chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Heavy menstrual bleeding
Clinical narrative: Diarrhea; Stomach pain; Was at end of period but flow has increased; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on an unknown date (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL), and experienced drug allergy. On an unknown date, the patient experienced diarrhea, stomach pain started about 4 hours after until 24 hours later. The patient was at end of period but flow had increased since about 24 hours after shot. 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 diarrhea, stomach pain and was at end of period but flow had increased was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea exertional
Clinical narrative: Dizziness; Shortness of breath when exerted at all; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 10:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/norethisterone acetate (JUNEL) taken for birth control from an unknown date and unknown if ongoing. The patient previously received measles vaccine/mumps vaccine/rubella vaccine on an unknown date for an unknown indication and experienced allergy to vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 12:00, 36 hours after vaccination, the patient experienced dizziness and shortness of breath when exerted at all. 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 dizziness and shortness of breath when exerted at all were 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Oropharyngeal discomfort, Pharyngeal swelling, Sensation of foreign body
Clinical narrative: I cant take deep breaths without mildly coughing; I cant take deep breaths without mildly coughing; my throat felt weird; it felt like a big lump was in my left side throat; Now right side is swelling up; My neck was obviously swollen from even the outside appearance; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. Prior to vaccination the patient had not received any other vaccines within 4 weeks, had no known allergies, and was not diagnosed with COVID-19 prior to vaccination. The patient reported that within about 5-10 minutes of receiving her first Pfizer COVID shot, her throat felt weird, and she thought she just needed some water since she had her mask on. She waited until her time was up and then was heading to her car and turned around because it felt like a big lump was in her left side throat. The emergency medical technician (EMT) desk gave her diphenhydramine hydrochloride (BENADRYL) and checked oxygen. They told her to wait and wanted to monitor her, then the right side was swelling up. She reported her neck was obviously swollen from even the outside appearance. They put her in the ambulance and took her to emergency room (ER). At the ER she received an epinephrine shot in her right arm and a dose of steroids intravenously (IV) in her left arm. They monitored her for 4 hours and let her go home. The patient was told not to get the second shot and was told to take two diphenhydramine hydrochloride three times a day and two prednisone for four days. The patient reported the next day she went to work but found it difficult to keep her mask on, which she usually wore for 8 hours a day. She had been feeling okay but now (as of 18Apr2021) three days later, she couldn't take deep breaths without mildly coughing. The clinical outcomes of couldn't take deep breaths without mildly coughing were not recovered; the outcomes of the other events were recovered with sequelae in Apr2021. Since vaccination the patient had not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I cant take deep breaths without mildly coughing; I cant take deep breaths without mildly coughing; my throat felt weird; it felt like a big lump was in my left side throat; Now right side is swelling up; My neck was obviously swollen from even the outside appearance; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. Prior to vaccination the patient had not received any other vaccines within 4 weeks, had no known allergies, and was not diagnosed with COVID-19 prior to vaccination. The patient reported that within about 5-10 minutes of receiving her first Pfizer COVID shot, her throat felt weird, and she thought she just needed some water since she had her mask on. She waited until her time was up and then was heading to her car and turned around because it felt like a big lump was in her left side throat. The emergency medical technician (EMT) desk gave her diphenhydramine hydrochloride (BENADRYL) and checked oxygen. They told her to wait and wanted to monitor her, then the right side was swelling up. She reported her neck was obviously swollen from even the outside appearance. They put her in the ambulance and took her to emergency room (ER). At the ER she received an epinephrine shot in her right arm and a dose of steroids intravenously (IV) in her left arm. They monitored her for 4 hours and let her go home. The patient was told not to get the second shot and was told to take two diphenhydramine hydrochloride three times a day and two prednisone for four days. The patient reported the next day she went to work but found it difficult to keep her mask on, which she usually wore for 8 hours a day. She had been feeling okay but now (as of 18Apr2021) three days later, she couldn't take deep breaths without mildly coughing. The clinical outcomes of couldn't take deep breaths without mildly coughing were not recovered; the outcomes of the other events were recovered with sequelae in Apr2021. Since vaccination the patient had not been tested for COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 06Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient did not have any 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. Concomitant medications included rosuvastatin calcium (MANUFACTURER UNKNOWN), taken for an unspecified 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: EN6208) via an unspecified route of administration in the right arm on an unknown date at 15:45 as a single dose for COVID-19 immunisation. On 07Apr2021 at 21:00, the patient experienced difficulty breathing. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. 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 difficulty breathing was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: extremely sore arm; headache; fever of 100.2; body aches; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and pre-diabetes. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an 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: ER8732) via an unspecified route of administration in the right arm on 25Mar2021 as a single dose for COVID-19 immunisation. 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. On 16Apr2021 at 06:00, the patient experienced extremely sore arm, headache, fever of 100.2 (unspecified unit) and body aches. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 16Apr2021, The patient underwent body temperature test and the result was 100.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely sore arm, headache, fever of 100.2 (unspecified unit) and body aches was resolved on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Inappropriate schedule of product administration, Nausea, Retching, Vomiting
Clinical narrative: Nausea; severe stomach cramping with vomiting and dry heaving. Cramping lasted several hours,; severe stomach cramping with vomiting and dry heaving.; severe stomach cramping with vomiting and dry heaving.; DOSE 1: 29Mar2021; DOSE 2: 12Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 42-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 arm left on 12Apr2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The medical history included hypothyroidism, IBS (irritable bowel syndrome) and gluten sensitive. 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 concomitant medications included levothyroxine sodium (SYNTHROID), epidium meyenii root (MACA ROOT), withania somnifera (ASHWAGANDHA) and chaseberry(unspecified); all taken for unknown indication from unknown dates 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 arm left on 29Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 07:00, the patient experienced nausea and severe stomach cramping with vomiting and dry heaving. It was reported that cramping lasted several hours. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, severe stomach cramping with vomiting and dry heaving was recovering 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Shortness of breath; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 10:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 19:00, the patient experienced shortness of breath and heart palpitations. 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 shortness of breath and heart palpitations were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Nausea
Clinical narrative: Severe nausea; Difficulty swallowing; This is a spontaneous report from a contactable consumer, the patient. A 27-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 10Apr2021 at 15:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included ehler-danlos syndrome type III. The patient had unspecified long list of allergies to medications, food or other products. 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 unspecified nutrients vegetarian enzymes 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: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced severe nausea and difficulty swallowing. 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 severe nausea and difficulty swallowing was not resolved 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: on the 18th sore arm both days; 2nd dose received around noon the 16th by midnight had a 102-103 fever lasted till around 7pm them occasionally 99-100+ fever; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) in the left arm on 16Apr2021 at 11:45 (at the age of 34-year-old) as a dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included paracetamol, chlorphenamine maleate, pseudoephedrine hydrochloride (TYLENOL SINUS) was taken occasionally for unspecified indication and unknown if ongoing. The patient previously received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER8733) in the left arm on 26Mar2021 at 13:00 (at the age of 34-year-old) as a dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 16Apr2021 at 00:00 the patient experienced, the second dose received around noon the 16th by midnight had a 102-103 fever lasted till around 19:00 then occasionally 99-100+ fever. On the 18Apr2021 sore arm for both days. The patient did not receive any treatment for the event. The clinical outcome of the event fever and sore was recovering at this time of report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Influenza
Clinical narrative: Diarrhea; Severe flu symptoms; Abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the right arm on 19Mar2021 at 14:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient's medical history was not relevant to COVID -19. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 20Mar2021, the patient experienced severe flu symptoms 3 days after with diarrhea, continue to have diarrhea after 6 weeks with catamount and on an unknown date in 2021, the patient also experienced abdominal pain. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 flu symptoms, diarrhea and abdominal pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Breath odour, Parosmia, Taste disorder
Clinical narrative: Began to sense an abnormal taste in the mouth; Smell abnormal odors; The taste and odor are like persistent bad breath.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0150) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not receive any concomitant medications. On 10Apr2021, approximately 2 days after vaccination, the patient began to sense an abnormal taste in the mouth and smelt abnormal odours. The taste and odor were like persistent bad breath. This had persisted then ever since. The patient had been experiencing that for 5 days total as on the day of reporting. 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 abnormal taste in mouth, smell abnormal odours and persistent bad breath was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: My menstrual cycle is normally like clockwork; very predictable, but it's 5 days late; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included tubal ligation (tubes have been tied for 9 years). The patient had no known allergies to medications, food, or other products. 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 Vitamins C&D (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN) and black elderberry (MANUFACTURER UNKNOWN); all medications for unknown indications from unknown dates 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 on an unknown date (at the age of 45-year-old), as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced late period. The patient reported that her menstrual cycle was normally like clockwork; very predictable, but it was 5 days late and her tubes have been tied for 9 years. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period 5 days late was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Fever; Pain at injection site; Diarrhea; Vomiting; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 20-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 13Apr2021 at 13:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic constipation, depression, anxiety, sleep apnea and COVID-19 from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) and macrogol 3350 (MIRALAX), both taken for an unspecified indication; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control, all 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: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 16:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient experienced chills, fever, pain at injection site, diarrhea, vomiting and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL EXTRA STRENGTH). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, pain at injection site, diarrhea, vomiting and muscle pain were 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; Fever; Pain at injection site; Diarrhea; Vomiting; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 20-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 13Apr2021 at 13:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic constipation, depression, anxiety, sleep apnea and COVID-19 from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) and macrogol 3350 (MIRALAX), both taken for an unspecified indication; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control, all 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: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 16:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient experienced chills, fever, pain at injection site, diarrhea, vomiting and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL EXTRA STRENGTH). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, pain at injection site, diarrhea, vomiting and muscle pain were 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Insomnia, Myalgia
Clinical narrative: Headache; brain fog; nauseous; sleepless night; swelling injection site; pain at injection site; muscle aches; extreme tiredness (body feels like it has weights on it); This is a spontaneous report from a non-contactable healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) on an unknown date (at the age of 33-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) in the left arm on an unknown date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included dust allergy, pollen allergy and allergy to molds. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 14Apr2021 the patient experienced headache, brain fog, nauseous, sleepless night, swelling at injection site, pain at injection site, muscle aches and extreme tiredness (body feels like it has weights on it). 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. On an unknown date, the patient underwent SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcomes of the events headache, brain fog, nauseous, sleepless night, swelling at injection site, pain at injection site, muscle aches and extreme tiredness (body feels like it has weights on it) was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache; brain fog; nauseous; sleepless night; swelling injection site; pain at injection site; muscle aches; extreme tiredness (body feels like it has weights on it); This is a spontaneous report from a non-contactable healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) on an unknown date (at the age of 33-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) in the left arm on an unknown date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included dust allergy, pollen allergy and allergy to molds. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 14Apr2021 the patient experienced headache, brain fog, nauseous, sleepless night, swelling at injection site, pain at injection site, muscle aches and extreme tiredness (body feels like it has weights on it). 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. On an unknown date, the patient underwent SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcomes of the events headache, brain fog, nauseous, sleepless night, swelling at injection site, pain at injection site, muscle aches and extreme tiredness (body feels like it has weights on it) was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 14Apr2021 at 08:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient's medical history and known allergies reported were not applicable. 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. Concomitant medications were not reported. On 14Apr2021 at 09:30, the patient experienced nausea and diarrhoea. 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 nausea and diarrhoea was recovering 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait disturbance, Nausea, Pyrexia
Clinical narrative: Severe chills; Fever; Nausea; Dizziness; Unsteady gait; Severe vertigo; This is a spontaneous report from a contactable nurse, the patient. A 77-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 13:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and HCTZ (hydrochlorothiazide) (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first  dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 16Apr2021 at 16:00, the patient experienced severe chills, fever, nausea, dizziness which remained after 3 days also. She also experienced unsteady gait, severe vertigo and it was the worst feeling of her life. The patient was a nurse and cared for herself but could not drive and lived alone. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events severe chills, fever, nausea, dizziness, unsteady gait and severe vertigo were 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe chills; Fever; Nausea; Dizziness; Unsteady gait; Severe vertigo; This is a spontaneous report from a contactable nurse, the patient. A 77-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 13:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and HCTZ (hydrochlorothiazide) (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first  dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 16Apr2021 at 16:00, the patient experienced severe chills, fever, nausea, dizziness which remained after 3 days also. She also experienced unsteady gait, severe vertigo and it was the worst feeling of her life. The patient was a nurse and cared for herself but could not drive and lived alone. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events severe chills, fever, nausea, dizziness, unsteady gait and severe vertigo were 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Body temperature, Chest pain, Chills
Clinical narrative: Chills; 101.1 temperature; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Chest pains; Shortness of breath; Anxiety; Fatigue; Jaw pain; Teeth pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164, Expiration date: Aug2021) via an unspecified route of administration in the left arm on 16Apr2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The medical history included chronic back leg pain and allergy to ACE inhibitors. 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-19 vaccine. The concomitant medications included hydrocodone bitartrate/ paracetamol (VICODIN), tramadol (MANUFACTURER UNKNOWN), alprazolam (XANAX), hydrochlorothiazide/ triamterene (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN); all for an unspecified indications from an unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730, Expiration date:Jul2021) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 19:00, the patient experienced chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache. On the same date, the patient underwent body temperature test and the result was 101.1 (unspecified units). The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Neck pain, Pain in jaw
Clinical narrative: Chills; 101.1 temperature; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Chest pains; Shortness of breath; Anxiety; Fatigue; Jaw pain; Teeth pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164, Expiration date: Aug2021) via an unspecified route of administration in the left arm on 16Apr2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The medical history included chronic back leg pain and allergy to ACE inhibitors. 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-19 vaccine. The concomitant medications included hydrocodone bitartrate/ paracetamol (VICODIN), tramadol (MANUFACTURER UNKNOWN), alprazolam (XANAX), hydrochlorothiazide/ triamterene (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN); all for an unspecified indications from an unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730, Expiration date:Jul2021) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 19:00, the patient experienced chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache. On the same date, the patient underwent body temperature test and the result was 101.1 (unspecified units). The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: Chills; 101.1 temperature; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Chest pains; Shortness of breath; Anxiety; Fatigue; Jaw pain; Teeth pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164, Expiration date: Aug2021) via an unspecified route of administration in the left arm on 16Apr2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The medical history included chronic back leg pain and allergy to ACE inhibitors. 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-19 vaccine. The concomitant medications included hydrocodone bitartrate/ paracetamol (VICODIN), tramadol (MANUFACTURER UNKNOWN), alprazolam (XANAX), hydrochlorothiazide/ triamterene (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN); all for an unspecified indications from an unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730, Expiration date:Jul2021) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 19:00, the patient experienced chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache. On the same date, the patient underwent body temperature test and the result was 101.1 (unspecified units). The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Yesterday, 4 weeks after the seconddose- the pain has returned at the injection location (same upper right arm). It feels like I've been repeatedly punched. It hurts more today.; After second dose- Had some pretty severe pain at injection location (upper right arm) that subsided and went away after a few days.; 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: ep7534) via an unspecified route of administration in the right arm on 16Mar2021 at 08:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6203) via an unspecified route of administration in the right arm on 23Feb2021 at 08:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, after second dose, the patient experienced some pretty severe pain at injection location (upper right arm) that subsided and went away after a few days. On 18Apr2021 at 15:00, 4 weeks after the second dose, the patient experienced the pain had returned at the injection location (same upper right arm). It felt like she had been repeatedly punched and it hurted more on the day of reporting. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or 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, after second dose some pretty severe pain at injection location (upper right arm) that subsided and recovered after a few days on an unknown date in 2021, while the event pain returned at the injection location (same upper right arm) 4 weeks after the second dose, felt like she had been repeatedly punched and hurted more was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Night sweats, Pain, Pyrexia
Clinical narrative: Night sweat; Loss of appetite; Severe body ache; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 14:45 (at the age of 46-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 vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 14Apr2021 at 12:00, the patient experienced severe body ache, fever, headache, night sweat and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events severe body ache, fever, headache, night sweat and loss of appetite was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.