chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain/swelling/discomfort of left arm (injection location).; Pain/swelling/discomfort of left arm (injection location).; Pain/swelling/discomfort of left arm (injection location).; Six days later still have pain/swelling/discomfort, lumps, rash, swelling from left shoulder, chest, to sternum.; Six days later still have pain/swelling/discomfort, lumps, rash, swelling from left shoulder, chest, to sternum.; Six days later still have pain/swelling/discomfort, lumps, rash, swelling from left shoulder, chest, to sternum.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 17:00, the patient experienced pain, swelling, discomfort of left arm (injection location). Six days later, the patient still had pain, swelling, discomfort, lumps, rash, swelling from left shoulder, chest, to sternum. All side effects were reported on left side from shoulder to left leg. 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 prescribed steroid and blood test. On an unknown date in 2021, the patient underwent lab test which included blood test and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, swelling, discomfort of left arm (injection location), six days later, the patient still had pain, swelling, discomfort, lumps, rash, swelling from left shoulder, chest, to sternum were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Rigors; Hyperhidrosis; Fever of 103.4; General myalgia; Intermittent severe nausea; Sleep interruptions; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 21Apr2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and generalised anxiety disorder. 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 sildenafil citrate (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN). The patient previously received BNT162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 as a single dose for COVID-19 immunisation. On 22Apr2021 at 02:30, the patient experienced rigors, hyperhidrosis, fever of 103.4, general myalgia, intermittent severe nausea and sleep interruptions. On 22Apr2021 at 02:30, the patient body temperature measured and the result was 103.4 (unspecified unit). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rigors, hyperhidrosis, fever of 103.4, general myalgia, intermittent severe nausea and sleep interruptions was recovered on 24Apr2021, after the duration of 34 hours.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Rigors; Hyperhidrosis; Fever of 103.4; General myalgia; Intermittent severe nausea; Sleep interruptions; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 21Apr2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and generalised anxiety disorder. 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 sildenafil citrate (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN). The patient previously received BNT162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 as a single dose for COVID-19 immunisation. On 22Apr2021 at 02:30, the patient experienced rigors, hyperhidrosis, fever of 103.4, general myalgia, intermittent severe nausea and sleep interruptions. On 22Apr2021 at 02:30, the patient body temperature measured and the result was 103.4 (unspecified unit). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rigors, hyperhidrosis, fever of 103.4, general myalgia, intermittent severe nausea and sleep interruptions was recovered on 24Apr2021, after the duration of 34 hours.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Amenorrhoea, Dysmenorrhoea, SARS-CoV-2 test
Clinical narrative: Since receiving the second dose of the vaccine patient have not had her period; feel very crampy and bloated; feel very crampy and bloated; 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: ER2613) via an unspecified route of administration on 23Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 02Mar2021 at 08:30 am (at the age of 45-years-old) as a single dose for COVID-19 immunisation. It was reported that, the patient typically had very regular menstrual cycles. On an unknown date in Mar2021, after receiving the second dose of the vaccine patient did not have her period. She felt very crampy and bloated but have not gotten it. Unfortunately, she could not recall the date of her last period but it has definitely been more than 28 days. It had been about a month and a half. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested negative for COVID-19. On 15Apr2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the events patient did not have her period, felt very crampy and bloated, was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pyrexia
Clinical narrative: Chills; high fever in the range of 101-103 throughout the day; severe weakness/ could not get out the bed throughout the day; This is a spontaneous report from a contactable consumer (patient) received via reporting system. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in the left arm on 21Apr2021, at 14:00 as dose number unknown, single for COVID-19 immunisation. Medical history included dengue fever in the past (in year 2016). The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks of vaccination. On 22Apr2021, at 03:00. the patient experienced chills, high fever in the range of 101-103 throughout the day, and severe weakness - could not get out the bed throughout the day. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events which included paracetamol (TYLENOL). The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Red rash and big red circle on arm; Red rash and big red circle on arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to Cephalosporins. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Apr2021. the patient experienced red rash and big red circle on arm from Saturday until Tuesday. 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 red rash and big red circle on arm was resolved on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Headache, Myalgia
Clinical narrative: Vomiting; Diarrhea; Stomach cramping which lasted for 5 days; For 5 days following ''I'' had daily headaches; For 2 days following the 2nd dose had 101 fever/ 10 days following a fever of 102; Nausea; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal asthma and allergy to sulfa. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included estradiol/ norethisterone acetate (COMBIPATCH), 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: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 15:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, 2 days following the 2nd dose, the patient experienced 101 (unspecified units) fever, nausea and muscle aches. On 12Apr2021, 5 days following dose, the patient experienced headaches daily. On 17Apr2021, 10 days following, the patient experienced a fever of 102 (unspecified units), vomiting and diarrhea which lasted for 36 hours and stomach cramping which lasted for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. On 20Apr2021, the patient underwent lab test which included SARS-CoV-2 RNA, QL, RT PCR via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever, nausea, muscle aches, headaches were resolved on an unknown date in Apr2021 whereas vomiting and diarrhea were resolved on 18Apr2021, after the duration of 36 hours. The clinical outcome of the event stomach cramping was resolved on 22Apr2021, after the duration of 5days.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting; Diarrhea; Stomach cramping which lasted for 5 days; For 5 days following ''I'' had daily headaches; For 2 days following the 2nd dose had 101 fever/ 10 days following a fever of 102; Nausea; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal asthma and allergy to sulfa. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included estradiol/ norethisterone acetate (COMBIPATCH), 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: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 15:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, 2 days following the 2nd dose, the patient experienced 101 (unspecified units) fever, nausea and muscle aches. On 12Apr2021, 5 days following dose, the patient experienced headaches daily. On 17Apr2021, 10 days following, the patient experienced a fever of 102 (unspecified units), vomiting and diarrhea which lasted for 36 hours and stomach cramping which lasted for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. On 20Apr2021, the patient underwent lab test which included SARS-CoV-2 RNA, QL, RT PCR via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever, nausea, muscle aches, headaches were resolved on an unknown date in Apr2021 whereas vomiting and diarrhea were resolved on 18Apr2021, after the duration of 36 hours. The clinical outcome of the event stomach cramping was resolved on 22Apr2021, after the duration of 5days.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Menopause delayed
Clinical narrative: Got a period after a year of menopause.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: En6208, Expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 15Mar2021 11:00 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was non pregnant at the time of vaccination. Historical vaccine included: The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: El9266, Expiry date: not reported) via an unspecified route of administration, administered in right arm on 22Feb2021 at 11:00 (at the age of 55 years old) as dose 1, single for COVID-19 immunization The patient had no known allergies to medications, food, or other products. The patient had not received any other vaccine within 4 weeks. list of any other medications the patient received within 2 weeks of vaccination was no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced got a period after a year of menopause on 19Apr2021 at 12:00. The patient did not receive any treatment for the event. The outcome of the event was recovered on unspecified date in Apr2021.  No Follow-up attempts are needed. No Further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Headache, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Body chills; Severe headache; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 18-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 09:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 21:00, the patient experienced fever, body aches, body chills, severe headache and dehydration. 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 fever, body aches, body chills, severe headache and dehydration 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: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Bladder spasm
Clinical narrative: Bladder spasms; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old patient of unknown gender 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 27Mar2021 at 10:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control and allergy to possible others (unspecified). 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 medroxyprogesterone acetate (DEPO PROVERA) for birth control from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole; trimethoprim (BACTRIM) and acetylsalicylic acid (ASPIRIN) for unknown indication on an unknown date and experienced drug allergy. On 27Mar2021 at 16:00, the night after receiving the shot the patient began to feel symptoms similar to a UTI (urinary tract infection). The patient went to urgent care but there was no infection, but had bladder spasms ever since and it had not gone away. It was stated that, the patient would see the doctor this week. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event (also reported as yes and yes but hope to). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bladder spasms 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Dizzy/Nauseous when moving eyes- especially when driving; Sweating profusely; Vertigo; High fever (103.3); Dizziness / Dizzy when moving eyes- especially when driving; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 at 18:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and vitiligo. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received promethazine (PHENERGAN) and experienced drug allergy. 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 right arm on an unknown date in Mar2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021, 5 to 10 minutes after the vaccination, the patient started sweating profusely and got vertigo which lasted for 3 minutes. On an unknown date in Apr2021, over the next two days, the patient experienced high fever of 103.3 (unspecified units) and dizziness. On 20Apr2021, 6 days after the vaccination, the patient experienced dizzy/nauseous when moving eyes, especially when driving. 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 sweating profusely and vertigo were resolved on 14Apr2021 while high fever (103.3), dizziness, dizzy/nauseous when moving eyes, especially when driving was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Dizzy/Nauseous when moving eyes- especially when driving; Sweating profusely; Vertigo; High fever (103.3); Dizziness / Dizzy when moving eyes- especially when driving; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 at 18:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and vitiligo. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received promethazine (PHENERGAN) and experienced drug allergy. 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 right arm on an unknown date in Mar2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021, 5 to 10 minutes after the vaccination, the patient started sweating profusely and got vertigo which lasted for 3 minutes. On an unknown date in Apr2021, over the next two days, the patient experienced high fever of 103.3 (unspecified units) and dizziness. On 20Apr2021, 6 days after the vaccination, the patient experienced dizzy/nauseous when moving eyes, especially when driving. 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 sweating profusely and vertigo were resolved on 14Apr2021 while high fever (103.3), dizziness, dizzy/nauseous when moving eyes, especially when driving was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Whole body aches; Fever; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW161) via an unspecified route of administration in the left arm on 17Apr2021 at 16:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any 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 were not reported. 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 18Apr2021 at 06:30, the patient experienced whole body aches and fever. 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 whole body aches and fever was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersomnia, Nausea, Pain
Clinical narrative: Headache; Nausea; I slept almost the whole day; Fever; Chills; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 02Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. 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: EN6199) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 02Apr2021 at 23:00, the night of the vaccination, the patient experienced fever, chills and body aches. On 03Apr2021, the patient experienced headache, nausea the next day and the patient slept almost the whole day. The events did not result in doctor or other healthcare professional office/clinic visit and 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 fever, chills, body aches, headache, nausea and the patient slept almost the whole day was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Nausea; I slept almost the whole day; Fever; Chills; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 02Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. 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: EN6199) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 02Apr2021 at 23:00, the night of the vaccination, the patient experienced fever, chills and body aches. On 03Apr2021, the patient experienced headache, nausea the next day and the patient slept almost the whole day. The events did not result in doctor or other healthcare professional office/clinic visit and 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 fever, chills, body aches, headache, nausea and the patient slept almost the whole day was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate decreased, Oxygen saturation decreased, SARS-CoV-2 test
Clinical narrative: plummeting oxygen and pulse levels; plummeting oxygen and pulse levels; sharp, excruciating chest pains; major difficulty breathing; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 02Apr2021 at 01:30 PM (Batch/Lot number was unknown) (at the age of 50 years old) as dose 1, single for COVID-19 immunisation in a pharmacy or drug store. Medical history included depression; asthma. Hospitalized for severe COVID-19 and hypoxia on mid Dec2020, diagnosed sequela of COVID-19 included cognitive, cardiac and pulmonary dysfunction. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has known allergies to neomycin and tobramycin. On 03Apr2021, at 01:00 AM (however, also reported as within 8 hours of first Pfizer dose), the patient experienced horrible symptoms. Most alarming was plummeting oxygen and pulse levels accompanied by sharp, excruciating chest pains with major difficulty breathing. The patient used her supplemental oxygen as treatment for the events. The patient felt worse ever since the first vaccine dose and personally decided not to take the second dose. The events did not result to emergency room or physician office visit. The patient underwent lab tests and procedures which included a negative result of nasal swab on 19Apr2021. The outcome of all events was recovered with sequel on an unspecified date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is day 7 since the vaccine and "I'm" still getting a fever daily.; "I" have been sick every single day since the vaccine; "I'm" also still having headaches; Joint pain; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0164) via an unspecified route of administration in the left arm on 16Apr2021 at 10:00 (at the age of 28-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. Concomitant medications were not reported. On 16Apr2021 at 12:00, the patient experienced fever, sick, headache and joint pain. The patient reported that "this was day 7 since vaccination and she still getting fever daily, she has been sick every single day since the vaccine and also getting headaches and joint pain". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient has been tested for COVID-19. On 22Apr2021, the patient underwent COVID-19 test via nasal swab and the result was found to be negative. The clinical outcome of the events fever, sick, headache and joint pain were not resolved 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: Anxiety, Dizziness, Dyspnoea, Fatigue, Flushing
Clinical narrative: Sleepy; Tired; Dizzy; skin burning sensation through out body; Pain spread from left arm to right arm; Both legs cramping; My face turn red flushed with headache; Rapid and strong heartbeats; Some short of breathe; Anxiety; FACE TURN RED FLUSHED WITH HEADACHE; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0169) via an unspecified route of administration in the left arm on 20Apr2021 at 08:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS) and adenoma. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication taken within two weeks were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 08:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 21:15, the patient initially once she got vaccine she began sleepy, tired, and dizzy 12-13 hours after vaccine. Also experienced skin burning sensation through out body, pain spread from left arm to right arm down both legs cramping. The patient's face turned red flushed with headache with very rapid and strong heartbeats. Some short of breathe and top of it anxiety same time. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit 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 sleepy, tiredness, dizzy, burning sensation skin, pain spread from left arm to right arm down both legs cramping patient's face turned red flushed with headache with very rapid and strong heartbeats, some short of breathe and top of it anxiety was recovering 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: Headache, Heart rate increased, Muscle spasms, Pain in extremity, Skin burning sensation
Clinical narrative: Sleepy; Tired; Dizzy; skin burning sensation through out body; Pain spread from left arm to right arm; Both legs cramping; My face turn red flushed with headache; Rapid and strong heartbeats; Some short of breathe; Anxiety; FACE TURN RED FLUSHED WITH HEADACHE; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0169) via an unspecified route of administration in the left arm on 20Apr2021 at 08:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS) and adenoma. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication taken within two weeks were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 08:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 21:15, the patient initially once she got vaccine she began sleepy, tired, and dizzy 12-13 hours after vaccine. Also experienced skin burning sensation through out body, pain spread from left arm to right arm down both legs cramping. The patient's face turned red flushed with headache with very rapid and strong heartbeats. Some short of breathe and top of it anxiety same time. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit 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 sleepy, tiredness, dizzy, burning sensation skin, pain spread from left arm to right arm down both legs cramping patient's face turned red flushed with headache with very rapid and strong heartbeats, some short of breathe and top of it anxiety was recovering 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: Somnolence
Clinical narrative: Sleepy; Tired; Dizzy; skin burning sensation through out body; Pain spread from left arm to right arm; Both legs cramping; My face turn red flushed with headache; Rapid and strong heartbeats; Some short of breathe; Anxiety; FACE TURN RED FLUSHED WITH HEADACHE; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0169) via an unspecified route of administration in the left arm on 20Apr2021 at 08:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS) and adenoma. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication taken within two weeks were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 08:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 21:15, the patient initially once she got vaccine she began sleepy, tired, and dizzy 12-13 hours after vaccine. Also experienced skin burning sensation through out body, pain spread from left arm to right arm down both legs cramping. The patient's face turned red flushed with headache with very rapid and strong heartbeats. Some short of breathe and top of it anxiety same time. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit 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 sleepy, tiredness, dizzy, burning sensation skin, pain spread from left arm to right arm down both legs cramping patient's face turned red flushed with headache with very rapid and strong heartbeats, some short of breathe and top of it anxiety was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe rashes all over the body; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 08Apr2021 at 17:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pollen and dust. 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 COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 14:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 15:00, the patient experienced severe rashes all over the body after about 4 days of vaccination. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with steroids medication and lotion. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe rashes all over the body was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Body aches; Numbness in hand; Chills; Headache; Feverish; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 22Apr2021 at 09:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma 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 vaccination. Concomitant medications were not reported. On 22Apr2021 at 23:45, the patient experienced body aches, numbness in hand, chills, headache and feverish. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, numbness in hand, chills, headache and feverish were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Oropharyngeal discomfort, Rhinorrhoea
Clinical narrative: Throat closing sensation; Severe runny nose; Changes in voice; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 17Apr2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included latex 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 were not reported. On 18Apr2021, 1 day after vaccination the patient had throat closing sensation that was lasting after 7 days (highly concerned about this). Severe runny nose for 2 days, changes in voice for 2 days and fatigue for 2 days. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe runny nose, changes in voice and fatigue were recovered on 20Apr2021. The clinical outcome of the event throat closing sensation was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Urticaria
Clinical narrative: Had some hives emerge on my back within 24 hours of the 1st shot. It was not that bad but I had not expected that as a symptom.; I also had a couple of hours feeling foggy; Tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (YUVAFEM); for an unknown indication from unknown date and unknown if ongoing. On 15Apr2021 at 17:30, the patient experienced some hives emerged on her back within 24 hours of the first shot. It was not that bad but she had not expected that as a symptom. She also had a couple of hours feeling foggy and tired. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a couple of hours feeling foggy and tired were recovered on 15Apr2021 and hives emerge on her back within 24 hours of the first shot was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.