chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site irritation, Anxiety, Cerebral palsy, Chest discomfort, Contusion
Clinical narrative: bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.    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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling hot, Haemorrhage, Mental disorder
Clinical narrative: bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.    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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervous system disorder, Nervousness, Ocular discomfort, Pain in extremity
Clinical narrative: bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.    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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.    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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Gastrooesophageal reflux disease, Pain in extremity
Clinical narrative: Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable consumer, the patient. A 51-Year-old (non-pregnant) female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 27Feb2021 14:30 (at the age of 51-year-old) as single dose for COVID-19 immunization.   The patient medical history included colitis ulcerative, fibromyalgia, premenstrual dysphoric disorder all from an unknown date and unknown if ongoing. Known allergies includes food allergy (lobster), contrast media allergy (contrast dye). Allergies to medications includes, drug hypersensitivity with ZIPACK, BACTRIM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications were not reported. No COVID prior vaccination. Prior to vaccination, the patient has not been tested for COVID-19.  On 27Feb2021 14:45 (at 02:45 PM) the patient experienced Significant GERD immediately following administration and left arm and shoulder pain within a couple of hours. The GERD was surprising not the arm and shoulder pain. The patient did not receive treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID. Seriousness of the event was reported as non-serious. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Electrocardiogram normal, Loss of consciousness
Clinical narrative: Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable consumer, the patient. A 51-Year-old (non-pregnant) female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 27Feb2021 14:30 (at the age of 51-year-old) as single dose for COVID-19 immunization.   The patient medical history included colitis ulcerative, fibromyalgia, premenstrual dysphoric disorder all from an unknown date and unknown if ongoing. Known allergies includes food allergy (lobster), contrast media allergy (contrast dye). Allergies to medications includes, drug hypersensitivity with ZIPACK, BACTRIM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications were not reported. No COVID prior vaccination. Prior to vaccination, the patient has not been tested for COVID-19.  On 27Feb2021 14:45 (at 02:45 PM) the patient experienced Significant GERD immediately following administration and left arm and shoulder pain within a couple of hours. The GERD was surprising not the arm and shoulder pain. The patient did not receive treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID. Seriousness of the event was reported as non-serious. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Blood test normal, Decreased appetite, Dizziness, Electrocardiogram normal
Clinical narrative: Nauseous and lightheaded; Nauseous and lightheaded; Left arm sore; Horrible reflux and belching; made her reflux worse; Horrible reflux and belching; Not sleeping as well because she does not feel as good; Not sleeping as well because she does not feel as good; Weakness; burning into her esophagus; She does not hardly have any appetite; She has been sick ever since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (PREVNAR 13, Solution for injection in pre-filled syringe) via unspecified route of administration on 05Jan2021 at single dose in upper left arm for Routine vaccination at Doctor's office. Medical history included ongoing reflux in the past in 1998. Prior Vaccinations (within 4 weeks) was none. Patient previously got shingles shot. She did not have any problem with that. Family medical history was none. Concomitant medications were not reported. It was reported that patient had been sick ever since she got the shot in 2021. Her symptoms appeared as soon as she got into car. She had blood drawn after the shot, so it was probably 30 minutes after she got the shot. She started feeling nauseous and lightheaded on 05Jan2021. This progressed into reflux in Jan2021 and she was still lightheaded and cannot drive. She tried Omeprazole and it might have made her reflux worse in Jan2021. She has been to the doctor three times since then. She stopped taking it because it did not make her better. It was 20 mg. She may have thrown it away. It was in a pharmacy vial. The light-headedness was worse and nausea was about the same. It has gone into this horrible reflux and she has tons of belching. She does not hardly have any appetite in Jan2021. The horrible reflux and belching started in Jan2021. It has gone into burning into her esophagus and she has had tons of reflux in Jan2021. Not sleeping as well because she does not feel as good started end of Jan2021. Weakness probably started about the same time she could not sleep, which would be towards the end of Jan2021 for the last month. She then stated her left arm was sore for 3 days started on 05Jan2021. She noticed it more on 06Jan2021, and after a couple of days, it was not very noticeable. She has fought some reflux in the past. She was not on anything for it. It was just occasional. She has had this since 1998 mildly off and on. The patient underwent labs and procedures included blood test the second time, EKG (Electrocardiogram) to double check and ordered an ultrasound of her abdomen with result negative for all on unknown date. The outcome of sickness was unknown, pain in arm was recovered on 08Jan2021, while for other events was not recovered.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Eructation, Gastrooesophageal reflux disease, Impaired driving ability, Malaise, Nausea
Clinical narrative: Nauseous and lightheaded; Nauseous and lightheaded; Left arm sore; Horrible reflux and belching; made her reflux worse; Horrible reflux and belching; Not sleeping as well because she does not feel as good; Not sleeping as well because she does not feel as good; Weakness; burning into her esophagus; She does not hardly have any appetite; She has been sick ever since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (PREVNAR 13, Solution for injection in pre-filled syringe) via unspecified route of administration on 05Jan2021 at single dose in upper left arm for Routine vaccination at Doctor's office. Medical history included ongoing reflux in the past in 1998. Prior Vaccinations (within 4 weeks) was none. Patient previously got shingles shot. She did not have any problem with that. Family medical history was none. Concomitant medications were not reported. It was reported that patient had been sick ever since she got the shot in 2021. Her symptoms appeared as soon as she got into car. She had blood drawn after the shot, so it was probably 30 minutes after she got the shot. She started feeling nauseous and lightheaded on 05Jan2021. This progressed into reflux in Jan2021 and she was still lightheaded and cannot drive. She tried Omeprazole and it might have made her reflux worse in Jan2021. She has been to the doctor three times since then. She stopped taking it because it did not make her better. It was 20 mg. She may have thrown it away. It was in a pharmacy vial. The light-headedness was worse and nausea was about the same. It has gone into this horrible reflux and she has tons of belching. She does not hardly have any appetite in Jan2021. The horrible reflux and belching started in Jan2021. It has gone into burning into her esophagus and she has had tons of reflux in Jan2021. Not sleeping as well because she does not feel as good started end of Jan2021. Weakness probably started about the same time she could not sleep, which would be towards the end of Jan2021 for the last month. She then stated her left arm was sore for 3 days started on 05Jan2021. She noticed it more on 06Jan2021, and after a couple of days, it was not very noticeable. She has fought some reflux in the past. She was not on anything for it. It was just occasional. She has had this since 1998 mildly off and on. The patient underwent labs and procedures included blood test the second time, EKG (Electrocardiogram) to double check and ordered an ultrasound of her abdomen with result negative for all on unknown date. The outcome of sickness was unknown, pain in arm was recovered on 08Jan2021, while for other events was not recovered.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Oesophageal pain, On and off phenomenon, Pain in extremity, Poor quality sleep, Sleep disorder
Clinical narrative: Nauseous and lightheaded; Nauseous and lightheaded; Left arm sore; Horrible reflux and belching; made her reflux worse; Horrible reflux and belching; Not sleeping as well because she does not feel as good; Not sleeping as well because she does not feel as good; Weakness; burning into her esophagus; She does not hardly have any appetite; She has been sick ever since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (PREVNAR 13, Solution for injection in pre-filled syringe) via unspecified route of administration on 05Jan2021 at single dose in upper left arm for Routine vaccination at Doctor's office. Medical history included ongoing reflux in the past in 1998. Prior Vaccinations (within 4 weeks) was none. Patient previously got shingles shot. She did not have any problem with that. Family medical history was none. Concomitant medications were not reported. It was reported that patient had been sick ever since she got the shot in 2021. Her symptoms appeared as soon as she got into car. She had blood drawn after the shot, so it was probably 30 minutes after she got the shot. She started feeling nauseous and lightheaded on 05Jan2021. This progressed into reflux in Jan2021 and she was still lightheaded and cannot drive. She tried Omeprazole and it might have made her reflux worse in Jan2021. She has been to the doctor three times since then. She stopped taking it because it did not make her better. It was 20 mg. She may have thrown it away. It was in a pharmacy vial. The light-headedness was worse and nausea was about the same. It has gone into this horrible reflux and she has tons of belching. She does not hardly have any appetite in Jan2021. The horrible reflux and belching started in Jan2021. It has gone into burning into her esophagus and she has had tons of reflux in Jan2021. Not sleeping as well because she does not feel as good started end of Jan2021. Weakness probably started about the same time she could not sleep, which would be towards the end of Jan2021 for the last month. She then stated her left arm was sore for 3 days started on 05Jan2021. She noticed it more on 06Jan2021, and after a couple of days, it was not very noticeable. She has fought some reflux in the past. She was not on anything for it. It was just occasional. She has had this since 1998 mildly off and on. The patient underwent labs and procedures included blood test the second time, EKG (Electrocardiogram) to double check and ordered an ultrasound of her abdomen with result negative for all on unknown date. The outcome of sickness was unknown, pain in arm was recovered on 08Jan2021, while for other events was not recovered.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Ultrasound abdomen normal
Clinical narrative: Nauseous and lightheaded; Nauseous and lightheaded; Left arm sore; Horrible reflux and belching; made her reflux worse; Horrible reflux and belching; Not sleeping as well because she does not feel as good; Not sleeping as well because she does not feel as good; Weakness; burning into her esophagus; She does not hardly have any appetite; She has been sick ever since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (PREVNAR 13, Solution for injection in pre-filled syringe) via unspecified route of administration on 05Jan2021 at single dose in upper left arm for Routine vaccination at Doctor's office. Medical history included ongoing reflux in the past in 1998. Prior Vaccinations (within 4 weeks) was none. Patient previously got shingles shot. She did not have any problem with that. Family medical history was none. Concomitant medications were not reported. It was reported that patient had been sick ever since she got the shot in 2021. Her symptoms appeared as soon as she got into car. She had blood drawn after the shot, so it was probably 30 minutes after she got the shot. She started feeling nauseous and lightheaded on 05Jan2021. This progressed into reflux in Jan2021 and she was still lightheaded and cannot drive. She tried Omeprazole and it might have made her reflux worse in Jan2021. She has been to the doctor three times since then. She stopped taking it because it did not make her better. It was 20 mg. She may have thrown it away. It was in a pharmacy vial. The light-headedness was worse and nausea was about the same. It has gone into this horrible reflux and she has tons of belching. She does not hardly have any appetite in Jan2021. The horrible reflux and belching started in Jan2021. It has gone into burning into her esophagus and she has had tons of reflux in Jan2021. Not sleeping as well because she does not feel as good started end of Jan2021. Weakness probably started about the same time she could not sleep, which would be towards the end of Jan2021 for the last month. She then stated her left arm was sore for 3 days started on 05Jan2021. She noticed it more on 06Jan2021, and after a couple of days, it was not very noticeable. She has fought some reflux in the past. She was not on anything for it. It was just occasional. She has had this since 1998 mildly off and on. The patient underwent labs and procedures included blood test the second time, EKG (Electrocardiogram) to double check and ordered an ultrasound of her abdomen with result negative for all on unknown date. The outcome of sickness was unknown, pain in arm was recovered on 08Jan2021, while for other events was not recovered.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Decreased appetite, Disturbance in attention, Flatulence, Nervousness
Clinical narrative: Nauseous and lightheaded; Nauseous and lightheaded; Left arm sore; Horrible reflux and belching; made her reflux worse; Horrible reflux and belching; Not sleeping as well because she does not feel as good; Not sleeping as well because she does not feel as good; Weakness; burning into her esophagus; She does not hardly have any appetite; She has been sick ever since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (PREVNAR 13, Solution for injection in pre-filled syringe) via unspecified route of administration on 05Jan2021 at single dose in upper left arm for Routine vaccination at Doctor's office. Medical history included ongoing reflux in the past in 1998. Prior Vaccinations (within 4 weeks) was none. Patient previously got shingles shot. She did not have any problem with that. Family medical history was none. Concomitant medications were not reported. It was reported that patient had been sick ever since she got the shot in 2021. Her symptoms appeared as soon as she got into car. She had blood drawn after the shot, so it was probably 30 minutes after she got the shot. She started feeling nauseous and lightheaded on 05Jan2021. This progressed into reflux in Jan2021 and she was still lightheaded and cannot drive. She tried Omeprazole and it might have made her reflux worse in Jan2021. She has been to the doctor three times since then. She stopped taking it because it did not make her better. It was 20 mg. She may have thrown it away. It was in a pharmacy vial. The light-headedness was worse and nausea was about the same. It has gone into this horrible reflux and she has tons of belching. She does not hardly have any appetite in Jan2021. The horrible reflux and belching started in Jan2021. It has gone into burning into her esophagus and she has had tons of reflux in Jan2021. Not sleeping as well because she does not feel as good started end of Jan2021. Weakness probably started about the same time she could not sleep, which would be towards the end of Jan2021 for the last month. She then stated her left arm was sore for 3 days started on 05Jan2021. She noticed it more on 06Jan2021, and after a couple of days, it was not very noticeable. She has fought some reflux in the past. She was not on anything for it. It was just occasional. She has had this since 1998 mildly off and on. The patient underwent labs and procedures included blood test the second time, EKG (Electrocardiogram) to double check and ordered an ultrasound of her abdomen with result negative for all on unknown date. The outcome of sickness was unknown, pain in arm was recovered on 08Jan2021, while for other events was not recovered.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he tested positive for Covid-19; he tested positive for Covid-19; This is a spontaneous report from a contactable physician (Patient) from a Pfizer-sponsored program. A male patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Jan2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Dec2020, as a single dose for COVID-19 immunization. Reporter stated that he received his first dose of the vaccine in Dec2020 and his second dose in Jan2021 but did not remember the dates. 24 hours after the second dose (in Jan2021), he tested positive for COVID-19 and he thought it was just a reaction to the vaccine. Another 36 hours later he received monoclonal antibodies. He asked if it is recommended that the vaccine be repeated given the timing of the monoclonal antibody therapy. It was also reported that patient received both dose of COVID vaccine 18 or 19 days apart. Right after 2nd dose of COVID vaccine, came down with COVID virus. Outcome of the event was unknown.  Information on about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: body ache; fever 100.6; Chills; Muscle ache; This is a spontaneous report from a contactable consumer. A 69-year-old Female consumer reported in response to Non-HCP letter sent in cross-referenced case which included that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, in arm left on 09Feb2021 12:45 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in arm left on 19Jan2021 12:30 as single dose for COVID-19 immunization and experienced headache, chills, fever and muscle ache. Patient concomitant medications were not reported. No other product(s) were taken together with the COVID-19 vaccine. illness at time of vaccination was None.  On 09Feb2021 at 20:00, patient experienced body ache, fever 100.6, chills, muscle ache lasted about 24 hrs. The patient underwent lab tests and procedures which included body temperature: 100.6 on 09Feb2021. Adverse events did not require visit to Emergency room nor Physician Office. Seriousness of the event was reported as non-serious. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Computerised tomogram head, Computerised tomogram neck, Cough
Clinical narrative: cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without more pain was very small); painful neck (back of neck) (turning radius without more pain was very small); headache; large swollen lymph node in neck (right side); Pain in neck irradiates more when coughing; 1 week after 2nd dose nose infection very prominent again (same nostril); This is spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in right arm on 19Feb2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included panic disorder. Patient (self) has no underlying medical issues outside of panic disorder. No known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone, doxycycline, sulfamethoxazole, trimethoprim (BACTRIM); All received in two weeks within the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 28Jan2021 as a single dose for COVID-19 immunisation and presented with a nose infection (left nostril, suspected MRSA), prescribed doxycycline for 7 days. Infection reduced (but not completely resolved). The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, second dose 19Feb2021 approx. 1 week after 2nd dose (on an unspecified date in 2021) nose infection very prominent again (same nostril), prescribed Bactrim for 10 days. On 02Mar2021, patient experienced lethargic, fever, chills, stiff, painful neck (back of neck) (turning radius without more pain was very small), headache, large swollen lymph node in neck (right side). Pain in neck irradiates more when coughing. On 03March2021, patient experienced fever, chills, and cold sweats in addition to the same issues as 02March2021 with no resolve or progress on symptoms reducing. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included rapid COVID test: Negative, nasal swab: Negative on 04Feb2021 (performed one week after 1st dose), blood work: Nothing standing out to support symptoms, heat CT: Nothing standing out to support symptoms, neck CT: Nothing standing out to support symptoms completed in the ER, nasal swab: Negative, rapid COVID test: Negative on 02Mar2021. The events were considered as non-serious by the consumer. The patient was treated with Bactrim, fluids. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021235826 Similar report from same reporter
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Musculoskeletal stiffness, Pyrexia, Staphylococcal infection
Clinical narrative: cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without more pain was very small); painful neck (back of neck) (turning radius without more pain was very small); headache; large swollen lymph node in neck (right side); Pain in neck irradiates more when coughing; 1 week after 2nd dose nose infection very prominent again (same nostril); This is spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in right arm on 19Feb2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included panic disorder. Patient (self) has no underlying medical issues outside of panic disorder. No known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone, doxycycline, sulfamethoxazole, trimethoprim (BACTRIM); All received in two weeks within the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 28Jan2021 as a single dose for COVID-19 immunisation and presented with a nose infection (left nostril, suspected MRSA), prescribed doxycycline for 7 days. Infection reduced (but not completely resolved). The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, second dose 19Feb2021 approx. 1 week after 2nd dose (on an unspecified date in 2021) nose infection very prominent again (same nostril), prescribed Bactrim for 10 days. On 02Mar2021, patient experienced lethargic, fever, chills, stiff, painful neck (back of neck) (turning radius without more pain was very small), headache, large swollen lymph node in neck (right side). Pain in neck irradiates more when coughing. On 03March2021, patient experienced fever, chills, and cold sweats in addition to the same issues as 02March2021 with no resolve or progress on symptoms reducing. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included rapid COVID test: Negative, nasal swab: Negative on 04Feb2021 (performed one week after 1st dose), blood work: Nothing standing out to support symptoms, heat CT: Nothing standing out to support symptoms, neck CT: Nothing standing out to support symptoms completed in the ER, nasal swab: Negative, rapid COVID test: Negative on 02Mar2021. The events were considered as non-serious by the consumer. The patient was treated with Bactrim, fluids. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021235826 Similar report from same reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Both times like mini version of covid which I had a year ago.; Both times like mini version of covid which I had a year ago.  Now right side of my neck hurts and still inflamed.  Feeling extremely fatigued.  Headaches.  Exhaustion; This is a spontaneous report from a contactable other HCP(patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262 and expiration date was not reported) via unspecified route at right arm on 20Jan2021 at 09:15 AM as single dose for covid-19 immunization. Medical history included arthritis, joint issues, chronic pain in knees and back. The patient's concomitant medications include aspirin or tylenol occasionally. The patient was sensitive to augmentin and allergic to insect stings. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 16Feb2021, at 03:00 AM, both times the patient had like mini version of covid which she had a year ago. Now right side of her neck hurts and still inflamed, feeling extremely fatigued, headaches and exhaustion. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of drug ineffective, suspected Covid-19 and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypothermia
Clinical narrative: I was freezing.Went to bed had terrible chills for 2-3hrs.; I had pain on the left side of my head above the ear; I was very tired for over a day; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: PAA156051) via unspecified route of administration at arm right on 10Feb2021 at a single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included Atenolol at 50mg twice daily. No covid prior vaccination and no covid tested post vaccination. It was reported that on an unknown date in 2021, patient was very tired for over a day. 2 nd shot received at arm left on 05Mar2021. Stated that within 6 hrs patient had pain on the left side of head above the ear. Patient was freezing, went to bed had terrible chills for 2-3 hrs. Had to be covered with several blankets. She did warm up, but completely exhausted into Sunday AM. Her stomach hurt, couldn't eat, lost 2 1/2 lbs. Patient was known with unspecified allergies. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Illness, Magnetic resonance imaging, Pyrexia
Clinical narrative: Fever; sick; I developed Covid symptoms; I was tested Positive; This is a spontaneous report from a contactable consumer(patient). A 58-years-old female patient (weight (kg): 90.72, height (cm): 155) received bnt162b2 (BNT162B2, solution for injection, batch/Lot number not reported), first dose via an unspecified route of administration on 09Jan2021 as SINGLE DOSE, for covid-19 immunization. Patient was 58 years old at the time of vaccination. Medical history included thyroid disorder and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID), both taken for an unspecified indication, start and stop date were not reported. On 12Jan2021, patient developed Covid symptoms and on 18Jan2021, she was tested Positive. She had fever and became sick from all. The patient was not hospitalized and was seen in the emergency room. Her fever stopped at the end. The patient underwent lab tests and procedures which included blood test: unknown results on 2021 assuming its third Nerve Palsy at this point , computerised tomogram which was normal on 2021 , magnetic resonance imaging was negative  on 2021 it was not Aneurysm or brain tumor, Sars-cov-2 test: positive on 18Jan2021. The outcome of the event fever was recovering and for other events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Fever; sick; I developed Covid symptoms; I was tested Positive; This is a spontaneous report from a contactable consumer(patient). A 58-years-old female patient (weight (kg): 90.72, height (cm): 155) received bnt162b2 (BNT162B2, solution for injection, batch/Lot number not reported), first dose via an unspecified route of administration on 09Jan2021 as SINGLE DOSE, for covid-19 immunization. Patient was 58 years old at the time of vaccination. Medical history included thyroid disorder and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID), both taken for an unspecified indication, start and stop date were not reported. On 12Jan2021, patient developed Covid symptoms and on 18Jan2021, she was tested Positive. She had fever and became sick from all. The patient was not hospitalized and was seen in the emergency room. Her fever stopped at the end. The patient underwent lab tests and procedures which included blood test: unknown results on 2021 assuming its third Nerve Palsy at this point , computerised tomogram which was normal on 2021 , magnetic resonance imaging was negative  on 2021 it was not Aneurysm or brain tumor, Sars-cov-2 test: positive on 18Jan2021. The outcome of the event fever was recovering and for other events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: Chilblains/Covid Toes; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL9261, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 10Feb2021 at 16:00 (at the age of 71 years old) as a single dose for COVID-19 immunisation in a hospital. Medical history included Raynaud's Syndrome (self-diagnosed because fingers turn white when cold/discussed with dermatologist) from an unknown date. The patient was not pregnant and was not diagnosed with COVID-19 prior the vaccination. The patient's concomitant medications were not reported. It was reported that patient did not have other vaccine in four weeks. On 13Feb2021, 3 days after being vaccinated, the patient developed very swollen, red toes on one foot (right) and was diagnosed as Chilblains/Covid Toes. Events resulted in doctor or other healthcare professional office/clinic visit wherein therapeutic measure was given in response with the events which included Clobetasol Propionate Ointment. The patient was not tested for COVID-19 after vaccination. The patient was recovering from the event.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Burning sensation, Headache, Pain, Sensory disturbance
Clinical narrative: Throwing up for almost a week, she's violently throwing up, can't hold anything down liquid or food; Severe pain; If you just touch her, her whole body is like on fire; Headache; Senses are magnified, her sense of smell is overwhelming. Her hearing, she is in tears because just somebody talking to her in a normal voice is like they are screaming at her; Can't taste anything; This is a spontaneous report from a contactable consumer, reporting on behalf of a friend (Patient) via India Call Centre. A female patient (Friend) of an unspecified age received second dose bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The Patient's Medical history included Blood cancer, Heart problems and concomitant medications included unspecified heart medications. The Patient received first dose of historical vaccine, bnt162b2 on an unspecified date for covid-19 immunisation. It was reported that the patient has been throwing up for almost a week, she was violently throwing up. She cannot hold anything down liquid or food. She has had severe pain like if you just touch her, her whole body was like on fire, have a horrible headache, her senses are magnified, her sense of smell was overwhelming. Her hearing, she was in tears because just somebody talking to her in a normal voice was like they were screaming at her. Taste, well she cannot taste anything because has not been eating anything on an unspecified date around 23Feb2021 (Reporter was not sure about the date). Reporter stated, "That they don't have. She has been throwing up for a week and she has had vaccine probably 3 days prior to that 2 or 3 days prior to that." Reporter stated, When probed if still experiencing events (event not specified), "Yes it continues to get worse." It was also reported that that patient was in the hospital right now. They believe that she has had a reaction to her Pfizer vaccine, the hospital there doesn't seem to know what to do, they were kind of just given up on her and we don't know who to contact for help. The Clinical outcome of the events was unknown.  Information about batch number has been requested.