chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (the patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6203), via an unknown route of administration on 20Feb2021 (at the age of 82-years-old) as a single dose for Covid-19 immunization. Medical history included glaucoma from an unknown date. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 30Jan2021. The patient's concomitant medications included timolol (MANUFACTURER UNKNOWN) and latanoprost (MANUFACTUER UNKNOWN), both from an unknown date for glaucoma. On 21Feb2021, the patient experienced fever and "all of the side effects is  listed on the website". Treatment for the fever included aspirin and a lot of water. The clinical outcome of the fever was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rhinorrhoea
Clinical narrative: he was experiencing chills; runny nose; his temp, it was about 100.3 degrees Fahrenheit; This is a spontaneous report from contactable consumer reported for a patient (Reporters husband) via a   Sponsored Program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Not Provided), via an unspecified route of administration  on 13Feb2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On 19Feb2021, The patient experienced chills, , runny nose and his temp, it was about 100.3 degrees Fahrenheit.  The caller inquired  if her husband's symptoms, are due to the vaccine side effects or should he test for COVID? The clinical course is as follows Her husband got his first dose last 13Feb2021. Last night 19Feb2021, he was experiencing chills, runny nose and upon checking his temp, it was about 100.3 degrees Fahrenheit. The patient underwent lab tests and procedures which included pyrexia: 100.3 Fahrenheit on 19Feb2021. The he clinical outcome of the events chills, runny nose and fever were unknown.    Information on the lot/batch number has been requested
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Developed watery diarrhea; This is a spontaneous report from a contactable physician, the patient. An 81-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL1284), via an unspecified route of administration in the left arm on 31Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medications included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN) and simvastatin (ZOCOR); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on 19Jan2021 and result was negative. The patient developed watery diarrhea about 5 days after the administration of vaccine on 05Jan2021. Therapeutic measures were taken as a result of developed watery diarrhea with anti-diarrheals, budesinide. The event, diarrhea was resulted in doctor or other healthcare professional office/clinic visit. The outcome of event, diarrhea was recovering as it was improved somewhat.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185835 second dose
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Anaemia of chronic disease, Colitis microscopic, Colonoscopy abnormal
Clinical narrative: Developed watery diarrhea; This is a spontaneous report from a contactable physician, the patient. An 81-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL1284), via an unspecified route of administration in the left arm on 31Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medications included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN) and simvastatin (ZOCOR); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on 19Jan2021 and result was negative. The patient developed watery diarrhea about 5 days after the administration of vaccine on 05Jan2021. Therapeutic measures were taken as a result of developed watery diarrhea with anti-diarrheals, budesinide. The event, diarrhea was resulted in doctor or other healthcare professional office/clinic visit. The outcome of event, diarrhea was recovering as it was improved somewhat.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185835 second dose
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Developed watery diarrhea; This is a spontaneous report from a contactable physician, the patient. An 81-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL1284), via an unspecified route of administration in the left arm on 31Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medications included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN) and simvastatin (ZOCOR); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on 19Jan2021 and result was negative. The patient developed watery diarrhea about 5 days after the administration of vaccine on 05Jan2021. Therapeutic measures were taken as a result of developed watery diarrhea with anti-diarrheals, budesinide. The event, diarrhea was resulted in doctor or other healthcare professional office/clinic visit. The outcome of event, diarrhea was recovering as it was improved somewhat.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185835 second dose
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Body temperature, Investigation, Pyrexia
Clinical narrative: 101.3 deg F temperature; too week to get out of bed; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 05Mar2021 at 11:30 at single dose for covid-19 immunisation. Medical history included covid-19 from 22Nov2020 to 03Dec2020 with hospital stay required, but patient was not on ventilator. The concomitant medications were not reported. On 05Mar2021, the patient received the first dose of vaccine. After this first dose on 06Mar2021 at 05:00PM, paramedics called because patient was too week to get out of bed. Paramedics helped patient come to a sitting position and measured a 101.3 deg F temperature. Patient transferred to hospital for observation. Blood & urine samples taken. Administered nasal oxygen and paracetamol (TYLENOL). Patient released approximately on 07Mar2021 at 2 AM. The outcome of the events was recovered in Mar2021.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Headache
Clinical narrative: Bell's Palsy; headache; very low energy; This is a spontaneous report from a contactable consumer who reported for herself. This 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) at single dose for COVID-19 immunisation on 19Feb2021 04:00 PM. Relevant history and concomitant drugs were unknown. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. No known allergies to medications, food, or other products. The patient stated on the day of my vaccine, she felt fine. She had a slight headache that worsened into the next day, but it was managble. She also felt very low energy, so she laid low. The next day when she woke up on 21Feb2021 she felt fine, no headache and had my energy back. She was feeling fine until she was diagnosed with Bell's Palsy on 05Mar2021 in the Emergency Room at 9:00 AM. She had numbness in her tongue earlier in the day and at night was not able to drink out of a straw or eat off a spoon. Her smile was crooked and so she went in. They ruled out a stroke and tumor and then diagnosed her with Bell's Palsy. The left side of her face was the impacted side with weakness of that side of her face and pain behind her left ear. The patient received medication as treatment. The outcome of event Bell's Palsy was not resolved. The outcome of events headache and low energy was resolving.  The reporter considered the events were non-serious. The patient was not diagnosed with COVID-19 prior vaccination; Nor COVID tested post vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Nor any other medications the patient received within 2 weeks of vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photopsia, Vitreous degeneration
Clinical narrative: vitreous degeneration; laser flashes of light in right eye; This is a spontaneous report from a contactable other healthcare professional (patient).  This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 26Feb2021 at 14:15 (at the age of 68-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included long QT syndrome, arthritis, back problems, colon polyp and digestion problems. Concomitant medication included hydrocodone bitartrate/paracetamol (HYDROCODONE/ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported. On 28Feb2021, the patient experienced vitreous degeneration and laser flashes of light in right eye, considered serious as medically significant. The patient specified that she continued to see flashes of light in right eye one week since being vaccinated.  Eye doctor diagnosed vitreous degeneration. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments received as a result of the events included "numbed eye and examination". Prior to vaccination, the patient was not diagnosed with COVID-19 and, since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: Based solely on chronological connection to the vaccine a causal relationship between reported events Vitreous degeneration and Flashing vision and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitreous degeneration
Clinical narrative: vitreous degeneration; laser flashes of light in right eye; This is a spontaneous report from a contactable other healthcare professional (patient).  This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 26Feb2021 at 14:15 (at the age of 68-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included long QT syndrome, arthritis, back problems, colon polyp and digestion problems. Concomitant medication included hydrocodone bitartrate/paracetamol (HYDROCODONE/ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported. On 28Feb2021, the patient experienced vitreous degeneration and laser flashes of light in right eye, considered serious as medically significant. The patient specified that she continued to see flashes of light in right eye one week since being vaccinated.  Eye doctor diagnosed vitreous degeneration. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments received as a result of the events included "numbed eye and examination". Prior to vaccination, the patient was not diagnosed with COVID-19 and, since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: Based solely on chronological connection to the vaccine a causal relationship between reported events Vitreous degeneration and Flashing vision and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Fatigue, Headache, Vaccination site pain
Clinical narrative: Bells Palsy on right side of face; Headache; fatigue; sore right arm(injection arm); This is a spontaneous report received from a Pfizer sponsored program . A contactable consumer (patient) reported that a 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration in the right arm on 21Feb2021 at a single dose for COVID-19 immunization. Medical history included 20 years ago (in 2001), he had Bell's Palsy on left side of face which was more severe, he had lost his hearing and the paralysis was present for a long period of time. The patient's concomitant medications were not reported. The patient had a sore right arm (injection arm), headache, and fatigue after the vaccine (unspecified date in 2021). On 02Mar2021, 10 days after the first dose (as reported), he developed Bell's Palsy on right side of face. He has been put on prednisone by his MD to treat the Bell's Palsy that he was currently experiencing. He was on Prednisone for Palsy and wondering if it could decrease efficacy of vaccine. He wanted to know if the second dose is going to create a problem with the Bell's Palsy. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Nasal oedema, Pyrexia, SARS-CoV-2 test, Swelling face
Clinical narrative: Fever 101.2, lips, nose and facial swelling; Fever 101.2, lips, nose and facial swelling; nose swelling; Fever 101.2, lips, nose and facial swelling; This 38- year-old male consumer (patient) reported for himself, received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9264 ), via an unspecified route of administration, on 25Feb2021 at 01:00 PM (at the age of 38-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 on 04Feb2021 at 1:00PM for COVID-19 immunization, lot number EN5318, in left arm. Medical history and concomitant medications were not reported. The patient had no known allergies.  On 26Feb2021, she experienced fever 101.2, lips, nose and facial swelling and was hospitalized 3 days. She went to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received included: prednisone, potassium, zyrtex, famotadine. Covid PCR test negative (04Mar2021). The outcome of the events fever 101.2, lips, nose and facial swelling was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Dizziness, Facial paralysis
Clinical narrative: facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported.  First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Palpitations, Panic reaction, Paraesthesia
Clinical narrative: facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported.  First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Blood albumin, Blood creatinine, Peripheral swelling
Clinical narrative: kidney injury; swelling of her lower extremeties; proteinuria; acute tubular injury; This is a spontaneous report from a non-contactable healthcare professional. A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 28Jan2021 (at the age of 70-year-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246), intramuscular in the left arm on 07Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included valaciclovir hydrochloride (VALTREX), atenolol (MANUFACTURER UNKNOWN), zolmitriptan (MANUFACTURER UNKNOWN), alprazolam (XANAX) and multivitamins (unspecified), all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021, 3 days after the second dose, the patient experienced swelling of her lower extremities with proteinuria and acute kidney injury. The patient was hospitalized on 24Feb2021. The patient underwent lab tests and procedures which included creatinine of 0.7 mg/dl in Nov2020, albumin of 4.7 mg/dl in Nov2020, creatinine of 1.02 on 03Feb2021, and on arrival to  Hospital on 24Feb2021: creatinine of 2.2 mg/dl, proteinuria of 19.99g, and kidney biopsy which showed minimal change disease and acute tubular injury. Therapeutic measures were taken as a result of the events which included prednisone 70mg daily. The clinical outcome of the events acute kidney injury, peripheral swelling and proteinuria was recovering; renal tubular injury was unknown.     No follow-up attempts are possible. No contact Information available.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Proteinuria, Renal tubular injury
Clinical narrative: kidney injury; swelling of her lower extremeties; proteinuria; acute tubular injury; This is a spontaneous report from a non-contactable healthcare professional. A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 28Jan2021 (at the age of 70-year-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246), intramuscular in the left arm on 07Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included valaciclovir hydrochloride (VALTREX), atenolol (MANUFACTURER UNKNOWN), zolmitriptan (MANUFACTURER UNKNOWN), alprazolam (XANAX) and multivitamins (unspecified), all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021, 3 days after the second dose, the patient experienced swelling of her lower extremities with proteinuria and acute kidney injury. The patient was hospitalized on 24Feb2021. The patient underwent lab tests and procedures which included creatinine of 0.7 mg/dl in Nov2020, albumin of 4.7 mg/dl in Nov2020, creatinine of 1.02 on 03Feb2021, and on arrival to  Hospital on 24Feb2021: creatinine of 2.2 mg/dl, proteinuria of 19.99g, and kidney biopsy which showed minimal change disease and acute tubular injury. Therapeutic measures were taken as a result of the events which included prednisone 70mg daily. The clinical outcome of the events acute kidney injury, peripheral swelling and proteinuria was recovering; renal tubular injury was unknown.     No follow-up attempts are possible. No contact Information available.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: Passed out; Chills during the night; Weak/weakness; Fever in the morning; Nausea; fatigue; dose 1 on 16Feb2021 15:00 and dose 2 on 05Mar2021 15:00; dose 1 on 16Feb2021 15:00 and dose 2 on 05Mar2021 15:00; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 (lot number EN6200) on 16Feb2021 15:00 and dose 2 (Lot Number: EN6198) on 05Mar2021 15:00 both via an unspecified route of administration in arm left as single dose for COVID-19 immunisation. Medical history included allergy to Thimerosal. The patient was not pregnant at the time of vaccination. Concomitant medication received within 2 weeks of vaccination included estradiol (ESTRADIOL TRANSDERMAL) 0.05 mg per day, Multivitamin and colecalciferol (D3 5000). 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Symptoms after the second vaccine on 06Mar2021 04:00 included chills during the night, weak, fever in the morning, fatigue. Took 2 extra strength Tylenol at 9:00 am, back to bed. Up at 12:00 pm and overwhelmed with weakness, nausea, passed out, when she woke up she was laying on the floor. She did not know how long she was out, but she did not think it was more than 5-10 minutes. No treatment was received for the adverse event. The outcome of events chills, weakness, nausea, passed out, fever and fatigue was recovered, other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pyrexia
Clinical narrative: Passed out; Chills during the night; Weak/weakness; Fever in the morning; Nausea; fatigue; dose 1 on 16Feb2021 15:00 and dose 2 on 05Mar2021 15:00; dose 1 on 16Feb2021 15:00 and dose 2 on 05Mar2021 15:00; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 (lot number EN6200) on 16Feb2021 15:00 and dose 2 (Lot Number: EN6198) on 05Mar2021 15:00 both via an unspecified route of administration in arm left as single dose for COVID-19 immunisation. Medical history included allergy to Thimerosal. The patient was not pregnant at the time of vaccination. Concomitant medication received within 2 weeks of vaccination included estradiol (ESTRADIOL TRANSDERMAL) 0.05 mg per day, Multivitamin and colecalciferol (D3 5000). 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Symptoms after the second vaccine on 06Mar2021 04:00 included chills during the night, weak, fever in the morning, fatigue. Took 2 extra strength Tylenol at 9:00 am, back to bed. Up at 12:00 pm and overwhelmed with weakness, nausea, passed out, when she woke up she was laying on the floor. She did not know how long she was out, but she did not think it was more than 5-10 minutes. No treatment was received for the adverse event. The outcome of events chills, weakness, nausea, passed out, fever and fatigue was recovered, other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy skin, Cutaneous vasculitis, Haematuria, Henoch-Schonlein purpura
Clinical narrative: AKI; IgA vasculitis; dleukocytoclastic vasculitis; Petechial rash; Hematuria; This is a spontaneous report from a contactable physician.   A 77-years-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE);  intramuscular, administered in Arm Left on 23Feb2021 at 15:30 as SINGLE DOSE for covid-19 immunization.  Medical history included type 2 diabetes mellitus,  hypertension,  benign prostatic hyperplasia.  Past Drug Event included a 'Dulaglutide-Rash'. Concomitant medication(s) included metoprolol tartrate (METOPROLOL TARTRATE),  gabapentin (GABAPENTIN, ; insulin (INSULIN), metformin (METFORMIN), amlodipine (AMLODIPINE),  atorvastatin (ATORVASTATIN),  hctz (HCTZ),  alfuzosin (ALFUZOSIN),  triamcinolone (TRIAMCINOLONE), hydroxyzine (HYDROXYZINE),  sertraline (SERTRALINE). Historical vaccine includesBNT162B2, Dose 1, on 02-FEB-2021 at 15:30 intramuscular, administered in Arm Left.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Feb2021 the patient experienced petechial rash, hematuria and Acute kidney injury,  IgA vasculitis and dleukocytoclastic vasculitis. The clinical course is as follows patient presented to the Emergency Room with complaint  of acute onset of petechial rash, hematuria, Acute Kidney Injury 48 hours after the second dose of Pfizer vaccine. Urine microscopy showed rare dysmorphic RBC's and hence IgA vasculitis was suspected. Skin biopsy was done that showed dleukocytoclastic vasculitis thus confirming the diagnosis. The patient was hospitalized for four days for the events Treatment was given. The clinical outcome of the events was recovering. The patient underwent lab tests and procedures which included biopsy skin: dleukocytoclastic vasculitis on an unspecified date, sars-cov-2 test: sars-cov-2 test on an unspecified date, sars-cov-2 test: (PCR) TEST obtained via a nasal swab negative  on 01Mar2021,  urine analysis: showed rare dysmorphic red blood cells on an unspecified date. The clinical outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely 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.
Sex: M
Vaccine: COVID19
Symptoms: Petechiae, SARS-CoV-2 test, Urine analysis
Clinical narrative: AKI; IgA vasculitis; dleukocytoclastic vasculitis; Petechial rash; Hematuria; This is a spontaneous report from a contactable physician.   A 77-years-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE);  intramuscular, administered in Arm Left on 23Feb2021 at 15:30 as SINGLE DOSE for covid-19 immunization.  Medical history included type 2 diabetes mellitus,  hypertension,  benign prostatic hyperplasia.  Past Drug Event included a 'Dulaglutide-Rash'. Concomitant medication(s) included metoprolol tartrate (METOPROLOL TARTRATE),  gabapentin (GABAPENTIN, ; insulin (INSULIN), metformin (METFORMIN), amlodipine (AMLODIPINE),  atorvastatin (ATORVASTATIN),  hctz (HCTZ),  alfuzosin (ALFUZOSIN),  triamcinolone (TRIAMCINOLONE), hydroxyzine (HYDROXYZINE),  sertraline (SERTRALINE). Historical vaccine includesBNT162B2, Dose 1, on 02-FEB-2021 at 15:30 intramuscular, administered in Arm Left.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Feb2021 the patient experienced petechial rash, hematuria and Acute kidney injury,  IgA vasculitis and dleukocytoclastic vasculitis. The clinical course is as follows patient presented to the Emergency Room with complaint  of acute onset of petechial rash, hematuria, Acute Kidney Injury 48 hours after the second dose of Pfizer vaccine. Urine microscopy showed rare dysmorphic RBC's and hence IgA vasculitis was suspected. Skin biopsy was done that showed dleukocytoclastic vasculitis thus confirming the diagnosis. The patient was hospitalized for four days for the events Treatment was given. The clinical outcome of the events was recovering. The patient underwent lab tests and procedures which included biopsy skin: dleukocytoclastic vasculitis on an unspecified date, sars-cov-2 test: sars-cov-2 test on an unspecified date, sars-cov-2 test: (PCR) TEST obtained via a nasal swab negative  on 01Mar2021,  urine analysis: showed rare dysmorphic red blood cells on an unspecified date. The clinical outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely 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.
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease, Pain in extremity
Clinical narrative: Lyme's disease; Arm where she was vaccinated was sore; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient's doctor thought that the patient may have Lyme's disease and he would like to put her on antibiotics and probiotics and called to see if she can take them and still get an effective vaccine. The patient also mentioned that the arm where she was vaccinated was sore, on an unknown date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: patient received QUADRACEL at 4 and 6 month instead of PENTACEL/ NO AE; male patient received QUADRACEL at 2-month and 6-month of age/ NO AE; while administering vaccine nurse added the ActHIB in QUADRACEL/ NO AE; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a nurse via call-center.  This case involves a patient (current age 12 month) who received 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiry date not reported via intramuscular route at an unknown administration site) at the age of 2-months and then 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number and expiry date not reported via intramuscular route at an unknown administration site) (in error) instead of PENTACEL (wrong product administered) at 4 months and 6 months of age (product administered to patient of inappropriate age) while administrating nurse added ActHIB to the QUADRACEL vaccine (wrong technique in product usage process) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to Wrong product administered, Product administered to patient of inappropriate age and Wrong technique in product usage process (latency: 1-day).  Caller wants to know if QUADRACEL valid for there age of 4 and 6 month.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: PATIENT EXPERIENCED SWELLIN, REDNESS AND HIVES 8 DAYS AFTER VACCINE ADMINISTRATION
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and DOH, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Chest pain, Diarrhoea, Feeling abnormal
Clinical narrative: Chest pain, chest tightness, stomach upset, diarrhea , headache, arm soreness, brain fog
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Chest pain, chest tightness, stomach upset, diarrhea , headache, arm soreness, brain fog
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram normal, Concussion, Disorientation, Dizziness
Clinical narrative: Patient received the first Moderna vaccine at nine o'clock Thursday morning, felt fine until 2pm. She began to feel feverish, achy, nauseous, weak.  All symptoms lasted through Sunday when she passed out early in the morning.  We found her on the kitchen floor, having hit her head and bleeding.  She was conscious and alert but a little disoriented and very weak.  We called for an ambulance which took her to the same facility where she had been vaccinated.  She was diagnosed with a concussion and low blood pressure (62/49).   Today she still feels weak and dizzy and nauseous.  She has not returned to work yet, pending recommendation from her cardiologist and PCP.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Haemorrhage, Head injury, Hypotension, Impaired work ability
Clinical narrative: Patient received the first Moderna vaccine at nine o'clock Thursday morning, felt fine until 2pm. She began to feel feverish, achy, nauseous, weak.  All symptoms lasted through Sunday when she passed out early in the morning.  We found her on the kitchen floor, having hit her head and bleeding.  She was conscious and alert but a little disoriented and very weak.  We called for an ambulance which took her to the same facility where she had been vaccinated.  She was diagnosed with a concussion and low blood pressure (62/49).   Today she still feels weak and dizzy and nauseous.  She has not returned to work yet, pending recommendation from her cardiologist and PCP.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: Patient received the first Moderna vaccine at nine o'clock Thursday morning, felt fine until 2pm. She began to feel feverish, achy, nauseous, weak.  All symptoms lasted through Sunday when she passed out early in the morning.  We found her on the kitchen floor, having hit her head and bleeding.  She was conscious and alert but a little disoriented and very weak.  We called for an ambulance which took her to the same facility where she had been vaccinated.  She was diagnosed with a concussion and low blood pressure (62/49).   Today she still feels weak and dizzy and nauseous.  She has not returned to work yet, pending recommendation from her cardiologist and PCP.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: My type 1 diabetes was diagnosed a year ago and has been well controlled (A1C of 5.3) with very little insulin (3 units tresiba per day). Hours after the vaccination, My blood sugar shot up to levels I haven't seen since diagnosis--up to in the 300s--with no change in diet or exercise. It's been 2 weeks and I am taking significantly more insulin than I did for the year prior, with both long-and short-acting insulin as prescribed my my doctor 10 days ago to address the issue.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache, low grade fever for about 12 hours...and then it tapered off to just body aches and feeling feverish for another 12 hours.
Age: 88.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Head discomfort, Hypersomnia
Clinical narrative: The vaccine is by Johnson and Johnson.  There was no lot number.  Side effects are absolutely no energy.  I just want to sleep all day.  My head has pressure.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea
Clinical narrative: 15 min. after administration, pt became short of breath and hoarse.  Hospital Rapid Response called, pt took Benadryl 50mg PO and then transported immediately to the ED for further evaluation.  ED administered Solumedrol and epinephrine.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea
Clinical narrative: Patient received dose 1 of Pfizer vaccine - developed hoarse voice and increased SOB
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme abnormal, Liver function test abnormal
Clinical narrative: Very liver enzymes
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Connective tissue inflammation, Foot fracture, Gait inability, Osteoarthritis, Weight bearing difficulty
Clinical narrative: Severe reaction in feet and knees that I have had osteoarthritis....could not walk 24 hours after vaccine was given.  Quite certain vaccine caused this reaction, I was able to get around with a manual walker before the reaction....
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Essential tremor, Feeling abnormal
Clinical narrative: 2 weeks after vaccine, noted increased essential tremor; "cotton head"  trouble wit balance.  This lasted about 2 weeks.  However, essential tremor continues
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Vomiting, diarrhea, low fever (99.5), body aches, chills, headache Symptoms began 12 hours after dose, ongoing for 24 hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Vomiting, diarrhea, low fever (99.5), body aches, chills, headache Symptoms began 12 hours after dose, ongoing for 24 hours
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Started feeling dizzy around 20 minutes after vaccine, when nurses responded she had 3 episodes of LOC, eyes were open but unresponsive, regained consciousness after a few seconds and was able to respond to commands, EMS activated and evaluated then released
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine was mistakenly administered to him at age 17 years, 11 months. When charting the next day, the error was discovered. Immediately notified his mother of the error, as well as supervisor RN. Mom states there was no problem/side effects with the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Vertigo
Clinical narrative: Slight fever and nausea at first. 4 days later severe chills for 8 hours.  Two weeks later severe chills and dizziness feeling as though about to pass out like Vertigo. Since continue to experience dizziness when rising from prone position - daily.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Rash pruritic
Clinical narrative: Stated that 45 min after vaccine when walking to car, began having SOB, felt like she was breathing through cotton and then sand. Increased her prednisone to 20 mg per day. Day 3-4 became dizzy, weak, developed a rash with itching.  SOB continued Day 8 SOB is getting better and weaning down to 8 mg prednisone
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I started having ringing/clicking in my left ear the day after my injection. It has continued since that time (about 2 1/2 weeks), but does seem to be gradually improving. I do have intermittent tinnitus, but this has been more severe and more long lasting than my usual bouts.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Ophthalmological examination, Optic neuritis, Visual field tests, Visual impairment
Clinical narrative: Partial vision loss in right eye. Eye pain. Diagnosed with optic neuritis.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Epstein-Barr virus antibody
Clinical narrative: Patient tested positive for Epstein Barr virus on 3/11/2021 Dose #1 of vaccine 1/25/2021 Dose #2 of Vaccine 2/15/2021
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Arthralgia, Blood urine present, Cough
Clinical narrative: High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, cough. I am now suffering with kidney stones, water retention and gained 15 lbs since I had the injection. Puffiness, bloating. Puffiness in hands, ankles, stomach. I have shortness of breath with sever anxiety that wakes me up. My heart races over 120 beats per minute during these anxiety attacks.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Dyspnoea, Fluid retention, Headache, Nausea
Clinical narrative: High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, cough. I am now suffering with kidney stones, water retention and gained 15 lbs since I had the injection. Puffiness, bloating. Puffiness in hands, ankles, stomach. I have shortness of breath with sever anxiety that wakes me up. My heart races over 120 beats per minute during these anxiety attacks.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis, Oropharyngeal pain, Pain, Palpitations, Pyrexia
Clinical narrative: High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, cough. I am now suffering with kidney stones, water retention and gained 15 lbs since I had the injection. Puffiness, bloating. Puffiness in hands, ankles, stomach. I have shortness of breath with sever anxiety that wakes me up. My heart races over 120 beats per minute during these anxiety attacks.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Weight increased
Clinical narrative: High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, cough. I am now suffering with kidney stones, water retention and gained 15 lbs since I had the injection. Puffiness, bloating. Puffiness in hands, ankles, stomach. I have shortness of breath with sever anxiety that wakes me up. My heart races over 120 beats per minute during these anxiety attacks.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Tenderness in lymph node located in the armpit of the same arm as the injection site.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness
Clinical narrative: Diarrhea, chills, and dizziness
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death