chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Mouth swelling, Pain, Sensation of foreign body, Swelling face
Clinical narrative: Body ache; Swollen left cheek; Swollen tongue; Feels like it is burning when she eats something; She also has been throwing up; Headache; Muscle pain; Feeling like a lot of pressure to my, like I have something large on the left side; Tingling in my face; Feeling my left side a little swollen; I am feeling like if I eat something very hot and my left side of my tongue is burnt but its only on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202), via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension (Verbatim: Hypertension), rheumatoid arthritis (Verbatim: Rheumatoid arthritis), have severe allergies to flu and any type of insect bite, allergic to certain medications, I am allergic to Lyrica, I am allergic to Doxycycline, I am allergic to Amoxicillin Clavulanate, I am allergic to Propranolol and migraine headache. Concomitant medications included lisinopril, gabapentin, hydrocodone bitartrate, paracetamol (NORCO) and budesonide (BUDESONIDE). On an unknown date the patient experienced body ache, swollen left cheek, swollen tongue, feels like it is burning when she eats something, she also has been throwing up, headache, muscle pain, feeling like a lot of pressure to my, like i have something large on the left side, tingling in my face, feeling my left side a little swollen, i am feeling like if i eat something very hot and my left side of my tongue is burnt but its only on the left side. Therapeutic measures were taken as a result of swollen left cheek and swollen tongue. The patient reported that she received her first dose of Pfizer vaccine on 23Jul (not clarified) and she was experiencing body ache and she had swollen left cheek as well as swollen tongue and feels like it is burning when she eats something and she has also been throwing up lately. She was told to call and report the symptoms. She took the vaccine on Friday near about 4 clock in the afternoon and symptoms were usual onset headache, muscle pain, body ache and everything, last night she felt like a lot of pressure to her, like she have something large on the left side and then this morning she started feeling tingling in face and started feeling left side a little swollen. She felt like if she ate something very hot and her left side of her tongue is burnt but its only on the left side not on the right side. Scheduled date for second shot was13August2021. The patient had no prior vaccinations. Treatment of the event included: 60 milligrams of Benadryl today to help with swelling on her face and her tongue. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort, Vomiting
Clinical narrative: Body ache; Swollen left cheek; Swollen tongue; Feels like it is burning when she eats something; She also has been throwing up; Headache; Muscle pain; Feeling like a lot of pressure to my, like I have something large on the left side; Tingling in my face; Feeling my left side a little swollen; I am feeling like if I eat something very hot and my left side of my tongue is burnt but its only on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202), via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension (Verbatim: Hypertension), rheumatoid arthritis (Verbatim: Rheumatoid arthritis), have severe allergies to flu and any type of insect bite, allergic to certain medications, I am allergic to Lyrica, I am allergic to Doxycycline, I am allergic to Amoxicillin Clavulanate, I am allergic to Propranolol and migraine headache. Concomitant medications included lisinopril, gabapentin, hydrocodone bitartrate, paracetamol (NORCO) and budesonide (BUDESONIDE). On an unknown date the patient experienced body ache, swollen left cheek, swollen tongue, feels like it is burning when she eats something, she also has been throwing up, headache, muscle pain, feeling like a lot of pressure to my, like i have something large on the left side, tingling in my face, feeling my left side a little swollen, i am feeling like if i eat something very hot and my left side of my tongue is burnt but its only on the left side. Therapeutic measures were taken as a result of swollen left cheek and swollen tongue. The patient reported that she received her first dose of Pfizer vaccine on 23Jul (not clarified) and she was experiencing body ache and she had swollen left cheek as well as swollen tongue and feels like it is burning when she eats something and she has also been throwing up lately. She was told to call and report the symptoms. She took the vaccine on Friday near about 4 clock in the afternoon and symptoms were usual onset headache, muscle pain, body ache and everything, last night she felt like a lot of pressure to her, like she have something large on the left side and then this morning she started feeling tingling in face and started feeling left side a little swollen. She felt like if she ate something very hot and her left side of her tongue is burnt but its only on the left side not on the right side. Scheduled date for second shot was13August2021. The patient had no prior vaccinations. Treatment of the event included: 60 milligrams of Benadryl today to help with swelling on her face and her tongue. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Discomfort, Headache, Myalgia, Pain
Clinical narrative: Body ache; Swollen left cheek; Swollen tongue; Feels like it is burning when she eats something; She also has been throwing up; Headache; Muscle pain; Feeling like a lot of pressure to my, like I have something large on the left side; Tingling in my face; Feeling my left side a little swollen; I am feeling like if I eat something very hot and my left side of my tongue is burnt but its only on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202), via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension (Verbatim: Hypertension), rheumatoid arthritis (Verbatim: Rheumatoid arthritis), have severe allergies to flu and any type of insect bite, allergic to certain medications, I am allergic to Lyrica, I am allergic to Doxycycline, I am allergic to Amoxicillin Clavulanate, I am allergic to Propranolol and migraine headache. Concomitant medications included lisinopril, gabapentin, hydrocodone bitartrate, paracetamol (NORCO) and budesonide (BUDESONIDE). On an unknown date the patient experienced body ache, swollen left cheek, swollen tongue, feels like it is burning when she eats something, she also has been throwing up, headache, muscle pain, feeling like a lot of pressure to my, like i have something large on the left side, tingling in my face, feeling my left side a little swollen, i am feeling like if i eat something very hot and my left side of my tongue is burnt but its only on the left side. Therapeutic measures were taken as a result of swollen left cheek and swollen tongue. The patient reported that she received her first dose of Pfizer vaccine on 23Jul (not clarified) and she was experiencing body ache and she had swollen left cheek as well as swollen tongue and feels like it is burning when she eats something and she has also been throwing up lately. She was told to call and report the symptoms. She took the vaccine on Friday near about 4 clock in the afternoon and symptoms were usual onset headache, muscle pain, body ache and everything, last night she felt like a lot of pressure to her, like she have something large on the left side and then this morning she started feeling tingling in face and started feeling left side a little swollen. She felt like if she ate something very hot and her left side of her tongue is burnt but its only on the left side not on the right side. Scheduled date for second shot was13August2021. The patient had no prior vaccinations. Treatment of the event included: 60 milligrams of Benadryl today to help with swelling on her face and her tongue. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Swelling, Swelling face, Swollen tongue, Tongue discomfort
Clinical narrative: Body ache; Swollen left cheek; Swollen tongue; Feels like it is burning when she eats something; She also has been throwing up; Headache; Muscle pain; Feeling like a lot of pressure to my, like I have something large on the left side; Tingling in my face; Feeling my left side a little swollen; I am feeling like if I eat something very hot and my left side of my tongue is burnt but its only on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202), via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension (Verbatim: Hypertension), rheumatoid arthritis (Verbatim: Rheumatoid arthritis), have severe allergies to flu and any type of insect bite, allergic to certain medications, I am allergic to Lyrica, I am allergic to Doxycycline, I am allergic to Amoxicillin Clavulanate, I am allergic to Propranolol and migraine headache. Concomitant medications included lisinopril, gabapentin, hydrocodone bitartrate, paracetamol (NORCO) and budesonide (BUDESONIDE). On an unknown date the patient experienced body ache, swollen left cheek, swollen tongue, feels like it is burning when she eats something, she also has been throwing up, headache, muscle pain, feeling like a lot of pressure to my, like i have something large on the left side, tingling in my face, feeling my left side a little swollen, i am feeling like if i eat something very hot and my left side of my tongue is burnt but its only on the left side. Therapeutic measures were taken as a result of swollen left cheek and swollen tongue. The patient reported that she received her first dose of Pfizer vaccine on 23Jul (not clarified) and she was experiencing body ache and she had swollen left cheek as well as swollen tongue and feels like it is burning when she eats something and she has also been throwing up lately. She was told to call and report the symptoms. She took the vaccine on Friday near about 4 clock in the afternoon and symptoms were usual onset headache, muscle pain, body ache and everything, last night she felt like a lot of pressure to her, like she have something large on the left side and then this morning she started feeling tingling in face and started feeling left side a little swollen. She felt like if she ate something very hot and her left side of her tongue is burnt but its only on the left side not on the right side. Scheduled date for second shot was13August2021. The patient had no prior vaccinations. Treatment of the event included: 60 milligrams of Benadryl today to help with swelling on her face and her tongue. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Body ache; Swollen left cheek; Swollen tongue; Feels like it is burning when she eats something; She also has been throwing up; Headache; Muscle pain; Feeling like a lot of pressure to my, like I have something large on the left side; Tingling in my face; Feeling my left side a little swollen; I am feeling like if I eat something very hot and my left side of my tongue is burnt but its only on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202), via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension (Verbatim: Hypertension), rheumatoid arthritis (Verbatim: Rheumatoid arthritis), have severe allergies to flu and any type of insect bite, allergic to certain medications, I am allergic to Lyrica, I am allergic to Doxycycline, I am allergic to Amoxicillin Clavulanate, I am allergic to Propranolol and migraine headache. Concomitant medications included lisinopril, gabapentin, hydrocodone bitartrate, paracetamol (NORCO) and budesonide (BUDESONIDE). On an unknown date the patient experienced body ache, swollen left cheek, swollen tongue, feels like it is burning when she eats something, she also has been throwing up, headache, muscle pain, feeling like a lot of pressure to my, like i have something large on the left side, tingling in my face, feeling my left side a little swollen, i am feeling like if i eat something very hot and my left side of my tongue is burnt but its only on the left side. Therapeutic measures were taken as a result of swollen left cheek and swollen tongue. The patient reported that she received her first dose of Pfizer vaccine on 23Jul (not clarified) and she was experiencing body ache and she had swollen left cheek as well as swollen tongue and feels like it is burning when she eats something and she has also been throwing up lately. She was told to call and report the symptoms. She took the vaccine on Friday near about 4 clock in the afternoon and symptoms were usual onset headache, muscle pain, body ache and everything, last night she felt like a lot of pressure to her, like she have something large on the left side and then this morning she started feeling tingling in face and started feeling left side a little swollen. She felt like if she ate something very hot and her left side of her tongue is burnt but its only on the left side not on the right side. Scheduled date for second shot was13August2021. The patient had no prior vaccinations. Treatment of the event included: 60 milligrams of Benadryl today to help with swelling on her face and her tongue. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Headache, Pain in extremity
Clinical narrative: Feeling very fatigued after first dose of the Covid 19 Vaccine; Legs hurting after first dose of the Covid 19 Vaccine; Dry Cough after first dose of the Covid 19 Vaccine; Really bad headaches after first dose of the Covid 19 Vaccine; Was not feeling well; This is a spontaneous report from a contactable consumer (patient friend). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date: unknown), via an unspecified route of administration on 21Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medication included naproxen (NAPROSYNE) and benzonatate, both taken for an unspecified indication from 05Apr2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date after the first dose of the vaccine, the patient experienced feeling very fatigued, legs hurting, dry cough, really bad headaches and was not feeling well. Patient visited physician office for urgent care for legs hurting and bad headaches. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative (COVID-19 PCR test) on 05Apr2021. Patient received second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729), via an unspecified route of administration on 11Apr2021 as dose 2, single for COVID-19 immunization. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: Feeling very fatigued after first dose of the Covid 19 Vaccine; Legs hurting after first dose of the Covid 19 Vaccine; Dry Cough after first dose of the Covid 19 Vaccine; Really bad headaches after first dose of the Covid 19 Vaccine; Was not feeling well; This is a spontaneous report from a contactable consumer (patient friend). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date: unknown), via an unspecified route of administration on 21Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medication included naproxen (NAPROSYNE) and benzonatate, both taken for an unspecified indication from 05Apr2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date after the first dose of the vaccine, the patient experienced feeling very fatigued, legs hurting, dry cough, really bad headaches and was not feeling well. Patient visited physician office for urgent care for legs hurting and bad headaches. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative (COVID-19 PCR test) on 05Apr2021. Patient received second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729), via an unspecified route of administration on 11Apr2021 as dose 2, single for COVID-19 immunization. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Feeling very fatigued after first dose of the Covid 19 Vaccine; Legs hurting after first dose of the Covid 19 Vaccine; Dry Cough after first dose of the Covid 19 Vaccine; Really bad headaches after first dose of the Covid 19 Vaccine; Was not feeling well; This is a spontaneous report from a contactable consumer (patient friend). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date: unknown), via an unspecified route of administration on 21Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medication included naproxen (NAPROSYNE) and benzonatate, both taken for an unspecified indication from 05Apr2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date after the first dose of the vaccine, the patient experienced feeling very fatigued, legs hurting, dry cough, really bad headaches and was not feeling well. Patient visited physician office for urgent care for legs hurting and bad headaches. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative (COVID-19 PCR test) on 05Apr2021. Patient received second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729), via an unspecified route of administration on 11Apr2021 as dose 2, single for COVID-19 immunization. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss/ There are quite large bald spots; This is a spontaneous report from a contactable consumer (patient). A 12-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 12Jun2021 (at the age of 12-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Lil Critters Gummy Vites Daily Kids Multivitamin. The patient experienced hair loss, there are quite large bald spots on 01Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR): negative on an unspecified date (nasal Swab). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient received injection on the bald area as treatment for adverse events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Hair loss/ There are quite large bald spots; This is a spontaneous report from a contactable consumer (patient). A 12-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 12Jun2021 (at the age of 12-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Lil Critters Gummy Vites Daily Kids Multivitamin. The patient experienced hair loss, there are quite large bald spots on 01Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR): negative on an unspecified date (nasal Swab). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient received injection on the bald area as treatment for adverse events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Ocular hyperaemia, Photophobia, Uveitis
Clinical narrative: Eye pain, redness, decreased vision.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Ocular hyperaemia, Visual impairment
Clinical narrative: Eye pain, redness, decreased vision.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoxia, Mental status changes, Sepsis
Clinical narrative: pt was hospitalized on 09.29.21 for hypoxia, sepsis, fever covid positive
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypoxia, Pyrexia, SARS-CoV-2 test positive, Sepsis
Clinical narrative: pt was hospitalized on 09.29.21 for hypoxia, sepsis, fever covid positive
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chronic lymphocytic leukaemia, White blood cell count increased
Clinical narrative: STRESS; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); ARM SORENESS; This spontaneous report received from a consumer concerned a 54 year old White male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient was healthy and always did physical. On 14-JUL-2020, Laboratory data included: Blood count (NR: not provided) normal. On 17-DEC-2020, Laboratory data included: Blood count (NR: not provided) normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 01-APR-2021 (around 4 pm) for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient did not have any symptoms after the shot. The patient could possibly have had a little soreness in the arm. He took Tylenol that night to be able to sleep well. On an unspecified date in JUN-2021, the patient went for his routine yearly physical. The patient's blood work showed that his white blood cell count was too high so the doctor requested that he would monitor his blood count. On an unspecified date in JUN-2021, Laboratory data included: Blood count (NR: not provided) WBC high. The patient did his blood work again afterwards and the result showed 12 to 15 percent increase in his WBC. On an unspecified date in 2021, Laboratory data included: Blood count (NR: not provided) WBC (12 to 15 percent) high. His WBC continued to increase by 12 to 15 percent increments. He was later diagnosed on 03-AUG-2021 with Chronic Lymphocytic Leukemia (CLL). The patient had blood work done couple of times because he changed Jobs and Insurance. On an unspecified date, Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported. The reporter stated that if we were to go backward (WBC decrease rate of 12 to 15 percent), then she would assume that the patient's WBC was supposed to be normal in APR-2021 before he received the vaccine. The reporter did not mention any other symptoms except that the patient was really stressed about the diagnosis. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, had not recovered from chronic lymphocytic leukemia (CLL), and the outcome of stress was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211116245.; Sender's Comments: V0: 20211116191-covid-19 vaccine ad26.cov2.s-chronic lymphocytic leukemia (CLL). 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).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chronic lymphocytic leukaemia, Pain in extremity, Stress
Clinical narrative: STRESS; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); ARM SORENESS; This spontaneous report received from a consumer concerned a 54 year old White male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient was healthy and always did physical. On 14-JUL-2020, Laboratory data included: Blood count (NR: not provided) normal. On 17-DEC-2020, Laboratory data included: Blood count (NR: not provided) normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 01-APR-2021 (around 4 pm) for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient did not have any symptoms after the shot. The patient could possibly have had a little soreness in the arm. He took Tylenol that night to be able to sleep well. On an unspecified date in JUN-2021, the patient went for his routine yearly physical. The patient's blood work showed that his white blood cell count was too high so the doctor requested that he would monitor his blood count. On an unspecified date in JUN-2021, Laboratory data included: Blood count (NR: not provided) WBC high. The patient did his blood work again afterwards and the result showed 12 to 15 percent increase in his WBC. On an unspecified date in 2021, Laboratory data included: Blood count (NR: not provided) WBC (12 to 15 percent) high. His WBC continued to increase by 12 to 15 percent increments. He was later diagnosed on 03-AUG-2021 with Chronic Lymphocytic Leukemia (CLL). The patient had blood work done couple of times because he changed Jobs and Insurance. On an unspecified date, Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported. The reporter stated that if we were to go backward (WBC decrease rate of 12 to 15 percent), then she would assume that the patient's WBC was supposed to be normal in APR-2021 before he received the vaccine. The reporter did not mention any other symptoms except that the patient was really stressed about the diagnosis. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, had not recovered from chronic lymphocytic leukemia (CLL), and the outcome of stress was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211116245.; Sender's Comments: V0: 20211116191-covid-19 vaccine ad26.cov2.s-chronic lymphocytic leukemia (CLL). 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).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Pain, Pericarditis, Troponin normal
Clinical narrative: Pericarditis; sharp chest pain; could not take a deep breathe; white blood cell count high; stated that her left arm turned red; booster; This is a spontaneous report from a contactable consumer(patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 25Sep2021 (Batch/Lot Number: FF2588) at age of 67-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (MANUFACTURER UNKNOWN), on 19Jan2021 at age of 67-year-old (lot no: EL9261), and second dose on 09Feb2021 at age of 67-year-old (lot no: EN6201) for covid-19 immunisation. The patient completed first two rounds on 09Feb2021 and it had been 6 months. After the Covid booster (third shot) that she ended up in the ER with pericarditis on 03Oct2021. Stated that she is on two anti-inflammatories. Wanted to know how long to expect this to last. She is almost at the end of first prescription (month) of Colchicine. 6mg twice a day and a high dose of Ibrupofen 600mg every four hours to take for 10 days which helped bring the inflammation down. Stated that they wanted her to take it for three months. Stated that her left arm turned red on 26Sep2021 for 4-5 days. Stated that she used ice for the red left arm for Treatment. Stated that she recovered completely. Stated that she went to have echocardiogram on 03Oct2021. Stated that it revealed that it did not show any acute abnormality and to follow up with her primary care doctor. Stated that she had had the sharp chest pain and could not take a deep breathe on 03Oct202. Stated that they did a chest X-ray on 03Oct2021. The patient experienced white blood cell count high on 03Oct2021. The outcome weas recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Echocardiogram normal, Erythema
Clinical narrative: Pericarditis; sharp chest pain; could not take a deep breathe; white blood cell count high; stated that her left arm turned red; booster; This is a spontaneous report from a contactable consumer(patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 25Sep2021 (Batch/Lot Number: FF2588) at age of 67-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (MANUFACTURER UNKNOWN), on 19Jan2021 at age of 67-year-old (lot no: EL9261), and second dose on 09Feb2021 at age of 67-year-old (lot no: EN6201) for covid-19 immunisation. The patient completed first two rounds on 09Feb2021 and it had been 6 months. After the Covid booster (third shot) that she ended up in the ER with pericarditis on 03Oct2021. Stated that she is on two anti-inflammatories. Wanted to know how long to expect this to last. She is almost at the end of first prescription (month) of Colchicine. 6mg twice a day and a high dose of Ibrupofen 600mg every four hours to take for 10 days which helped bring the inflammation down. Stated that they wanted her to take it for three months. Stated that her left arm turned red on 26Sep2021 for 4-5 days. Stated that she used ice for the red left arm for Treatment. Stated that she recovered completely. Stated that she went to have echocardiogram on 03Oct2021. Stated that it revealed that it did not show any acute abnormality and to follow up with her primary care doctor. Stated that she had had the sharp chest pain and could not take a deep breathe on 03Oct202. Stated that they did a chest X-ray on 03Oct2021. The patient experienced white blood cell count high on 03Oct2021. The outcome weas recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exercise electrocardiogram, Myocardial infarction, Pericarditis, Pleurisy
Clinical narrative: Pericarditis; sharp chest pain; could not take a deep breathe; white blood cell count high; stated that her left arm turned red; booster; This is a spontaneous report from a contactable consumer(patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 25Sep2021 (Batch/Lot Number: FF2588) at age of 67-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (MANUFACTURER UNKNOWN), on 19Jan2021 at age of 67-year-old (lot no: EL9261), and second dose on 09Feb2021 at age of 67-year-old (lot no: EN6201) for covid-19 immunisation. The patient completed first two rounds on 09Feb2021 and it had been 6 months. After the Covid booster (third shot) that she ended up in the ER with pericarditis on 03Oct2021. Stated that she is on two anti-inflammatories. Wanted to know how long to expect this to last. She is almost at the end of first prescription (month) of Colchicine. 6mg twice a day and a high dose of Ibrupofen 600mg every four hours to take for 10 days which helped bring the inflammation down. Stated that they wanted her to take it for three months. Stated that her left arm turned red on 26Sep2021 for 4-5 days. Stated that she used ice for the red left arm for Treatment. Stated that she recovered completely. Stated that she went to have echocardiogram on 03Oct2021. Stated that it revealed that it did not show any acute abnormality and to follow up with her primary care doctor. Stated that she had had the sharp chest pain and could not take a deep breathe on 03Oct202. Stated that they did a chest X-ray on 03Oct2021. The patient experienced white blood cell count high on 03Oct2021. The outcome weas recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Echocardiogram, Erythema
Clinical narrative: Pericarditis; sharp chest pain; could not take a deep breathe; white blood cell count high; stated that her left arm turned red; booster; This is a spontaneous report from a contactable consumer(patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 25Sep2021 (Batch/Lot Number: FF2588) at age of 67-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (MANUFACTURER UNKNOWN), on 19Jan2021 at age of 67-year-old (lot no: EL9261), and second dose on 09Feb2021 at age of 67-year-old (lot no: EN6201) for covid-19 immunisation. The patient completed first two rounds on 09Feb2021 and it had been 6 months. After the Covid booster (third shot) that she ended up in the ER with pericarditis on 03Oct2021. Stated that she is on two anti-inflammatories. Wanted to know how long to expect this to last. She is almost at the end of first prescription (month) of Colchicine. 6mg twice a day and a high dose of Ibrupofen 600mg every four hours to take for 10 days which helped bring the inflammation down. Stated that they wanted her to take it for three months. Stated that her left arm turned red on 26Sep2021 for 4-5 days. Stated that she used ice for the red left arm for Treatment. Stated that she recovered completely. Stated that she went to have echocardiogram on 03Oct2021. Stated that it revealed that it did not show any acute abnormality and to follow up with her primary care doctor. Stated that she had had the sharp chest pain and could not take a deep breathe on 03Oct202. Stated that they did a chest X-ray on 03Oct2021. The patient experienced white blood cell count high on 03Oct2021. The outcome weas recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation, Pericarditis, White blood cell count, White blood cell count increased
Clinical narrative: Pericarditis; sharp chest pain; could not take a deep breathe; white blood cell count high; stated that her left arm turned red; booster; This is a spontaneous report from a contactable consumer(patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 3 administered in Arm Left on 25Sep2021 (Batch/Lot Number: FF2588) at age of 67-year-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (MANUFACTURER UNKNOWN), on 19Jan2021 at age of 67-year-old (lot no: EL9261), and second dose on 09Feb2021 at age of 67-year-old (lot no: EN6201) for covid-19 immunisation. The patient completed first two rounds on 09Feb2021 and it had been 6 months. After the Covid booster (third shot) that she ended up in the ER with pericarditis on 03Oct2021. Stated that she is on two anti-inflammatories. Wanted to know how long to expect this to last. She is almost at the end of first prescription (month) of Colchicine. 6mg twice a day and a high dose of Ibrupofen 600mg every four hours to take for 10 days which helped bring the inflammation down. Stated that they wanted her to take it for three months. Stated that her left arm turned red on 26Sep2021 for 4-5 days. Stated that she used ice for the red left arm for Treatment. Stated that she recovered completely. Stated that she went to have echocardiogram on 03Oct2021. Stated that it revealed that it did not show any acute abnormality and to follow up with her primary care doctor. Stated that she had had the sharp chest pain and could not take a deep breathe on 03Oct202. Stated that they did a chest X-ray on 03Oct2021. The patient experienced white blood cell count high on 03Oct2021. The outcome weas recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus - seeming to be right ear - very high pitch (10k-12k Hz); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 50-year-old female patient (not pregnant) received bnt162b2 (Pfizer COVID-19 vaccine), dose 3 via an unspecified route of administration, administered in Arm Left on 02Oct2021 at 50 years old (Batch/Lot Number: FF8839) as dose 3 (booster), single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. Medical history included migraine (aura only) - every 6 months, known allergies to lima beans, Ear infection fungal. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included clotrimazole cream in outer ears for fungus, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 (lot number: EN6200) on 03Mar2021 at 50 years old in Left arm for covid-19 immunisation, bnt162b2 dose 2 (lot number: EP7534) on 25Mar2021 at 50 years old in Left arm for covid-19 immunisation, dicloxacillin and bactrim and experienced drug allergy. The patient experienced tinnitus - seeming to be right ear - very high pitch (10k-12k Hz) on 12Oct2021. No treatment was received for the event. The event resulted in Doctor or other healthcare professional office/clinic visit. No hospitalization was prolonged. The outcome of the event was not recovered. Serious criteria for the event was reported as disabling/Incapacitating.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Laboratory test, Urticaria
Clinical narrative: Swollen lips/face' rash on face; hives all over body; itchy/burning feet and lower legs; heart rate spike IV; Prednisone, Famotidine
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Heart rate increased, Lip swelling, Pruritus, Rash
Clinical narrative: Swollen lips/face' rash on face; hives all over body; itchy/burning feet and lower legs; heart rate spike IV; Prednisone, Famotidine
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Swollen lips/face' rash on face; hives all over body; itchy/burning feet and lower legs; heart rate spike IV; Prednisone, Famotidine
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunodeficiency, Pain, Rash, Skin discolouration
Clinical narrative: pretty severe rash had broken out on both of lower legs. Not itchy but stings a bit; headache; joint pain the next day; booster dose; For the booster shot, I had chills that night; A few days later I had a few episodes of vertigo; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in arm right on 09Oct2021 11:15 (Batch/Lot Number: 301358A) as single dose for covid-19 immunisation (age at vaccination was 56-year-old). Medical history included allergies: scallops. There were no concomitant medications. Patient was not pregnant. The patient previously took erythromycin and experienced drug allergy. Historical vaccine included 1st dose BNT162B2 (Batch/Lot No: SW6208) on 19Mar2021 at 11:00 am in arm left and 2nd dose BNT162B2 (Batch/Lot No: EN6208) on 09Apr2021 at 11:00 am in arm left, both for COVID-19 immunization and experienced pain at site for a couple of days. For the booster shot, patient had chills that night (09Oct2021), headache, joint pain the next day (10Oct2021). A few days later (Oct2021) patient had a few episodes of vertigo. Patient had never experienced this before. No further episodes since. Then, 2 weeks later (25Oct2021), a pretty severe rash had broken out on both of lower legs. Not itchy but stings a bit. Patient took two diphenhydramine hydrochloride (BENADRYL) and nothing. Last night (26Oct2021) patient took two more diphenhydramine hydrochloride and it seemed to be getting better. Patient received treatment for severe rash had broken out on both of lower legs, not itchy but stings a bit. No treatment was received for other events. Outcome of vertigo was resolved. Outcome of other events was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Immunisation, Rash
Clinical narrative: pretty severe rash had broken out on both of lower legs. Not itchy but stings a bit; headache; joint pain the next day; booster dose; For the booster shot, I had chills that night; A few days later I had a few episodes of vertigo; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in arm right on 09Oct2021 11:15 (Batch/Lot Number: 301358A) as single dose for covid-19 immunisation (age at vaccination was 56-year-old). Medical history included allergies: scallops. There were no concomitant medications. Patient was not pregnant. The patient previously took erythromycin and experienced drug allergy. Historical vaccine included 1st dose BNT162B2 (Batch/Lot No: SW6208) on 19Mar2021 at 11:00 am in arm left and 2nd dose BNT162B2 (Batch/Lot No: EN6208) on 09Apr2021 at 11:00 am in arm left, both for COVID-19 immunization and experienced pain at site for a couple of days. For the booster shot, patient had chills that night (09Oct2021), headache, joint pain the next day (10Oct2021). A few days later (Oct2021) patient had a few episodes of vertigo. Patient had never experienced this before. No further episodes since. Then, 2 weeks later (25Oct2021), a pretty severe rash had broken out on both of lower legs. Not itchy but stings a bit. Patient took two diphenhydramine hydrochloride (BENADRYL) and nothing. Last night (26Oct2021) patient took two more diphenhydramine hydrochloride and it seemed to be getting better. Patient received treatment for severe rash had broken out on both of lower legs, not itchy but stings a bit. No treatment was received for other events. Outcome of vertigo was resolved. Outcome of other events was resolving.   Follow-up attempts are completed. No further information is expected.