chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Vision loss; Balance issues; Tingling in Extremities; Fatigue; Chills; A spontaneous report was received from a consumer concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) on an unspecified date in Jan 2021 intramuscularly. On 12-Feb-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of Covid-19 infection.   On 13 Feb 2021, Patient experiencedvision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills. Laboratory details included an increased white blood cell count..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 is not applicable.  The outcomes of the events of vision loss, tingling in extremities, balance issues, fatigue, and chills 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Muscle spasms
Clinical narrative: Hyperthyroid; muscle spasm; A spontaneous case report was received from a health care provider concerning a 39-year-old, female patient who received first dose of Moderna COVID-19 Vaccine (mRNA-1273) and experienced muscle spasm and hyperthyroidism.  The patient's medical history was not provided.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins, Coenzyme 10 and multivitamins.   On 11FEB2021, the patient received her first of two doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient started experiencing muscle spasms the next day. Two weeks after she received the vaccine, the thyroid test was done again and her TSH went down and now has hyperthyroidism. The muscle spasm  had become more frequent.  Action taken with mRNA-1273 in response to the events was unknown.  Outcome of the events of muscle spasm and hyperthyroidism 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 these events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Cardiac flutter, Dizziness, Ear pain
Clinical narrative: fainting spells or passing out; severe stomach pain, abdominal pain; nausea; Swollen lymph nodes in three places like a triangle; low blood pressure with faint pulse; faint heart beat or rate with flutters; lightheadedness; blurry vision; right ear ache; face flush or red face; burning sensation on his hands; red rash on under arm; HEART FLUTTER; A spontaneous report was received from a Consumer concerning himself as a 72 Years-old male elder patient who  experienced severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm.  The patient's medical history was low glycemia and atrial arrhythmia.His concomitant medications were reported as Vitamin D31000 IU as supplement, Prevacid 30 for acid reflux prevention  and Magnesium 400mg as supplement.  On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced fainting spells which is medically significant and the other events are severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of the event(s) severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand, red rash on his under arm 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 these events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypotension, Lymphadenopathy, Nausea, Pulse abnormal
Clinical narrative: fainting spells or passing out; severe stomach pain, abdominal pain; nausea; Swollen lymph nodes in three places like a triangle; low blood pressure with faint pulse; faint heart beat or rate with flutters; lightheadedness; blurry vision; right ear ache; face flush or red face; burning sensation on his hands; red rash on under arm; HEART FLUTTER; A spontaneous report was received from a Consumer concerning himself as a 72 Years-old male elder patient who  experienced severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm.  The patient's medical history was low glycemia and atrial arrhythmia.His concomitant medications were reported as Vitamin D31000 IU as supplement, Prevacid 30 for acid reflux prevention  and Magnesium 400mg as supplement.  On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced fainting spells which is medically significant and the other events are severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of the event(s) severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand, red rash on his under arm 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 these events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Syncope, Vision blurred
Clinical narrative: fainting spells or passing out; severe stomach pain, abdominal pain; nausea; Swollen lymph nodes in three places like a triangle; low blood pressure with faint pulse; faint heart beat or rate with flutters; lightheadedness; blurry vision; right ear ache; face flush or red face; burning sensation on his hands; red rash on under arm; HEART FLUTTER; A spontaneous report was received from a Consumer concerning himself as a 72 Years-old male elder patient who  experienced severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm.  The patient's medical history was low glycemia and atrial arrhythmia.His concomitant medications were reported as Vitamin D31000 IU as supplement, Prevacid 30 for acid reflux prevention  and Magnesium 400mg as supplement.  On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced fainting spells which is medically significant and the other events are severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of the event(s) severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand, red rash on his under arm 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 these events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain
Clinical narrative: Joint pain in neck and hip; nausea; excruciating pain on the right side of her body from bicep to shoulder and neck area; A spontaneous report was received from a consumer concerning a 67 years old, female patient who experienced joint pain in neck and hip/PT: arthralgia, excruciating pain on the right side of her body from bicep to shoulder and neck area/PT: pain and nausea/PT: nausea.   The patient's medical condition included discomfort in right arm.    Concomitant product use was not provided by the reporter.   On 09 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) in the left arm for prophylaxis of COVID-19 infection.    The patient experienced excruciating pain on the right side of her body from  bicep to shoulder and neck area since an unknown date in Feb 2021; nausea since an unknown date in Feb 2021 and joint pain in neck and hip since an unknown date. The patient was administered to emergency room on 10 Feb 2021 due to excruciating pain on the right side of her body from bicep to shoulder and neck area.  Laboratory investigations included electrocardiogram and X-ray both since 10 Feb 2021 whose results are unknown.  Treatment information in emergency room included methylprednisolone injection into tendon, ketorolac 15 mg intravenously, ondansetron 4mg for the indication nausea, fentanyl, ketorolac 15 mg and sodium chloride 1000 mg.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events excruciating pain on the right side of her body from bicep to shoulder and neck area, nausea and joint pain in neck and hip 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 se events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Bad Rheumatoid Arthritis flare up; sore arm; chills; fever; fatigue; A spontaneous report was received from a consumer concerning a 71-years-old who received Moderna COVID-19 vaccine (mRNA-1273) and experienced rheumatoid arthritis flare up, sore arm, chills, fever, and fatigue.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prednisone, tofacitinib citrate, folic acid, sertraline, ropinirole, clonazepam, gabapentin, and nortriptyline.  On 04 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 04-Mar-2021, the patient experienced chills, fever, fatigue, sore arm, and a bad rheumatoid arthritis flare up all since 04 Mar 2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event chills, fever, fatigue, sore arm, and a bad rheumatoid arthritis flare 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 events, a causal relationship cannot be excluded.
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 who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   The patient received the first dose of the Moderna COVID-19 vaccine (Batch number not provided) on 05 Jan 2021 in left arm for prophylaxis of COVID-19 infection  On 02 Feb 2021, prior to the onset of event, the patient received their second dose of mRNA-1273 (lot/batch: 028L20A) intramuscularly in left arm for COVID-19 infection.  On 26 Feb 2021, the patient experienced Bell's Palsy which was considered as medically significant event.  Laboratory details was not provided.   Treatment information was provided as Valacyclovir HCl, Methylprednisolone and Bupropion, vitamin D, biotin.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event Bell's Palsy was 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 event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Confusional state, Coronavirus test, Fatigue
Clinical narrative: Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her balance; Had no control of her bladder and urinated on the bed; Wasn't feeling well; Tired and didn't want to get up; A spontaneous report was received from a consumer concerning a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination related malaise, urinary incontinence, fatigue, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid 19.   The patient's medical history, as provided by the reporter, stated she was sneezing and coughing few days before receiving her first dose vaccine. Concomitant medications reported included iron, metolazone, nicardipine, simvastatin, torsemide, levothyroxine, glimepiride, apixaban, potassium chloride, acetyl salicylic acid, and donepezil 5mg.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of COVID-19 infection. The route of administration was not provided.  On an unspecified date in Jan 2021 after receiving the first dose vaccine, the patient experienced not feeling well, urinary incontinence, tiredness, and didn't want to get up.  On 25 Jan 2021, the patient was losing her balance and confused. She was hospitalized and diagnosed with renal failure, as well as, severe urinary tract infection that was septic.  On an unknown date post hospitalization, the patient tested positive for Covid-19.  Treatment drug administered included Tylenol, Azithromycin, Promethazine, 325mg aspirin, and Vitamin D.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, like not feeling well, urinary incontinence, tiredness, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid-19 positive test 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 except for the event of COVID-19.  The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033912:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure, Urinary incontinence, Urosepsis, Vaccination complication
Clinical narrative: Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her balance; Had no control of her bladder and urinated on the bed; Wasn't feeling well; Tired and didn't want to get up; A spontaneous report was received from a consumer concerning a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination related malaise, urinary incontinence, fatigue, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid 19.   The patient's medical history, as provided by the reporter, stated she was sneezing and coughing few days before receiving her first dose vaccine. Concomitant medications reported included iron, metolazone, nicardipine, simvastatin, torsemide, levothyroxine, glimepiride, apixaban, potassium chloride, acetyl salicylic acid, and donepezil 5mg.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of COVID-19 infection. The route of administration was not provided.  On an unspecified date in Jan 2021 after receiving the first dose vaccine, the patient experienced not feeling well, urinary incontinence, tiredness, and didn't want to get up.  On 25 Jan 2021, the patient was losing her balance and confused. She was hospitalized and diagnosed with renal failure, as well as, severe urinary tract infection that was septic.  On an unknown date post hospitalization, the patient tested positive for Covid-19.  Treatment drug administered included Tylenol, Azithromycin, Promethazine, 325mg aspirin, and Vitamin D.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, like not feeling well, urinary incontinence, tiredness, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid-19 positive test 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 except for the event of COVID-19.  The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033912:
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Drooling, Dyspnoea, Hemiparesis, Muscular weakness
Clinical narrative: lost strength in both his feet; loss feeling in his left side of the body mainly; Tongue swelling; couldn't breathe; weakness of left facial area, arm and leg; tightness of neck; Bells Palsy; drooling/saliva on his pillow when he sleeps at night; nauseous; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed loss of feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, drooling, and nausea.     The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.   On 25 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Mar 221, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, patient experienced nausea and couldn't breath, lost strength in his left face, arm, leg, developed Bell's Palsy, and suffered from  droopiness of the face a bit and drooling/saliva on his pillow when he sleeps at night.   On 01 Mar 2021, the patient developed developed loss feeling in his left side of the body mainly, had tongue swelling, and lost strength in both his feet .  Treatment for the event was not reported.  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 outcome of the events, loss feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, and nausea, were considered unknown. The outcome of drooling was not resolved.; 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: Musculoskeletal stiffness, Nausea, SARS-CoV-2 antibody test, SARS-CoV-2 test, Sensory loss
Clinical narrative: lost strength in both his feet; loss feeling in his left side of the body mainly; Tongue swelling; couldn't breathe; weakness of left facial area, arm and leg; tightness of neck; Bells Palsy; drooling/saliva on his pillow when he sleeps at night; nauseous; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed loss of feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, drooling, and nausea.     The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.   On 25 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Mar 221, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, patient experienced nausea and couldn't breath, lost strength in his left face, arm, leg, developed Bell's Palsy, and suffered from  droopiness of the face a bit and drooling/saliva on his pillow when he sleeps at night.   On 01 Mar 2021, the patient developed developed loss feeling in his left side of the body mainly, had tongue swelling, and lost strength in both his feet .  Treatment for the event was not reported.  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 outcome of the events, loss feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, and nausea, were considered unknown. The outcome of drooling was not resolved.; 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: Swollen tongue
Clinical narrative: lost strength in both his feet; loss feeling in his left side of the body mainly; Tongue swelling; couldn't breathe; weakness of left facial area, arm and leg; tightness of neck; Bells Palsy; drooling/saliva on his pillow when he sleeps at night; nauseous; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed loss of feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, drooling, and nausea.     The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.   On 25 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Mar 221, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, patient experienced nausea and couldn't breath, lost strength in his left face, arm, leg, developed Bell's Palsy, and suffered from  droopiness of the face a bit and drooling/saliva on his pillow when he sleeps at night.   On 01 Mar 2021, the patient developed developed loss feeling in his left side of the body mainly, had tongue swelling, and lost strength in both his feet .  Treatment for the event was not reported.  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 outcome of the events, loss feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, and nausea, were considered unknown. The outcome of drooling was not resolved.; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Ear discomfort, Hyperhidrosis
Clinical narrative: A spontaneous report was received from a consumer concerning a 80-year-old, female patient who suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), head fell forward and she was out for 20-30 seconds (loss of consciousness), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia).                                                                                                                      The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On 01-FEB-2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 007M20A)  intramuscularly for prophylaxis of COVID-19 infection.    On 01-MAR-2021, the patient received her 2nd dose of the Moderna COVID-19 vaccine (Batch number: 023M20A) in her left (dominant) arm.   On 02-MAR-2021, she experienced a side effect which was not listed in the sheet she was given. She wanted to call and report the side effect. She said that she was at the stove cooking and suddenly felt very weak and felt that her vision started to flip. She called for her husband to come over who seated her on a chair. After that she says she doesn't remember what happened, but her husband told her that her whole body was shaking, her head fell forward and she was out for 20-30 seconds. When she came back, she could hear a rushing sound coming out of her left ear. She was also drenched in perspiration. She felt very nauseated and cold the whole afternoon.  On 03-MAR-2021 she felt better. She had a low grade fever of 99.4 degrees Fahrenheit.   Treatment for the event included paracetamol.   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, suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia) was considered recovered/resolved on an unknown date.   The out come of the event, head fell forward and she was out for 20-30 seconds (loss of consciousness), was 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 events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Pyrexia, Tremor, Visual impairment
Clinical narrative: A spontaneous report was received from a consumer concerning a 80-year-old, female patient who suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), head fell forward and she was out for 20-30 seconds (loss of consciousness), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia).                                                                                                                      The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On 01-FEB-2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 007M20A)  intramuscularly for prophylaxis of COVID-19 infection.    On 01-MAR-2021, the patient received her 2nd dose of the Moderna COVID-19 vaccine (Batch number: 023M20A) in her left (dominant) arm.   On 02-MAR-2021, she experienced a side effect which was not listed in the sheet she was given. She wanted to call and report the side effect. She said that she was at the stove cooking and suddenly felt very weak and felt that her vision started to flip. She called for her husband to come over who seated her on a chair. After that she says she doesn't remember what happened, but her husband told her that her whole body was shaking, her head fell forward and she was out for 20-30 seconds. When she came back, she could hear a rushing sound coming out of her left ear. She was also drenched in perspiration. She felt very nauseated and cold the whole afternoon.  On 03-MAR-2021 she felt better. She had a low grade fever of 99.4 degrees Fahrenheit.   Treatment for the event included paracetamol.   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, suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia) was considered recovered/resolved on an unknown date.   The out come of the event, head fell forward and she was out for 20-30 seconds (loss of consciousness), was 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 events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Palpitations, Vaccination site pain
Clinical narrative: Heart flattering fast; Her resting heart race is 54-56, but that morning was higher; Sore arm; This spontaneous report was received from a consumer (patient) and concerns a 66 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore, felt the heart flattering fast. Her resting heart race was 54-56, but that morning was higher.   The patient was very active, exercised every day and ate very healthy. Patient was a very healthy person and has no medical conditions, only was allergic to Sulfas.  On 09 Feb 2021, the patient received her first dose of mRNA-1273 (Lot number: 016M20A) solution for injection intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 10-Feb-2021, patient felt the heart flattering fast. This sensation lasted 2 minutes. The doctor stated that this could be a heart attack and because it happened after receiving the Covid-19 vaccine, this could be a possible side effect.   On 10 Feb 2021, the patient resting heart race was (54-56s), but in the morning it was higher.   On an unknown date the patient had laboratory test AKG.  Seriousness Criteria for the events of heart flattering fast was medically significant.  Action taken with suspect drug mRNA-1273 was unknown; Reporter's Comments: Being sent back to CP
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Tunnel vision
Clinical narrative: tunnel vision; dizziness; headache in different regions; A spontaneous report received from a consumer concerning a 47-years-old  male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, tunnel vision, and headache in different regions.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient experienced dizziness, had tunnel vision and headache in different regions. Went to the ER.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events,Tunnel vision, dizziness and headache in different regions, 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.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature, Body temperature increased, Cough, Dysphonia
Clinical narrative: left eye had burst blood vessels; bruise on the injection site; temperature was higher by one or two degrees; tired; cough; voice went out; throat was rough; voice keeps going in and out; headache; A spontaneous report received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cough, voice went out (aphonia), throat was rough (oropharyngeal discomfort), voice keeps going in and out (dysphonia), headache, tired (fatigue), left eye had burst blood vessels (eye haemorrhage), body temperature was higher by one or two degrees (body temperature increased),and bruise on the injection site (injection site bruise).  The patient's medical history was not provided. Concomitant medications included an unspecified thyroid medication.  On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced cough. her voice went out like her throat was rough.  Her voice kept going in and out.  That night, she had a headache.   On 02 Mar 2021, the patient felt tired, still had headaches, and her temperature was higher by one or two degrees.    On 03 Mar 2021, the patient woke up and her left eye had burst blood vessels. She also had a bruise on the injection site on left, non-dominant arm.  Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.   The events of cough and voice went out like her throat was rough were considered resolved on 01 Mar 2021.  The outcome of the events of voice keeps going in and out, tired, left eye had burst blood vessels, headache, bruise on the injection site 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.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Fatigue, Headache, Injection site bruising, Oropharyngeal discomfort
Clinical narrative: left eye had burst blood vessels; bruise on the injection site; temperature was higher by one or two degrees; tired; cough; voice went out; throat was rough; voice keeps going in and out; headache; A spontaneous report received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cough, voice went out (aphonia), throat was rough (oropharyngeal discomfort), voice keeps going in and out (dysphonia), headache, tired (fatigue), left eye had burst blood vessels (eye haemorrhage), body temperature was higher by one or two degrees (body temperature increased),and bruise on the injection site (injection site bruise).  The patient's medical history was not provided. Concomitant medications included an unspecified thyroid medication.  On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced cough. her voice went out like her throat was rough.  Her voice kept going in and out.  That night, she had a headache.   On 02 Mar 2021, the patient felt tired, still had headaches, and her temperature was higher by one or two degrees.    On 03 Mar 2021, the patient woke up and her left eye had burst blood vessels. She also had a bruise on the injection site on left, non-dominant arm.  Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.   The events of cough and voice went out like her throat was rough were considered resolved on 01 Mar 2021.  The outcome of the events of voice keeps going in and out, tired, left eye had burst blood vessels, headache, bruise on the injection site 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Lymph node pain, Migraine, Thrombosis
Clinical narrative: Migraines have became more frequent and more intense to the point of were she could not function; Developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site; Pain under lymph nodes; Developed thrombosis on her head, but it went away; A spontaneous report was received from a consumer on 04 Mar 2021 concerning a 45-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed thrombosis on her head, but it went away, migraines have become more frequent and more intense to the point of were she could not function, developed a welt at the injection site that she describes as COVID arm  which was a 3-4inch raised circle underneath the injection site,  lymph nodes pain, which she still has.  The patient's medical history was not reported. Current conditions included migraine. The patinet had allergy to latex and pineapple. No relevant concomitant medications were reported  On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection.  Since 14 Feb 2021, patient's migraines had became more frequent and more intense to the point of were she could not function. She also developed thrombosis on her head, but it went away. The patient also developed a welt at the injection site that she described as COVID arm which was a 3-4 inch raised circle underneath the injection site. She also developed pain under lymph nodes, which she still had.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event of migraines have became more frequent and more intense to the point of were she could not function and pain under lymph nodes which she still has were unresolved, the event of developed thrombosis on her head but it went away was resolved, while the outcome of the event of developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site was unknown.   The reporter did not provide an assessment for the events thrombosis on her head, but it went away, migraines have became more frequent and more intense to the point of were she could not function, developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site, Pain under lymph nodes, which she still has.; 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: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Hypokinesia, Influenza like illness, Myalgia
Clinical narrative: Woke up with like the flu; Just sick, with body very sensitive to temperatures; Dont have the energy to do anything; Body aches; The arm  hurt worst that the first one; Was hard to move the arm; A spontaneous report, was received from a consumer (patient), a 69 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced the arm hurt worst that the first one (pain in extremity), was hard to move the arm (hypokinesia), woke up with like the flu (influenza like illness), body aches (pain), just sick, with the body very sensitive to temperatures (feeling hot), and don't have the energy to do anything (asthenia).  The patient's medical history was not provided. The relevant concomitant medications included blood pressure medication.  On 03 Mar 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot: 010A21A), intramuscularly for the prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient reported feeling really horrible after the second dose. On the same day, after receiving the vaccine, the patient's arm was hurting worst that the first one and, in the evening, it was hard to move the arm. On 04 Mar 2021, the patient reported that she woke up with flu from thirty years ago and felt like a horrible flu, very bad, with body aches. The patient stated that it was just sick, with the body very sensitive to temperatures. The patient reported that she started to feel a little tiny bit better now but do not have the energy to do anything. The treatment medication included two ibuprofen on the night and two more on the morning.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, arm hurt worst that the first one, was hard to move the arm, woke up with like the flu, body aches, just sick, with the body very sensitive to temperatures, and don't have the energy to do anything were considered as recovering.; 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: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Woke up with like the flu; Just sick, with body very sensitive to temperatures; Dont have the energy to do anything; Body aches; The arm  hurt worst that the first one; Was hard to move the arm; A spontaneous report, was received from a consumer (patient), a 69 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced the arm hurt worst that the first one (pain in extremity), was hard to move the arm (hypokinesia), woke up with like the flu (influenza like illness), body aches (pain), just sick, with the body very sensitive to temperatures (feeling hot), and don't have the energy to do anything (asthenia).  The patient's medical history was not provided. The relevant concomitant medications included blood pressure medication.  On 03 Mar 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot: 010A21A), intramuscularly for the prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient reported feeling really horrible after the second dose. On the same day, after receiving the vaccine, the patient's arm was hurting worst that the first one and, in the evening, it was hard to move the arm. On 04 Mar 2021, the patient reported that she woke up with flu from thirty years ago and felt like a horrible flu, very bad, with body aches. The patient stated that it was just sick, with the body very sensitive to temperatures. The patient reported that she started to feel a little tiny bit better now but do not have the energy to do anything. The treatment medication included two ibuprofen on the night and two more on the morning.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, arm hurt worst that the first one, was hard to move the arm, woke up with like the flu, body aches, just sick, with the body very sensitive to temperatures, and don't have the energy to do anything were considered as recovering.; 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: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Passed out; Sweats; Lightheaded; Fatigue; Chills; Nausea; Vomit; Headache; A spontaneous report was received from a consumer concerning herself, a 68 year old female patient who experienced passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received her first of two planned doses of mRNA-1273 on unknown date for prophylaxis of Covid-19 infection.  On 01-Mar-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Batch number 014M20A) intramuscularly into her left arm for prophylaxis of Covid-19 infection.  On 02-Mar-2021, the patient stated she "passed out", she also experienced sweats, lightheadedness, fatigue chills, nauseas, vomit, and headache.    No other 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, passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.was considered unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fatigue, chills vomiting, headache and nausea are consistent with the known safety profile of the vaccine