chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Ear discomfort, Ear pain, Tinnitus
Clinical narrative: Constant louder tinnitus/ ear ringing; Inner ear pain; Ear fullness that will notgo away; Loss of appetite.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route in left arm on 13Mar2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included hemochromatosis, CHEK2 mutation, gastroesophageal reflux disease (GERD), thyroid nodules, interstitial cystitis and allergies (dust, cats, mold). Concomitant medications received within two weeks of vaccination included women's daily vitamins, CBD Oil (MANUFACTURER UNKNOWN) and ADVIL all taken for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Mar2021 at 20:00, the patient experienced constant louder tinnitus/ear ringing, inner ear pain and ear fullness that will not go away. It started within hours of the vaccine, worsened and continued, also had ongoing loss of appetite. Therapeutic measures for the events included lipo-flavonoid. The outcome of constant louder tinnitus/ear ringing, inner ear pain, ear fullness that will not go away and loss of appetite was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Feeling abnormal, Feeling drunk, Nausea, Urticaria
Clinical narrative: Rapid rise in blood pressure; Dizziness; Extreme vertigo; Sweating; Hives on torso; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 63-years old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199) (at the age of 63-Years-Old) via an unspecified route in the left arm on 18Mar2021 at 10:30 hours, as a single dose for COVID-19 immunisation. The patient medical history included often normal dizzy, nauseated, postural orthostatic tachycardia syndrome (POTS), had vertigo many times previously. The patients relevant drug history included fire ant on right arm and yellow jacket venom on left arm on 10Mar2021, received within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 100 mmg and calcium with vitamin D (MANUFACTURER UNKNOWN), received within 2 weeks of vaccination. It was reported that the patient was allergic to all penicillin, sulfa, insects, dogs, cats and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 10:30 hours, immediately after sitting down, the patient experienced rapid rise in blood pressure, sweating, extreme vertigo, dizziness, and nausea. 12 hours after injection, hives on torso, not arms or legs. The patient did not receive any treatment for 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 blood pressure raised and sweating was recovered, whereas hives lasted about an hour and recovered, nausea was recovered at 11:30 AM, dizziness was recovered at 15:30 PM and vertigo completely recovered after 24 hours, that was on 19Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Rapid rise in blood pressure; Dizziness; Extreme vertigo; Sweating; Hives on torso; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 63-years old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199) (at the age of 63-Years-Old) via an unspecified route in the left arm on 18Mar2021 at 10:30 hours, as a single dose for COVID-19 immunisation. The patient medical history included often normal dizzy, nauseated, postural orthostatic tachycardia syndrome (POTS), had vertigo many times previously. The patients relevant drug history included fire ant on right arm and yellow jacket venom on left arm on 10Mar2021, received within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 100 mmg and calcium with vitamin D (MANUFACTURER UNKNOWN), received within 2 weeks of vaccination. It was reported that the patient was allergic to all penicillin, sulfa, insects, dogs, cats and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 10:30 hours, immediately after sitting down, the patient experienced rapid rise in blood pressure, sweating, extreme vertigo, dizziness, and nausea. 12 hours after injection, hives on torso, not arms or legs. The patient did not receive any treatment for 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 blood pressure raised and sweating was recovered, whereas hives lasted about an hour and recovered, nausea was recovered at 11:30 AM, dizziness was recovered at 15:30 PM and vertigo completely recovered after 24 hours, that was on 19Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Hyperhidrosis, Nausea, Urticaria
Clinical narrative: Rapid rise in blood pressure; Dizziness; Extreme vertigo; Sweating; Hives on torso; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 63-years old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199) (at the age of 63-Years-Old) via an unspecified route in the left arm on 18Mar2021 at 10:30 hours, as a single dose for COVID-19 immunisation. The patient medical history included often normal dizzy, nauseated, postural orthostatic tachycardia syndrome (POTS), had vertigo many times previously. The patients relevant drug history included fire ant on right arm and yellow jacket venom on left arm on 10Mar2021, received within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 100 mmg and calcium with vitamin D (MANUFACTURER UNKNOWN), received within 2 weeks of vaccination. It was reported that the patient was allergic to all penicillin, sulfa, insects, dogs, cats and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 10:30 hours, immediately after sitting down, the patient experienced rapid rise in blood pressure, sweating, extreme vertigo, dizziness, and nausea. 12 hours after injection, hives on torso, not arms or legs. The patient did not receive any treatment for 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 blood pressure raised and sweating was recovered, whereas hives lasted about an hour and recovered, nausea was recovered at 11:30 AM, dizziness was recovered at 15:30 PM and vertigo completely recovered after 24 hours, that was on 19Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: dizziness; fatigue; nausea; This is a spontaneous report received from a contactable consumer, the patient. A 71-year-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the left arm on 07Mar2021 04:45 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to sulfur drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received zinc (MANUFACTURER UNKNOWN), vitamin d3 (MANUFACTURER UNKNOWN) and vitamin c (MANUFACTURER UNKNOWN) within two weeks of vaccination. On 21Mar2021 at 03:00, the patient experienced dizziness (2 weeks after vaccination), fatigue and slight nausea. The patient had been waiting to hear from doctor for recommendation as the patient was very concerned about receiving the second dose. It was unknown whether patient did receive treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events dizziness, nausea and fatigue were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: dizziness; fatigue; nausea; This is a spontaneous report received from a contactable consumer, the patient. A 71-year-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the left arm on 07Mar2021 04:45 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to sulfur drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received zinc (MANUFACTURER UNKNOWN), vitamin d3 (MANUFACTURER UNKNOWN) and vitamin c (MANUFACTURER UNKNOWN) within two weeks of vaccination. On 21Mar2021 at 03:00, the patient experienced dizziness (2 weeks after vaccination), fatigue and slight nausea. The patient had been waiting to hear from doctor for recommendation as the patient was very concerned about receiving the second dose. It was unknown whether patient did receive treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events dizziness, nausea and fatigue were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sciatica
Clinical narrative: within 24 hours I experienced sciatic pain, which I have not felt in years.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 59267-1000-01), via an unspecified route of administration in the left arm on 15Mar2021 at 12:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN) at the dose of 10 mg. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19.On 16Mar2021, the patient experienced sciatic pain. The patient did not receive any treatment for the sciatic pain. The 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 of sciatic pain was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sciatica
Clinical narrative: within 24 hours I experienced sciatic pain, which I have not felt in years.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 59267-1000-01), via an unspecified route of administration in the left arm on 15Mar2021 at 12:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN) at the dose of 10 mg. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19.On 16Mar2021, the patient experienced sciatic pain. The patient did not receive any treatment for the sciatic pain. The 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 of sciatic pain was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the injection site that got worsen as time goes by. Physical Tx for tear of rotator cuff for 3 month. Gotten better after a week but have it.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: Pain in the injection site that got worsen as time goes by. Physical Tx for tear of rotator cuff for 3 month. Gotten better after a week but have it.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood test, Dizziness, Headache
Clinical narrative: Some increased sensitivity to sounds; Ringing in ears; Burning skin all over body; Severe pain; Headache; Dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 15Mar2021 at 18:00 (at the age of 62-years-old), as single dose for COVID-19 immunisation. Medical history included fibromyalgia mostly controlled, interstitial cystitis, history of breast cancer 9.5 years ago and arthritis.  The patient was allergic to most antibiotics. Concomitant medications included hydroxyzine 10 mg (MANUFACTURER UNKNOWN) and lorazepam 5 mg (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. Prior to 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 vaccine. On 16Mar2021 at 00:00, the patient experienced severe pain and burning skin all over body. Seven days after the vaccine, it got worse. The patient felt like she had been dropped in acid. The patient also experienced headache and some dizziness. The patient had ringing in ears and some increased sensitivity to sounds. The pain was increasing. The clinical outcomes of the events severe pain, burning skin all over body, headache, dizziness, ringing in ears and some increased sensitivity to sounds were not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Pain, Skin burning sensation, Tinnitus, Tremor
Clinical narrative: Some increased sensitivity to sounds; Ringing in ears; Burning skin all over body; Severe pain; Headache; Dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 15Mar2021 at 18:00 (at the age of 62-years-old), as single dose for COVID-19 immunisation. Medical history included fibromyalgia mostly controlled, interstitial cystitis, history of breast cancer 9.5 years ago and arthritis.  The patient was allergic to most antibiotics. Concomitant medications included hydroxyzine 10 mg (MANUFACTURER UNKNOWN) and lorazepam 5 mg (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. Prior to 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 vaccine. On 16Mar2021 at 00:00, the patient experienced severe pain and burning skin all over body. Seven days after the vaccine, it got worse. The patient felt like she had been dropped in acid. The patient also experienced headache and some dizziness. The patient had ringing in ears and some increased sensitivity to sounds. The pain was increasing. The clinical outcomes of the events severe pain, burning skin all over body, headache, dizziness, ringing in ears and some increased sensitivity to sounds were not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Hyperacusis, Pain, Skin burning sensation
Clinical narrative: Some increased sensitivity to sounds; Ringing in ears; Burning skin all over body; Severe pain; Headache; Dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 15Mar2021 at 18:00 (at the age of 62-years-old), as single dose for COVID-19 immunisation. Medical history included fibromyalgia mostly controlled, interstitial cystitis, history of breast cancer 9.5 years ago and arthritis.  The patient was allergic to most antibiotics. Concomitant medications included hydroxyzine 10 mg (MANUFACTURER UNKNOWN) and lorazepam 5 mg (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. Prior to 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 vaccine. On 16Mar2021 at 00:00, the patient experienced severe pain and burning skin all over body. Seven days after the vaccine, it got worse. The patient felt like she had been dropped in acid. The patient also experienced headache and some dizziness. The patient had ringing in ears and some increased sensitivity to sounds. The pain was increasing. The clinical outcomes of the events severe pain, burning skin all over body, headache, dizziness, ringing in ears and some increased sensitivity to sounds were not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Some increased sensitivity to sounds; Ringing in ears; Burning skin all over body; Severe pain; Headache; Dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 15Mar2021 at 18:00 (at the age of 62-years-old), as single dose for COVID-19 immunisation. Medical history included fibromyalgia mostly controlled, interstitial cystitis, history of breast cancer 9.5 years ago and arthritis.  The patient was allergic to most antibiotics. Concomitant medications included hydroxyzine 10 mg (MANUFACTURER UNKNOWN) and lorazepam 5 mg (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. Prior to 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 vaccine. On 16Mar2021 at 00:00, the patient experienced severe pain and burning skin all over body. Seven days after the vaccine, it got worse. The patient felt like she had been dropped in acid. The patient also experienced headache and some dizziness. The patient had ringing in ears and some increased sensitivity to sounds. The pain was increasing. The clinical outcomes of the events severe pain, burning skin all over body, headache, dizziness, ringing in ears and some increased sensitivity to sounds were not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was hospitalized within 60 days of receiving a COVID vaccine series and later passed away
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was hospitalized within 60 days of receiving a COVID vaccine series and later passed away
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Throat burned and it felt tight; Broke out in hives; Her skin turned red; Throat burned and it felt tight; A bruise on her arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 46-years old at the time of vaccination), via an unspecified route of administration in left arm on an unspecified date in Mar2021 as single dose for covid-19 immunization. Medical history included she is allergic to bees. There were no concomitant medications. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had no prior Vaccinations (within 4 weeks) and no adverse events following prior vaccination. On an unspecified date in Mar2021 (Patient was not sure whether first dose was given either 24Mar or the 25Mar), the hives and tightness in her throat happened immediately after the shot was given. Patient reported that everything resolved except for she has a bruise on her arm it is about a 50 cent piece sized bruise. She stated that began almost immediately after the dose was given. The bruise had improved a little but not much. Time the Vaccination was given about 2:00, about 2:30 she clarifies about 2:10PM in the afternoon. Clinical course of the events: the patient stated that her throat burned and it felt tight, broke out in hives, her skin turned red, a bruise on her arm. Patient received treatment for reported events with Benadryl. Reporter stated that events experienced about 20 minutes later after the dose was given. It was about 20 minutes to a half hour later. Patient visit physician office and doctor looked at her arm and he told her not to get the second shot. Patient was checked out by EMS and her breathing was okay, her vitals were all good but her throat felt tight and her doctor told not to take the second shot. It was reported that patient was only able to get one dose of the Pfizer COVID-19 vaccine because of reaction. Patient wanted to know how much immunity she has to the corona virus as her father had COPD and she wanted to know if she will be protected. Reporter seriousness for broke out in hives, skin turned red, her throat burned and felt tight was unspecified. The outcomes of reported events throat burned and it felt tight, broke out in hives, her skin turned red was recovered and outcome of event a bruise on her arm was recovering.  Follow-up attempts are needed. further information requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Erythema, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Throat burned and it felt tight; Broke out in hives; Her skin turned red; Throat burned and it felt tight; A bruise on her arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 46-years old at the time of vaccination), via an unspecified route of administration in left arm on an unspecified date in Mar2021 as single dose for covid-19 immunization. Medical history included she is allergic to bees. There were no concomitant medications. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had no prior Vaccinations (within 4 weeks) and no adverse events following prior vaccination. On an unspecified date in Mar2021 (Patient was not sure whether first dose was given either 24Mar or the 25Mar), the hives and tightness in her throat happened immediately after the shot was given. Patient reported that everything resolved except for she has a bruise on her arm it is about a 50 cent piece sized bruise. She stated that began almost immediately after the dose was given. The bruise had improved a little but not much. Time the Vaccination was given about 2:00, about 2:30 she clarifies about 2:10PM in the afternoon. Clinical course of the events: the patient stated that her throat burned and it felt tight, broke out in hives, her skin turned red, a bruise on her arm. Patient received treatment for reported events with Benadryl. Reporter stated that events experienced about 20 minutes later after the dose was given. It was about 20 minutes to a half hour later. Patient visit physician office and doctor looked at her arm and he told her not to get the second shot. Patient was checked out by EMS and her breathing was okay, her vitals were all good but her throat felt tight and her doctor told not to take the second shot. It was reported that patient was only able to get one dose of the Pfizer COVID-19 vaccine because of reaction. Patient wanted to know how much immunity she has to the corona virus as her father had COPD and she wanted to know if she will be protected. Reporter seriousness for broke out in hives, skin turned red, her throat burned and felt tight was unspecified. The outcomes of reported events throat burned and it felt tight, broke out in hives, her skin turned red was recovered and outcome of event a bruise on her arm was recovering.  Follow-up attempts are needed. further information requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vital signs measurement
Clinical narrative: Throat burned and it felt tight; Broke out in hives; Her skin turned red; Throat burned and it felt tight; A bruise on her arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 46-years old at the time of vaccination), via an unspecified route of administration in left arm on an unspecified date in Mar2021 as single dose for covid-19 immunization. Medical history included she is allergic to bees. There were no concomitant medications. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had no prior Vaccinations (within 4 weeks) and no adverse events following prior vaccination. On an unspecified date in Mar2021 (Patient was not sure whether first dose was given either 24Mar or the 25Mar), the hives and tightness in her throat happened immediately after the shot was given. Patient reported that everything resolved except for she has a bruise on her arm it is about a 50 cent piece sized bruise. She stated that began almost immediately after the dose was given. The bruise had improved a little but not much. Time the Vaccination was given about 2:00, about 2:30 she clarifies about 2:10PM in the afternoon. Clinical course of the events: the patient stated that her throat burned and it felt tight, broke out in hives, her skin turned red, a bruise on her arm. Patient received treatment for reported events with Benadryl. Reporter stated that events experienced about 20 minutes later after the dose was given. It was about 20 minutes to a half hour later. Patient visit physician office and doctor looked at her arm and he told her not to get the second shot. Patient was checked out by EMS and her breathing was okay, her vitals were all good but her throat felt tight and her doctor told not to take the second shot. It was reported that patient was only able to get one dose of the Pfizer COVID-19 vaccine because of reaction. Patient wanted to know how much immunity she has to the corona virus as her father had COPD and she wanted to know if she will be protected. Reporter seriousness for broke out in hives, skin turned red, her throat burned and felt tight was unspecified. The outcomes of reported events throat burned and it felt tight, broke out in hives, her skin turned red was recovered and outcome of event a bruise on her arm was recovering.  Follow-up attempts are needed. further information requested.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Hyperhidrosis, Lacrimation increased, Pyrexia, Rhinorrhoea
Clinical narrative: 103.3 fever; severe chills; shaking,; watering eyes; profusely runny nose; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patients medical history included diabetes mellitus type2, hypoactive thyroid, and hypertension. The patient did not have any allergies to medications, food or other products. It was unknown whether patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Mar2021 at 03:00, the patient had fever (103.3), severe chills and shaking, profusely watering eyes and profusely runny nose.  The treatment medication provided was TYLENOL. The clinical outcome of fever, severe chills, shaking, profusely watering eyes and profusely runny nose were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Lacrimation increased, Pyrexia, Rhinorrhoea
Clinical narrative: 103.3 fever; severe chills; shaking,; watering eyes; profusely runny nose; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patients medical history included diabetes mellitus type2, hypoactive thyroid, and hypertension. The patient did not have any allergies to medications, food or other products. It was unknown whether patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Mar2021 at 03:00, the patient had fever (103.3), severe chills and shaking, profusely watering eyes and profusely runny nose.  The treatment medication provided was TYLENOL. The clinical outcome of fever, severe chills, shaking, profusely watering eyes and profusely runny nose were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: 103.3 fever; severe chills; shaking,; watering eyes; profusely runny nose; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patients medical history included diabetes mellitus type2, hypoactive thyroid, and hypertension. The patient did not have any allergies to medications, food or other products. It was unknown whether patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Mar2021 at 03:00, the patient had fever (103.3), severe chills and shaking, profusely watering eyes and profusely runny nose.  The treatment medication provided was TYLENOL. The clinical outcome of fever, severe chills, shaking, profusely watering eyes and profusely runny nose were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Stridor, Throat tightness
Clinical narrative: Anaphylaxis
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102; Headache; Body aches; extreme fatigue/ Slight fatigue on morning of day three; Extreme soreness in arm; Developed rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208 and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Mar2020 to an unknown date. The patient was not pregnant at the time of vaccination and has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. On 24Mar2021, the patient experienced fever of 102 (as reported), headache, body aches and extreme fatigue. It was reported that the symptoms were similar when the patient had COVID in March 2020. The symptoms lasted for two days following vaccine. However, it was reported that the patient further experienced slight fatigue on morning of day three. Also, the patient experienced extreme soreness in arm, and developed rash at injection right on 24Mar2021 (reported as on day two of vaccination). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from fever, headache, body aches and fatigue on 26Mar2021 and from extreme soreness in arm and rash at injection of an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash
Clinical narrative: Fever of 102; Headache; Body aches; extreme fatigue/ Slight fatigue on morning of day three; Extreme soreness in arm; Developed rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208 and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Mar2020 to an unknown date. The patient was not pregnant at the time of vaccination and has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. On 24Mar2021, the patient experienced fever of 102 (as reported), headache, body aches and extreme fatigue. It was reported that the symptoms were similar when the patient had COVID in March 2020. The symptoms lasted for two days following vaccine. However, it was reported that the patient further experienced slight fatigue on morning of day three. Also, the patient experienced extreme soreness in arm, and developed rash at injection right on 24Mar2021 (reported as on day two of vaccination). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from fever, headache, body aches and fatigue on 26Mar2021 and from extreme soreness in arm and rash at injection of an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Fever of 102; Headache; Body aches; extreme fatigue/ Slight fatigue on morning of day three; Extreme soreness in arm; Developed rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208 and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Mar2020 to an unknown date. The patient was not pregnant at the time of vaccination and has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. On 24Mar2021, the patient experienced fever of 102 (as reported), headache, body aches and extreme fatigue. It was reported that the symptoms were similar when the patient had COVID in March 2020. The symptoms lasted for two days following vaccine. However, it was reported that the patient further experienced slight fatigue on morning of day three. Also, the patient experienced extreme soreness in arm, and developed rash at injection right on 24Mar2021 (reported as on day two of vaccination). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from fever, headache, body aches and fatigue on 26Mar2021 and from extreme soreness in arm and rash at injection of an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: Fever of 102; Headache; Body aches; extreme fatigue/ Slight fatigue on morning of day three; Extreme soreness in arm; Developed rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208 and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Mar2020 to an unknown date. The patient was not pregnant at the time of vaccination and has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. On 24Mar2021, the patient experienced fever of 102 (as reported), headache, body aches and extreme fatigue. It was reported that the symptoms were similar when the patient had COVID in March 2020. The symptoms lasted for two days following vaccine. However, it was reported that the patient further experienced slight fatigue on morning of day three. Also, the patient experienced extreme soreness in arm, and developed rash at injection right on 24Mar2021 (reported as on day two of vaccination). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from fever, headache, body aches and fatigue on 26Mar2021 and from extreme soreness in arm and rash at injection of an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Influenza like illness, Injection site pain, Pain, Pruritus
Clinical narrative: Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female consumer (Patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 02:15 AM (at 77-year old) on left arm at dose 1, single for COVID-19 immunization. The medical history of the patient included that she was tested covid-19 positive. The patient had no allergies. The patient's concomitant medications were not reported. Patient had not received any Other vaccine same date and had not received other vaccine same date product. It was mentioned that patient got no other vaccine in four weeks and no medications in two weeks. On 30Jan2021, the same day patient had itchy at injection site; Monday he was site still itchy. On 31Jan2021 at 12:00 hours the patient experienced flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen. On 08Feb2021 the nasal swab covid test was done for which results was unknown. The patient was scheduled for 2nd shot on 20Feb2021. The outcome of injection site itchy was not recovered and outcome of other events flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen was unknown.  No follow-up attempts were possible; information about Lot/batch number could not be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female consumer (Patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 02:15 AM (at 77-year old) on left arm at dose 1, single for COVID-19 immunization. The medical history of the patient included that she was tested covid-19 positive. The patient had no allergies. The patient's concomitant medications were not reported. Patient had not received any Other vaccine same date and had not received other vaccine same date product. It was mentioned that patient got no other vaccine in four weeks and no medications in two weeks. On 30Jan2021, the same day patient had itchy at injection site; Monday he was site still itchy. On 31Jan2021 at 12:00 hours the patient experienced flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen. On 08Feb2021 the nasal swab covid test was done for which results was unknown. The patient was scheduled for 2nd shot on 20Feb2021. The outcome of injection site itchy was not recovered and outcome of other events flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen was unknown.  No follow-up attempts were possible; information about Lot/batch number could not be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Vaccination site pruritus
Clinical narrative: Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female consumer (Patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 02:15 AM (at 77-year old) on left arm at dose 1, single for COVID-19 immunization. The medical history of the patient included that she was tested covid-19 positive. The patient had no allergies. The patient's concomitant medications were not reported. Patient had not received any Other vaccine same date and had not received other vaccine same date product. It was mentioned that patient got no other vaccine in four weeks and no medications in two weeks. On 30Jan2021, the same day patient had itchy at injection site; Monday he was site still itchy. On 31Jan2021 at 12:00 hours the patient experienced flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen. On 08Feb2021 the nasal swab covid test was done for which results was unknown. The patient was scheduled for 2nd shot on 20Feb2021. The outcome of injection site itchy was not recovered and outcome of other events flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen was unknown.  No follow-up attempts were possible; information about Lot/batch number could not be obtained.