chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Platelet count decreased, Pyrexia, Rash macular, Vomiting
Clinical narrative: rare condition Immune Thrombocytopenia (ITT); platelets decreased; A spontaneous report  was received from a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low platelets and rare condition Immune Thrombocytopenia (ITT).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25-FEB-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. On an unspecified date, in the same week after receiving the vaccine, the patient had been for a dermatologist appointment and her blood work showed low level of platelets. On an unspecified date, the patient went to hematologist and was diagnosed with rare condition Immune Thrombocytopenia (ITT) which caused patient bruises and red spots on mostly knee down. The patient was treated with steroid medication.  The seriousness criteria for the events low platelets and rare condition Immune Thrombocytopenia (ITT) was considered as medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events low platelets and rare condition Immune Thrombocytopenia (ITT) was unknown.  The reporter did not provide the assessment for the event, rare condition Immune Thrombocytopenia (ITT).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: rare condition Immune Thrombocytopenia (ITT); platelets decreased; A spontaneous report  was received from a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low platelets and rare condition Immune Thrombocytopenia (ITT).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25-FEB-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. On an unspecified date, in the same week after receiving the vaccine, the patient had been for a dermatologist appointment and her blood work showed low level of platelets. On an unspecified date, the patient went to hematologist and was diagnosed with rare condition Immune Thrombocytopenia (ITT) which caused patient bruises and red spots on mostly knee down. The patient was treated with steroid medication.  The seriousness criteria for the events low platelets and rare condition Immune Thrombocytopenia (ITT) was considered as medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events low platelets and rare condition Immune Thrombocytopenia (ITT) was unknown.  The reporter did not provide the assessment for the event, rare condition Immune Thrombocytopenia (ITT).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Borrelia test negative, Facial paralysis, Laboratory test normal, Lagophthalmos
Clinical narrative: Bell's palsy facial paralysis right side of face was droopy with no control on eye, nasal, and mouth; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Left Arm on 06Mar2021 18:15 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included COVID from Dec2020 to an unknown date. There were no concomitant medications. The patient previously took cefalexin (KEFLEX) and experienced known allergies to KEFLEX. The patient experienced Bell's palsy facial paralysis right side of face was droopy with no control on eye, nasal, and mouth on 07Mar2021 18:00 with outcome of not recovered. The event resulted in doctor or healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood labs: unknown results on an unknown date. Therapeutic measures were taken as a result of the event.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test
Clinical narrative: Bell's palsy facial paralysis right side of face was droopy with no control on eye, nasal, and mouth; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Left Arm on 06Mar2021 18:15 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included COVID from Dec2020 to an unknown date. There were no concomitant medications. The patient previously took cefalexin (KEFLEX) and experienced known allergies to KEFLEX. The patient experienced Bell's palsy facial paralysis right side of face was droopy with no control on eye, nasal, and mouth on 07Mar2021 18:00 with outcome of not recovered. The event resulted in doctor or healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood labs: unknown results on an unknown date. Therapeutic measures were taken as a result of the event.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: Had a major nosebleed with blood clots; Had a major nosebleed with blood clots; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, intramuscular on 08Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient had a major nosebleed with blood clots on an unknown day in Mar2021. The patient reported that he never got nosebleeds before. There was no treatment taken for the event, it stopped on itself. The outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Thrombosis
Clinical narrative: Had a major nosebleed with blood clots; Had a major nosebleed with blood clots; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, intramuscular on 08Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient had a major nosebleed with blood clots on an unknown day in Mar2021. The patient reported that he never got nosebleeds before. There was no treatment taken for the event, it stopped on itself. The outcome of the events was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Chills, Pyrexia
Clinical narrative: 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present.  3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted.   3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills.  3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Chest X-ray normal, Chest discomfort, Chills
Clinical narrative: 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present.  3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted.   3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills.  3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Dizziness, Fibrin D dimer increased, Influenza virus test negative, Pain in extremity
Clinical narrative: 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present.  3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted.   3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills.  3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Pneumonia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present.  3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted.   3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills.  3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Blood test, COVID-19, Chest X-ray
Clinical narrative: 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present.  3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted.   3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills.  3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chills, Computerised tomogram, Dizziness, Heart rate increased
Clinical narrative: 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present.  3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted.   3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills.  3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Investigation, Pain in extremity, Pneumonia, Pyrexia
Clinical narrative: 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present.  3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted.   3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills.  3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epinephrine, Heart rate increased, Immediate post-injection reaction, Nausea, Pruritus
Clinical narrative: Almost immediately after injection felt nauseous, then felt shooting pain up left side of neck; developed full body itching / hives and sensation of cotton ball in throat. Consulted with medical staff because of history of anaphylaxis. Agreed to administration of Epinephrine, followed by dose of Benadryl.   Transported to hospital. Given sodium chloride 1,000 ml/Hr 1, with dexaMETHazone 6mg, famotidine 20mg. Released 03/10/2021 at about 5:30 am. Developed acutel sore and swollen arm at site of injection (worst at day 3), as well as weakness, pins and needles, and numbness in hands and feet, especially left side. Next week; night itching and asthma.  Panic attacks. It seemed as thoug
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory rate increased, Retching
Clinical narrative: Almost immediately after injection felt nauseous, then felt shooting pain up left side of neck; developed full body itching / hives and sensation of cotton ball in throat. Consulted with medical staff because of history of anaphylaxis. Agreed to administration of Epinephrine, followed by dose of Benadryl.   Transported to hospital. Given sodium chloride 1,000 ml/Hr 1, with dexaMETHazone 6mg, famotidine 20mg. Released 03/10/2021 at about 5:30 am. Developed acutel sore and swollen arm at site of injection (worst at day 3), as well as weakness, pins and needles, and numbness in hands and feet, especially left side. Next week; night itching and asthma.  Panic attacks. It seemed as thoug
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Oropharyngeal discomfort, Pain, Pruritus
Clinical narrative: Almost immediately after injection felt nauseous, then felt shooting pain up left side of neck; developed full body itching / hives and sensation of cotton ball in throat. Consulted with medical staff because of history of anaphylaxis. Agreed to administration of Epinephrine, followed by dose of Benadryl.   Transported to hospital. Given sodium chloride 1,000 ml/Hr 1, with dexaMETHazone 6mg, famotidine 20mg. Released 03/10/2021 at about 5:30 am. Developed acutel sore and swollen arm at site of injection (worst at day 3), as well as weakness, pins and needles, and numbness in hands and feet, especially left side. Next week; night itching and asthma.  Panic attacks. It seemed as thoug
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Almost immediately after injection felt nauseous, then felt shooting pain up left side of neck; developed full body itching / hives and sensation of cotton ball in throat. Consulted with medical staff because of history of anaphylaxis. Agreed to administration of Epinephrine, followed by dose of Benadryl.   Transported to hospital. Given sodium chloride 1,000 ml/Hr 1, with dexaMETHazone 6mg, famotidine 20mg. Released 03/10/2021 at about 5:30 am. Developed acutel sore and swollen arm at site of injection (worst at day 3), as well as weakness, pins and needles, and numbness in hands and feet, especially left side. Next week; night itching and asthma.  Panic attacks. It seemed as thoug
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse reaction, Asthenia, Asthma, Hypoaesthesia, Injection site pain
Clinical narrative: Almost immediately after injection felt nauseous, then felt shooting pain up left side of neck; developed full body itching / hives and sensation of cotton ball in throat. Consulted with medical staff because of history of anaphylaxis. Agreed to administration of Epinephrine, followed by dose of Benadryl.   Transported to hospital. Given sodium chloride 1,000 ml/Hr 1, with dexaMETHazone 6mg, famotidine 20mg. Released 03/10/2021 at about 5:30 am. Developed acutel sore and swollen arm at site of injection (worst at day 3), as well as weakness, pins and needles, and numbness in hands and feet, especially left side. Next week; night itching and asthma.  Panic attacks. It seemed as thoug
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Nausea, Pain, Panic attack, Pruritus
Clinical narrative: Almost immediately after injection felt nauseous, then felt shooting pain up left side of neck; developed full body itching / hives and sensation of cotton ball in throat. Consulted with medical staff because of history of anaphylaxis. Agreed to administration of Epinephrine, followed by dose of Benadryl.   Transported to hospital. Given sodium chloride 1,000 ml/Hr 1, with dexaMETHazone 6mg, famotidine 20mg. Released 03/10/2021 at about 5:30 am. Developed acutel sore and swollen arm at site of injection (worst at day 3), as well as weakness, pins and needles, and numbness in hands and feet, especially left side. Next week; night itching and asthma.  Panic attacks. It seemed as thoug
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: Almost immediately after injection felt nauseous, then felt shooting pain up left side of neck; developed full body itching / hives and sensation of cotton ball in throat. Consulted with medical staff because of history of anaphylaxis. Agreed to administration of Epinephrine, followed by dose of Benadryl.   Transported to hospital. Given sodium chloride 1,000 ml/Hr 1, with dexaMETHazone 6mg, famotidine 20mg. Released 03/10/2021 at about 5:30 am. Developed acutel sore and swollen arm at site of injection (worst at day 3), as well as weakness, pins and needles, and numbness in hands and feet, especially left side. Next week; night itching and asthma.  Panic attacks. It seemed as thoug
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Asthma, Chills, Depression
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fall, Fatigue, Flank pain
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Grip strength decreased, Haemoptysis, Hypoaesthesia, Impaired work ability, Injection site pain
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Lacrimation increased, Muscular weakness, Nightmare, Pain
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pollakiuria, Pyrexia, Rhinorrhoea, Taste disorder
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Urinary incontinence, Vision blurred
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Asthma, Body temperature abnormal, Chills
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Disability, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flank pain, Haemoptysis, Hypoaesthesia, Lacrimation increased, Muscular weakness
Clinical narrative: Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered.  Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.