chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Feeling abnormal, Muscle spasms, Pain in extremity, Palpitations
Clinical narrative: Mental fog (diminishing with time); Arm pain (continued sensitivity); Heart pounding; elevated BP woke the patient up in the middle of the night; Muscle cramps (legs); Occasional unusually sensitivity to cold; This is a spontaneous report from a contactable consumer patient (reported for himself).  A 64-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left (age at vaccination: 64 years) on Sep2021 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history includes allergies to raw eggs, long ago. May not be the case today. Patient had not tested for this and do not plan consuming. Relevant concurrent conditions was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included zinc taken for an unspecified indication, start and stop date were not reported but being received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported event was several, patient had a PDF for each one submitted to VAERS. On 01Sep2021 at 07:00, the patient experienced arm pain (continued sensitivity), heart pounding/elevated BP woke the patient up in the middle of the night,  mental fog (diminishing with time),  muscle cramps (legs), occasional unusually sensitivity to cold. Patient was scheduled for the second dose and needs a definitive go/no-go based on your experience. Medical professional education in this area is very poor. No treatment received. No hospitalization or prolongation. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures that includes COVID test BinaxNow Nasal Swab with result negative on 20Aug2021. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sleep disorder, Temperature intolerance
Clinical narrative: Mental fog (diminishing with time); Arm pain (continued sensitivity); Heart pounding; elevated BP woke the patient up in the middle of the night; Muscle cramps (legs); Occasional unusually sensitivity to cold; This is a spontaneous report from a contactable consumer patient (reported for himself).  A 64-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left (age at vaccination: 64 years) on Sep2021 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history includes allergies to raw eggs, long ago. May not be the case today. Patient had not tested for this and do not plan consuming. Relevant concurrent conditions was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included zinc taken for an unspecified indication, start and stop date were not reported but being received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported event was several, patient had a PDF for each one submitted to VAERS. On 01Sep2021 at 07:00, the patient experienced arm pain (continued sensitivity), heart pounding/elevated BP woke the patient up in the middle of the night,  mental fog (diminishing with time),  muscle cramps (legs), occasional unusually sensitivity to cold. Patient was scheduled for the second dose and needs a definitive go/no-go based on your experience. Medical professional education in this area is very poor. No treatment received. No hospitalization or prolongation. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures that includes COVID test BinaxNow Nasal Swab with result negative on 20Aug2021. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Lung opacity, Malaise, SARS-CoV-2 test positive
Clinical narrative: Hospitalization
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest X-ray normal, Electrocardiogram normal, Fatigue, Lethargy
Clinical narrative: EVENTS August 1rst. I received a phone call from Security not to come to work without proof of vaccination, as the client was requiring all to show proof. This didn?t cause any problems other than a slightly sore arm, and what I perceived as being more fatigued, but I didn?t think it was the vaccine that was causing the fatigue. September 1rst. I received the second Pfizer dosage and spent two days in bed with flu-like symptoms, body aches and bad dreams. Thereafter I was exhausted and stayed home and slept and rested. By Friday September 3rd, I developed a rash or hives from my shoulders to thighs, and on Sunday the 5th I had swelling of the face and throat. A nurse suggested that I might be having an allergic reaction and to come in.  I went to hospital which is in-network for my insurance and was seen by a P.A. who thought I had Covid, (maybe because I had a deep cough) and ordered an x-ray and a Covid swab, even though I informed him about my previous x-ray for you, and asthma. He totally discounted my full body rash and facial swelling, saying, ?We don?t know why that?s happening?, which I suppose is completely true. X-ray, EKG and Covid test were negative which I knew would be the case. His notes do not refer to the vaccine in any way. He suggested I take Benadryl. Today, September 12th I still have the rash, from nape of neck to legs. I have intermittent heavy joint pain in my right hip, and I?m sleeping 10-12 hours a day and falling asleep at work. I?m bright and alert for about 7 hours after I wake up, and then I?m struggling to keep my eyes open. The fatigue is the worst of this. I?m taking some Benadryl before I go to sleep to try and get rid of the rash, and that may not assist the fatigue even though it is one pill. I use topical Benadryl on the locations by my belt line and underwear. Hasn?t gone down. 10/01/21 I still have fatigue and joint soreness in knees and hip. Hives are still present but diminished. Have deep non productive cough when I lay down in my sleep and frequent when awake.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Rash, SARS-CoV-2 test negative, Somnolence, Swelling face
Clinical narrative: EVENTS August 1rst. I received a phone call from Security not to come to work without proof of vaccination, as the client was requiring all to show proof. This didn?t cause any problems other than a slightly sore arm, and what I perceived as being more fatigued, but I didn?t think it was the vaccine that was causing the fatigue. September 1rst. I received the second Pfizer dosage and spent two days in bed with flu-like symptoms, body aches and bad dreams. Thereafter I was exhausted and stayed home and slept and rested. By Friday September 3rd, I developed a rash or hives from my shoulders to thighs, and on Sunday the 5th I had swelling of the face and throat. A nurse suggested that I might be having an allergic reaction and to come in.  I went to hospital which is in-network for my insurance and was seen by a P.A. who thought I had Covid, (maybe because I had a deep cough) and ordered an x-ray and a Covid swab, even though I informed him about my previous x-ray for you, and asthma. He totally discounted my full body rash and facial swelling, saying, ?We don?t know why that?s happening?, which I suppose is completely true. X-ray, EKG and Covid test were negative which I knew would be the case. His notes do not refer to the vaccine in any way. He suggested I take Benadryl. Today, September 12th I still have the rash, from nape of neck to legs. I have intermittent heavy joint pain in my right hip, and I?m sleeping 10-12 hours a day and falling asleep at work. I?m bright and alert for about 7 hours after I wake up, and then I?m struggling to keep my eyes open. The fatigue is the worst of this. I?m taking some Benadryl before I go to sleep to try and get rid of the rash, and that may not assist the fatigue even though it is one pill. I use topical Benadryl on the locations by my belt line and underwear. Hasn?t gone down. 10/01/21 I still have fatigue and joint soreness in knees and hip. Hives are still present but diminished. Have deep non productive cough when I lay down in my sleep and frequent when awake.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest X-ray normal, Condition aggravated, Cough, Electrocardiogram normal
Clinical narrative: EVENTS August 1rst. I received a phone call from Security not to come to work without proof of vaccination, as the client was requiring all to show proof. This didn?t cause any problems other than a slightly sore arm, and what I perceived as being more fatigued, but I didn?t think it was the vaccine that was causing the fatigue. September 1rst. I received the second Pfizer dosage and spent two days in bed with flu-like symptoms, body aches and bad dreams. Thereafter I was exhausted and stayed home and slept and rested. By Friday September 3rd, I developed a rash or hives from my shoulders to thighs, and on Sunday the 5th I had swelling of the face and throat. A nurse suggested that I might be having an allergic reaction and to come in.  I went to hospital which is in-network for my insurance and was seen by a P.A. who thought I had Covid, (maybe because I had a deep cough) and ordered an x-ray and a Covid swab, even though I informed him about my previous x-ray for you, and asthma. He totally discounted my full body rash and facial swelling, saying, ?We don?t know why that?s happening?, which I suppose is completely true. X-ray, EKG and Covid test were negative which I knew would be the case. His notes do not refer to the vaccine in any way. He suggested I take Benadryl. Today, September 12th I still have the rash, from nape of neck to legs. I have intermittent heavy joint pain in my right hip, and I?m sleeping 10-12 hours a day and falling asleep at work. I?m bright and alert for about 7 hours after I wake up, and then I?m struggling to keep my eyes open. The fatigue is the worst of this. I?m taking some Benadryl before I go to sleep to try and get rid of the rash, and that may not assist the fatigue even though it is one pill. I use topical Benadryl on the locations by my belt line and underwear. Hasn?t gone down. 10/01/21 I still have fatigue and joint soreness in knees and hip. Hives are still present but diminished. Have deep non productive cough when I lay down in my sleep and frequent when awake.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Mobility decreased, Nightmare, Pain
Clinical narrative: EVENTS August 1rst. I received a phone call from Security not to come to work without proof of vaccination, as the client was requiring all to show proof. This didn?t cause any problems other than a slightly sore arm, and what I perceived as being more fatigued, but I didn?t think it was the vaccine that was causing the fatigue. September 1rst. I received the second Pfizer dosage and spent two days in bed with flu-like symptoms, body aches and bad dreams. Thereafter I was exhausted and stayed home and slept and rested. By Friday September 3rd, I developed a rash or hives from my shoulders to thighs, and on Sunday the 5th I had swelling of the face and throat. A nurse suggested that I might be having an allergic reaction and to come in.  I went to hospital which is in-network for my insurance and was seen by a P.A. who thought I had Covid, (maybe because I had a deep cough) and ordered an x-ray and a Covid swab, even though I informed him about my previous x-ray for you, and asthma. He totally discounted my full body rash and facial swelling, saying, ?We don?t know why that?s happening?, which I suppose is completely true. X-ray, EKG and Covid test were negative which I knew would be the case. His notes do not refer to the vaccine in any way. He suggested I take Benadryl. Today, September 12th I still have the rash, from nape of neck to legs. I have intermittent heavy joint pain in my right hip, and I?m sleeping 10-12 hours a day and falling asleep at work. I?m bright and alert for about 7 hours after I wake up, and then I?m struggling to keep my eyes open. The fatigue is the worst of this. I?m taking some Benadryl before I go to sleep to try and get rid of the rash, and that may not assist the fatigue even though it is one pill. I use topical Benadryl on the locations by my belt line and underwear. Hasn?t gone down. 10/01/21 I still have fatigue and joint soreness in knees and hip. Hives are still present but diminished. Have deep non productive cough when I lay down in my sleep and frequent when awake.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: EVENTS August 1rst. I received a phone call from Security not to come to work without proof of vaccination, as the client was requiring all to show proof. This didn?t cause any problems other than a slightly sore arm, and what I perceived as being more fatigued, but I didn?t think it was the vaccine that was causing the fatigue. September 1rst. I received the second Pfizer dosage and spent two days in bed with flu-like symptoms, body aches and bad dreams. Thereafter I was exhausted and stayed home and slept and rested. By Friday September 3rd, I developed a rash or hives from my shoulders to thighs, and on Sunday the 5th I had swelling of the face and throat. A nurse suggested that I might be having an allergic reaction and to come in.  I went to hospital which is in-network for my insurance and was seen by a P.A. who thought I had Covid, (maybe because I had a deep cough) and ordered an x-ray and a Covid swab, even though I informed him about my previous x-ray for you, and asthma. He totally discounted my full body rash and facial swelling, saying, ?We don?t know why that?s happening?, which I suppose is completely true. X-ray, EKG and Covid test were negative which I knew would be the case. His notes do not refer to the vaccine in any way. He suggested I take Benadryl. Today, September 12th I still have the rash, from nape of neck to legs. I have intermittent heavy joint pain in my right hip, and I?m sleeping 10-12 hours a day and falling asleep at work. I?m bright and alert for about 7 hours after I wake up, and then I?m struggling to keep my eyes open. The fatigue is the worst of this. I?m taking some Benadryl before I go to sleep to try and get rid of the rash, and that may not assist the fatigue even though it is one pill. I use topical Benadryl on the locations by my belt line and underwear. Hasn?t gone down. 10/01/21 I still have fatigue and joint soreness in knees and hip. Hives are still present but diminished. Have deep non productive cough when I lay down in my sleep and frequent when awake.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Stroke like symptoms and seizures. Hospitalized 2 days; Stroke like symptoms and seizures. Hospitalized 2 days; This is a spontaneous report from a contactable Nurse (patient). A 50-years-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Right on 15Sep2021 09:00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. Medical history included cross sensitivity reaction from an unknown date and unknown if ongoing. The patient was taking an unspecified concomitant medications. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination. On 19Sep2021 15:00, patient had Stroke like symptoms and seizures. Hospitalized 2 days. On 19Sep2021 patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) and computerised tomogram, electroencephalogram, magnetic resonance imaging on an unknown date with unknown results. Therapeutic measures were taken as a result of seizures, stroke like symptoms. The patient visited Emergency room and Physician office. The clinical outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As per the information in the case provided, the causal association between the events Seizures and Cerebrovascular accident and the suspect drug bnt162b2  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Electroencephalogram, Magnetic resonance imaging, Seizure
Clinical narrative: Stroke like symptoms and seizures. Hospitalized 2 days; Stroke like symptoms and seizures. Hospitalized 2 days; This is a spontaneous report from a contactable Nurse (patient). A 50-years-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Right on 15Sep2021 09:00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. Medical history included cross sensitivity reaction from an unknown date and unknown if ongoing. The patient was taking an unspecified concomitant medications. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination. On 19Sep2021 15:00, patient had Stroke like symptoms and seizures. Hospitalized 2 days. On 19Sep2021 patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) and computerised tomogram, electroencephalogram, magnetic resonance imaging on an unknown date with unknown results. Therapeutic measures were taken as a result of seizures, stroke like symptoms. The patient visited Emergency room and Physician office. The clinical outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As per the information in the case provided, the causal association between the events Seizures and Cerebrovascular accident and the suspect drug bnt162b2  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: but now my whole neck is swollen.; like I was wrapped in million blanket and taking tons of hand gloves and then breaking out into giant sweat.; I had severe chills like Tuesday it was really bad; My neck is like super swollen like my lymph node.; I started getting like the arm that''s whatever I know your arm is going to hurt; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 36-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in Arm Left on 20Sep2021 17:00 (Age at vaccination: 36-years-old) as dose 2, single for covid-19 immunization. (Vaccination facility: pharmacy). Medical history was reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Age at vaccination: 36-years-old) for covid-19 immunization. It was reported that patient god second dose and next day she started getting like the arm that whatever she know your arm is going to hurt but now her whole neck is swollen and she had severe chills like Tuesday it was really bad like she was wrapped in million blanket and taking tons of hand gloves and then breaking out into giant sweat now on her neck is like super swollen like her lymph node like they think they are and she just do not know what do. Wait or to go way. Wanted to ask Is that normal Or have to make doctor appointment. Patient did not done any lab test. The outcome for the event was reported as unknown at the time of this report.   Follow-Up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hyperhidrosis, Lymphadenopathy, Pain in extremity, Swelling
Clinical narrative: but now my whole neck is swollen.; like I was wrapped in million blanket and taking tons of hand gloves and then breaking out into giant sweat.; I had severe chills like Tuesday it was really bad; My neck is like super swollen like my lymph node.; I started getting like the arm that''s whatever I know your arm is going to hurt; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 36-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in Arm Left on 20Sep2021 17:00 (Age at vaccination: 36-years-old) as dose 2, single for covid-19 immunization. (Vaccination facility: pharmacy). Medical history was reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Age at vaccination: 36-years-old) for covid-19 immunization. It was reported that patient god second dose and next day she started getting like the arm that whatever she know your arm is going to hurt but now her whole neck is swollen and she had severe chills like Tuesday it was really bad like she was wrapped in million blanket and taking tons of hand gloves and then breaking out into giant sweat now on her neck is like super swollen like her lymph node like they think they are and she just do not know what do. Wait or to go way. Wanted to ask Is that normal Or have to make doctor appointment. Patient did not done any lab test. The outcome for the event was reported as unknown at the time of this report.   Follow-Up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test abnormal, Dyspnoea exertional, Echocardiogram abnormal, Fatigue, Heart rate increased
Clinical narrative: Mitral Valve Prolapse; Get out of breath easily on my regular walks and hikes.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL926) dose 2 via an unspecified route of administration, administered in the left arm on 01Feb2021 09:45 (at the age of 69 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included asthma, Gluten allergey. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EK9231) dose 1 via an unspecified route of administration, administered in the left arm on 11Jan2021 09:30 as dose 1, single for COVID-19 immunisation. Concomitant medication was not reported. Patient received asthma inhalers within 2 weeks of vaccination. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient underwent Covid test post vaccination type by nasal swab.On 02Feb2021 the patient experienced mitral valve prolapse, get out of breath easily on my regular walks and hikes. AE resulted in physician office visit. No treatment was given. The patient underwent lab tests and procedures which included cardiac stress test resulted mitral valve prolapse on an unspecified date of 2020, cardiac stress test resulted mitral valve prolapse on an unspecified date of 2021, sars-cov-2 test resulted unknown results on an unknown date. The clinical outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mitral valve prolapse, Palpitations
Clinical narrative: Mitral Valve Prolapse; Get out of breath easily on my regular walks and hikes.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL926) dose 2 via an unspecified route of administration, administered in the left arm on 01Feb2021 09:45 (at the age of 69 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included asthma, Gluten allergey. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EK9231) dose 1 via an unspecified route of administration, administered in the left arm on 11Jan2021 09:30 as dose 1, single for COVID-19 immunisation. Concomitant medication was not reported. Patient received asthma inhalers within 2 weeks of vaccination. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient underwent Covid test post vaccination type by nasal swab.On 02Feb2021 the patient experienced mitral valve prolapse, get out of breath easily on my regular walks and hikes. AE resulted in physician office visit. No treatment was given. The patient underwent lab tests and procedures which included cardiac stress test resulted mitral valve prolapse on an unspecified date of 2020, cardiac stress test resulted mitral valve prolapse on an unspecified date of 2021, sars-cov-2 test resulted unknown results on an unknown date. The clinical outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Dyspnoea, Mitral valve prolapse, SARS-CoV-2 test
Clinical narrative: Mitral Valve Prolapse; Get out of breath easily on my regular walks and hikes.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL926) dose 2 via an unspecified route of administration, administered in the left arm on 01Feb2021 09:45 (at the age of 69 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included asthma, Gluten allergey. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EK9231) dose 1 via an unspecified route of administration, administered in the left arm on 11Jan2021 09:30 as dose 1, single for COVID-19 immunisation. Concomitant medication was not reported. Patient received asthma inhalers within 2 weeks of vaccination. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient underwent Covid test post vaccination type by nasal swab.On 02Feb2021 the patient experienced mitral valve prolapse, get out of breath easily on my regular walks and hikes. AE resulted in physician office visit. No treatment was given. The patient underwent lab tests and procedures which included cardiac stress test resulted mitral valve prolapse on an unspecified date of 2020, cardiac stress test resulted mitral valve prolapse on an unspecified date of 2021, sars-cov-2 test resulted unknown results on an unknown date. The clinical outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immunisation, Off label use
Clinical narrative: soreness for at least 24 hours in her left shoulder/soreness was more than the 1st and 2nd shots; received dose 3, single of BNT162b2; received dose 3, single of BNT162b2; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative.   A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in arm on an unspecified date as dose 3, single for COVD-19 immunisation. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single and experienced soreness of left shoulder and received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported via an unspecified route of administration, administered in arm on an unspecified date as dose 2, single for COVD-19 immunisation and experienced soreness of left shoulder. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced soreness for at least 24 hours in her left shoulder. This soreness was more than the 1st and 2nd shots. There were no other unusual symptoms. Event took place after use of product. The outcome of all the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be re-quested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Extra dose administered, Off label use
Clinical narrative: soreness for at least 24 hours in her left shoulder/soreness was more than the 1st and 2nd shots; received dose 3, single of BNT162b2; received dose 3, single of BNT162b2; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative.   A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in arm on an unspecified date as dose 3, single for COVD-19 immunisation. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single and experienced soreness of left shoulder and received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported via an unspecified route of administration, administered in arm on an unspecified date as dose 2, single for COVD-19 immunisation and experienced soreness of left shoulder. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced soreness for at least 24 hours in her left shoulder. This soreness was more than the 1st and 2nd shots. There were no other unusual symptoms. Event took place after use of product. The outcome of all the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be re-quested during follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th April 2019, 75 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were  reported as follows: The patient reported for herself. The patient received Shingrix vaccine and experienced shingles, which was resolved after being treated. The reporter does not have lot number and expiration date, dosage of the first dose of Shingrix, and does not know if administered in left or right arm. The reporter consented for follow-up. The reporter gave a consent to follow-up with HCP. However, she does not have full mailing address, fax number, and email address to health care professional. For tolerance of second dose refer linked case US2021AMR202745, reported by the same patient. This case is linked to the case US2021AMR202744 for the 2nd episode of Shingles after the 1st dose of Shingix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202744:same reporter US-GLAXOSMITHKLINE-US2021AMR202745:same reporter
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Fatigue, Head discomfort
Clinical narrative: Correct vaccine was administered. However sticker with expired lot # was stuck to patient vaccine card
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Correct vaccine was administered. However sticker with expired lot # was stuck to patient vaccine card
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Chronic headache, chronic fatigue/tiredness
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Dyspnoea, Fibrin D dimer, Rash
Clinical narrative: D-Dimer test results were 3.3 Horrible, itchy rash all over body. I have pictures if you need them.  Drop in blood pressure.  I have picture of the machine results if you need them.  Shortness of breath Dizziness
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: D-Dimer test results were 3.3 Horrible, itchy rash all over body. I have pictures if you need them.  Drop in blood pressure.  I have picture of the machine results if you need them.  Shortness of breath Dizziness
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes nest to collar bone are huge and swollen and very tender
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Extra dose administered, Hyperhidrosis, Pain
Clinical narrative: Temp at 24 hours was 100.4 which was slightly higher than the 100.1 temp at about the 30 hour mark post 2nd course.  However, during the 3rd course, at about the 27 hour mark my temp was 102.1 with significant chills, sweats, body aches. This was markedly more severe than the 2nd course (which I thought was bad enough!), and seems worthy of reporting.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Emotional distress, Heavy menstrual bleeding, Ultrasound scan abnormal
Clinical narrative: LMP 12/12/2020 first dose moderna vaccine one 1/25/2021  patient states heavy vaginal bleeding on 2/22/2021
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Pain in extremity
Clinical narrative: Elevated heart rate, arm pain, fatigue, and headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives & itching- all over body, bottom of my feet and in bilateral groins.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Hyperhidrosis, Muscle discomfort, Musculoskeletal pain, Neck pain
Clinical narrative: I submitted a first report w adverse reactions already; this is a follow up report w additional symptoms: Shortly after I submitted first report, I experienced additional symptoms which included profuse sweating from approx 3:00am-8:00am, 10/2/2021, day after vaccination, drenched/soaking wet in sweat, all throughout the early morning, and what felt like a low grade fever throughout the day, 10/2/2021. As well as continued left arm, shoulder blade, shoulder, and up through the left side of neck pain/soreness/muscle discomfort, on side injection was received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I submitted a first report w adverse reactions already; this is a follow up report w additional symptoms: Shortly after I submitted first report, I experienced additional symptoms which included profuse sweating from approx 3:00am-8:00am, 10/2/2021, day after vaccination, drenched/soaking wet in sweat, all throughout the early morning, and what felt like a low grade fever throughout the day, 10/2/2021. As well as continued left arm, shoulder blade, shoulder, and up through the left side of neck pain/soreness/muscle discomfort, on side injection was received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Dysuria, Headache, Hyperhidrosis
Clinical narrative: Full body convulsions. Violent, alarming. Extreme headache, sweating and thirst, dramatic dizziness and lethargy.  Muscle spasms.  1st convulsion lasted 10 minutes, fully conscious, breathing labored but still effective. Slept 15 hours in total, waking every 1.5 to 2 hours, convulsing less upon awakening each time.  Drank six bottles of 16 oz water in an 8 hour period without urination.  For the next 2 days, the symptoms occurred but became dramatically muted.  My stomach is still spasming 4 days removed.  Following emergency (as to pain) lower lumbar epidural injections (4) on 10/01, neurologist administering shots said the x-ray showed my stomach to be in spasm and asked how long.  He also said that my calf muscle was spasming.  I was only aware of the stomach as it was a tangible physical effect. Following 1st dose of Moderna vaccine, inexperienced headache, extremeextreme dizziness and dry heaves (absent vomitting) on the 2nd day.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Muscle spasms, Retching, Seizure, Sleep disorder
Clinical narrative: Full body convulsions. Violent, alarming. Extreme headache, sweating and thirst, dramatic dizziness and lethargy.  Muscle spasms.  1st convulsion lasted 10 minutes, fully conscious, breathing labored but still effective. Slept 15 hours in total, waking every 1.5 to 2 hours, convulsing less upon awakening each time.  Drank six bottles of 16 oz water in an 8 hour period without urination.  For the next 2 days, the symptoms occurred but became dramatically muted.  My stomach is still spasming 4 days removed.  Following emergency (as to pain) lower lumbar epidural injections (4) on 10/01, neurologist administering shots said the x-ray showed my stomach to be in spasm and asked how long.  He also said that my calf muscle was spasming.  I was only aware of the stomach as it was a tangible physical effect. Following 1st dose of Moderna vaccine, inexperienced headache, extremeextreme dizziness and dry heaves (absent vomitting) on the 2nd day.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Full body convulsions. Violent, alarming. Extreme headache, sweating and thirst, dramatic dizziness and lethargy.  Muscle spasms.  1st convulsion lasted 10 minutes, fully conscious, breathing labored but still effective. Slept 15 hours in total, waking every 1.5 to 2 hours, convulsing less upon awakening each time.  Drank six bottles of 16 oz water in an 8 hour period without urination.  For the next 2 days, the symptoms occurred but became dramatically muted.  My stomach is still spasming 4 days removed.  Following emergency (as to pain) lower lumbar epidural injections (4) on 10/01, neurologist administering shots said the x-ray showed my stomach to be in spasm and asked how long.  He also said that my calf muscle was spasming.  I was only aware of the stomach as it was a tangible physical effect. Following 1st dose of Moderna vaccine, inexperienced headache, extremeextreme dizziness and dry heaves (absent vomitting) on the 2nd day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tachyarrhythmia
Clinical narrative: Tachyarrhythmia for 2 days, I had to be admitted from the ER to Inpatient.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Bone pain, Chest X-ray normal, Chills, Diagnostic procedure
Clinical narrative: 11:30 pm 9-28-21- fever,chills, nausea,vomiting, excruciating bone and muscle pain .  Called dr at 7am on 9-29-21- instructed to take ibuprofen q8h and benedryl q8h. Did seem to help a little.  9-30-21 felt better in am until about noon then fever-chills-nausea- vomiting resumed and throat started to feel tight. Went to er. Treated for allergic reaction possibly from vaccine. Treated with injections of solumedrol,  benadryl,zofran, epinephrine, and pepcid. 1 liter of iv fluids given. Labs showed high d dimer results. Cant do ct scan as im allergic to iodine contrast. Did nuclear scan and didnt see any clots. Cxr done showed no problem. Ekg showed abnormal rythmn after epi. Second ekg showed resolved. Sent home on pred for 5 days. 10-1-21 mouth ulcers appeared and legs are weak.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer increased, Hypersensitivity, Mouth ulceration, Muscular weakness
Clinical narrative: 11:30 pm 9-28-21- fever,chills, nausea,vomiting, excruciating bone and muscle pain .  Called dr at 7am on 9-29-21- instructed to take ibuprofen q8h and benedryl q8h. Did seem to help a little.  9-30-21 felt better in am until about noon then fever-chills-nausea- vomiting resumed and throat started to feel tight. Went to er. Treated for allergic reaction possibly from vaccine. Treated with injections of solumedrol,  benadryl,zofran, epinephrine, and pepcid. 1 liter of iv fluids given. Labs showed high d dimer results. Cant do ct scan as im allergic to iodine contrast. Did nuclear scan and didnt see any clots. Cxr done showed no problem. Ekg showed abnormal rythmn after epi. Second ekg showed resolved. Sent home on pred for 5 days. 10-1-21 mouth ulcers appeared and legs are weak.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Throat tightness, Vomiting
Clinical narrative: 11:30 pm 9-28-21- fever,chills, nausea,vomiting, excruciating bone and muscle pain .  Called dr at 7am on 9-29-21- instructed to take ibuprofen q8h and benedryl q8h. Did seem to help a little.  9-30-21 felt better in am until about noon then fever-chills-nausea- vomiting resumed and throat started to feel tight. Went to er. Treated for allergic reaction possibly from vaccine. Treated with injections of solumedrol,  benadryl,zofran, epinephrine, and pepcid. 1 liter of iv fluids given. Labs showed high d dimer results. Cant do ct scan as im allergic to iodine contrast. Did nuclear scan and didnt see any clots. Cxr done showed no problem. Ekg showed abnormal rythmn after epi. Second ekg showed resolved. Sent home on pred for 5 days. 10-1-21 mouth ulcers appeared and legs are weak.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Oral herpes
Clinical narrative: Days after the first shot I began to develop a cold sore on my lower lip.  Two weeks later, days before the second shot on February 25, I developed another herpes patch on my hard palate.  I saw my doctor and he agreed with my diagnosis of a herpes outbreak.   I researched and learned this was not an uncommon side effect of the COVID19 vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: 18 hrs after vaccination i had severe shortness of breath Condition lasts for about 2 hrs 30 mints.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Dyspnoea, Extrasystoles
Clinical narrative: Heart feels like it is fluttering or skipping beats. At the same time, shortness of breath occurs with feeling of passing out. This happens every day at random times .
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Asthma, Chest pain, Chills, Dyspnoea
Clinical narrative: Fever, chills, shortness of breath,headache, chest pain, lower abdomen,/side pain, fever,  asthma flare up
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Pyrexia
Clinical narrative: Fever, chills, shortness of breath,headache, chest pain, lower abdomen,/side pain, fever,  asthma flare up
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash erythematous
Clinical narrative: I suddenly got a red rash or flush after taking my nightly medications. This has happened a few other times this year, but not so closely after taking the covid-19 vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Severe rash/hives lasting 2 days as of thisreporting
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: Medical Assistant reporting a temperature excursion for GARDASIL 9; This spontaneous report was received from a Medical Assistant referring to an 11 year old patient. Information regrading the patient's pertinent medical history concurrent conditions, known allergies and concomitant therapies was not provided.      It was reported that, on 06-AUG-2021, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # T026323 and expiration date on 22-FEB-2023, was exposed to a temperature excursion of 47F for a time frame of 47 minutes and that, on 10-AUG-2021, the patient was vaccinated with it on a dose of 0.5 milliliter by intramuscular route for prophylaxis.  Also, it was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not involved in previous temperature excursion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T026323; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product use issue
Clinical narrative: no additional adverse evetns; A 17 year old patient had two doses of GARDASIL 9 and was told that was all that was needed fro the series; A 17 year old patient had two doses of GARDASIL 9 and was told that was all that was needed fro the series; This spontaneous report was received from a pharmacist referring to a 17 year old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On approximately 2021, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter for prophylaxis (route and site of administration, lot number and expiration date were not reported) and was told that was all that was needed for the series (wrong schedule and product use issue).  No adverse event were reported.   Pharmacist had encouraged patient's mom to talk to her child's healthcare physician to seek recommendations of 3 dose series for age of 17.