chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 77-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 05Feb2021 14:00 (at the age of 77-years-old) as single dose for COVID-19 immunization. The patient's medical history included digestion problems, ongoing coeliac disease and allergic to gluten. Concomitant medications included vitamin B complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 05Feb2021 at 18:00, the patient was exhausted and experienced chills, headache, joint pain started in left ankle, later she had achy pains all over and felt lousy like she had the flu. The patient had new floaters in her eyes and a strange feeling in her head and was also extremely nauseous and dizzy. The patient did not take any treatment. The patient was not tested for Covid prior vaccination and post vaccination. The outcome of the events was recovered on an unspecified date in 2021. As of 07May2021, patient after shot, had some side effects with outcome of event unknown. Follow up attempts are completed. No further information is expected. Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain, Sensory disturbance
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 77-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 05Feb2021 14:00 (at the age of 77-years-old) as single dose for COVID-19 immunization. The patient's medical history included digestion problems, ongoing coeliac disease and allergic to gluten. Concomitant medications included vitamin B complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 05Feb2021 at 18:00, the patient was exhausted and experienced chills, headache, joint pain started in left ankle, later she had achy pains all over and felt lousy like she had the flu. The patient had new floaters in her eyes and a strange feeling in her head and was also extremely nauseous and dizzy. The patient did not take any treatment. The patient was not tested for Covid prior vaccination and post vaccination. The outcome of the events was recovered on an unspecified date in 2021. As of 07May2021, patient after shot, had some side effects with outcome of event unknown. Follow up attempts are completed. No further information is expected. Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: This is a Spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9261, Expiration date May2021), via subcutaneous, administered in left arm on 28Jan2021 14:35 as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot number: EL0142) via Intramuscular in left arm on 07Jan2021 for covid-19 immunisation. The patient received the second dose of the vaccine yesterday 28Jan2021. The vaccine was given subcutaneously, below the deltoid and not in the muscle at all. The patient wants to know the efficacy and safety information for the vaccine being given subcutaneously. The patient asked if she should receive a third dose after this route of administration? The patient stated she is more concerned with efficacy because patient did not have any other reactions other than injection site pain and bruising on an unspecified date in 2021. The outcome of the events unknown.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising, Vaccination site pain
Clinical narrative: This is a Spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9261, Expiration date May2021), via subcutaneous, administered in left arm on 28Jan2021 14:35 as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot number: EL0142) via Intramuscular in left arm on 07Jan2021 for covid-19 immunisation. The patient received the second dose of the vaccine yesterday 28Jan2021. The vaccine was given subcutaneously, below the deltoid and not in the muscle at all. The patient wants to know the efficacy and safety information for the vaccine being given subcutaneously. The patient asked if she should receive a third dose after this route of administration? The patient stated she is more concerned with efficacy because patient did not have any other reactions other than injection site pain and bruising on an unspecified date in 2021. The outcome of the events unknown.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Tendonitis, Tinnitus
Clinical narrative: continuing hissing noise that is quite bothersome, and does  somewhat disturb my sleep; woke up with severe hissing in head and  realized it was Tendinitis; woke up with severe hissing in head and  realized it was Tendinitis; This is a spontaneous report from a contactable consumer (patient himself). An 81-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL3247), via an unspecified route of administration administered in arm left on 12Feb2021 09:15 am as single dose for covid-19 immunization. Patient did not take other vaccine in four weeks. Medical history included high blood pressure which is under control and had put two stents in 2003 and concomitant medications (other medications in two weeks) included omeprazole, losartan, atorvastatin, metoprolol and acetylsalicylic acid (ASPRIN). Caller stated that on 14Feb2021 on Sunday morning at 4:23 he woke up with severe hissing in head and he realized it was Tendinitis. He further stated that he has a touch of this over the years, never for long period or continuous. At 08:30 am the heavy hissing noise died down, however he has since then hear a continuing hissing noise that is quite bothersome and did somewhat disturb his sleep. The patient did not receive any treatment. Patient did not received treatment for AE and not COVID prior vaccination. He was not COVID tested post vaccination. He had no known allergies. The outcome of the events was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Sleep disorder, Tendonitis
Clinical narrative: continuing hissing noise that is quite bothersome, and does  somewhat disturb my sleep; woke up with severe hissing in head and  realized it was Tendinitis; woke up with severe hissing in head and  realized it was Tendinitis; This is a spontaneous report from a contactable consumer (patient himself). An 81-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL3247), via an unspecified route of administration administered in arm left on 12Feb2021 09:15 am as single dose for covid-19 immunization. Patient did not take other vaccine in four weeks. Medical history included high blood pressure which is under control and had put two stents in 2003 and concomitant medications (other medications in two weeks) included omeprazole, losartan, atorvastatin, metoprolol and acetylsalicylic acid (ASPRIN). Caller stated that on 14Feb2021 on Sunday morning at 4:23 he woke up with severe hissing in head and he realized it was Tendinitis. He further stated that he has a touch of this over the years, never for long period or continuous. At 08:30 am the heavy hissing noise died down, however he has since then hear a continuing hissing noise that is quite bothersome and did somewhat disturb his sleep. The patient did not receive any treatment. Patient did not received treatment for AE and not COVID prior vaccination. He was not COVID tested post vaccination. He had no known allergies. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Autoscopy, Cold sweat, Dizziness, Fear
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hypopnoea, Impaired driving ability, Pain in extremity
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Panic attack
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Chills, Dehydration, Dizziness, Eye infection
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Nausea, Ophthalmological examination
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Panic attack
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Nausea, Pain
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Panic attack, Weight decreased
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Cold sweat, Dizziness, Dyspnoea, Palpitations
Clinical narrative: felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Liver function test, Muscular weakness, Myocardial necrosis marker, Tremor
Clinical narrative: she had severe non-stop shakiness/Shakiness; weakness in knees and legs; This is a spontaneous report from a contactable consumer or other non health care professional.  A 75-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 06Feb2021 10:00 as first single dose for covid-19 immunization. She has no medical history that was pertinent to this. Patient did not receive any vaccination prior. There were no concomitant medications. On 06Feb2021 15:30, the patient had severe non-stop shakiness/shakiness (9 days) and  weakness in knees and legs. After taking vaccine she was sitting there for 15 minutes. She got shaky inside. She thought it was just a little nerves. She was nervous. They asked her to stay for 15 more minutes. The shakiness was gone so she thought it was just nerves she left. Patient had already reported this adverse event to her doctors and she was doing tests for her conditions. She wanted to know what to do for the second dose of the vaccine. She did not receive any treatment for the events. Her doctor was investigating. Her doctor has scheduled an EKG and has to get a halter monitor. She went to the hospital. At first she was waiting 4 to 5 days to see if it would stop.  They were also looking at her diet to check her insulin and  see if she has hypoglycemia. They were wondering if something is triggering the process. She can't do anything normal  or she will start shaking. The shaking lasts anywhere from 30min to 1 hour to 2 hours. She doesn't know if rest helps it, but she doesn't think it does. It seems to come in waves. Sometimes she woke  up with it. She goes to bed with it sometimes too . The outcome of the events was not recovered.  Upon follow up on 15Feb2021 it was reported that patient was a reporter. Patient did not use other products. Information is merge in the narrative.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Tremor
Clinical narrative: she had severe non-stop shakiness/Shakiness; weakness in knees and legs; This is a spontaneous report from a contactable consumer or other non health care professional.  A 75-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 06Feb2021 10:00 as first single dose for covid-19 immunization. She has no medical history that was pertinent to this. Patient did not receive any vaccination prior. There were no concomitant medications. On 06Feb2021 15:30, the patient had severe non-stop shakiness/shakiness (9 days) and  weakness in knees and legs. After taking vaccine she was sitting there for 15 minutes. She got shaky inside. She thought it was just a little nerves. She was nervous. They asked her to stay for 15 more minutes. The shakiness was gone so she thought it was just nerves she left. Patient had already reported this adverse event to her doctors and she was doing tests for her conditions. She wanted to know what to do for the second dose of the vaccine. She did not receive any treatment for the events. Her doctor was investigating. Her doctor has scheduled an EKG and has to get a halter monitor. She went to the hospital. At first she was waiting 4 to 5 days to see if it would stop.  They were also looking at her diet to check her insulin and  see if she has hypoglycemia. They were wondering if something is triggering the process. She can't do anything normal  or she will start shaking. The shaking lasts anywhere from 30min to 1 hour to 2 hours. She doesn't know if rest helps it, but she doesn't think it does. It seems to come in waves. Sometimes she woke  up with it. She goes to bed with it sometimes too . The outcome of the events was not recovered.  Upon follow up on 15Feb2021 it was reported that patient was a reporter. Patient did not use other products. Information is merge in the narrative.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crohn's disease, Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Tues, 2/9, entire upper arm became very red  and very swollen, and some itching.  Wed. 2/10, Major GI problems.  Constipated, PAIN, for several hours, then Difficult multiple BMs with blood, blood clots, & mucus,  Thurs, 2/11  BMs with blood clots, mucus, Thurs 2/12 BMs with fewer blood clots
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Tues, 2/9, entire upper arm became very red  and very swollen, and some itching.  Wed. 2/10, Major GI problems.  Constipated, PAIN, for several hours, then Difficult multiple BMs with blood, blood clots, & mucus,  Thurs, 2/11  BMs with blood clots, mucus, Thurs 2/12 BMs with fewer blood clots
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Erythema, Full blood count abnormal, Gastrointestinal pain, Haematochezia
Clinical narrative: Tues, 2/9, entire upper arm became very red  and very swollen, and some itching.  Wed. 2/10, Major GI problems.  Constipated, PAIN, for several hours, then Difficult multiple BMs with blood, blood clots, & mucus,  Thurs, 2/11  BMs with blood clots, mucus, Thurs 2/12 BMs with fewer blood clots
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mucous stools, Peripheral swelling, Thrombosis
Clinical narrative: Tues, 2/9, entire upper arm became very red  and very swollen, and some itching.  Wed. 2/10, Major GI problems.  Constipated, PAIN, for several hours, then Difficult multiple BMs with blood, blood clots, & mucus,  Thurs, 2/11  BMs with blood clots, mucus, Thurs 2/12 BMs with fewer blood clots
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Fall, Hyperaesthesia
Clinical narrative: chills, burning in joints and muscles and nerves, couldn't sleep, intense pain, only on left side, couldn't walk, fell 3 times, severe joint pain
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Malaise, Muscular weakness, Paraesthesia, X-ray
Clinical narrative: chills, burning in joints and muscles and nerves, couldn't sleep, intense pain, only on left side, couldn't walk, fell 3 times, severe joint pain
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pain, Sleep disorder
Clinical narrative: chills, burning in joints and muscles and nerves, couldn't sleep, intense pain, only on left side, couldn't walk, fell 3 times, severe joint pain
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Blood thyroid stimulating hormone decreased, Computerised tomogram head normal, Electrocardiogram abnormal, Fall
Clinical narrative: The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Metabolic function test normal, Pain
Clinical narrative: The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus bradycardia
Clinical narrative: The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Blood test, Computerised tomogram, Disturbance in attention, Dizziness
Clinical narrative: The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Influenza like illness, Magnetic resonance imaging, Speech disorder
Clinical narrative: The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Confusional state, Dizziness, Dysphemia
Clinical narrative: The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Influenza like illness, Magnetic resonance imaging, Nausea
Clinical narrative: The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: HEART RACING; EXTREME DIZZINESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced heart racing. On 17-MAR-2021, the subject experienced extreme dizziness. On 19-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) Not reported. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from heart racing, and had not recovered from extreme dizziness. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Palpitations
Clinical narrative: HEART RACING; EXTREME DIZZINESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced heart racing. On 17-MAR-2021, the subject experienced extreme dizziness. On 19-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) Not reported. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from heart racing, and had not recovered from extreme dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: HEADACHE; HIVES ON FACE, NECK, AND CHEST; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, the subject experienced hives on face, neck, and chest. On 26-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normal. Treatment medications (dates unspecified) included: ibuprofen, butalbital/caffeine/paracetamol, sumatriptan, dexamethasone, prochlorperazine, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on face, neck, and chest, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Headache, Urticaria
Clinical narrative: HEADACHE; HIVES ON FACE, NECK, AND CHEST; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, the subject experienced hives on face, neck, and chest. On 26-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normal. Treatment medications (dates unspecified) included: ibuprofen, butalbital/caffeine/paracetamol, sumatriptan, dexamethasone, prochlorperazine, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on face, neck, and chest, and had not recovered from headache. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Mobility decreased, Muscle spasms, Thrombosis, Ultrasound scan abnormal
Clinical narrative: 48­/72 hours after injection patient states that she was experiencing spasms, tightening of her left calf, several days later she felt like she had a catch in her calf, gradually pain increased, 4/14/21, patient felt that she was having increasing discomfort and she presented to the emergency room, underwent venous Doppler ultrasound which revealed segmental nonocclusive thrombus in the left posterior tibial vein of the calf
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Muscle spasms, Muscle tightness, Pain in extremity, Peripheral vein thrombus extension
Clinical narrative: 48­/72 hours after injection patient states that she was experiencing spasms, tightening of her left calf, several days later she felt like she had a catch in her calf, gradually pain increased, 4/14/21, patient felt that she was having increasing discomfort and she presented to the emergency room, underwent venous Doppler ultrasound which revealed segmental nonocclusive thrombus in the left posterior tibial vein of the calf
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: 48­/72 hours after injection patient states that she was experiencing spasms, tightening of her left calf, several days later she felt like she had a catch in her calf, gradually pain increased, 4/14/21, patient felt that she was having increasing discomfort and she presented to the emergency room, underwent venous Doppler ultrasound which revealed segmental nonocclusive thrombus in the left posterior tibial vein of the calf
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscular weakness, Pain, Product administered at inappropriate site
Clinical narrative: At the vaccination site, the vaccinator did not open the car door to administer the vaccine - someone was instructing him and pointed out the acromion and stepped away.  The patient reports that he did not mention it should be 3 finger widths below.  The patient reports receiving the vaccine into the bony part, she said it felt like childbirth pain.  The next morning she reports not being able to raise her arm.  The patient reports that she has received steroids, PT, and acupuncture and is now looking at surgery since she still cannot play tennis or exercise like she used to.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Pain, Product administered at inappropriate site
Clinical narrative: At the vaccination site, the vaccinator did not open the car door to administer the vaccine - someone was instructing him and pointed out the acromion and stepped away.  The patient reports that he did not mention it should be 3 finger widths below.  The patient reports receiving the vaccine into the bony part, she said it felt like childbirth pain.  The next morning she reports not being able to raise her arm.  The patient reports that she has received steroids, PT, and acupuncture and is now looking at surgery since she still cannot play tennis or exercise like she used to.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal, Myocarditis, Orchidopexy
Clinical narrative: Chest pain with troponin elevation to 6. Cardiac MRI performed on 4/21/21 as an outpatient with no definite evidence of myocarditis but clinical syndrome consistent with myocarditis with no other etiology likely.  Symptoms resolved on initial day of symptoms on 4/17/21 and have no recurred. He's being treated with colchicine 0.6mg daily and aspirin 81mg daily.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Chest pain with troponin elevation to 6. Cardiac MRI performed on 4/21/21 as an outpatient with no definite evidence of myocarditis but clinical syndrome consistent with myocarditis with no other etiology likely.  Symptoms resolved on initial day of symptoms on 4/17/21 and have no recurred. He's being treated with colchicine 0.6mg daily and aspirin 81mg daily.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure normal, Chest pain, Magnetic resonance imaging heart, Myocarditis, Troponin increased
Clinical narrative: Chest pain with troponin elevation to 6. Cardiac MRI performed on 4/21/21 as an outpatient with no definite evidence of myocarditis but clinical syndrome consistent with myocarditis with no other etiology likely.  Symptoms resolved on initial day of symptoms on 4/17/21 and have no recurred. He's being treated with colchicine 0.6mg daily and aspirin 81mg daily.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Facial paralysis, Hypoaesthesia oral
Clinical narrative: Bell's palsy at right of the face
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Immunology test, Laboratory test
Clinical narrative: Bell's palsy at right of the face
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Nausea, Night sweats, Ocular discomfort, Pain
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.