chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Fatigue, Headache, Nausea, Ophthalmoplegia
Clinical narrative: feeling tired; cant open her eyes for few minutes, it's like eyelids are paralyzed; her eyelids dropped; Achy; fever; nausea; headache; A spontaneous report was received from consumer, concerning herself, a 65-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a cant open her eyes for few minutes, it's like eyelids were paralyzed/ophthalmoplegia, her eyelids dropped/eyelid ptosis, achy/pain, fever/pyrexia, nausea, headache, feeling tired/fatigue.  The patient's medical procedure included corneal transplant and cataract surgery, historical condition included adverse reaction to a historical vaccine Hepatitis B vaccine. Concomitant medication was not reported.  On 04 March 2021, prior to onset of events, the patient received their first planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 04 March 2021, soon after taking mRNA-1273 vaccine, patient was achy, fever, nausea, headache and feeling tired for 3 to 4 days. On 08 Mar 2021, patient's eyelids dropped, couldn't open her eyes for few minutes, it's like eyelids were paralyzed. The event eyelids were paralyzed was assessed as serious as per IME. This came on and off for 4 days. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events patient's eyelids dropped, couldn't open her eyes for few minutes, it's like eyelids were paralyzed were resolved on 12-Mar-2021. The outcome of events achy, fever, nausea, headache and feeling tired was resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: feeling tired; cant open her eyes for few minutes, it's like eyelids are paralyzed; her eyelids dropped; Achy; fever; nausea; headache; A spontaneous report was received from consumer, concerning herself, a 65-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a cant open her eyes for few minutes, it's like eyelids were paralyzed/ophthalmoplegia, her eyelids dropped/eyelid ptosis, achy/pain, fever/pyrexia, nausea, headache, feeling tired/fatigue.  The patient's medical procedure included corneal transplant and cataract surgery, historical condition included adverse reaction to a historical vaccine Hepatitis B vaccine. Concomitant medication was not reported.  On 04 March 2021, prior to onset of events, the patient received their first planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 04 March 2021, soon after taking mRNA-1273 vaccine, patient was achy, fever, nausea, headache and feeling tired for 3 to 4 days. On 08 Mar 2021, patient's eyelids dropped, couldn't open her eyes for few minutes, it's like eyelids were paralyzed. The event eyelids were paralyzed was assessed as serious as per IME. This came on and off for 4 days. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events patient's eyelids dropped, couldn't open her eyes for few minutes, it's like eyelids were paralyzed were resolved on 12-Mar-2021. The outcome of events achy, fever, nausea, headache and feeling tired was resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperpyrexia
Clinical narrative: 106 degree fever; A spontaneous report  was received from a consumer concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed 106 degree fever/hyperpyrexia.  Medical history or concomitant product use was not reported.  On 26 Feb 2021, the patient received their first of  two planned doses of mRNA-1273 (batch number: 029a21a) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient developed 106 degrees fever that lasted one day. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event,106 degrees fever, was considered resolved on 27 Feb 2021.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Headache, Hypertensive crisis
Clinical narrative: High blood pressure of 197/97, and 226/106; pains in navel, aching; headache; dizziness; A spontaneous report was received from a consumer who was an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, high blood pressure of 197/97, blood pressure was 226/106, pains in navel, headache, and aching.  The patient's medical history included allergies to sulfa, tetanus shots, and amoxicillin. Products known to have been used by the patient, within two weeks prior to the events, included losartan.  On 23 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced dizziness. On 11 Mar 2021, the patient experienced a blood pressure of 197/97, and took two blood pressure pills. The patient went to the emergency room and her blood pressure was 226/106. The patient was not given any treatment at the hospital. The patient also reported having pains in navel and a headache.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events, hypertension, dizziness, pain, headache, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood urine, Fatigue, Feeling abnormal, Flank pain
Clinical narrative: Vaccine Induced Hepatitis; liver enzymes were elevated; terrible flank pain; very cranky since the shot; nauseous; fatigue; vomiting; severe epigastric pain; urine had blood in it; sicker than a dog; A spontaneous report was received from nurse, concerning herself, a 72-year-old female patient, who received  Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, sickness, epigastric pain, covid arm, rusty urine, vomiting, nauseous and vaccine induced hepatitis.  The patient medical history was reported as unknown. concomitant drugs were not provided.  On 4 Mar 2021, the patient received their first two of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the arm of prophylaxis of COVID-19 infection.  On 4 Mar 2021, Patient experienced fatigue, sickness, epigastric pain, rusty urine, blood I urine, vomiting, nauseous.   On 19 Mar 2021 for her annual exam and her liver enzymes were elevated, doctor states that it was vaccine induced hepatitis.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of all events were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Hepatitis, Illness, Nausea
Clinical narrative: Vaccine Induced Hepatitis; liver enzymes were elevated; terrible flank pain; very cranky since the shot; nauseous; fatigue; vomiting; severe epigastric pain; urine had blood in it; sicker than a dog; A spontaneous report was received from nurse, concerning herself, a 72-year-old female patient, who received  Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, sickness, epigastric pain, covid arm, rusty urine, vomiting, nauseous and vaccine induced hepatitis.  The patient medical history was reported as unknown. concomitant drugs were not provided.  On 4 Mar 2021, the patient received their first two of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the arm of prophylaxis of COVID-19 infection.  On 4 Mar 2021, Patient experienced fatigue, sickness, epigastric pain, rusty urine, blood I urine, vomiting, nauseous.   On 19 Mar 2021 for her annual exam and her liver enzymes were elevated, doctor states that it was vaccine induced hepatitis.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of all events were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis abnormal, Vomiting
Clinical narrative: Vaccine Induced Hepatitis; liver enzymes were elevated; terrible flank pain; very cranky since the shot; nauseous; fatigue; vomiting; severe epigastric pain; urine had blood in it; sicker than a dog; A spontaneous report was received from nurse, concerning herself, a 72-year-old female patient, who received  Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, sickness, epigastric pain, covid arm, rusty urine, vomiting, nauseous and vaccine induced hepatitis.  The patient medical history was reported as unknown. concomitant drugs were not provided.  On 4 Mar 2021, the patient received their first two of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the arm of prophylaxis of COVID-19 infection.  On 4 Mar 2021, Patient experienced fatigue, sickness, epigastric pain, rusty urine, blood I urine, vomiting, nauseous.   On 19 Mar 2021 for her annual exam and her liver enzymes were elevated, doctor states that it was vaccine induced hepatitis.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of all events were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Episode of atrial fibrillation; A spontaneous report was received from a consumer concerning a male patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced episode of atrial fibrillation.  The patient's medical history as reported included atrial fibrillation. Concomitant medications as provided by the reporter was unknown.  The received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) on an unknown date. On 04 Mar 2021, prior to the onset of the event, the patient received second of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the patient experienced episode of atrial fibrillation and was subsequently hospitalized for 24 hours. Treatment for the event included intravenous amiodaron and propofol during a cardioversion procedure and attempted to cardiovert three times.  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.  The outcome of the event episode of atrial fibrillation was resolved on 05 Mar 2021.; 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: Drug interaction, Infection, Pyrexia
Clinical narrative: patient got an infection to his hand and it was a minor infection but antibiotics did not work.; Moderna vaccine is hindering antibiotics from working,no response to antibiotics; fever, temperature goes up and down again; A spontaneous report was received from a pharmacist concerning a 78-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event fever, temperature goes up and down again, patient got an infection to his hand and it was a minor infection but antibiotics did not work, infection spread and did not know where it spread and reported moderna vaccine is hindering antibiotics from working, no response to antibiotics.  The patient's current conditions included type 1 diabetes and heart problem. Concomitant medications included insulin pump for type 1 diabetes.  On an unknown date, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection. On 16-FEB-2021, the patient received the second of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event fever, temperature goes up and down again. The patient got an infection to his hand and it was a minor infection but antibiotics did not work. The caller stated that the infection spread and did not know where it spread, and patient has been in hospital for 2 weeks plus. The caller stated that vaccine is hindering his immunity since he has been on IV antibiotics and does not seem to be doing the job. The caller stated that patient does not have Covid-19 but think that the vaccine is hindering the antibiotics.   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.  The outcome of the event fever, temperature goes up and down again was not resolving. The outcome of events patient got an infection to his hand and it was a minor infection but antibiotics did not work, infection spread and did not know where it spread and reported moderna vaccine is hindering antibiotics from working, no response to antibiotics was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Fatigue, Head discomfort
Clinical narrative: lack of oxygen; numb left hand; heaviness of head and back; very high pressure in the chest; circulatory issues in the legs with varices; sinusitis; has lymph nodes in the neck , such a big ball t; weakness; joint and muscle pains; joint and muscle pains; feeling tired; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following event: numb left hand, joint and muscle pains (arthralgia), feeling tired (fatigue), weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24-FEB-2021, the patient experienced the event(s) numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  Treatment details included antibiotics.  Action taken with mRNA-1273 in response to the events is unknown.   The outcome of event(s), numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis 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 these events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoxia, Lymphadenopathy, Myalgia, Sinusitis
Clinical narrative: lack of oxygen; numb left hand; heaviness of head and back; very high pressure in the chest; circulatory issues in the legs with varices; sinusitis; has lymph nodes in the neck , such a big ball t; weakness; joint and muscle pains; joint and muscle pains; feeling tired; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following event: numb left hand, joint and muscle pains (arthralgia), feeling tired (fatigue), weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24-FEB-2021, the patient experienced the event(s) numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  Treatment details included antibiotics.  Action taken with mRNA-1273 in response to the events is unknown.   The outcome of event(s), numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis 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 these events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Varicose vein
Clinical narrative: lack of oxygen; numb left hand; heaviness of head and back; very high pressure in the chest; circulatory issues in the legs with varices; sinusitis; has lymph nodes in the neck , such a big ball t; weakness; joint and muscle pains; joint and muscle pains; feeling tired; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following event: numb left hand, joint and muscle pains (arthralgia), feeling tired (fatigue), weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24-FEB-2021, the patient experienced the event(s) numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis.  Treatment details included antibiotics.  Action taken with mRNA-1273 in response to the events is unknown.   The outcome of event(s), numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis 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 these events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Narcolepsy, Vision blurred
Clinical narrative: migraine headache with vision interruption; migraine headache with vision interruption; extreme sleepiness; calls it narcolepsy; A spontaneous report was received from a consumer concerning a 69 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events narcolepsy, migraine headache with vision interruption/migraine, vision blurred. The patient's medical history includes excruciating pain in the back that went down to her left leg, She is able to put a little bit of weight on her leg; barely able to get water from fridge and barely able walk to go to the bathroom: Walking difficulty, She is not able to sleep through the pain. The concomitant medications on use were also not provided. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 011M20A) through unknown route of administration in the right arm for prophylaxis of COVID-19 infection.  On 15 Mar 2021, at 11:45am, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Lot number: 002B21A) through unknown route of administration in the right arm for prophylaxis of COVID-19 infection.  On 15 Mar 2021, from 2pm on wards patient experienced events extreme sleepiness. On 16 Mar 2021, around 8pm patient experienced migraine headache with vision interruption.  Self treating with paracetamol and ice packs.  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.  The events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; A spontaneous report was received from a healthcare professional concerning a 63-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events seizure.  The patient's medical history was not provided. Concomitant medications reported were Phenytoin, Norvasc for drug use for unknown indication.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: not provided) via unknown route for prophylaxis of COVID-19 infection.  Lab parameters done was not provided.  On 1 Mar 2021, in the evening she went to bed and had a seizure. She was fine in the morning and her husband told her that she had a seizure last night. She is allergic to peanuts and peanuts oil. She has Epilepsy and take medications for that but didn't have a seizure for a long time.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), seizure was unknown.  Action taken with mRNA-1273 in response to the event 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Pain in extremity, Palpitations
Clinical narrative: loss of consciousness 7 hours later/blacked out; rapid heartbeat; Sweats; Arm pain; A Regulatory report was received from a Consumer concerning a female patient of 47 years who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Loss of consciousness, Palpitations, Hyperhidrosis, Pain in extremity.  The patient's medical history was not provided. Although the patient had loss consciousness before to other vaccines.  No relevant concomitant medications were reported.  On 26 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 010A21A) on left arm for prophylaxis of COVID-19 infection via intramuscular route.  On 26 Feb 2021, seven hours later the patient reports she received a dose of Moderna's COVID-19 vaccine (mRNA-1273) had severe reaction, rapid heart beat and black out, she felt weird and she got up and walked around and she got the sweats, she said she laid on the floor, she woke up and was kind of fine. she suffered arm pain.   The patient suffered loss of consciousness is medically significant.  Laboratory details were not provided.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  On date of this report, the outcome of the events, Loss of consciousness, Palpitations, Hyperhidrosis, Pain in extremity 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood pressure abnormal, Blood pressure measurement, COVID-19
Clinical narrative: tested positive for Covid infection; BP: 130/68; loss of taste; loss of smell; right lower lobe pneumonia; A Spontaneous was received from a Consumer concerning a 82-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right lower lobe pneumonia (Pneumonia), loss of taste (Ageusia), loss of smell (Anosmia), tested positive for Covid infection (COVID-19) and BP: 130/68 (Blood pressure abnormal).   The patient's medical history was included Chronic Obstructive Pulmonary Disease(COPD), blood pressure and Obstructive sleep Apnoea. Concomitant medications was included ATORVASTATIN CALCIUM for cholesterol, ACETYLSALICYLIC ACID for unknown indication, Advair for COPD, SALBUTAMOL for COPD, TIOTROPIUM BROMIDE for COPD and CPAP for Obstructive Sleep Apnoea.     On 22-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch no: 013L20) via unknown route in the Left arm  for prophylaxis of COVID-19 infection.  On 03-MAR-2021, It was reported that the patient experienced loss of taste, loss of smell and BP: 130/68.  On 04 Mar 2021, the patient was tested positive for Covid infection . On 09 Mar 2021, the patient was experienced right lower lobe pneumonia. The pneumonia was medically significant.  Treatment information was Nebulizer treatment, Antibiotics for 5 days for Pneumonia and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 19 Mar 2021, the outcome of the event, tested positive for Covid Infection was resolved. On an unknown date, the outcome of the events right lower lobe pneumonia, loss of taste, loss of smell, and BP: 130/68 was unknown.; Reporter's Comments: This case concerns an 82 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected COVID-19, anosmia, ageusia, and blood pressure abnormal.  Event onset 19 days after first dose mRNA-1273. Treated with antibiotics and Tylenol.  COVID-19 resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pneumonia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid infection; BP: 130/68; loss of taste; loss of smell; right lower lobe pneumonia; A Spontaneous was received from a Consumer concerning a 82-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right lower lobe pneumonia (Pneumonia), loss of taste (Ageusia), loss of smell (Anosmia), tested positive for Covid infection (COVID-19) and BP: 130/68 (Blood pressure abnormal).   The patient's medical history was included Chronic Obstructive Pulmonary Disease(COPD), blood pressure and Obstructive sleep Apnoea. Concomitant medications was included ATORVASTATIN CALCIUM for cholesterol, ACETYLSALICYLIC ACID for unknown indication, Advair for COPD, SALBUTAMOL for COPD, TIOTROPIUM BROMIDE for COPD and CPAP for Obstructive Sleep Apnoea.     On 22-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch no: 013L20) via unknown route in the Left arm  for prophylaxis of COVID-19 infection.  On 03-MAR-2021, It was reported that the patient experienced loss of taste, loss of smell and BP: 130/68.  On 04 Mar 2021, the patient was tested positive for Covid infection . On 09 Mar 2021, the patient was experienced right lower lobe pneumonia. The pneumonia was medically significant.  Treatment information was Nebulizer treatment, Antibiotics for 5 days for Pneumonia and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 19 Mar 2021, the outcome of the event, tested positive for Covid Infection was resolved. On an unknown date, the outcome of the events right lower lobe pneumonia, loss of taste, loss of smell, and BP: 130/68 was unknown.; Reporter's Comments: This case concerns an 82 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected COVID-19, anosmia, ageusia, and blood pressure abnormal.  Event onset 19 days after first dose mRNA-1273. Treated with antibiotics and Tylenol.  COVID-19 resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Burning sensation, Injection site mass, Nerve injury, Sensory loss
Clinical narrative: Could not feel her feet; Severe autoimmune reaction; Extraordinary burning on both of her feet; Nerve damaged on her feet,Nerve damaged travelled to calf; Raised lump at injection site; Itchy injection site; Red injection site; Sore injection arm; A spontaneous report was received from a consumer concerning a female patient of 65 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced event(s) Sore injection arm, injection site redness, Raised lump at injection site, Itchy injection site, Severe autoimmune reaction, Extraordinary burning on both of her feet, Nerve damaged on her feet to calf, Could not feel her feet.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 14 Jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(batch number: 011L20A) vaccine intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021,later the day of vaccination, the injection arm became sore, the injection site had a red, itchy and raised lump. These symptoms progressed for some days.   On 24 Jan 2021, she started experiencing a severe autoimmune reaction, she had extraordinary burning on both of her feet. She took Tylenol and Benadryl hoping it will help alleviate the symptoms but the morning she could not feel her feet, her nerves were significantly damaged. The symptoms travelled to her calf. She has no previous autoimmune or health issues. the event severe autoimmune disorder was also considered to be medically significant. Her doctors has instructed her not to get the 2nd dose due to her side effects.   Treatment for the event included Tylenol and Benadryl.  Action taken with the mRNA-1273 in response to the event was not provided.  the outcome of the event(s) Sore injection arm, injection site redness, Raised lump at injection site, Itchy injection site, Severe autoimmune reaction, Extraordinary burning on both of her feet, Nerve damaged on her feet to calf and Could not feel her feet were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product onset of the event and excluding any other etiology, a causal relationship with the event cannot be excluded.  Injection arm became sore, the injection site had a red, itchy and raised lump are consistent with the product safety profile.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Could not feel her feet; Severe autoimmune reaction; Extraordinary burning on both of her feet; Nerve damaged on her feet,Nerve damaged travelled to calf; Raised lump at injection site; Itchy injection site; Red injection site; Sore injection arm; A spontaneous report was received from a consumer concerning a female patient of 65 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced event(s) Sore injection arm, injection site redness, Raised lump at injection site, Itchy injection site, Severe autoimmune reaction, Extraordinary burning on both of her feet, Nerve damaged on her feet to calf, Could not feel her feet.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 14 Jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(batch number: 011L20A) vaccine intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021,later the day of vaccination, the injection arm became sore, the injection site had a red, itchy and raised lump. These symptoms progressed for some days.   On 24 Jan 2021, she started experiencing a severe autoimmune reaction, she had extraordinary burning on both of her feet. She took Tylenol and Benadryl hoping it will help alleviate the symptoms but the morning she could not feel her feet, her nerves were significantly damaged. The symptoms travelled to her calf. She has no previous autoimmune or health issues. the event severe autoimmune disorder was also considered to be medically significant. Her doctors has instructed her not to get the 2nd dose due to her side effects.   Treatment for the event included Tylenol and Benadryl.  Action taken with the mRNA-1273 in response to the event was not provided.  the outcome of the event(s) Sore injection arm, injection site redness, Raised lump at injection site, Itchy injection site, Severe autoimmune reaction, Extraordinary burning on both of her feet, Nerve damaged on her feet to calf and Could not feel her feet were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product onset of the event and excluding any other etiology, a causal relationship with the event cannot be excluded.  Injection arm became sore, the injection site had a red, itchy and raised lump are consistent with the product safety profile.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Asthenia, Decreased appetite, Defaecation urgency, Fatigue
Clinical narrative: muscle aches; weakness; lack of appetite; tiredness; fever; feelings of passing out; stomach cramping; nausea; dry heaves; hot flashes; hot sweats; feeling the need to defecate; headache; body ache; A spontaneous report was received from a consumer  concerning a 75 year old, female patient who experienced stomach cramping/abdominal pain lower, nausea, dry heaves/retching, hot flashes/ hot flush, hot sweats/hyperhidrosis, feelings of passing out/loss of consciousness, feeling the need to defecate/defaecation urgency, tiredness/ fatigue, headache, body ache/ pain, fever/pyrexia, lack of appetite/ decreased appetite, weakness/ asthenia and muscle aches/myalgia.  The patient's medical history included esophageal cancer and kidney failure. Products known to have been used by the patient, within two weeks prior to the event, included tylenol and cyanocobalamin injections.  On 20 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in the left arm (deltoid) for prophylaxis of COVID-19 infection.   The patient had sudden onset of stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, and feeling the need to defecate beginning two hours post administration. The episode lasted approximately 4-5 minutes, and she felt better after she was finally able to produce a bowel movement (indicates BM had a horrible odor). The patient began experiencing additional symptoms of tiredness, headache, body aches, and fever during the night of 20 Mar 2021. The patient administered Tylenol to alleviate her symptoms and returned to bed. The patient reported sleeping the entire day 21 Mar 2021 and had little to no appetite. the patient had headache and fever resolved 21 Mar 2021 during the afternoon hours. The patient had continued tiredness and weakness lasting throughout the day on 22 Mar 2021. Her symptoms prevented her from performing her work obligations on 22 Mar 2021. The patient was feeling better on 23 Mar 2021 other than muscle aches. The event feelings of passing out was considered as medically significant. Treatment for the event included Tylenol.  Action taken with mrna-1273 in response to the events was not provided.  The events, stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, feeling the need to defecate, tiredness, headache, body ache, fever, lack of appetite, and weakness, were considered resolved. The outcome of event, muscle aches was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: muscle aches; weakness; lack of appetite; tiredness; fever; feelings of passing out; stomach cramping; nausea; dry heaves; hot flashes; hot sweats; feeling the need to defecate; headache; body ache; A spontaneous report was received from a consumer  concerning a 75 year old, female patient who experienced stomach cramping/abdominal pain lower, nausea, dry heaves/retching, hot flashes/ hot flush, hot sweats/hyperhidrosis, feelings of passing out/loss of consciousness, feeling the need to defecate/defaecation urgency, tiredness/ fatigue, headache, body ache/ pain, fever/pyrexia, lack of appetite/ decreased appetite, weakness/ asthenia and muscle aches/myalgia.  The patient's medical history included esophageal cancer and kidney failure. Products known to have been used by the patient, within two weeks prior to the event, included tylenol and cyanocobalamin injections.  On 20 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in the left arm (deltoid) for prophylaxis of COVID-19 infection.   The patient had sudden onset of stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, and feeling the need to defecate beginning two hours post administration. The episode lasted approximately 4-5 minutes, and she felt better after she was finally able to produce a bowel movement (indicates BM had a horrible odor). The patient began experiencing additional symptoms of tiredness, headache, body aches, and fever during the night of 20 Mar 2021. The patient administered Tylenol to alleviate her symptoms and returned to bed. The patient reported sleeping the entire day 21 Mar 2021 and had little to no appetite. the patient had headache and fever resolved 21 Mar 2021 during the afternoon hours. The patient had continued tiredness and weakness lasting throughout the day on 22 Mar 2021. Her symptoms prevented her from performing her work obligations on 22 Mar 2021. The patient was feeling better on 23 Mar 2021 other than muscle aches. The event feelings of passing out was considered as medically significant. Treatment for the event included Tylenol.  Action taken with mrna-1273 in response to the events was not provided.  The events, stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, feeling the need to defecate, tiredness, headache, body ache, fever, lack of appetite, and weakness, were considered resolved. The outcome of event, muscle aches was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Presyncope, Pyrexia, Retching
Clinical narrative: muscle aches; weakness; lack of appetite; tiredness; fever; feelings of passing out; stomach cramping; nausea; dry heaves; hot flashes; hot sweats; feeling the need to defecate; headache; body ache; A spontaneous report was received from a consumer  concerning a 75 year old, female patient who experienced stomach cramping/abdominal pain lower, nausea, dry heaves/retching, hot flashes/ hot flush, hot sweats/hyperhidrosis, feelings of passing out/loss of consciousness, feeling the need to defecate/defaecation urgency, tiredness/ fatigue, headache, body ache/ pain, fever/pyrexia, lack of appetite/ decreased appetite, weakness/ asthenia and muscle aches/myalgia.  The patient's medical history included esophageal cancer and kidney failure. Products known to have been used by the patient, within two weeks prior to the event, included tylenol and cyanocobalamin injections.  On 20 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in the left arm (deltoid) for prophylaxis of COVID-19 infection.   The patient had sudden onset of stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, and feeling the need to defecate beginning two hours post administration. The episode lasted approximately 4-5 minutes, and she felt better after she was finally able to produce a bowel movement (indicates BM had a horrible odor). The patient began experiencing additional symptoms of tiredness, headache, body aches, and fever during the night of 20 Mar 2021. The patient administered Tylenol to alleviate her symptoms and returned to bed. The patient reported sleeping the entire day 21 Mar 2021 and had little to no appetite. the patient had headache and fever resolved 21 Mar 2021 during the afternoon hours. The patient had continued tiredness and weakness lasting throughout the day on 22 Mar 2021. Her symptoms prevented her from performing her work obligations on 22 Mar 2021. The patient was feeling better on 23 Mar 2021 other than muscle aches. The event feelings of passing out was considered as medically significant. Treatment for the event included Tylenol.  Action taken with mrna-1273 in response to the events was not provided.  The events, stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, feeling the need to defecate, tiredness, headache, body ache, fever, lack of appetite, and weakness, were considered resolved. The outcome of event, muscle aches was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Death, Pneumonia
Clinical narrative: Pneumonia; Stage four stomach cancer; Parent died after receiving both doses; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stage four stomach cancer/gastric cancer stage IV, pneumonia and parent died after receiving both doses.  The patient's medical history, as provided by the reporter, included stomach cancer. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route of administration for prophylaxis of COVID-19 infection. On an unspecified date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route of administration for prophylaxis of COVID-19 infection.   On an unspecified date, patient was diagnosed of stage four stomach cancer and developed pneumonia after both doses of vaccine with seriousness criteria as medically significant. The patient died on 21 Mar 2021. Treatment information was not 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 were not applicable.  The outcome of the events, stage four stomach cancer and pneumonia were fatal.  The patient died on 21 Mar 2021. The cause of death was reported as stage four stomach cancer and pneumonia. Plans for an autopsy were unknown.; Reporter's Comments: This patient's stage IVgastric cancer is unlikely due to the Moderna's mRNA-1273 vaccine due to the latency of gastric cancer. Very limited information regarding these events have been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache.   The patient's medical history was provided. Concomitant medications were not reported.  On 19 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, prior to receiving mRNA-1273, the patient felt headache. He contacted his HCP and due to the location of the headaches was told he should go to the hospital to rule out a stroke. He was admitted to the hospital and stayed for 2 days. He was started on 40mg of steroids prophylactically. Caller states many different tests were performed but an MRI ruled out a stroke. He was then allowed to taper off the steroids. Prior to hospitalization, he was scheduled to have his second Moderna COVID-19 vaccination on 15 FEB 2021. He consulted his neurologist who told him to go ahead with the vaccination even though he would not complete his steroid taper until 19 FEB 2021. He was advised to also have an antibody test done 2-3 weeks after the vaccination. He has received the lab results and believes it is negative, but is confused by the results.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event headache was not reported.; 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.