chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: I had a headache before getting the vaccine at 10am.  Worsened over time.; By 10pm I was vomiting for 6 hours until 4:30 in the morning.  I must have vomited over 12 times.; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 10:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included headaches that started prior to the vaccination. The patient was drug allergic to codeine. Concomitant medications included vitamin d nos (VIT D), probiotics and multivitamins. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 22:00 the patient had a headache before getting the vaccine at 10:00 which worsened over time. By 22:00 she had vomited for 6 hours until 04:30 in the morning. The patient must have had vomited over 12 times. She also had sweats and chills, dizziness and fatigue. The vomiting seemed excessive by any account. The patient also reports that it took a few days to recuperate. Therapeutic measures were taken as a result of a worsened headache, vomited, sweats, chills, dizziness, fatigue included treatment with acetaminophen (TYLENOL). The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. The clinical outcome of the event vomiting for 6 hours until 4:30 in the morning and must have vomited over 12 times was recovered on 06Apr2021 at 04:30, after the duration of 6.5 hours. The clinical outcome of the events worsened headache, also had sweats and chills, dizziness and fatigue were all recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I had a headache before getting the vaccine at 10am.  Worsened over time.; By 10pm I was vomiting for 6 hours until 4:30 in the morning.  I must have vomited over 12 times.; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; I also had sweats and chills, dizziness and fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 10:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included headaches that started prior to the vaccination. The patient was drug allergic to codeine. Concomitant medications included vitamin d nos (VIT D), probiotics and multivitamins. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 22:00 the patient had a headache before getting the vaccine at 10:00 which worsened over time. By 22:00 she had vomited for 6 hours until 04:30 in the morning. The patient must have had vomited over 12 times. She also had sweats and chills, dizziness and fatigue. The vomiting seemed excessive by any account. The patient also reports that it took a few days to recuperate. Therapeutic measures were taken as a result of a worsened headache, vomited, sweats, chills, dizziness, fatigue included treatment with acetaminophen (TYLENOL). The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. The clinical outcome of the event vomiting for 6 hours until 4:30 in the morning and must have vomited over 12 times was recovered on 06Apr2021 at 04:30, after the duration of 6.5 hours. The clinical outcome of the events worsened headache, also had sweats and chills, dizziness and fatigue were all recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in ring and pinky fingers of left hand after injection.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) escitalopram oxalate (LEXAPRO) and eicosapentaenoic acid ethyl ester (VASCEPA); all for unknown indications from unspecified dates. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Apr2021 at 15:00, the patient experienced tingling in ring and pinky fingers of left hand after injection which persisted at least 1-day post-injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of events tingling in ring finger and pinky fingers was not resolved at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye pain, Head discomfort, Nasal congestion, Nasopharyngitis
Clinical narrative: all the basic side effects to include difficulty breathing; cold, one nostril clogged; one nostril clogged; lots of pressure in my head; eyes hurt; nipples became hard andpainful to the touch; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), mixed connective tissue disease (MCTD), allergy, asthma and covid-19 in Nov2020.Concomitant medications included RA, MCTD, Allergy, Asthma medications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 08:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient previously received fluticasone(MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 17:00, the patient experienced all the basic side effects to include difficulty breathing (cold, one nostril clogged), lots of pressure in head, eyes hurt, nipples became hard and painful to the touch, the side effects she was experiencing from the vaccine was defiantly on the same level as Covid-19 side effects. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events difficulty breathing (cold, one nostril clogged), lots of pressure in head, eyes hurt, nipples became hard and painful to the touch were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nipple pain
Clinical narrative: all the basic side effects to include difficulty breathing; cold, one nostril clogged; one nostril clogged; lots of pressure in my head; eyes hurt; nipples became hard andpainful to the touch; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), mixed connective tissue disease (MCTD), allergy, asthma and covid-19 in Nov2020.Concomitant medications included RA, MCTD, Allergy, Asthma medications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 08:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient previously received fluticasone(MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 17:00, the patient experienced all the basic side effects to include difficulty breathing (cold, one nostril clogged), lots of pressure in head, eyes hurt, nipples became hard and painful to the touch, the side effects she was experiencing from the vaccine was defiantly on the same level as Covid-19 side effects. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events difficulty breathing (cold, one nostril clogged), lots of pressure in head, eyes hurt, nipples became hard and painful to the touch were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Circular red rash at injection site; Circular red rash at injection site; This is a spontaneous report from a contactable consumer, the parent. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), taken for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced circular red rash at injection site approximately 2 inches in diameter, which was not painful or itchy. Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event circular red rash at injection site approximately 2 inches in diameter was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache; body aches; "fevers"; fatigue and very tired; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6203) via an unspecified route of administration in the right arm on 07Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 16:00 the patient experienced headache, body aches, fevers, fatigue and felt very tired. The events resulted in emergency room/department visit or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, body aches, fevers, fatigue and very tired were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Burning sensation, Dizziness, Hot flush
Clinical narrative: red rash on neck/chest; hives on arms/feet; Tingling sensation in tongue (swelling); Feeling hot and flushed facial area; Dizziness; Burning in feet; Increased blood pressure; Tingling sensation in tongue (swelling); This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6208) via an unspecified route of administration on 02Apr2021 at 09:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were none. The patient had unspecified allergies. On 03Apr2021 at 10:00 the patient experienced dizziness, burning in feet, red rash on neck and chest, hives on arms and feet, "tingling sensation in tongue (swelling)," feeling hot and flushed facial area, and increased blood pressure. She had no history of hypertension. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited an emergency department or urgent care as a result of the events. The patient received treatment with steroids and antihistamines. The outcomes of dizziness, burning in feet, red rash on neck and chest, hives on arms and feet, "tingling sensation in tongue (swelling)," feeling hot and flushed facial area, and increased blood pressure were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash erythematous, Swollen tongue, Urticaria
Clinical narrative: red rash on neck/chest; hives on arms/feet; Tingling sensation in tongue (swelling); Feeling hot and flushed facial area; Dizziness; Burning in feet; Increased blood pressure; Tingling sensation in tongue (swelling); This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6208) via an unspecified route of administration on 02Apr2021 at 09:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were none. The patient had unspecified allergies. On 03Apr2021 at 10:00 the patient experienced dizziness, burning in feet, red rash on neck and chest, hives on arms and feet, "tingling sensation in tongue (swelling)," feeling hot and flushed facial area, and increased blood pressure. She had no history of hypertension. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited an emergency department or urgent care as a result of the events. The patient received treatment with steroids and antihistamines. The outcomes of dizziness, burning in feet, red rash on neck and chest, hives on arms and feet, "tingling sensation in tongue (swelling)," feeling hot and flushed facial area, and increased blood pressure were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Cough, Fatigue, Migraine
Clinical narrative: Fever of 101 for a day, then 99 the following day. Fever went away on day 3.; Body aches for over 2 days; Severe tiredness for 3 days; Migraine on lower right side back head / upper neck that lasted 2 days.  Migraine pain stillcomes and goes.; Migraine pain was severe enough to cause vomiting.; Muscles still sore in area of migraine 3 days after vaccine.; Sharp pulsing pain on upper left side of chest near heart.  Pain would come and go.; Pain significant enough that caused my body to cough when I felt it; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER-8727), via an unspecified route of administration in the left arm on 06Apr2021 at 11:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 23:00, the patient experienced fever of 101 for a day, then 99 the following day which went away on day 3, body aches for over 2 days, severe tiredness for 3 days after vaccine. Migraine on lower right side back head / upper neck that lasted 2 days, migraine pain was severe enough to cause vomiting, muscles still sore in area of migraine 3 days after vaccine. Migraine pain still comes and goes. For 2 days after shot, sharp pulsing pain on upper left side of chest near heart. Pain would come and go. Pain significant enough that caused the patient's body to cough when he felt it. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On06Apr2021 at 23:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101 and on 07Apr2021, the patient underwent lab test and procedure which included body temperature and result was shown as 99. The clinical outcome of fever was resolved on 08Apr2021 and  the clinical outcome of body aches was recovered on 07Apr2021. The clinical outcome of the events severe tiredness for 3 days after vaccine now, migraine on lower right side back head/ upper neck that lasted 2 days, migraine pain was severe enough to cause vomiting, muscles still sore in area of migraine 3 days after vaccine, migraine pain still comes and goes, sharp pulsing pain on upper left side of chest near heart, pain would come and go and pain significant enough that caused the patient's body to cough when he felt it were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 101 for a day, then 99 the following day. Fever went away on day 3.; Body aches for over 2 days; Severe tiredness for 3 days; Migraine on lower right side back head / upper neck that lasted 2 days.  Migraine pain stillcomes and goes.; Migraine pain was severe enough to cause vomiting.; Muscles still sore in area of migraine 3 days after vaccine.; Sharp pulsing pain on upper left side of chest near heart.  Pain would come and go.; Pain significant enough that caused my body to cough when I felt it; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER-8727), via an unspecified route of administration in the left arm on 06Apr2021 at 11:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 23:00, the patient experienced fever of 101 for a day, then 99 the following day which went away on day 3, body aches for over 2 days, severe tiredness for 3 days after vaccine. Migraine on lower right side back head / upper neck that lasted 2 days, migraine pain was severe enough to cause vomiting, muscles still sore in area of migraine 3 days after vaccine. Migraine pain still comes and goes. For 2 days after shot, sharp pulsing pain on upper left side of chest near heart. Pain would come and go. Pain significant enough that caused the patient's body to cough when he felt it. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On06Apr2021 at 23:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101 and on 07Apr2021, the patient underwent lab test and procedure which included body temperature and result was shown as 99. The clinical outcome of fever was resolved on 08Apr2021 and  the clinical outcome of body aches was recovered on 07Apr2021. The clinical outcome of the events severe tiredness for 3 days after vaccine now, migraine on lower right side back head/ upper neck that lasted 2 days, migraine pain was severe enough to cause vomiting, muscles still sore in area of migraine 3 days after vaccine, migraine pain still comes and goes, sharp pulsing pain on upper left side of chest near heart, pain would come and go and pain significant enough that caused the patient's body to cough when he felt it were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Severe cramps in hips and knees; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration on 06Apr2021 at 10:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy.  Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER6207) via an unspecified route of administration on 16Mar2021 at 13:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 04:00, the patient experienced severe cramps in hips and knees. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event severe cramps in hips and knees was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Hypokinesia
Clinical narrative: A left arm pit has been swollen; A left arm pit has been swollen and leading to difficulty in movement of left hand and arm movement significantly; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included prenatal tablets (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 at 14:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 20:00, the patient's left arm pit has been swollen and leading to difficulty in movement of left hand and arm movement significantly. The patient did not receive any treatment for the events. The clinical outcome of the events left arm pit has been swollen and leading to difficulty in movement of left hand and arm movement significantly were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Decreased appetite, Discomfort
Clinical narrative: discoloration in my face; Looks like hives; Later day and I was restless; couldnt get comfortable; I developed a fever; Chills; Significant loss of appetite; severe night sweats; Nauseous; I felt slightly ill; I began to feel aches in my joints; sick to my stomach.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 on unknown date in Nov2020. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 23:00, Within 8 hours of the first vaccine shot, the patient began to feel aches in joints, slightly ill and sick to stomach. On 08Apr2021 later day, the patient was restless and could not get comfortable, the following evening he became quite ill, developed fever, chills, significant loss of appetite, severe night sweats and was nauseous. On 09Apr2021 on the day of reporting it appears that the patient had some discoloration in face that looks like hives. That side effects were serious enough that the patient  would not get the vaccine again. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of feeling aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives that  included home self care and fever reducing medications (unspecified). The clinical outcome of the events feel aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Night sweats, Pyrexia, Restlessness
Clinical narrative: discoloration in my face; Looks like hives; Later day and I was restless; couldnt get comfortable; I developed a fever; Chills; Significant loss of appetite; severe night sweats; Nauseous; I felt slightly ill; I began to feel aches in my joints; sick to my stomach.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 on unknown date in Nov2020. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 23:00, Within 8 hours of the first vaccine shot, the patient began to feel aches in joints, slightly ill and sick to stomach. On 08Apr2021 later day, the patient was restless and could not get comfortable, the following evening he became quite ill, developed fever, chills, significant loss of appetite, severe night sweats and was nauseous. On 09Apr2021 on the day of reporting it appears that the patient had some discoloration in face that looks like hives. That side effects were serious enough that the patient  would not get the vaccine again. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of feeling aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives that  included home self care and fever reducing medications (unspecified). The clinical outcome of the events feel aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: discoloration in my face; Looks like hives; Later day and I was restless; couldnt get comfortable; I developed a fever; Chills; Significant loss of appetite; severe night sweats; Nauseous; I felt slightly ill; I began to feel aches in my joints; sick to my stomach.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 on unknown date in Nov2020. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 23:00, Within 8 hours of the first vaccine shot, the patient began to feel aches in joints, slightly ill and sick to stomach. On 08Apr2021 later day, the patient was restless and could not get comfortable, the following evening he became quite ill, developed fever, chills, significant loss of appetite, severe night sweats and was nauseous. On 09Apr2021 on the day of reporting it appears that the patient had some discoloration in face that looks like hives. That side effects were serious enough that the patient  would not get the vaccine again. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of feeling aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives that  included home self care and fever reducing medications (unspecified). The clinical outcome of the events feel aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Nausea, Pruritus, Throat tightness
Clinical narrative: Itching on upper torso, face, and scalp; Rapid heartbeat; Tight throat; Dizziness; Nausea; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733) via an unspecified route of administration in the left arm on 09Apr2021 at 10:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6208) via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 10:45, the patient experienced Itching on upper torso, face, and scalp, rapid heartbeat,  tight throat, dizziness, nausea and injection site pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the reported events and included treatment with Benadryl. The clinical outcome of the events Itching on upper torso, face, and scalp, rapid heartbeat, tight throat, dizziness, nausea and injection site pain were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Itching on upper torso, face, and scalp; Rapid heartbeat; Tight throat; Dizziness; Nausea; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733) via an unspecified route of administration in the left arm on 09Apr2021 at 10:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6208) via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 10:45, the patient experienced Itching on upper torso, face, and scalp, rapid heartbeat,  tight throat, dizziness, nausea and injection site pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the reported events and included treatment with Benadryl. The clinical outcome of the events Itching on upper torso, face, and scalp, rapid heartbeat, tight throat, dizziness, nausea and injection site pain were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: SWOLLEN PAINFUL LYMPH NODE UNDER ARMPIT ON RIGHT SIDE; SWOLLEN PAINFUL LYMPH NODE UNDER ARMPIT ON RIGHT SIDE; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ewu62) via an unspecified route of administration in the right arm on 07Apr2021 at 12:00 PM (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypothyroidism, penicillin allergy and allergy to antibiotic (CECHLOR). The concomitant medications included levothyroxine sodium (SYNTHROID), ascorbic acid (VITAMIN C), vitamin B12  (MANUFACTURER UNKNOWN) and Biotin (MANUFACTURER UNKNOWN); all from an unknown date and for an unknown indication. The patient had known allergies to medications include penicillin and cechlor. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: er2613) via an unspecified route of administration in the right arm on 17Mar2021 at 12:30 PM (at the age of 59-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 06:00, after 2 days of vaccination, the patient experienced swollen painful lymph node under armpit on right side. No therapeutic measures were taken for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen painful lymph node under the armpit on the right side was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Severe headache; Nausea; diarrhea; sore throat; cough; Muscle pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and the patient had an unspecified allergy. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN), both taken from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 16:00, immediately after the shot was administered, the patient experienced severe headache that had lessened slightly over the next few days. On 05Apr2021, the patient experienced nausea, diarrhea, sore throat, cough and muscle pain in arm for first 48 hours after the shot. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, diarrhea, sore throat, cough and muscle pain in arm were resolved on 07Apr2021, while that of severe headache was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Severe headache; Nausea; diarrhea; sore throat; cough; Muscle pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and the patient had an unspecified allergy. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN), both taken from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 16:00, immediately after the shot was administered, the patient experienced severe headache that had lessened slightly over the next few days. On 05Apr2021, the patient experienced nausea, diarrhea, sore throat, cough and muscle pain in arm for first 48 hours after the shot. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, diarrhea, sore throat, cough and muscle pain in arm were resolved on 07Apr2021, while that of severe headache was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 05Apr2021 at 10:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included reactive airways/asthma and known allergy to sulfa drugs. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 08:00, on Friday; 4 days after the first dose, the patient was very dizzy and a little nauseous. The patient had received first dose vaccine on Monday. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events very dizzy and a little nauseous were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Lime/citrus taste in mouth between 24 and 42 hours of vaccination; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 16:00(at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder and  lavender and mollusks allergy. The patient previously received Amoxicillin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN,60mg), ascorbic acid (VITAMIN C,1000mg) levocetirizine dihydrochloride (XYZAL,5mg) all from unknown date for unknown indication. The patient previously took first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Mar2021 at 12:30 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 08:00 the patient experienced Lime/citrus taste in mouth between 24 and 42 hours of vaccination. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Lime/citrus taste in mouth between 24 and 42 hours of vaccination was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.