chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Lymphadenopathy, Vaccination site pain
Clinical narrative: 2 Hemorrhages - Left Eye; Swollen Lymph Nodes - Left Side of Body; Arm Pain - Near Injection Site; A spontaneous report , was received from a  health care professional, concerning a 65-year-old female patient, , who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2 hemorrhages - left eye/eye hemorrhage , swollen Lymph Nodes - Left Side of Body/lymphadenopathy and arm pain - Near Injection Site/injection site pain.  The patient's medical history and concomitant history was not provided by the reporter , no lab data was reported .    on 04 MAR 2021 the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 13 MAR 2021, the patient experienced  2 Hemorrhages - Left Eye , Swollen Lymph Nodes - Left Side of Body, Arm Pain - Near Injection Site. The treatment included were acetaminophen and ibuprofen.  The Action taken with the first dose of mRNA-1273 in response to the event was not reported.   The  outcome of the events, 2 hemorrhages - left eye/eye hemorrhage , swollen lymph nodes - left side of body/lymphadenopathy and arm pain - near Injection Site/injection site pain  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 event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Broken blood vessel in her right eye; A spontaneous report was received from a consumer concerning a 61-year-old, adult female patient who received Moderna's COVID-19 vaccine and experienced broken blood vessel in her right eye/eye haemorrhage.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number 014M20A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.   On 06 Mar 2021, after receiving the first dose, the patient observed broken blood vessel in her right eye. She had no pain and no vision impairment. The event broken blood vessel in her right eye was considered as medically significant. No treatment information was provided for the event.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event broken blood vessel in her right eye was 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Headache, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Diarrhea; loss of appetite; Swelling on her right side of face/Swelling in right cheek; Muscle weakness on her right side; Tremor in right leg; Headache in right side/Headache in total head; A spontaneous report  was received from a consumer concerning a 29-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling on her right side of face/swelling in right cheek/swelling face, muscle weakness on her right side/muscular weakness, tremor in right leg/tremor, headache in right side/headache in total head/headache, diarrhea, loss of appetite/decreased appetite.   The patient's medical history included liver transplant eight years ago and from eight years she was on immunosuppressant medication. Concomitant medications reported were adivant, sertraline hydrochloride, all used for unknown indication.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event(s) swelling on her right side of face, muscle weakness on her right side, tremor in right leg, headache on right side, swelling in right cheek, diarrhea, loss of appetite.   On 11 Mar 2021, these symptoms got worse  progressively and the patient was hospitalized on 11 Mar 2021 and hospitalization was prolonged.   On 15 Mar 2021, the patient experienced the event(s) headache, swelling in right cheek, diarrhea, loss of appetite.   Laboratory tests performed included, MRI scan ,neurologist looked at her spinal fluid, got tested for meningitis, did reading on CMS.   Treatment details included morphine and hydrocodone.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), swelling on her right side of face, muscle weakness on her right side, tremor in right leg, headache in right side, swelling in right cheek, diarrhea, loss of appetite, headache in total head 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tremor
Clinical narrative: Diarrhea; loss of appetite; Swelling on her right side of face/Swelling in right cheek; Muscle weakness on her right side; Tremor in right leg; Headache in right side/Headache in total head; A spontaneous report  was received from a consumer concerning a 29-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling on her right side of face/swelling in right cheek/swelling face, muscle weakness on her right side/muscular weakness, tremor in right leg/tremor, headache in right side/headache in total head/headache, diarrhea, loss of appetite/decreased appetite.   The patient's medical history included liver transplant eight years ago and from eight years she was on immunosuppressant medication. Concomitant medications reported were adivant, sertraline hydrochloride, all used for unknown indication.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event(s) swelling on her right side of face, muscle weakness on her right side, tremor in right leg, headache on right side, swelling in right cheek, diarrhea, loss of appetite.   On 11 Mar 2021, these symptoms got worse  progressively and the patient was hospitalized on 11 Mar 2021 and hospitalization was prolonged.   On 15 Mar 2021, the patient experienced the event(s) headache, swelling in right cheek, diarrhea, loss of appetite.   Laboratory tests performed included, MRI scan ,neurologist looked at her spinal fluid, got tested for meningitis, did reading on CMS.   Treatment details included morphine and hydrocodone.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), swelling on her right side of face, muscle weakness on her right side, tremor in right leg, headache in right side, swelling in right cheek, diarrhea, loss of appetite, headache in total head was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Violent vertigo attack; Felt like the world was going in one direction and she was going in anothe; legs felt very heavy; Eyes are burning; Head was heavy; Tired; Head felt like it was splitting; Aches and pains; A spontaneous report was sent by a consumer who is a female patient of unknown age that received Modern's COVID-19 vaccine (mRNA-1273) and experienced vertigo, legs felt heavy/restless legs, fatigue, head was heavy/ tension headache, head felt like it was splitting/headache, and aches and pains/myalgia.   The patient's medical history was unknown. Concomitant medication included Nexium.  On 08-FEB-2021, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.   She developed adverse events after this initial dose but these are part of a separate case.  On 08-MAR-2021, prior to the onset of the events, the patient received the second dose of mRNA-1273 for prophylaxis of COVID-19 infection.  Around 14-MAR-20221, she experienced violent vertigo attack where the world is going in one direction and she was going in another. Her head felt like it was spitting at this time. The patient was admitted to the hospital on 14-MAR-2021 around 12 AM and discharged by 6 AM on the same day and prescribed with Meclizine. The provided treatment made her head heavy and it made her felt tired. Her legs feel very heavy and she has aches and pains. She also described her eyes are burning.  The seriousness criteria for the event vertigo were reported as hospitalization and medically significant.  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, vertigo, legs felt heavy/restless legs, fatigue, head was heavy/ tension headache, head felt like it was splitting/headache, and aches and pains/myalgia 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 vertigo and headache, a causal relationship cannot be excluded. Based on reporter's causality, the head felt heavy, tiredness, and eyes burning is assessed as unlikely related to mRNA-1273 and related to meclizine.
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome, SARS-CoV-2 test, Tension headache, Vertigo
Clinical narrative: Violent vertigo attack; Felt like the world was going in one direction and she was going in anothe; legs felt very heavy; Eyes are burning; Head was heavy; Tired; Head felt like it was splitting; Aches and pains; A spontaneous report was sent by a consumer who is a female patient of unknown age that received Modern's COVID-19 vaccine (mRNA-1273) and experienced vertigo, legs felt heavy/restless legs, fatigue, head was heavy/ tension headache, head felt like it was splitting/headache, and aches and pains/myalgia.   The patient's medical history was unknown. Concomitant medication included Nexium.  On 08-FEB-2021, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.   She developed adverse events after this initial dose but these are part of a separate case.  On 08-MAR-2021, prior to the onset of the events, the patient received the second dose of mRNA-1273 for prophylaxis of COVID-19 infection.  Around 14-MAR-20221, she experienced violent vertigo attack where the world is going in one direction and she was going in another. Her head felt like it was spitting at this time. The patient was admitted to the hospital on 14-MAR-2021 around 12 AM and discharged by 6 AM on the same day and prescribed with Meclizine. The provided treatment made her head heavy and it made her felt tired. Her legs feel very heavy and she has aches and pains. She also described her eyes are burning.  The seriousness criteria for the event vertigo were reported as hospitalization and medically significant.  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, vertigo, legs felt heavy/restless legs, fatigue, head was heavy/ tension headache, head felt like it was splitting/headache, and aches and pains/myalgia 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 vertigo and headache, a causal relationship cannot be excluded. Based on reporter's causality, the head felt heavy, tiredness, and eyes burning is assessed as unlikely related to mRNA-1273 and related to meclizine.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: Blood clot; Swelling in lower leg; A spontaneous report  was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling in lower leg and blood clot .   The patient's medical history was not provided.Concomitant medications reported included  blood thinners Xarelto.  On 21 Feb 2021  prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   Treatment for the events  was unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events, swelling in lower leg and blood clot was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Vaccination site pain
Clinical narrative: Bells Palsy; Sore arm; A spontaneous report was received from a consumer concerning her husband a 68-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy / facial paralysis and sore arm / pain in extremity.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient experienced had a sore arm. On 13 Mar 2021, the patient developed medically significant event of Bell's Pplsy.  Treatment for the event included prednisone, 'doxixclavir', and eye drops.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events Bell's palsy and sore arm was not reported.; 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.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, visual
Clinical narrative: Visual hallucinations; A spontaneous report was received from a consumer concerning a 81-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced visual hallucinations.  The consumer's medical history included vision loss in the right eye. Relevant concomitant medications provided as eliquis, latanoprost, azopt, rhopressa, fluticasone, losartan, rosuvastatin, metformin, glimepiiride, tylenol, fish oil, cod liver oil, cinnamon, vitamin d3, vitamin b12 and melatonin as needed.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 05 FEB 2021. On 12 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12-MAR-2021, the patient began to see pin point, blood colored dots all over his face and hands. He then noticed the pin point dots all over the walls, desk, books, etc.  The patient reported seeing an image and when he would go closer, it wasn't there. He also felt like someone was standing next to him when no one was. The visions would come and go over the weekend.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, visual hallucinations, was considered recovered/resolved on 15 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fear, Feeling abnormal
Clinical narrative: lacerations on her head; Bleeding; had a weird feeling; dizziness; afraid to go upstairs; chills; nauseas; feels so weak; Might have had syncope; Minor pain at injection site; A spontaneous report  was received from a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who have experienced syncope (might have had syncope), skin laceration (lacerations on her head), nausea (nauseas), vaccination site pain(minor pain at injection site), feeling abnormal (had a weird feeling), fear (afraid to go upstairs), dizziness (dizziness), chills (chills), and asthenia (feels so weak) and bleeding (was on the floor and saw blood on the floor).  The patient's medical history include fluctuating blood pressure. The patient was allergic to mono sodium  glutamate, NutraSweet, codeine and prednisone.No concomitant product use was reported.  On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  It was known that the patient was scheduled to receive the second dose of vaccine on 09-Mar-2021.  On 08 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: D77727310) intramuscularly for prophylaxis of COVID-19 infection. On 08-Mar-2021, the patient experienced minor pain at the injection site, and chills during the night time. On 09-Mar-2021, the patient reported "had a weird feeling", "was on the floor and saw blood on the floor". On the same day, an unspecified duration later, the patient "passed out again" on the bed and reported that the pillow was full of blood. On 09-Mar-2021, a neck brace was placed and the patient was taken to the hospital. It was known that the patient had experienced nauseas and was sick, "almost like a blur". During the patient's stay in the hospital, over a period of 3 days, the patient reported "everything spins", experienced lacerations on the head and dizziness. The patient had surgical staples placed on head and felt very weak. The patient was "afraid to go upstairs". According to the physician the patient could have had a fever leading to the drop in the blood pressure and might have experienced syncope.   Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events, syncope (might have had syncope), skin laceration (lacerations on her head), nausea (nauseas), loss of consciousness (she might have passed out again), injection site pain (minor pain at injection site), illness (so sick), feeling abnormal (had a weird feeling), fear (afraid to go upstairs), dizziness (dizziness), chills (chills), asthenia (feels so weak), was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Nausea, Skin laceration, Syncope, Vaccination site pain
Clinical narrative: lacerations on her head; Bleeding; had a weird feeling; dizziness; afraid to go upstairs; chills; nauseas; feels so weak; Might have had syncope; Minor pain at injection site; A spontaneous report  was received from a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who have experienced syncope (might have had syncope), skin laceration (lacerations on her head), nausea (nauseas), vaccination site pain(minor pain at injection site), feeling abnormal (had a weird feeling), fear (afraid to go upstairs), dizziness (dizziness), chills (chills), and asthenia (feels so weak) and bleeding (was on the floor and saw blood on the floor).  The patient's medical history include fluctuating blood pressure. The patient was allergic to mono sodium  glutamate, NutraSweet, codeine and prednisone.No concomitant product use was reported.  On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  It was known that the patient was scheduled to receive the second dose of vaccine on 09-Mar-2021.  On 08 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: D77727310) intramuscularly for prophylaxis of COVID-19 infection. On 08-Mar-2021, the patient experienced minor pain at the injection site, and chills during the night time. On 09-Mar-2021, the patient reported "had a weird feeling", "was on the floor and saw blood on the floor". On the same day, an unspecified duration later, the patient "passed out again" on the bed and reported that the pillow was full of blood. On 09-Mar-2021, a neck brace was placed and the patient was taken to the hospital. It was known that the patient had experienced nauseas and was sick, "almost like a blur". During the patient's stay in the hospital, over a period of 3 days, the patient reported "everything spins", experienced lacerations on the head and dizziness. The patient had surgical staples placed on head and felt very weak. The patient was "afraid to go upstairs". According to the physician the patient could have had a fever leading to the drop in the blood pressure and might have experienced syncope.   Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events, syncope (might have had syncope), skin laceration (lacerations on her head), nausea (nauseas), loss of consciousness (she might have passed out again), injection site pain (minor pain at injection site), illness (so sick), feeling abnormal (had a weird feeling), fear (afraid to go upstairs), dizziness (dizziness), chills (chills), asthenia (feels so weak), 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoaesthesia, Tinnitus
Clinical narrative: Deafness in the right ear; Ear ringing; Numbness on the ears; A spontaneous report  was received from a 33-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness in ears/hypoesthesia, ears ringing /tinnitus, and deafness in right ear/deafness unilateral.  The patient has no known medical history. No relevant concomitant medications were taken during vaccination.    On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) for prophylaxis of COVID-19 infection. The patient did not experience any adverse events after the first dose.  On 13 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 001B21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, 45 minutes after the second dose, the patient experienced ringing in ears and 2 hours later numbness in ears. Approximately 3 hours after vaccination, the patient experienced deafness in his right ear, which was considered as medically significant event. The event deafness persisted, and the patient went to emergency room for consultation.   The patient was treated with prednisone for the events.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events ringing in ears and numbness in ears were considered as unknown. The outcome of the event deafness in his right ear was considered as not recovered.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pharyngitis bacterial
Clinical narrative: bacterial throat infection; SWOLLEN THROAT; A spontaneous case was received from a non health care professional concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bacterial throat infection and throat 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, was not reported.  On 24 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient developed bacterial throat infection and throat swelling.  Treatment for the event included oral antibiotics for 7 days, but patient had not started yet.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for both events were not recovered.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Arthralgia, Chills, Hallucination, visual, Pain
Clinical narrative: Mind wonderings at night, like visions or hallucinations; Misspelling issue; Arm sore; Burning aches, not just joint aches; Chills; Burning aches, not just joint aches; A spontaneous report was received from a consumer concerning a 65-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, arm sore/pain in extremity, chills, burning aches/pain not just joint aches/arthralgia, Mind wonderings at night, like visions or hallucinations/ hallucinations visual and misspelling issue/aphasia.  The patient's medical history provided included allergy to sulfa drugs, shrimps, enthesis and has non- alcoholic fatty liver and hypertension. Also, her grandmother experienced a condition with platters bleeding without clots. Concomitant medications reported included lutropin alfa, rosuvastatin calcium, bisoprolol HCPC, vitamin D3 and calcium.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) unknown route for prophylaxis of COVID-19 infection. On 13 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscular in the left arm for prophylaxis of COVID-19 infection.   On 14Mar 2021, the patient reported having arm sore, chills, burning aches not just joint aches, mind wonderings at night, like visions or hallucinations. Before falling sleep or waking up, patient had images of black and white live photos. She sees image with one eye, and they are not like a dream. When she opens the eyes, the photos disappear, but when closing again, the shots are in color and like cartoons or childish videogames. patient states that this is like a sleep pattern and that she has never been on drugs. She also has misspelling issues. She reported that while writing things down, she notices that are wrongly written and that letters are not coming easy to her mind. The patient states that she does crosswords all the time, so this was very strange for her. The event hallucinations was considered medically significant. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  At the time of this report, the outcome of the events, arm sore, chills, burning aches not just joint aches, mind wonderings at night, like visions or hallucinations and misspelling issue were unknown.; Reporter's Comments: This case concerns a 65 Y/O F with a serious unexpected event of visual hallucinations along with nonserious unexpected aphasia, pain, pain in extremity, and expected chills and arthralgia. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between 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: Pain in extremity
Clinical narrative: Mind wonderings at night, like visions or hallucinations; Misspelling issue; Arm sore; Burning aches, not just joint aches; Chills; Burning aches, not just joint aches; A spontaneous report was received from a consumer concerning a 65-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, arm sore/pain in extremity, chills, burning aches/pain not just joint aches/arthralgia, Mind wonderings at night, like visions or hallucinations/ hallucinations visual and misspelling issue/aphasia.  The patient's medical history provided included allergy to sulfa drugs, shrimps, enthesis and has non- alcoholic fatty liver and hypertension. Also, her grandmother experienced a condition with platters bleeding without clots. Concomitant medications reported included lutropin alfa, rosuvastatin calcium, bisoprolol HCPC, vitamin D3 and calcium.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) unknown route for prophylaxis of COVID-19 infection. On 13 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscular in the left arm for prophylaxis of COVID-19 infection.   On 14Mar 2021, the patient reported having arm sore, chills, burning aches not just joint aches, mind wonderings at night, like visions or hallucinations. Before falling sleep or waking up, patient had images of black and white live photos. She sees image with one eye, and they are not like a dream. When she opens the eyes, the photos disappear, but when closing again, the shots are in color and like cartoons or childish videogames. patient states that this is like a sleep pattern and that she has never been on drugs. She also has misspelling issues. She reported that while writing things down, she notices that are wrongly written and that letters are not coming easy to her mind. The patient states that she does crosswords all the time, so this was very strange for her. The event hallucinations was considered medically significant. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  At the time of this report, the outcome of the events, arm sore, chills, burning aches not just joint aches, mind wonderings at night, like visions or hallucinations and misspelling issue were unknown.; Reporter's Comments: This case concerns a 65 Y/O F with a serious unexpected event of visual hallucinations along with nonserious unexpected aphasia, pain, pain in extremity, and expected chills and arthralgia. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Inappropriate schedule of product administration, Incontinence
Clinical narrative: passed out; doesn't remember much; fatigue; incontinence; tingling of toes; shaking; extreme weakness; unable to lift arms, legs or move. Could not turn over; achy; chills; 39 days between 1st and 2nd dose; A spontaneous report was received from a consumer concerning a 37 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced achy, chills, shaking, passed out, incontinence, extreme weakness, tingling toes, fatigue and 39 days between 1st and 2nd dose.   The patient's current medical history included several autoimmune disorders, Rheumatoid arthritis, Raynaud's, Ankylosing spondylitis. Patient has had bladder surgery and reports having difficulty with urinary incontinence No relevant concomitant medications were reported.    On 01 March 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch:006m20a) unknown route and in left arm for prophylaxis of COVID-19 infection. On 01 March 2021, the patient experienced 39 days between 1st and 2nd dose, and at the same night after the vaccination the patient began to felt achy, chills.  On 02 March 2021, the patient experienced the events shaking, passed out, incontinent, extreme weakness, unable to lift her arms, legs and could not move or turn over, tingling in her toes. Ambulance took patient to hospital meanwhile patient was in and out of consciousness. She came back to home and experienced weakness and fatigue. The event Passed out was a serious event.   Laboratory details not included. Treatment details included as IV fluids was given in the hospital. Action taken with mRNA-1273 in response to the events was not applicable. On 01 March 2021, the outcome of the event 39 days between 1st and 2nd dose was Resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine for mRNA-1273, lot # 006M20A with associated AEs achy, chills, shaking, incontinence, extreme weakness, fatigue, loss of consciousness. 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Paraesthesia, Tremor
Clinical narrative: passed out; doesn't remember much; fatigue; incontinence; tingling of toes; shaking; extreme weakness; unable to lift arms, legs or move. Could not turn over; achy; chills; 39 days between 1st and 2nd dose; A spontaneous report was received from a consumer concerning a 37 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced achy, chills, shaking, passed out, incontinence, extreme weakness, tingling toes, fatigue and 39 days between 1st and 2nd dose.   The patient's current medical history included several autoimmune disorders, Rheumatoid arthritis, Raynaud's, Ankylosing spondylitis. Patient has had bladder surgery and reports having difficulty with urinary incontinence No relevant concomitant medications were reported.    On 01 March 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch:006m20a) unknown route and in left arm for prophylaxis of COVID-19 infection. On 01 March 2021, the patient experienced 39 days between 1st and 2nd dose, and at the same night after the vaccination the patient began to felt achy, chills.  On 02 March 2021, the patient experienced the events shaking, passed out, incontinent, extreme weakness, unable to lift her arms, legs and could not move or turn over, tingling in her toes. Ambulance took patient to hospital meanwhile patient was in and out of consciousness. She came back to home and experienced weakness and fatigue. The event Passed out was a serious event.   Laboratory details not included. Treatment details included as IV fluids was given in the hospital. Action taken with mRNA-1273 in response to the events was not applicable. On 01 March 2021, the outcome of the event 39 days between 1st and 2nd dose was Resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine for mRNA-1273, lot # 006M20A with associated AEs achy, chills, shaking, incontinence, extreme weakness, fatigue, loss of consciousness. 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: difficulty in breathing; dizziness, light headed; A spontaneous report  was received behalf of Consumer concerning a 84 Years-old elder female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, light headed and difficulty in breathing.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event as difficulty in breathing which considerable as seriousness and admitted in the hospital.   On an unknown date, the patient experienced the events as dizziness, lightheaded.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   On an unknown date, the outcome of the events difficulty in breathing and dizziness lightheaded was UNKNOWN; Reporter's Comments: This case concerns an 84-year-old female who was hospitalized with a serious unexpected event of dyspnea along with NS unexpected dizziness and lightheadedness. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Gastric haemorrhage
Clinical narrative: bleed on her stomach; blood clot on her leg; A spontaneous report  was received from a consumer concerning a 69-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced blood clot on their leg/Deep vein thrombosis and bleed on their stomach/Gastric hemorrhage.  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.   On 14 Feb 2021, the patient had a blood clot on their leg for which the patient was hospitalized. While on treatment the patient had a bleed on their stomach. The patient was in ICU for 2 weeks and another week on a regular room. The event, bleed on their stomach, was considered life-threatening.  On 4 Mar 2021, the patient was sent to a rehabilitation facility and on 16 Mar 2021, the patient was sent to their home.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the events, blood clot on their leg and bleed on their stomach were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Critical details such as the patient's medical history, list of concomitant medications, diagnostic findings and hospitalization details are lacking. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chills, Dysarthria, Dyskinesia
Clinical narrative: very weak; teeth chattering; could not hold body still, both of her arms were jumping like a seizure; both arms and legs started jumping, head started moving side to side; could not talk clearly to understand; mouth numbness; left arm tingling; Blood pressure 200/95; back of neck sweating; A spontaneous report  was received from a 67-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not hold body still, both of her arms were jumping like a seizure/ seizure like phenomena, both arms and legs started jumping, head started moving side to side/ dyskinesia, could not talk clearly to understand/ dysarthria, mouth numbness/ hypoesthesia oral, left arm tingling/ paresthesia, back of neck sweating/ hyperhidrosis, very weak/ asthenia, and teeth chattering/ chills.  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 duloxetine hydrochloride, evolocumab, and metoprolol.  On 15 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Mar 2021, 5 minutes after the administration of the vaccine, the patient experienced mouth numbness, left arm  tingling, sweating at the back of neck with both arms started jumping, head started moving side to side, teeth chattering, and the patient could not hold body still as both legs were jumping, and could not talk clearly to understand. A nurse gave the patient an injection of Epi-pen and Benadryl, which did not work and called emergency medical service. The patient went to the hospital for care, where both of her arms were jumping like a seizure. Blood pressure reading was 200/95 mmHg. On 16 Mar 2021, the patient was very weak. Treatment information included oxygen, Ativan, warm blankets and a warm  room until the patient's discharge.  Action taken with mRNA-1273 was unknown.  The outcomes of the events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Hypoaesthesia oral, Paraesthesia, Seizure like phenomena
Clinical narrative: very weak; teeth chattering; could not hold body still, both of her arms were jumping like a seizure; both arms and legs started jumping, head started moving side to side; could not talk clearly to understand; mouth numbness; left arm tingling; Blood pressure 200/95; back of neck sweating; A spontaneous report  was received from a 67-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not hold body still, both of her arms were jumping like a seizure/ seizure like phenomena, both arms and legs started jumping, head started moving side to side/ dyskinesia, could not talk clearly to understand/ dysarthria, mouth numbness/ hypoesthesia oral, left arm tingling/ paresthesia, back of neck sweating/ hyperhidrosis, very weak/ asthenia, and teeth chattering/ chills.  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 duloxetine hydrochloride, evolocumab, and metoprolol.  On 15 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Mar 2021, 5 minutes after the administration of the vaccine, the patient experienced mouth numbness, left arm  tingling, sweating at the back of neck with both arms started jumping, head started moving side to side, teeth chattering, and the patient could not hold body still as both legs were jumping, and could not talk clearly to understand. A nurse gave the patient an injection of Epi-pen and Benadryl, which did not work and called emergency medical service. The patient went to the hospital for care, where both of her arms were jumping like a seizure. Blood pressure reading was 200/95 mmHg. On 16 Mar 2021, the patient was very weak. Treatment information included oxygen, Ativan, warm blankets and a warm  room until the patient's discharge.  Action taken with mRNA-1273 was unknown.  The outcomes of the events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia after the 1st dose of Modernavaccine; A spontaneous report was received from a Pharmacist  concerning an 85-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pneumonia (Pneumonia).  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 10 Feb 2021, prior to the onset of the event, 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 the patient developed pneumonia after the first dose of Moderna's COVID-19 vaccine (mRNA-1273). On an unknown date, the patient was hospitalized after developing pneumonia. On 11 Mar 2021 patient was discharged from the hospital.  No treatment information related event was provided. Patient currently on steroid treatment.  No relevant laboratory details were included.  Action taken with the drug in response to the events were not reported.  The outcome of the event, pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Carditis, Chills, Headache, Viral infection
Clinical narrative: heart was inflamed; hospitalized and was diagnosed with a viral infection; feeling chills; feeling headaches; joint pain specially in leg; A spontaneous report was received from a consumer  concerning a 46 year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experience the following:  viral infection/ viral infection, heart was inflamed/ carditis, feeling headaches/headache, joint pain specially in leg/ arthralgia, and chills.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 05 Feb 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly for prophylaxis of cCovid-19 infection.    On 05 Feb 2021, the patient started to have headaches and joint pain specially in the leg. The reporter stated the headaches and joint pain stopped, then came back this month (March).  The patient also stated they started feeling chills this month (March) as well. She was hospitalized (dates not reported) and was diagnosed with a viral infection and was told her heart was inflamed.   Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, viral infection, heart was inflamed, feeling headaches, joint pain specially in leg, and chills, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded except for the events of headache, arthralgia, chills, and carditis.  The event of viral infection is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: Hospitalized; missed dose; A Spontaneous report was received from a pharmacist, concerning a female patient of unspecified age, who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized and missed dose  The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.   On 29 Jan 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On an unknown date, the patient was hospitalized for unknown reason and had not received the second dose in recommended timeframe.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event missed dose was considered as  recovered. The outcome of the event hospitalized was unknown.; Reporter's Comments: Very limited information regarding this event of hospitalization has been provided at this time.  Further information has been requested. The causality assessment for the event of missed dose remains not applicable.