chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Symptoms like a stroke; Slurring her words; Became uncoordinated; Not feeling 100%; Very nauseous; Little headache; Tired for a few days; A spontaneous report  was received from a consumer concerning a 77-year-old female patient who experienced slurring her words (dysarthria), became uncoordinated (coordination) abnormal and had symptoms like a stroke (cerebrovascular) accident, felt very nauseous (Nausea) and not feeling 100% (Malaise).  The patient's medical history was not provided. Relevant concomitant medications reported included Baby Aspirin and Vitamins NOS for unknown indication.  On 10 Mar 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: 048AZIA) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient began slurring their words, became uncoordinated and had symptoms like a stroke. The patient was also very nauseous and went to the emergency room. The event, symptoms like a stroke was considered medically significant.  On, the same day, the patient was discharged. The patient still was not feeling 100% still.  No Treatment information were provided.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  On an unknown date, the outcome of the event, was slurring their words, became uncoordinated and had symptoms like a stroke, felt very nauseous and not feeling 100% resolved on 11MAR2021.; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Joint swelling
Clinical narrative: Clot on the lower left leg; foot and ankle swollen; A spontaneous report was received from a physician concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced foot and ankle swelling (joint swelling) and clot on the lower left leg (deep vein thrombosis).  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 5 Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) via  intramuscular route  on left side for prophylaxis of COVID-19 infection.   On 5 Mar 2021 prior to the onset of the events, the patient received their  second planned dose of mRNA-1273 (Lot number: 036A21A ) via  intramuscular route  on left side for prophylaxis of COVID-19 infection.   Doctor found a clot in her lower  left leg. Patient said that on Feb 2 before receiving the first dose on Feb 5 needed to have an x ray and blood work due to foot and ankle got swollen. Patient said they checked it for different things and that the doctor thought It would be a pseudo gout. As the ankle was still swollen patient went to her family doctor and doctor insisted to have a test for deep vein thrombosis. They have found a clot on the lower left leg. The patient had stated she have not a had a surgery or an injury and that it happened between doses. Treatment drug used for the event included was apixaban.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome for the events, foot and ankle swelling and clot on the lower left leg, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. It was reported that the patient had an x ray and blood work due to foot and ankle swelling before receiving the first dose of vaccine and that the doctor thought it to be a pseudo gout.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Immune thrombocytopenia, Leukaemia, Platelet count, Rectal haemorrhage
Clinical narrative: Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain.  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 their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine.   The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal.  Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific.  Action taken with mRNA-1273 in response to the events was not provided.  The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; 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.; Sender's Comments:  MOD-2021-047223:Crosslinked case
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain.  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 their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine.   The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal.  Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific.  Action taken with mRNA-1273 in response to the events was not provided.  The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; 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.; Sender's Comments:  MOD-2021-047223:Crosslinked case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Could not close eye and mouth would not move; A spontaneous report was sent by a consumer who was a 68-year old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced an episode of "could not close eye and mouth " and was diagnosed with Bell's palsy.  The patient's medical history is unknown. Concomitant medication include Metformin 500 twice in a day, Losartan 50 mg, Atorvastatin, valacyclovir 1000 mg thrice in a day, Hydrochloride 12.5 mg, Prednisone.  On 18 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient reported she noticed her eye would not close and her mouth would not move. She has no events prior to this date. The patient went to the emergency room and was prescribed valacyclovir 1000 milligrams and prednisone 60 milligrams. At the time of this report, the patient reported she was feeling fine and her speech was improving, but her eye still would not shut.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event of Bell's palsy, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Autoimmune disorder, Blood pressure increased, Chills, Epistaxis
Clinical narrative: flare up her autoimmune condition; bleeding from the nose; increase heartrate; increase blood pressure; sweating; bleeding from the eye; joint problem; fever; body aches; nausea; chills; A spontaneous report was received from a consumer  concerning herself,a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, body aches, nausea, increased heartrate, increased blood pressure, sweating, flare up of her auto immune condition, bleeding from the eye and nose, and joint problem.  The patient's medical history, was not provided.No Concomitant medications were  reported .  On 15 Feb 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A)  for prophylaxis of COVID-19 infection.   On an unknown date , the patient experienced Fever,chills,nausea,pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up of her auto immune condition(Auto immune disorder NOS), eye haemorrhage,epistaxis, and joint problem . No seriousness reported for events. Seriousness of event autoimmune disorder considered to be to medically significant according to IME list.  Treatment for the events  was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events Fever,chills,nausea, pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up her auto immune condition(Auto immune disorder NOS), eye haemorrhage, epistaxis, and joint problem was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Heart rate increased, Hyperhidrosis, Nausea, Pain
Clinical narrative: flare up her autoimmune condition; bleeding from the nose; increase heartrate; increase blood pressure; sweating; bleeding from the eye; joint problem; fever; body aches; nausea; chills; A spontaneous report was received from a consumer  concerning herself,a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, body aches, nausea, increased heartrate, increased blood pressure, sweating, flare up of her auto immune condition, bleeding from the eye and nose, and joint problem.  The patient's medical history, was not provided.No Concomitant medications were  reported .  On 15 Feb 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A)  for prophylaxis of COVID-19 infection.   On an unknown date , the patient experienced Fever,chills,nausea,pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up of her auto immune condition(Auto immune disorder NOS), eye haemorrhage,epistaxis, and joint problem . No seriousness reported for events. Seriousness of event autoimmune disorder considered to be to medically significant according to IME list.  Treatment for the events  was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events Fever,chills,nausea, pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up her auto immune condition(Auto immune disorder NOS), eye haemorrhage, epistaxis, and joint problem 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: Pyrexia
Clinical narrative: flare up her autoimmune condition; bleeding from the nose; increase heartrate; increase blood pressure; sweating; bleeding from the eye; joint problem; fever; body aches; nausea; chills; A spontaneous report was received from a consumer  concerning herself,a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, body aches, nausea, increased heartrate, increased blood pressure, sweating, flare up of her auto immune condition, bleeding from the eye and nose, and joint problem.  The patient's medical history, was not provided.No Concomitant medications were  reported .  On 15 Feb 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A)  for prophylaxis of COVID-19 infection.   On an unknown date , the patient experienced Fever,chills,nausea,pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up of her auto immune condition(Auto immune disorder NOS), eye haemorrhage,epistaxis, and joint problem . No seriousness reported for events. Seriousness of event autoimmune disorder considered to be to medically significant according to IME list.  Treatment for the events  was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events Fever,chills,nausea, pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up her auto immune condition(Auto immune disorder NOS), eye haemorrhage, epistaxis, and joint problem 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pyrexia
Clinical narrative: Patient have fever of 100.0 - 104.0 / due to not getting the fever controlled; not doing very good; very weak; A spontaneous report was received from 63-year-old female patient, who received Moderna's COVID-19 vaccine and experienced fever of 100.0 - 104.0/ pyrexia, not doing very good/feeling abnormal, and very weak/asthenia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Jan 2021, prior to the onset of events, the patient received an unspecified dose of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.   On 16 Feb 2021, after an unspecified dose of vaccine, the patient experienced fever of 100.0 - 104.0, was not doing very good, very weak. On 14 MAR 2021, patient was admitted to the hospital due to uncontrolled fever. No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, fever of 100.0 - 104.0, not doing very good, very weak was ongoing at the time of this report.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273  and the start date of the reported events and excluding any other etiology, a causal relationship with the events cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Epistaxis, Haemorrhage, Pain in extremity
Clinical narrative: spontaneous bleed; bruise on the shin; sore arm; hives; nose bleed; A spontaneous report was received from a consumer, concerning a 69 years-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, hives, nose bleed, spontaneous bleed, and bruise on the shin.    The patient's medical history included Von Willebrand Disease and breast cancer. Concomitant product use was not provided by the reporter.  On 19 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date post-vaccination, the patient experienced a sore arm and some hives. Approximately two weeks after the first dose, the patient experienced a spontaneous bleed resulting in a huge bruise on the shin the size of the palm of their hand. The patient consulted their Hematologist who performed blood work which was perfect. There were no abnormal results. The physician administered DDAVP.  On 09 Feb 2021, the patient experienced their first nose bleed described as "horrific".  The patient reported they had blood gushing out of their nose and that they bled for four hours. The patient ended up in the hospital emergency department where they were sprayed with DDAVP to stop the bleeding.  Treatment details included DDAVP.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.  The events, nose bleed and spontaneous bleed were considered not recovered / not resolved.  The outcome of the events sore arm, hives, and bruise on the shin was unknown.; Reporter's Comments: Based on the information provided and the patient's history of Von Willebrand Disease, a causal association between the events nose bleed, spontaneous bleed, and bruise on the shin with mRNA-1273 use is assessed as unlikely.  However, based on temporal association, causality for the events of sore arm and hives cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: spontaneous bleed; bruise on the shin; sore arm; hives; nose bleed; A spontaneous report was received from a consumer, concerning a 69 years-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, hives, nose bleed, spontaneous bleed, and bruise on the shin.    The patient's medical history included Von Willebrand Disease and breast cancer. Concomitant product use was not provided by the reporter.  On 19 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date post-vaccination, the patient experienced a sore arm and some hives. Approximately two weeks after the first dose, the patient experienced a spontaneous bleed resulting in a huge bruise on the shin the size of the palm of their hand. The patient consulted their Hematologist who performed blood work which was perfect. There were no abnormal results. The physician administered DDAVP.  On 09 Feb 2021, the patient experienced their first nose bleed described as "horrific".  The patient reported they had blood gushing out of their nose and that they bled for four hours. The patient ended up in the hospital emergency department where they were sprayed with DDAVP to stop the bleeding.  Treatment details included DDAVP.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.  The events, nose bleed and spontaneous bleed were considered not recovered / not resolved.  The outcome of the events sore arm, hives, and bruise on the shin was unknown.; Reporter's Comments: Based on the information provided and the patient's history of Von Willebrand Disease, a causal association between the events nose bleed, spontaneous bleed, and bruise on the shin with mRNA-1273 use is assessed as unlikely.  However, based on temporal association, causality for the events of sore arm and hives cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Colitis, Diarrhoea, Haematochezia, Malaise
Clinical narrative: Colitis; Blood in the diarrhea; Felt so sick; Rash in her stomach; Abdominal pain; Diarrhea; A spontaneous report was received from a consumer concerning herself, a 59 years old female patient who experienced colitis, abdominal pain, diarrhea, blood in diarrhea/hematochezia, sick/malaise and rash in her stomach/rash.    The patient's medical history included current conditions such as diabetes, asthma, reflux, dry eyes, osteoporosis.  Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medication, blood thinner for heart attacks, asthma medication, medicines for reflux, dry eyes medicines, osteoporosis medicine shot every 6 months and liraglutide.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A) on 03-Mar-2021 intramuscularly in left arm for prophylaxis of COVID-19 infection.    On the same day of vaccination, the dose of liraglutide was increased. On Saturday, March 06, patient experienced abdominal pain and diarrhea. On Tuesday 09 Mar 2021, Liraglutide was stopped because patient experienced rashes in the stomach. On Wednesday 10-March 2021, patient experienced blood in diarrhea and was very sick and was hospitalized for one day for Colitis and was given medication. She is feeling better now and has colonoscopy on 09 Mar 2021.    Treatment information was unknown.    Action taken with mRNA-1273 in response to the events was unknown.  The event(s), abdominal pain, diarrhea, blood in diarrhea/hematochezia, sick/malaise, rash in her stomach/rash were considered were unknown. The event colitis was considered recovering.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Colitis; Blood in the diarrhea; Felt so sick; Rash in her stomach; Abdominal pain; Diarrhea; A spontaneous report was received from a consumer concerning herself, a 59 years old female patient who experienced colitis, abdominal pain, diarrhea, blood in diarrhea/hematochezia, sick/malaise and rash in her stomach/rash.    The patient's medical history included current conditions such as diabetes, asthma, reflux, dry eyes, osteoporosis.  Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medication, blood thinner for heart attacks, asthma medication, medicines for reflux, dry eyes medicines, osteoporosis medicine shot every 6 months and liraglutide.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A) on 03-Mar-2021 intramuscularly in left arm for prophylaxis of COVID-19 infection.    On the same day of vaccination, the dose of liraglutide was increased. On Saturday, March 06, patient experienced abdominal pain and diarrhea. On Tuesday 09 Mar 2021, Liraglutide was stopped because patient experienced rashes in the stomach. On Wednesday 10-March 2021, patient experienced blood in diarrhea and was very sick and was hospitalized for one day for Colitis and was given medication. She is feeling better now and has colonoscopy on 09 Mar 2021.    Treatment information was unknown.    Action taken with mRNA-1273 in response to the events was unknown.  The event(s), abdominal pain, diarrhea, blood in diarrhea/hematochezia, sick/malaise, rash in her stomach/rash were considered were unknown. The event colitis was considered recovering.; 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: Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Eye pruritus
Clinical narrative: Coughing; RUNNY NOSE; CONGESTION; SNEEZING; Itching under my tongue; Hard to swallow; lips started puffing up; difficulty breathing; Anaphylactic reaction; Itching on both sides of her jaw; Itching in my eyes; Sore arm; A spontaneous report was received from a consumer, concerning a female patient of 70 years age, who received Moderna's COVID-19 vaccine and experienced itching on both sides of her jaw, but not at her chin, and itching in her eyes.He had sore arm, coughing, runny nose, congestion, sneezing, itching under my tongue, had to swallow, lips started puffing up, anaphylactic reaction.  The patient has SIRS(Systemic Inflammatory Response Syndrome) and is being treated for mold toxicity. Patient was receiving an IV treatment for mold toxicity. Patient took Benadryl (diphenhydramine) as a treatment for events such as itching on both sides of her jaw, but not at chin, and itching in eyes and sore arm.Concomitant product use was not provided by the reporter.  On 20 Jan 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (042L20A) via unknown route for COVID-19 infection prophylaxis.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, such as itching on both sides of  jaw, itching in eyes, sore arm were considered as resolved and events such as coughing, runny nose, congestion, sneezing, itching under tongue, had to swallow, lips started puffing up, anaphylactic reaction were considered to be not resolved 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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Nasal congestion, Pruritus, Rhinorrhoea, Sneezing
Clinical narrative: Coughing; RUNNY NOSE; CONGESTION; SNEEZING; Itching under my tongue; Hard to swallow; lips started puffing up; difficulty breathing; Anaphylactic reaction; Itching on both sides of her jaw; Itching in my eyes; Sore arm; A spontaneous report was received from a consumer, concerning a female patient of 70 years age, who received Moderna's COVID-19 vaccine and experienced itching on both sides of her jaw, but not at her chin, and itching in her eyes.He had sore arm, coughing, runny nose, congestion, sneezing, itching under my tongue, had to swallow, lips started puffing up, anaphylactic reaction.  The patient has SIRS(Systemic Inflammatory Response Syndrome) and is being treated for mold toxicity. Patient was receiving an IV treatment for mold toxicity. Patient took Benadryl (diphenhydramine) as a treatment for events such as itching on both sides of her jaw, but not at chin, and itching in eyes and sore arm.Concomitant product use was not provided by the reporter.  On 20 Jan 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (042L20A) via unknown route for COVID-19 infection prophylaxis.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, such as itching on both sides of  jaw, itching in eyes, sore arm were considered as resolved and events such as coughing, runny nose, congestion, sneezing, itching under tongue, had to swallow, lips started puffing up, anaphylactic reaction were considered to be not resolved 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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus, Vaccination site pain
Clinical narrative: Coughing; RUNNY NOSE; CONGESTION; SNEEZING; Itching under my tongue; Hard to swallow; lips started puffing up; difficulty breathing; Anaphylactic reaction; Itching on both sides of her jaw; Itching in my eyes; Sore arm; A spontaneous report was received from a consumer, concerning a female patient of 70 years age, who received Moderna's COVID-19 vaccine and experienced itching on both sides of her jaw, but not at her chin, and itching in her eyes.He had sore arm, coughing, runny nose, congestion, sneezing, itching under my tongue, had to swallow, lips started puffing up, anaphylactic reaction.  The patient has SIRS(Systemic Inflammatory Response Syndrome) and is being treated for mold toxicity. Patient was receiving an IV treatment for mold toxicity. Patient took Benadryl (diphenhydramine) as a treatment for events such as itching on both sides of her jaw, but not at chin, and itching in eyes and sore arm.Concomitant product use was not provided by the reporter.  On 20 Jan 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (042L20A) via unknown route for COVID-19 infection prophylaxis.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, such as itching on both sides of  jaw, itching in eyes, sore arm were considered as resolved and events such as coughing, runny nose, congestion, sneezing, itching under tongue, had to swallow, lips started puffing up, anaphylactic reaction were considered to be not resolved 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 these events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Hallucination, Pyrexia
Clinical narrative: Hallucinations; Could not eat for 2 days; On the floor for 2 days; Chills; Fever; A spontaneous report was received from a 77 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, could not eat for 2 days/decreased appetite, on the floor for 2 days/asthenia, chills and fever/pyrexia.  The patient's medical history was not provided. The relevant concomitant medications were also not provided.  On 10 Mar 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA (Lot number: 001821A) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 10 Mar 2021, the patient experienced hallucinations, chills, fever, could not eat and was on the floor for 2 days.   No laboratory data was provided. Patient took paracetamol and hydroxyzine as treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The events could not eat and on the floor for two days were recovered on 12 Mar 2021.  The outcome of hallucinations, chills and fever were not known.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Pneumonia, Suspected COVID-19
Clinical narrative: Pneumonia; COVID-19; COVID-19; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, the patient's sibling.   A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198; Expiration Date: 30Jun2021), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  Medical history included ongoing cancer. The patient's concomitant medications included unspecified cancer treatment, which he stopped as it was not helping him.  On 03Feb2021, the patient experienced COVID-19.  On an unknown date, he developed pneumonia. The events did not require hospitalization. The patient received unspecified treatment for the COVID-19. There was no treatment given for the pneumonia. The clinical outcome of the COVID-19 was not recovered, while that of the pneumonia was recovered on an unknown date.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: small rashes inner left arm; burning sensation inner left arm; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number ENG201) via an unspecified route of administration on 19Feb2021 at 16:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Prior to the vaccine the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) from an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. On the first day (also reported as 12Feb2021) at 18:00, the patient experienced burning sensation on the inner left arm. On the second day, the patient experienced small rashes on the inner left arm but different spots from the first day. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcome of burning sensation on the inner left arm and small rashes on the inner left arm were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Severe body pain; severe headache; slight fever; Chills; nausea; This is a spontaneous report from a contactable consumer (patient). This 21-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via an unspecified route of administration on 21Feb2021 at 11:15 (at the age of 21-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included iron and melatonin from unspecified dates for unspecified indications. The patient previously received dose 1 of BNT162B2 (lot number EL3246) on 31Jan2021 at 11:15 as a single dose in the right arm for COVID-19 immunization. On 21Feb2021 at 22:45 after dose 2 of BNT162B2 the patient experienced severe body pain, severe headache, chills, nausea, and slight fever. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of severe body pain, severe headache, chills, nausea, and slight fever were not recovered. It was also reported that the patient was tested for COVID-19 with a nasal swab on 03Feb2021 with a result of negative.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe body pain; severe headache; slight fever; Chills; nausea; This is a spontaneous report from a contactable consumer (patient). This 21-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via an unspecified route of administration on 21Feb2021 at 11:15 (at the age of 21-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included iron and melatonin from unspecified dates for unspecified indications. The patient previously received dose 1 of BNT162B2 (lot number EL3246) on 31Jan2021 at 11:15 as a single dose in the right arm for COVID-19 immunization. On 21Feb2021 at 22:45 after dose 2 of BNT162B2 the patient experienced severe body pain, severe headache, chills, nausea, and slight fever. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of severe body pain, severe headache, chills, nausea, and slight fever were not recovered. It was also reported that the patient was tested for COVID-19 with a nasal swab on 03Feb2021 with a result of negative.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: My taste and smell are inconsistent; My taste and smell are inconsistent; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EM9809) intramuscularly on 06Feb2021 at 13:15 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Feb2021 the patient experienced taste and smell were inconsistent. He could not taste certain foods. It was mostly more noticeable at night. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of taste and smell were inconsistent was unknown. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 at 14:00 (at the age of 64-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did not receive any other medications in two weeks. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 13Feb2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. Therapeutic measures were not given for the events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell was not recovered.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 at 14:00 (at the age of 64-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did not receive any other medications in two weeks. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 13Feb2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. Therapeutic measures were not given for the events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell was not recovered.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL9265) via an unspecified route of administration in the right arm on 18Feb2021 at 17:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, Lyme disease syndrome, and gluten allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL) from an unknown date for thyroid, vitamins from unknown dates for unknown indications and herbs from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 05:00 the patient experienced vertigo, which was continuing Monday, 22Feb (2021). The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The outcome of vertigo was reported as not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on Torso and arms; This is a spontaneous report from a contactable consumer (patient). This 54-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9265) via an unspecified route of administration on 19Feb2021 at 14:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included high blood pressure and cholesterol medication. The patient did not have any allergies to medications, food, or other products. On 19Feb2021 at 18:00 the patient experienced a rash on torso and arms. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of rash on torso and arms was not recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Lymph node pain, Myalgia, Peripheral swelling
Clinical narrative: Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, under arm; hard lump at injection site; Swelling down to hand and fingers; 99.3 fever; pain in tricep, under arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Feb2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient reported she had allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Jan2021 at 16:00 (at the age of 57-years-old) in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 22:00 the patient experienced a heart shaped rash six inches below the injection site 8 hours after the shot. 10 hours later the patient had excruciating lymph node pain and pain in the tricep, under arm and hard lump at injection site. She also experienced swelling down to hand and fingers and 99.3 fever. The events were reported as non-serious and didn't require hospitalization. No treatment was provided for the events. The clinical outcomes of heart shapes rash six inches below injection site, excruciating lymph node pain, pain in tricep under arm, hard lump at injection site, swelling down to hand and fingers, and 99.3 fever were reported as not recovered. It as also reported that since vaccination the patient had not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass, Vaccination site rash
Clinical narrative: Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, under arm; hard lump at injection site; Swelling down to hand and fingers; 99.3 fever; pain in tricep, under arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Feb2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient reported she had allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Jan2021 at 16:00 (at the age of 57-years-old) in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 22:00 the patient experienced a heart shaped rash six inches below the injection site 8 hours after the shot. 10 hours later the patient had excruciating lymph node pain and pain in the tricep, under arm and hard lump at injection site. She also experienced swelling down to hand and fingers and 99.3 fever. The events were reported as non-serious and didn't require hospitalization. No treatment was provided for the events. The clinical outcomes of heart shapes rash six inches below injection site, excruciating lymph node pain, pain in tricep under arm, hard lump at injection site, swelling down to hand and fingers, and 99.3 fever were reported as not recovered. It as also reported that since vaccination the patient had not been tested for COVID-19.