chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Tinnitus, Tremor, Vertigo, Vestibular disorder
Clinical narrative: Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache
Clinical narrative: Cerebral venous sinus thrombosis; Computerised tomogram head abnormal; Headache; This spontaneous report received via a Regulatory Authority vaccine adverse event reporting system(VAERS) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastroesophageal reflux disease, chronic obstructive pulmonary disease (COPD), hypertension (HTN), and migraine. The patient had drug allergies to ampicillin, macrodantin, and amoxicillin (vomiting).  The patient received COVID-19 Vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown), administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide/lisinopril, labetalol, and simvastatin.  On 16-APR-2021, the patient presented with headache and was hospitalized. Head CT showed dural sinus venous thrombosis. The patient was treated with argatroban.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral venous sinus thrombosis, computerized tomogram head abnormal, and headache. This report was serious (Hospitalization Caused / Prolonged).  This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. Update of start date and addition of MAC.; Sender's Comments: V1: This case received describes a 52-year-old female with known hypertension and migraine, who presented with a headache and was found to have a dural sinus venous thrombosis 11 days after receiving Janssen COVID-19 vaccine.  Platelet count was not reported.  She was treated with argatroban.  Information is limited in this case, and the occurrence of cerebral venous sinus thrombosis could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. More information will be requested if reporter contact becomes available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head, Computerised tomogram head abnormal, Headache
Clinical narrative: Cerebral venous sinus thrombosis; Computerised tomogram head abnormal; Headache; This spontaneous report received via a Regulatory Authority vaccine adverse event reporting system(VAERS) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastroesophageal reflux disease, chronic obstructive pulmonary disease (COPD), hypertension (HTN), and migraine. The patient had drug allergies to ampicillin, macrodantin, and amoxicillin (vomiting).  The patient received COVID-19 Vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown), administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide/lisinopril, labetalol, and simvastatin.  On 16-APR-2021, the patient presented with headache and was hospitalized. Head CT showed dural sinus venous thrombosis. The patient was treated with argatroban.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral venous sinus thrombosis, computerized tomogram head abnormal, and headache. This report was serious (Hospitalization Caused / Prolonged).  This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. Update of start date and addition of MAC.; Sender's Comments: V1: This case received describes a 52-year-old female with known hypertension and migraine, who presented with a headache and was found to have a dural sinus venous thrombosis 11 days after receiving Janssen COVID-19 vaccine.  Platelet count was not reported.  She was treated with argatroban.  Information is limited in this case, and the occurrence of cerebral venous sinus thrombosis could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. More information will be requested if reporter contact becomes available.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Developed two blood clots in my left calf; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the right arm on 05Apr2021 at 10:00 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. Medical history included ADD (attention deficit hyperactivity disorder). Concomitant medication included mirtazapine (AVANZA). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient developed two blood clots in my left calf on 13Apr2021 at 14:00 which resulted in emergency room/department or urgent care visit. Treatment for the event blood clots included rivaroxaban (XARELTO). The outcome of the event blood clots was recovering. The patient was not tested for Covid post vaccination.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Developed two blood clots in my left calf; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the right arm on 05Apr2021 at 10:00 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. Medical history included ADD (attention deficit hyperactivity disorder). Concomitant medication included mirtazapine (AVANZA). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient developed two blood clots in my left calf on 13Apr2021 at 14:00 which resulted in emergency room/department or urgent care visit. Treatment for the event blood clots included rivaroxaban (XARELTO). The outcome of the event blood clots was recovering. The patient was not tested for Covid post vaccination.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: several large clots/globs; I got my period and experience several large clots/globs resembling what you would expect when having a miscarriage but it was not a miscarriage; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 08:30 (Lot Number: EL9266) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included autoimmune disease from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VITAMIN D), VITAMIN C and docosahexaenoic acid (DHA) and Prenatal Multivitamin; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated, "The day after the vaccine, I got my period and experience several large clots/globs resembling what you would expect when having a miscarriage but it was not a miscarriage as I definitely was not pregnant" on 20Mar2021 07:00 AM. The outcome of event was unknown. No treatment was given to the patient for the events.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Uterine haemorrhage
Clinical narrative: several large clots/globs; I got my period and experience several large clots/globs resembling what you would expect when having a miscarriage but it was not a miscarriage; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 08:30 (Lot Number: EL9266) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included autoimmune disease from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VITAMIN D), VITAMIN C and docosahexaenoic acid (DHA) and Prenatal Multivitamin; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated, "The day after the vaccine, I got my period and experience several large clots/globs resembling what you would expect when having a miscarriage but it was not a miscarriage as I definitely was not pregnant" on 20Mar2021 07:00 AM. The outcome of event was unknown. No treatment was given to the patient for the events.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Tachycardia
Clinical narrative: High blood pressure, increased heart rate. Started 5 mins after vaccination. Increased heart rate still happens on occasion. No previous issues with heart rate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Electrocardiogram, Fibrin D dimer normal, Heart rate increased, Hypertension
Clinical narrative: High blood pressure, increased heart rate. Started 5 mins after vaccination. Increased heart rate still happens on occasion. No previous issues with heart rate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Neck pain, Rash, Sensation of foreign body, Throat irritation
Clinical narrative: lymph node swelling; lumps on neck; Burning sensation all through her throat; Neck deformity; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 04Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced burning in throat, neck deformity and swollen lymph nodes on an unspecified date. Soon after the vaccination, the patient experienced lymph node swelling and lumps on neck, and burning sensation all through her throat. Patient still had burning feeling on her throat and lumps around her neck. Patient shared this info and the burning feeling was still there. Lumps around her neck were still there. She said she was documenting all this and would submit the report soon. Outcome of the events was not resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Neck deformity, Neck mass, Throat irritation
Clinical narrative: lymph node swelling; lumps on neck; Burning sensation all through her throat; Neck deformity; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 04Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced burning in throat, neck deformity and swollen lymph nodes on an unspecified date. Soon after the vaccination, the patient experienced lymph node swelling and lumps on neck, and burning sensation all through her throat. Patient still had burning feeling on her throat and lumps around her neck. Patient shared this info and the burning feeling was still there. Lumps around her neck were still there. She said she was documenting all this and would submit the report soon. Outcome of the events was not resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram head, Computerised tomogram thorax abnormal, Pulmonary embolism, Ultrasound Doppler normal
Clinical narrative: Hospitalized 18Apr2021 with bilateral Pulmonary embolism; This is a spontaneous report received from a contactable nurse (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 02Apr2021 11:00, as single dose, for COVID-19 immunisation, at a pharmacy/drug store. Medical history included esophageal dysmotility, thyroid nodules, ACL tear and ACL repair on 15Apr2021. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO); and paracetamol (TYLENOL), both taken for unspecified indications, start and stop dates were not reported. The patient previously took prochlorperazine (COMPAZINE) and experienced allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) at age 42 years, via an unspecified route of administration in the left arm, on 19Mar2021, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient was hospitalized on 18Apr2021 with bilateral pulmonary embolism (onset date was 18Apr2021). Treatment for the event included Lovenix. The patient underwent COVID nasal swab on 05Apr2021 and 18Apr2021 which both resulted to negative. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported bilateral pulmonary embolism occurred in a plausible temporal relationship.  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: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Hospitalized 18Apr2021 with bilateral Pulmonary embolism; This is a spontaneous report received from a contactable nurse (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 02Apr2021 11:00, as single dose, for COVID-19 immunisation, at a pharmacy/drug store. Medical history included esophageal dysmotility, thyroid nodules, ACL tear and ACL repair on 15Apr2021. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO); and paracetamol (TYLENOL), both taken for unspecified indications, start and stop dates were not reported. The patient previously took prochlorperazine (COMPAZINE) and experienced allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) at age 42 years, via an unspecified route of administration in the left arm, on 19Mar2021, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient was hospitalized on 18Apr2021 with bilateral pulmonary embolism (onset date was 18Apr2021). Treatment for the event included Lovenix. The patient underwent COVID nasal swab on 05Apr2021 and 18Apr2021 which both resulted to negative. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported bilateral pulmonary embolism occurred in a plausible temporal relationship.  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: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood calcium decreased, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Patient experienced fatigue, muscle aches, dyspnea and chest pain.  Was told to go to ER and was diagnosed with myocarditis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood sodium normal, Blood urea decreased, Carbon dioxide normal, Chest pain, Chills
Clinical narrative: Patient experienced fatigue, muscle aches, dyspnea and chest pain.  Was told to go to ER and was diagnosed with myocarditis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Haematocrit normal, Haemoglobin normal, Metabolic function test
Clinical narrative: Patient experienced fatigue, muscle aches, dyspnea and chest pain.  Was told to go to ER and was diagnosed with myocarditis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pain in extremity, Platelet count normal, Pyrexia, Troponin increased
Clinical narrative: Patient experienced fatigue, muscle aches, dyspnea and chest pain.  Was told to go to ER and was diagnosed with myocarditis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient experienced fatigue, muscle aches, dyspnea and chest pain.  Was told to go to ER and was diagnosed with myocarditis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Fatigue, Myalgia
Clinical narrative: Patient experienced fatigue, muscle aches, dyspnea and chest pain.  Was told to go to ER and was diagnosed with myocarditis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Patient experienced fatigue, muscle aches, dyspnea and chest pain.  Was told to go to ER and was diagnosed with myocarditis.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myalgia, Pain in extremity
Clinical narrative: Covid vaccine monitoring documentation.  SARS-COVID-19 detected 4/19/21. Patient received the Janssen covid vaccine 3/9/21, Lot 1802068.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid vaccine monitoring documentation.  SARS-COVID-19 detected 4/19/21. Patient received the Janssen covid vaccine 3/9/21, Lot 1802068.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Confusional state, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Was feeling fine and health when prior to the shot.  We were directed (wife and I) to sit down for 15 minutes before leaving.  For the first 13 minutes I was talking to my wife, joking, etc.  I felt fine.  However, after 13 minutes or so, I started to felt light heading and week.   Then started to sweat and then I couldn't speak.  I felt like passing out.   My wife told me that the a man was trying to told we up and prevent me from falling.   I could hear what others were saying.  My wife states I turned pale, eyes looked stright ahead, and my mouth was distorted.  This came all at once and within a minute experienced all these symptoms.  The pharmacy staff gave me an eppy shot to get me back, then I was told to lay down on the floor.  I came to withing a minute or two and felt much better.  They had called 911 for an ambulence to come out.   The responders checked me out (vitals) and all looked fine, but I was highly advised to go with them to the ER to get checked out.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Was feeling fine and health when prior to the shot.  We were directed (wife and I) to sit down for 15 minutes before leaving.  For the first 13 minutes I was talking to my wife, joking, etc.  I felt fine.  However, after 13 minutes or so, I started to felt light heading and week.   Then started to sweat and then I couldn't speak.  I felt like passing out.   My wife told me that the a man was trying to told we up and prevent me from falling.   I could hear what others were saying.  My wife states I turned pale, eyes looked stright ahead, and my mouth was distorted.  This came all at once and within a minute experienced all these symptoms.  The pharmacy staff gave me an eppy shot to get me back, then I was told to lay down on the floor.  I came to withing a minute or two and felt much better.  They had called 911 for an ambulence to come out.   The responders checked me out (vitals) and all looked fine, but I was highly advised to go with them to the ER to get checked out.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Asthenia, Dizziness, Dyskinesia, Hyperhidrosis
Clinical narrative: Was feeling fine and health when prior to the shot.  We were directed (wife and I) to sit down for 15 minutes before leaving.  For the first 13 minutes I was talking to my wife, joking, etc.  I felt fine.  However, after 13 minutes or so, I started to felt light heading and week.   Then started to sweat and then I couldn't speak.  I felt like passing out.   My wife told me that the a man was trying to told we up and prevent me from falling.   I could hear what others were saying.  My wife states I turned pale, eyes looked stright ahead, and my mouth was distorted.  This came all at once and within a minute experienced all these symptoms.  The pharmacy staff gave me an eppy shot to get me back, then I was told to lay down on the floor.  I came to withing a minute or two and felt much better.  They had called 911 for an ambulence to come out.   The responders checked me out (vitals) and all looked fine, but I was highly advised to go with them to the ER to get checked out.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pallor
Clinical narrative: Was feeling fine and health when prior to the shot.  We were directed (wife and I) to sit down for 15 minutes before leaving.  For the first 13 minutes I was talking to my wife, joking, etc.  I felt fine.  However, after 13 minutes or so, I started to felt light heading and week.   Then started to sweat and then I couldn't speak.  I felt like passing out.   My wife told me that the a man was trying to told we up and prevent me from falling.   I could hear what others were saying.  My wife states I turned pale, eyes looked stright ahead, and my mouth was distorted.  This came all at once and within a minute experienced all these symptoms.  The pharmacy staff gave me an eppy shot to get me back, then I was told to lay down on the floor.  I came to withing a minute or two and felt much better.  They had called 911 for an ambulence to come out.   The responders checked me out (vitals) and all looked fine, but I was highly advised to go with them to the ER to get checked out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: Shingles/severe pain shingles; Inflamed lymph nodes in her armpit and stomach; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program COVAX US support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient contracted shingles about 6 days after her first dose of the Pfizer-Biontech Covid19 vaccine.  She first noticed inflamed lymph nodes in her armpit and stomach, which her HCP said could have been from the first dose of vaccine.  She is due for her second dose, next week, but is still suffering with severe pain shingles, she wondered if she should get the second dose as scheduled. She said that her HCP suggested waiting a month before receiving the second dose. She wondered if there is information about this and if she will still be protected if the vaccine is given at a longer interval. Outcome of shingles was not recovered, outcome of the other event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Lymphadenitis
Clinical narrative: Shingles/severe pain shingles; Inflamed lymph nodes in her armpit and stomach; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program COVAX US support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient contracted shingles about 6 days after her first dose of the Pfizer-Biontech Covid19 vaccine.  She first noticed inflamed lymph nodes in her armpit and stomach, which her HCP said could have been from the first dose of vaccine.  She is due for her second dose, next week, but is still suffering with severe pain shingles, she wondered if she should get the second dose as scheduled. She said that her HCP suggested waiting a month before receiving the second dose. She wondered if there is information about this and if she will still be protected if the vaccine is given at a longer interval. Outcome of shingles was not recovered, outcome of the other event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Erythema, Peripheral swelling, SARS-CoV-2 test positive
Clinical narrative: 2 days after second dose, she was tested for COVID-19 infection and resulted positive/physician suggested to repeat the COVID-19 test and result was negative; 2 days after second dose, she was tested for COVID-19 infection and resulted positive/physician suggested to repeat the COVID-19 test and result was negative; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 23Mar2021 as first dose and on 13Apr2021 as second dose at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 23Mar2021 and the second dose on 13Apr2021. Two days after second dose (15Apr2021), she was tested for COVID-19 infection and result was positive. Two days ago (18Apr2021), her physician suggested to repeat the COVID-19 test and the result was negative. The outcome of the events was recovered on 18Apr2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2 days after second dose, she was tested for COVID-19 infection and resulted positive/physician suggested to repeat the COVID-19 test and result was negative; 2 days after second dose, she was tested for COVID-19 infection and resulted positive/physician suggested to repeat the COVID-19 test and result was negative; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 23Mar2021 as first dose and on 13Apr2021 as second dose at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 23Mar2021 and the second dose on 13Apr2021. Two days after second dose (15Apr2021), she was tested for COVID-19 infection and result was positive. Two days ago (18Apr2021), her physician suggested to repeat the COVID-19 test and the result was negative. The outcome of the events was recovered on 18Apr2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Immunoglobulin therapy, Laboratory test, Lumbar puncture, Unevaluable event
Clinical narrative: GUILLAIN BARRE SYNDROME; FACIAL PARALYSIS; PAIN; SEVERE LEG PAIN; This spontaneous report received from a parent concerned a 25 year old not Hispanic or Latino, white female (daughter). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced Guillain barre syndrome, leg paralysis (subsumed under Guillain barre syndrome), facial paralysis, pain and severe leg pain and was hospitalized (date unspecified), 2 weeks after getting the Janssen vaccine. Patient was hospitalized for 5 days and she had since recovered and was doing well now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Guillain barre syndrome, facial paralysis, pain, and severe leg pain on APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210502069-COVID-19 VACCINE AD26.COV2.S- GuillaIn -Barre syndrome, facial paralysis, pain.- These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210502069-COVID-19 VACCINE AD26.COV2.S-Severe leg pain. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: GUILLAIN BARRE SYNDROME; FACIAL PARALYSIS; PAIN; SEVERE LEG PAIN; This spontaneous report received from a parent concerned a 25 year old not Hispanic or Latino, white female (daughter). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced Guillain barre syndrome, leg paralysis (subsumed under Guillain barre syndrome), facial paralysis, pain and severe leg pain and was hospitalized (date unspecified), 2 weeks after getting the Janssen vaccine. Patient was hospitalized for 5 days and she had since recovered and was doing well now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Guillain barre syndrome, facial paralysis, pain, and severe leg pain on APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210502069-COVID-19 VACCINE AD26.COV2.S- GuillaIn -Barre syndrome, facial paralysis, pain.- These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210502069-COVID-19 VACCINE AD26.COV2.S-Severe leg pain. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Guillain-Barre syndrome, Pain, Pain in extremity
Clinical narrative: GUILLAIN BARRE SYNDROME; FACIAL PARALYSIS; PAIN; SEVERE LEG PAIN; This spontaneous report received from a parent concerned a 25 year old not Hispanic or Latino, white female (daughter). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced Guillain barre syndrome, leg paralysis (subsumed under Guillain barre syndrome), facial paralysis, pain and severe leg pain and was hospitalized (date unspecified), 2 weeks after getting the Janssen vaccine. Patient was hospitalized for 5 days and she had since recovered and was doing well now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Guillain barre syndrome, facial paralysis, pain, and severe leg pain on APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210502069-COVID-19 VACCINE AD26.COV2.S- GuillaIn -Barre syndrome, facial paralysis, pain.- These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210502069-COVID-19 VACCINE AD26.COV2.S-Severe leg pain. This event is labeled per RSI and is therefore considered potentially related.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Gait disturbance, Headache, Loss of personal independence in daily activities
Clinical narrative: BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Night sweats, Pain, Pain in extremity
Clinical narrative: BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Body temperature, Burning sensation, Chills, Headache
Clinical narrative: BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Migraine, Nausea, Night sweats, Pain
Clinical narrative: BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.