chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma skin
Clinical narrative: Swelling or granulomas developed on face; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9264) via an unspecified route of administration in the right arm on 23Mar2021 at 12:30 (at the age of 53-years-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 receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 30Mar2021 at 00:00, the patient experienced swelling or granulomas developed on face where artefill polymethylmethacrylate (PMMA) filler was placed 8 years ago. She stated granulomas appeared around 1 week after first Pfizer vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling or granulomas developed on face was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Back pain, Chills, Epistaxis
Clinical narrative: Swollen lymph node underarm; Nausea; Fatigue; Fever; Backache; Joint pain; Chills; Hot flashes; Taste off; Nose bleed; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on the left arm on 12Apr2021 at 10:00 (at the age of 31-years-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 4 weeks prior to the vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration on the left arm on 22Mar2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 01:00, the patient experienced swollen lymph node underarm, nausea, fatigue, fever, backache, joint pain, chills, hot flashes, taste off and nose bleed. The events did not result in doctor or other healthcare professional office/clinic, 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 swollen lymph node underarm, nausea, fatigue, fever, backache, joint pain, chills, hot flashes, taste off and nose bleed was recovered on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Swollen lymph node underarm; Nausea; Fatigue; Fever; Backache; Joint pain; Chills; Hot flashes; Taste off; Nose bleed; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on the left arm on 12Apr2021 at 10:00 (at the age of 31-years-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 4 weeks prior to the vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration on the left arm on 22Mar2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 01:00, the patient experienced swollen lymph node underarm, nausea, fatigue, fever, backache, joint pain, chills, hot flashes, taste off and nose bleed. The events did not result in doctor or other healthcare professional office/clinic, 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 swollen lymph node underarm, nausea, fatigue, fever, backache, joint pain, chills, hot flashes, taste off and nose bleed was recovered on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; slight fever; felt very dehydrated; fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on 23Apr2021 at 09:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and shrimp allergy. 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 iron (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 23Apr2021, the patient experienced pain in arm, slight fever, felt very dehydrated and fatigue. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in arm, slight fever, felt very dehydrated and fatigue was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 22Apr2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and allergy to lobster (shellfish allergy). 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 vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), atorvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 20:00, the patient experienced diarrhea. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Red spots on both legs and extreme itching; Extreme itching; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the arm right on 28Mar2021 at 00:00 as a single dose for COVID-19 immunisation. Medical history reported as heart. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient received other medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine.  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 an unknown date of 2021 as a single dose for COVID-19 immunisation. On 04Apr2021 at 00:00, 7 days after the vaccination, the patient experienced red spots on both legs and extreme itching. Therapeutic measures were not taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event red spots on both legs and extreme itching was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Day 1- extremely sore. Day 2 extremely sore entire body but painful on left side of breast extending from my armpit to neck. Hurts if not touched but hurts a lot worse when touched.; extremely sore - felt like a badflu; Terrible headache; Very sore to move my arm; There also is a stinging type feeling in that arm.; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 22Apr2021 at 16:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), high cholesterol, bipolar disorder, gastroesophageal reflux disorder (GERD). 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 bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), metoprolol (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC), all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously 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 01Apr2021 at 16:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 18:00, the patient experienced day 1 extremely sore - felt like a bad flu, no vomiting, no nausea, no diarrhea and terrible headache. On day 2, she had extremely sore entire body but painful on left side of breast extending from her armpit to neck; hurts if it was not touched but hurts a lot worse when touched. She had a very sore to move my arm. She was having stinging type feeling in that arm. She did not have breathing issues at all. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flue like symptoms, headache, radiating pain, pain in arm and pricking skin sensation was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Started period morning after I had the first shot, and had more clotting; Was not due to have period for another week; This is a spontaneous report from a contactable consumer, the patient. A 40-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 14Apr2021 at 18:45 (at the age of 40-years-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. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); both taken for unknown indications from an unknown date and unknown if ongoing. On 15Apr2021, the patient started period morning after she had the first shot, and had more clotting. She was not due to have period for another week. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started period morning after the patient had the first shot, and had more clotting and was not due to have period for another week was resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Vomiting
Clinical narrative: Vomiting within 18 hrs; Unable to move arm within 12 hrs; Severe headache within 6hrs; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to food and penicillin. 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 received unspecified medications within two weeks of vaccination. The patient previously took sulfur (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 12:45 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 18:00, the patient experienced severe headache within 6 hours. On 23Apr2021 at 01:00, within 12 hours, the patient was unable to move arm and same day at 07:00, within 18 hours, patient experienced vomiting. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 severe headache, unable to move arm and vomiting was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Disease recurrence, Eye pain, Fatigue, Lymph node pain
Clinical narrative: Mild fever; Could not move my eyes up/down or sideways because it hurts to move them; Neck lymph glands are a little swollen; Lymph glands are tender to touch; Mild asthma attack; Asthama attack; Throat was itchy; Itches in my face; Arm soreness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 23Apr2021 at 09:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included rarely asthma, cholesterol high, triglycerides slightly high, hypothyroidism and overweight (body mass index 26). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (ARMOUR THYROID) from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 10:00, within 1 hour of vaccination, the patient had a mild asthma attack for which the patient used a levosalbutamol (XOPENEX) inhaler and took care of it. Right after that, the patient felt her throat was itchy and took diphenhydramine hydrochloride (BENADRYL) liquid dose and gargled which took care of throat and a few other itches in the patient face. On the same day, the patient also experienced arm soreness and fatigue. On 24Apr2021, in the morning patient woke up with a mild fever and could not move her eyes up or down or sideways since it hurts to move them. It was reported that the patient got a similar reaction when she had a small surgery and was because of an anesthesiologist. The patient could not move her eyes even at the time of the report because of pain. On the same day, the patient's neck lymph glands were little swollen and were tender to touch. The patient was very tired on the following day of vaccination too. Therapeutic measures were taken as a result of adverse events included treatment with levosalbutamol (XOPENEX) inhaler, diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, arm soreness, itches in my face, throat was itchy, mild asthma attack, mild fever, neck lymph glands are a little swollen, lymph glands are tender to touch and could not move my eyes up/down or sideways because it hurts to move them was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pruritus, Pyrexia, Throat irritation
Clinical narrative: Mild fever; Could not move my eyes up/down or sideways because it hurts to move them; Neck lymph glands are a little swollen; Lymph glands are tender to touch; Mild asthma attack; Asthama attack; Throat was itchy; Itches in my face; Arm soreness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 23Apr2021 at 09:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included rarely asthma, cholesterol high, triglycerides slightly high, hypothyroidism and overweight (body mass index 26). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (ARMOUR THYROID) from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 10:00, within 1 hour of vaccination, the patient had a mild asthma attack for which the patient used a levosalbutamol (XOPENEX) inhaler and took care of it. Right after that, the patient felt her throat was itchy and took diphenhydramine hydrochloride (BENADRYL) liquid dose and gargled which took care of throat and a few other itches in the patient face. On the same day, the patient also experienced arm soreness and fatigue. On 24Apr2021, in the morning patient woke up with a mild fever and could not move her eyes up or down or sideways since it hurts to move them. It was reported that the patient got a similar reaction when she had a small surgery and was because of an anesthesiologist. The patient could not move her eyes even at the time of the report because of pain. On the same day, the patient's neck lymph glands were little swollen and were tender to touch. The patient was very tired on the following day of vaccination too. Therapeutic measures were taken as a result of adverse events included treatment with levosalbutamol (XOPENEX) inhaler, diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, arm soreness, itches in my face, throat was itchy, mild asthma attack, mild fever, neck lymph glands are a little swollen, lymph glands are tender to touch and could not move my eyes up/down or sideways because it hurts to move them was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: Heavy period after second dose administered. I am filling one overnight Always pad every three hours.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 15:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. 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 medication included Lamotrigine (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and unknown if ongoing.  The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 12Mar2021 at 15:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 12:30, the patient experienced heavy period after second dose administered, filling one overnight always pad every three hours. The event 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 event. On 17Apr2021, the patient underwent Nasal Swab and the result was negative. On 18Apr2021, the patient underwent blood test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event heavy period was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Nasal congestion, Oral pruritus, Oropharyngeal pain
Clinical narrative: Hives on left eyelid, left cheek, some on neck and upper chest; Itchy roof of mouth; Watery eyes; Slight tingly sensation on scalp; Severe sneezing; Sore throat; Congestion; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 18Apr2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included fibrous displaysea. 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 took sulfers and 10/30-hackensack ER/IV vancomycin (antibiotic) 1g dose (MANUFACTURE UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 19Apr2021 the patient experienced congestion and headache. On 20Apr2021 at 12:00, the patient experienced hives on left eyelid, left cheek, some on neck and upper chest, itchy roof of mouth, watery eyes, slight tingly sensation on scalp, severe sneezing and sore throat. The events resulted in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of congestion, headache, hives on left eyelid, left cheek, some on neck and upper chest, itchy roof of mouth, watery eyes, slight tingly sensation on scalp, severe sneezing and sore throat that included treatment with over the counter Claritin D (MANUFACTURER UNKNOWN) and Tylenol (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events congestion, headache, hives on left eyelid, left cheek, some on neck and upper chest, itchy roof of mouth, watery eyes, slight tingly sensation on scalp, severe sneezing and sore throat were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sneezing, Urticaria
Clinical narrative: Hives on left eyelid, left cheek, some on neck and upper chest; Itchy roof of mouth; Watery eyes; Slight tingly sensation on scalp; Severe sneezing; Sore throat; Congestion; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 18Apr2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included fibrous displaysea. 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 took sulfers and 10/30-hackensack ER/IV vancomycin (antibiotic) 1g dose (MANUFACTURE UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 19Apr2021 the patient experienced congestion and headache. On 20Apr2021 at 12:00, the patient experienced hives on left eyelid, left cheek, some on neck and upper chest, itchy roof of mouth, watery eyes, slight tingly sensation on scalp, severe sneezing and sore throat. The events resulted in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of congestion, headache, hives on left eyelid, left cheek, some on neck and upper chest, itchy roof of mouth, watery eyes, slight tingly sensation on scalp, severe sneezing and sore throat that included treatment with over the counter Claritin D (MANUFACTURER UNKNOWN) and Tylenol (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events congestion, headache, hives on left eyelid, left cheek, some on neck and upper chest, itchy roof of mouth, watery eyes, slight tingly sensation on scalp, severe sneezing and sore throat were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vertigo
Clinical narrative: Extreme vertigo; Sharp pain behind left ear; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included protein s deficiency. The patient was allergic to latex. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 15:00, the patient experienced extreme vertigo and sharp pain behind left ear. 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 extreme vertigo and sharp pain behind left ear was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Depression, Myalgia, Pain in extremity
Clinical narrative: Mild depression; joint leg and arm pain; Mild muscle pain; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 23Feb2021 at 10:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history includes thyroid disease, high cholesterol, sleep disorder and anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included temazepam (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN) and famotidine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in left arm on 26Jan2021 at 10:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 02Mar2021 at 06:00, a week after the second shot, the patient experienced mild muscle and joint, leg and arm pain. On an unknown date in April2021, two months after the second shot the pain became severe in both legs and arms and developed mild depression. The events resulted in doctor or other healthcare professional office/clinic visit.  No therapeutic measures were 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 mild muscle and joint, leg and arm pain, pain became severe in both legs and arms and mild depression was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Urticaria
Clinical narrative: Skin hives on both forearms; Could not sleep; This is a spontaneous report from a contactable healthcare professional, the patient. A 55-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 19Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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 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 29Mar2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 06:15, on day 3 the patient could not sleep. On 23Apr2021, at day 4 and day 5 after the second doses of COVID vaccine injections, the patient experienced skin hives on both forearms. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event skin hives on both forearms was resolved on 24Apr2021 and could not sleep was resolved on an unknown date of Apr2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; All "my" joints aching; Fever 99.8; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient 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 23Apr2021 at 12:00 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history included charcot-marie-tooth disease (CMT neuromuscular disease), celiac disease, known allergy to gluten and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC) and naproxen (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 23Apr2021, the patient experienced pain in arm, all her joints aching and fever 99.8. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 23Apr2021, the patient underwent lab tests and procedures which included body temperature and the result was 99.8 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm, all her joints aching and fever 99.8 was not resolved 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Genital rash, Periorbital swelling, Product use issue, Rash, Rash pruritic
Clinical narrative: Rash on face under eyes with some swelling mostly in morning when first wake up/ Rash on right forearm spreading up to bicept/Rash on left hand and ring finger; Rash on face under eyes with some swelling mostly in morning when first wake up; Rash on genital; Very itchy; BNT162b2 was administered on same day when other vaccine (Moderna) was administered; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 15:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient also received COVID-19 vaccine MRNA (MRNA 1273)(MODERNA COVID-19 VACCINE; Lot number: unknown) via an unspecified route of administration on 19Apr2021, 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 other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MOTRIN), gabapentin (MANUFACTURER UNKNOWN), naloxone hydrochloride/ buprenorphine hydrochloride (SUBOXONE) and cannabis sativa (MARIJUANA); all for unknown indication from unknown date and unknown if ongoing. On 21Apr2021, the patient experienced rash on face under eyes with some swelling mostly in morning when first woke up. The patient also had rash on right forearm spreading up to bicept, rash on left hand and ring finger, rash on genital and it was very itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with diphenhydramine hydrochloride (BENADRYL) and cortisone cream (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on face under eyes with some swelling mostly in morning when first wake up/ rash on right forearm spreading up to bicept/rash on left hand and ring finger, rash on genital and very itchy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Hot flashes; Fever; Headache; Jaw pain; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 20Apr2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and penicillin allergy. 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 cannabis sativa (MARIJUANA); from unknown date for unknown indication and unknown if ongoing. 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 left arm on 30Mar2021 at 14:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced hot flashes, fever, headache, jaw pain and arm soreness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hot flashes, fever, headache, jaw pain and arm soreness was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysmenorrhoea, Nausea, Pain
Clinical narrative: I'm dizzy and nauseous anytime I'm standing; I was pretty much in pain and sleeping for four days; I was pretty much in pain and sleeping for four days; My cramps are particularly horrible and weirder still; I'm dizzy and nauseous anytime I'm standing; I'm also having diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression and anxiety. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6955) via an unspecified route of administration in the left arm on 19Mar2021 at 12:15 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 14:00, the patient had an incredibly hard time with the vaccine itself, she was pretty much in pain and sleeping for four days, but her biggest problem was now she had her first period since the second shot and her cramps were particularly horrible and weirder still, she was dizzy and nauseous anytime when she was standing. The patient also had diarrhea. It's been about three days and she was still experiencing those horrible period symptoms. The patient had pretty bad cramps normally but the dizziness and nausea were new. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she was dizzy and nauseous anytime she was standing, she was pretty much in pain and sleeping for four days, her cramps were particularly horrible and weirder still and the patient also had diarrhea was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I'm dizzy and nauseous anytime I'm standing; I was pretty much in pain and sleeping for four days; I was pretty much in pain and sleeping for four days; My cramps are particularly horrible and weirder still; I'm dizzy and nauseous anytime I'm standing; I'm also having diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression and anxiety. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6955) via an unspecified route of administration in the left arm on 19Mar2021 at 12:15 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 14:00, the patient had an incredibly hard time with the vaccine itself, she was pretty much in pain and sleeping for four days, but her biggest problem was now she had her first period since the second shot and her cramps were particularly horrible and weirder still, she was dizzy and nauseous anytime when she was standing. The patient also had diarrhea. It's been about three days and she was still experiencing those horrible period symptoms. The patient had pretty bad cramps normally but the dizziness and nausea were new. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she was dizzy and nauseous anytime she was standing, she was pretty much in pain and sleeping for four days, her cramps were particularly horrible and weirder still and the patient also had diarrhea was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: The day following my second dose i had fever; Body aches; Swollen lymph nodes; Fatigue; The night of the day after the vaccine my injection site began to swell and turn red; The night of the day after the vaccine my injection site began to swell and turn red; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. The patient had unspecified known allergies. 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 montelukast sodium (SINGULAIR); taken daily for allergies from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 08:00, the day following her second dose, she had experienced fever, body aches, swollen lymph nodes and fatigue. On 23Apr2021, the night of the day after the vaccine her injection site began to swell and turned red. 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 reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, swollen lymph nodes, fatigue and the night of the day after the vaccine her injection site began to swell and turn red was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.