chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: She experienced rash and itching; She experienced rash and itching; This is a spontaneous report from a contactable consumer, the patient. A Female patient (unknown if pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration as a single dose for covid-19 immunisation on 04Mar2021. NDC number of COVID vaccine was not provided. Investigation Assessment was not provided. The patient's relevant medical history and concomitant medications were not reported. Caller said that she received her Pfizer shot on 04MAR2021, the first dose, and she is having a little bit of a rash and some itching. She went to see her doctor yesterday and she was put on a 3 day dose of prednisone. Her question is, is this considered a mild case and should she get the second shot?   She was reading that what she experienced is a side effect and it is on the mild side. The itching was bad enough. She didn't know if Pfizer had any recommendation for what she should do and she is wondering what they are saying about it. When asked if caller had time to complete a safety report in regard to what she had experienced she said that she would like to just have her question answered. She said the safety thing is not going to get her an answer to her question. She just wanted to talk to someone about this. Caller declined to complete a report at that time, unable to obtain any further information in regard to the safety report or the supplemental form. Informed caller that the medical information department is unable to provide any medical advice or instruct the caller to receive or not to receive the second COVID vaccine. She was referred to her physician to discuss this. Reporter seriousness for having a little bit of a rash and some itching was Unspecified. The outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.  Follow up (10Mar2021): This is follow-up report received from a contactable consumer. Included: Dates for COVID vaccine, Lot number.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lymph node pain, Nipple exudate bloody
Clinical narrative: able to express old blood out of nipple; Chest pains; a minor red rash on one side of breast; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2 (Lot Number was EN6198, expiration date was unknown) via an unspecified route of administration at left arm on 21Feb2021 16:45 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient previously took Sumatriptan 1 week before vaccination on Feb2021. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. The patient experienced chest pains in the left upper side close to her collar bone able to express old blood out of nipple and had a minor red rash on one side of breast on 07Mar2021 at 14:00. She did not receive any treatment for the event. Patient had been tested for COVID-19 via nasal swab with negative result on 01Mar2021. The outcome of events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Nipple exudate bloody, Rash erythematous, SARS-CoV-2 test
Clinical narrative: able to express old blood out of nipple; Chest pains; a minor red rash on one side of breast; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2 (Lot Number was EN6198, expiration date was unknown) via an unspecified route of administration at left arm on 21Feb2021 16:45 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient previously took Sumatriptan 1 week before vaccination on Feb2021. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. The patient experienced chest pains in the left upper side close to her collar bone able to express old blood out of nipple and had a minor red rash on one side of breast on 07Mar2021 at 14:00. She did not receive any treatment for the event. Patient had been tested for COVID-19 via nasal swab with negative result on 01Mar2021. The outcome of events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Fatigue, Swelling, Urticaria
Clinical narrative: Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at 15:30 at single dose in left arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EM9810. Medical history included possible atrial fibrillation, allergy to sulfa. Past drug history included allergy to antibiotic drugs, Betoptic, Motrin, Iodine, Nickel, Latex, Ragweed, Mold, Grass, Cat, Bee. The patient was not pregnant. On 03Mar2021 at 18:00 approximately, the patient experienced angioedema (Face), Hives (between the eyes and forehead), Extreme Fatigue. The patient was not treated for the events. The patient was recovering from the events. In 2017, IgG Anti-IgE resulted elevated. It was unknown if the patient had Covid before vaccination. The patient was not tested for Covid after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Blood immunoglobulin E, Fatigue, Urticaria
Clinical narrative: Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at 15:30 at single dose in left arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EM9810. Medical history included possible atrial fibrillation, allergy to sulfa. Past drug history included allergy to antibiotic drugs, Betoptic, Motrin, Iodine, Nickel, Latex, Ragweed, Mold, Grass, Cat, Bee. The patient was not pregnant. On 03Mar2021 at 18:00 approximately, the patient experienced angioedema (Face), Hives (between the eyes and forehead), Extreme Fatigue. The patient was not treated for the events. The patient was recovering from the events. In 2017, IgG Anti-IgE resulted elevated. It was unknown if the patient had Covid before vaccination. The patient was not tested for Covid after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Note: This VAERS report is associated with the patient self-reported VAERS # 348989 submitted 3/11/2021. I, as the Medical Director of Occupational Health at Hospital (patient's employer)submitting this VAERS on behalf of the patient since none of the other involved HCPs to her knowledge have submitted a VAERS.  On February 27,2021 about 36 hours after the vaccine administration, patient noted some speech difficulty, but no other symptoms were present at the time.  She went to sleep that night. She woke up the next morning February 28 at 6:30 am and noted slurred speech, lack of strength and coordination on her right arm and some asymmetry in her face.She was taken to the emergency room where a CT brain was performed and came back with no anomalies found.  She was transferred to the hospital where she lives. She was hospitalized Feb 28th - March 3rd during which time extensive diagnostic workup was done and she was discharged with a diagnosis of ischemic stroke.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram cerebral normal, Asthenia, Chest X-ray normal, Computerised tomogram head
Clinical narrative: Note: This VAERS report is associated with the patient self-reported VAERS # 348989 submitted 3/11/2021. I, as the Medical Director of Occupational Health at Hospital (patient's employer)submitting this VAERS on behalf of the patient since none of the other involved HCPs to her knowledge have submitted a VAERS.  On February 27,2021 about 36 hours after the vaccine administration, patient noted some speech difficulty, but no other symptoms were present at the time.  She went to sleep that night. She woke up the next morning February 28 at 6:30 am and noted slurred speech, lack of strength and coordination on her right arm and some asymmetry in her face.She was taken to the emergency room where a CT brain was performed and came back with no anomalies found.  She was transferred to the hospital where she lives. She was hospitalized Feb 28th - March 3rd during which time extensive diagnostic workup was done and she was discharged with a diagnosis of ischemic stroke.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Coordination abnormal, Dysarthria, Facial asymmetry
Clinical narrative: Note: This VAERS report is associated with the patient self-reported VAERS # 348989 submitted 3/11/2021. I, as the Medical Director of Occupational Health at Hospital (patient's employer)submitting this VAERS on behalf of the patient since none of the other involved HCPs to her knowledge have submitted a VAERS.  On February 27,2021 about 36 hours after the vaccine administration, patient noted some speech difficulty, but no other symptoms were present at the time.  She went to sleep that night. She woke up the next morning February 28 at 6:30 am and noted slurred speech, lack of strength and coordination on her right arm and some asymmetry in her face.She was taken to the emergency room where a CT brain was performed and came back with no anomalies found.  She was transferred to the hospital where she lives. She was hospitalized Feb 28th - March 3rd during which time extensive diagnostic workup was done and she was discharged with a diagnosis of ischemic stroke.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Scan with contrast normal, Speech disorder
Clinical narrative: Note: This VAERS report is associated with the patient self-reported VAERS # 348989 submitted 3/11/2021. I, as the Medical Director of Occupational Health at Hospital (patient's employer)submitting this VAERS on behalf of the patient since none of the other involved HCPs to her knowledge have submitted a VAERS.  On February 27,2021 about 36 hours after the vaccine administration, patient noted some speech difficulty, but no other symptoms were present at the time.  She went to sleep that night. She woke up the next morning February 28 at 6:30 am and noted slurred speech, lack of strength and coordination on her right arm and some asymmetry in her face.She was taken to the emergency room where a CT brain was performed and came back with no anomalies found.  She was transferred to the hospital where she lives. She was hospitalized Feb 28th - March 3rd during which time extensive diagnostic workup was done and she was discharged with a diagnosis of ischemic stroke.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Ultrasound scan normal
Clinical narrative: Note: This VAERS report is associated with the patient self-reported VAERS # 348989 submitted 3/11/2021. I, as the Medical Director of Occupational Health at Hospital (patient's employer)submitting this VAERS on behalf of the patient since none of the other involved HCPs to her knowledge have submitted a VAERS.  On February 27,2021 about 36 hours after the vaccine administration, patient noted some speech difficulty, but no other symptoms were present at the time.  She went to sleep that night. She woke up the next morning February 28 at 6:30 am and noted slurred speech, lack of strength and coordination on her right arm and some asymmetry in her face.She was taken to the emergency room where a CT brain was performed and came back with no anomalies found.  She was transferred to the hospital where she lives. She was hospitalized Feb 28th - March 3rd during which time extensive diagnostic workup was done and she was discharged with a diagnosis of ischemic stroke.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Urticaria
Clinical narrative: VACCINE GIVEN 3/4, PATIENT STATED ON 4/1 THAT ON 3/7 SHE FELT NUMBNESS ON SIDE OF CHEEK AND NECK AND FELT IT MOVING TO THROAT, SHE TOOK A BENADRYL. ALSO WELT ON BACK OF NECK
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pharyngeal hypoaesthesia, Urticaria
Clinical narrative: VACCINE GIVEN 3/4, PATIENT STATED ON 4/1 THAT ON 3/7 SHE FELT NUMBNESS ON SIDE OF CHEEK AND NECK AND FELT IT MOVING TO THROAT, SHE TOOK A BENADRYL. ALSO WELT ON BACK OF NECK
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: SEIZURES; SEVERE CHILLS; SEVERE FEVER; CARDIAC ARREST; HEART FAILURE; FEELING ILL; VERY BAD HEADACHE; This spontaneous report received from parent of patient via social media post and concerned a 32 year old male. The patient's height, and weight were not reported. The patient did not have any underlying health conditions.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the patient had a very bad headache. Patient was feeling ill, went to sleep and then woke up to severe fever and chills at 1 am on 14-MAR-2021. He had seizures at 4 am on 14-MAR-2021 and went into cardiac arrest minutes later. It was reported that emergency services tried to revive him at his apartment and they tried at the hospital until he was declared dead at 6:05 am, less than 24 hours after receiving the vaccine.  On 14-MAR-2021, the patient died from cardiac arrest, and heart failure. An autopsy was performed on an unspecified date. It was reported that the autopsy came back suspicious and inconclusive pending further investigation. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome for feeling ill, seizures, headache, fever and chills was unknown. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report received via a social media post reported a 32-year-old male, with no reported significant underlying health issues, who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died less than 24 hours later.  Concomitant medications were not reported.  The day that the patient received his vaccination, he experienced a "very bad" headache.  He reportedly was feeling "ill" and went to sleep. Early the next morning (1:00 AM), he awoke with "severe" fever and chills.  Three hours later, he reportedly experienced seizures and "minutes later" went into "cardiac arrest".   The patient subsequently died of "cardiac arrest" and "heart failure".  Autopsy results reportedly came back as "suspicious and inconclusive pending further investigation".   There is insufficient information provided in this case to make a meaningful medical assessment.; Reported Cause(s) of Death: CARDIAC ARREST; HEART FAILURE
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Chills, Death, Headache, Malaise
Clinical narrative: SEIZURES; SEVERE CHILLS; SEVERE FEVER; CARDIAC ARREST; HEART FAILURE; FEELING ILL; VERY BAD HEADACHE; This spontaneous report received from parent of patient via social media post and concerned a 32 year old male. The patient's height, and weight were not reported. The patient did not have any underlying health conditions.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the patient had a very bad headache. Patient was feeling ill, went to sleep and then woke up to severe fever and chills at 1 am on 14-MAR-2021. He had seizures at 4 am on 14-MAR-2021 and went into cardiac arrest minutes later. It was reported that emergency services tried to revive him at his apartment and they tried at the hospital until he was declared dead at 6:05 am, less than 24 hours after receiving the vaccine.  On 14-MAR-2021, the patient died from cardiac arrest, and heart failure. An autopsy was performed on an unspecified date. It was reported that the autopsy came back suspicious and inconclusive pending further investigation. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome for feeling ill, seizures, headache, fever and chills was unknown. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report received via a social media post reported a 32-year-old male, with no reported significant underlying health issues, who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died less than 24 hours later.  Concomitant medications were not reported.  The day that the patient received his vaccination, he experienced a "very bad" headache.  He reportedly was feeling "ill" and went to sleep. Early the next morning (1:00 AM), he awoke with "severe" fever and chills.  Three hours later, he reportedly experienced seizures and "minutes later" went into "cardiac arrest".   The patient subsequently died of "cardiac arrest" and "heart failure".  Autopsy results reportedly came back as "suspicious and inconclusive pending further investigation".   There is insufficient information provided in this case to make a meaningful medical assessment.; Reported Cause(s) of Death: CARDIAC ARREST; HEART FAILURE
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: SEIZURES; SEVERE CHILLS; SEVERE FEVER; CARDIAC ARREST; HEART FAILURE; FEELING ILL; VERY BAD HEADACHE; This spontaneous report received from parent of patient via social media post and concerned a 32 year old male. The patient's height, and weight were not reported. The patient did not have any underlying health conditions.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the patient had a very bad headache. Patient was feeling ill, went to sleep and then woke up to severe fever and chills at 1 am on 14-MAR-2021. He had seizures at 4 am on 14-MAR-2021 and went into cardiac arrest minutes later. It was reported that emergency services tried to revive him at his apartment and they tried at the hospital until he was declared dead at 6:05 am, less than 24 hours after receiving the vaccine.  On 14-MAR-2021, the patient died from cardiac arrest, and heart failure. An autopsy was performed on an unspecified date. It was reported that the autopsy came back suspicious and inconclusive pending further investigation. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome for feeling ill, seizures, headache, fever and chills was unknown. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report received via a social media post reported a 32-year-old male, with no reported significant underlying health issues, who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died less than 24 hours later.  Concomitant medications were not reported.  The day that the patient received his vaccination, he experienced a "very bad" headache.  He reportedly was feeling "ill" and went to sleep. Early the next morning (1:00 AM), he awoke with "severe" fever and chills.  Three hours later, he reportedly experienced seizures and "minutes later" went into "cardiac arrest".   The patient subsequently died of "cardiac arrest" and "heart failure".  Autopsy results reportedly came back as "suspicious and inconclusive pending further investigation".   There is insufficient information provided in this case to make a meaningful medical assessment.; Reported Cause(s) of Death: CARDIAC ARREST; HEART FAILURE
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cardiac failure, Chills, Headache, Malaise
Clinical narrative: SEIZURES; SEVERE CHILLS; SEVERE FEVER; CARDIAC ARREST; HEART FAILURE; FEELING ILL; VERY BAD HEADACHE; This spontaneous report received from parent of patient via social media post and concerned a 32 year old male. The patient's height, and weight were not reported. The patient did not have any underlying health conditions.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the patient had a very bad headache. Patient was feeling ill, went to sleep and then woke up to severe fever and chills at 1 am on 14-MAR-2021. He had seizures at 4 am on 14-MAR-2021 and went into cardiac arrest minutes later. It was reported that emergency services tried to revive him at his apartment and they tried at the hospital until he was declared dead at 6:05 am, less than 24 hours after receiving the vaccine.  On 14-MAR-2021, the patient died from cardiac arrest, and heart failure. An autopsy was performed on an unspecified date. It was reported that the autopsy came back suspicious and inconclusive pending further investigation. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome for feeling ill, seizures, headache, fever and chills was unknown. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report received via a social media post reported a 32-year-old male, with no reported significant underlying health issues, who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died less than 24 hours later.  Concomitant medications were not reported.  The day that the patient received his vaccination, he experienced a "very bad" headache.  He reportedly was feeling "ill" and went to sleep. Early the next morning (1:00 AM), he awoke with "severe" fever and chills.  Three hours later, he reportedly experienced seizures and "minutes later" went into "cardiac arrest".   The patient subsequently died of "cardiac arrest" and "heart failure".  Autopsy results reportedly came back as "suspicious and inconclusive pending further investigation".   There is insufficient information provided in this case to make a meaningful medical assessment.; Reported Cause(s) of Death: CARDIAC ARREST; HEART FAILURE
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: SEIZURES; SEVERE CHILLS; SEVERE FEVER; CARDIAC ARREST; HEART FAILURE; FEELING ILL; VERY BAD HEADACHE; This spontaneous report received from parent of patient via social media post and concerned a 32 year old male. The patient's height, and weight were not reported. The patient did not have any underlying health conditions.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the patient had a very bad headache. Patient was feeling ill, went to sleep and then woke up to severe fever and chills at 1 am on 14-MAR-2021. He had seizures at 4 am on 14-MAR-2021 and went into cardiac arrest minutes later. It was reported that emergency services tried to revive him at his apartment and they tried at the hospital until he was declared dead at 6:05 am, less than 24 hours after receiving the vaccine.  On 14-MAR-2021, the patient died from cardiac arrest, and heart failure. An autopsy was performed on an unspecified date. It was reported that the autopsy came back suspicious and inconclusive pending further investigation. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome for feeling ill, seizures, headache, fever and chills was unknown. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report received via a social media post reported a 32-year-old male, with no reported significant underlying health issues, who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died less than 24 hours later.  Concomitant medications were not reported.  The day that the patient received his vaccination, he experienced a "very bad" headache.  He reportedly was feeling "ill" and went to sleep. Early the next morning (1:00 AM), he awoke with "severe" fever and chills.  Three hours later, he reportedly experienced seizures and "minutes later" went into "cardiac arrest".   The patient subsequently died of "cardiac arrest" and "heart failure".  Autopsy results reportedly came back as "suspicious and inconclusive pending further investigation".   There is insufficient information provided in this case to make a meaningful medical assessment.; Reported Cause(s) of Death: CARDIAC ARREST; HEART FAILURE
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature increased, Chest pain, Dizziness, Gait disturbance
Clinical narrative: couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went numb; lips, tongue, face, hands and arms went numb; Extreme weakness and dizziness; Extreme weakness and dizziness; had chest pains that would come and go near my heart; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 12:00 Left arm at single dose (Lot EM9810) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Hashimoto's thyroiditis (autoimmune disease) and Allergies to food and Gluten, methergine. No covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), and calcium carbonate, colecalciferol (VITAMIN D 2000). No other vaccine in four weeks. Extreme weakness and dizziness, lips, tongue, face, hands and arms went numb. She couldn't see right. Had chest pains that would come and go near heart. Felt like she was going to throw up. The numbness only lasted about an hour. The extreme weakness and dizziness lasted about a day. The chest pains started about an hour after the vaccine was given and lasted on and off for about 12 hours. All events were on 03Mar2021 and non serious. No covid tested post vaccination. No treatments were received. Outcome of the events was unknown.  Information about batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Malaise, Pain in extremity, Vision blurred
Clinical narrative: couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went numb; lips, tongue, face, hands and arms went numb; Extreme weakness and dizziness; Extreme weakness and dizziness; had chest pains that would come and go near my heart; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 12:00 Left arm at single dose (Lot EM9810) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Hashimoto's thyroiditis (autoimmune disease) and Allergies to food and Gluten, methergine. No covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), and calcium carbonate, colecalciferol (VITAMIN D 2000). No other vaccine in four weeks. Extreme weakness and dizziness, lips, tongue, face, hands and arms went numb. She couldn't see right. Had chest pains that would come and go near heart. Felt like she was going to throw up. The numbness only lasted about an hour. The extreme weakness and dizziness lasted about a day. The chest pains started about an hour after the vaccine was given and lasted on and off for about 12 hours. All events were on 03Mar2021 and non serious. No covid tested post vaccination. No treatments were received. Outcome of the events was unknown.  Information about batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went numb; lips, tongue, face, hands and arms went numb; Extreme weakness and dizziness; Extreme weakness and dizziness; had chest pains that would come and go near my heart; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 12:00 Left arm at single dose (Lot EM9810) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Hashimoto's thyroiditis (autoimmune disease) and Allergies to food and Gluten, methergine. No covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), and calcium carbonate, colecalciferol (VITAMIN D 2000). No other vaccine in four weeks. Extreme weakness and dizziness, lips, tongue, face, hands and arms went numb. She couldn't see right. Had chest pains that would come and go near heart. Felt like she was going to throw up. The numbness only lasted about an hour. The extreme weakness and dizziness lasted about a day. The chest pains started about an hour after the vaccine was given and lasted on and off for about 12 hours. All events were on 03Mar2021 and non serious. No covid tested post vaccination. No treatments were received. Outcome of the events was unknown.  Information about batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Visual impairment
Clinical narrative: couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went numb; lips, tongue, face, hands and arms went numb; Extreme weakness and dizziness; Extreme weakness and dizziness; had chest pains that would come and go near my heart; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 12:00 Left arm at single dose (Lot EM9810) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Hashimoto's thyroiditis (autoimmune disease) and Allergies to food and Gluten, methergine. No covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), and calcium carbonate, colecalciferol (VITAMIN D 2000). No other vaccine in four weeks. Extreme weakness and dizziness, lips, tongue, face, hands and arms went numb. She couldn't see right. Had chest pains that would come and go near heart. Felt like she was going to throw up. The numbness only lasted about an hour. The extreme weakness and dizziness lasted about a day. The chest pains started about an hour after the vaccine was given and lasted on and off for about 12 hours. All events were on 03Mar2021 and non serious. No covid tested post vaccination. No treatments were received. Outcome of the events was unknown.  Information about batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood alkaline phosphatase, Proteinuria, Urine analysis
Clinical narrative: See attached explanation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood chloride, Blood potassium, Blood sodium, Fatigue, Nephrolithiasis
Clinical narrative: See attached explanation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Protein urine, Urine analysis, Vaccination site pain
Clinical narrative: See attached explanation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood chloride increased, Blood potassium increased, Blood sodium normal, Discomfort, Fatigue
Clinical narrative: See attached explanation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain, Metabolic function test, Pain, Protein urine, Protein urine absent
Clinical narrative: See attached explanation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Renal pain, Somnolence, Urine analysis, pH urine increased
Clinical narrative: See attached explanation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: See attached explanation
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal hypoaesthesia, Throat irritation
Clinical narrative: Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Chest discomfort, Confusional state, Dyspnoea
Clinical narrative: Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Hypoaesthesia oral, Pharyngeal swelling
Clinical narrative: Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Confusional state, Disorientation, Heart rate
Clinical narrative: Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia oral, Pharyngeal swelling, Swollen tongue
Clinical narrative: Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Feeling abnormal, Gait disturbance
Clinical narrative: SHORTNESS OF BREATH; CHEST DISCOMFORT; LEG CRAMPS; OFF-BALANCE/DIZZINESS/LIGHT HEADEDNESS; JITTERY; BRAIN FOG; CHILLS; LEG PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: 1802070, expiry: 21-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 11:13 for prophylactic vaccination. Vaccinated on right deltoid. No concomitant medications were reported.  On 13-MAR-2021 19:00, the subject experienced leg cramps, off-balance/dizziness/light headedness, jittery, brain fog, chills, leg pain and fever.. On 15-MAR-2021, the patient started feeling short of breath and chest discomfort, which got worse on March 16th. On 16-MAR-2021 she went to the emergency room around 13:00. In emergency room she was treated with one liter of oxygen. Shortness of breath and chest discomfort and all other symptoms were getting to get better. The patient mostly had slight shortness of breath, chest pain and a little bit of leg cramping. The patient was going to make an appointment for F/U with her PCP. The patient was treated with steroids and inhalers. On 16-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 100% on room air, Pulse rate (NR: not provided) 120 bpm, and Respiratory rate (NR: not provided) 20 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, leg pain, fever, chills, off-balance/dizziness/light headedness, jittery, brain fog, shortness of breath, and chest discomfort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210335101- Covid-19 vaccine ad26.cov2.s-Shortness of breath. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Painful respiration, Paraesthesia, Peripheral coldness
Clinical narrative: SHORTNESS OF BREATH; CHEST DISCOMFORT; LEG CRAMPS; OFF-BALANCE/DIZZINESS/LIGHT HEADEDNESS; JITTERY; BRAIN FOG; CHILLS; LEG PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: 1802070, expiry: 21-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 11:13 for prophylactic vaccination. Vaccinated on right deltoid. No concomitant medications were reported.  On 13-MAR-2021 19:00, the subject experienced leg cramps, off-balance/dizziness/light headedness, jittery, brain fog, chills, leg pain and fever.. On 15-MAR-2021, the patient started feeling short of breath and chest discomfort, which got worse on March 16th. On 16-MAR-2021 she went to the emergency room around 13:00. In emergency room she was treated with one liter of oxygen. Shortness of breath and chest discomfort and all other symptoms were getting to get better. The patient mostly had slight shortness of breath, chest pain and a little bit of leg cramping. The patient was going to make an appointment for F/U with her PCP. The patient was treated with steroids and inhalers. On 16-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 100% on room air, Pulse rate (NR: not provided) 120 bpm, and Respiratory rate (NR: not provided) 20 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, leg pain, fever, chills, off-balance/dizziness/light headedness, jittery, brain fog, shortness of breath, and chest discomfort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210335101- Covid-19 vaccine ad26.cov2.s-Shortness of breath. 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).