chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, UNK, UNK, VARZOS, VARZOS, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster
Clinical narrative: Mild Shingles symptoms on left side of abdomen and left side of back; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included acid reflux (GERD), shingles, allergy to fresh pineapple and raw shrimp. 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 vaccine. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) 10 mcg, estradiol/norethisterone acetate (COMBIPATCH) 0.05-0.14 mg; both from unknown dates for unspecified indications. The patient previously received varicella zoster vaccine live (ZOSTAVAX) on 01Sep2015 (at the age of 59-years-old) and varicella zoster vaccine (SHINGRIX) on 12Jan2018 and 07Feb2018 (at the age of 61-years-old); both taken for shingles. The patient previously received sulfamethoxazole TMP DS 800-160 (MANUFACTURER UNKNOWN) and rofecoxib (VIOXX); both on unknown dates for unspecified indications and experienced drug allergy. The patient had no shingles side effects until 8 hours after the first COVID vaccine. On 16Apr2021 at 20:00, the patient experienced mild shingles symptoms on left side of abdomen and left side of back. Ten years ago, the patient experienced one severe case of shingles and one mild case of shingles when the patient was in mid-50s.The event 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 event. The clinical outcome of the event mild shingles symptoms on left side of abdomen and left side of back was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Swollen lymph node in armpit and painful; Fever; Chills; Achy joints; This is a spontaneous report from a contactable consumer, the patient. A 48-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 right arm on 08Apr2021 at 09:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18May2021 at 13:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 10:00 the patient experienced swollen lymph node in arm pit, painful, fever, chills and achy joints. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, achy joints, swollen lymph node in arm pit and painful were recovered on unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph node in armpit and painful; Fever; Chills; Achy joints; This is a spontaneous report from a contactable consumer, the patient. A 48-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 right arm on 08Apr2021 at 09:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18May2021 at 13:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 10:00 the patient experienced swollen lymph node in arm pit, painful, fever, chills and achy joints. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, achy joints, swollen lymph node in arm pit and painful were recovered on unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus 6 hours after 2nd dose; Severe Pain at base of skull; Nausea; Extreme Fatigue; Chest pain; internal inflammation; Eye Floaters; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 54-years-old via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:15 (Batch/Lot Number: EW0164) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Concomitant medications included metformin and atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54-years-old administered in arm left on 30Mar2021 11:00 (batch/lot number: ER8132) for covid-19 immunisation. The patient experienced tinnitus 6 hours after 2nd dose, severe pain at base of skull, nausea, extreme fatigue, chest pain, internal inflammation and eye floaters on 19Apr2021 11:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of the events which included Steroid injection in ear - Anti viral for inflamma (as reported). The patient did not recover from the events.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Fatigue, Headache, Inflammation, Nausea
Clinical narrative: Tinnitus 6 hours after 2nd dose; Severe Pain at base of skull; Nausea; Extreme Fatigue; Chest pain; internal inflammation; Eye Floaters; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 54-years-old via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:15 (Batch/Lot Number: EW0164) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Concomitant medications included metformin and atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54-years-old administered in arm left on 30Mar2021 11:00 (batch/lot number: ER8132) for covid-19 immunisation. The patient experienced tinnitus 6 hours after 2nd dose, severe pain at base of skull, nausea, extreme fatigue, chest pain, internal inflammation and eye floaters on 19Apr2021 11:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of the events which included Steroid injection in ear - Anti viral for inflamma (as reported). The patient did not recover from the events.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vitreous floaters
Clinical narrative: Tinnitus 6 hours after 2nd dose; Severe Pain at base of skull; Nausea; Extreme Fatigue; Chest pain; internal inflammation; Eye Floaters; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 54-years-old via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:15 (Batch/Lot Number: EW0164) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Concomitant medications included metformin and atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54-years-old administered in arm left on 30Mar2021 11:00 (batch/lot number: ER8132) for covid-19 immunisation. The patient experienced tinnitus 6 hours after 2nd dose, severe pain at base of skull, nausea, extreme fatigue, chest pain, internal inflammation and eye floaters on 19Apr2021 11:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of the events which included Steroid injection in ear - Anti viral for inflamma (as reported). The patient did not recover from the events.  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Pyrexia, Rash, Rash papular, Rash pruritic
Clinical narrative: really bad head to toe hives/ a rash; a rash, its red; starting to get warm italy and swollen; starting to get warm; bumpy; hot; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er-8731) via an unspecified route of administration in the left arm on 09Apr2021 at 06:45 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN)  ibuprofen (MANUFACTURER UNKNOWN) , birth control (UNSPECIFIED) and hydrocodone (MANUFACTURER UNKNOWN). 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 11Apr2021 at 13:00, the patient experienced really bad head to toe hives/ a rash, it was red, bumpy and hot. The patient started getting warm and swollen. The clinical outcome of the events hives head to toe, red, bumpy and hot rash, warm and swollen  was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hot flush, Rash, Rash erythematous, Swelling
Clinical narrative: really bad head to toe hives/ a rash; a rash, its red; starting to get warm italy and swollen; starting to get warm; bumpy; hot; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er-8731) via an unspecified route of administration in the left arm on 09Apr2021 at 06:45 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN)  ibuprofen (MANUFACTURER UNKNOWN) , birth control (UNSPECIFIED) and hydrocodone (MANUFACTURER UNKNOWN). 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 11Apr2021 at 13:00, the patient experienced really bad head to toe hives/ a rash, it was red, bumpy and hot. The patient started getting warm and swollen. The clinical outcome of the events hives head to toe, red, bumpy and hot rash, warm and swollen  was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: really bad head to toe hives/ a rash; a rash, its red; starting to get warm italy and swollen; starting to get warm; bumpy; hot; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er-8731) via an unspecified route of administration in the left arm on 09Apr2021 at 06:45 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN)  ibuprofen (MANUFACTURER UNKNOWN) , birth control (UNSPECIFIED) and hydrocodone (MANUFACTURER UNKNOWN). 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 11Apr2021 at 13:00, the patient experienced really bad head to toe hives/ a rash, it was red, bumpy and hot. The patient started getting warm and swollen. The clinical outcome of the events hives head to toe, red, bumpy and hot rash, warm and swollen  was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Biopsy skin, Blister, Blood test, Chest X-ray abnormal
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Computerised tomogram thorax, Cough, Decreased appetite, Diarrhoea
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Hilar lymphadenopathy, Lymphadenopathy, Lymphadenopathy mediastinal
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Ocular hyperaemia, Pain, Pneumonitis, Pyrexia
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash papular, Rhinorrhoea, SARS-CoV-2 test negative, Skin exfoliation
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Stomatitis, Streptococcus test negative
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Condition aggravated, Cough, Decreased appetite, Diarrhoea
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: cough; breathing worse/difficulty breathing; breathing worse/difficulty breathing; diarrhea; no appetite; rash on feet/ full body rash; tired/ exhaustion; low grade fever/ fever 100 -102.4; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0169) via an unspecified route of administration on 16Apr2021 at 09:00 (at the age of 56-years-old) in right arm as a single dose for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient was tested for covid-19. The patient had no known allergies. Concomitant medications received in two weeks included tadalafil (TADALAFIL); thyroid (ARMOUR THYROID); spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: FL9296) on 25Mar2021 at 16:45 in right arm for covid-19 immunization. On 18Apr2021 the patient experienced rash on feet, was tired, and had low grade fever. On 20Apr2021 he experienced full body rash, had no appetite and fever 100 - 102.4. On 23Apr2021 he continued with rash, fever, diarrhoea, difficulty breathing and exhaustion. On 24Apr2021 he continued with full body rash, breathing worse with cough, fever was present and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 100 -102.4 on 20Apr2021 and sars-cov-2 test (nasal swab): negative on 22Apr2021. The patient was treated with Prednisone 50 mg. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Cycle was shortened by about 4 days. Cycle generally runs like clockwork every 25 days, but period came 4 days earlier than usual.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female 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 07Apr2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 12:00, the patient's cycle was shortened by about 4 days. Her cycle generally runs like clockwork every 25 days, but her period came 4 days earlier than usual.  Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event cycle was shortened by about 4 days was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular
Clinical narrative: Cycle was shortened by about 4 days. Cycle generally runs like clockwork every 25 days, but period came 4 days earlier than usual.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female 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 07Apr2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 12:00, the patient's cycle was shortened by about 4 days. Her cycle generally runs like clockwork every 25 days, but her period came 4 days earlier than usual.  Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event cycle was shortened by about 4 days was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Chills, Headache
Clinical narrative: Fever as high at 101.8; Terrible chills; Ache; Headache; Nausea; Felt like i had a bad flu; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9810) intramuscularly in left arm on 06Feb2021 12:30 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) intramuscularly in left arm on 27Feb2021 11:45 as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. Vaccine was not administered at a military facility. Patient medical history included ongoing allergies (hypersensitivity), ongoing GERD (gastroesophageal reflux disease), heart valve calcification repair from 03Dec2019 and ongoing. The concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy (hypersensitivity) via oral route from an unspecified start date and ongoing, metoprolol tartrate via oral route taken for allergy (hypersensitivity, reported as heart) from an unspecified start date and ongoing, pantoprazole via oral route taken for GERDS (gastroesophageal reflux disease) from an unspecified start date and ongoing, fluticasone propionate (FLONASE ALLERGY RELIEF) via oral route taken for an unspecified indication from an unspecified start date and ongoing.  The patient experienced fever as high at 101.8 degrees (after 9 hours from vaccination), terrible chills, ache, headache, nausea, felt like had a bad flu on an unspecified date in 2021. Patient did not go to ER or Doctor. However, for both shots he had nasty side effects for 48 hours, fever as high as 101.8 degree, terrible chills, aches, headaches for 12 hours, nauseated, felt like he had a bad flu started 8-9 hours after shot. The patient underwent lab tests and procedures which included computerized tomogram with result as computerized tomogram (issues from COVID pneumonia) on 31Dec2020. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: Fever as high at 101.8; Terrible chills; Ache; Headache; Nausea; Felt like i had a bad flu; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9810) intramuscularly in left arm on 06Feb2021 12:30 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) intramuscularly in left arm on 27Feb2021 11:45 as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. Vaccine was not administered at a military facility. Patient medical history included ongoing allergies (hypersensitivity), ongoing GERD (gastroesophageal reflux disease), heart valve calcification repair from 03Dec2019 and ongoing. The concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy (hypersensitivity) via oral route from an unspecified start date and ongoing, metoprolol tartrate via oral route taken for allergy (hypersensitivity, reported as heart) from an unspecified start date and ongoing, pantoprazole via oral route taken for GERDS (gastroesophageal reflux disease) from an unspecified start date and ongoing, fluticasone propionate (FLONASE ALLERGY RELIEF) via oral route taken for an unspecified indication from an unspecified start date and ongoing.  The patient experienced fever as high at 101.8 degrees (after 9 hours from vaccination), terrible chills, ache, headache, nausea, felt like had a bad flu on an unspecified date in 2021. Patient did not go to ER or Doctor. However, for both shots he had nasty side effects for 48 hours, fever as high as 101.8 degree, terrible chills, aches, headaches for 12 hours, nauseated, felt like he had a bad flu started 8-9 hours after shot. The patient underwent lab tests and procedures which included computerized tomogram with result as computerized tomogram (issues from COVID pneumonia) on 31Dec2020. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Condition aggravated, Feeling abnormal
Clinical narrative: Fever as high at 101.8; Terrible chills; Ache; Headache; Nausea; Felt like i had a bad flu; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9810) intramuscularly in left arm on 06Feb2021 12:30 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) intramuscularly in left arm on 27Feb2021 11:45 as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. Vaccine was not administered at a military facility. Patient medical history included ongoing allergies (hypersensitivity), ongoing GERD (gastroesophageal reflux disease), heart valve calcification repair from 03Dec2019 and ongoing. The concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy (hypersensitivity) via oral route from an unspecified start date and ongoing, metoprolol tartrate via oral route taken for allergy (hypersensitivity, reported as heart) from an unspecified start date and ongoing, pantoprazole via oral route taken for GERDS (gastroesophageal reflux disease) from an unspecified start date and ongoing, fluticasone propionate (FLONASE ALLERGY RELIEF) via oral route taken for an unspecified indication from an unspecified start date and ongoing.  The patient experienced fever as high at 101.8 degrees (after 9 hours from vaccination), terrible chills, ache, headache, nausea, felt like had a bad flu on an unspecified date in 2021. Patient did not go to ER or Doctor. However, for both shots he had nasty side effects for 48 hours, fever as high as 101.8 degree, terrible chills, aches, headaches for 12 hours, nauseated, felt like he had a bad flu started 8-9 hours after shot. The patient underwent lab tests and procedures which included computerized tomogram with result as computerized tomogram (issues from COVID pneumonia) on 31Dec2020. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Influenza like illness, Nausea, Pain
Clinical narrative: Fever as high at 101.8; Terrible chills; Ache; Headache; Nausea; Felt like i had a bad flu; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9810) intramuscularly in left arm on 06Feb2021 12:30 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) intramuscularly in left arm on 27Feb2021 11:45 as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. Vaccine was not administered at a military facility. Patient medical history included ongoing allergies (hypersensitivity), ongoing GERD (gastroesophageal reflux disease), heart valve calcification repair from 03Dec2019 and ongoing. The concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy (hypersensitivity) via oral route from an unspecified start date and ongoing, metoprolol tartrate via oral route taken for allergy (hypersensitivity, reported as heart) from an unspecified start date and ongoing, pantoprazole via oral route taken for GERDS (gastroesophageal reflux disease) from an unspecified start date and ongoing, fluticasone propionate (FLONASE ALLERGY RELIEF) via oral route taken for an unspecified indication from an unspecified start date and ongoing.  The patient experienced fever as high at 101.8 degrees (after 9 hours from vaccination), terrible chills, ache, headache, nausea, felt like had a bad flu on an unspecified date in 2021. Patient did not go to ER or Doctor. However, for both shots he had nasty side effects for 48 hours, fever as high as 101.8 degree, terrible chills, aches, headaches for 12 hours, nauseated, felt like he had a bad flu started 8-9 hours after shot. The patient underwent lab tests and procedures which included computerized tomogram with result as computerized tomogram (issues from COVID pneumonia) on 31Dec2020. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Retching
Clinical narrative: Fever as high at 101.8; Terrible chills; Ache; Headache; Nausea; Felt like i had a bad flu; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9810) intramuscularly in left arm on 06Feb2021 12:30 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) intramuscularly in left arm on 27Feb2021 11:45 as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. Vaccine was not administered at a military facility. Patient medical history included ongoing allergies (hypersensitivity), ongoing GERD (gastroesophageal reflux disease), heart valve calcification repair from 03Dec2019 and ongoing. The concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy (hypersensitivity) via oral route from an unspecified start date and ongoing, metoprolol tartrate via oral route taken for allergy (hypersensitivity, reported as heart) from an unspecified start date and ongoing, pantoprazole via oral route taken for GERDS (gastroesophageal reflux disease) from an unspecified start date and ongoing, fluticasone propionate (FLONASE ALLERGY RELIEF) via oral route taken for an unspecified indication from an unspecified start date and ongoing.  The patient experienced fever as high at 101.8 degrees (after 9 hours from vaccination), terrible chills, ache, headache, nausea, felt like had a bad flu on an unspecified date in 2021. Patient did not go to ER or Doctor. However, for both shots he had nasty side effects for 48 hours, fever as high as 101.8 degree, terrible chills, aches, headaches for 12 hours, nauseated, felt like he had a bad flu started 8-9 hours after shot. The patient underwent lab tests and procedures which included computerized tomogram with result as computerized tomogram (issues from COVID pneumonia) on 31Dec2020. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.