chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expiration date. it appears that vaccine was given 3 days after expiration date; No adverse reaction after vaccination
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expiration date. it appears that vaccine was given 3-5 days after expiration date; No adverse reaction after vaccination
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expiration date. it appears that vaccine was given 3-5 days after expiration date; No adverse reaction after vaccination
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expiration date. it appears that vaccine was given 3-5 days after expiration date; No adverse reaction after vaccination
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Headache, Myalgia, CHILLS, BODY ACHES, HEADACHE Narrative:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Headache, Fever, FEVER, HEADACHE, CHILLS, INJECTION SITE PAIN Narrative:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Tachycardia,  Chills, ShOB, Redness and swelling at injection site Narrative:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Sedation, Tachycardia
Clinical narrative: Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Tachycardia,  Chills, ShOB, Redness and swelling at injection site Narrative:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Tachycardia,  Chills, ShOB, Redness and swelling at injection site Narrative:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Myalgia FATIGUE Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizziness, Headache, Myalgia, chills, no fever Narrative:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Nausea, Paranasal sinus discomfort
Clinical narrative: Dizziness, Headache, NauseaVomiting, Lightheaded Narrative:  Patient was given 2nd Moderna Booster. Immediately he started to complain of being lightheaded, dizzy with nausea and some pressure in his sinus area. He stayed in the clinic room for approx an hour with none of the symptoms resolving. VS's were taken- 130/92, HR 99, and O2 sat 96%. He had no airway difficulties, no slurred speach or trouble with vision notted. I contacted his PCP, who was out of office for the day. I then contacted a nurse for the team, LVN to see who would be able to see the patient as a walk in. She spoke with Dr. who suggested the patient go to the ER so in the event his condition worsened they would be able to care for him appropriately. I spoke with the patient about this suggestion and that I would need to call 911 for an ER visit and he declined. Stated he did not feel bad enough to go to an ER and would prefer to go home. He left the COVID clinic in no distress per steady gait ambulation to go discuss the situation with his supervisor.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness, Headache, NauseaVomiting, Lightheaded Narrative:  Patient was given 2nd Moderna Booster. Immediately he started to complain of being lightheaded, dizzy with nausea and some pressure in his sinus area. He stayed in the clinic room for approx an hour with none of the symptoms resolving. VS's were taken- 130/92, HR 99, and O2 sat 96%. He had no airway difficulties, no slurred speach or trouble with vision notted. I contacted his PCP, who was out of office for the day. I then contacted a nurse for the team, LVN to see who would be able to see the patient as a walk in. She spoke with Dr. who suggested the patient go to the ER so in the event his condition worsened they would be able to care for him appropriately. I spoke with the patient about this suggestion and that I would need to call 911 for an ER visit and he declined. Stated he did not feel bad enough to go to an ER and would prefer to go home. He left the COVID clinic in no distress per steady gait ambulation to go discuss the situation with his supervisor.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, FATIGUE, MUSCLE/JOINT PAIN, HEADACHE Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning mouth syndrome, Dysgeusia, Myalgia, Neuropathy peripheral, Pyrexia
Clinical narrative: Sedation, Myalgia, Fever, neuropathy flare up bilateral arms. Metallic taste then burning mouth syndrome Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sedation
Clinical narrative: Sedation, Myalgia, Fever, neuropathy flare up bilateral arms. Metallic taste then burning mouth syndrome Narrative:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: Confusion, Myalgia, Diarrhea, Brain FOG, CRAMPING, MUSCLE PAIN, FATIGUE, INJECTION SITE PAIN, DIARRHEA Narrative:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Confusion, Myalgia, Diarrhea, Brain FOG, CRAMPING, MUSCLE PAIN, FATIGUE, INJECTION SITE PAIN, DIARRHEA Narrative:
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Gait disturbance, Herpes zoster
Clinical narrative: Patient experienced loss of vision, trouble walking, and developed shingles as an immune response. The patient did not report the manufacturer or dates of vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pfizer Booster shot (#3). Fever, chills, swollen armpit on injection arm, aches and pains from jaw to toes
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: I was doing dishes and all of a sudden my left ear started ringing and then was followed by decreased hearing. Ringing occurs intermittently but 2 days later I have not recovered me full hearing back.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Tachycardia
Clinical narrative: my arm was sore; Fever; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6200) via intramuscular route of administration, administered in arm right on 11Mar2021 08:00 as dose 2, single for COVID-19 immunization (Urgent Care Center). Medical history included obesity, depression, and generalised anxiety disorder from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL), metformin, amoxicillin trihydrate, clavulanic acid (CLAVATIN), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO) and ascorbic acid, biotin, folic acid, iodine, nicotinic acid, omega-3 fatty acids, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin b12 nos, vitamin e nos (PRENATAL + DHA) all were taken for an unspecified indication and start and stop date were not reported for them. Prior vaccination the patient received TDAP (Sanofi, Batch/Lot# C5735AA, Left arm) on 25Feb2021 for an unspecified indication. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9269) via an intramuscular route of administration, administered in arm left on 17Feb2021 03:30 as dose 1, single for COVID-19 immunization. The patient had not received vaccine administered at military facility. On an unspecified date, the patient experienced my arm was sore, fever and headache. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: my arm was sore; Fever; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6200) via intramuscular route of administration, administered in arm right on 11Mar2021 08:00 as dose 2, single for COVID-19 immunization (Urgent Care Center). Medical history included obesity, depression, and generalised anxiety disorder from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL), metformin, amoxicillin trihydrate, clavulanic acid (CLAVATIN), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO) and ascorbic acid, biotin, folic acid, iodine, nicotinic acid, omega-3 fatty acids, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin b12 nos, vitamin e nos (PRENATAL + DHA) all were taken for an unspecified indication and start and stop date were not reported for them. Prior vaccination the patient received TDAP (Sanofi, Batch/Lot# C5735AA, Left arm) on 25Feb2021 for an unspecified indication. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9269) via an intramuscular route of administration, administered in arm left on 17Feb2021 03:30 as dose 1, single for COVID-19 immunization. The patient had not received vaccine administered at military facility. On an unspecified date, the patient experienced my arm was sore, fever and headache. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: very slightly swollen lip/swelling in her top lip; This is a spontaneous report from a contactable Consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FA7484) via an unspecified route of administration, administered at Arm Right on 27Jul2021 at 13:15 (age at vaccination was 20 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications reported as none. Caller is a 20-year-old female patient who received the first dose of the Pfizer COVID-19 vaccine on Tuesday 27Jul2021 at around 13:15. On Wednesday 28Jul2021 she reports having a "very slightly swollen lip" when she first woke up and her lip is like pretty noticeably swollen. She did not notice any swelling of her lips the day she received the vaccine. She stated that the swelling is worse today and has "not gone down yet." No other areas of her mouth, throat, tongue or face are swollen. Patient spoked to Withheld, and they said she is probably having an allergic reaction and that she should call to report it to Pfizer. Patient was wondering if this is a side effect of the product or maybe an allergic reaction. Patient asked if she should receive the second dose of the Pfizer COVID-19 vaccine after having this type of reaction to the first dose. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Lip and tongue swelling; Lip and tongue swelling; Tongue, mouth and throat numbness and tingling; Tongue, mouth and throat numbness and tingling; Tongue, mouth and throat numbness and tingling; tingling; This is a spontaneous report from a contactable consumer (Patient). A 37-years-old non-pregnant female patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: Ew0177), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 10:00 AM as DOSE 1, SINGLE for covid-19 immunisation (at the age of 37 Years). Medical history includes Hypothyroidism from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Patient was having Known allergies Sulfa, penicillin, imitrex, shellfish, cinnamon oil. Patient had Lyrica, levoxyl, sertraline,cyclobenzaprine in two week. On 02Aug2021 at 10:00 AM patient experienced Lip and tongue swelling and Tongue, mouth and throat numbness and tingling. Treatment was received for the events as was Self medicated with Benadryl. The outcome for the events was recovered in 2021.   Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia, Pharyngeal hypoaesthesia, Swollen tongue
Clinical narrative: Lip and tongue swelling; Lip and tongue swelling; Tongue, mouth and throat numbness and tingling; Tongue, mouth and throat numbness and tingling; Tongue, mouth and throat numbness and tingling; tingling; This is a spontaneous report from a contactable consumer (Patient). A 37-years-old non-pregnant female patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: Ew0177), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 10:00 AM as DOSE 1, SINGLE for covid-19 immunisation (at the age of 37 Years). Medical history includes Hypothyroidism from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Patient was having Known allergies Sulfa, penicillin, imitrex, shellfish, cinnamon oil. Patient had Lyrica, levoxyl, sertraline,cyclobenzaprine in two week. On 02Aug2021 at 10:00 AM patient experienced Lip and tongue swelling and Tongue, mouth and throat numbness and tingling. Treatment was received for the events as was Self medicated with Benadryl. The outcome for the events was recovered in 2021.   Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Headache
Clinical narrative: I had heart palpitations; severe migraine headaches; Photophobia; noise sensitivity; vision issues; dizziness; tachycardia; I was diagnosed with a PFO in my heart; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a hospital facility on 16Aug2021 13:00 (Batch/Lot number was not reported) (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. There were no relevant medical history and concomitant medications. The patient had no known allergies. On 18Aug2021 at 01:00 PM, the patient had heart palpitations and severe migraine headaches that have lasted for months. The severity of the migraines has increased over time and have become debilitating. Photophobia, noise sensitivity, vision issues, dizziness, tachycardia, etc. The patient was in the emergency room (ER) 3 times after the vaccine. The patient had brain magnetic resonance imagings (MRIs) and electrocardiogram (EKGs and ECGs), blood tests and nothing bad was found on unspecified date in Aug2021. The patient was diagnosed with a patent foramen ovale (PFO) in his heart through a transesophageal echocardiogram (TEE). The patient believes that the clotting risks of Covid/covid vaccine and the PFO (increased risk of blood clots reaching your brain) are what is causing the migraines. And that somehow the vaccine triggered something with the PFO. Patient have over $5000 in out-of-pocket medical bills now. The patient received the second vaccination of bnt162b2, intramuscular on 09Sep2021 04:00 PM. The patient had a covid test (nasal swab: RT-PCR at least 5-6 times on 31Oct2021 which showed negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as serious due to disability or permanent damage. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: I had heart palpitations; severe migraine headaches; Photophobia; noise sensitivity; vision issues; dizziness; tachycardia; I was diagnosed with a PFO in my heart; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a hospital facility on 16Aug2021 13:00 (Batch/Lot number was not reported) (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. There were no relevant medical history and concomitant medications. The patient had no known allergies. On 18Aug2021 at 01:00 PM, the patient had heart palpitations and severe migraine headaches that have lasted for months. The severity of the migraines has increased over time and have become debilitating. Photophobia, noise sensitivity, vision issues, dizziness, tachycardia, etc. The patient was in the emergency room (ER) 3 times after the vaccine. The patient had brain magnetic resonance imagings (MRIs) and electrocardiogram (EKGs and ECGs), blood tests and nothing bad was found on unspecified date in Aug2021. The patient was diagnosed with a patent foramen ovale (PFO) in his heart through a transesophageal echocardiogram (TEE). The patient believes that the clotting risks of Covid/covid vaccine and the PFO (increased risk of blood clots reaching your brain) are what is causing the migraines. And that somehow the vaccine triggered something with the PFO. Patient have over $5000 in out-of-pocket medical bills now. The patient received the second vaccination of bnt162b2, intramuscular on 09Sep2021 04:00 PM. The patient had a covid test (nasal swab: RT-PCR at least 5-6 times on 31Oct2021 which showed negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as serious due to disability or permanent damage. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial septal defect, Blood test, Dizziness, Electrocardiogram, Hyperacusis
Clinical narrative: I had heart palpitations; severe migraine headaches; Photophobia; noise sensitivity; vision issues; dizziness; tachycardia; I was diagnosed with a PFO in my heart; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a hospital facility on 16Aug2021 13:00 (Batch/Lot number was not reported) (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. There were no relevant medical history and concomitant medications. The patient had no known allergies. On 18Aug2021 at 01:00 PM, the patient had heart palpitations and severe migraine headaches that have lasted for months. The severity of the migraines has increased over time and have become debilitating. Photophobia, noise sensitivity, vision issues, dizziness, tachycardia, etc. The patient was in the emergency room (ER) 3 times after the vaccine. The patient had brain magnetic resonance imagings (MRIs) and electrocardiogram (EKGs and ECGs), blood tests and nothing bad was found on unspecified date in Aug2021. The patient was diagnosed with a patent foramen ovale (PFO) in his heart through a transesophageal echocardiogram (TEE). The patient believes that the clotting risks of Covid/covid vaccine and the PFO (increased risk of blood clots reaching your brain) are what is causing the migraines. And that somehow the vaccine triggered something with the PFO. Patient have over $5000 in out-of-pocket medical bills now. The patient received the second vaccination of bnt162b2, intramuscular on 09Sep2021 04:00 PM. The patient had a covid test (nasal swab: RT-PCR at least 5-6 times on 31Oct2021 which showed negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as serious due to disability or permanent damage. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Migraine, Palpitations, Photophobia, SARS-CoV-2 test
Clinical narrative: I had heart palpitations; severe migraine headaches; Photophobia; noise sensitivity; vision issues; dizziness; tachycardia; I was diagnosed with a PFO in my heart; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a hospital facility on 16Aug2021 13:00 (Batch/Lot number was not reported) (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. There were no relevant medical history and concomitant medications. The patient had no known allergies. On 18Aug2021 at 01:00 PM, the patient had heart palpitations and severe migraine headaches that have lasted for months. The severity of the migraines has increased over time and have become debilitating. Photophobia, noise sensitivity, vision issues, dizziness, tachycardia, etc. The patient was in the emergency room (ER) 3 times after the vaccine. The patient had brain magnetic resonance imagings (MRIs) and electrocardiogram (EKGs and ECGs), blood tests and nothing bad was found on unspecified date in Aug2021. The patient was diagnosed with a patent foramen ovale (PFO) in his heart through a transesophageal echocardiogram (TEE). The patient believes that the clotting risks of Covid/covid vaccine and the PFO (increased risk of blood clots reaching your brain) are what is causing the migraines. And that somehow the vaccine triggered something with the PFO. Patient have over $5000 in out-of-pocket medical bills now. The patient received the second vaccination of bnt162b2, intramuscular on 09Sep2021 04:00 PM. The patient had a covid test (nasal swab: RT-PCR at least 5-6 times on 31Oct2021 which showed negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as serious due to disability or permanent damage. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Visual impairment
Clinical narrative: I had heart palpitations; severe migraine headaches; Photophobia; noise sensitivity; vision issues; dizziness; tachycardia; I was diagnosed with a PFO in my heart; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a hospital facility on 16Aug2021 13:00 (Batch/Lot number was not reported) (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. There were no relevant medical history and concomitant medications. The patient had no known allergies. On 18Aug2021 at 01:00 PM, the patient had heart palpitations and severe migraine headaches that have lasted for months. The severity of the migraines has increased over time and have become debilitating. Photophobia, noise sensitivity, vision issues, dizziness, tachycardia, etc. The patient was in the emergency room (ER) 3 times after the vaccine. The patient had brain magnetic resonance imagings (MRIs) and electrocardiogram (EKGs and ECGs), blood tests and nothing bad was found on unspecified date in Aug2021. The patient was diagnosed with a patent foramen ovale (PFO) in his heart through a transesophageal echocardiogram (TEE). The patient believes that the clotting risks of Covid/covid vaccine and the PFO (increased risk of blood clots reaching your brain) are what is causing the migraines. And that somehow the vaccine triggered something with the PFO. Patient have over $5000 in out-of-pocket medical bills now. The patient received the second vaccination of bnt162b2, intramuscular on 09Sep2021 04:00 PM. The patient had a covid test (nasal swab: RT-PCR at least 5-6 times on 31Oct2021 which showed negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as serious due to disability or permanent damage. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: she's had a fever that has gone up and down from 103.8 to 101.1; Vomiting; Diarrhea; coughing and has the phlegm; Coughing and has the phlegm; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198) via an unspecified route of administration, administered in Arm Right on 21Jul2021 at 10:30 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing gastrooesophageal reflux disease (This is why she had to have her throat opened up), she had 15 inches of colon removed on 07Jan2021, then had to have her throat opened up a little bit on 15Jul2021 and ongoing blood pressure. Patient family medical history was reported as none. Concomitant medications included amlodipine taken for blood pressure abnormal from an unspecified start date and ongoing; famotidine taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none but she does get allergy shots every 2 weeks. Adverse events following prior vaccinations reported as none. On 22Jul2021 the patient experienced a fever that has gone up and down from 103.8 to 101.1, vomiting, diarrhea, coughing and has the phlegm. Nausea on unknown date in Jul2021. The patient underwent lab tests and procedures which included body temperature: up and down from 103.8 to 101.1 on 22Jul2021. It was reported that patient went to the doctor and the doctor said that everything was okay. Patient stated that her Oncologist was the one that told her to get the vaccine, but if she knew it was going to do this she would never have gotten it, and she may not get the 2nd dose. Patient stated that her Oncologist gave her Zofran for nausea and told her to stick to a clear liquid diet. Patient stated that it's bad when you eat a banana and it comes back up. It was reported that the Oncologist also told her to call her kids and have them take her. The PA at the doctor's office never did a covid test, so the Oncologist wants her and her husband to go to the ER for a covid test and wants one of the kids to drive them cause neither one of them is able to drive right now. Patient relevant tests reported as none. Patient stated that she also took 2 Imodium, which the Oncologist said was okay. All events resulted in physician office visit. Outcome of the event nausea was unknown and other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Diarrhoea, Nausea, Productive cough
Clinical narrative: she's had a fever that has gone up and down from 103.8 to 101.1; Vomiting; Diarrhea; coughing and has the phlegm; Coughing and has the phlegm; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198) via an unspecified route of administration, administered in Arm Right on 21Jul2021 at 10:30 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing gastrooesophageal reflux disease (This is why she had to have her throat opened up), she had 15 inches of colon removed on 07Jan2021, then had to have her throat opened up a little bit on 15Jul2021 and ongoing blood pressure. Patient family medical history was reported as none. Concomitant medications included amlodipine taken for blood pressure abnormal from an unspecified start date and ongoing; famotidine taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none but she does get allergy shots every 2 weeks. Adverse events following prior vaccinations reported as none. On 22Jul2021 the patient experienced a fever that has gone up and down from 103.8 to 101.1, vomiting, diarrhea, coughing and has the phlegm. Nausea on unknown date in Jul2021. The patient underwent lab tests and procedures which included body temperature: up and down from 103.8 to 101.1 on 22Jul2021. It was reported that patient went to the doctor and the doctor said that everything was okay. Patient stated that her Oncologist was the one that told her to get the vaccine, but if she knew it was going to do this she would never have gotten it, and she may not get the 2nd dose. Patient stated that her Oncologist gave her Zofran for nausea and told her to stick to a clear liquid diet. Patient stated that it's bad when you eat a banana and it comes back up. It was reported that the Oncologist also told her to call her kids and have them take her. The PA at the doctor's office never did a covid test, so the Oncologist wants her and her husband to go to the ER for a covid test and wants one of the kids to drive them cause neither one of them is able to drive right now. Patient relevant tests reported as none. Patient stated that she also took 2 Imodium, which the Oncologist said was okay. All events resulted in physician office visit. Outcome of the event nausea was unknown and other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: she's had a fever that has gone up and down from 103.8 to 101.1; Vomiting; Diarrhea; coughing and has the phlegm; Coughing and has the phlegm; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198) via an unspecified route of administration, administered in Arm Right on 21Jul2021 at 10:30 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing gastrooesophageal reflux disease (This is why she had to have her throat opened up), she had 15 inches of colon removed on 07Jan2021, then had to have her throat opened up a little bit on 15Jul2021 and ongoing blood pressure. Patient family medical history was reported as none. Concomitant medications included amlodipine taken for blood pressure abnormal from an unspecified start date and ongoing; famotidine taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none but she does get allergy shots every 2 weeks. Adverse events following prior vaccinations reported as none. On 22Jul2021 the patient experienced a fever that has gone up and down from 103.8 to 101.1, vomiting, diarrhea, coughing and has the phlegm. Nausea on unknown date in Jul2021. The patient underwent lab tests and procedures which included body temperature: up and down from 103.8 to 101.1 on 22Jul2021. It was reported that patient went to the doctor and the doctor said that everything was okay. Patient stated that her Oncologist was the one that told her to get the vaccine, but if she knew it was going to do this she would never have gotten it, and she may not get the 2nd dose. Patient stated that her Oncologist gave her Zofran for nausea and told her to stick to a clear liquid diet. Patient stated that it's bad when you eat a banana and it comes back up. It was reported that the Oncologist also told her to call her kids and have them take her. The PA at the doctor's office never did a covid test, so the Oncologist wants her and her husband to go to the ER for a covid test and wants one of the kids to drive them cause neither one of them is able to drive right now. Patient relevant tests reported as none. Patient stated that she also took 2 Imodium, which the Oncologist said was okay. All events resulted in physician office visit. Outcome of the event nausea was unknown and other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Abdominal pain, Anaphylactic reaction, Arthralgia, Asthenia, Autoimmune disorder
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Bell's palsy, Blood disorder, Cardiac disorder, Cerebrovascular accident, Chest discomfort
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Chest pain, Chills, Confusional state, Diarrhoea, Dizziness
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Dyspnoea, Eye swelling, Fatigue, Flushing, Headache
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Hyperhidrosis, Hypertension, Hyperventilation, Hypoaesthesia, Hypotension
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Insomnia, Lethargy, Lymphadenopathy, Mouth swelling, Multisystem inflammatory syndrome in adults
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Myocardial infarction, Nausea, Neck pain, Neurological symptom, Pain
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Paraesthesia, Rash, Seizure, Swelling, Swelling face
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Swollen tongue, Syncope, Tachycardia, Tinnitus, Tremor
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Ultrasound scan abnormal, Unresponsive to stimuli, Visual impairment, Vomiting
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: With my First vaccine on 10/5/2021, i experienced extreme pan in my neck about 2 weeks AFTER being vaccinated. I went to the emergency room and followed up with my primary care doctor where I was sent for an ultrasound. The ultrasound showed multiple swollen lymph nodes on the left side (that is the side I was given the first Maderna vaccination.  The ultrasound determined that it is possible that this is due to the vaccine.   My second dose I experienced extreme itching and burning of my skin on my torso and both legs. It feels as though my skin is in fire!
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Anticoagulant therapy, Arterial thrombosis, Computerised tomogram abnormal
Clinical narrative: BLOOD CLOT IN THE LOWER ARTERY THAT BLOCKED BLOOD SUPPLY TO THE DIGESTIVE SYSTEM, KIDNEY AND SOME OF THE OTHER ORGANS; INTESTINAL SWELLING; COULD NOT SLEEP; NOT FELT TOO WELL; RINGING IN BOTH EARS; FEVER; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient had no history of blood clot issues. The patient previously received covid-19 vaccine (manufacturer unspecified) in MAR-2021 and had no reported reactions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 1822811, expiry: UNKNOWN) on 23-OCT-2021, 1 total administered to the left deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban. On 23-OCT-2021, later in the day after receiving the vaccination, patient developed a fever and took ibuprofen (Advil). The next day on 24-OCT-2021, he did not felt too well and later that night experienced stomach ache which worsened during the night and he could not sleep due to the pain. He also experienced nausea and vomiting and ringing in both ears. On 25-OCT-2021, the stomach pain was there along with nausea and vomiting at the time of reporting. He went to the Emergency Room (ER) where an ultrasound was performed which did not reveal any issues. A computed tomography (CT) showed a clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, as well as intestinal swelling and he was admitted the same day. He was kept on blood thinners via IV for 4 days and was also on painkillers. The stomach pain subsided and he was discharged from hospital after 4 days on 28-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, fever, and ringing in both ears, was recovering from intestinal swelling, and blood clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, and had not recovered from not felt too well. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211061177-covid-19 vaccine ad26.cov2.s-blood clot in the lower artery that was blocking blood supply to the digestive system, kidney and some of the other organs, and intestinal swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).