chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Menstrual disorder, Pain in extremity
Clinical narrative: Change in menstruation. Period started 14 days early and has been heavy and long; Change in menstruation. Period started 14 days early and has been heavy and long; Change in menstruation. Period started 14 days early and has been heavy and long; Also having stabbing/burning pain in legs, feet and chest; Also having stabbing/burning pain in legs, feet and chest; Also having stabbing/burning pain in legs, feet and chest; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-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 right arm on 03Apr2021 at 10:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medication taken within two weeks of vaccination included Antihistamine (unspecified) from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 08:00, the patient experienced change in menstruation. Period started 14 days early and had been heavy and long. The patient was also having stabbing/burning pain in legs, feet and chest. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events change in menstruation; period started 14 days early and had been heavy and long, also having stabbing/burning pain in legs, feet and chest was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heavy menstrual bleeding, Menstruation irregular, Pain
Clinical narrative: Change in menstruation. Period started 14 days early and has been heavy and long; Change in menstruation. Period started 14 days early and has been heavy and long; Change in menstruation. Period started 14 days early and has been heavy and long; Also having stabbing/burning pain in legs, feet and chest; Also having stabbing/burning pain in legs, feet and chest; Also having stabbing/burning pain in legs, feet and chest; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-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 right arm on 03Apr2021 at 10:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medication taken within two weeks of vaccination included Antihistamine (unspecified) from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 08:00, the patient experienced change in menstruation. Period started 14 days early and had been heavy and long. The patient was also having stabbing/burning pain in legs, feet and chest. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events change in menstruation; period started 14 days early and had been heavy and long, also having stabbing/burning pain in legs, feet and chest was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I've been having adverse ringing in my ears since my first shot. It's been more prevalent at night time but it is constant throughout the day; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN),fish oil (MANUFACTURER UNKNOWN),tocopherol (VIT E),zinc (MANUFACTURER UNKNOWN),vitamin d nos (VIT D)all taken  for an unknown indication from an unknown date  taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had  been tested for COVID-19. On 25Mar2021 at 21:00 the patient experienced ringing in ears since the first shot and it had been more prevalent at night time but it was constant throughout the day. On an unknown date, the patient underwent nasal Swab test, SARS CoV-2 test  and the result was negative. No therapeutic measures were taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event ringing in ears since the first shot and it had been more prevalent at night time but it was constant throughout the day was not resolved at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: I've been having adverse ringing in my ears since my first shot. It's been more prevalent at night time but it is constant throughout the day; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN),fish oil (MANUFACTURER UNKNOWN),tocopherol (VIT E),zinc (MANUFACTURER UNKNOWN),vitamin d nos (VIT D)all taken  for an unknown indication from an unknown date  taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had  been tested for COVID-19. On 25Mar2021 at 21:00 the patient experienced ringing in ears since the first shot and it had been more prevalent at night time but it was constant throughout the day. On an unknown date, the patient underwent nasal Swab test, SARS CoV-2 test  and the result was negative. No therapeutic measures were taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event ringing in ears since the first shot and it had been more prevalent at night time but it was constant throughout the day was not resolved at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under arm on same side as vaccination site.; This is a spontaneous report from a contactable consumer, the patient. A 61-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 12Apr2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no side effect with first dose. The patient previously also took codeine (MANUFACTURER UNKNOWN) and experienced allergy.  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 13Apr2021 at 17:00, the patient experienced swollen lymph nodes under arm on same side as vaccination site which occurred after second dose only. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes under arm on same side as vaccination site was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 26-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8734), at the age of 26, via an unspecified route of administration, left arm, on Apr 13, 2021, at 07:45, single dose, for COVID-19 immunisation. Medical history not reported. The patient has allergies to seafood. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN0206), via an unspecified route of administration, left arm, on Mar 23, 2021, at 09:15, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 14, 2021, at 02:00, patient experienced headache and periodic pains on one spot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. The clinical outcome of headache and periodic pains on one spot: unresolved (at the time of report). No follow-up attempts needed. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Irritability, Pain, Pyrexia
Clinical narrative: headache; body aches; mild fever(99+); irritability; Overnight chills; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not available. The patient had no known allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (MANUFACTURER UNKNOWN), dipenten (LIMONENE) and multivitamins; all from an unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient underwent temperature check and  the result was 99+ with unspecified units. On 14Apr2021 at 04:00,  the patient experienced overnight chills, woke up with headache, body aches, mild fever (99+) and irritability. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of overnight chills, headache, body aches, mild fever  and irritability were recovering at the time of this report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Headache, Irritability, Pain
Clinical narrative: headache; body aches; mild fever(99+); irritability; Overnight chills; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not available. The patient had no known allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (MANUFACTURER UNKNOWN), dipenten (LIMONENE) and multivitamins; all from an unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient underwent temperature check and  the result was 99+ with unspecified units. On 14Apr2021 at 04:00,  the patient experienced overnight chills, woke up with headache, body aches, mild fever (99+) and irritability. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of overnight chills, headache, body aches, mild fever  and irritability were recovering at the time of this report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: headache; body aches; mild fever(99+); irritability; Overnight chills; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not available. The patient had no known allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (MANUFACTURER UNKNOWN), dipenten (LIMONENE) and multivitamins; all from an unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient underwent temperature check and  the result was 99+ with unspecified units. On 14Apr2021 at 04:00,  the patient experienced overnight chills, woke up with headache, body aches, mild fever (99+) and irritability. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of overnight chills, headache, body aches, mild fever  and irritability were recovering at the time of this report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Photopsia, Pyrexia, Vitreous floaters
Clinical narrative: The most troubling one, if it is related, is that I had an eye "floater" for the first time in my life on April 12, 2021. It started about 12:00 p.m. on that day.; Other, more common and less troubling side effects: The day after I received my second dose, I had a fever of 101.2 and sore left arm; Other, more common and less troubling side effects: The day after I received my second dose, I had a fever of 101.2 and sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 07Apr2021 at 08:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included primary biliary cholangitis, in remission. The patient did not have any allergies to food, medications, or other products. Concomitant medications taken within two weeks of vaccination included vitamin d nos (VITAMIN D) and tretinoin (MANUFACTURER UNKNOWN), both for unknown indication from unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 17Mar2021 at 09:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced other, more common and less troubling side effects: On 08Apr2021, the day after she received her second dose, the patient had a fever of 101.2 (unspecified units) and sore left arm. The most troubling one, if it was related, was that the patient had an eye "floater" for the first time in her life on 12Apr2021. It started about 12:00 on that day. The next day, the patient went to an optometrist at an Eye Institute, and he confirmed it was a floater. The event eye "floater" resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever of 101.2 (unspecified units) and sore left arm and the most troubling one, an eye "floater" for the first time in patients life was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Vitreous floaters
Clinical narrative: The most troubling one, if it is related, is that I had an eye "floater" for the first time in my life on April 12, 2021. It started about 12:00 p.m. on that day.; Other, more common and less troubling side effects: The day after I received my second dose, I had a fever of 101.2 and sore left arm; Other, more common and less troubling side effects: The day after I received my second dose, I had a fever of 101.2 and sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 07Apr2021 at 08:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included primary biliary cholangitis, in remission. The patient did not have any allergies to food, medications, or other products. Concomitant medications taken within two weeks of vaccination included vitamin d nos (VITAMIN D) and tretinoin (MANUFACTURER UNKNOWN), both for unknown indication from unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 17Mar2021 at 09:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced other, more common and less troubling side effects: On 08Apr2021, the day after she received her second dose, the patient had a fever of 101.2 (unspecified units) and sore left arm. The most troubling one, if it was related, was that the patient had an eye "floater" for the first time in her life on 12Apr2021. It started about 12:00 on that day. The next day, the patient went to an optometrist at an Eye Institute, and he confirmed it was a floater. The event eye "floater" resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever of 101.2 (unspecified units) and sore left arm and the most troubling one, an eye "floater" for the first time in patients life was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness on and off; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 23Mar2021 at 00:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included Hx leiomyosarcoma, high cholesterol and overweight. The patient was allergic to Regalan and IVP dye. 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. Concomitant medications included anastrozole (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. On 24Mar2021 at 12:00, the patient experienced dizziness on and off. Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness on and off was resolved on 24Mar2021 at 18:00.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for unknown indication on unknown date. The patient had no allergic to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 14:00 as a single dose. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 11:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with valtrex. The clinical outcome of the event shingles was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelids pruritus, Lip pain, Lip swelling, Ocular hyperaemia, Periorbital swelling
Clinical narrative: Edema left eyelids; itchy; rash in same location and on left side of face, neck, jawline; swollen; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8737), via an unspecified route of administration, administered in left arm, on 07Apr2021 at 12:15 as dose 2, single for COVID-19 immunisation. Medical history included seasonal allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (CLARITIN); and, mometasone furoate (NASONEX), both taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and CIPRO (ciprofloxacin hydrochloride) and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EP7534) administere at the left arm, on 17Mar2021 at 12:30 PM (at the age of 45 years old), as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 10Apr2021 at 08:00 A.M (also reported 3 days after the vaccine), it was reported that the patient experienced edema left eyelids, rash in same location and on left side of face, neck, jawline; it was reported to be very itchy, and very swollen (medically significant). 5 days after vaccine, it was reported that the right eyelids started to swell, and that patient decided to go to the emergency room. The patient received Solumedrol, Pepcid, Benadryl, Prednisone and Atarax as the treatment for the events.  The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no covid prior vaccination and was not tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash pruritic, Swelling of eyelid
Clinical narrative: Edema left eyelids; itchy; rash in same location and on left side of face, neck, jawline; swollen; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8737), via an unspecified route of administration, administered in left arm, on 07Apr2021 at 12:15 as dose 2, single for COVID-19 immunisation. Medical history included seasonal allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (CLARITIN); and, mometasone furoate (NASONEX), both taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and CIPRO (ciprofloxacin hydrochloride) and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EP7534) administere at the left arm, on 17Mar2021 at 12:30 PM (at the age of 45 years old), as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 10Apr2021 at 08:00 A.M (also reported 3 days after the vaccine), it was reported that the patient experienced edema left eyelids, rash in same location and on left side of face, neck, jawline; it was reported to be very itchy, and very swollen (medically significant). 5 days after vaccine, it was reported that the right eyelids started to swell, and that patient decided to go to the emergency room. The patient received Solumedrol, Pepcid, Benadryl, Prednisone and Atarax as the treatment for the events.  The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no covid prior vaccination and was not tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid oedema, Pruritus, Rash, Swelling
Clinical narrative: Edema left eyelids; itchy; rash in same location and on left side of face, neck, jawline; swollen; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8737), via an unspecified route of administration, administered in left arm, on 07Apr2021 at 12:15 as dose 2, single for COVID-19 immunisation. Medical history included seasonal allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (CLARITIN); and, mometasone furoate (NASONEX), both taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and CIPRO (ciprofloxacin hydrochloride) and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EP7534) administere at the left arm, on 17Mar2021 at 12:30 PM (at the age of 45 years old), as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 10Apr2021 at 08:00 A.M (also reported 3 days after the vaccine), it was reported that the patient experienced edema left eyelids, rash in same location and on left side of face, neck, jawline; it was reported to be very itchy, and very swollen (medically significant). 5 days after vaccine, it was reported that the right eyelids started to swell, and that patient decided to go to the emergency room. The patient received Solumedrol, Pepcid, Benadryl, Prednisone and Atarax as the treatment for the events.  The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no covid prior vaccination and was not tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glossodynia, Lip blister, Lip swelling, Oral mucosal blistering, Pruritus
Clinical narrative: Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 08Apr2021 12:45 (Batch/Lot Number: EW 0151) dose 1, single (at the age of 17-years-old) for COVID-19 immunisation. Medical history included migraines, depression/anxiety, exercise induced asthma and anxiety; all from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone hydrochloride (BUSPAR); carbamazepine (TEGRETOL); caffeine, paracetamol (EXCEDRIN ASPIRIN FREE); paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On 12Apr2021 on 11:00, the patient experienced full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes. The patient required a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatments of steroid injection, prednisone RX and steroid cream. The patient has not recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Stomatitis
Clinical narrative: Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 08Apr2021 12:45 (Batch/Lot Number: EW 0151) dose 1, single (at the age of 17-years-old) for COVID-19 immunisation. Medical history included migraines, depression/anxiety, exercise induced asthma and anxiety; all from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone hydrochloride (BUSPAR); carbamazepine (TEGRETOL); caffeine, paracetamol (EXCEDRIN ASPIRIN FREE); paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On 12Apr2021 on 11:00, the patient experienced full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes. The patient required a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatments of steroid injection, prednisone RX and steroid cream. The patient has not recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip blister, Lip swelling, Lymph node pain, Lymphadenopathy, Rash pruritic
Clinical narrative: Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; Full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes.; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 08Apr2021 12:45 (Batch/Lot Number: EW 0151) dose 1, single (at the age of 17-years-old) for COVID-19 immunisation. Medical history included migraines, depression/anxiety, exercise induced asthma and anxiety; all from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone hydrochloride (BUSPAR); carbamazepine (TEGRETOL); caffeine, paracetamol (EXCEDRIN ASPIRIN FREE); paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On 12Apr2021 on 11:00, the patient experienced full body itchy rash- including, palms and soles; swollen, blistered lips; sore, swollen lymph nodes. The patient required a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatments of steroid injection, prednisone RX and steroid cream. The patient has not recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Cough, Feeling hot, Hyperhidrosis, Impaired work ability
Clinical narrative: Lymph nodes in neck hurt so bad; Fever went up to 102; Wheezing a little but not in distress; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 11Apr2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. 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 COVID vaccine. Concomitant medications included paracetamol (TYLENOL), naproxen sodium (ALEVE), diphenhydramine hydrochloride (MANUFACTURER UNKNOWN); all since unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 07:00, the day after the vaccination, the patient was in tears because her lymph nodes in her neck hurt so bad. The patient could not turn her head and fever also went up to 102. Three days after the vaccination, patient's lymph nodes in neck were still painful. The patient also wheezed a little but not in distress. The patient also reported having hot flashes since one day after the second dose. On 12Apr2021 at 07:00, the patient body temperature was measured and the result was 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes in neck hurt so bad, fever went up to 102, wheezing a little but not in distress and hot flashes were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Wheezing
Clinical narrative: Lymph nodes in neck hurt so bad; Fever went up to 102; Wheezing a little but not in distress; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 11Apr2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. 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 COVID vaccine. Concomitant medications included paracetamol (TYLENOL), naproxen sodium (ALEVE), diphenhydramine hydrochloride (MANUFACTURER UNKNOWN); all since unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 07:00, the day after the vaccination, the patient was in tears because her lymph nodes in her neck hurt so bad. The patient could not turn her head and fever also went up to 102. Three days after the vaccination, patient's lymph nodes in neck were still painful. The patient also wheezed a little but not in distress. The patient also reported having hot flashes since one day after the second dose. On 12Apr2021 at 07:00, the patient body temperature was measured and the result was 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes in neck hurt so bad, fever went up to 102, wheezing a little but not in distress and hot flashes were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Hot flush, Lymph node pain, Pyrexia, Wheezing
Clinical narrative: Lymph nodes in neck hurt so bad; Fever went up to 102; Wheezing a little but not in distress; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 11Apr2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. 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 COVID vaccine. Concomitant medications included paracetamol (TYLENOL), naproxen sodium (ALEVE), diphenhydramine hydrochloride (MANUFACTURER UNKNOWN); all since unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 07:00, the day after the vaccination, the patient was in tears because her lymph nodes in her neck hurt so bad. The patient could not turn her head and fever also went up to 102. Three days after the vaccination, patient's lymph nodes in neck were still painful. The patient also wheezed a little but not in distress. The patient also reported having hot flashes since one day after the second dose. On 12Apr2021 at 07:00, the patient body temperature was measured and the result was 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes in neck hurt so bad, fever went up to 102, wheezing a little but not in distress and hot flashes were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Red raised itchy rash on face; Red raised itchy rash on face; Swollen eyes; This is a spontaneous report from a contactable nurse, the patient. A 32-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 12Apr2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 as a single dose for COVID-19 immunisation. On 12Apr2021, at 20:00 the patient experienced red raised itchy rash on face and swollen eyes. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red raised itchy rash on face and swollen eyes was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Rash erythematous, Rash pruritic
Clinical narrative: Red raised itchy rash on face; Red raised itchy rash on face; Swollen eyes; This is a spontaneous report from a contactable nurse, the patient. A 32-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 12Apr2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 as a single dose for COVID-19 immunisation. On 12Apr2021, at 20:00 the patient experienced red raised itchy rash on face and swollen eyes. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red raised itchy rash on face and swollen eyes was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained