chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: My cycle came back and was very short. I had one 12 day cycle where I bled for 5 days beginning March 22, a 13 day cycle starting April 3 bleeding for 3 days, a 16 day cycle starting April 16 bleeding for 4 days, and my current cycle starting May 2.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 5121), via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 22-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9267), via an unspecified route of administration in the right arm on 26Mar2021 (at the age of 23-years-old), as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced the cycle came back and was very short. She had one 12-day cycle where she bled for 5 days beginning 22Mar2021, a 13-day cycle starting 03Apr2021 bleeding for 3 days, a 16-day cycle starting 16Apr2021 bleeding for 4 days and the current cycle starting 02May2021 bleeding for 4 days. In the 6 years prior to receiving the vaccine the patient did not have a menstrual cycle. 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 event. The clinical outcome of the event the cycle came back and was very short, she had one 12-day cycle where she bled for 5 days beginning 22Mar2021, a 13-day cycle starting 03Apr2021 bleeding for 3 days, a 16-day cycle starting 16Apr2021 bleeding for 4 days and the current cycle starting 02May2021 bleeding for 4 days were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Started menstrual cycle by noon of vaccination day. She has a very regular cycle and should not have started for 10 more days.; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 21May2021 at 08:45 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication was not reported. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 12:00, the patient started experiencing menstrual cycle by noon of vaccination day. The patient had a very regular cycle and should not had periods started for 10 more days. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event irregular periods was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Purpura, Rash pruritic, SARS-CoV-2 test
Clinical narrative: swelling of arm and hand; rashes on arm, lower legs, back on spline, itching, bleeding of rashes; rashes on arm, lower legs, back on spline, itching, bleeding of rashes; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 1573035), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 11:15 (Age at vaccination: 71 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Metoprolol Succinate; Losartan Potassium; Pravastatin. Patient did not receive other vaccines in four weeks. Patient did not have COVID prior vaccination. Patient tested COVID post vaccination. The patient experienced swelling of arm and hand, rashes on arm, lower legs, back on spline, itching, bleeding of rashes on 27Apr2021 at 11:15.  The patient underwent lab tests and procedures which included sars-cov-2 test which was negative. Treatment received was unknown. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: Shingles that began May 17, 2021; Cold sore that began April 13, 2021; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously took sulfa drugs and experienced sulfonamide allergy. Concomitant medications taken within two weeks of vaccination included estradiol (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN) both from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced cold sore that began on 13Apr2021 at 04:00. The patient experienced shingles that began on 17May2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with Valtrex from 21May2021. The clinical outcome of the events cold sore that began on 13Apr2021 and shingles that began on 17May2021 was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: Shortness of breath; Heart palpitations; "Feeling dizzy or as if I was about to faint"; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 17May2021 at 19:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included DVT (deep vein thrombosis) more than ten years ago and an allergy to "possibly shrimp". The patient reported that she had no current health issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and multivitamins. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 20May2021 at 22:00, the patient experienced shortness of breath, heart palpitations and felt dizzy as if she was about to faint. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events shortness of breath, heart palpitations and felt dizzy as if she was about to faint were resolved on unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Hypomenorrhoea, Menstruation delayed, Mood swings, Vaginal discharge
Clinical narrative: Period immediately after first shot was late by a week and only lasted 2 days.; Period immediately after first shot was late by a week and only lasted 2 days.; Really terrible mood swings; Vaginal wetness has increased too; Emotional more than usual.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175), via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any known allergies. The patient did not receive any other medications in two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 26Apr2021, the patient experienced period immediately after the first shot was late by a week and only lasted 2 days. The patient had really terrible mood swings, emotional more than usual, vaginal wetness has increased too. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events period immediately after first shot was late by a week and only lasted 2 days, really terrible mood swings, emotional more than usual, vaginal wetness has increased too were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Muscular weakness, Myalgia, Postmenopausal haemorrhage
Clinical narrative: Menstruated in Apr and May even though past menopause for more than 2 years; Extreme muscle soreness; weakness in legs (thigh muscles, calves, hips, knees, feet and bottom of feet); Headaches; swollen glands in neck and armpits; This is a spontaneous report from a contactable consumer (patient). This 49-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN8208) via an unspecified route of administration on 16Mar2021 (at the age of 49-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, and allergies to sulfa drugs, latex, and shellfish. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included metoprolol succinate (TOPROL XL), olmesartan medoxomil (BENICAR), and escitalopram oxalate (LEXAPRO) from unknown dates for unknown indications. The day after the first shot (17Mar2021) the patient experienced extreme muscle soreness and weakness in legs (thigh muscles, calves, hips, knees, feet, and bottom of feet). The patient menstruated in April and May even though she was past menopause for more than two years. She also had headaches and swollen glands in neck and armpits. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited a doctor or other healthcare professional office/clinic visit as a result of the events. The patient received treatment with paracetamol (TYLENOL) and rest. The outcomes of extreme muscle soreness, weakness, menstruated, headaches, and swollen glands were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582799 same patient, different event, different dose of vaccine
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Lymphocyte count increased, Muscular weakness, Neck pain
Clinical narrative: Lower back pain; High Lymph abs (3.48 k/uL); Sore neck; Vertigo; Weakness/ heaviness in legs; Weakness/ heaviness in chest; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 28Apr2021 at 09:00(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. 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: ER8729) via an unspecified route of administration in the arm right on 07Apr2021 at 08:30(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 the patient experienced lower back pain, high lymph abs (3.48 k/ul), sore neck, vertigo, weakness/ heaviness in legs and weakness/ heaviness in chest. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with anti-inflammatory prescribed and chiropractor visit. The clinical outcome of the events lower back pain, high lymph abs (3.48 k/uL), sore neck, vertigo, weakness/ heaviness in legs and weakness/ heaviness in chest was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Lower back pain; High Lymph abs (3.48 k/uL); Sore neck; Vertigo; Weakness/ heaviness in legs; Weakness/ heaviness in chest; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 28Apr2021 at 09:00(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. 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: ER8729) via an unspecified route of administration in the arm right on 07Apr2021 at 08:30(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 the patient experienced lower back pain, high lymph abs (3.48 k/ul), sore neck, vertigo, weakness/ heaviness in legs and weakness/ heaviness in chest. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with anti-inflammatory prescribed and chiropractor visit. The clinical outcome of the events lower back pain, high lymph abs (3.48 k/uL), sore neck, vertigo, weakness/ heaviness in legs and weakness/ heaviness in chest was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 100.7; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 20May2021 at 15:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included ehlers-danlos syndrome, asthma, dysautonomia and latex allergy. The patient had known allergies to biaxin, morphine, codiene and compazine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fremanezumab vfrm (AJOVY) and gabapentin (MANUFACTURER UNKNOWN); both for unknown indications 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: Ew0171) via an unspecified route of administration in the right arm on 29Apr2021 at 15:30 (at the age of 26-year-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 21May2021 at 17:30, after second dose COVID-19 vaccine, the patient experienced fever 100.7. On 21May2021 at 17:30 patient underwent lab tests which include body temperature and the result was found to be 100.7 (unit unspecified). 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 fever and included treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever 100.7 was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia oral, Swollen tongue, Vision blurred
Clinical narrative: numbness and swelling of the tongue; numbness and swelling of the tongue; mild blurred vision; back pain; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via intramuscular route of administration on 21May2021 at 15:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in left arm on an unknown date for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 15:00 the patient experienced numbness and swelling of the tongue, mild blurred vision and back pain. Therapeutic measures were taken as a result of the events (Unspecified) checked for vitals. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events numbness and swelling of the tongue, mild blurred vision and back pain were recovered on 21May2021.   No follow-up attempts are needed: information about lot number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: About a month after getting my first dose of the Pfizer vaccine, I began my period (menstruation) for the first time since May2021; This is a spontaneous report from a non-contactable consumer (patient).  A 54-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at 100:00 at single dose in left arm for COVID-19 immunisation at the age of 54-year-old. Lot number was EW0158. Medical history included menopause in May2020. The patient was not pregnant at the time of vaccination. The patient never had period during the past year. About a month after getting her first dose of the suspect vaccine (13May2021), she began her period (menstruation) for the first time since May2020. The period lasted a week. The patient was not treated for the event. The patient recovered from the event in May2021. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat through the days proceeding the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 185) via an unspecified route of administration in the left arm on 14May2021 at 17:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic allergy. It was unknown if patient had any allergies to food, medications or other products. Concomitant medications included allergy pills (MANUFACTURER UNKNOWN) from an unknown start date and for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15May2021 at 06:00, the patient experienced sore throat through the days proceeding the vaccination. No therapeutic measures were taken as a result of the events. The clinical outcome of the event sore throat was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: after first shot, hives on thighs. Progressed to upper legs, backside and stomach from day ten until second shot slight decrease in hives a few days before second shot. Within 12 hours of second shot, hives from head to ankles all over body.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 23Apr2021 at 13:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 14May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history and known allergies to medications, food, or other products. Concomitant medication taken within two weeks of vaccination included over the counter sleeping pill doxylamine succinate (UNISOM) from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Five days after first shot, on 28Apr2021, the patient noticed appearance of hives on thighs. Progressed to upper legs, backside and stomach from day ten until second shot. There was slight decrease in hives a few days before second shot. No medications were taken (upon advise of family physician). Within 12 hours of second shot, hives appeared from head to ankles all over body (down to elbows on arms). Seventy-two hours after first shot, the patient started taking antihistamines and took one prednisone pill at 72 hours as a therapeutic measures for the event hives. Stopped prednisone after one pill and continued with antihistamine. One week, post-shot if antihistamine was stopped, hives reappeared within 32 hours. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event hives was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I started vomitting on and off afternoon receiving the vaccine.; 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: EW0176) via an unspecified route of administration in the arm left on 20May2021 at 16:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included soy allergy. 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: EW0176) via an unspecified route of administration in the arm left on 27Apr2021 at 16:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 19:00, the patient started vomiting on and off afternoon receiving the vaccine. 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 event. The clinical outcome of the event vomiting was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Inflammation
Clinical narrative: Intestinal discomfort; Ileocecal valve inflammation; This is a spontaneous report from a contactable consumer, the patient. A 74-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 left arm on 07Apr2021 at 13:45 (at the age of 74-year-old), as a single dose for COVID-19 immunisation. Medical history included GERD and overweight. The patient had a history of allergy to sulfa and iodine internal. The patient received unknown medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7835), via an unspecified route of administration in the left arm on 17Mar2021 at 14:00 (at the age of 73-year-old), 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 vaccination. On 08Apr2021, the patient experienced intestinal discomfort and ileocecal valve inflammation probably started the following day and has continued ever since. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the events intestinal discomfort and ileocecal valve inflammation were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Round rash at injection site; Itchy, but not bad.; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the right deltoid on 13May2021 at 11:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included methylphenidate hydrochloride (CONCERTA) 54 mg used for an unknown indication from an unknown start date. The patient previously took tetanus shot (MANUFACTURER UNKNOWN) when younger for unknown indication and had a swelling of site reaction on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20May2021, the patient experienced round rash at injection site which appeared 1 week post vaccination and it was itchy, but not bad. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events round rash at injection site and itchy, but not bad were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: The morning after shot, I had a bad headache; slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included tadalafil (CIALIS) once a week for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 after the shot at 12:00, the patient experienced headache and slight nausea for hours or so. Both faded, but the headache never went away completely. It was low-grade (1 on the 10 point pain scale) except if the patient coughed, sneezed, or otherwise suddenly moved his head, then it was maybe a 3 on the 10 point pain scale. The patient was expecting it to go away, but it had been almost two months, and there's been no change since the second day after his second shot. Before the patient virtually never got headaches, maybe once a year or so. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event headache and slight nausea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Swollen tongue; Swollen cheeks; Swollen lips; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0177), via an unspecified route of administration in the left arm on 21May2021 at 17:15 (at the age of 56-year-old), as a single dose for COVID-19 immunization. Medical history included hypertension, hypothyroid, hyperlipidemia and migraine  from unspecified dates. The patient had a history of allergies to penicillin, atorvastatin calcium (LIPITOR),  rosuvastatin calcium (CRESTOR), and  terbinafine hcl (LAMISIL). The patient received unspecified medications within two weeks prior to the vaccination for years. 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 21May2021 at 17:15, the patient experienced swollen tongue, swollen cheeks and swollen lips.  Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included rapid (nasal swab) test on 19May2021 and the result was negative. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as the result of adverse events which included diphenhydramine 25 milligrams x 2. The clinical outcome of the events, swollen tongue, swollen cheeks and swollen lips was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Vaccination site pain
Clinical narrative: Pain in left arm where shot administered; Pain due to pinched nerve; This is a spontaneous report from a contactable consumer, the patient. A 39-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 left arm on 12Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date and the patient had no other relevant medical history. The patient was allergic to strawberries. 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: En204) via an unspecified route of administration in the left arm on 18Mar2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced pain in left arm where shot was administered and the was pain due to pinched nerve. Therapeutic measures were taken as a result of events and included treatment with steroid pack. The clinical outcome of the events pain in left arm due to pinched nerve was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hot flush, Hypoaesthesia, Neck pain, Pain in jaw
Clinical narrative: jaw pain on right side; face pain in nasal region; Left arm numbness; back of neck pain; flush of heat; numbness in left side of face; left jaw pain; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170), via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur and septorhinoplasty. Concomitant medications included etonogestrel (NEXPLANON IMPLANT) from an unknown date and unknown if ongoing for an unknown indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 12:30, the patient experienced left arm numbness, back of neck pain, flush of heat and numbness in the left side of the face, left jaw pain all on day one. On 07May2021, the patient experienced jaw pain on the right side and face pain in the nasal region on day two. The patient also reported that she still had on and off numbness in her left arm but other symptoms have subsided thus far. Therapeutic measures were not taken as a result of the events. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The clinical outcome of the events back of neck pain, flush of heat and numbness in the left side of the face, left jaw pain, jaw pain on right side and face pain in nasal region was recovering. The clinical outcome of the event left arm numbness was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Palpitations, Pruritus
Clinical narrative: After receiving vaccine fast heart beat; High blood pressure; Extreme body itching; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of unspecified age and gender 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 12May2021 10:00, as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient's concomitant medications included losartan 50mg, and atorvastatin 20mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 10:00, the patient experienced after receiving vaccine fast heart beat, high blood pressure, and extreme body itching. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome for all the events was not recovered.  Information on lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dysgeusia, Fatigue, Muscular weakness
Clinical narrative: Unfamiliar taste in mouth accompanied by excessive salivation; Unfamiliar taste in mouth accompanied by excessive salivation; Severe muscle weakness at injection site; Severe muscle soreness/pain; Fatigue/tiredness; Gastrointestinal upset; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0171) via an unspecified route of administration in the left arm on 30Apr2021(at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and genetically high total cholesterol (good Cholesterol also high from diet) from an unknown date. The patient had known allergies to sulfa drugs, contrast used with CT scans, gluten allergy, lots of hair/body products (cosmetic allergy), scents and smoke allergy. Concomitant medications included erenumab aooe (AIMOVIG); from an unknown date for an unknown indication and unknown if ongoing. The patient previously took Paba and experienced 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. On 30Apr2021, within approximately 5 minutes of shot, the patient experienced unfamiliar taste in mouth accompanied by excessive salivation, severe muscle weakness at injection site within approximately 4 hours followed by severe muscle soreness/pain that gradually recovered after the duration of 2.5 days, fatigue/tiredness for 2 days, gastrointestinal upset and diarrhea starting within approximately 5 hours of shot and lasted approximately 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle weakness at injection site, severe muscle soreness/pain, gastrointestinal upset and diarrhea was recovered on an unknown date in May2021. The clinical outcome of the event fatigue/tiredness was recovered on 02May2021. The clinical outcome of the event unfamiliar taste in mouth accompanied by excessive salivation was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Salivary hypersecretion
Clinical narrative: Unfamiliar taste in mouth accompanied by excessive salivation; Unfamiliar taste in mouth accompanied by excessive salivation; Severe muscle weakness at injection site; Severe muscle soreness/pain; Fatigue/tiredness; Gastrointestinal upset; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0171) via an unspecified route of administration in the left arm on 30Apr2021(at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and genetically high total cholesterol (good Cholesterol also high from diet) from an unknown date. The patient had known allergies to sulfa drugs, contrast used with CT scans, gluten allergy, lots of hair/body products (cosmetic allergy), scents and smoke allergy. Concomitant medications included erenumab aooe (AIMOVIG); from an unknown date for an unknown indication and unknown if ongoing. The patient previously took Paba and experienced 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. On 30Apr2021, within approximately 5 minutes of shot, the patient experienced unfamiliar taste in mouth accompanied by excessive salivation, severe muscle weakness at injection site within approximately 4 hours followed by severe muscle soreness/pain that gradually recovered after the duration of 2.5 days, fatigue/tiredness for 2 days, gastrointestinal upset and diarrhea starting within approximately 5 hours of shot and lasted approximately 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle weakness at injection site, severe muscle soreness/pain, gastrointestinal upset and diarrhea was recovered on an unknown date in May2021. The clinical outcome of the event fatigue/tiredness was recovered on 02May2021. The clinical outcome of the event unfamiliar taste in mouth accompanied by excessive salivation was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives covering arms abs chest; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 18May2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection. The patient had known allergies to penicillin. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19May2021, the patient experienced hives covering arms abs chest. No therapeutic measures were taken as a result of reported event. It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event hives covering arms abs chest was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash
Clinical narrative: About 6-7 days after first dose my son developed a rash on chest and back.; Took to dr who said he had pityriasisrosea.; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Unknown) via an unspecified route of administration in the left arm on 13May2021 at 16:30 (at the age of 13-year-old) as a dose 1, single for COVID-19 immunisation. Relevant medical history and known allergies included none. Concomitant medications included dexmethylphenidate hydrochloride (FOCALIN XR) and fexofenadine hydrochloride (ALLEGRA) for unspecified indication, start and stop dates were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that about 6 to 7 days after first dose, the patient developed a rash on chest and back, was taken to doctor who said he had pityriasis rosea on 19May2021 16:00. The reporter asked if it was related to vaccine and the doctor said who knows. The reporter searched online and saw reports even others had rashes on day 7 and wanted to report for the sake of documentation. Not itchy but all over torso and back. And the patient's age was 13 at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was recovering at the time of this report.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.