chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Paraplegia
Clinical narrative: Face was crooked like she had a stroke; Could not move arms and legs; A spontaneous report was received from a consumer concerning a 67 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face was crooked like a stroke/cerebrovascular accident, could not move arms and legs/paraplegia.  The patient medical history included stage IV cancer and multiple sclerosis. No relevant concomitant medications were reported.  On 09 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273(batch no: 011a21a) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Mar 2021, approximately an hour after receiving the vaccine, the patient's face was crooked like she had a stroke. She also could not move her arms and legs. The reporter called 911 and the patient went back to normal 45 minutes after ambulance had come.   Laboratory details are not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable, as the patient received both their doses.   The outcome of the events, face was crooked like a stroke, could not move arms and could not move legs were considered resolved on 09 Mar 2021; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Thrombosis, Vertigo, Vomiting
Clinical narrative: blood clot; Vertigo; Nausea; Vomiting; A spontaneous report, was received from a consumer concerning a 53 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced vertigo , nausea, vomiting  and also developed a blood clot (thrombosis) during hospitalization.  Patient had no medical history. The concomitant medication included were zolpidem tartrate 10mg nightly, allopurinol 100mg daily, duloxetine 50mg daily, multivitamin, vitamin d and acetylsalicylic acid 81mg.   On 05 Feb 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Batch no- 010MZ0A), intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, few days after administering the vaccine, the consumer experienced vertigo related nausea and vomiting. The patient was hospitalized for two days and experienced a blood clot during hospitalization. Patient was treated with only diazepam on first two days of treatment. In hospital, patient was given meclizine, diazepam and other anti-nausea medication whereas at home, patient was treated with ondansetron 8 mg, meclizine and diazepam.   On 05 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Batch no- 036A21A), intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  The action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the events, vertigo, nausea, vomiting was not recovered whereas the outcome of blood clot was unknown 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in his left leg; A spontaneous report was received from a consumer concerning a 70-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a blood clot in his left leg/thrombosis.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 10 Feb 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A)  intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Two weeks after the vaccination, the patient developed a blood clot in his left leg. He got his second vaccine on 10 Mar 2021.  Treatment information was not provided.  There was no change planned to the dosing schedule of mRNA-1273 in response to the event.  The outcome of the event blood clot in his left leg 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 event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood pressure measurement, Headache, Hepatic enzyme abnormal, Hypertension
Clinical narrative: liver and pancreas enzymes were high; liver and pancreas enzymes were high; high blood pressure; belly pain; headache; A spontaneous report was received from a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high blood pressure 100/100 mmHg, headache, belly pain and her liver and pancreas enzymes were high.  The patient's medical history was not provided.  Concomitant medications of the patient included lisinopril and atenolol for blood pressure. The patient had performed lab test before receiving the vaccine and the results were normal.  On 26-Feb-2021, the patient received her first dose of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 28-Feb-2021, the patient went to ER due to high blood pressure 100/100 mmHg, headache and belly pain. Her lisinopril dose was increased to 20mg/day. On 1-Mar-2021, patient went again to ER and there lab test and an scan were performed and she was told that her liver and pancreas enzymes were high. On 4-Mar-2021 belly pain, high blood pressure and "liver and pancreas enzymes were still there". Lisinopril increased dose did not work and so they changed to atenolol 25mg/day.  On 18-Mar-2021,the patient has an appointment with her cardiologist.  Seriousness criteria for the events of liver and pancreas enzymes were high was life threatening.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatic enzymes increased
Clinical narrative: liver and pancreas enzymes were high; liver and pancreas enzymes were high; high blood pressure; belly pain; headache; A spontaneous report was received from a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high blood pressure 100/100 mmHg, headache, belly pain and her liver and pancreas enzymes were high.  The patient's medical history was not provided.  Concomitant medications of the patient included lisinopril and atenolol for blood pressure. The patient had performed lab test before receiving the vaccine and the results were normal.  On 26-Feb-2021, the patient received her first dose of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 28-Feb-2021, the patient went to ER due to high blood pressure 100/100 mmHg, headache and belly pain. Her lisinopril dose was increased to 20mg/day. On 1-Mar-2021, patient went again to ER and there lab test and an scan were performed and she was told that her liver and pancreas enzymes were high. On 4-Mar-2021 belly pain, high blood pressure and "liver and pancreas enzymes were still there". Lisinopril increased dose did not work and so they changed to atenolol 25mg/day.  On 18-Mar-2021,the patient has an appointment with her cardiologist.  Seriousness criteria for the events of liver and pancreas enzymes were high was life threatening.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Confusional state, Speech disorder
Clinical narrative: She experienced stroke,between the first and second dose; I'm not speaking well; Patient had difficulties to understand; 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 stroke (cerebrovascular accident) and was not able to speak well (speech disorder) and understand (confusional state).  The patient had claustrophobia. Concomitant medications were multivitamins.  On an unknown date, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 00M20A), intramuscularly in the arm for prophylaxis of COVID-19 infection.  On an unknown date in Mar 2021, after administering the vaccine, the consumer experienced stroke. She was hospitalized to perform an open-MRI as she was claustrophobic. Reporter also stated that patient was not able to speak and understand well and required an assistance while speaking over the phone at the time of this report. Patient did not receive any treatment.   On 10 Mar 2021, after the events occurred, the patient received her second of two planned doses of mRNA-1273 (Batch number: 044A21A), intramuscularly in the arm for prophylaxis of COVID-19 infection.  The outcome of the event stroke was unknown and the events speech disorder and confusional state were not recovered at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: Anaphylaxis; Rash all across her leg; Swelling; Itching; Red; Hot; A spontaneous report was received from a consumer concerning a 22-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, rash all across her leg/rash, swelling, itching,/pruritus, red/erythema, hot/feeling hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) Intramuscularly on right leg for prophylaxis of COVID-19 infection.  On 10 Mar 2021, the patient experienced the event(s) anaphylaxis symptoms of  swelling, itching, rash all across her leg. It was red, and hot.S he was a very fragile person with many syndromes and so they took her to the doctor. She was feeling better on 14 Mar 2021. Treatment for the events were none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), anaphylaxis, rash all across her leg, swelling, itching, red, hot were reported as recovering on 14 Mar 2021..; Reporter's Comments: This case concerns a 23-year-old female who experienced a serious expected event of anaphylactic reaction along with unexpected rash, erythema, pruritus, swelling, and feeling hot. Event onset occurred on Day 6 after the first dose of mRNA-1273. Treatment not reported. Events resolving. 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Anaphylaxis; Rash all across her leg; Swelling; Itching; Red; Hot; A spontaneous report was received from a consumer concerning a 22-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, rash all across her leg/rash, swelling, itching,/pruritus, red/erythema, hot/feeling hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) Intramuscularly on right leg for prophylaxis of COVID-19 infection.  On 10 Mar 2021, the patient experienced the event(s) anaphylaxis symptoms of  swelling, itching, rash all across her leg. It was red, and hot.S he was a very fragile person with many syndromes and so they took her to the doctor. She was feeling better on 14 Mar 2021. Treatment for the events were none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), anaphylaxis, rash all across her leg, swelling, itching, red, hot were reported as recovering on 14 Mar 2021..; Reporter's Comments: This case concerns a 23-year-old female who experienced a serious expected event of anaphylactic reaction along with unexpected rash, erythema, pruritus, swelling, and feeling hot. Event onset occurred on Day 6 after the first dose of mRNA-1273. Treatment not reported. Events resolving. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burns third degree, Injection site discomfort, Injection site erythema, Injection site vesicles, Skin burning sensation
Clinical narrative: Red circle at injection site; like a 3rd degree burn; looked like a flesh-eating disease, affected area looked like pastrami; when the blisters oozed out, it burned her skin; 3 quarter size blisters appeared at the injection site on left arm; injection site bothered her a little bit; A spontaneous report was received from a consumer, a 60-year old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced like a 3rd degree burn/ burns third degree, 3 quarter size blisters appeared at the injection site on left arm/ injection site blisters, looked like a flesh-eating disease, affected area looked like pastrami/ skin disorder, when the blisters oozed out, it burned her skin/ skin burning sensation, injection site bothered her a little bit/ injection site discomfort, and red circle at injection site/ injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The night of vaccination, the injection site bothered the patient a little bit. On 17 Feb 2021, 3 quarter size blisters appeared at the injection site on the left arm. On 18 Feb 2021, when the blisters oozed out, it burned the patient's skin. The patient stated it looked like a flesh-eating disease, like a third degree burn. On 19 Feb 2021, the patient saw her doctor. On 01 Mar 2021, the patient stated the affected area was healing, but it looked like pastrami- she had a red circle at the affected area.Treatment for the events included ice pack, silver sulfadiazine cream 1% and triamcinolone acetonide cream 0.5%.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Red circle at injection site; like a 3rd degree burn; looked like a flesh-eating disease, affected area looked like pastrami; when the blisters oozed out, it burned her skin; 3 quarter size blisters appeared at the injection site on left arm; injection site bothered her a little bit; A spontaneous report was received from a consumer, a 60-year old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced like a 3rd degree burn/ burns third degree, 3 quarter size blisters appeared at the injection site on left arm/ injection site blisters, looked like a flesh-eating disease, affected area looked like pastrami/ skin disorder, when the blisters oozed out, it burned her skin/ skin burning sensation, injection site bothered her a little bit/ injection site discomfort, and red circle at injection site/ injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The night of vaccination, the injection site bothered the patient a little bit. On 17 Feb 2021, 3 quarter size blisters appeared at the injection site on the left arm. On 18 Feb 2021, when the blisters oozed out, it burned the patient's skin. The patient stated it looked like a flesh-eating disease, like a third degree burn. On 19 Feb 2021, the patient saw her doctor. On 01 Mar 2021, the patient stated the affected area was healing, but it looked like pastrami- she had a red circle at the affected area.Treatment for the events included ice pack, silver sulfadiazine cream 1% and triamcinolone acetonide cream 0.5%.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: blood clots that had apparently broken up and gotten stuck in my lungs; A spontaneous report was received from a consumer who is a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clots that had apparently broken up and gotten stuck in lungs/thrombosis/pulmonary embolism.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Mar 2021, five days post-vaccination, the patient reported he had a significant event in which his wife had to call an ambulance and rush him to the hospital. It was discovered that he had blood clots that had broken up and got stuck in his lungs. The patient reported he was put on heparin and apixaban blood thinners. The patient stated he is scheduled for further testing.   Treatment included, heparin and apixaban.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, blood clots that had apparently broken up and gotten stuck in my lungs/thrombosis/pulmonary embolism, 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Fatigue, Speech disorder
Clinical narrative: disoriented, completely confused; sort of non-verbal; weak; tired; shivers; A spontaneous report  was received from consumer concerning a 73-year-old, female patient, who experienced  being weak/asthenia, disorientated,completely confused/confusional state, tired/fatigue, shivering/chills and was sort of non-verbal/speech disorder.  The patient's medical history was not  provided by the reporter. The relevant concomitant medication use were not reported.  On 10 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number:unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021, patient felt weak and tired. On 13 Mar 2021 the patient was completely confused, disoriented, sort of non-verbal, and had shivers.  She was hospitalized that day and was diagnosed with a stroke.  On 15 MAR 2021, the doctors removed the diagnosis of stroke but were unsure of what it was.   The treatment for the events included acetaminophen, metoprolol, losartan and nexium.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, weak/asthenia, disorientated,completely confused/confusional state, tired/fatigue, shivering/chills and was sort of non-verbal/speech disorder were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Liver abscess, Pyrexia
Clinical narrative: Abscess on the liver; missed his second dose; Fever; A spontaneous report  was received from a consumer (patient's wife), regarding a 61 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced abscess on the liver (liver abscess), fever (pyrexia) and inappropriate schedule of product administration.    The patient's medical history was not reported. Concomitant medications was not reported.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Feb 2021, the patient developed fever and was hospitalized because of abscess on the liver. The patient was hospitalized for eight days and missed his second dose because doctors said that the patient was still weak to take the second vaccine dose. The patient was discharged on 27 Feb 2021. Treatment for the events included unspecified antibiotics.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, abscess on the liver, and fever, were considered as unknown.  The event, inappropriate schedule of product administration, was considered recovered/resolved.; Reporter's Comments: Although a temporal association exist, and there is lack of patient's medical history and list of concomitant medications, based on the known risk and etiology of liver abscess, the events are assessed as unlikely related to mRNA-1273 administration.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gingival pain, Gingival swelling, Paraesthesia, Postmenopausal haemorrhage
Clinical narrative: feeling of pins and needles in their face; swollen and sore gums; swollen and sore gums; fever of 102F; heavy bleeding; A spontaneous report was received from consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heavy bleeding/ postmenopausal bleeding, and contained  large blood clots/postmenopausal bleeding, fever of 102F/ pyrexia,  swollen and sore gums/gum swelling, swollen and sore gums /gum pain.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided.   On 14 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection  On 18 Feb 2021 four days after the first dose of vaccination, patient began to bleed as if the menstrual cycle began. Patient reported that she was at a menopausal phase in life to typically do not bleed or if they do there was a light pink blood excreted, the last time this had occurred was in November. Patient had a bleeding that was very heavy and contained large blood clots. The event heavy bleeding/ post menopausal bleeding was a medically significant event.   Patient stated that this bleeding lasted 7 consecutive days until 25 Feb 2021. The bleeding then stopped 26 Feb 2021 for 2 days, and then heavy bleeding episode came back again on 28 Feb 2021 for 2 days lasting until 02 March 2021. On 03 March 2021 patient reported that she had a fever of 102F which lasted for 24 hours. Patient also reported that she had very very sore gums and swelling inside of mouth. Patient reported that she was not sure if these events were due to the vaccination.   Treatment activities for event was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, experienced heavy bleeding, bleeding was very heavy, and contained  large blood clots was resolved on 02-MAR-2021. The outcome of events,  swollen and sore gums were unknown  and fever of 102 F was  resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling of pins and needles in their face; swollen and sore gums; swollen and sore gums; fever of 102F; heavy bleeding; A spontaneous report was received from consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heavy bleeding/ postmenopausal bleeding, and contained  large blood clots/postmenopausal bleeding, fever of 102F/ pyrexia,  swollen and sore gums/gum swelling, swollen and sore gums /gum pain.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided.   On 14 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection  On 18 Feb 2021 four days after the first dose of vaccination, patient began to bleed as if the menstrual cycle began. Patient reported that she was at a menopausal phase in life to typically do not bleed or if they do there was a light pink blood excreted, the last time this had occurred was in November. Patient had a bleeding that was very heavy and contained large blood clots. The event heavy bleeding/ post menopausal bleeding was a medically significant event.   Patient stated that this bleeding lasted 7 consecutive days until 25 Feb 2021. The bleeding then stopped 26 Feb 2021 for 2 days, and then heavy bleeding episode came back again on 28 Feb 2021 for 2 days lasting until 02 March 2021. On 03 March 2021 patient reported that she had a fever of 102F which lasted for 24 hours. Patient also reported that she had very very sore gums and swelling inside of mouth. Patient reported that she was not sure if these events were due to the vaccination.   Treatment activities for event was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, experienced heavy bleeding, bleeding was very heavy, and contained  large blood clots was resolved on 02-MAR-2021. The outcome of events,  swollen and sore gums were unknown  and fever of 102 F was  resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Vaccination site pain
Clinical narrative: "Faint for 5 minutes 6 hs after the shot"; "Some dizzy and light headed'; Arm Sore; A spontaneous report  was received from a consumer concerning a 32-year-old female patient who received Moderna (mRNA-1273) vaccine and Fainted/Syncope and was dizzy and light headed/dizziness, and experienced Arm sore/ Vaccination site pain.  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 15 Mar 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 002B21A) for prophylaxis of COVID-19 infection.   On 15 Mar 2021, the patient fainted for 5 minutes, about 6 to 8 hours post vaccine administration. The patient was dizzy and lightheaded and experienced arm soreness. The event, fainted for 5 minutes, about 6 to 8 hours post vaccine administration was considered medically significant.  No Treatment information were provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On 15 Mar 2021, the outcome of the event, fainted for 5 minutes, about 6 to 8 hours post vaccine administration was considered resolved   The outcome of the events,  was dizzy and  lightheaded, and experienced Arm sore 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Pruritus, Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: Cellulitis in left arm with his first dose; Tremendous painful itch; Bad rash all over body; Swelling at injection site; Sore; A spontaneous report was received from a consumer concerning himself, a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis in left arm after the first dose (cellulitis), bad rash all over body (rash), tremendous painful itch (pruritus), swelling at injection site (vaccination site swelling) and sore (vaccination site pain).  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 dutasteride, chlormadinone acetate and trazodone.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced cellulitis in left arm with his first dose. The patient had bad rash all over the body and tremendous painful itch. The patient reports swelling at injection site and sore. Treatment information included cefalexin, methylprednisolone sodium succinate, hydroxyzine and trimeolon.  On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, cellulitis in left arm after the first dose, bad rash all over body, tremendous painful itch, swelling at injection site and sore, was not recovered.; Reporter's Comments: This case concerns a 77 Y/O M who had serious unexpected cellulitis with NS unexpected painful pruritus and rash and expected vaccination site pain and vaccination site swelling.  Event onset with unknown latency after the first dose of mRNA-1273. Treated with cefalexin, methylprednisolone, hydroxyzine, trimeolon. Events ongoing. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Blood test, Dizziness
Clinical narrative: Felt like fainting; Weakness; Sudden drop of blood pressure; I had trouble sleeping at night; Headache; My arm was sore; A spontaneous report was received from consumer concerning himself, a 68-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness (asthenia), felt like fainting (dizziness), sudden drop of blood pressure (blood pressure decreased), arm was sore (pain in extremity), had trouble sleeping at night (insomnia) and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, 10 minutes after the vaccination, the patient experienced weakness and felt like fainting. The patient had low blood pressure and was hospitalized. On 28 Jan 2021, the patient's arm was sore. The patient also experienced trouble for sleeping at night and had headache. Treatment information included IV.  Laboratory data included low blood pressure measurement, stress test (results unknown), chest x-ray (results unknown), covid test negative and blood test (normal).  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, weakness, felt like fainting, sudden drop of blood pressure, arm was sore, had trouble sleeping at night and headache, was considered as unknown.; Reporter's Comments: This case concerns a 68-year-old male who was hospitalized for serious unexpected events of blood pressure decreased, dizziness, asthenia, along with NS unexpected insomnia, and NS expected pain in extremity, headache.  Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment unknown. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: Felt like fainting; Weakness; Sudden drop of blood pressure; I had trouble sleeping at night; Headache; My arm was sore; A spontaneous report was received from consumer concerning himself, a 68-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness (asthenia), felt like fainting (dizziness), sudden drop of blood pressure (blood pressure decreased), arm was sore (pain in extremity), had trouble sleeping at night (insomnia) and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, 10 minutes after the vaccination, the patient experienced weakness and felt like fainting. The patient had low blood pressure and was hospitalized. On 28 Jan 2021, the patient's arm was sore. The patient also experienced trouble for sleeping at night and had headache. Treatment information included IV.  Laboratory data included low blood pressure measurement, stress test (results unknown), chest x-ray (results unknown), covid test negative and blood test (normal).  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, weakness, felt like fainting, sudden drop of blood pressure, arm was sore, had trouble sleeping at night and headache, was considered as unknown.; Reporter's Comments: This case concerns a 68-year-old male who was hospitalized for serious unexpected events of blood pressure decreased, dizziness, asthenia, along with NS unexpected insomnia, and NS expected pain in extremity, headache.  Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment unknown. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: Hospitilization; Missed second dose appointment and he is beyond day 36; A spontaneous report was received from a Consumer  concerning a male patient of an unknown age who missed  Moderna's COVID-19 vaccine (mRNA-1273) second dose due to hospitalization.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 5-FEB-2021, 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.  Patient was scheduled to take second dose on 15-MAR-2021 but he was missed it due to hospitalization. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event missing second dose due to hospitalization was considered resolved.; Reporter's Comments: This report refers to a male patient of unspecified age who experienced non-serious unexpected event of missed second dose (missed dose) for mRNA-1273 due to hospitalization. There were no reported AEs associated with this case of missed dose. Very limited information regarding the event of hospitalization NOS has been provided at this time.  Further information has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased, Hyperventilation
Clinical narrative: Passed out /Lost all awareness; Light-headed; Hyperventilating; He caught his breath; Elevated heart rate; Tingling sensation; He was unable to form cohesive sentences; Muscles movements were impeded; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6206) single dose, in the left arm, on 08Mar2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks. Relevant medical history and concomitant medications were unknown. No known allergies were reported. The patient had not experienced COVID-19 prior vaccination. On 08Mar2021, at 12:00 PM, 5 minutes after vaccination, the patient became very light-headed. In a few seconds his vision went dark and he passed out. After an unknown amount of time, he became semiconscious and was hyperventilating. While hyperventilating, his eyes were open, but he could not see anything. Once he caught his breath, after about 15 seconds, his vision came back and he lost all awareness of where he was. After about 30 seconds, the patient realized he was in the observation area for the facility and alerted the medical professionals near his vehicle he was sitting in. Medical professionals checked his vitals, which were fine other than an elevated heart rate, and he had a tingling sensation over his body for the next two minutes. In this time, he was unable to form cohesive sentences, and his muscles movements were impeded. It took another 40 minutes to return to a relatively normal state. No treatment was received. The patient recovered from the adverse events. Post the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Movement disorder, Paraesthesia, Speech disorder
Clinical narrative: Passed out /Lost all awareness; Light-headed; Hyperventilating; He caught his breath; Elevated heart rate; Tingling sensation; He was unable to form cohesive sentences; Muscles movements were impeded; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6206) single dose, in the left arm, on 08Mar2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks. Relevant medical history and concomitant medications were unknown. No known allergies were reported. The patient had not experienced COVID-19 prior vaccination. On 08Mar2021, at 12:00 PM, 5 minutes after vaccination, the patient became very light-headed. In a few seconds his vision went dark and he passed out. After an unknown amount of time, he became semiconscious and was hyperventilating. While hyperventilating, his eyes were open, but he could not see anything. Once he caught his breath, after about 15 seconds, his vision came back and he lost all awareness of where he was. After about 30 seconds, the patient realized he was in the observation area for the facility and alerted the medical professionals near his vehicle he was sitting in. Medical professionals checked his vitals, which were fine other than an elevated heart rate, and he had a tingling sensation over his body for the next two minutes. In this time, he was unable to form cohesive sentences, and his muscles movements were impeded. It took another 40 minutes to return to a relatively normal state. No treatment was received. The patient recovered from the adverse events. Post the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Chills; Migraine; Vomiting; Nausea; Body aches; This is a spontaneous report received from a non-contactable pharmacist (patient, reported herself). A 33-year-old female (who was not pregnant at the time of vaccination), received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 3n6203, and Expiration date was unknown), via an unspecified route of administration, in arm right, on 10Mar2021, 09:00 AM, as a single dose for COVID-19 immunization. Medical history included allergies to NSAIDs. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El9266, and Expiration date was unknown), via an unspecified route of administration in right arm, on 17Feb2021 09:00 AM for COVID-19 immunization. Patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. It was reported that on 10Mar2021 at 10:00 PM, the patient experienced Fever, Chills, Migraine, Vomiting, Nausea and Body aches. The patient was treated with Zofran ODT, Tylenol and oral rehydration as corrective treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of underlying medical conditions cannot be excluded with the available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Chills; Migraine; Vomiting; Nausea; Body aches; This is a spontaneous report received from a non-contactable pharmacist (patient, reported herself). A 33-year-old female (who was not pregnant at the time of vaccination), received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 3n6203, and Expiration date was unknown), via an unspecified route of administration, in arm right, on 10Mar2021, 09:00 AM, as a single dose for COVID-19 immunization. Medical history included allergies to NSAIDs. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El9266, and Expiration date was unknown), via an unspecified route of administration in right arm, on 17Feb2021 09:00 AM for COVID-19 immunization. Patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. It was reported that on 10Mar2021 at 10:00 PM, the patient experienced Fever, Chills, Migraine, Vomiting, Nausea and Body aches. The patient was treated with Zofran ODT, Tylenol and oral rehydration as corrective treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of underlying medical conditions cannot be excluded with the available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.