chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Swelling
Clinical narrative: HOT AND COLD FLASHES LIKE FEVER; SORE AT THE INJECTION SITE SORE THAT WON'T HEAL; MUSCLE AND JOINT PAIN; TINGLING; SWOLLEN ARMPITS; EXTREMELY OR SEVERE RIGHT SHOULDER PAIN; DIFFICULT TO MOVE; This spontaneous report received from a health care professional concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the patient experienced difficult to move. On 02-JUN-2021, the patient experienced extremely or severe right shoulder pain. On 09-JUN-2021, the patient experienced swollen armpits. On an unspecified date, the patient experienced hot and cold flashes like fever, sore at the injection site sore that won't heal, muscle and joint pain, and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes like fever, had not recovered from extremely or severe right shoulder pain, sore at the injection site sore that won't heal, muscle and joint pain, difficult to move, and tingling, and the outcome of swollen armpits was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: After the first shot, her arm hurt; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in 2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2021, after the first shot, the patient experienced pain in arm. Then, the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in May2021, at single dose, for COVID-19 immunisation. It was confirmed that the patient was fully vaccinated with the Pfizer Covid 19 vaccine in May2021, and since then, has experienced extreme arm pain. The adverse event was described as "extreme arm pain, both arms, after both vaccinations, felt like a needle was in her arm or like she was being punched over and over again. After the first shot, her arm hurt and then she used the opposite arm for the second shot, and that probably was not a good idea". She was treated with Tylenol and Advil for the pain, but both medications were not effective to help her pain. Clinical outcome of the adverse event was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first shot, her arm hurt; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in 2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2021, after the first shot, the patient experienced pain in arm. Then, the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in May2021, at single dose, for COVID-19 immunisation. It was confirmed that the patient was fully vaccinated with the Pfizer Covid 19 vaccine in May2021, and since then, has experienced extreme arm pain. The adverse event was described as "extreme arm pain, both arms, after both vaccinations, felt like a needle was in her arm or like she was being punched over and over again. After the first shot, her arm hurt and then she used the opposite arm for the second shot, and that probably was not a good idea". She was treated with Tylenol and Advil for the pain, but both medications were not effective to help her pain. Clinical outcome of the adverse event was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: After the first shot, her arm hurt; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in 2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2021, after the first shot, the patient experienced pain in arm. Then, the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in May2021, at single dose, for COVID-19 immunisation. It was confirmed that the patient was fully vaccinated with the Pfizer Covid 19 vaccine in May2021, and since then, has experienced extreme arm pain. The adverse event was described as "extreme arm pain, both arms, after both vaccinations, felt like a needle was in her arm or like she was being punched over and over again. After the first shot, her arm hurt and then she used the opposite arm for the second shot, and that probably was not a good idea". She was treated with Tylenol and Advil for the pain, but both medications were not effective to help her pain. Clinical outcome of the adverse event was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein increased, Full blood count normal, Gait disturbance
Clinical narrative: mild tightness in his hips; lower back pain; Right shoulder pain; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Tendinitis and Surgery.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain). The patient was treated with CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE ongoing since an unknown date for Adverse event, at a dose of 6 milligram. In 2021, ARTHRALGIA (Right shoulder pain) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips) and BACK PAIN (lower back pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. Patient treatment information include cortisone injection in the shoulder which helped and helped his hip & back too, but within 3 days all the pain came back.  A week later he later started on Dexamethasone 6mg & all symptoms improved & he was able to hike again. He has continued on steroids.   This case was linked to MOD-2021-330942 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Joint injection, Laboratory test, Metabolic function test normal
Clinical narrative: mild tightness in his hips; lower back pain; Right shoulder pain; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Tendinitis and Surgery.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain). The patient was treated with CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE ongoing since an unknown date for Adverse event, at a dose of 6 milligram. In 2021, ARTHRALGIA (Right shoulder pain) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips) and BACK PAIN (lower back pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. Patient treatment information include cortisone injection in the shoulder which helped and helped his hip & back too, but within 3 days all the pain came back.  A week later he later started on Dexamethasone 6mg & all symptoms improved & he was able to hike again. He has continued on steroids.   This case was linked to MOD-2021-330942 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Musculoskeletal discomfort, Polymyalgia rheumatica, Red blood cell sedimentation rate normal
Clinical narrative: mild tightness in his hips; lower back pain; Right shoulder pain; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Tendinitis and Surgery.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain). The patient was treated with CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE ongoing since an unknown date for Adverse event, at a dose of 6 milligram. In 2021, ARTHRALGIA (Right shoulder pain) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips) and BACK PAIN (lower back pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. Patient treatment information include cortisone injection in the shoulder which helped and helped his hip & back too, but within 3 days all the pain came back.  A week later he later started on Dexamethasone 6mg & all symptoms improved & he was able to hike again. He has continued on steroids.   This case was linked to MOD-2021-330942 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Musculoskeletal discomfort
Clinical narrative: mild tightness in his hips; lower back pain; Right shoulder pain; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Tendinitis and Surgery.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips), BACK PAIN (lower back pain) and ARTHRALGIA (Right shoulder pain). The patient was treated with CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE ongoing since an unknown date for Adverse event, at a dose of 6 milligram. In 2021, ARTHRALGIA (Right shoulder pain) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (mild tightness in his hips) and BACK PAIN (lower back pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. Patient treatment information include cortisone injection in the shoulder which helped and helped his hip & back too, but within 3 days all the pain came back.  A week later he later started on Dexamethasone 6mg & all symptoms improved & he was able to hike again. He has continued on steroids.   This case was linked to MOD-2021-330942 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oedema genital, Rash
Clinical narrative: inflammation and rash in genital area; inflammation and rash in genital area and a skin rash on his whole body; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Jul2021 (age at vaccination: 27 Years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced inflammation and rash in genital area on 29Jul2021 with outcome of not recovered, inflammation and rash in genital area and a skin rash on his whole body on 29Jul2021.The patient underwent lab tests and procedures which included blood test: clean on unspecified date. Therapeutic measures were taken as a result of inflammation and rash in genital area, inflammation and rash in genital area and a skin rash on his whole body was Benadryl for 2 weeks it was not working limited information was provided by the caller. The outcome of the events inflammation, rash was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Inflammation, Rash
Clinical narrative: inflammation and rash in genital area; inflammation and rash in genital area and a skin rash on his whole body; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Jul2021 (age at vaccination: 27 Years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced inflammation and rash in genital area on 29Jul2021 with outcome of not recovered, inflammation and rash in genital area and a skin rash on his whole body on 29Jul2021.The patient underwent lab tests and procedures which included blood test: clean on unspecified date. Therapeutic measures were taken as a result of inflammation and rash in genital area, inflammation and rash in genital area and a skin rash on his whole body was Benadryl for 2 weeks it was not working limited information was provided by the caller. The outcome of the events inflammation, rash was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUA3, UNK
Symptoms: Erythema, Peripheral swelling, Poor quality sleep, Pruritus
Clinical narrative: Restless sleep; Right arm is red; Right arm is swollen; Patient has head to toe itching; This spontaneous case was retrieved on 20-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1675023-1), reported by other health professional and concerned a 73-year-old, female patient.  The patient's medical history included congestive heart failure (CHF), coronary artery disease (CAD), hypertension, subclavian steal syndrome and allergy to Percocet (oxycodone / paracetamol), tramadol, meloxicam and morphine. The patient's concomitant medications included Plavix (clopidogrel bisulfate) used for an unknown indication, and the rest of concomitant medications were unknown.  On 02-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was 312841.  On the same day, the patient was vaccinated with non-company co-suspect Pfizer-Biontech Covid19 vaccine (Covid19 vaccine; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was FC3182.  On 04-Sep-2021, two days after receiving Fluad Quadrivalent and non-company co-suspect Pfizer-Biontech Covid19 vaccine, the patient experienced head to toe itching, her right arm was swollen and red, and she had restless sleep.   At the time of the initial reporting, the patient had not recovered from events.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 73-year-old, female patient experienced generalized pruritus, swollen and erythematous right arm, and restless sleep two days after vaccination with the suspect product Fluad Quadrivalent and non-company co-suspect Pfizer-Biontech COVID-19 vaccine. Causality for poor quality sleep is unassessable. Causality is confounded by concurrent administration of co-suspect vaccine. Nevertheless, causality could not be ruled out and is therefore assessed as possibly related for all other events.; Sender's Comments: A 73-year-old, female patient experienced generalized pruritus, swollen and erythematous right arm, and restless sleep two days after vaccination with the suspect product Fluad Quadrivalent and non-company co-suspect Pfizer-Biontech COVID-19 vaccine. Causality for poor quality sleep is unassessable. Causality is confounded by concurrent administration of co-suspect vaccine. Nevertheless, causality could not be ruled out and is therefore assessed as possibly related for all other events.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Livedo reticularis, Rash, Rash erythematous, Rash pruritic, Skin discolouration
Clinical narrative: Red itchy rash - Chest, Shoulders, legs; Generalized urticaria - Chest, legs; Generalized pruritus with skin rash - Chest, legs; Difficulty breathing; This is a spontaneous report from a contactable pharmacist (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number ZL3249 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 27Jan2021 13:00, as dose 1, single, for COVID-19 immunisation. Medical history included Sulfa allergy and tree nuts allergy. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and keflex [cefalexin monohydrate] and experienced allergy. Patient was not taking any medications prior to the event being reported. Patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On morning of 02Feb2021, red rash appeared in chest, had red itchy rash in chest, shoulders, legs. The patient also experienced generalized urticaria in chest and legs and generalized pruritus with skin rash in chest and legs on 02Feb2021. On an unspeciifedd ate in Feb2021, the patient had breathing difficulty. The patient was treated with corticosteroids. On 06Feb2021 with Solumedrol injection and prednisone for 6 days and then was treated with Medrol injection and Medrol on an unspecified date. Patient was not seen in emergency department and was not hospitalized. The outcome for the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship the causal role of  bnt162b2 vaccine cannot be excluded for reported events.  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
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: Red itchy rash - Chest, Shoulders, legs; Generalized urticaria - Chest, legs; Generalized pruritus with skin rash - Chest, legs; Difficulty breathing; This is a spontaneous report from a contactable pharmacist (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number ZL3249 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 27Jan2021 13:00, as dose 1, single, for COVID-19 immunisation. Medical history included Sulfa allergy and tree nuts allergy. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and keflex [cefalexin monohydrate] and experienced allergy. Patient was not taking any medications prior to the event being reported. Patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On morning of 02Feb2021, red rash appeared in chest, had red itchy rash in chest, shoulders, legs. The patient also experienced generalized urticaria in chest and legs and generalized pruritus with skin rash in chest and legs on 02Feb2021. On an unspeciifedd ate in Feb2021, the patient had breathing difficulty. The patient was treated with corticosteroids. On 06Feb2021 with Solumedrol injection and prednisone for 6 days and then was treated with Medrol injection and Medrol on an unspecified date. Patient was not seen in emergency department and was not hospitalized. The outcome for the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship the causal role of  bnt162b2 vaccine cannot be excluded for reported events.  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
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Red itchy rash - Chest, Shoulders, legs; Generalized urticaria - Chest, legs; Generalized pruritus with skin rash - Chest, legs; Difficulty breathing; This is a spontaneous report from a contactable pharmacist (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number ZL3249 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 27Jan2021 13:00, as dose 1, single, for COVID-19 immunisation. Medical history included Sulfa allergy and tree nuts allergy. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and keflex [cefalexin monohydrate] and experienced allergy. Patient was not taking any medications prior to the event being reported. Patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On morning of 02Feb2021, red rash appeared in chest, had red itchy rash in chest, shoulders, legs. The patient also experienced generalized urticaria in chest and legs and generalized pruritus with skin rash in chest and legs on 02Feb2021. On an unspeciifedd ate in Feb2021, the patient had breathing difficulty. The patient was treated with corticosteroids. On 06Feb2021 with Solumedrol injection and prednisone for 6 days and then was treated with Medrol injection and Medrol on an unspecified date. Patient was not seen in emergency department and was not hospitalized. The outcome for the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship the causal role of  bnt162b2 vaccine cannot be excluded for reported events.  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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood test, Chest X-ray normal, Chest pain
Clinical narrative: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram ambulatory, Electrocardiogram normal, Heart rate decreased
Clinical narrative: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myocardial infarction, Ocular discomfort, Palpitations
Clinical narrative: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest X-ray normal, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate, Hypertension, Hypoaesthesia, Myocardial infarction
Clinical narrative: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ocular discomfort, Pain in extremity, Palpitations, Paraesthesia, Presyncope
Clinical narrative: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulse abnormal, Vertigo
Clinical narrative: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sensitive skin, Sensory disturbance
Clinical narrative: Mental fog (diminishing with time); Arm pain (continued sensitivity); Heart pounding; elevated BP woke the patient up in the middle of the night; Muscle cramps (legs); Occasional unusually sensitivity to cold; This is a spontaneous report from a contactable consumer patient (reported for himself).  A 64-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left (age at vaccination: 64 years) on Sep2021 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history includes allergies to raw eggs, long ago. May not be the case today. Patient had not tested for this and do not plan consuming. Relevant concurrent conditions was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included zinc taken for an unspecified indication, start and stop date were not reported but being received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported event was several, patient had a PDF for each one submitted to VAERS. On 01Sep2021 at 07:00, the patient experienced arm pain (continued sensitivity), heart pounding/elevated BP woke the patient up in the middle of the night,  mental fog (diminishing with time),  muscle cramps (legs), occasional unusually sensitivity to cold. Patient was scheduled for the second dose and needs a definitive go/no-go based on your experience. Medical professional education in this area is very poor. No treatment received. No hospitalization or prolongation. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures that includes COVID test BinaxNow Nasal Swab with result negative on 20Aug2021. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.