chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss in the right ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the second COVID-19 shot and had developed hearing loss in the right ear on an unspecified date. The patient was trying to get information on this effect. The patient asked if the company had any data on hearing loss, duration, remedy, etc. The patient also advised to feel free to contact him/her to help the patient and/or use him/her to help others. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Joint stiffness, Migraine
Clinical narrative: Patient experienced vertigo and nausea after returning home following receiving the vaccine.  Arm swelled noticeably and stayed swollen for 14 days.  Three days after the vaccine administration she developed a large bump on the back of her head, which her doctor told her was a swollen lymph node.  She experienced nausea for up to 9 days after receiving the vaccine..  She currently is being evaluated for a rheumatoid condition due to chronic joint pain, which she has had for an unspecified time prior to receiving the vaccine.  According to the patient her doctor considers this an immune reaction to the shot, possibly related to an overactive immune condition.  Today, 29 days after receiving the vaccine the patient says she has recovered completely but her doctor recommends she not receive the second shot.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash, Skin burning sensation
Clinical narrative: Patient experienced vertigo and nausea after returning home following receiving the vaccine.  Arm swelled noticeably and stayed swollen for 14 days.  Three days after the vaccine administration she developed a large bump on the back of her head, which her doctor told her was a swollen lymph node.  She experienced nausea for up to 9 days after receiving the vaccine..  She currently is being evaluated for a rheumatoid condition due to chronic joint pain, which she has had for an unspecified time prior to receiving the vaccine.  According to the patient her doctor considers this an immune reaction to the shot, possibly related to an overactive immune condition.  Today, 29 days after receiving the vaccine the patient says she has recovered completely but her doctor recommends she not receive the second shot.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Incomplete course of vaccination, Lymphadenopathy, Nausea, Peripheral swelling
Clinical narrative: Patient experienced vertigo and nausea after returning home following receiving the vaccine.  Arm swelled noticeably and stayed swollen for 14 days.  Three days after the vaccine administration she developed a large bump on the back of her head, which her doctor told her was a swollen lymph node.  She experienced nausea for up to 9 days after receiving the vaccine..  She currently is being evaluated for a rheumatoid condition due to chronic joint pain, which she has had for an unspecified time prior to receiving the vaccine.  According to the patient her doctor considers this an immune reaction to the shot, possibly related to an overactive immune condition.  Today, 29 days after receiving the vaccine the patient says she has recovered completely but her doctor recommends she not receive the second shot.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Vertigo
Clinical narrative: Patient experienced vertigo and nausea after returning home following receiving the vaccine.  Arm swelled noticeably and stayed swollen for 14 days.  Three days after the vaccine administration she developed a large bump on the back of her head, which her doctor told her was a swollen lymph node.  She experienced nausea for up to 9 days after receiving the vaccine..  She currently is being evaluated for a rheumatoid condition due to chronic joint pain, which she has had for an unspecified time prior to receiving the vaccine.  According to the patient her doctor considers this an immune reaction to the shot, possibly related to an overactive immune condition.  Today, 29 days after receiving the vaccine the patient says she has recovered completely but her doctor recommends she not receive the second shot.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: seizure one week after second vaccine; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Apr2021 at 11:00 as single dose for COVID-19 immunisation at the age of 39-year-old. Medical history was unknown and concomitant medications included ibuprofen (ADVIL), mometasone furoate (FLONASE). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 for COVID-19 immunisation at the age of 39-year-old. On 11Apr2021, the patient experienced seizure; the patient was treated for the event. On unknown date, the patient underwent Computerised tomogram, Electroencephalogram, Magnetic resonance imaging (results unknown). The patient was recovering from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Magnetic resonance imaging, Seizure
Clinical narrative: seizure one week after second vaccine; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Apr2021 at 11:00 as single dose for COVID-19 immunisation at the age of 39-year-old. Medical history was unknown and concomitant medications included ibuprofen (ADVIL), mometasone furoate (FLONASE). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 for COVID-19 immunisation at the age of 39-year-old. On 11Apr2021, the patient experienced seizure; the patient was treated for the event. On unknown date, the patient underwent Computerised tomogram, Electroencephalogram, Magnetic resonance imaging (results unknown). The patient was recovering from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pulmonary embolism, Thromboembolectomy
Clinical narrative: DIZZY; PULMONARY EMBOLISM; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1201922) concerned a 69 year old male. The patient's weight, height, and medical history were not reported. The patient did not have any events following vaccines previously.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered in the left arm on 08-MAR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the patient became dizzy and was taken to the hospital by an ambulance. On 28-MAR-2021 9:30, the patient was diagnosed with pulmonary embolism and was hospitalized. The patient had a thromboembolectomy to remove clots and had tissue plasminogen activator (TPA). The patient was put on blood thinner apixaban (Eliquis).  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the pulmonary embolism and dizzy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: This case received via VAERS (VAERS ID 1201922) concerns a 69 year old male patient who was hospitalized for life-threatening pulmonary embolism after feeling dizzy 20 days after receiving the Janssen Covid-19 vaccine. Medical history, family history, social history, and concomitant medications were not reported. He reported being taken to the hospital by ambulance. Thromboembolectomy to remove clots with tissue plasminogen activator was performed. Information regarding diagnostic testing (e.g. ultrasounds, CT scans, blood tests) were not reported. Corrective treatment also included apixaban. Outcome was unknown. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) will be sought when contact information becomes available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pulmonary embolism
Clinical narrative: DIZZY; PULMONARY EMBOLISM; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1201922) concerned a 69 year old male. The patient's weight, height, and medical history were not reported. The patient did not have any events following vaccines previously.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered in the left arm on 08-MAR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the patient became dizzy and was taken to the hospital by an ambulance. On 28-MAR-2021 9:30, the patient was diagnosed with pulmonary embolism and was hospitalized. The patient had a thromboembolectomy to remove clots and had tissue plasminogen activator (TPA). The patient was put on blood thinner apixaban (Eliquis).  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the pulmonary embolism and dizzy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: This case received via VAERS (VAERS ID 1201922) concerns a 69 year old male patient who was hospitalized for life-threatening pulmonary embolism after feeling dizzy 20 days after receiving the Janssen Covid-19 vaccine. Medical history, family history, social history, and concomitant medications were not reported. He reported being taken to the hospital by ambulance. Thromboembolectomy to remove clots with tissue plasminogen activator was performed. Information regarding diagnostic testing (e.g. ultrasounds, CT scans, blood tests) were not reported. Corrective treatment also included apixaban. Outcome was unknown. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) will be sought when contact information becomes available.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Lymphadenopathy, Pharyngeal swelling, Pyrexia, Rash
Clinical narrative: I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Skin warm
Clinical narrative: I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Body temperature, Body temperature increased, Burning sensation, Condition aggravated
Clinical narrative: I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Fatigue, Insomnia, Oropharyngeal pain, Pain
Clinical narrative: I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash, Skin exfoliation, Swelling
Clinical narrative: I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: MIGRAINE; DIFFICULTY BREATHING; SWEATING; CHEST PAIN; BACK PAIN; LUNG PAIN; LETHARGY; SLEEPY ALL DAY; WEAKNESS; JOINT PAIN; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy, sleepy all day, weakness, joint pain, muscle pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, migraine, joint pain, nausea, muscle pain, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy and sleepy all day was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Nervousness, Somnolence
Clinical narrative: MIGRAINE; DIFFICULTY BREATHING; SWEATING; CHEST PAIN; BACK PAIN; LUNG PAIN; LETHARGY; SLEEPY ALL DAY; WEAKNESS; JOINT PAIN; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy, sleepy all day, weakness, joint pain, muscle pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, migraine, joint pain, nausea, muscle pain, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy and sleepy all day was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chest pain, Dyspnoea
Clinical narrative: MIGRAINE; DIFFICULTY BREATHING; SWEATING; CHEST PAIN; BACK PAIN; LUNG PAIN; LETHARGY; SLEEPY ALL DAY; WEAKNESS; JOINT PAIN; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy, sleepy all day, weakness, joint pain, muscle pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, migraine, joint pain, nausea, muscle pain, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy and sleepy all day was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Lethargy, Migraine, Myalgia, Nausea
Clinical narrative: MIGRAINE; DIFFICULTY BREATHING; SWEATING; CHEST PAIN; BACK PAIN; LUNG PAIN; LETHARGY; SLEEPY ALL DAY; WEAKNESS; JOINT PAIN; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy, sleepy all day, weakness, joint pain, muscle pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, migraine, joint pain, nausea, muscle pain, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy and sleepy all day was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary pain, Somnolence
Clinical narrative: MIGRAINE; DIFFICULTY BREATHING; SWEATING; CHEST PAIN; BACK PAIN; LUNG PAIN; LETHARGY; SLEEPY ALL DAY; WEAKNESS; JOINT PAIN; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy, sleepy all day, weakness, joint pain, muscle pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, migraine, joint pain, nausea, muscle pain, difficulty breathing, sweating, chest pain, back pain, lung pain, lethargy and sleepy all day was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis bullous, Injection site rash, Rash, Rash maculo-papular, Rash vesicular
Clinical narrative: Rash on arms (Slightly Bullous), and hives spread across upper torso-arms
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash on arms (Slightly Bullous), and hives spread across upper torso-arms
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: bilateral numbness in her arms; This is a spontaneous report from a contactable consumer (patient). A 47 (unit of measure not reported) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 05Apr2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 06Apr2021, the patient had bilateral numbness in her arms and it continues. The patient went to the ER, a neurologist and internist and no one has an answer. The event was assessed as serious (hospitalization). Outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient's husband). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 (lot number: ER8733) at the age of 46 years old, as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included desogestrel, ethinylestradiol (ISIBLOOM) taken for birth control from an unspecified start date and ongoing. On Saturday, 10Apr2021, she was fine, but she had some pain on the left side of her body. On Sunday (11Apr2021), the pain was much "much" worse, and her breathing was affected. On Monday (12Apr2021), she had the same symptoms and was taken to the Emergency Department for her problems breathing. On 13Apr2021, she had blood clots, 2 of them in both lungs. She is on pain medication and it is improving for her. The only medication she is taking is birth control pills.  She has been taking them for years with no complications. The reporter added not long ago, she was in the doctor for a physical and all was fine. The patient was hospitalized due to the events and was still admitted. The events resulted in emergency room visit. The patient was recovering from the events. Event assessment by the reporter for the events blood clot in both lungs, problem breathing and left side pain was reported as related to the Pfizer COVID-19 vaccine. Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain, Pulmonary thrombosis
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient's husband). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 (lot number: ER8733) at the age of 46 years old, as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included desogestrel, ethinylestradiol (ISIBLOOM) taken for birth control from an unspecified start date and ongoing. On Saturday, 10Apr2021, she was fine, but she had some pain on the left side of her body. On Sunday (11Apr2021), the pain was much "much" worse, and her breathing was affected. On Monday (12Apr2021), she had the same symptoms and was taken to the Emergency Department for her problems breathing. On 13Apr2021, she had blood clots, 2 of them in both lungs. She is on pain medication and it is improving for her. The only medication she is taking is birth control pills.  She has been taking them for years with no complications. The reporter added not long ago, she was in the doctor for a physical and all was fine. The patient was hospitalized due to the events and was still admitted. The events resulted in emergency room visit. The patient was recovering from the events. Event assessment by the reporter for the events blood clot in both lungs, problem breathing and left side pain was reported as related to the Pfizer COVID-19 vaccine. Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood pressure decreased, Computerised tomogram, Magnetic resonance imaging, Vertigo
Clinical narrative: vertigo; Severe blood pressure drop; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 22Mar2021 at 16:00 (Lot Number: EN6206) (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis, gastrooesophageal reflux disease (GERD), iodine allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and pantoprazole sodium sesquihydrate (PROTONIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe blood pressure drop on 24Mar2021 at 07:00 and vertigo on 26Mar2021, which caused hospitalization from 27Mar2021 to 03Apr2021 for 7 days. It was reported that the severe blood pressure drop occurred two days after vaccination and two days later, vertigo occurred. The patient underwent lab tests and procedures which included blood pressure: drop on 24Mar2021, COVID PCR (nasal swab): negative on 29Mar2021, and COVID PCR (blood test): negative on 04Apr2021. Therapeutic measures were taken as a result of the events, which included unspecified blood pressure medication, unspecified vertigo medication, and intravenous (IV) fluids. The clinical outcome of severe blood pressure drop and vertigo was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, SARS-CoV-2 test, Vertigo
Clinical narrative: vertigo; Severe blood pressure drop; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 22Mar2021 at 16:00 (Lot Number: EN6206) (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis, gastrooesophageal reflux disease (GERD), iodine allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and pantoprazole sodium sesquihydrate (PROTONIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe blood pressure drop on 24Mar2021 at 07:00 and vertigo on 26Mar2021, which caused hospitalization from 27Mar2021 to 03Apr2021 for 7 days. It was reported that the severe blood pressure drop occurred two days after vaccination and two days later, vertigo occurred. The patient underwent lab tests and procedures which included blood pressure: drop on 24Mar2021, COVID PCR (nasal swab): negative on 29Mar2021, and COVID PCR (blood test): negative on 04Apr2021. Therapeutic measures were taken as a result of the events, which included unspecified blood pressure medication, unspecified vertigo medication, and intravenous (IV) fluids. The clinical outcome of severe blood pressure drop and vertigo was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Ear pain, Hypoaesthesia
Clinical narrative: her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; half of her face is numb; ear infection; Bell's palsy/face droopiness; Ear ache/Ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734 and expiration date not provided), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) first dose on 01Apr2021 10:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Multivitamin at 2 gummies once a day for immune support, bone support, and health reasons. The patient historical vaccine includes flu shot and experienced sore arm. On 03Apr2021, the patient stated that two days after the vaccine the patient experienced earache, went to the ED (emergency department) this Sunday diagnosed bell's palsy. On 11Apr2021, the patient experienced ear pain that she thought was an earache or ear infection, then she went to the ER because she woke up with half of her face numb. She says she was diagnosed with Bell's Palsy and she did some research. She says during the trials people did get Bell's palsy but they didn't know if it was connected to the vaccine. She says she is reporting it and she wants to get more information, she's due to get the second dose next Thursday. She says it was a mild case but she was concerned it will come back and come back worse. She says she has a meeting at 3 pm and it is currently 2:13 pm where she lives. The patient stated that now she was left with the face stuff, the face droopiness. The patient was still taking the Bell's Palsy medications every day, she thinks she is getting better. She says about her face being numb she woke up and felt it in her mouth, her lip, her right eye was not cooperating, there was a very noticeable difference between both of her eyes. She says she went to the ER where they did a couple of tests to see if it was a stroke or something else, they didn't do any imaging, with what they aw on her face and the way they were testing the conclusion was Bell's Palsy. She says she saw her primary care physician today because she needed to follow up and it looks like a mild case of Bell's Palsy. She says her face is getting better with medications. She says she is taking Prednisone 60 mg a day for 7 days. She is also taking Valacyclovir 1000 mg 3 times, she clarifies it says to take 1 tablet 1000 mg total 3 times a day by mouth.  The events prompted the patient to Emergency room visit and physician office visit. The outcome of the event facial paralysis, hypoaesthesia was recovering.  The outcome of the event ear pain was Recovered with Sequel on 11Apr2021. The outcome of the remaining events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Lip disorder, Oral disorder
Clinical narrative: her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; half of her face is numb; ear infection; Bell's palsy/face droopiness; Ear ache/Ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734 and expiration date not provided), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) first dose on 01Apr2021 10:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Multivitamin at 2 gummies once a day for immune support, bone support, and health reasons. The patient historical vaccine includes flu shot and experienced sore arm. On 03Apr2021, the patient stated that two days after the vaccine the patient experienced earache, went to the ED (emergency department) this Sunday diagnosed bell's palsy. On 11Apr2021, the patient experienced ear pain that she thought was an earache or ear infection, then she went to the ER because she woke up with half of her face numb. She says she was diagnosed with Bell's Palsy and she did some research. She says during the trials people did get Bell's palsy but they didn't know if it was connected to the vaccine. She says she is reporting it and she wants to get more information, she's due to get the second dose next Thursday. She says it was a mild case but she was concerned it will come back and come back worse. She says she has a meeting at 3 pm and it is currently 2:13 pm where she lives. The patient stated that now she was left with the face stuff, the face droopiness. The patient was still taking the Bell's Palsy medications every day, she thinks she is getting better. She says about her face being numb she woke up and felt it in her mouth, her lip, her right eye was not cooperating, there was a very noticeable difference between both of her eyes. She says she went to the ER where they did a couple of tests to see if it was a stroke or something else, they didn't do any imaging, with what they aw on her face and the way they were testing the conclusion was Bell's Palsy. She says she saw her primary care physician today because she needed to follow up and it looks like a mild case of Bell's Palsy. She says her face is getting better with medications. She says she is taking Prednisone 60 mg a day for 7 days. She is also taking Valacyclovir 1000 mg 3 times, she clarifies it says to take 1 tablet 1000 mg total 3 times a day by mouth.  The events prompted the patient to Emergency room visit and physician office visit. The outcome of the event facial paralysis, hypoaesthesia was recovering.  The outcome of the event ear pain was Recovered with Sequel on 11Apr2021. The outcome of the remaining events was unknown.