary embolism, deep vein thrombosis,  for which she  required hospitalization.  Relevant laboratory investigations included increased D-dimer.  Treatment for the events included Heparin and  oral blood thinner.  Action taken with mRNA-1273 in response to the events was unknown.  On 16 FEB 2021, the outcome of the event's chills, headache was considered as resolved. At the  time of this report, the outcome of the event's chest pain, dyspnoea, pulmonary embolism, deep vein thrombosis, heart rate increased, fibrin D dimer increased and urticaria were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the events Pulmonary embolism, DVT,  is Unlikely related to mRNA-1273 and a very limited information regarding these events has been provided.  Further information has been requested
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Clostridium difficile colitis, Decreased appetite, Diarrhoea, Fall
Clinical narrative: Diagnosed with C. difficile.; Nasty abdominal cramps; Passing out; Lack of appetite; Diarrhea; Falling; Arm pain; A spontaneous report was received from a consumer concerning a 68 year old, female patient who developed severe stomach cramps, passed out, lack of appetite, falling and diarrhea.   The patient's medical history was not provided. Concomitant product use included Tums (up to 2 tabs five times per day), Gas-X, Pepto, Probiotic (30 billion units) and clindamycin, all were used for an unknown indication.   The patient received the first of two planned doses of mRNA-1273 (Batch number: 010M20A) on 27 Jan 2021. On 24 Feb 2021, approximately 5 hours prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After the first shot of vaccine the patient reported no reactions other than mild arm pain. After the second dose of vaccine the patient had gastrointestinal distress. The patient had severe stomach cramps, she passed out while on the toilet, she fell in toilet and her husband helped to stabilize, lack of appetite and diarrhea. Patient had been instructed to adhere to a bland diet consisting of toast, rice, bananas, broth, and Pedialyte by her physician. She reported that she was hospitalized on 09 Mar 2021 and was released on 11 Mar 2021. She stated that she ended up being diagnosed with C. difficile. She stated the gastroenterologist did not believe the C. difficile was caused directly from the second dose in the series from Moderna's COVID-19 vaccination. Consumer reported that she was originally was taking a three days course of clindamycin which is a suspect for C. difficile. She was prescribed a 10 days course of vancomycin. Treatment for the event included Bland diet, Tums, Gas- X, Pepto, Probiotic.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, severe stomach cramps, passed out, lack of appetite, diarrhea, was considered resolving.; Reporter'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: Loss of consciousness, Pain in extremity
Clinical narrative: Diagnosed with C. difficile.; Nasty abdominal cramps; Passing out; Lack of appetite; Diarrhea; Falling; Arm pain; A spontaneous report was received from a consumer concerning a 68 year old, female patient who developed severe stomach cramps, passed out, lack of appetite, falling and diarrhea.   The patient's medical history was not provided. Concomitant product use included Tums (up to 2 tabs five times per day), Gas-X, Pepto, Probiotic (30 billion units) and clindamycin, all were used for an unknown indication.   The patient received the first of two planned doses of mRNA-1273 (Batch number: 010M20A) on 27 Jan 2021. On 24 Feb 2021, approximately 5 hours prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After the first shot of vaccine the patient reported no reactions other than mild arm pain. After the second dose of vaccine the patient had gastrointestinal distress. The patient had severe stomach cramps, she passed out while on the toilet, she fell in toilet and her husband helped to stabilize, lack of appetite and diarrhea. Patient had been instructed to adhere to a bland diet consisting of toast, rice, bananas, broth, and Pedialyte by her physician. She reported that she was hospitalized on 09 Mar 2021 and was released on 11 Mar 2021. She stated that she ended up being diagnosed with C. difficile. She stated the gastroenterologist did not believe the C. difficile was caused directly from the second dose in the series from Moderna's COVID-19 vaccination. Consumer reported that she was originally was taking a three days course of clindamycin which is a suspect for C. difficile. She was prescribed a 10 days course of vancomycin. Treatment for the event included Bland diet, Tums, Gas- X, Pepto, Probiotic.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, severe stomach cramps, passed out, lack of appetite, diarrhea, was considered resolving.; Reporter'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: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Product administration error, Underdose, Vaccination site discharge, Vaccination site haemorrhage
Clinical narrative: Blood mixed with the vaccine ran down his arm; Felt like the lady didn't puncture it correctly; Vaccine site discharge; wrong twchnique; exposure via skin; Vaccine ran down his arm; A spontaneous report was received from a 51-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood mixed with the vaccine ran down his arm, felt like the lady didn't puncture it correctly and vaccine ran down his arm, vaccination site discharge, wrong technique was used in product usage process, exposure via skin contact and  vaccine under dose.    The patient's medical history was not provided. No concomitant product use was reported.  On 01-MAR-2021, the patient received their one of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly for prophylaxis of COVID-19 infection.   While vaccinating the lady did not puncture it correctly and blood mixed with vaccine ran down from his arm, there was vaccination site discharge, the wrong techniques was use in product usage process, exposure via skin contact and vaccine under dose.  Treatment for the event was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events blood mixed with the vaccine ran down his arm was unknown, felt like the lady didn't puncture it correctly, vaccine ran down his arm was recovered/ resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # 010A21A with associated Adverse events of vaccination site bleeding and vaccination site discharge. 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: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Blood mixed with the vaccine ran down his arm; Felt like the lady didn't puncture it correctly; Vaccine site discharge; wrong twchnique; exposure via skin; Vaccine ran down his arm; A spontaneous report was received from a 51-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood mixed with the vaccine ran down his arm, felt like the lady didn't puncture it correctly and vaccine ran down his arm, vaccination site discharge, wrong technique was used in product usage process, exposure via skin contact and  vaccine under dose.    The patient's medical history was not provided. No concomitant product use was reported.  On 01-MAR-2021, the patient received their one of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly for prophylaxis of COVID-19 infection.   While vaccinating the lady did not puncture it correctly and blood mixed with vaccine ran down from his arm, there was vaccination site discharge, the wrong techniques was use in product usage process, exposure via skin contact and vaccine under dose.  Treatment for the event was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events blood mixed with the vaccine ran down his arm was unknown, felt like the lady didn't puncture it correctly, vaccine ran down his arm was recovered/ resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # 010A21A with associated Adverse events of vaccination site bleeding and vaccination site discharge. 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: Body temperature, Illness, Loss of consciousness, Nausea, Peripheral swelling
Clinical narrative: Fever (T101F); Passed out  for 10 minutes; Felt sick; Arm swollen and big; Big rash on the area; Felt like vomiting; A spontaneous report was received from a consumer concerning a 68 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm swollen and big rash on the area, felt sick (illness), felt like vomiting (nausea) , passed out for 10 minutes (loss of consciousness), and fever (pyrexia).   The patient's medical history was not provided. No information of the concomitant medication was given.   On Mar-01-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 batch no: 022M20A in the left arm for prophylaxis of COVID-19 infection.  On Mar-02-2021, The patient experienced arm swollen and big, big rash on the area, felt sick, felt like vomiting, passed out for 10 minutes.  On Mar-03-2021, The patient experienced fever(101F).  No treatment information was given.   The outcome of the events arm swollen and big rash on the area, felt sick (illness), felt like vomiting (nausea) , passed out for 10 minutes (loss of consciousness), and fever (pyrexia) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: Fever (T101F); Passed out  for 10 minutes; Felt sick; Arm swollen and big; Big rash on the area; Felt like vomiting; A spontaneous report was received from a consumer concerning a 68 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm swollen and big rash on the area, felt sick (illness), felt like vomiting (nausea) , passed out for 10 minutes (loss of consciousness), and fever (pyrexia).   The patient's medical history was not provided. No information of the concomitant medication was given.   On Mar-01-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 batch no: 022M20A in the left arm for prophylaxis of COVID-19 infection.  On Mar-02-2021, The patient experienced arm swollen and big, big rash on the area, felt sick, felt like vomiting, passed out for 10 minutes.  On Mar-03-2021, The patient experienced fever(101F).  No treatment information was given.   The outcome of the events arm swollen and big rash on the area, felt sick (illness), felt like vomiting (nausea) , passed out for 10 minutes (loss of consciousness), and fever (pyrexia) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Thyrotoxic crisis
Clinical narrative: Thyroid storm; Incomplete course of vaccination; A spontaneous report was received from a consumer (patient) concerning 68 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and was hospitalized due to thyroid storm and ill.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot: 025-J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 02-Feb-2021, the patient got ill and went to the hospital for seven days. The patient reported that she had a thyroid storm. The patient stated she did not have side effects from the vaccine first dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  On 09-Feb-2021, the events of thyroid storm (thyrotoxic crisis) and ill (illness) were resolved.; Reporter's Comments: Based on reporter's causality, the events are assessed as unlikely related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration
Clinical narrative: Hospitalized because of a dehydration; This spontaneous report was received on 03 Mar 2021 from a consumer concerning, a patient of unspecified gender and age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized because of a dehydration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was hospitalized because of a dehydration. The reporter wanted to know what happens if the second dose of the vaccine is given after the 42 days after the first shot. No treatment information was provided.  Action taken with suspect drug mRNA-1273 was unknown.  The outcome of the event, hospitalized because of a dehydration, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Illness
Clinical narrative: faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday started to get itch and rash around the injection site; Was sick for days; joint pains; fatigue; headache; muscle pain; chills; sore arm; A spontaneous report was received from a consumer who was an  82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills, itch and rash around the injection site and faints when I get up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03-Mar-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Mar-2021, the patient experienced the events sore arm. She reported that she was sick for days, suffered fatigue, headache, muscle and joint pain and chills.  On 06-Mar-2021, she stated that her vaccination site started to itch and a rash developed around it and that she felt tired all day.  On 07-Mar-2021, she reported that the redness and itchiness at the injection site was gone and that she felt better but still like when she had Covid in the past.  Additionally, patient reported that she fainted when she got up (date unknown).     Treatment included paracetamol 2 tablets on 06-Mar-2021 in the evening.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itch and rash around the injection site, was considered recovered/resolved. The outcome of the events, sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills and faints when I get up, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Syncope, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday started to get itch and rash around the injection site; Was sick for days; joint pains; fatigue; headache; muscle pain; chills; sore arm; A spontaneous report was received from a consumer who was an  82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills, itch and rash around the injection site and faints when I get up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03-Mar-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Mar-2021, the patient experienced the events sore arm. She reported that she was sick for days, suffered fatigue, headache, muscle and joint pain and chills.  On 06-Mar-2021, she stated that her vaccination site started to itch and a rash developed around it and that she felt tired all day.  On 07-Mar-2021, she reported that the redness and itchiness at the injection site was gone and that she felt better but still like when she had Covid in the past.  Additionally, patient reported that she fainted when she got up (date unknown).     Treatment included paracetamol 2 tablets on 06-Mar-2021 in the evening.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itch and rash around the injection site, was considered recovered/resolved. The outcome of the events, sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills and faints when I get up, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Diverticulum, Vaccination site pain
Clinical narrative: diverticulosis; pain at injection site; A spontaneous report was received from a consumer concerning a 70 year old male patient, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced diverticulosis and pain at injection site.  The patients medical history was not provided. No relevant Concomitant medications were reported.  On 02 mar 2021,prior to the onset of events, the Patient received the first of two planned dose of mRNA-1273(Lot number: 022M20A ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 02 mar 2021, patient experienced pain at the injection site and diverticulosis. The patient was admitted to Hospital on 02 mar 2021. No surgery performed. Discharged on 04 mar 2021.The event caused two days of hospitalization.   Treatment for the event included Amoxicillin . Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event diverticulosis and pain at injection site was not provided.; Reporter'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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Immunology test abnormal
Clinical narrative: Low Immune results in regular blood workup; A spontaneous report was received from a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lowimmune results in regular blood workup.  The patient's current conditions includes kidney problems. The patient was on multiple unknown concomitant medications.  On 04-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 83605) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 08-Feb-2021, 5 days after receiving the vaccine, the patient completed routine blood work which showed her immune system was down. The patient and her physician were concerned if it was because of the vaccine. The patient was scheduled for her second shot of vaccine on 04-MAR-2021, but it was rescheduled to 18-MAR-2021. The patient wanted to know if this change in blood work was because of the vaccine and if she can take the second dose on 18-MAR-2021.  Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, low immune results in regular blood workup was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoxia, Myalgia, Nausea
Clinical narrative: O2 saturations is getting low; Fever; Chills; Muscle aches and pain; Nausea; Fatigue; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced saturations was getting low, fever, chills, muscle aches and pain, nausea, fatigue.  The patient's medical history included COVID-19, eight months ago. No relevant concomitant medications were reported.  On 04 Mar 2021, at 10:30 am and 10-11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 029A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the patient started covid-19 like symptoms fatigue, muscle aches and pain, chills, nausea, fever, and his oxygen saturations was getting low at 93 percent. No treatment information was provided.  The seriousness criterion for the event his oxygen saturations was getting low was medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, saturations was getting low, fever, chills, muscle aches and pain, nausea, fatigue was unknown.  The reporter did not provide an assessment for the events saturations is getting low, fever, chills, muscle aches and pain, nausea, fatigue; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 10-11 hours after vaccination, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia
Clinical narrative: O2 saturations is getting low; Fever; Chills; Muscle aches and pain; Nausea; Fatigue; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced saturations was getting low, fever, chills, muscle aches and pain, nausea, fatigue.  The patient's medical history included COVID-19, eight months ago. No relevant concomitant medications were reported.  On 04 Mar 2021, at 10:30 am and 10-11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 029A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the patient started covid-19 like symptoms fatigue, muscle aches and pain, chills, nausea, fever, and his oxygen saturations was getting low at 93 percent. No treatment information was provided.  The seriousness criterion for the event his oxygen saturations was getting low was medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, saturations was getting low, fever, chills, muscle aches and pain, nausea, fatigue was unknown.  The reporter did not provide an assessment for the events saturations is getting low, fever, chills, muscle aches and pain, nausea, fatigue; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 10-11 hours after vaccination, a causal relationship cannot be excluded. Further information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Pancreatitis acute
Clinical narrative: Acute pancreatitis; A spontaneous report  was received from a healthcare professional concerning a male patient  of unknown age,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  acute pancreatitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received  mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced acute pancreatitis.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, acute pancreatitis, was considered unknown .; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm, Erythema
Clinical narrative: Aneurysm; red splotches on arm skin; A spontaneous report was received from a Consumer concerning a HCP, male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced developed red splotches on his arm skin and patient died from an aneurysm.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their unknown of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date, after vaccination the patient had a reaction and developed red splotches on his arm skin.   Then four to five days, later in the hospital the patient died from an aneurysm (Seriousness criteria: death).  The cause of death was aneurysm. No autopsy details reported  No Laboratory investigations were provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of aneurysm was fatal and for erythema was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: Aneurysm
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Chills, Death, Headache, Myalgia
Clinical narrative: fever; chills; headaches; excruciating generalized body aches like he had just be ran over by a truck; nausea; patient has passed away; A spontaneous report from was received from a Consumer concerning a 74 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck, patient has passed away.    The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 23-02-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, The patient experienced  nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck.  The patient had a cardiac angiography on 24-02-2021. The result was unknown.  The patient was found dead on 06-03-2021.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck was recovering.  The patient died on 06-03-2021.   The information about the autopsy was unknown. The cause of the death was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. The patient must have been in some form of cardiac issues before death, that's reason why cardiac angiography was done.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; chills; headaches; excruciating generalized body aches like he had just be ran over by a truck; nausea; patient has passed away; A spontaneous report from was received from a Consumer concerning a 74 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck, patient has passed away.    The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 23-02-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, The patient experienced  nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck.  The patient had a cardiac angiography on 24-02-2021. The result was unknown.  The patient was found dead on 06-03-2021.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck was recovering.  The patient died on 06-03-2021.   The information about the autopsy was unknown. The cause of the death was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. The patient must have been in some form of cardiac issues before death, that's reason why cardiac angiography was done.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Rash
Clinical narrative: Walks with a walker because is without stability to walk; Rash in both legs; A spontaneous report was received from a consumer (patient) who is a 85-year-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash in both legs (rash) and the use of a walker because is without stability to walk (balance disorder).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 22-Feb-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 08-Mar-2021, the patient experienced a rash in both legs and walked with a walker because was without stability to walk.  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 is not applicable.  The events of rash in both legs (rash), walks with a walker because is without stability to walk (balance disorder) were unresolved.  The reporter did not provide an assessment for the events rash in both legs (rash), walks with a walker because is without stability to walk (balance disorder).; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure increased, Blood pressure systolic, Cardiac stress test, Dehydration
Clinical narrative: blood pressure was going real high, then go low; dehydration; diarrhea; blood pressure would drop to 40; will go upto walking rate 95 to lower 100s; heart rate normally stays 60s - 70s (averages 66 for resting rate); heart rate going up now; A spontaneous report was received from a consumer who is a 82-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase, which led to hospitalization.   The patient's medication history included diabetes and high blood pressure. Concomitant medications included amlodipine , irbesartan and pravastatin.  On 21-Jan-2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 012L20A ) intramuscularly in the the left arm for prophylaxis  of COVID-19 infection.  The patient referred he had diarrhea prior to the administration of the vaccine. Following the vaccine administration, he continued having the diarrhea during 3 weeks that made him lost a lot of fluids. He attended to the ER several times for dehydration but in the last visit, he got admitted due to increased blood pressure, dehydration, increased heart rate and prior history of diabetes.   Laboratory details included electrocardiogram, stress test. Treatment information included fluids,taken off metformin and metoprolol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Electrocardiogram, Heart rate increased, Heart rate normal, Heart rate variability increased
Clinical narrative: blood pressure was going real high, then go low; dehydration; diarrhea; blood pressure would drop to 40; will go upto walking rate 95 to lower 100s; heart rate normally stays 60s - 70s (averages 66 for resting rate); heart rate going up now; A spontaneous report was received from a consumer who is a 82-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase, which led to hospitalization.   The patient's medication history included diabetes and high blood pressure. Concomitant medications included amlodipine , irbesartan and pravastatin.  On 21-Jan-2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 012L20A ) intramuscularly in the the left arm for prophylaxis  of COVID-19 infection.  The patient referred he had diarrhea prior to the administration of the vaccine. Following the vaccine administration, he continued having the diarrhea during 3 weeks that made him lost a lot of fluids. He attended to the ER several times for dehydration but in the last visit, he got admitted due to increased blood pressure, dehydration, increased heart rate and prior history of diabetes.   Laboratory details included electrocardiogram, stress test. Treatment information included fluids,taken off metformin and metoprolol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; A spontaneous report was received from a consumer concerning a female patient of 54-years-old who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.   The patient's medical history included Bell's palsy in the past (15 years ago). No relevant concomitant medications were reported.   On 02-Feb-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02-Mar-2021, the patient was diagnosed with Bell's palsy. Treatment for the event included steroid and antiviral medications.   Action taken with mRNA-1273 in response to the event was not reported.    The outcome of event Bell's palsy was considered recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.  However, patient's prior medical history of Bell's palsy may have been contributory.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Ear infection, Pneumonia
Clinical narrative: Chest started hurting really bad like a stabbing pain; Getting worse to the point she couldn't breath; Double pneumonia; Ear infection; Back pain; A spontaneous report was received on 08 Mar 2021 from a consumer, who was a 56-year-old,  female patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced double pneumonia, ear infection, back pain, chest started hurting really bad like a stabbing pain/ chest pain, and getting worse to the point she couldn't breathe/ dyspnea.  The patient's medical history was not provided. Concomitant product used, included hydrochlorothiazide (HCTZ) 25 milligrams, rosuvastatin, losartan 50 milligrams, acetylsalicylic acid, benzonatate, ezetimibe 10 milligrams and dulaglutide.  On 03 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 043L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 03 Mar 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 03 Mar 2021, on the night of the same day of receiving the vaccine, the patient felt severely sick. The patient also felt like she got hit by a truck, she had back pain, extremely cold and felt like flu like symptoms. The next two days patient went to work. On Thursday of 04 Mar 2021, the patient's chest started to really hurt bad like a stabbing pain and kept getting worse to the point where she could not breath. On Saturday of 06 Mar 2021, patient had been to the urgent care and was diagnosed with double pneumonia and an ear infection. The patient was given an antibiotic shot in her hip and oral antibiotics doxycycline. The patient was quarantined till 09 Mar 2021.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, double pneumonia/ pneumonia, ear infection, back pain, chest started hurting really bad like a stabbing pain/ chest pain and getting worse to the point she couldn't breathe/ dyspnea, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: some trouble breathing; just a little wheezy at first; started not feeling well; Blood pressure reading high; Heart rate increased; A spontaneous report was received from a consumer who was also a 50 years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced some trouble breathing, started not feeling well, just a little wheezy at first, blood pressure increased and heart rate increased.  The patient's medical history included asthma and interstitial lung disease. Products known to have been used by the patient included were "oxygen tank" and "nebulizer medicines".  The patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) on 19 Feb 2021, approximately one day prior to the onset of the symptoms intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 19 Feb 2021 about 8 minutes after the shot, patient experienced not feeling well, breathing trouble, wheezy, high blood pressure and heart rate. Patient blood pressure shot up to 210/112, heart rate was 160.  On 19 Feb 2021, patient ended up in the hospital with IV steroids and other meds, she went home on 20 Feb 2021. On 22 Feb 2021, her breathing was worse and did not feel well and she was back in the hospital. On 26 Feb 2021 patient was discharged from the hospital.  Action taken with the drug in response to the events were not reported.  The outcome of the event, some trouble breathing was considered as not recovered. The outcome of events,just a little wheezy at first and started not feeling well, blood pressure increased and heart rate increased were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.