chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Throat tightness, Vaccination site reaction
Clinical narrative: The same swelling and pressure in my throat occurred after the second Pfizer shot; burning and tingling at the site of the FIRST vaccine at this time.; The pressure in my throat lasted throughout the afternoon; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old o-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Apr2021 11:30 (Batch/Lot Number: EW0153; Expiration Date: 21Jul2021) as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 08Apr2021 at 01:15 (Batch/Lot Number: Er8737; Expiration Date: 21Jul2021) as DOSE 1, SINGLE for covid-19 immunization and experienced swelling .The patient experienced the same swelling and pressure in my throat occurred after the second pfizer shot, burning and tingling at the site of the first vaccine at this time, the pressure in my throat lasted throughout the afternoon on an unspecified date. Just under 48 hours after the vaccine, the patient experienced a large swelling on either side of neck, up and down the neck. She assume it was my lymph nodes. She felt as if someone was pushing my Adam's apple. Unpleasant and scary as she though it might get worse and I would choke. This lasted most of the day Saturday. The same swelling and pressure in throat occurred after the second Pfizer shot on 29Apr2021 (Lot Number: EW0153 ; 21Jul2021). This time it happened more quickly. Five hours after received the shot. (Vaccine received at 11:30 am). The pressure in throat lasted throughout the afternoon. Also felt burning and tingling at the site of the FIRST vaccine at this time. She got a headache on 10Apr2021 and have had one ever since. The only other symptom have had is a sore arm. She did not feel ill. She was not tired. In fact she was awake at night (not normal for me). It felt like had an adrenaline rush. The outcome was recovered on an unspecified date.  No follow-up attempts are required. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Eczema, Insomnia, Lactation disorder
Clinical narrative: Temporary Insomnia (1 night); Breastmilk supply surpressed; Mild Dehydration; Eczema flair up; This is a spontaneous report from a contactable consumer. This 30-year-old non-pregnant female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0162) via an unspecified route of administration on 22Apr2021 at 06:00 PM on left arm (at 30-year-old), as dose 1, single for COVID-19 immunization. The medical history of the patient included uterine fibroids and nickel allergy. It was mentioned that the patient received no other vaccine in four weeks and no medications in two weeks. It was reported that patient did not have Covid prior vaccination and was not tested for covid post vaccination. On 22Apr2021 at 10:00 PM the patient experienced temporary Insomnia (1 night) breastmilk supply surpressed/ lowered substantial, mild dehydration and eczema flair up. No treatment was received for event. The patient had not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: afterwards he had pain from shingles; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205, Expiry date: not provided), via an unspecified route of administration on 17Mar2021 at the age of 72-years-old as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number and Expiry date are unknown, Lot Number: EL9265), via an unspecified route of administration on 24Feb2021 at the age of 72-years-old as single dose for covid-19 immunisation. Investigations were not provided. The patient said that he got Pfizer COVID-19 shots and two weeks afterwards he had pain from shingles on an unspecified date. The reporter said he has a complaint about Pfizer COVID-19 vaccine side effect of shingles after, he wants to know a response about the vaccine, he got the second dose of the vaccine 19Mar2021, later clarified to being 17Mar2021. He says the shingles are a very painful experience, he has seen many people on the internet have incidence due to Pfizer vaccine issue. He doesn't provide any further details about what he saw on the internet and doesn't clarify what he meant by issue. He says he gave his details to someone who said that someone would call him back, but no one has in the last four or five days. He said he got his first vaccine dose on 15Feb2021, clarified to 24Feb2021, of LOT: EL9265 at location (Name). NDC queried but not provided, he says there is no expiry date provided on the vaccine card for either dose. He said three weeks later on 17Mar2021, he got his second dose which was LOT: EN6205. He said something about suffering from excruciating pain of shingles, unable to clarify with patient. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient has developed rash on left side of back that was diagnosed by a doctor as shingles.; Patient has developed rash on left side of back that was diagnosed by a doctor as shingles.; This is a spontaneous report from a non-contactable consumer via Pfizer company representative. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8736, Expiration date: not reported), via intramuscular on 22Apr2021 (at the age of 35-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included known allergies: Medical gauze. The patient received weekly allergy shot in two weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8737, Expiration date: not reported), via intramuscular on 01Apr2021 (at the age of 35-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 29Apr2021, the patient has developed rash on left side of back that was diagnosed by a doctor as shingles. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment medication included Valtrex (Valacyclovir). The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: Prolonged Menstruation; This is a spontaneous report received from a contactable consumer or other non hcp. A 35-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 21Mar2021,at the age of 35 years old,as Dose 2, Single for covid-19 immunization.The patient medical history was not reported.Concomitant medication(s) included collagen taken for an unspecified indication, start and stop date were not reported.The patient experienced prolonged menstruation on 05Apr2021.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Apr2021 Nasal Swab.The patient didn't receive any treatment for the event.The patient had not received any other vaccine within 4 weeks.The patient was not diagnosed with covid19 prior to vaccination.The outcome of the event was recovered.The patient previously received her 1st dose of Pfizer covid19 vaccine on 27th feb2021.The event resulted in patient visit to physician clinic visit.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Herpes zoster, Skin discolouration
Clinical narrative: the right axilla spot grew further and pain radiated toward the right breast; the right axilla spot grew further and pain radiated toward the right breast; shingles; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 39 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:00 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included herpes zoster from 2018 to an unknown date Previously had shingles in 2018. Concomitant medication(s) included fluoxetine hcl (FLUOXETINE HCL) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced rash. The patient experienced the right axilla spot grew further and pain radiated toward the right breast with skin discolouration on an unspecified date with outcome of not recovered and shingles with herpes zoster on an unspecified date with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Myalgia, SARS-CoV-2 antibody test, Sensitive skin
Clinical narrative: shingles; I developed sensitive skin; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Apr2021 at 13:00 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. Medical history included COVID-19 from 02Apr2021 to 12Apr2021 (had Covid starting 02Apr2021 - a light case lasting 10 days). The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00, 5 days after vaccination, the patient developed sensitive skin and muscle aches. 10 days after vaccine, the patient developed shingles. The patient's doctor told me to contact you. The patient still glad that got the vaccine. The patient had COVID starting 02Apr2021 - a light case lasting 10 days. The adverse events were resulted in doctor or other healthcare professional: office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 antibody test) was negative on 18Mar2021. Antiviral medication for shingles was received as treatment. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Antibody test, Anxiety, Chills, Colitis
Clinical narrative: Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Computerised tomogram, Cytokine increased, Cytokine test, Decreased appetite
Clinical narrative: Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Dizziness, Fatigue, Fear
Clinical narrative: Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inflammatory marker increased, Inflammatory marker test, Insomnia, Malaise
Clinical narrative: Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nucleic acid test, Ovarian vein thrombosis, Pain, Pain in extremity
Clinical narrative: Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Poor quality sleep, Rheumatoid factor, Rheumatoid factor increased, SARS-CoV-2 test
Clinical narrative: Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Heavy menstrual bleeding, Menstrual disorder, Mood swings
Clinical narrative: PMS week before blood flow abnormal bloating; diarrhea; mood swings; Blood flow heavy clotting/Bleeding thru tampons; bloating; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 09:45 (at the age of 27-years-old) as dose 1, single for covid-19 immunization and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported) via an unspecified route of administration, administered in right arm on 01Apr2021 (at the age of 27-years-old) as dose 1, single (as reported) for covid-19 immunization. The patient medical history was none. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 08Apr2021 the patient experienced PMS week before blood flow abnormal bloating, diarrhea, mood swings, Blood flow heavy clotting. Bleeding thru tampons need to change more often than usual. No treatment was received for adverse event. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: My period mad gone from heavy to uncontrollable. 10 hour pads are full within an hour when they used to last for half the day.; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient).  A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unspecified route, administered in left arm on 08Apr2021 01:00 PM (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0176, Expiration date: unknown), via unspecified route, administered in left arm on 06May2021 01:00 PM (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications includes Zyrtec [CETIRIZINE HYDROCHLORIDE] and Levothyroxine both from unknown onset. On 12Apr2021, after the vaccination, the patient experienced heavy to uncontrollable menstrual bleeding, 10-hour pads were full within an hour when they used to last for half the day. Patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination. No known allergies. The outcome of the events was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills at night; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 16:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (THYRONORM) and telmisartan (MANUFACTURER UNKNOWN); taken for unspecified indications from unknown dates and unknown if ongoing. On 04May2021 at 01:00, the patient experienced chills at night since the vaccination. The patient had no fever and no other reaction. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event chills at night was resolving at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Macule
Clinical narrative: Big red spot on arm; This is a spontaneous report from a contactable consumer. This consumer (patient's Mother) reported for a 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 08May2021 13:35 (Batch/Lot Number: EW0165; Expiration Date: 31Aug2021) as dose 2, single (at age of 17-years old) for covid-19 immunization. Medical history included ongoing anxiety. She has had anxiety forever since she was little. She has always been an anxious kid since she was 5 or 6. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for anxiety, start and stop date were not reported and reported as she has been on it for about a year. The patient previously took first dose of bnt162b2, Solution for injection, via an unspecified route of administration, administered in Arm Right on 17Apr2021 at 13:35 (Batch/Lot Number: ER8731; Expiration Date: 31Jul2021) as dose 1, single (at age of 17-years old) for covid-19 immunization. Both appointments were at the same time. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks) and no Adverse events following prior vaccinations. There was no family Medical History Relevant to AE(s). The patient experienced big red spot-on arm on 09May2021 20:00. It was reported that, Caller's daughter was 17, and she got the second shot of the Covid vaccine on Saturday. Last night she developed this big red spot on her arm like a big welt. She asks if that was normal. There was no Emergency Room/Physician Office visit. Relevant Tests was none. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased activity, Pain, Pain in extremity
Clinical narrative: Pain at vaccination site; Pain radiates down to pinky and up through next shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Interferes with activity 5-6 times a day; Waking me up 2 -3 times a night; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 53-years old) as a single dose for COVID-19 immunisation. Medical history included Non-Alcoholic Steatohepatitis (NASH), hay fever, Selective IgM deficiency (SIgMD) and fibromyalgia. The patient was allergic to narcotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 53-years old) at as a single dose for COVID-19 immunisation. On 09Mar2021, the patient experienced pain at vaccination site which was ongoing 2 months after shot. The pain radiated down to pinky and up through next, shoulder and upper back. The pain interfered with activity 5-6 times a day in addition to waking up 2 -3 times a night. Since the vaccination, the patient had been tested for COVID-19. On 28Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with unspecified muscle relaxants, chiropractic, massage and Nerve cal. The clinical outcome of the events pain at vaccination site, pain radiated down to pinky and up through next, shoulder and upper back, interfered with activity 5-6 times a day and waking up 2 -3 times a night  was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sleep disorder, Vaccination site pain
Clinical narrative: Pain at vaccination site; Pain radiates down to pinky and up through next shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Interferes with activity 5-6 times a day; Waking me up 2 -3 times a night; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 53-years old) as a single dose for COVID-19 immunisation. Medical history included Non-Alcoholic Steatohepatitis (NASH), hay fever, Selective IgM deficiency (SIgMD) and fibromyalgia. The patient was allergic to narcotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 53-years old) at as a single dose for COVID-19 immunisation. On 09Mar2021, the patient experienced pain at vaccination site which was ongoing 2 months after shot. The pain radiated down to pinky and up through next, shoulder and upper back. The pain interfered with activity 5-6 times a day in addition to waking up 2 -3 times a night. Since the vaccination, the patient had been tested for COVID-19. On 28Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with unspecified muscle relaxants, chiropractic, massage and Nerve cal. The clinical outcome of the events pain at vaccination site, pain radiated down to pinky and up through next, shoulder and upper back, interfered with activity 5-6 times a day and waking up 2 -3 times a night  was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia, Vertigo
Clinical narrative: chills; I had a fever; lethargic; I woke up with a severe case of vertigo; This is a spontaneous report from a contactable other-healthcare professional (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 02Mar2021 (at the age of 69-years -old) as dose 2, single for COVID-19 immunisation. The facility in which the vaccination administered was other. The patient medical history included sinusitis, tinnitus, hypertension, hypothyroidism, anxiety, food allergy (Shellfish), drug hypersensitivity (sulfa), drug hypersensitivity (penicillin's). The patient concomitant medications within 2 weeks included thyroid (ARMOUR THYROID): buspirone (BUSPIRONE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); cholecalciferol, menaquinone (D3 +K2). The patient did not receive any other vaccines within 4 weeks of vaccination. The patient previously took first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269), via an unspecified route of administration, in the right arm on 09Feb2021 10:00 as dose 1, single for COVID-19 immunisation, cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested COVID-19. On an unspecified date in Mar2021, the patient experienced I woke up with a severe case of vertigo. On 02Mar2021 chills, I had a fever, lethargic. Therapeutic measures were taken as a result of I woke up with a severe case of vertigo, chills, I had a fever, lethargic and included treatment with stimulation with a machine on my head. Patient stated that 3 weeks later, I woke up with a severe case of vertigo. For 5 days I could not be alone, needed help toileting, walking, bathing and was in bed. I went to an ENT and diagnosed me. I have been treated weekly by him with treatments for my head. To date, one month later. I still have symptoms and will be treated again tomorrow. I never had vertigo and it is truly debilitating. The events result in physician office visit. The clinical outcome of the event I woke up with a severe case of vertigo was not recovered. The clinical outcome of the events chills, I had a fever, lethargic was recovered on an unspecified date of 2021.  No follow-up attempts are required. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal dreams, Chills, Fatigue, Feeding disorder
Clinical narrative: Chills; Nausea; Stomach aches; Vomit; cannot eat very well without feeling disgusted; cannot eat very well without feeling disgusted; Fatigue; just feel like a hazy dream.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06May2021 at 02:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), lurasidone hydrochloride (LATUDA) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL); all taken for an unknown indication on an unknown date and unknown if ongoing. On 08Jan2021,the patient underwent lab test and procedures which included nasal swab test and the result was found to be negative. On 15Apr2021, the patient received unspecified "tinnitus shot" via an unspecified route of administration in the left arm within 4 weeks prior to the vaccination. On 07May2021 at 17:15, on the second day, the patient had chills, nausea, stomach aches and vomit until stomach acid was coming out. She could not eat very well without feeling disgusted but symptoms were kind of light now. She had nausea and fatigue for the past 5 days. On 11May2021 (day 6), the patient just felt like a hazy dream. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, nausea, stomach aches, vomit, cannot eat very well without feeling disgusted, fatigue and hazy dreams was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Food aversion, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Chills; Nausea; Stomach aches; Vomit; cannot eat very well without feeling disgusted; cannot eat very well without feeling disgusted; Fatigue; just feel like a hazy dream.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06May2021 at 02:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), lurasidone hydrochloride (LATUDA) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL); all taken for an unknown indication on an unknown date and unknown if ongoing. On 08Jan2021,the patient underwent lab test and procedures which included nasal swab test and the result was found to be negative. On 15Apr2021, the patient received unspecified "tinnitus shot" via an unspecified route of administration in the left arm within 4 weeks prior to the vaccination. On 07May2021 at 17:15, on the second day, the patient had chills, nausea, stomach aches and vomit until stomach acid was coming out. She could not eat very well without feeling disgusted but symptoms were kind of light now. She had nausea and fatigue for the past 5 days. On 11May2021 (day 6), the patient just felt like a hazy dream. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, nausea, stomach aches, vomit, cannot eat very well without feeling disgusted, fatigue and hazy dreams was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Some very light spotting occurred after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 19Apr2021 at 11:30 AM as dose 1, single for COVID-19 immunization. The patient medical history included breast cancer, high blood pressure, both from an unknown date and unknown if ongoing. The patient concomitant medications included tamoxifen 20 mg, lisinopril 2.5 mg, trazodone 50 mg, all drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took quinoa for drug allergy. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On an unspecified date in 2021, the patient experienced some very light spotting occurred after first dose. AE resulted in doctor or other healthcare professional office/clinic visit. Adverse event: Post-menopausal bleeding started occurring 2 days after 2nd dose. Some very light spotting occurred after first dose. I have not had a period in over a year. Due to taking Tamoxifen for breast cancer dx 4 years ago, I have scheduled an appointment with my OBGyn on 17May to be checked out. Treatment for the adverse event was unknown. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.