chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: sore injection site; very swollen area in right arm pit; low grade fever; Diarrhea; upset stomach; fever (102 degrees F); chills; extreme fatigue; headache; migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Sep2021 18:00 (Lot number: Fc3184) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE HCL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer, Lot number=Ew0181, Lot unknown=False, Administration date=18Aug2021, Administration time=11:30 AM, Dose number=1, Vaccine location=Right arm}]), administration date: 18Aug2021, when the patient was 41 years old, for covid-19 immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "upset stomach"; PYREXIA (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "fever (102 degrees F)"; CHILLS (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "extreme fatigue"; HEADACHE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "headache"; MIGRAINE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "migraine"; VACCINATION SITE PAIN (non-serious) with onset 11Sep2021, outcome "recovering", described as "sore injection site"; LYMPHADENOPATHY (non-serious) with onset 11Sep2021, outcome "recovering", described as "very swollen area in right arm pit"; PYREXIA (non-serious) with onset 11Sep2021, outcome "recovering", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, abdominal discomfort, pyrexia, chills, fatigue, headache, migraine, vaccination site pain, lymphadenopathy, pyrexia.  Additional information: Patient has not received any other vaccine in four weeks. Patient had no covid prior to vaccination and not tested post vaccination and had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Migraine, Pyrexia, Vaccination site pain
Clinical narrative: sore injection site; very swollen area in right arm pit; low grade fever; Diarrhea; upset stomach; fever (102 degrees F); chills; extreme fatigue; headache; migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Sep2021 18:00 (Lot number: Fc3184) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE HCL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer, Lot number=Ew0181, Lot unknown=False, Administration date=18Aug2021, Administration time=11:30 AM, Dose number=1, Vaccine location=Right arm}]), administration date: 18Aug2021, when the patient was 41 years old, for covid-19 immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "upset stomach"; PYREXIA (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "fever (102 degrees F)"; CHILLS (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "extreme fatigue"; HEADACHE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "headache"; MIGRAINE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "migraine"; VACCINATION SITE PAIN (non-serious) with onset 11Sep2021, outcome "recovering", described as "sore injection site"; LYMPHADENOPATHY (non-serious) with onset 11Sep2021, outcome "recovering", described as "very swollen area in right arm pit"; PYREXIA (non-serious) with onset 11Sep2021, outcome "recovering", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, abdominal discomfort, pyrexia, chills, fatigue, headache, migraine, vaccination site pain, lymphadenopathy, pyrexia.  Additional information: Patient has not received any other vaccine in four weeks. Patient had no covid prior to vaccination and not tested post vaccination and had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Tremor
Clinical narrative: my lower back also hands shake; 1st vaccine gave me pain in my joints; pain in my joints and across my lower back; This is a spontaneous report received from a non-contactable reporter consumer or other non HCP. The reporter is the patient reported that  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 11:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 2021, outcome "not recovered", described as "my lower back also hands shake"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "1st vaccine gave me pain in my joints"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain in my joints and across my lower back".  Additional information:-Patient had not received any other vaccine within 4 weeks.Adverse event follows that 1st vaccine gave me pain in my joints and across my lower back also hands shake 2 shot made joint pain worse lower back made it hard to get up and walk.Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Fatigue, Rash macular, Skin exfoliation, Swelling
Clinical narrative: Her arm is getting blotchy; She is fatigue like very quickly; She would be walking around doing her chores and she is like to pee and start crying; Her arm is like swelling; It's kind of skin peeling off kind of where she got the shot; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 20Aug2021 (Lot number: FE3592) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LORYNA taken for contraception. Past drug history included: Augmentin, reaction(s): "Allergic to Augmentin". The following information was reported: RASH MACULAR (non-serious) with onset 01Sep2021, outcome "unknown", described as "Her arm is getting blotchy"; FATIGUE (non-serious) with onset 01Sep2021, outcome "unknown", described as "She is fatigue like very quickly"; CRYING (non-serious) with onset 01Sep2021, outcome "unknown", described as "She would be walking around doing her chores and she is like to pee and start crying"; SWELLING (non-serious) with onset 01Sep2021, outcome "unknown", described as "Her arm is like swelling"; SKIN EXFOLIATION (non-serious) with onset 01Sep2021, outcome "unknown", described as "It's kind of skin peeling off kind of where she got the shot". Therapeutic measures were taken as a result of rash macular, fatigue, crying, swelling, skin exfoliation.  Additional information: Reporter stated, "He was calling because his fiance she just took the COVID vaccine through Pfizer and he think it was 20Aug2021 was first shot and second shot she took was two days ago. He was noticing her arm was getting blotchy, she was fatigue like very quickly, she would be walking around doing her chores and she was like to pee and start crying, so he don't know weather and her arm was like swelling, and it's kind of skin peeling off kind of where she got the shot, so he just wanted to what if he can question was like anything have you heard about this, was there anything he can do to mitigate the symptoms and he don't know what going on. "Age when adverse event started: Reporter stated, "So her age, she was 22 (not clarified hence not captured in tab) going to be 23 she started having the first symptom, he don't know, he was just trying to track it, she had the first symptom 01Sep2021 (Confirmed as start date of adverse event as 01Sep2021) and she got her vaccine on the 20Aug and the next dose, her next dose was on the 10th of this month and she feeling symptoms today that was the 11th, so she was feeling one day after shot". Treatment received was "Ibuprofen 800 mg.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear discomfort, Pain, Paraesthesia oral, Pruritus
Clinical narrative: Itchy; Sore; ears on fire; Mouth on fire and lips burning/ Mouth on fire was reported as worsened/ Lips burning was worsened/ burning; Tingling lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 15:00 (Lot number: 30130BA) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Lot: EW0181, Exp: unknown , Lot Number / Expiry Date: EW0181/UNKNOWN), administration date: 18Aug2021, when the patient was 30 years old, for COVID-19 immunization  The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 09Sep2021, outcome "unknown", described as "Tingling lips"; BURNING SENSATION (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Mouth on fire and lips burning/ Mouth on fire was reported as worsened/ Lips burning was worsened/ burning"; PRURITUS (non-serious), outcome "unknown", described as "Itchy"; PAIN (non-serious), outcome "unknown", described as "Sore"; EAR DISCOMFORT (non-serious) with onset 10Sep2021, outcome "not recovered", described as "ears on fire". Therapeutic measures were not taken as a result of paraesthesia oral, burning sensation, pruritus, pain, ear discomfort.  Additional information: It was reported that, she was calling to report reactions. She did not have these reactions after the first dose. She just got the second dose. Mouth and ears on fire. Her lips were burning. It was like a spicy taco. Her lips started tingling, but now were burning. The burning was getting worse. It is the whole area around her lips going a quarter all the way around. The patient did not require emergency room and physician office visit. Prior Vaccinations (within 4 weeks) were reported as none.   No follow-up attempts are possible. No
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: pregnant: Yes; last menstrual date: 02May2021; Fever; chills; Diarrhea; vomiting; Shakes; shivers; Severe arm pain; Headache; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 11:00 (Lot number: Fc3184) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 02May2021. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 16 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (lot number Fc3181, lot unknown False, administration date 20Aug2021, dose number 1, vaccine location Left arm), administration date: 20Aug2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnant: Yes; last menstrual date: 02May2021"; PYREXIA (non-serious) with onset 10Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 10Sep2021, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 10Sep2021, outcome "recovering", described as "vomiting"; TREMOR (non-serious) with onset 10Sep2021, outcome "recovering", described as "Shakes"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovering", described as "shivers"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "recovering", described as "Severe arm pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "recovering", described as "Headache"; DIZZINESS (non-serious) with onset 10Sep2021, outcome "recovering", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, pyrexia, chills, diarrhoea, vomiting, tremor, chills, pain in extremity, headache, dizziness.  Additional information: Fever and chills over night. Diarrhea and vomiting (I haven't had vomiting in a few weeks from pregnancy). Shakes/shivers. Severe arm pain. Headache and dizziness right after vaccination. Patient did not receive other vaccine in four weeks. Patient did not receive treatment AE. Patient was not covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: pregnant: Yes; last menstrual date: 02May2021; Fever; chills; Diarrhea; vomiting; Shakes; shivers; Severe arm pain; Headache; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 11:00 (Lot number: Fc3184) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 02May2021. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 16 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (lot number Fc3181, lot unknown False, administration date 20Aug2021, dose number 1, vaccine location Left arm), administration date: 20Aug2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnant: Yes; last menstrual date: 02May2021"; PYREXIA (non-serious) with onset 10Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 10Sep2021, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 10Sep2021, outcome "recovering", described as "vomiting"; TREMOR (non-serious) with onset 10Sep2021, outcome "recovering", described as "Shakes"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovering", described as "shivers"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "recovering", described as "Severe arm pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "recovering", described as "Headache"; DIZZINESS (non-serious) with onset 10Sep2021, outcome "recovering", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, pyrexia, chills, diarrhoea, vomiting, tremor, chills, pain in extremity, headache, dizziness.  Additional information: Fever and chills over night. Diarrhea and vomiting (I haven't had vomiting in a few weeks from pregnancy). Shakes/shivers. Severe arm pain. Headache and dizziness right after vaccination. Patient did not receive other vaccine in four weeks. Patient did not receive treatment AE. Patient was not covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tremor
Clinical narrative: My left nose is all swelled up; My hand shakes so bad I can't sign a check or write anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Lot number: FC3182) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PHENOBARBITAL. Vaccination history included: Bnt162b2 (Shot date (first shot): 12Aug2021), administration date: 12Aug2021, when the patient was 76 years old, for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "My left nose is all swelled up"; TREMOR (non-serious), outcome "unknown", described as "My hand shakes so bad I can't sign a check or write anything".  Additional information: Consumer stated, I was calling about side effects. My left nose is all swelled up, my hand shakes so bad I can't sign a check or write anything, the second Pfizer shot (Covid-19 Vaccine).  Follow-Up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache started in the afternoon yesterday and got progressed; I took Tylenol but it is not going away; Muscle pain; Chills; Joint pain; Fever; Nausea; Injection site pain; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 09:00 (Lot number: FC3184) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety; "Chronic pain" (unspecified if ongoing), notes: Verbatim: Chronic pain. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 10Sep2021 13:00, outcome "recovering", described as "Headache started in the afternoon yesterday and got progressed; I took Tylenol but it is not going away"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". Therapeutic measures were taken as a result of headache.  Additional information: Patient stated calling to report the side effects. Patient stated, injection pain site, tiredness, headache, muscle pain, chills, joint pain, fever and nausea having that all. The vaccine dose received Just the first dose. yesterday morning, 10Sep2021 about 9 o'clock in the morning. Patient stated, My headache started about 1 o'clock in the afternoon yesterday and It's progressed. Patient stated, I take a lot of medications. Prior vaccination, patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no family history related to vaccination similar adverse event. The patient stated, took some Tylenol, That's all. I am taking treatment for the events. The patient stated that still experiencing the event. The patient stated I took Tylenol but It's not going away (headache). The second dose vaccination due date was 01Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Headache started in the afternoon yesterday and got progressed; I took Tylenol but it is not going away; Muscle pain; Chills; Joint pain; Fever; Nausea; Injection site pain; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 09:00 (Lot number: FC3184) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety; "Chronic pain" (unspecified if ongoing), notes: Verbatim: Chronic pain. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 10Sep2021 13:00, outcome "recovering", described as "Headache started in the afternoon yesterday and got progressed; I took Tylenol but it is not going away"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". Therapeutic measures were taken as a result of headache.  Additional information: Patient stated calling to report the side effects. Patient stated, injection pain site, tiredness, headache, muscle pain, chills, joint pain, fever and nausea having that all. The vaccine dose received Just the first dose. yesterday morning, 10Sep2021 about 9 o'clock in the morning. Patient stated, My headache started about 1 o'clock in the afternoon yesterday and It's progressed. Patient stated, I take a lot of medications. Prior vaccination, patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no family history related to vaccination similar adverse event. The patient stated, took some Tylenol, That's all. I am taking treatment for the events. The patient stated that still experiencing the event. The patient stated I took Tylenol but It's not going away (headache). The second dose vaccination due date was 01Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Headache, Heart rate
Clinical narrative: Fever up to 102.5 F; pulse up to 136; BP 154/97; PO2 lowest 87%,; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); headache; pain and mild swelling at injection site; pain and mild swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 09Sep2021 13:00 (Lot number: FC3183) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Relevant medical history included: "Seizure Disorder", start date: 02Dec2020 (ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE] taken for seizure; XANAX; TORSEMIDE. The following information was reported: BODY TEMPERATURE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "Fever up to 102.5 F"; HEART RATE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "pulse up to 136"; BLOOD PRESSURE MEASUREMENT (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "BP 154/97"; PO2 DECREASED (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "PO2 lowest 87%,"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 10Sep2021 03:00, outcome "recovered" (2021) and all described as "body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch)"; HEADACHE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "headache"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 10Sep2021 03:00, outcome "recovered" (2021) and all described as "pain and mild swelling at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature, heart rate, blood pressure measurement, po2 decreased, pain, arthralgia, headache, vaccination site swelling, vaccination site pain.  Additional information: Patient had no other vaccine in four weeks. Patient had no Covid prior vaccination. Patient had not tested for COVID post vaccination. Patient had no vaccinations within 4 weeks prior to vaccinations. The facility type vaccine was pharmacy or drug store. Patient had no family medical history relevant to adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: PO2, PO2 decreased, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever up to 102.5 F; pulse up to 136; BP 154/97; PO2 lowest 87%,; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); headache; pain and mild swelling at injection site; pain and mild swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 09Sep2021 13:00 (Lot number: FC3183) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Relevant medical history included: "Seizure Disorder", start date: 02Dec2020 (ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE] taken for seizure; XANAX; TORSEMIDE. The following information was reported: BODY TEMPERATURE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "Fever up to 102.5 F"; HEART RATE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "pulse up to 136"; BLOOD PRESSURE MEASUREMENT (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "BP 154/97"; PO2 DECREASED (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "PO2 lowest 87%,"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 10Sep2021 03:00, outcome "recovered" (2021) and all described as "body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch)"; HEADACHE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "headache"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 10Sep2021 03:00, outcome "recovered" (2021) and all described as "pain and mild swelling at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature, heart rate, blood pressure measurement, po2 decreased, pain, arthralgia, headache, vaccination site swelling, vaccination site pain.  Additional information: Patient had no other vaccine in four weeks. Patient had no Covid prior vaccination. Patient had not tested for COVID post vaccination. Patient had no vaccinations within 4 weeks prior to vaccinations. The facility type vaccine was pharmacy or drug store. Patient had no family medical history relevant to adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Pain in extremity, Pyrexia
Clinical narrative: migraine; my Lymph Nodes under my left arm swollen; fever; under my arm started to hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 11Sep2021 13:00 (Lot number: FC3183) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Amoxicillin Allergy". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=FC3182,, lot unknown=False,, administration date=21Aug2021,, administration time=01:00 PM,, dose number=1,, vaccine_location=Left arm), administration date: 21Aug2021, when the patient was 31 years old, for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 11Sep2021 23:00, outcome "not recovered", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 11Sep2021 23:00, outcome "not recovered", described as "under my arm started to hurt"; MIGRAINE (non-serious) with onset 12Sep2021 02:00, outcome "not recovered", described as "migraine"; LYMPHADENOPATHY (non-serious) with onset 12Sep2021 02:00, outcome "not recovered", described as "my Lymph Nodes under my left arm swollen". Therapeutic measures were not taken as a result of pyrexia, pain in extremity, migraine, lymphadenopathy. Additional information-Patient did not received any vaccine in four weeks. Patient did not received any medications in two weeks. Patient did not received any treatment for AE. Patient did not had Covid prior vaccination. Patient did not had Covid post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Urticaria
Clinical narrative: Headache; severe body ache; Woke up with Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 (Lot number: FF2589) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe Arthritis" (unspecified if ongoing), notes: Verbatim: Severe Arthritis. Concomitant medication(s) included: OXYCODONE taken for arthritis. The following information was reported: HEADACHE (non-serious) with onset 10Sep2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 10Sep2021, outcome "unknown", described as "severe body ache"; URTICARIA (non-serious) with onset 10Sep2021, outcome "unknown", described as "Woke up with Hives". Therapeutic measures were not taken as a result of headache, pain, urticaria.  Additional information: The patient received 1st dose on 09Sep2021 of Pfizer vaccination and on 10Sep2021, patient woke up like severe body ache and headache. The patient woke up with Hives in area, hive, that was with lot of people.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Heart rate increased
Clinical narrative: severe hip left pain; Light headed feeling like I was going to pass out; Fast heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 16:30 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 14Aug2021, outcome "recovered" (2021), described as "severe hip left pain"; DIZZINESS (non-serious) with onset 14Aug2021, outcome "recovered" (2021), described as "Lightheaded feeling like I was going to pass out"; HEART RATE INCREASED (non-serious) with onset 14Aug2021, outcome "recovered" (2021), described as "Fast heartbeat".  Additional information: Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Dysstasia, Gait disturbance
Clinical narrative: 2 shot made joint pain worse; 2 shot made joint pain worse; lower back made it hard to get up and walk; lower back made it hard to get up and walk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "pain in my joints", "pain in my joints and across my lower back", "also hands shake". The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "2 shot made joint pain worse"; DYSSTASIA (non-serious), GAIT DISTURBANCE (non-serious), outcome "not recovered" and all described as "lower back made it hard to get up and walk".  Additional Information: No, other vaccine in four weeks. No, covid prior vaccination and No covid test post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Chills, Fatigue, Lymphadenopathy
Clinical narrative: swollen neck glands on right side for 3 weeks; chills; fever 99.6 - 101.9 for 5 days; I was exhausted; Covid toe,(red rash pain and burn) on left big toe; Covid toe,(red rash pain and burn) on left big toe; Covid toe,(red rash pain and burn) on left big toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 14:30 (Lot number: EWO165) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "hashimotos" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; ARMOUR THYROID. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EWO217, lot unknown=False, administration date=03Aug2021, administration time=01:30 PM, dose number=1, vaccine location=Left arm, After I got first shot on left side which caused swollen neck glands on left side which lasted for 3 weeks), administration date: 03Aug2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "swollen neck glands on left side which lasted for 3 weeks". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "swollen neck glands on right side for 3 weeks"; CHILLS (non-serious), outcome "recovering", described as "chills"; PYREXIA (non-serious), outcome "recovering", described as "fever 99.6 - 101.9 for 5 days"; FATIGUE (non-serious), outcome "recovering", described as "exhausted"; ERYTHEMA (non-serious), RASH (non-serious), PAIN IN EXTREMITY (non-serious), BURNING SENSATION (non-serious), outcome "recovering" and all described as "Covid toe,(red rash pain and burn) on left big toe". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, chills, pyrexia, fatigue, erythema, rash, pain in extremity, burning sensation.  Additional Information: facility type vaccine: Public Health Clinic/Veterans Administration facility. if other vaccine in four weeks was no. other medications in two weeks was Bystolic, Armour Thyroid. I also got Covid toe,(red rash pain and burn) on left big toe, and have had it for 7 days so far. It was reported adverse event start date and time was 06Aug2021 02:30 PM. if covid prior vaccination was no. if covid tested post vaccination was yes. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, SARS-CoV-2 test
Clinical narrative: swollen neck glands on right side for 3 weeks; chills; fever 99.6 - 101.9 for 5 days; I was exhausted; Covid toe,(red rash pain and burn) on left big toe; Covid toe,(red rash pain and burn) on left big toe; Covid toe,(red rash pain and burn) on left big toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 14:30 (Lot number: EWO165) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "hashimotos" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; ARMOUR THYROID. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EWO217, lot unknown=False, administration date=03Aug2021, administration time=01:30 PM, dose number=1, vaccine location=Left arm, After I got first shot on left side which caused swollen neck glands on left side which lasted for 3 weeks), administration date: 03Aug2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "swollen neck glands on left side which lasted for 3 weeks". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "swollen neck glands on right side for 3 weeks"; CHILLS (non-serious), outcome "recovering", described as "chills"; PYREXIA (non-serious), outcome "recovering", described as "fever 99.6 - 101.9 for 5 days"; FATIGUE (non-serious), outcome "recovering", described as "exhausted"; ERYTHEMA (non-serious), RASH (non-serious), PAIN IN EXTREMITY (non-serious), BURNING SENSATION (non-serious), outcome "recovering" and all described as "Covid toe,(red rash pain and burn) on left big toe". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, chills, pyrexia, fatigue, erythema, rash, pain in extremity, burning sensation.  Additional Information: facility type vaccine: Public Health Clinic/Veterans Administration facility. if other vaccine in four weeks was no. other medications in two weeks was Bystolic, Armour Thyroid. I also got Covid toe,(red rash pain and burn) on left big toe, and have had it for 7 days so far. It was reported adverse event start date and time was 06Aug2021 02:30 PM. if covid prior vaccination was no. if covid tested post vaccination was yes. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Injection site is red, has a rash, is warm to the touch; Injection site is red, has a rash, is warm to the touch; Injection site is red, has a rash, is warm to the touch; Fingers feel a little pricky; has the vaccine it was tender to the touch; It itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 10:30 (Lot number: FC3183) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing), notes: Has a heart condition she takes medicine for; "A-fib" (unspecified if ongoing), notes: Had this for a few years. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 2021, outcome "not recovered" and all described as "Injection site is red, has a rash, is warm to the touch"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Fingers feel a little pricky"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "has the vaccine it was tender to the touch"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "It itches".  Additional information: Injection site was red, had a rash, was warm to the touch: When patient first had the vaccine it was tender to the touch. It was not tender now. Did not pay much attention to it. Been a couple days and noticed the rash, patient did not notice it before. It itches. It was warm to the touch and there was a round circle located where the vaccine was injected at. Should have been administered higher, but because of her blouse sleeve, they could not get it up high enough. States maybe it was given a little lower. Patient did not feel sick. Fingers feel a little pricky: It comes and goes. It was a little bit strange. No prior vaccinations within four weeks to the first administration date of the suspect vaccine. Never received a Flu vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site is red, has a rash, is warm to the touch; Injection site is red, has a rash, is warm to the touch; Injection site is red, has a rash, is warm to the touch; Fingers feel a little pricky; has the vaccine it was tender to the touch; It itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 10:30 (Lot number: FC3183) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing), notes: Has a heart condition she takes medicine for; "A-fib" (unspecified if ongoing), notes: Had this for a few years. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 2021, outcome "not recovered" and all described as "Injection site is red, has a rash, is warm to the touch"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Fingers feel a little pricky"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "has the vaccine it was tender to the touch"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "It itches".  Additional information: Injection site was red, had a rash, was warm to the touch: When patient first had the vaccine it was tender to the touch. It was not tender now. Did not pay much attention to it. Been a couple days and noticed the rash, patient did not notice it before. It itches. It was warm to the touch and there was a round circle located where the vaccine was injected at. Should have been administered higher, but because of her blouse sleeve, they could not get it up high enough. States maybe it was given a little lower. Patient did not feel sick. Fingers feel a little pricky: It comes and goes. It was a little bit strange. No prior vaccinations within four weeks to the first administration date of the suspect vaccine. Never received a Flu vaccine.  No follow-up attempts are possible. No further information is expected.