chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Burning sensation, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: 3 days after receiving the vaccine I started having a very painful shoulder pain as days passed the pain intensified in severity and I could feel the left side of my face num, my picky and ring finger on my left arm and numbness that went from my neck down to my spinal cord this was accompanied with a burning sensation.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nodule, X-ray normal
Clinical narrative: 3 days after receiving the vaccine I started having a very painful shoulder pain as days passed the pain intensified in severity and I could feel the left side of my face num, my picky and ring finger on my left arm and numbness that went from my neck down to my spinal cord this was accompanied with a burning sensation.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, COVID-19, Chest discomfort, Chills, Cough
Clinical narrative: Pt tested positive for COVID and developed COVID pneumonia post vaccination
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Nucleic acid test, Pyrexia
Clinical narrative: Pt tested positive for COVID and developed COVID pneumonia post vaccination
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pt tested positive for COVID and developed COVID pneumonia post vaccination
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Influenza virus test, Respiratory syncytial virus test, SARS-CoV-2 test positive
Clinical narrative: Pt tested positive for COVID and developed COVID pneumonia post vaccination
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Asthenia, Chills, Gait disturbance, Headache
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Nausea, Oropharyngeal pain, Pain, Rash
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Urticaria, Vomiting
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hospitalisation
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Loss of consciousness, Memory impairment, Nausea, Vomiting
Clinical narrative: I supposedly had a seizure/diagnosis was Convulsions; I began vomiting non-stop.; dry heaving; This is spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164) via an unspecified route of administration in left arm on 19Apr2021 12:15 as 1st single dose (at the age of 58-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history was not reported. The concomitant medication included escitalopram at a dose of 10 mg. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been diagnosed with COVID-19 since the vaccination. At about the 13 minute mark post-vaccination and while waiting in the facility, on 19Apr2021 at 00:30 (as reported) patient supposedly had a seizure. She was sitting and feeling fine and then came into the medical tent. The military medic/personnel insisted she had a seizure. After she came to, she began vomiting non-stop. They put her in an ambulance and she continued vomiting/dry heaving at that point on the way to the hospital and at the hospital. She was given anti-nausea medication in the ambulance and again in the emergency room. The diagnosis at (withheld) was convulsions, unspecified type. The adverse event resulted in a visit to Emergency room/department or urgent care. The treatment given for the adverse events included Lab tests, CT Head without Contrast, Zofran. The outcome of the events was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Retching, Seizure, Vomiting
Clinical narrative: I supposedly had a seizure/diagnosis was Convulsions; I began vomiting non-stop.; dry heaving; This is spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164) via an unspecified route of administration in left arm on 19Apr2021 12:15 as 1st single dose (at the age of 58-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history was not reported. The concomitant medication included escitalopram at a dose of 10 mg. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been diagnosed with COVID-19 since the vaccination. At about the 13 minute mark post-vaccination and while waiting in the facility, on 19Apr2021 at 00:30 (as reported) patient supposedly had a seizure. She was sitting and feeling fine and then came into the medical tent. The military medic/personnel insisted she had a seizure. After she came to, she began vomiting non-stop. They put her in an ambulance and she continued vomiting/dry heaving at that point on the way to the hospital and at the hospital. She was given anti-nausea medication in the ambulance and again in the emergency room. The diagnosis at (withheld) was convulsions, unspecified type. The adverse event resulted in a visit to Emergency room/department or urgent care. The treatment given for the adverse events included Lab tests, CT Head without Contrast, Zofran. The outcome of the events was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Chest pain, Computerised tomogram thorax, Gene mutation identification test negative, Hypoaesthesia
Clinical narrative: BLOOD CLOTS IN LUNGS; COMPLICATED MIGRAINE; ANEMIA; INJECTION SITE PAIN; BODY PAIN; This spontaneous report received from a patient concerned a 31 year old African American and not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: 20-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included escitalopram oxalate.   On 09-APR-2021, the patient experienced body pain, injection site pain on left arm as it had been injected incorrectly that lasted for 4 days. On 17-APR-2021, the patient experienced experienced chest pain, complicated migraine, shortness of breath, left arm numbness, anxiety and weakness. The patient took tylenol (paracetamol) to sleep at night. The patient went to the hospital on 18-APR-2021 and was hospitalized for 3 days. It was found that she had blood clots in her lungs. The patient was discharged on 20-APR-2021 and was put on treatment medications, 2 tablets of xarelto 15 milligram once daily for 3 weeks and it was decreased to 1 tablet 20 milligram daily for 6 months. The patient was put on topiramate 50 milligram daily for migraine, ferrous gluconate 195 milligram for anemia, hydroxyzine 50 milligram for anxiety due to chest pain and 2 tablets of tylenol (extra strength) for chest pain. The patient had no relevant medical history. The patient had a nuvaring for birth control. On 26- MAR-2021, she was also started on lexapro 10 milligram. The symptoms were not resolved except injection site pain and the doctor thought the left arm numbness was due to migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-APR-2021, was recovering from body pain, complicated migraine (left arm numbness and weakness) and the outcome blood clots in lungs (chest pain, shortness of breath and anxiety) and anemia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523268-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots in lungs, Complicated migraine. 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myocardial strain, Pulmonary embolism
Clinical narrative: BLOOD CLOTS IN LUNGS; COMPLICATED MIGRAINE; ANEMIA; INJECTION SITE PAIN; BODY PAIN; This spontaneous report received from a patient concerned a 31 year old African American and not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: 20-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included escitalopram oxalate.   On 09-APR-2021, the patient experienced body pain, injection site pain on left arm as it had been injected incorrectly that lasted for 4 days. On 17-APR-2021, the patient experienced experienced chest pain, complicated migraine, shortness of breath, left arm numbness, anxiety and weakness. The patient took tylenol (paracetamol) to sleep at night. The patient went to the hospital on 18-APR-2021 and was hospitalized for 3 days. It was found that she had blood clots in her lungs. The patient was discharged on 20-APR-2021 and was put on treatment medications, 2 tablets of xarelto 15 milligram once daily for 3 weeks and it was decreased to 1 tablet 20 milligram daily for 6 months. The patient was put on topiramate 50 milligram daily for migraine, ferrous gluconate 195 milligram for anemia, hydroxyzine 50 milligram for anxiety due to chest pain and 2 tablets of tylenol (extra strength) for chest pain. The patient had no relevant medical history. The patient had a nuvaring for birth control. On 26- MAR-2021, she was also started on lexapro 10 milligram. The symptoms were not resolved except injection site pain and the doctor thought the left arm numbness was due to migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-APR-2021, was recovering from body pain, complicated migraine (left arm numbness and weakness) and the outcome blood clots in lungs (chest pain, shortness of breath and anxiety) and anemia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523268-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots in lungs, Complicated migraine. 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Injection site pain, Migraine, Pain, Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN LUNGS; COMPLICATED MIGRAINE; ANEMIA; INJECTION SITE PAIN; BODY PAIN; This spontaneous report received from a patient concerned a 31 year old African American and not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: 20-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included escitalopram oxalate.   On 09-APR-2021, the patient experienced body pain, injection site pain on left arm as it had been injected incorrectly that lasted for 4 days. On 17-APR-2021, the patient experienced experienced chest pain, complicated migraine, shortness of breath, left arm numbness, anxiety and weakness. The patient took tylenol (paracetamol) to sleep at night. The patient went to the hospital on 18-APR-2021 and was hospitalized for 3 days. It was found that she had blood clots in her lungs. The patient was discharged on 20-APR-2021 and was put on treatment medications, 2 tablets of xarelto 15 milligram once daily for 3 weeks and it was decreased to 1 tablet 20 milligram daily for 6 months. The patient was put on topiramate 50 milligram daily for migraine, ferrous gluconate 195 milligram for anemia, hydroxyzine 50 milligram for anxiety due to chest pain and 2 tablets of tylenol (extra strength) for chest pain. The patient had no relevant medical history. The patient had a nuvaring for birth control. On 26- MAR-2021, she was also started on lexapro 10 milligram. The symptoms were not resolved except injection site pain and the doctor thought the left arm numbness was due to migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-APR-2021, was recovering from body pain, complicated migraine (left arm numbness and weakness) and the outcome blood clots in lungs (chest pain, shortness of breath and anxiety) and anemia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523268-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots in lungs, Complicated migraine. 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: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Oropharyngeal pain, Pyrexia
Clinical narrative: I have been running on fever now from 100-102 was reported as worsened; I have been running on fever now from 100-102 was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0158, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 53-year-old) as 1ST dose, single for covid-19 immunization. The patient medical history included to stabilize my thyroid. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken 0.05 mg, 1x/day (One tablet daily before breakfast) for to stabilize her thyroid with ongoing; liothyronine sodium (CYTOMEL) taken 5 ug, 2x/day(2 tablets orally daily in the morning before breakfast) orally for to stabilize her thyroid with ongoing. Consumer stated that she was reported the first reaction to the vaccine. She has been running on fever now from 100-102 since Friday afternoon. She was received the vaccine last Wednesday and she just did not think that was normal. Consumer further stated, she did not know if she was going to take second shot if she feels like that. The second shot is rescheduled for 05May2021. Consumer wanted to know if that was normal. On 16Apr2021, the patient reported, I have been running on fever now from 100-102 was reported as worsened. Reported seriousness for the event was unspecified. The patient underwent lab tests and procedures which included body temperature: 100-102 on 16Apr2021. Therapeutic measures were taken as a result of the event a treatment included with, she took 2 tablets of Tylenol Extra Strength 500 mg and orally when her fever was high. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Condition aggravated, Pyrexia
Clinical narrative: I have been running on fever now from 100-102 was reported as worsened; I have been running on fever now from 100-102 was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0158, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 53-year-old) as 1ST dose, single for covid-19 immunization. The patient medical history included to stabilize my thyroid. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken 0.05 mg, 1x/day (One tablet daily before breakfast) for to stabilize her thyroid with ongoing; liothyronine sodium (CYTOMEL) taken 5 ug, 2x/day(2 tablets orally daily in the morning before breakfast) orally for to stabilize her thyroid with ongoing. Consumer stated that she was reported the first reaction to the vaccine. She has been running on fever now from 100-102 since Friday afternoon. She was received the vaccine last Wednesday and she just did not think that was normal. Consumer further stated, she did not know if she was going to take second shot if she feels like that. The second shot is rescheduled for 05May2021. Consumer wanted to know if that was normal. On 16Apr2021, the patient reported, I have been running on fever now from 100-102 was reported as worsened. Reported seriousness for the event was unspecified. The patient underwent lab tests and procedures which included body temperature: 100-102 on 16Apr2021. Therapeutic measures were taken as a result of the event a treatment included with, she took 2 tablets of Tylenol Extra Strength 500 mg and orally when her fever was high. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Guillian-Barre syndrome; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (Lot Number: EP6955) via an unspecified route of administration, administered in left arm on 24Mar2021 at 15:30 at age of 42-year-old as single dose, and second dose of BNT162B2 (Lot Number: ER8735) via an unspecified route of administration, administered in left arm on 15Apr2021 at 15:30 at age of 42-year-old as single dose for covid-19 immunisation. Medical history was not reported. There were none other medications in two weeks, no other medications in four weeks. No COVID prior vaccination, no COVID tested post vaccination. The patient experienced guillian-barre syndrome on 19Apr2021 at 06:00. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian-Barre syndrome; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (Lot Number: EP6955) via an unspecified route of administration, administered in left arm on 24Mar2021 at 15:30 at age of 42-year-old as single dose, and second dose of BNT162B2 (Lot Number: ER8735) via an unspecified route of administration, administered in left arm on 15Apr2021 at 15:30 at age of 42-year-old as single dose for covid-19 immunisation. Medical history was not reported. There were none other medications in two weeks, no other medications in four weeks. No COVID prior vaccination, no COVID tested post vaccination. The patient experienced guillian-barre syndrome on 19Apr2021 at 06:00. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Pruritus
Clinical narrative: Pt received 1st dose Pfizer at 1102. At 1123 pt complained of "itching all over", SOB, and coughing. LPN called ED Charge RN. Pt transported to ED via wheelchair for evaluation. Pt accompanied by husband. Reaction documented in EMR.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Choking sensation, Cough, Dizziness, Electrocardiogram
Clinical narrative: Pt received 1st dose Pfizer at 1102. At 1123 pt complained of "itching all over", SOB, and coughing. LPN called ED Charge RN. Pt transported to ED via wheelchair for evaluation. Pt accompanied by husband. Reaction documented in EMR.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Throat clearing
Clinical narrative: Pt received 1st dose Pfizer at 1102. At 1123 pt complained of "itching all over", SOB, and coughing. LPN called ED Charge RN. Pt transported to ED via wheelchair for evaluation. Pt accompanied by husband. Reaction documented in EMR.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: 5:11 pt fall from chair, hit R side of head on asphalt 5:12 911 called DR. states she thinks it is Vaso Vegal Reponse 5:19 pt sitting up now, c/o headache, states he has had this response before 5:27 paramedics arrive, evaluate and leave at 5:35 6:02 Pt with his friend and drove him home.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Skin abrasion
Clinical narrative: 5:11 pt fall from chair, hit R side of head on asphalt 5:12 911 called DR. states she thinks it is Vaso Vegal Reponse 5:19 pt sitting up now, c/o headache, states he has had this response before 5:27 paramedics arrive, evaluate and leave at 5:35 6:02 Pt with his friend and drove him home.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Headache, Presyncope
Clinical narrative: 5:11 pt fall from chair, hit R side of head on asphalt 5:12 911 called DR. states she thinks it is Vaso Vegal Reponse 5:19 pt sitting up now, c/o headache, states he has had this response before 5:27 paramedics arrive, evaluate and leave at 5:35 6:02 Pt with his friend and drove him home.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: VAULT - Saliva, covid test positive on 22Feb2021; VAULT - Saliva, covid test positive on 22Feb2021; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; Weakness in my right arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jan2021 18:30 (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 22Jan2021 18:30, immediately after administration, the patient experienced shooting tingling/numbness/pain that went from the injection site down my arm to my fingers. The sensation worsened and became more painful accompanied by a weakness in her right arm. The patient went my primary care physician to have this looked at. Her injection was nearly 3.5 months ago and she still continue to experience the same symptoms. The events were considered serious, disability.  The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included VAULT - Saliva, covid test on 08Feb2021, 24Feb2021 and 01Mar2021 with negative result and positive on 22Feb2021. The outcome of events VAULT - Saliva, covid test positive on 22Feb2021 was unknown; all other events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain, Paraesthesia
Clinical narrative: VAULT - Saliva, covid test positive on 22Feb2021; VAULT - Saliva, covid test positive on 22Feb2021; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; Weakness in my right arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jan2021 18:30 (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 22Jan2021 18:30, immediately after administration, the patient experienced shooting tingling/numbness/pain that went from the injection site down my arm to my fingers. The sensation worsened and became more painful accompanied by a weakness in her right arm. The patient went my primary care physician to have this looked at. Her injection was nearly 3.5 months ago and she still continue to experience the same symptoms. The events were considered serious, disability.  The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included VAULT - Saliva, covid test on 08Feb2021, 24Feb2021 and 01Mar2021 with negative result and positive on 22Feb2021. The outcome of events VAULT - Saliva, covid test positive on 22Feb2021 was unknown; all other events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Muscular weakness, SARS-CoV-2 test, Suspected COVID-19, Vaccination site hypoaesthesia
Clinical narrative: VAULT - Saliva, covid test positive on 22Feb2021; VAULT - Saliva, covid test positive on 22Feb2021; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; Weakness in my right arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jan2021 18:30 (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 22Jan2021 18:30, immediately after administration, the patient experienced shooting tingling/numbness/pain that went from the injection site down my arm to my fingers. The sensation worsened and became more painful accompanied by a weakness in her right arm. The patient went my primary care physician to have this looked at. Her injection was nearly 3.5 months ago and she still continue to experience the same symptoms. The events were considered serious, disability.  The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included VAULT - Saliva, covid test on 08Feb2021, 24Feb2021 and 01Mar2021 with negative result and positive on 22Feb2021. The outcome of events VAULT - Saliva, covid test positive on 22Feb2021 was unknown; all other events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: VAULT - Saliva, covid test positive on 22Feb2021; VAULT - Saliva, covid test positive on 22Feb2021; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; shooting tingling/numbness/pain that went from the injection site down my arm to my fingers; Weakness in my right arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jan2021 18:30 (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 22Jan2021 18:30, immediately after administration, the patient experienced shooting tingling/numbness/pain that went from the injection site down my arm to my fingers. The sensation worsened and became more painful accompanied by a weakness in her right arm. The patient went my primary care physician to have this looked at. Her injection was nearly 3.5 months ago and she still continue to experience the same symptoms. The events were considered serious, disability.  The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included VAULT - Saliva, covid test on 08Feb2021, 24Feb2021 and 01Mar2021 with negative result and positive on 22Feb2021. The outcome of events VAULT - Saliva, covid test positive on 22Feb2021 was unknown; all other events was not recovered.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chills, Dizziness, Heart rate increased, Hypotension
Clinical narrative: Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 17 years old) (Lot Number: EW0171, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history reported as none. No known allergies. The patient's concomitant medications were not reported. The patient also received first dose of BNT162B2 on 08Apr2021 at 16:30 in the left arm (at the age of 16 years old; Lot number: EW0150, unknown expiration) for COVID-19 immunization. The patient experienced fainting/syncope, high fever, and lightheadedness on 30Apr2021 at 06:45 AM. The events resulted in emergency room/department or urgent care visit.  The patient received IV fluids as treatment for the events. No COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is recovering from the events.   Information on lot/batch number was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 17 years old) (Lot Number: EW0171, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history reported as none. No known allergies. The patient's concomitant medications were not reported. The patient also received first dose of BNT162B2 on 08Apr2021 at 16:30 in the left arm (at the age of 16 years old; Lot number: EW0150, unknown expiration) for COVID-19 immunization. The patient experienced fainting/syncope, high fever, and lightheadedness on 30Apr2021 at 06:45 AM. The events resulted in emergency room/department or urgent care visit.  The patient received IV fluids as treatment for the events. No COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is recovering from the events.   Information on lot/batch number was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pyrexia, Syncope
Clinical narrative: Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 17 years old) (Lot Number: EW0171, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history reported as none. No known allergies. The patient's concomitant medications were not reported. The patient also received first dose of BNT162B2 on 08Apr2021 at 16:30 in the left arm (at the age of 16 years old; Lot number: EW0150, unknown expiration) for COVID-19 immunization. The patient experienced fainting/syncope, high fever, and lightheadedness on 30Apr2021 at 06:45 AM. The events resulted in emergency room/department or urgent care visit.  The patient received IV fluids as treatment for the events. No COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is recovering from the events.   Information on lot/batch number was available. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram head normal, Computerised tomogram thorax normal, Fibrin D dimer increased, Head injury
Clinical narrative: concussion; lost consciousness; fell; hit my head on the bathroom floor; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 33-years-old, via an unspecified route of administration, administered in Arm Left on 27Apr2021 12:45 PM (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, syncope from an unknown date and unknown if ongoing (last episode 2008). Concomitant medication included minocycline hcl taken for an unspecified indication, start and stop date were not reported at 50mg. (patient received within 2 weeks of vaccination). Patient received first dose of bnt162b2 at the age of 33-years-old, administered in Arm Right on 06Apr2021 12:30 PM (Lot Number: EW0158) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In the middle of the night, patient woke up to use the bathroom. At some time, he lost consciousness, fell, and hit head on the bathroom floor. Patient regained consciousness around 3am. At the hospital, he was diagnosed with a concussion. Event start date was at 28Apr2021 01:00 AM. Events resulted in Emergency room/department or urgent care, Hospitalization. Days hospitalization was 1. Treatment received for the adverse event was Testing and observation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Covid test name post vaccination was BioFire, Type post vaccination was Nasal Swab, test date on 28Apr2021, test result was Negative. Events outcome was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Scan with contrast normal, Syncope, Troponin normal
Clinical narrative: concussion; lost consciousness; fell; hit my head on the bathroom floor; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 33-years-old, via an unspecified route of administration, administered in Arm Left on 27Apr2021 12:45 PM (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, syncope from an unknown date and unknown if ongoing (last episode 2008). Concomitant medication included minocycline hcl taken for an unspecified indication, start and stop date were not reported at 50mg. (patient received within 2 weeks of vaccination). Patient received first dose of bnt162b2 at the age of 33-years-old, administered in Arm Right on 06Apr2021 12:30 PM (Lot Number: EW0158) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In the middle of the night, patient woke up to use the bathroom. At some time, he lost consciousness, fell, and hit head on the bathroom floor. Patient regained consciousness around 3am. At the hospital, he was diagnosed with a concussion. Event start date was at 28Apr2021 01:00 AM. Events resulted in Emergency room/department or urgent care, Hospitalization. Days hospitalization was 1. Treatment received for the adverse event was Testing and observation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Covid test name post vaccination was BioFire, Type post vaccination was Nasal Swab, test date on 28Apr2021, test result was Negative. Events outcome was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Concussion, Fall, Head injury, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: concussion; lost consciousness; fell; hit my head on the bathroom floor; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 33-years-old, via an unspecified route of administration, administered in Arm Left on 27Apr2021 12:45 PM (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, syncope from an unknown date and unknown if ongoing (last episode 2008). Concomitant medication included minocycline hcl taken for an unspecified indication, start and stop date were not reported at 50mg. (patient received within 2 weeks of vaccination). Patient received first dose of bnt162b2 at the age of 33-years-old, administered in Arm Right on 06Apr2021 12:30 PM (Lot Number: EW0158) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In the middle of the night, patient woke up to use the bathroom. At some time, he lost consciousness, fell, and hit head on the bathroom floor. Patient regained consciousness around 3am. At the hospital, he was diagnosed with a concussion. Event start date was at 28Apr2021 01:00 AM. Events resulted in Emergency room/department or urgent care, Hospitalization. Days hospitalization was 1. Treatment received for the adverse event was Testing and observation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Covid test name post vaccination was BioFire, Type post vaccination was Nasal Swab, test date on 28Apr2021, test result was Negative. Events outcome was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Full blood count normal, Platelet count normal, Pulmonary embolism
Clinical narrative: Recall right knee pain about 10 days after injection. Have had previous knee surgery years ago and discounted it. Then on morning of 5/02 had two episodes of severe shortness of breath with elevated, resting heart rate (high 130 beats per minute) per smart watch device. Went to Emergency Room at 1 PM and was diagnosed with two large, bilateral pulmonary embolisms and two DVTs in right leg. Transferred to another Hospital as this hospital did not have a Pulmonologist on site for the weekend. Admitted ICU at about 6 PM.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest X-ray, Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea
Clinical narrative: Recall right knee pain about 10 days after injection. Have had previous knee surgery years ago and discounted it. Then on morning of 5/02 had two episodes of severe shortness of breath with elevated, resting heart rate (high 130 beats per minute) per smart watch device. Went to Emergency Room at 1 PM and was diagnosed with two large, bilateral pulmonary embolisms and two DVTs in right leg. Transferred to another Hospital as this hospital did not have a Pulmonologist on site for the weekend. Admitted ICU at about 6 PM.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate increased, Laboratory test, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: Recall right knee pain about 10 days after injection. Have had previous knee surgery years ago and discounted it. Then on morning of 5/02 had two episodes of severe shortness of breath with elevated, resting heart rate (high 130 beats per minute) per smart watch device. Went to Emergency Room at 1 PM and was diagnosed with two large, bilateral pulmonary embolisms and two DVTs in right leg. Transferred to another Hospital as this hospital did not have a Pulmonologist on site for the weekend. Admitted ICU at about 6 PM.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Blood test, Cranial nerve disorder, Electromyogram
Clinical narrative: Concern for progressive acute demyelinating encephalomyelitis possibly post vaccination (Moderna COVID-19 2nd does late February 2021,  2 weeks prior to symptoms onset). Patient was treated with 5 sessions of plasma exchange, IV methylprednisolone, IVIG and rituxan x1 dose prior to discharge. This entry is an update to the ADR entered by Dr. Patient has expired at the rehab facility s/p discharge.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck, Magnetic resonance imaging spinal
Clinical narrative: Concern for progressive acute demyelinating encephalomyelitis possibly post vaccination (Moderna COVID-19 2nd does late February 2021,  2 weeks prior to symptoms onset). Patient was treated with 5 sessions of plasma exchange, IV methylprednisolone, IVIG and rituxan x1 dose prior to discharge. This entry is an update to the ADR entered by Dr. Patient has expired at the rehab facility s/p discharge.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Death, Immunoglobulin therapy, Plasmapheresis
Clinical narrative: Concern for progressive acute demyelinating encephalomyelitis possibly post vaccination (Moderna COVID-19 2nd does late February 2021,  2 weeks prior to symptoms onset). Patient was treated with 5 sessions of plasma exchange, IV methylprednisolone, IVIG and rituxan x1 dose prior to discharge. This entry is an update to the ADR entered by Dr. Patient has expired at the rehab facility s/p discharge.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Brain stem infarction, Cerebrovascular disorder, Dysarthria, General physical health deterioration
Clinical narrative: Concern for progressive acute demyelinating encephalomyelitis possibly post vaccination (Moderna COVID-19 2nd does late February 2021,  2 weeks prior to symptoms onset). Patient was treated with 5 sessions of plasma exchange, IV methylprednisolone, IVIG and rituxan x1 dose prior to discharge. This entry is an update to the ADR entered by Dr. Patient has expired at the rehab facility s/p discharge.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ischaemia, Magnetic resonance imaging head abnormal, Osmotic demyelination syndrome
Clinical narrative: Concern for progressive acute demyelinating encephalomyelitis possibly post vaccination (Moderna COVID-19 2nd does late February 2021,  2 weeks prior to symptoms onset). Patient was treated with 5 sessions of plasma exchange, IV methylprednisolone, IVIG and rituxan x1 dose prior to discharge. This entry is an update to the ADR entered by Dr. Patient has expired at the rehab facility s/p discharge.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Magnetic resonance imaging, Status migrainosus
Clinical narrative: Status Migrainsosus; headaches; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:45 (Lot Number: ER 8735) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (lot number: EP6955) 1ST DOSE, on 03Mar2021 04:30pm for COVID-19 immunisation. On 13Apr2021, the patient experienced status migrainsosus and was being seen at the hospital. The patient had severe headaches on 13Apr2021 that's been ongoing since the day the second shot was given. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): negative on 27apr2021. The outcome of the events was not recovered. Treatment of IV infusions migraine emergency medicine was given for the events. The events resulted in emergency room/department or urgent care. The patient was in the hospital for 2 days.