chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Thinking abnormal, Tinnitus
Clinical narrative: Suicidal thoughts; Both ears ringing, nonstop; Can't sleep; No appetite; Either hot or cold, no in between/hot and cold sweats; Feels boxed in; Having weird thoughts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), TINNITUS (Both ears ringing, nonstop), INSOMNIA (Can't sleep), DECREASED APPETITE (No appetite), BODY TEMPERATURE FLUCTUATION (Either hot or cold, no in between/hot and cold sweats), FEELING ABNORMAL (Feels boxed in) and THINKING ABNORMAL (Having weird thoughts). On 26-Mar-2021, DECREASED APPETITE (No appetite) had resolved. At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), INSOMNIA (Can't sleep), FEELING ABNORMAL (Feels boxed in) and THINKING ABNORMAL (Having weird thoughts) was resolving, TINNITUS (Both ears ringing, nonstop) had not resolved and BODY TEMPERATURE FLUCTUATION (Either hot or cold, no in between/hot and cold sweats) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On Wednesday, 24-Mar-2021 the caller stated that out of nowhere, his ears starting ringing, both ears. The ringing is like yelling in his ear.   Ringing in his ears had not stopped yet and continued to drive him cray. He feels boxed in and can't sleep. He has no appetite and either feels extremely cold or extremely hot, it's one or the other, no in- between. Yesterday, 25-Mar-2021, the caller went to the emergency room due to these symptoms. He was not admitted. Caller stated that things are so bad  that he  even had suicidal thoughts and was prone to anxiety.  On the follow up report patient reported the ringing was in his left ear only and the other reported symptoms had started to get better. Since 26-Mar-2021, his appetite had returned and the felling of hot, cold sweats had gone away. Treatment was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: added additional reporter information, race, weight,; Sender'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.  Further information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: 12 seizures so far after getting 1st dose of coronavirus vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (12 seizures so far after getting 1st dose of coronavirus vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Seizures. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE SPRINKLE), CLONAZEPAM, LEVETIRACETAM, PYRIDOXINE HYDROCHLORIDE (VITAMINE) and CANNABIDIOL (CBD OIL) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (12 seizures so far after getting 1st dose of coronavirus vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (12 seizures so far after getting 1st dose of coronavirus vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event/s has been provided at this time.  Further information has been requested   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, COVID-19, Myalgia
Clinical narrative: Pneumonia; Arthritis; Back pain; Productive cough; Knee and shoulder pain; Ache body; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rotator cuff tear in 2011, Spinal stenosis in 2018 and Reverse shoulder replacement in 2014. Concurrent medical conditions included Seasonal allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRITIS (Arthritis), BACK PAIN (Back pain), PRODUCTIVE COUGH (Productive cough), ARTHRALGIA (Knee and shoulder pain) and MYALGIA (Ache body). On 08-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) and PRODUCTIVE COUGH (Productive cough) was resolving and ARTHRITIS (Arthritis), BACK PAIN (Back pain), ARTHRALGIA (Knee and shoulder pain) and MYALGIA (Ache body) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, COVID-19: negative (normal) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events included unspecified antibiotics, voltaren gel and ibuprofen.  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: 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: Pneumonia, Productive cough
Clinical narrative: Pneumonia; Arthritis; Back pain; Productive cough; Knee and shoulder pain; Ache body; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rotator cuff tear in 2011, Spinal stenosis in 2018 and Reverse shoulder replacement in 2014. Concurrent medical conditions included Seasonal allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRITIS (Arthritis), BACK PAIN (Back pain), PRODUCTIVE COUGH (Productive cough), ARTHRALGIA (Knee and shoulder pain) and MYALGIA (Ache body). On 08-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) and PRODUCTIVE COUGH (Productive cough) was resolving and ARTHRITIS (Arthritis), BACK PAIN (Back pain), ARTHRALGIA (Knee and shoulder pain) and MYALGIA (Ache body) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, COVID-19: negative (normal) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events included unspecified antibiotics, voltaren gel and ibuprofen.  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: 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: palsy bell; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (palsy bell) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History was reported).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-arterial) at an unspecified dose. On 29-Mar-2021, the patient experienced FACIAL PARALYSIS (palsy bell) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 29-Mar-2021 due to FACIAL PARALYSIS. At the time of the report, FACIAL PARALYSIS (palsy bell) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-arterial), the reporter did not provide any causality assessments.   The patient went to the ER on 29MAR2021 because he had facial paralysis, trouble talking, couldn't shut his eye or smile. Patient was diagnosed with bells palsy (ongoing) tx: prednisone, antiviral for a wk - bells palsy, facial issues tylenol 500 mg for headache
Sex: F
Vaccine: COVID19
Symptoms: Abdominal abscess
Clinical narrative: Lower abdominal abscess; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL ABSCESS (Lower abdominal abscess) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL ABSCESS (Lower abdominal abscess) (seriousness criterion medically significant). At the time of the report, ABDOMINAL ABSCESS (Lower abdominal abscess) had not resolved. Not Provided          Treatment information was not provided.  Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded.  The patient described the abscess as pre-existing, but as this was reported after 1st vaccine dose and prior to 2nd dose, it is not clear if it pre-exists the 1st dose; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded.  The patient described the abscess as pre-existing, but as this was reported after 1st vaccine dose and prior to 2nd dose, it is not clear if it pre-exists the 1st dose
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; Sender'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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Choking sensation, Cough, Secretion discharge, Somnolence
Clinical narrative: Severe cough with mucus; Cough brought up mucus; Feels sleepy all day; Felt like he was going to choke; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING SENSATION (Felt like he was going to choke) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported.   On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 04-Apr-2021, the patient experienced CHOKING SENSATION (Felt like he was going to choke) (seriousness criterion medically significant). The patient and drank some ginger tea which helped alleviate it.  On 05-Apr-2021, the patient woke up and had a severe cough and brought up mucus.  The patient COUGH (Severe cough with mucus), SECRETION DISCHARGE (Cough brought up mucus) and SOMNOLENCE (Feels sleepy all day). The patient was treated with Manual therapy (Ginger tea) for Choking sensation.   At the time of the report, COUGH (Severe cough with mucus), SECRETION DISCHARGE (Cough brought up mucus) and SOMNOLENCE (Feels sleepy all day) had not resolved.       Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; She realized that the diarrhea had turned into a colitis flare once she saw blood and mucus; a very sight sore arm; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 02Feb2021 (Lot Number: EN5318, at the age of 72-years-old) as single dose for covid-19 immunisation. Medical history included ongoing colitis (she does have a colitis history, but has not had an attack/flare in 6 years). She takes medication to control her Colitis and has taken it for many years. She takes nothing else, had no other vaccinations, has no new medications, no dose changes, no changes to her lifestyle, nothing. There were no concomitant medications. The patient experienced diarrhea on an unspecified date, a very sight sore arm on 02Feb2021 and she realized that the diarrhea had turned into a colitis flare once she saw blood and mucus on 05Feb2021. The outcome of the event a very sight sore arm was recovered and outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular in the upper arm on 05Feb2021 12:30 (Batch/Lot number was not reported) and dose 2 intramuscular in the upper arm on 05Mar2021 12:30 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. The patient medical history included coagulation disorder and heart problem, both ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) as blood thinner;  metoprolol (unknown manufacturer) as hearth medicine, Aspirin (acetylsalicylic acid) low dose as hearth medicine and ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) all oral and ongoing. The patient experienced arm pain on 05Feb2021 12:30, after the first dose and on 05Mar2021 12:30, after the second dose both with outcome of recovered in 2021 without treatment.  Follow up (12Mar2021): New information from the same contactable Consumer included: administration details (day and hour, route and site), medical history, concomitant medications, adverse event updated, second dose information.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first vaccine on the 26Jan2021. She had the COVID-19 test on the 31Jan2021 and received the results on 01Feb2021 and tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Feb2021. The patient was scheduled for the 2nd dose on 16Feb2021. The outcome of the event was unknown. Information about Batch/Lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; chills a little bit; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Patient's medical history included Smoker, Arthritis in her wrist and in November she had gotten an injection in the wrist for the arthritis, Allergy, environmental allergies, arthritis in neck and arthritis in back. Concomitant medication(s) included fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity from an unspecified start date and ongoing. These medications are 365 days for allergies. No vaccines administered on the same date or within four weeks prior. On 29Jan2021 at 13:00, patient experienced Chills, a little bit. The event chills only lasted a couple hours, she wrapped up in a blanket, took a nap and she was fine. It was reported that on 07Feb2021, her injection site swelled up to a size of a hockey puck with redness, hardness. The patient stated that she had no problem with it until last Sunday on 07Feb2021. Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red. Upon follow-up, she woke up with it and she clarified that she did not have a fever, she felt fine it was just the injection site. Her 2nd dose was scheduled on 19Feb2021, next Friday and she wanted to know if she could take the 2nd shot as she had heard that people will experience worse side effects on the 2nd shot. She really wanted to be had taken the 2nd shot for that level of comfort. The patient underwent lab tests and procedures which included X-Ray: Unknown result on an unspecified date in November. On 07Feb2021 as the treatment for the event Injection site swollen and red, the patient received Benadryl and she put ice on it and has been 99% better, but she can still see a shadow of redness and there was a little heat, the swelling had gone. The outcome of the event Chills, vaccination site swelling was recovered, vaccination site warmth, vaccination site erythema was recovering and vaccination site induration was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; . Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red; chills a little bit; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Patient's medical history included Smoker, Arthritis in her wrist and in November she had gotten an injection in the wrist for the arthritis, Allergy, environmental allergies, arthritis in neck and arthritis in back. Concomitant medication(s) included fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity from an unspecified start date and ongoing. These medications are 365 days for allergies. No vaccines administered on the same date or within four weeks prior. On 29Jan2021 at 13:00, patient experienced Chills, a little bit. The event chills only lasted a couple hours, she wrapped up in a blanket, took a nap and she was fine. It was reported that on 07Feb2021, her injection site swelled up to a size of a hockey puck with redness, hardness. The patient stated that she had no problem with it until last Sunday on 07Feb2021. Her injection site went crazy, it looked like a hockey puck, it was hot, hard, like it had a fever, it was swollen and red. Upon follow-up, she woke up with it and she clarified that she did not have a fever, she felt fine it was just the injection site. Her 2nd dose was scheduled on 19Feb2021, next Friday and she wanted to know if she could take the 2nd shot as she had heard that people will experience worse side effects on the 2nd shot. She really wanted to be had taken the 2nd shot for that level of comfort. The patient underwent lab tests and procedures which included X-Ray: Unknown result on an unspecified date in November. On 07Feb2021 as the treatment for the event Injection site swollen and red, the patient received Benadryl and she put ice on it and has been 99% better, but she can still see a shadow of redness and there was a little heat, the swelling had gone. The outcome of the event Chills, vaccination site swelling was recovered, vaccination site warmth, vaccination site erythema was recovering and vaccination site induration was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting projectile
Clinical narrative: headaches; pretty serious muscle aches; projectile vomiting; fever; chills; massive diarrhea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: May2021) on 27Jan2021 15:20-15:30 (at the age of 79-year-old) intramuscularly administered in Arm Left as single dose for prevention. The patient medical history were not reported and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was reported as none. Vaccination facility type was reported as hospital and not a military facility. The patient called for information about if her symptoms could be related to the administration of the Pfizer's COVID-19 vaccine. The patient reported that she has massive diarrhea (08:30), projectile vomiting (10:00), fever (10:00), pretty serious muscle aches (11:00), tiredness (07:30), headache (13:00) and chills (08:30) on 10Feb2021. Events fever, Pretty serious muscle aches and tiredness were reported as worsened. The patient reported that she was administered with the first dose of the vaccine 2 weeks ago and she was feeling fine starting with the symptoms today (10Feb2021). The patient reported that she thought it was possible that she has been infected of COVID-19 virus. The patient reported that she considered herself a healthy 79-year-old woman. Received call from the patient regarding the Pfizer COVID 19 vaccine. She had the first vaccine two weeks ago today (10Feb2021). She was having massive Diarrhea, Chills, projectile vomiting, fatigue, muscle aches and fever.  She started out with her normal body temp of 97.3 and this morning it was 98.2.  She took it an hour later, and it was 98.4 and then it was 100 and now it was 100.2.  That was why she was calling.  She would like to know if these were side effects. She said she cannot think. She filled out two forms on the second day after the shot. It came up on her email and it listed the symptoms and said have you had any today.  She was kind of fatigued today (10Feb2021). A week later she had pretty serious muscle aches and one more thing. The diarrhea was one massive one this morning and it got rid of everything. It was liquid. She has not had one since. Projectile vomiting was twice within 10 minutes of each other. It happened pretty fast at 09:30-10:00 this morning. She has not eaten anything at all. Muscle aches started at 10:00. The tiredness started before diarrhea and was progressively getting worse. Headache started an hour to hour and a half ago. Chills started at 08:00 and were worse for 2 hours and then got better. She could take off gloves and scarf around her neck but does not have chills now. Outcome of the events massive diarrhea, projectile vomiting and chills was reported as recovering. Outcome of the events fever, pretty serious muscle aches, tiredness and headache was reported as not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Malaise, Pain in extremity
Clinical narrative: a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling good at all; Feels miserable/horrible and woozy; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included , thyroid disorder from an unknown date and unknown if ongoing Thyroid is low ,diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin at 500 mg taken for diabetes mellitus, start and stop date were not reported and levothyroxine sodium (SYNTHROID) at 100 mcg taken for thyroid disorder, start and stop date were not reported. The patient previously took  Historical Vaccine BNT162B2  (she got her first shot on 19Jan2021 with no side effects; Batch/lot number: EN9581; Dosage text: Once by injection in the left arm )on 19Jan2021 for Covid-19 immunisation. The patient experienced a really bad headache, a very sore arm , fever with temperatures of 100.3 to 101f, she's not feeling good at all , feels miserable/horrible and woozy on 10Feb2021. she received the 1st dose of the vaccine last 19Jan2021 and had no side effects. She received the 2nd dose yesterday and woke up in the middle of the night due to a really bad headache and a very sore arm. She woke up today and still had the symptoms along with a fever with temperatures of 100.3 to 101 F. She's not feeling good at all and is asking if these are all common side effects of the vaccine and on what she should do. The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit on 10Feb2021 she took it again at 1:25 and it got up to 101.  The action taken in response to the event for bnt162b2 was not applicable. The outcome for the events a really bad headache, fever with temperatures of 100.3 to 101F, and Feels miserable/horrible and woozy not resolved and for other events was unknown.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling good at all; Feels miserable/horrible and woozy; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included , thyroid disorder from an unknown date and unknown if ongoing Thyroid is low ,diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin at 500 mg taken for diabetes mellitus, start and stop date were not reported and levothyroxine sodium (SYNTHROID) at 100 mcg taken for thyroid disorder, start and stop date were not reported. The patient previously took  Historical Vaccine BNT162B2  (she got her first shot on 19Jan2021 with no side effects; Batch/lot number: EN9581; Dosage text: Once by injection in the left arm )on 19Jan2021 for Covid-19 immunisation. The patient experienced a really bad headache, a very sore arm , fever with temperatures of 100.3 to 101f, she's not feeling good at all , feels miserable/horrible and woozy on 10Feb2021. she received the 1st dose of the vaccine last 19Jan2021 and had no side effects. She received the 2nd dose yesterday and woke up in the middle of the night due to a really bad headache and a very sore arm. She woke up today and still had the symptoms along with a fever with temperatures of 100.3 to 101 F. She's not feeling good at all and is asking if these are all common side effects of the vaccine and on what she should do. The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit on 10Feb2021 she took it again at 1:25 and it got up to 101.  The action taken in response to the event for bnt162b2 was not applicable. The outcome for the events a really bad headache, fever with temperatures of 100.3 to 101F, and Feels miserable/horrible and woozy not resolved and for other events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous case is report from a contactable consumer or other non hcp via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration on 19Jan2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history was and concomitant medications were not reported. Patient got a fever last night (07Feb2021, a day before this report) and she has a schedule of second shot tomorrow (Next day of this report, 09Feb2021). At the time of this report event outcome was unknown.    Information on the batch/lot number requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash/ after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 31Jan2021 (at the age of 74-years-old) as a single dose for an unspecified indication. Medical history included rheumatoid arthritis and autoimmune disorder. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced rash/ after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks. The caller is experiencing a rash after taking the first dose. Caller received Pfizer Covid-19 vaccine first shot on 31Jan2021 and after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks. There are also blisters in the face. Her next shot is on the 21st and wanting to know if she needs to continue the 2nd dose. Caller also had Rheumatoid arthritis and autoimmune disease. The patient did not receive any treatment for the events. The clinical outcome of rash/ after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks was unknown. No follow-up attempts are possible. Information about lot number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: a "good size red patch" at injection site that is hard, swollen, red.; a "good size red patch" at injection site that is hard, swollen, red.; a "good size red patch" at injection site that is hard, swollen, red.; Red, swollen, itching and kind of arm at injection site on left arm; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 9809), via an unspecified route of administration, administered in left arm on 04Feb2021 at a SINGLE DOSE for covid-19 immunization. Medical history included breast cancer. There were no concomitant medications. 08Feb2021 the patient experienced a "good size red patch" at injection site that is hard, swollen, red patient also reported red, swollen, itchy, and kind of hard area at the injection site. 7 days of Cefalexin (antibiotic treatment) was given from an urgent care. The patient stated that she wanted to report a reaction to the first COVID shot. She is due for her second shot on 25Feb2021. The outcome of the events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Low grade fever; nausea; vomiting; headache; sweating; chills; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). A 28-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiry date: unknown) via an unspecified route of administration in arm left on 10Feb2021 08:00 AM as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication of patient included gabapentin (GABA) (other medications the patient received within 2 weeks of vaccination). Patient had historical vaccine at 28-year-old, first dose of BNT162B2 (Lot number: EL3249) in left arm on 21Jan2021 at 12:45 PM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 11:45pm, patient experienced low grade fever, nausea, vomiting, headache, sweating, chills and couldn't sleep. Patient reported no for serious, seriousness criteria-results in death, seriousness criteria-Life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-Disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature was low grade fever on 10Feb2021. Patient did not receive any treatment for adverse event. The outcome of the events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Low grade fever; nausea; vomiting; headache; sweating; chills; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). A 28-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiry date: unknown) via an unspecified route of administration in arm left on 10Feb2021 08:00 AM as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication of patient included gabapentin (GABA) (other medications the patient received within 2 weeks of vaccination). Patient had historical vaccine at 28-year-old, first dose of BNT162B2 (Lot number: EL3249) in left arm on 21Jan2021 at 12:45 PM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 11:45pm, patient experienced low grade fever, nausea, vomiting, headache, sweating, chills and couldn't sleep. Patient reported no for serious, seriousness criteria-results in death, seriousness criteria-Life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-Disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature was low grade fever on 10Feb2021. Patient did not receive any treatment for adverse event. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Vaccination site rash
Clinical narrative: rash on the same arm that she got the vaccination; a rash on the same arm that she got the vaccination in. She reports that it got swollen; Itchy/itching between the elbow and wrist/it itched a lot; Little sore arm; Area got a little red; rash on her arm between her elbow and wrist; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in arm on 28Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date in 2021, the patient experienced rash on the same arm that she got the vaccination in and it got swollen, little sore arm, itching between the elbow and wrist, area got a little red and rash on her arm between her elbow and wrist. The patient wanted to know whether she could receive second dose. The outcome of the events rash on her arm between her elbow and wrist, Little sore arm, Area got a little red was unknown while for other events was recovering.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: rash on the same arm that she got the vaccination; a rash on the same arm that she got the vaccination in. She reports that it got swollen; Itchy/itching between the elbow and wrist/it itched a lot; Little sore arm; Area got a little red; rash on her arm between her elbow and wrist; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in arm on 28Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date in 2021, the patient experienced rash on the same arm that she got the vaccination in and it got swollen, little sore arm, itching between the elbow and wrist, area got a little red and rash on her arm between her elbow and wrist. The patient wanted to know whether she could receive second dose. The outcome of the events rash on her arm between her elbow and wrist, Little sore arm, Area got a little red was unknown while for other events was recovering.  Information about batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bumpy rash on ankles, toes, fingers, only on extremities, started with ankles; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received second dose bnt162b2 (BNT162B2) via an unspecified route of administration, administered in arm left on 08Feb2021 13:30 (Lot Number: EL8982) as single dose for covid-19 immunisation. Medical history included Numerous Allergies, Sulfa allergy, certain nuts allergy. The patient historical vaccine included first dose bnt162b2 lot number: EK-9231, 12Jan2021 03:30 PM at Left arm single dose for covid-19 immunisation. Concomitant medication included ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) and tocopherol (VIT E). The patient experienced bumpy rash on ankles, toes, fingers, only on extremities, started with ankles on 09Feb2021 08:00. There was no event treatment for the event. Facility where the most recent COVID-19 vaccine was administered hospital. The outcome of the event recovering.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Lip swelling, Swollen tongue
Clinical narrative: swollen lips; swollen tongue; hoarsness; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EL3247), via an unspecified route of administration in the right arm on 10Feb2021 at 3:00 PM (at the age of 53 years-of-old) at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, GERD and tree nuts allergy. Concomitant medication(s) included NEXIUM, PEPCID, QVAR and AMLODIPINE BESYLATE. On 11Feb2021, patient experienced swollen lips, swollen tongue, hoarseness and difficulty swallowing which resulted in emergency room visit. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration in the right arm on 20Jan2021 at 2:00 PM at single dose for COVID-19 immunization. Therapeutic measures were taken for events which include included Prednisone 50mg/5days and Benadryl. The patient took the most recent COVID-19 vaccine at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The outcome of all the events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body aches; chills; headache; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non pregnant female she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 10Feb2021 at 09:15 (at the age of 49-years-old) as a single dose for covid-19 vaccination. Medical history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 22Jan2021 at 09:15 as a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Allergies to medications, food, or other products included: Allergy to Penicillin, Amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  On 11Feb2021 at 08:30, the patient experienced body aches, chills, headache. Patient did not receive treatment for the adverse event. On an unknown date, the outcome of the events was recovered.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Insomnia
Clinical narrative: fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50-year-old male consumer reported that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Age at vaccination: 50 Years), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine besilate (NORVASC); telmisartan (MICARDIS); zinc; VITAMIN C [ASCORBIC ACID]; vitamin d nos. The patient previously received first single dose of bnt162b2 on Right arm on 21Jan2021,11:00 single (Age at vaccination: 50 Years) for Covid-19 immunization. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Norvasc, Micardis, multivitamin, vitamin C+D+zinc. On 11Feb2021 21:15, patient had fatigue, chills, hot flashes, headache, insomnia. Patient received treatment with Advil. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: Momentary sharp shooting pain in center of lower back; pain in upper left thigh, near left hip; Painful to arise from sitting position for 4 days.; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, Expiration date: unknown) via an unspecified route of administration at left arm on 20Jan2021 at 13:00 at single dose for COVID-19 Immunization. Medical history included CAD with 1 stent, history of cardiac arrest 2014, degenerative disc disease and allergies to Penicillin, Ceftin, Erythromycin. Concomitant medications included Lipitor, Levothyroxine, Metoprolol, aspirin (81 mg). Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. On 20Jan2021 16:00 (24-hour clock), patient experienced momentary sharp shooting pain in center of lower back, followed about an hour later by pain in upper left thigh, near left hip, painful to arise from sitting position for 4 days. Only comfortable in standing or lying on back in bed, it was resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for events, but patient was self-treated with Acetaminophen. Outcome for the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.