chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vertigo
Clinical narrative: Difficulty breathing; Ear was hurting inside for several hours; Back pain; Lip was itching; Bottom lip swelled; 1-2 hives on her lips; Dizzy spells; Vertigo; Migraines/ low grade headache; Coughing up dark mucus; Not feeling well; Itchy, 2 inches in diameter of a red circle at vaccination site; Respiratory infection; Bronchitis; Side of her neck was hurting; Itchy, 2 inches in diameter of a red circle at injection site; Congestion; Shoulder pain; A spontaneous report  was received from a  consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled, 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well.  The patient's medical history, as provided by the reporter, included chronic fatigue syndrome, respiratory infection. Concomitant medications were not reported.   On 10 Feb 2021, approximately same day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, prior to receiving mRNA-1273, the patient felt covid arm around 7 days later where it was itchy, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection. The event respiratory infection was considered medically significant.  Treatment for the events included antibiotics and steroids.  Action taken with mRNA-1273 in response to the events was not reported.   The events, itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Chronic obstructive pulmonary disease, Decreased appetite, Headache
Clinical narrative: Congestion; After getting the vaccine the COPD was worse; After getting the vaccine the COPD was worse, but now is better than before; did not feel well; recover appetite; headaches; Had no energy,felt weak for 3-4 days.; Chills; A spontaneous report  was received from a consumer who is a 67-year-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache. He also reported an improvement of the pre-existing COPD after receiving the vaccine and experiencing the exacerbation.  Medical history includes COPD (Chronic Obstructive Pulmonary Disease) and emphysema. Concomitant medications include oxygen, salmeterol xinafoate/fluticasone propionate and Tiotropium bromide.  On 27-JAN-2021, this patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 007M20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection.   On 27-JAN-2021, the day of vaccination, the patient felt fine, up until bedtime. When they started to undress for bed the patient experienced chills. He put on sweatpants, socks, and some warm clothes to get warm. The patient managed to get to sleep. The next day, the patient did not feel very well at all. The patient describe as having no energy and felt weak for 3-4 days. He also had headaches, for which he took some Tylenol. Towards the weekend he recovered his appetite and started to feel better. The patient mentioned they used a nebulizer to treat some congestion they experienced. He stated, at first after getting the vaccine, the COPD was worse, but now it was better than before the vaccine. Patient was suppose to get second dose next week and wonders if they should. Event congestion was considered medically significant. Laboratory test were not reported.  Action taken with the drug in response to the events is unknown.  The outcome for the events, congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache, was recovered. The outcome for the event preexisting condition improved is 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pre-existing condition improved, Pulmonary congestion
Clinical narrative: Congestion; After getting the vaccine the COPD was worse; After getting the vaccine the COPD was worse, but now is better than before; did not feel well; recover appetite; headaches; Had no energy,felt weak for 3-4 days.; Chills; A spontaneous report  was received from a consumer who is a 67-year-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache. He also reported an improvement of the pre-existing COPD after receiving the vaccine and experiencing the exacerbation.  Medical history includes COPD (Chronic Obstructive Pulmonary Disease) and emphysema. Concomitant medications include oxygen, salmeterol xinafoate/fluticasone propionate and Tiotropium bromide.  On 27-JAN-2021, this patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 007M20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection.   On 27-JAN-2021, the day of vaccination, the patient felt fine, up until bedtime. When they started to undress for bed the patient experienced chills. He put on sweatpants, socks, and some warm clothes to get warm. The patient managed to get to sleep. The next day, the patient did not feel very well at all. The patient describe as having no energy and felt weak for 3-4 days. He also had headaches, for which he took some Tylenol. Towards the weekend he recovered his appetite and started to feel better. The patient mentioned they used a nebulizer to treat some congestion they experienced. He stated, at first after getting the vaccine, the COPD was worse, but now it was better than before the vaccine. Patient was suppose to get second dose next week and wonders if they should. Event congestion was considered medically significant. Laboratory test were not reported.  Action taken with the drug in response to the events is unknown.  The outcome for the events, congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache, was recovered. The outcome for the event preexisting condition improved is 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: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Immunocompromised; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced an immunocompromised event.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23-Jan-2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after first dose of vaccine, the patient was immunocompromised. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, immunocompromised was considered 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 onset date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Dizziness, Heart rate increased, Palpitations
Clinical narrative: Increased heart rate when she walks; Very dizzy; May have received 1.5 dose instead of 1 dose; Heart racing (110 BPM heart rate); A spontaneous report was received from a consumer concerning his wife, a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing/ Palpitations (110 beats per minute) on walking/ Heart rate increased, felt very dizzy/ Dizziness, might have received 1.5 dose instead of 1 dose of vaccine/ Accidental overdose.  The patient's medical history was not provided. No concomitant product use was reported.  On 15 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 024M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, an unspecified duration after receiving the vaccine, the patient experienced heart racing (110 beats per minute) on walking and felt very dizzy. The patient reported normal heart rate while resting. It was known that the patient might have received 1.5 dose instead of 1 dose of vaccine.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event received 1.5 dose instead of 1 dose of vaccine was considered resolved on 15 Feb 2021. The outcome of the events, heart racing (110 beats per minute) on walking, felt very dizzy, may have received 1.5 dose instead of 1 dose of vaccine, was not reported.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273, lot # 024M20A with associated AEs of heart racing and dizziness. 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Chills, Eye pain, Eye swelling, Intraocular pressure increased
Clinical narrative: Still a little blurry; Her eye pressure was still high; Her eye was swollen; So much pain above her eye; Nausea; In the afternoon all of a sudden she lost sight of her left eye; She vomited 10 times; Achy; Soreness in the arm; Chills; Fever; Swollen arm; A spontaneous report  was received from a consumer, concerning a female patient of 65 years of age, who received Moderna's COVID-19 vaccine and experienced soreness in the arm (vaccination site pain), swollen arm (vaccination site swelling),c hills, achy (pain), fever (pyrexia), vomiting, all of a sudden lost sight of her left eye (unilateral blindness), swollen eye (eye swelling), so much pain above her eye (eye pain), her eye pressure was still high (intraocular pressure increased), nausea, and still a little blurry (vision blurred)  The patient's medical history included asthma. Concomitant product use included Montelukast sodium, fluticasone propionate/salmeterol xinofoate, and salbutamol sulfate.  On 20-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 030L20A) intramuscularly in the left arm for prohylaxis of COVID-19 infection.    On 20-Feb-2021 the patient received the first dose of the vaccine and had soreness in the arm, swollen arm, chills, was achy and had a fever. On 21-Feb-2021,  she vomited 10 times and in the afternoon all of a sudden she lost sight in her left eye. On 22-Feb-2021 her eye was swollen, hot, and there was so much pain above her eye. The patient went to the emergency room (ER) and received IV (intravenous) fluids and two different eye drops, her eye pressure was still high, and she had nausea. On 23-Feb-2021 she could tolerate light, had no pain but was still not able to see. On 24-Feb-2021 the patient reported they are getting better, but that blurred vision was still persisting.  Treatment medication included IV fluids and 2 different eye drops as well as anti-nausea medication.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, soreness in arm, swollen arm, chills, achy, and fever, were resolved on 20-Feb-2021. The outcome of the event, vomiting, was resolved on 21-Feb-2021. The outcome of the event, so much pain above her eye, was resolved on 23-Feb-2021. The outcome of the events, all of a sudden lost site in her left eye, swollen eye, eye pressure was still high, nausea, and still a little blurry, were considered not recovered/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. Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Still a little blurry; Her eye pressure was still high; Her eye was swollen; So much pain above her eye; Nausea; In the afternoon all of a sudden she lost sight of her left eye; She vomited 10 times; Achy; Soreness in the arm; Chills; Fever; Swollen arm; A spontaneous report  was received from a consumer, concerning a female patient of 65 years of age, who received Moderna's COVID-19 vaccine and experienced soreness in the arm (vaccination site pain), swollen arm (vaccination site swelling),c hills, achy (pain), fever (pyrexia), vomiting, all of a sudden lost sight of her left eye (unilateral blindness), swollen eye (eye swelling), so much pain above her eye (eye pain), her eye pressure was still high (intraocular pressure increased), nausea, and still a little blurry (vision blurred)  The patient's medical history included asthma. Concomitant product use included Montelukast sodium, fluticasone propionate/salmeterol xinofoate, and salbutamol sulfate.  On 20-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 030L20A) intramuscularly in the left arm for prohylaxis of COVID-19 infection.    On 20-Feb-2021 the patient received the first dose of the vaccine and had soreness in the arm, swollen arm, chills, was achy and had a fever. On 21-Feb-2021,  she vomited 10 times and in the afternoon all of a sudden she lost sight in her left eye. On 22-Feb-2021 her eye was swollen, hot, and there was so much pain above her eye. The patient went to the emergency room (ER) and received IV (intravenous) fluids and two different eye drops, her eye pressure was still high, and she had nausea. On 23-Feb-2021 she could tolerate light, had no pain but was still not able to see. On 24-Feb-2021 the patient reported they are getting better, but that blurred vision was still persisting.  Treatment medication included IV fluids and 2 different eye drops as well as anti-nausea medication.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, soreness in arm, swollen arm, chills, achy, and fever, were resolved on 20-Feb-2021. The outcome of the event, vomiting, was resolved on 21-Feb-2021. The outcome of the event, so much pain above her eye, was resolved on 23-Feb-2021. The outcome of the events, all of a sudden lost site in her left eye, swollen eye, eye pressure was still high, nausea, and still a little blurry, were considered not recovered/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. Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Still a little blurry; Her eye pressure was still high; Her eye was swollen; So much pain above her eye; Nausea; In the afternoon all of a sudden she lost sight of her left eye; She vomited 10 times; Achy; Soreness in the arm; Chills; Fever; Swollen arm; A spontaneous report  was received from a consumer, concerning a female patient of 65 years of age, who received Moderna's COVID-19 vaccine and experienced soreness in the arm (vaccination site pain), swollen arm (vaccination site swelling),c hills, achy (pain), fever (pyrexia), vomiting, all of a sudden lost sight of her left eye (unilateral blindness), swollen eye (eye swelling), so much pain above her eye (eye pain), her eye pressure was still high (intraocular pressure increased), nausea, and still a little blurry (vision blurred)  The patient's medical history included asthma. Concomitant product use included Montelukast sodium, fluticasone propionate/salmeterol xinofoate, and salbutamol sulfate.  On 20-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 030L20A) intramuscularly in the left arm for prohylaxis of COVID-19 infection.    On 20-Feb-2021 the patient received the first dose of the vaccine and had soreness in the arm, swollen arm, chills, was achy and had a fever. On 21-Feb-2021,  she vomited 10 times and in the afternoon all of a sudden she lost sight in her left eye. On 22-Feb-2021 her eye was swollen, hot, and there was so much pain above her eye. The patient went to the emergency room (ER) and received IV (intravenous) fluids and two different eye drops, her eye pressure was still high, and she had nausea. On 23-Feb-2021 she could tolerate light, had no pain but was still not able to see. On 24-Feb-2021 the patient reported they are getting better, but that blurred vision was still persisting.  Treatment medication included IV fluids and 2 different eye drops as well as anti-nausea medication.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, soreness in arm, swollen arm, chills, achy, and fever, were resolved on 20-Feb-2021. The outcome of the event, vomiting, was resolved on 21-Feb-2021. The outcome of the event, so much pain above her eye, was resolved on 23-Feb-2021. The outcome of the events, all of a sudden lost site in her left eye, swollen eye, eye pressure was still high, nausea, and still a little blurry, were considered not recovered/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. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Head discomfort, Headache
Clinical narrative: sweating a lot; have diarrhea; shivering, cold; fever; bad headache; congestion/tightness; head congestion; A spontaneous report was received from a consumer concerning a 50 years old, female patient who developed congestion/tightness (pulmonary congestion), sweating a lot (hyperhidrosis), diarrhea, head congestion (head discomfort), shivering, cold (chills), fever (pyrexia), and bad headache (headache).   The patient's medical history included asthma and migraine.  Concomitant product use was by the reporter were medication for asthma, medication for migraine, medication for chronic fatigue disease and meds for fibromyalgia.     On 21 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 03L20A)  for prophylaxis of COVID-19 infection.   On 17 Feb 2021,prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) for prophylaxis of COVID-19 infection.   On 17 Feb 2021, from the first 24 to 48 hours (hrs) post the second vaccine dose, the patient experienced shivering, cold, fever 101.8 Fahrenheit (F).  The next day on 18 Feb 2021, the patient experienced a bad headache, some congestion/tightness.  The patient reported that some of those events that were experienced had resolved, but the headache, diarrhea, and some head congestion were ongoing.  She also reported that she was now sweating a lot.  The treatment of the event included Tylenol.   The event(s), shivering ,cold and  fever had resolved on an unknown date.  The events of headache, diarrhea, and some head congestion/congestion/tightness were ongoing at the time of the 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 events a causal relationship cannot be excluded. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pulmonary congestion, Pyrexia
Clinical narrative: sweating a lot; have diarrhea; shivering, cold; fever; bad headache; congestion/tightness; head congestion; A spontaneous report was received from a consumer concerning a 50 years old, female patient who developed congestion/tightness (pulmonary congestion), sweating a lot (hyperhidrosis), diarrhea, head congestion (head discomfort), shivering, cold (chills), fever (pyrexia), and bad headache (headache).   The patient's medical history included asthma and migraine.  Concomitant product use was by the reporter were medication for asthma, medication for migraine, medication for chronic fatigue disease and meds for fibromyalgia.     On 21 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 03L20A)  for prophylaxis of COVID-19 infection.   On 17 Feb 2021,prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) for prophylaxis of COVID-19 infection.   On 17 Feb 2021, from the first 24 to 48 hours (hrs) post the second vaccine dose, the patient experienced shivering, cold, fever 101.8 Fahrenheit (F).  The next day on 18 Feb 2021, the patient experienced a bad headache, some congestion/tightness.  The patient reported that some of those events that were experienced had resolved, but the headache, diarrhea, and some head congestion were ongoing.  She also reported that she was now sweating a lot.  The treatment of the event included Tylenol.   The event(s), shivering ,cold and  fever had resolved on an unknown date.  The events of headache, diarrhea, and some head congestion/congestion/tightness were ongoing at the time of the 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 events a causal relationship cannot be excluded. Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Dizziness, Eye disorder, Feeling abnormal
Clinical narrative: Heart fluttering and weakness; Weakness; Eyes glazed over; Her eyes are bothering her, still feel weak; Head in a fog; Light headed; A spontaneous report  was received from consumer concerning a 76 years old female who experienced heart fluttering (cardiac flutter) and weakness(asthenia), eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort), head in a fog (feeling abnormal), and light headed (dizziness).  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On 02 FEB 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported that on 03 FEB 2021 her eyes seemed glazed over, her head felt like it was in fog, and she had feelings of experienced heart fluttering and weakness. She stated that weakness was also associated with the heart fluttering. The symptoms resolved in about a week, other than her eyes which still feel weak, and bothering her enough. Treatment information included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events of eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort) was considered as not recovered. The events of heart fluttering (cardiac flutter) and weakness(asthenia), head in a fog (feeling abnormal), and light headed (dizziness) were considered 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. Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: Heart fluttering and weakness; Weakness; Eyes glazed over; Her eyes are bothering her, still feel weak; Head in a fog; Light headed; A spontaneous report  was received from consumer concerning a 76 years old female who experienced heart fluttering (cardiac flutter) and weakness(asthenia), eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort), head in a fog (feeling abnormal), and light headed (dizziness).  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On 02 FEB 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported that on 03 FEB 2021 her eyes seemed glazed over, her head felt like it was in fog, and she had feelings of experienced heart fluttering and weakness. She stated that weakness was also associated with the heart fluttering. The symptoms resolved in about a week, other than her eyes which still feel weak, and bothering her enough. Treatment information included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events of eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort) was considered as not recovered. The events of heart fluttering (cardiac flutter) and weakness(asthenia), head in a fog (feeling abnormal), and light headed (dizziness) were considered 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: cellulitis; arm felt warm; arm was red; arm was swollen; A spontaneous report was received from a consumer who was also a female patient, unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, arm felt warm/ vaccination site warmth, arm was red/ vaccination site erythema,  and arm was swollen/ vaccination site swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date in Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient received their first dose of vaccine in Feb 2021. During the week of 14 Feb 2021, the patient's arm felt warm, was red and swollen, and the swelling started to go down to the upper arm. On 19 Feb 2021, the patient went to urgent care and the doctor said it was cellulitis. Treatment for the events included antibiotics.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was not resolved or reported at the time of event.; 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: Exposure during pregnancy, Haemorrhage, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: Bleeding right after the first shot; Pregnant; A spontaneous report  was received from consumer, concerning herself, a 39-year-old, pregnant female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a bleeding right after the 1st shot, pregnant.  The patient's medical history include 3 miscarriages on Dec 2013 , Feb 2013, Apr 2013 (all not more 2months). Products known to have been used by the patient, included Progesterone 300mg indicated for after 3miscarriages, Tylenol, Folic acid 1mg .  On 18JAN 2021, prior to onset of events, the patient received their first of two planned doses  of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 FEB 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She experienced bleeding right after the 1ST shot. She would like to be enrolled into the pregnancy registry. On 15JAN2021, the patient received a positive pregnancy test. Her last menstrual period was on 07 DEC 2020 and conception date was unknown. The patient's estimated due date is 12SEP2021.  No treatment information was provided.  Relevant laboratory test on 22 Feb 2021 last Ultrasound were done and the Result were normal.   Action taken with mRNA-1273 in response to events were not provided.  The outcome of the event bleeding right after the 1st shot was unknown and pregnant is ongoing.; Reporter's Comments: This is a case of product exposure on a 39-year-old pregnant of unknown gestation (LMP 07 DEC 2020)  and experienced PV bleed right after the first shot.  Very limited information regarding this event has been provided at this time. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dementia
Clinical narrative: dementia was exaggerated; Confused/mentally unwell; A spontaneous report was received from a consumer concerning an 84-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced, dementia was exaggerated (Dementia), confused/mentally unwell (Confusional state).  The patient's medical history included Covid-19 after first dose. Current conditions included underlying dementia. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number:011M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Mar 2021, after receiving her second dose of vaccine, the patient was confused and mentally unwell. It was reported that after the vaccine, it seemed that her dementia was exaggerated.   Treatment for the events was not provided by the reporter.  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 events, dementia was exaggerated and confused/mentally unwell was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. However, patient's elderly age along with underlying dementia may have been contributory.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspepsia, Fatigue, Paraesthesia, Rash
Clinical narrative: Rash that looks like red tiny bumps; Tired; Heart fluttering; Tingling in my left arm down into my finger tips; Heart burn; A spontaneous report was received from consumer, concerning herself, a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a heart fluttering, tingling in left arm up to fingertips, heart burn, rash that looks like red tiny bumps and felt tired.  The patient's medical history was provided as mixed connective tissue disease.  Concomitant product use was provided by the reporter. Following products were listed: Multi Vitamins, Calcium Vitamin D, Vitamin C, Vitamin B12, Zyrtec, Plaquenil, Imuran, Protonix and Probiotics.  On 23 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A)  intramuscularly in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient felt heart fluttering for 2 days. The event resolved on 25 Feb 2021.  On 23 Feb 2021, after 30 minutes of administration the patient felt tingling in her left arm down to the fingertips, which lasted for 5 minutes. The event resolved on the same day.  On 23 Feb 2021, the patient experienced heart burn since the shot. The outcome of the event is unknown.  On 24 Feb 2021, the patient felt a bit tired. The event outcome is recovered/resolved.  On 28 Feb 2021, the patient experienced a rash which is spread throughout the body. The outcome of the event is unknown.  The patient also described that she is immunosuppressed and she has mixed connective tissue disease.  No treatment information was provided.  Action taken with mRNA-1273 in response to events were not provided.  The outcome of the events, heart fluttering, tingling in left arm up to fingertips, heart burn, rash that looks like red tiny bumps and felt tired was considered to be 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Neuropathy In Lower Body; Numbness appeared in her calves/hips and glutes; tingling appeared in her calves/hips and glutes; she was unable to walk correctly; A spontaneous report was received from a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy in lower body, numbness in calves, hips and glutes, tingling in calves, hips and glutes, and unable to walk correctly.  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 trandolapril, zolpidem tartrate, daily vitamins, magnesium, zinc, EPA and vitamin D3.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  About one week after administration of the vaccine, the patient began to experience neuropathy in her lower body. Numbness and tingling appeared in her calves, hips and glutes. This progressed to a point where she was unable to walk correctly. After seeking treatment the condition began to resolve itself in a few weeks and is no longer present at this time. Treatment for the events included Flexural and Aleve.  Action taken with mRNA-1273 in response to the events was not provided.  The outcomes of events, neuropathy peripheral, hypoesthesia, paresthesia, and gait disturbance, were considered recovered on unspecified date.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Oedema, Pain, Swelling, Vaccination site warmth
Clinical narrative: cellulitis; Heat; Lumps; Pain; swollen; A spontaneous report  was received from a consumer who was also a 68-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis, heat/ vaccination site warmth , lumps/ oedema, pain and swelling.  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 Aspirin, Metformin, Vivo, Thyroxine, Metoprolol, Omeprazole, Singulair, Oxygen, B12 Injection, Flaxseed Oil, Cocu10, Libutrin, Evox, Alogliptin Calcium Citrate and Vitamin B/C/D nonspecific.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027620A) intramuscularly in the hip for prophylaxis of COVID-19 infection.  On 24 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 002A219A) intramuscularly in the hip for prophylaxis of COVID-19 infection.   On unspecified dates, following each of the injections the patient developed cellulitis, heat, lumps, painful and was swollen. On the most recent injection the patient has a lump that was 6 inhes by 2 inches in size. Some side effects are still present at the time of reporting.   Treatment for the event included Keflex both times and heat pad nonspecific.  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.  Outcome of the events of cellulitis, heat, lumps, pain and swelling was unknown at the time of this report.; Reporter's Comments: This case concerns a 68-year-old female who had a serious unexpected event of cellulitis along with nonserious unexpected vaccination site warmth, swelling, edema, and pain. Event onset occurred with unknown latency after the second dose of mRNA-1273. Treatment included Keflex. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: Practically fainted; Shortness of breath; Tingling in right hand; Numbness; Brain fog; Feels weak; Soreness; Itchiness; Fatigued; A spontaneous report  was received from a consumer concerning a 70-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness, tingling in right hand, fatigued, practically fainted/Syncope, feels weak, itchiness, soreness, shortness of breath, brain fog.  The patient's medical history was not provided. Concomitant medications were not reported.  On 21 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:028L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number:031L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient practically fainted, felt numbness, tingling in right hand, felt fatigued, feels weak, itchiness, soreness, shortness of breath and brain fog. Treatment for the events were not reported. The adverse event of practically fainted was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events of numbness, tingling in right hand, fatigued, practically fainted, feels weak, itchiness, soreness, shortness of breath, brain fog 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus, Syncope
Clinical narrative: Practically fainted; Shortness of breath; Tingling in right hand; Numbness; Brain fog; Feels weak; Soreness; Itchiness; Fatigued; A spontaneous report  was received from a consumer concerning a 70-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness, tingling in right hand, fatigued, practically fainted/Syncope, feels weak, itchiness, soreness, shortness of breath, brain fog.  The patient's medical history was not provided. Concomitant medications were not reported.  On 21 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:028L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number:031L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient practically fainted, felt numbness, tingling in right hand, felt fatigued, feels weak, itchiness, soreness, shortness of breath and brain fog. Treatment for the events were not reported. The adverse event of practically fainted was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events of numbness, tingling in right hand, fatigued, practically fainted, feels weak, itchiness, soreness, shortness of breath, brain fog 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Impaired work ability, Myalgia
Clinical narrative: Really really dizzy; Weakness; Blurry eyes; Severe headache; Fever; Muscle pain; Bad nausea; not able to work; A spontaneous report , was received from a consumer (patient), concerning a 42 year old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache (headache), fever (pyrexia), dizziness (dizziness), weakness (asthenia), blurry eyes (vision blurred), muscle pain (myalgia), inability to work, and bad nausea (nausea).  The patient's medical history was not provided. No concomitant medications were reported for the patient.  On 5 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030A21A), intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, two hours after the vaccination, the patient experienced severe headache, fever, dizziness, weakness, blurry eyes, muscle pain, inability to work, and bad nausea. On an unspecified date, headache and fever went away. The events muscle pain, dizzy, eyes blurry, and little weak were not recovered/not resolved/ongoing. The patient was not able to work, got dizzy when she tried to get on the computer. Treatment details included taking aspirin for headache.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, severe headache and fever was considered recovered. Dizziness, weakness, blurry eyes, and muscle pain were considered not recovered.  The event of nausea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vision blurred
Clinical narrative: Really really dizzy; Weakness; Blurry eyes; Severe headache; Fever; Muscle pain; Bad nausea; not able to work; A spontaneous report , was received from a consumer (patient), concerning a 42 year old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache (headache), fever (pyrexia), dizziness (dizziness), weakness (asthenia), blurry eyes (vision blurred), muscle pain (myalgia), inability to work, and bad nausea (nausea).  The patient's medical history was not provided. No concomitant medications were reported for the patient.  On 5 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030A21A), intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, two hours after the vaccination, the patient experienced severe headache, fever, dizziness, weakness, blurry eyes, muscle pain, inability to work, and bad nausea. On an unspecified date, headache and fever went away. The events muscle pain, dizzy, eyes blurry, and little weak were not recovered/not resolved/ongoing. The patient was not able to work, got dizzy when she tried to get on the computer. Treatment details included taking aspirin for headache.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, severe headache and fever was considered recovered. Dizziness, weakness, blurry eyes, and muscle pain were considered not recovered.  The event of nausea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: 4 seizure episodes, lasting for 3-4minutes; A spontaneous report  was received from a consumer and other healthcare professional concerning a 37 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced 4 seizure episodes, lasting for 3-4minutes( seizure) .  The patient's medical history was not reported. Concomitant medications taken by the patient were not provided.  On 5 Mar 2021, prior to the onset of the event, the patient received his first  of two planned vaccine doses of mRNA-1273 (Lot number: unknown) through unknown route and dose, in the left arm, for prophylaxis of COVID-19 infection.  On 14 Mar202,1 at 3:00am, patient had a seizure episode which lasted for around 3-4 minutes. The event seizure caused for the hospitalization and was considered as medically significant. An ambulance was called and on the way to the hospital, he had 2 more episodes of seizure. While in the hospital the episode had again recurred. Blood work was done but the results were not provided. Patient was prescribed  Levetiracetam 500mg 2x a day.   Treatment for event was levetiracetam.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, experienced 4 seizure episodes, lasting for 3-4minutes, 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: broken blood vessel in left eye; A spontaneous report was received from a consumer (patient's spouse) concerning 66-years-old  female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had broken blood vessel in left eye (eye haemorrhage).    No medical history was reported. No concomitant medications were provided.  On 17 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 014M20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 07 Mar 2021, the patient had a broken blood vessel in left eye (medically significant).  The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event of broken blood vessel in left eye was unknown.  The reporter did not provide assessment for the event of broken blood vessel in left eye.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested