chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Blood test, Cervical radiculopathy, Costochondritis, Dizziness
Clinical narrative: metal taste in mouth right after injection, right arm swelled in arm pit and pain in wrist right after injection, Felt heaviness in chest within 10 min of shot, and then strange feeling throughout my body for a good hour or so after injection. Day after injection headache and dizziness, Day 3 after both legs went numb and could not feel them to touch. Day 4 numbness, pain, tingling started in my hands, feet, and legs. Right Arm pain continued. Saw my pcp he thinks pharmacist hit the nerve in my arm why it was swollen and hurt. Dec diagnosed with Mild Guillain Barre, vaccine induced neuropathy by Neuro, chest pain cardiologist said either costochondritis or a little pericarditis. Muscle weakness continues to this day I am on anti inflammatory meds it seems the inflammation will not calm down. Diagnosed with cervical Radiculopathy due to neck, chest and arm pain that came after waking up in the morning. this was in May 2022. January of 2022 I lost feeling in my abdomen, I still cannot tell when I am tightening my stomach muscles. I could barely feel to go to the bathroom. When I was able to feel to pee again I could not stop going to the bathroom. Went to see urologist and said that my bladder was out of sync with my body I had to go on muscles relaxers to get it back. But after taking prednisone for swelling in neck nerves my bladder began overactive again so I am back on the muscles relaxers.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Fibrin D dimer, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: metal taste in mouth right after injection, right arm swelled in arm pit and pain in wrist right after injection, Felt heaviness in chest within 10 min of shot, and then strange feeling throughout my body for a good hour or so after injection. Day after injection headache and dizziness, Day 3 after both legs went numb and could not feel them to touch. Day 4 numbness, pain, tingling started in my hands, feet, and legs. Right Arm pain continued. Saw my pcp he thinks pharmacist hit the nerve in my arm why it was swollen and hurt. Dec diagnosed with Mild Guillain Barre, vaccine induced neuropathy by Neuro, chest pain cardiologist said either costochondritis or a little pericarditis. Muscle weakness continues to this day I am on anti inflammatory meds it seems the inflammation will not calm down. Diagnosed with cervical Radiculopathy due to neck, chest and arm pain that came after waking up in the morning. this was in May 2022. January of 2022 I lost feeling in my abdomen, I still cannot tell when I am tightening my stomach muscles. I could barely feel to go to the bathroom. When I was able to feel to pee again I could not stop going to the bathroom. Went to see urologist and said that my bladder was out of sync with my body I had to go on muscles relaxers to get it back. But after taking prednisone for swelling in neck nerves my bladder began overactive again so I am back on the muscles relaxers.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Neuralgia, Peripheral swelling, Peutz-Jeghers syndrome, Rheumatoid arthritis
Clinical narrative: metal taste in mouth right after injection, right arm swelled in arm pit and pain in wrist right after injection, Felt heaviness in chest within 10 min of shot, and then strange feeling throughout my body for a good hour or so after injection. Day after injection headache and dizziness, Day 3 after both legs went numb and could not feel them to touch. Day 4 numbness, pain, tingling started in my hands, feet, and legs. Right Arm pain continued. Saw my pcp he thinks pharmacist hit the nerve in my arm why it was swollen and hurt. Dec diagnosed with Mild Guillain Barre, vaccine induced neuropathy by Neuro, chest pain cardiologist said either costochondritis or a little pericarditis. Muscle weakness continues to this day I am on anti inflammatory meds it seems the inflammation will not calm down. Diagnosed with cervical Radiculopathy due to neck, chest and arm pain that came after waking up in the morning. this was in May 2022. January of 2022 I lost feeling in my abdomen, I still cannot tell when I am tightening my stomach muscles. I could barely feel to go to the bathroom. When I was able to feel to pee again I could not stop going to the bathroom. Went to see urologist and said that my bladder was out of sync with my body I had to go on muscles relaxers to get it back. But after taking prednisone for swelling in neck nerves my bladder began overactive again so I am back on the muscles relaxers.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL1284), on 05Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NATURE MADE B12 VITAMIN; NATURE MADE VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative, notes: Symptoms started on 12May2022, test negative; (13May2022) Positive, notes: Symptoms worse on 13May2022, test positive; (20May2022) Negative, notes: Tested negative on 20May2022; (28May2022) Positive, notes: test positive on 28May2022. Therapeutic measures were taken as a result of covid-19. Clinical Course: anti-viral details: product COVID 19 Treatment, brand: Paxlovid, treatment start date: 13May2022, treatment stop date: 18May2022, indication: Treatment of COVID-19. other medication details other medication in 2weeks product: Multivitamin. Adverse event: COVID rebound after course of Paxlovid. Original infection-symptoms started on 12May2022, test negative, symptoms worse on 13May2022, test positive and started Paxlovid. Tested negative on 20May2022 with residual congestion and occ cough. Congestion and cough worse on 27May2022, test positive on 28May2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL1284), on 05Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NATURE MADE B12 VITAMIN; NATURE MADE VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative, notes: Symptoms started on 12May2022, test negative; (13May2022) Positive, notes: Symptoms worse on 13May2022, test positive; (20May2022) Negative, notes: Tested negative on 20May2022; (28May2022) Positive, notes: test positive on 28May2022. Therapeutic measures were taken as a result of covid-19. Clinical Course: anti-viral details: product COVID 19 Treatment, brand: Paxlovid, treatment start date: 13May2022, treatment stop date: 18May2022, indication: Treatment of COVID-19. other medication details other medication in 2weeks product: Multivitamin. Adverse event: COVID rebound after course of Paxlovid. Original infection-symptoms started on 12May2022, test negative, symptoms worse on 13May2022, test positive and started Paxlovid. Tested negative on 20May2022 with residual congestion and occ cough. Congestion and cough worse on 27May2022, test positive on 28May2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Basedow's disease, Blood test abnormal, Blood thyroid stimulating hormone decreased, Heart rate increased, Supraventricular tachycardia
Clinical narrative: 2 emergency room visits 11/3/2021 and 11/14/2021 for  SVT  and my heart  rate was at 189 for hours each time and the ER had to inject medicine to lower it. Blood tests confirmed by my Endocrinologist that it was Graves? disease that I?ve never had before prior to my vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thyroxine free normal, Vaccination complication
Clinical narrative: 2 emergency room visits 11/3/2021 and 11/14/2021 for  SVT  and my heart  rate was at 189 for hours each time and the ER had to inject medicine to lower it. Blood tests confirmed by my Endocrinologist that it was Graves? disease that I?ve never had before prior to my vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, COVID-19, Heart rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 2 emergency room visits 11/3/2021 and 11/14/2021 for  SVT  and my heart  rate was at 189 for hours each time and the ER had to inject medicine to lower it. Blood tests confirmed by my Endocrinologist that it was Graves? disease that I?ve never had before prior to my vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Basedow's disease, Blood test abnormal, Cardiac stress test, Electrocardiogram abnormal, Supraventricular tachycardia
Clinical narrative: 2 emergency room visits 11/3/2021 and 11/14/2021 for  SVT  and my heart  rate was at 189 for hours each time and the ER had to inject medicine to lower it. Blood tests confirmed by my Endocrinologist that it was Graves? disease that I?ve never had before prior to my vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Basedow's disease, Blood test, Heart rate, Heart rate increased
Clinical narrative: 2 emergency room visits 11/3/2021 and 11/14/2021 for  SVT  and my heart  rate was at 189 for hours each time and the ER had to inject medicine to lower it. Blood tests confirmed by my Endocrinologist that it was Graves? disease that I?ve never had before prior to my vaccination.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Arthralgia, Bacterial infection, Biopsy skin, Blister
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Emotional distress, Fatigue, Gait disturbance, Impaired work ability
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Infection, Inflammation, Insomnia, Movement disorder, Myalgia
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain of skin, Rash, Sexual dysfunction, Skin irritation, Sleep disorder
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Stress
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Chest discomfort, Musculoskeletal discomfort, Pemphigus, Skin discolouration
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin irritation
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Toxic epidermal necrolysis
Clinical narrative: Toxic epidermal necrolysis (TEN); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. It was unknown if covid prior vaccination. Covid was not tested post vaccination. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TOXIC EPIDERMAL NECROLYSIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Toxic epidermal necrolysis (TEN)". The event "toxic epidermal necrolysis (ten)" required physician office visit and emergency room visit. Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood test, Chills, Dyspepsia
Clinical narrative: Felt really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3180) at the age of 65 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 24Aug2021, outcome "recovering", described as "Felt really tired". Therapeutic measures were not taken as a result of fatigue.  Addition information: It was reported that, she has been on it for 3 days and she doesn't feel much better and she doesn't know if it has worked for her. After the first shot, she felt really tired, that was all she experienced, but it took over a week to get better. After her second Dose of the Pfizer Covid-19 Vaccine, she ended up being so sick for 6 days with symptoms she never had experienced before. After being so sick from her second dose, she didn't want to get a Booster dose. She didn't want to have the same experience as she did after the second dose. Then she got tested for antibodies in Nov2021 and the result had shown zero antibodies. The patient experienced a high fever, she had chills, and she felt like she had COVID-19 instead of being vaccinate for the second time. She felt she got COVID-19 for 6 days. She felt better the following week, 6 days later and during this on the 4th day, she felt so bad that she went to the Urgent Care. She got a blood test that would indicate the antibodies and that result she received indicated how many antibodies she had and her test result showed she had zero antibodies. The caller is asking because she had such a severe reaction after receiving the second Pfizer Covid-19 Vaccine. She still had the chills and temperature was almost 102 degrees Fahrenheit. She had chest pains in back and then they went to her chest. It started in her back and went to her front. She had a lot of heart burn, but it only lasted about an hour. She later said that back pain was 20 minutes and then chest pain was 20 minutes and heart burn was 20 minutes. She said maybe it wasn't heart burn but just maybe chest pain. She then had terrible muscle joint aches and body aches and mind was telling her it was ridiculous. She does not take any medications.  No further information was provided at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain, Palpitations, Pyrexia
Clinical narrative: Felt really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3180) at the age of 65 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 24Aug2021, outcome "recovering", described as "Felt really tired". Therapeutic measures were not taken as a result of fatigue.  Addition information: It was reported that, she has been on it for 3 days and she doesn't feel much better and she doesn't know if it has worked for her. After the first shot, she felt really tired, that was all she experienced, but it took over a week to get better. After her second Dose of the Pfizer Covid-19 Vaccine, she ended up being so sick for 6 days with symptoms she never had experienced before. After being so sick from her second dose, she didn't want to get a Booster dose. She didn't want to have the same experience as she did after the second dose. Then she got tested for antibodies in Nov2021 and the result had shown zero antibodies. The patient experienced a high fever, she had chills, and she felt like she had COVID-19 instead of being vaccinate for the second time. She felt she got COVID-19 for 6 days. She felt better the following week, 6 days later and during this on the 4th day, she felt so bad that she went to the Urgent Care. She got a blood test that would indicate the antibodies and that result she received indicated how many antibodies she had and her test result showed she had zero antibodies. The caller is asking because she had such a severe reaction after receiving the second Pfizer Covid-19 Vaccine. She still had the chills and temperature was almost 102 degrees Fahrenheit. She had chest pains in back and then they went to her chest. It started in her back and went to her front. She had a lot of heart burn, but it only lasted about an hour. She later said that back pain was 20 minutes and then chest pain was 20 minutes and heart burn was 20 minutes. She said maybe it wasn't heart burn but just maybe chest pain. She then had terrible muscle joint aches and body aches and mind was telling her it was ridiculous. She does not take any medications.  No further information was provided at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Felt really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3180) at the age of 65 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 24Aug2021, outcome "recovering", described as "Felt really tired". Therapeutic measures were not taken as a result of fatigue.  Addition information: It was reported that, she has been on it for 3 days and she doesn't feel much better and she doesn't know if it has worked for her. After the first shot, she felt really tired, that was all she experienced, but it took over a week to get better. After her second Dose of the Pfizer Covid-19 Vaccine, she ended up being so sick for 6 days with symptoms she never had experienced before. After being so sick from her second dose, she didn't want to get a Booster dose. She didn't want to have the same experience as she did after the second dose. Then she got tested for antibodies in Nov2021 and the result had shown zero antibodies. The patient experienced a high fever, she had chills, and she felt like she had COVID-19 instead of being vaccinate for the second time. She felt she got COVID-19 for 6 days. She felt better the following week, 6 days later and during this on the 4th day, she felt so bad that she went to the Urgent Care. She got a blood test that would indicate the antibodies and that result she received indicated how many antibodies she had and her test result showed she had zero antibodies. The caller is asking because she had such a severe reaction after receiving the second Pfizer Covid-19 Vaccine. She still had the chills and temperature was almost 102 degrees Fahrenheit. She had chest pains in back and then they went to her chest. It started in her back and went to her front. She had a lot of heart burn, but it only lasted about an hour. She later said that back pain was 20 minutes and then chest pain was 20 minutes and heart burn was 20 minutes. She said maybe it wasn't heart burn but just maybe chest pain. She then had terrible muscle joint aches and body aches and mind was telling her it was ridiculous. She does not take any medications.  No further information was provided at the time of this report.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Eye pain, Migraine, Pain in jaw, Toothache
Clinical narrative: Patient had usual sore arm on the first day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had usual sore arm on the first day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 039F21A, 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Rhinitis (the patient currently breathe through both nostrils.). Concomitant products included ZINC for Rhinitis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced PAIN IN EXTREMITY (Patient had usual sore arm on the first day). At the time of the report, PAIN IN EXTREMITY (Patient had usual sore arm on the first day) outcome was unknown.            Concomitant medications also included zinc lozenges and nasal spray (when needed) for the non-allergic rhinitis.  On 05-Nov-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 21-May-2022 at 3:00 PM, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient had no other adverse effects after taking the second booster dose except the sore arm.  No treatment information was reported.   This case was linked to MOD-2022-546759, MOD-2022-546741 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient had usual sore arm on the first day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had usual sore arm on the first day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 039F21A, 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Rhinitis (the patient currently breathe through both nostrils.). Concomitant products included ZINC for Rhinitis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced PAIN IN EXTREMITY (Patient had usual sore arm on the first day). At the time of the report, PAIN IN EXTREMITY (Patient had usual sore arm on the first day) outcome was unknown.            Concomitant medications also included zinc lozenges and nasal spray (when needed) for the non-allergic rhinitis.  On 05-Nov-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 21-May-2022 at 3:00 PM, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient had no other adverse effects after taking the second booster dose except the sore arm.  No treatment information was reported.   This case was linked to MOD-2022-546759, MOD-2022-546741 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Eye pain, Gingival bleeding, Migraine, Pain in jaw
Clinical narrative: Patient had usual sore arm on the first day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had usual sore arm on the first day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 039F21A, 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Rhinitis (the patient currently breathe through both nostrils.). Concomitant products included ZINC for Rhinitis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced PAIN IN EXTREMITY (Patient had usual sore arm on the first day). At the time of the report, PAIN IN EXTREMITY (Patient had usual sore arm on the first day) outcome was unknown.            Concomitant medications also included zinc lozenges and nasal spray (when needed) for the non-allergic rhinitis.  On 05-Nov-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 21-May-2022 at 3:00 PM, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient had no other adverse effects after taking the second booster dose except the sore arm.  No treatment information was reported.   This case was linked to MOD-2022-546759, MOD-2022-546741 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Toothache
Clinical narrative: Patient had usual sore arm on the first day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had usual sore arm on the first day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 039F21A, 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Rhinitis (the patient currently breathe through both nostrils.). Concomitant products included ZINC for Rhinitis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced PAIN IN EXTREMITY (Patient had usual sore arm on the first day). At the time of the report, PAIN IN EXTREMITY (Patient had usual sore arm on the first day) outcome was unknown.            Concomitant medications also included zinc lozenges and nasal spray (when needed) for the non-allergic rhinitis.  On 05-Nov-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 21-May-2022 at 3:00 PM, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient had no other adverse effects after taking the second booster dose except the sore arm.  No treatment information was reported.   This case was linked to MOD-2022-546759, MOD-2022-546741 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort
Clinical narrative: The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine; The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyper S Protein deficiency" (unspecified if ongoing), notes: Hyper S Protein deficiency. The patient's concomitant medications were not reported. Vaccination history included: Hpv vaccine (I fought to have my HPV vaccine at age 65 and I got it.), when the patient was 65 years old, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine". The event "the caller has been infected with covid-19 two times after having four doses of the pfizer covid-19 vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (12May2022) Negative; (May2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Immunisation reaction, Pityriasis rosea, Suspected COVID-19
Clinical narrative: The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine; The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyper S Protein deficiency" (unspecified if ongoing), notes: Hyper S Protein deficiency. The patient's concomitant medications were not reported. Vaccination history included: Hpv vaccine (I fought to have my HPV vaccine at age 65 and I got it.), when the patient was 65 years old, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine". The event "the caller has been infected with covid-19 two times after having four doses of the pfizer covid-19 vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (12May2022) Negative; (May2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine; The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyper S Protein deficiency" (unspecified if ongoing), notes: Hyper S Protein deficiency. The patient's concomitant medications were not reported. Vaccination history included: Hpv vaccine (I fought to have my HPV vaccine at age 65 and I got it.), when the patient was 65 years old, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "The caller has been infected with COVID-19 two times after having four doses of the Pfizer COVID-19 vaccine". The event "the caller has been infected with covid-19 two times after having four doses of the pfizer covid-19 vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (12May2022) Negative; (May2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Incontinence, Tremor
Clinical narrative: Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too; Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An elderly female patient received BNT162b2 (BNT162B2), on 10Apr2022 at 12:30 as dose 4 (booster), single (Lot number: Fk9893) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), SOMNAMBULISM (non-serious) all with onset 10Apr2022, outcome "unknown" and all described as "Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too". It was unknown if therapeutic measures were taken as a result of loss of consciousness, somnambulism.  Additional information: Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too.Device Date was reported as 26May2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event LOSS OF CONSCIOUSNESS and BNT162B2. 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: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Somnambulism
Clinical narrative: Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too; Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An elderly female patient received BNT162b2 (BNT162B2), on 10Apr2022 at 12:30 as dose 4 (booster), single (Lot number: Fk9893) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), SOMNAMBULISM (non-serious) all with onset 10Apr2022, outcome "unknown" and all described as "Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too". It was unknown if therapeutic measures were taken as a result of loss of consciousness, somnambulism.  Additional information: Patient said that same night she was uncontious and woke up on the floor unaware of how she got there. She filled out a VAERS form too.Device Date was reported as 26May2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event LOSS OF CONSCIOUSNESS and BNT162B2. 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: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site pain, Paraesthesia, Sleep disorder
Clinical narrative: tingling in my toes, tingling in my Rt arm.; numbness in my toes; burning sensation in the Right arm; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. In May 2022, 8 hrs after receiving Shingrix, the patient experienced tingling of extremity, numbness in toes and burning sensation. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the tingling of extremity and burning sensation were not recovered/not resolved and the outcome of the numbness in toes was recovered/resolved.   The reporter considered the tingling of extremity, numbness in toes and burning sensation to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's comment: The patient self reported the case. One week prior to the reporting patient received 1st dose of vaccine and 8 hours after patient developed numbness and tingling in her toes. Now 10 days later patient continue to have on and off tingling in right arm. The numbness was gone on her toes. Asked was this normal. The patient took a Medrol dose pack and the toe numbness went away but now having tingling and burning sensation in right arm. The patient felt it was related to the vaccine because the symptoms started 8 hours after receiving the vaccine.  The patient was fine before then.