chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Dyspnoea, Pulmonary congestion, Pyrexia
Clinical narrative: Chest congestion; Contracted Covid 3 weeks after second dose/Exposed to someone with COVID; Hard time breathing; Fever; A spontaneous report was received from a consumer (patient's mother), regarding a 21 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chest congestion (pulmonary congestion), contracted COVID three weeks after second dose/exposed to someone with COVID (COVID-19), hard time breathing (dyspnea), and fever (pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On the same day, 11 Feb 2021, the patient developed fever with a body temperature of 102 (unknown units). On 02 Mar 2021, three weeks after his second dose, the consumer stated that her son was exposed to his girlfriend who had COVID. The consumer stated that his girlfriend, her roommates and four male friends that were visiting also contracted the COVID virus. The consumer reported that eight of ten people that were at girlfriend's house, contracted the COVID virus. The consumer stated that the patient had fever, a hard time breathing, and chest congestion. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of events, chest congestion, Contracted COVID three weeks after second dose/exposed to someone with COVID, hard time breathing, and fever were not reported.; Reporter's Comments: Based on temporal association and the known safety profile of the vaccine, a causal association between the event of fever and mRNA-1273 cannot be excluded.  The event of COVID s not consistent with the vaccine profile and is of an infective etiology, hence assessed as unlikely related to mRNA-1273. Pulmonary congestion and dyspnea are assessed as symptoms of COVID-19 also assessed as unlikely related.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pulmonary congestion, Pyrexia
Clinical narrative: Chest congestions; Trouble breathing; Coughing; Fever; A spontaneous report, was received from a consumer (patient's mother), regarding a 21 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chest congestions (pulmonary congestion), trouble breathing  (dyspnea), fever (pyrexia), and coughing (cough).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the consumer reported that for three days, the patient from fever, trouble breathing, a lot of chest congestions, and coughing. After a few days, the patient was doing fine. No treatment information was reported.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of events, chest congestions, trouble breathing, fever, and coughing were recovered/resolved.; Reporter's Comments: There is not enough information to assess the events of chest congestions, trouble breathing and coughing as the onset dates for the events were not provided.  In addition, the patient's medical history is lacking.  However fever is  consistent with the known safety profile of the vaccine. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Nasal discomfort, Oral pain
Clinical narrative: Her lupus condition got worse after receiving the first dose; Nasal and oral sores; Sweats; Nasal and oral sores; Rash; Joint pain; Fevers; Chills; A spontaneous report was received from a consumer concerning a 67 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her lupus condition got worse after receiving the first dose/systemic lupus erythematosus, nasal and oral sores/nasal discomfort/oral pain, sweats/hyperhidrosis, rash, joint pain/arthralgia, fevers/pyrexia, chills.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 002A211A) on 1 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.    On an unknown date, her lupus condition got worse after receiving the first dose. Symptoms of rash, joint pain, nasal and oral sores, low grade fevers, chills, sweats, rash on her legs within a few days after her injection. The systemic lupus erythematosus considered medically significant event . Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events 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 the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Systemic lupus erythematosus
Clinical narrative: Her lupus condition got worse after receiving the first dose; Nasal and oral sores; Sweats; Nasal and oral sores; Rash; Joint pain; Fevers; Chills; A spontaneous report was received from a consumer concerning a 67 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her lupus condition got worse after receiving the first dose/systemic lupus erythematosus, nasal and oral sores/nasal discomfort/oral pain, sweats/hyperhidrosis, rash, joint pain/arthralgia, fevers/pyrexia, chills.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 002A211A) on 1 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.    On an unknown date, her lupus condition got worse after receiving the first dose. Symptoms of rash, joint pain, nasal and oral sores, low grade fevers, chills, sweats, rash on her legs within a few days after her injection. The systemic lupus erythematosus considered medically significant event . Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events 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 the event, a causal relationship cannot be excluded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Product dose omission issue
Clinical narrative: Dementia; missed her second dose; A spontaneous report was received from a consumer concerning a 99 years old, male patient who developed Dementia.  The patient's medical history includes Dementia from 07-MAR-2021  Concomitant product use was not provided/unknown by the reporter.   The first of two planned doses of mRNA-1273 (Batch number:03920K20A on 05-FEB-2021) intramuscularly for prophylaxis of COVID-19 infection  After 1 st dose patient was admitted to the hospitaland was having dementia.   The second dose of mRNA-1273 was discontinued in response to dementia. The patient missed her second dose.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of missed dose was resolved and for dementia 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyskinesia, Emotional distress, Erythema, Feeling abnormal
Clinical narrative: arm swollen up; red pinkish all to elbow; she couldn't move, talk, reach her arm AND head, leg and body not working; no control of her body; had no feeling in her body; pee in her pants; mouth was hanging open, couldn't move; horrifying; so ill; "i'm going to hit myself"; not felt good; chills; fever; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema.   The patient's medical history was not provided. Concomitant product use was not provided.  On 14-Mar-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14-Mar-2021, patients had fever and chills. On 15-MAR-2021, she was so ill, lost all function of her body, she could not move, talk, reach her arm. She thought she was going to die. She did not felt good, went to bed and 5 minutes later she thought she was going to hit herself because she had no control of her body, her head in the bead, she pee in her pants. Her mouth was hanging open, could not move. The patient mentioned her head, leg and body not working, had no control of her body, she described the situation horrifying, so close to death, had no feeling in her body. Se did not want to go to the ER.. Husband stayed with her and she improved 3 hours later without treatment. On the next day, they contacted her physician who prescribed over the counter treatment.   Laboratory test were not reported. Treatment included Benadryl, Advil and Tylenol.  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, hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema 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 the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypotonia, Malaise, Movement disorder, Peripheral swelling
Clinical narrative: arm swollen up; red pinkish all to elbow; she couldn't move, talk, reach her arm AND head, leg and body not working; no control of her body; had no feeling in her body; pee in her pants; mouth was hanging open, couldn't move; horrifying; so ill; "i'm going to hit myself"; not felt good; chills; fever; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema.   The patient's medical history was not provided. Concomitant product use was not provided.  On 14-Mar-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14-Mar-2021, patients had fever and chills. On 15-MAR-2021, she was so ill, lost all function of her body, she could not move, talk, reach her arm. She thought she was going to die. She did not felt good, went to bed and 5 minutes later she thought she was going to hit herself because she had no control of her body, her head in the bead, she pee in her pants. Her mouth was hanging open, could not move. The patient mentioned her head, leg and body not working, had no control of her body, she described the situation horrifying, so close to death, had no feeling in her body. Se did not want to go to the ER.. Husband stayed with her and she improved 3 hours later without treatment. On the next day, they contacted her physician who prescribed over the counter treatment.   Laboratory test were not reported. Treatment included Benadryl, Advil and Tylenol.  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, hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema 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 the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urinary incontinence
Clinical narrative: arm swollen up; red pinkish all to elbow; she couldn't move, talk, reach her arm AND head, leg and body not working; no control of her body; had no feeling in her body; pee in her pants; mouth was hanging open, couldn't move; horrifying; so ill; "i'm going to hit myself"; not felt good; chills; fever; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema.   The patient's medical history was not provided. Concomitant product use was not provided.  On 14-Mar-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14-Mar-2021, patients had fever and chills. On 15-MAR-2021, she was so ill, lost all function of her body, she could not move, talk, reach her arm. She thought she was going to die. She did not felt good, went to bed and 5 minutes later she thought she was going to hit herself because she had no control of her body, her head in the bead, she pee in her pants. Her mouth was hanging open, could not move. The patient mentioned her head, leg and body not working, had no control of her body, she described the situation horrifying, so close to death, had no feeling in her body. Se did not want to go to the ER.. Husband stayed with her and she improved 3 hours later without treatment. On the next day, they contacted her physician who prescribed over the counter treatment.   Laboratory test were not reported. Treatment included Benadryl, Advil and Tylenol.  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, hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema 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 the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pruritus, Sensation of foreign body
Clinical narrative: whole body was itchy; Tongue tingling and numb/lips tingling and numb; lump in the back of her throat; Tongue tingling and numb/lips tingling and numb; A spontaneous report (UNITED STATES) was received from a 57-years-old consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events whole body was itchy, tongue tingling and numb/lips tingling and numb and lump on the back of her throat.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05-FEB-2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 05-FEB-2021, the consumer experienced the events whole body was itchy, tongue tingling and numb/lips tingling and numb and lump on the back of her throat. The reporter mentioned that she had to be transported to the ER from the vaccination center.  Treatment information included benadryl.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events was considered unknown.; Reporter's Comments: This case concerns a 57 Y/O  hospitalized with serious unexpected events of pruritus, paraesthesia oral, hypoaesthesia oral and sensation of foreign body. Event onset the same day as first dose mRNA-1273. Treated with diphenhydramine.  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.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Fatigue, Nausea, Pulmonary embolism
Clinical narrative: clot in lung; pain in her left lower lung from back; Shortness of breath; fever 102F; nausea; very very tired; A spontaneous report was received from a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pyrexia (fever 102F), nausea (nausea), illness (very sick), fatigue (very very tired), dyspnoea (shortness of breath) and back pain (pain in her left lower lung from back).  The patient's medical history was not provided. No concomitant product use was reported.  On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm  for prophylaxis of COVID-19 infection.   On 14-Feb-2021, the patient felt very sick, had fever of 102 degrees Fahrenheit, nausea, pain in her left lower lung which had radiated from the back, shortness of breath and was very tired. On 15-Feb-2021, the patient got hospitalized and underwent laboratory examination findings of which were unknown. On an unspecified date, it was known that the patient had clot in the lungs and was receiving a daily shot of an unspecified drug as a remedy.  On 13 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm  for prophylaxis of COVID-19 infection. The patient took 2X strength of Tylenol right before receiving the second dose of vaccine as per the Physician's recommendation.   Treatment information included Tylenol.  Action taken with mRNA-1273 was not applicable.  The outcome of the events,pyrexia (fever 102f), nausea (nausea), illness (very sick), fatigue (very very tired), dyspnoea (shortness of breath) and back pain (pain in her left lower lung from back), 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 (pyrexia, nausea, back pain, dyspnoea, and fatigue) a causal relationship cannot be excluded. Very limited information regarding these event (Pulmonary embolism) has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: clot in lung; pain in her left lower lung from back; Shortness of breath; fever 102F; nausea; very very tired; A spontaneous report was received from a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pyrexia (fever 102F), nausea (nausea), illness (very sick), fatigue (very very tired), dyspnoea (shortness of breath) and back pain (pain in her left lower lung from back).  The patient's medical history was not provided. No concomitant product use was reported.  On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm  for prophylaxis of COVID-19 infection.   On 14-Feb-2021, the patient felt very sick, had fever of 102 degrees Fahrenheit, nausea, pain in her left lower lung which had radiated from the back, shortness of breath and was very tired. On 15-Feb-2021, the patient got hospitalized and underwent laboratory examination findings of which were unknown. On an unspecified date, it was known that the patient had clot in the lungs and was receiving a daily shot of an unspecified drug as a remedy.  On 13 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm  for prophylaxis of COVID-19 infection. The patient took 2X strength of Tylenol right before receiving the second dose of vaccine as per the Physician's recommendation.   Treatment information included Tylenol.  Action taken with mRNA-1273 was not applicable.  The outcome of the events,pyrexia (fever 102f), nausea (nausea), illness (very sick), fatigue (very very tired), dyspnoea (shortness of breath) and back pain (pain in her left lower lung from back), 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 (pyrexia, nausea, back pain, dyspnoea, and fatigue) a causal relationship cannot be excluded. Very limited information regarding these event (Pulmonary embolism) has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Diverticulitis, Fatigue
Clinical narrative: very tired; Diverticulitis after first dose; A spontaneous report was received from a consumer concerning a 86-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diverticulitis and fatigue.  The patient's medical history included mononucleosis. No relevant concomitant medications were reported.   On 14 Feb 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 006M20A) for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient was diagnosed with diverticulitis. Treatment information included two different type of antibiotics.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events diverticulitis and fatigue was considered as unknown at the time of the report.  Follow up: Follow-up received on 22 Mar 2021 included concomitant medications of ticaglor Twice a day - for heart, Pepsin Twice a day,Blood pressure medicine twice a day and sertraline15 mg once a day.  On 14-Feb-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 006M20A) on right arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient experienced with ball irritation problem, diverticulosis as diagnosis.  Laboratory details include,CAT on abdomen on March 2nd and diagnosed that there is minimal fat stranding adjacent to the diverticula. Suggested of mild-acute uncomplicated diverticulosis.Treatment information included,Doxycycline 100 mg, twice a daystarted on 12 Mar 2021. This is for 14 days. In addition then in March 15th started to have Metronidazole 500 mg, 1 tablet three times a day For 14 days.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events diverticulitis and fatigue was considered as unknown at the time of the report.; Reporter's Comments: Based on the known etiology for diverticulosis and the  fact that patient stated that she was fatigued from the antibiotics, a causal association between the reported event and the administration of mRNA-1273  is assessed as unlikely.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait inability, Hospitalisation, Peripheral swelling
Clinical narrative: Hospitalized for 8 to 9 hours; Could not walk; Whole body shutdown; Swollen arm; nostalgic; A spontaneous report was received from a consumer concerning a 77 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nostalgia, could not walk, swollen arm and whole body shut down, and hospitalized for 8 to 9 hours.  The patient's medical history included allergies to bee stings. Products known to have been used by the patient within two weeks prior to the event include: unspecified cholesterol medication, aspirin and unspecified hernia meds.  On 08 March 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 036a21a) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient experienced nostalgia, could not walk, swollen arm, whole body shutdown and was hospitalized for 8 to 9 hours.   Laboratory details were not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of the report, the outcome of the events, nostalgic, could not walk, swollen arm, whole body shutdown and hospitalized for 8 to 9 hours,  were unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exophthalmos, Eye swelling, Pain
Clinical narrative: little ache; popped eye; swollen eye; A spontaneous report was received from a consumer, who is a 64-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  swollen and pooped eyes.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On 27-FEB-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number 0252A21A) via unknown route for COVID-19 infection prophylaxis.  On 27-FEB-2021, after second dose of vaccine, the patient experienced eyes swollen and pooped which she doesn't experienced after the first dose which she only had a little ache. No treatment medication was reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was 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: Condition aggravated, Dysphagia, Facial paralysis, Feeding tube user, Feeling hot
Clinical narrative: thrombocytopenia; neutropenia; facial paralysis; Body felt flushed; body felt warm; reaction to her myasthenia gravis symptoms; tremors; not been able to swallow the water; esophagus spazzing; acute exacerbation to her myasthenia gravis; couldn't eat for 7 days in hospital, needed feeding tube; symptoms of rheumatoid arthritis; A spontaneous report was received from consumer who is a 72-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Flushing (Body felt flushed), Feeling hot (body felt warm) , Myasthenic syndrome (reaction to her myasthenia gravis symptoms), Oesophageal spasm (esophagus spazzing), feeding tube user (couldn't eat for 7 days in hospital, needed feeding tube), Condition aggravated (acute exacerbation to her myasthenia gravis) , Neutropenia (neutropenia) , Thrombocytopenia (thrombocytopenia), Rheumatoid arthritis (symptoms of rheumatoid arthritis), Facial paralysis (facial paralysis), Tremor (tremors), and Dysphagia (not been able to swallow the water)   The patient's medical history included Myasthenia Gravis and breast cancer. No relevant laboratory tests were reported. Concomitant medications included: mestinon, pantoprazole, tamoxifene, methylprednisolone, clopidogrel, rosuvastatin, leflunomide, oxybutynin, actemra, vitamin B12, vitamin D3.  On 04-MAR-2021, the patient received her  first of two planned doses on her left non dominant deltoidof mRNA-1273 (lot/batch: 025A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04-MAR-2021, patient had reaction to her Myasthenia Gravis symptoms as she started having facial paralysis and tremors and  not been able to swallow the water due to her esophagus spazzing. She  admitted to the hospital for 11 days and finally discharged on 15-MAR-2021. While in the hospital she could not eat for 7 days so she was placed on a feeding tube.  Patient provided with the treatment: IV plasmapheresis, feeding tube put in, endoscopy, platelets and blood infusion, and medications to keep unspecified blood levels.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, flushing, feeling hot, Myasthenic Syndrome,  esophageal spasm , feeding tube user, condition aggravated, neutropenia, thrombocytopenia, rheumatoid arthritis, facial paralysis, tremor, dysphagia was resolved on 15-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 events, a causal relationship cannot be excluded. Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Myasthenic syndrome, Neutropenia, Oesophageal spasm, Rheumatoid arthritis
Clinical narrative: thrombocytopenia; neutropenia; facial paralysis; Body felt flushed; body felt warm; reaction to her myasthenia gravis symptoms; tremors; not been able to swallow the water; esophagus spazzing; acute exacerbation to her myasthenia gravis; couldn't eat for 7 days in hospital, needed feeding tube; symptoms of rheumatoid arthritis; A spontaneous report was received from consumer who is a 72-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Flushing (Body felt flushed), Feeling hot (body felt warm) , Myasthenic syndrome (reaction to her myasthenia gravis symptoms), Oesophageal spasm (esophagus spazzing), feeding tube user (couldn't eat for 7 days in hospital, needed feeding tube), Condition aggravated (acute exacerbation to her myasthenia gravis) , Neutropenia (neutropenia) , Thrombocytopenia (thrombocytopenia), Rheumatoid arthritis (symptoms of rheumatoid arthritis), Facial paralysis (facial paralysis), Tremor (tremors), and Dysphagia (not been able to swallow the water)   The patient's medical history included Myasthenia Gravis and breast cancer. No relevant laboratory tests were reported. Concomitant medications included: mestinon, pantoprazole, tamoxifene, methylprednisolone, clopidogrel, rosuvastatin, leflunomide, oxybutynin, actemra, vitamin B12, vitamin D3.  On 04-MAR-2021, the patient received her  first of two planned doses on her left non dominant deltoidof mRNA-1273 (lot/batch: 025A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04-MAR-2021, patient had reaction to her Myasthenia Gravis symptoms as she started having facial paralysis and tremors and  not been able to swallow the water due to her esophagus spazzing. She  admitted to the hospital for 11 days and finally discharged on 15-MAR-2021. While in the hospital she could not eat for 7 days so she was placed on a feeding tube.  Patient provided with the treatment: IV plasmapheresis, feeding tube put in, endoscopy, platelets and blood infusion, and medications to keep unspecified blood levels.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, flushing, feeling hot, Myasthenic Syndrome,  esophageal spasm , feeding tube user, condition aggravated, neutropenia, thrombocytopenia, rheumatoid arthritis, facial paralysis, tremor, dysphagia was resolved on 15-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 events, a causal relationship cannot be excluded. Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia, Tremor
Clinical narrative: thrombocytopenia; neutropenia; facial paralysis; Body felt flushed; body felt warm; reaction to her myasthenia gravis symptoms; tremors; not been able to swallow the water; esophagus spazzing; acute exacerbation to her myasthenia gravis; couldn't eat for 7 days in hospital, needed feeding tube; symptoms of rheumatoid arthritis; A spontaneous report was received from consumer who is a 72-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Flushing (Body felt flushed), Feeling hot (body felt warm) , Myasthenic syndrome (reaction to her myasthenia gravis symptoms), Oesophageal spasm (esophagus spazzing), feeding tube user (couldn't eat for 7 days in hospital, needed feeding tube), Condition aggravated (acute exacerbation to her myasthenia gravis) , Neutropenia (neutropenia) , Thrombocytopenia (thrombocytopenia), Rheumatoid arthritis (symptoms of rheumatoid arthritis), Facial paralysis (facial paralysis), Tremor (tremors), and Dysphagia (not been able to swallow the water)   The patient's medical history included Myasthenia Gravis and breast cancer. No relevant laboratory tests were reported. Concomitant medications included: mestinon, pantoprazole, tamoxifene, methylprednisolone, clopidogrel, rosuvastatin, leflunomide, oxybutynin, actemra, vitamin B12, vitamin D3.  On 04-MAR-2021, the patient received her  first of two planned doses on her left non dominant deltoidof mRNA-1273 (lot/batch: 025A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04-MAR-2021, patient had reaction to her Myasthenia Gravis symptoms as she started having facial paralysis and tremors and  not been able to swallow the water due to her esophagus spazzing. She  admitted to the hospital for 11 days and finally discharged on 15-MAR-2021. While in the hospital she could not eat for 7 days so she was placed on a feeding tube.  Patient provided with the treatment: IV plasmapheresis, feeding tube put in, endoscopy, platelets and blood infusion, and medications to keep unspecified blood levels.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, flushing, feeling hot, Myasthenic Syndrome,  esophageal spasm , feeding tube user, condition aggravated, neutropenia, thrombocytopenia, rheumatoid arthritis, facial paralysis, tremor, dysphagia was resolved on 15-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 events, a causal relationship cannot be excluded. Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Hepatitis acute
Clinical narrative: acute hepatitis; This spontaneous case was reported by a physician and describes the occurrence of HEPATITIS ACUTE (acute hepatitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine).    No Medical History information was reported.  Concomitant medications included insulin glargine, acetylsalicylic acid, atorvastatin, and anastrozole.   On 11 Mar 2021, the patient received their first dose of dose of mRNA-1273 (Moderna COVID-19 Vaccine) intramuscular (Batch number unknown).  On 15-Mar-2021, the patient came in for a follow-up visit with her physician and she presented with acute hepatitis. Relevant laboratory results included  aspartate aminotransferase (AST) -1900, alanine aminotransferase (ALT)- 2562, bilirubin of 3, alkaline phosphatase  550, and mild elevation for amylase. She was admitted in the Emergency Room (ER )for 6 hours, to be accessed.  For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.  The outcome for the event of HEPATITIS ACUTE (acute hepatitis) 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.  Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: Shortness of breath; A spontaneous report was received from a consumer concerning for herself, a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath/dyspnoea.  The patient's medical history included Covid-19 in an unknown date in Dec 2020 and current condition includes lung disease since birth, belly pain, arm and shoulder pain. Concomitant medications includes levothyroxine and vitamins.  On 11 Mar 2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (Batch number: 010A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced shortness of breath for which patient was admitted to hospital and was given oxygen. The patient stated that symptoms resolved.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome for the event, shortness of breath was resolved on an unknown date at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of shortness of breath, a causal relationship cannot be excluded. Patient's underlying lung disease may have been contributory.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; A spontaneous report was received from a consumer concerning an 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed  out/loss of consciousness.  Patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, approximately 17 hours prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 023M20A) for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced medically significant event of passed out. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event passed out was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; A spontaneous report was received from consumer, concerning an 80-Year-old female patient  who received  Moderna COVID-19 vaccine (mRNA-1273) and experienced Pneumonia and hospitalized.  The patient's medical history was not provided. concomitant product use was not provided.  On 17-Feb-2021 the patient received first dose of the mRNA-1273 vaccine (Batch number 024M20A ) in left non-dominant arm for the prophylaxis of COVID-19 infection.  On 23-Feb-2021 the patient hospitalized. the cause of hospitalization was pneumonia. Treatment included antibiotics and steroids.  Action taken with mRNA-1273 in response to event was unknown.  Outcome of the event, pneumonia was considered to be unknown at the time of this report.; 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: Asthenia, Blood pressure measurement, Dry mouth, Dyspnoea, Eye disorder
Clinical narrative: High blood pressure spike 186/81; Rapid heart rate; Difficulty breathing; I had a visual aura I saw a big red ball with my eyes closed; Arm soreness; trembly; dry mouth; weak; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth.  The patient's medical history was not provided. Concomitant medications reported were Lotrel 5/10mg for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura I saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), high blood pressure spike 186 81, rapid heart rate, difficulty breathing, i had a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Pain in extremity, Tremor
Clinical narrative: High blood pressure spike 186/81; Rapid heart rate; Difficulty breathing; I had a visual aura I saw a big red ball with my eyes closed; Arm soreness; trembly; dry mouth; weak; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth.  The patient's medical history was not provided. Concomitant medications reported were Lotrel 5/10mg for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura I saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), high blood pressure spike 186 81, rapid heart rate, difficulty breathing, i had a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth 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: M
Vaccine: COVID19
Symptoms: Facial discomfort, Facial paralysis
Clinical narrative: Paralyzed face; Felt like something was poking face; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced kind of a paralyzed face/ facial paralysis and like something was poking the face/ facial discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of the events, the patient received his dose of mRNA-1273(Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, patient experienced a paralyzed face and like something was poking the face. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, kind of a paralyzed face and like something was poking the face 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 events, a causal relationship cannot be excluded.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Delirium, Diarrhoea, Fatigue
Clinical narrative: Delirious; Diarrhea; Flu-like symptoms; Weak; Swollen; Fatigue; Joint achy; Fever; A spontaneous report was received from a consumer concerning a 95-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms/influenza like illness, fever/pyrexia, diarrhea, delirious/delirium, weak/asthenia, joint achy/ arthralgia, swollen/swelling and fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 11 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 0D1B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue. The event delirium was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue, 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: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Swelling
Clinical narrative: Delirious; Diarrhea; Flu-like symptoms; Weak; Swollen; Fatigue; Joint achy; Fever; A spontaneous report was received from a consumer concerning a 95-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms/influenza like illness, fever/pyrexia, diarrhea, delirious/delirium, weak/asthenia, joint achy/ arthralgia, swollen/swelling and fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 11 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 0D1B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue. The event delirium was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue, 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.
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism
Clinical narrative: Hyperthyroid issues; A Spontaneous  report was received from a consumer concerning a female  patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hyperthyroidism/hyperthyroid issues.  The patient's medical history was  provided as sinus infection and tooth extraction before vaccine administration. The concomitant medications were reported as unknown antibiotics.   On 18 Feb  2021 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 in an unknown location for prophylaxis of COVID-19 infection.  On an unknown day after vaccination patient experienced hyperthyroidism.   No treatment medication was reported.   The event hyperthyroidism was considered as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, hyperthyroidism  was considered as recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.