chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Rash
Clinical narrative: Rash; Light pain in arm; Headache; light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jun2021 at 10:15 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. Medical history included hay fever and allergy to pollen. The patient did not receive any medication within two weeks of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 14Jun2021 at 23:00, the patient experienced light pain in arm, headache and light-headedness. On 15Jun2021 the patient experienced rash about 1 inch in size that appeared about a day after vaccination. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event light pain in arm, headache, light-headedness and rash was recovered on an unknown date in Jun2021.     No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Nose bleed; Painful arm; Headache; Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Jun2021 at 11:30 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included carbamazepine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), Montelukast sodium (SINGULAIR) and medroxyprogesterone acetate (DEPOPROVERA); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27May2021 at 13:30 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient previously took fluoxetine hydrochloride (PROZAC) and clonidine (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021 at 07:30, the patient experienced nose bleed, painful arm, headache, body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nose bleed, painful arm, headache, body aches and fatigue were resolving at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Tender lymph nodes; Very large, swollen and groin right and left  lymph nodes.; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration in the left arm on 14Jun2021 at 09:00(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration in the left arm on 21May2021 at 16:00(at the age of 37-years-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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15Jun2021, the patient experienced slight headache. On 16Jun2021, the patient experienced very large, swollen and tender left arm lymph nodes. On 18Jun2021, the patient experienced swollen and tender right groin lymph nodes. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the event slight headache, very large tender swollen and tender left arm lymph nodes, swollen and tender right groin lymph nodes was not recovered at the time of this report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My Left Hand is having pain for  2 months where the vaccine is put and it get worst as days go from the date of vaccination; This is a spontaneous report from a contactable consumer. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176), dose 1 via an unspecified route of administration, administered in Arm Left on 06May2021 03:00 (at the age of 46-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. 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 experienced his left hand was having pain for 2 months where the vaccine was put and it get worst as days go from the date of vaccination on 11May2021. The patient did not receive any treatment. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: mild case of shingles; 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: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 12:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA) taken from an unknown date for an unspecified indication. 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 23Mar2021 at 21:00, the patient experienced mild case of shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with antibiotics. The clinical outcome of the event shingles was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: 02Feb2021=1dose and 02Feb2021=2dose; Hand Joint pain; Hand Joint pain and swelling; This is a spontaneous report from a contactable consumer. This 53-year-old male consumer reported for a himself.  A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EZ9266), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:45 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunization. Concomitant medication(s) included escitalopram oxalate (LEXAPRO), esomeprazole magnesium (NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]) montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. On 12Jun2021 The patient underwent lab tests and procedures which included sars-cov-2 test: negative. No other vaccine in four weeks. No Covid test  prior vaccination. On an unspecified date The patient experienced 02feb2021=1dose and 02feb2021=2dose, On 20May2021 05:15 hand joint pain, hand joint pain and swelling. Events were consider as non serious. Therapeutic measures were taken as a result of hand joint pain, hand joint pain and swelling. The outcome of events hand joint pain, hand joint pain and swelling were not resolved and rest was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 17Jun2021 at 16:00 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient's past drug history was reported as no. 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 4 weeks prior to the COVID vaccine. On 18Jun2021, the patient experienced headache and fever. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL) and acetaminophen (TYLENOL). The clinical outcome of the events, headache and fever was recovering at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm, Blood pressure measurement, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Ringing in ears two days after first shot which continues to present day; Two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizzines; sweating; dizziness; exhaustion; racing heart; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EN6205; Expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 28Feb2021 13:30 as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: ER2613; Expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:30 (age at vaccination 60-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine Other. There were no other vaccine in four weeks. No other medications in two weeks. Medical history included known allergies: Penicillin (penicillin). The patient's concomitant medications were not reported. Ringing in ears two days after first shot which continues to present day 18Jun2021. Two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, racing heart, exhaustion. Never had heart trouble, do not smoke, do not have high blood pressure. On an unspecified date the patient experienced ringing in ears two days after first shot which continues to present day, two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, sweating, dizziness, exhaustion, racing heart. Ae resulted in [Doctor or other healthcare professional office/clinic visit]. The patient underwent lab tests and procedures which included blood pressure measurement: high. The outcome of events ringing in ears two days after first shot which continues to present day, two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, sweating, dizziness were not recovered and for events exhaustion, racing heart were unknown.   Follow-up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tinnitus
Clinical narrative: Ringing in ears two days after first shot which continues to present day; Two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizzines; sweating; dizziness; exhaustion; racing heart; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EN6205; Expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 28Feb2021 13:30 as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: ER2613; Expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:30 (age at vaccination 60-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine Other. There were no other vaccine in four weeks. No other medications in two weeks. Medical history included known allergies: Penicillin (penicillin). The patient's concomitant medications were not reported. Ringing in ears two days after first shot which continues to present day 18Jun2021. Two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, racing heart, exhaustion. Never had heart trouble, do not smoke, do not have high blood pressure. On an unspecified date the patient experienced ringing in ears two days after first shot which continues to present day, two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, sweating, dizziness, exhaustion, racing heart. Ae resulted in [Doctor or other healthcare professional office/clinic visit]. The patient underwent lab tests and procedures which included blood pressure measurement: high. The outcome of events ringing in ears two days after first shot which continues to present day, two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, sweating, dizziness were not recovered and for events exhaustion, racing heart were unknown.   Follow-up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat tightness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 40-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: GW0170), via an unspecified route of administration (at the age of 40-years), administered in arm left on 28May2021 13:00 as dose 1, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and has not been tested for covid post vaccination. The patient had no known allergies. On 28May2021, the patient stated that within 5 minutes of receiving the vaccine, I felt throat tightness which lasted 2-3 seconds. It occurred three times. It did not interrupt my breathing. The treatment was not received for the event. The facility type of vaccine reported as pharmacy or drug store. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Fever 102 for three days; Nausea; Weak; Soreness in shot area; This is a spontaneous report from a contactable other healthcare professional, the patient. An 85-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 09Jun2021 at 00:00 (at the age of 85-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 09Jun2021 at 15:00, the patient experienced fever 102 (units unspecified) for three days, weak, nausea and soreness in shot area. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the event fever 102 for three days was recovered on 12Jun2021. The outcome of the events weak, nausea and soreness in shot area were recovered on unspecified date Jun2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ligament sprain, Myalgia, Pain in jaw, Paraesthesia
Clinical narrative: Headache; Neck spasm; muscular pain; Shoting pain in the head; Jaw pain; Burning; tingling; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 10:00(at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included naproxen (MANUFACTURER UNKNOWN) and naratriptan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, the patient experienced headache, neck spasm, muscular pain, shooting pain in the head, jaw pain, burning and tingling. The events 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 a result of events which included treatment with different medication but none of them helped. The clinical outcome of the events headache, neck spasm, muscular pain, shooting pain in the head, jaw pain, burning and tingling were not resolved at the time of reporting.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Headache; Neck spasm; muscular pain; Shoting pain in the head; Jaw pain; Burning; tingling; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 10:00(at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included naproxen (MANUFACTURER UNKNOWN) and naratriptan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, the patient experienced headache, neck spasm, muscular pain, shooting pain in the head, jaw pain, burning and tingling. The events 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 a result of events which included treatment with different medication but none of them helped. The clinical outcome of the events headache, neck spasm, muscular pain, shooting pain in the head, jaw pain, burning and tingling were not resolved at the time of reporting.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: Arm hot; large red circle; This is a spontaneous report from a non-contactable consumer. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Jun2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not know about any medications received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jun2021 at 14:00, after three days of vaccination, the patient experienced arm hot and large red circle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of arm hot and large red circle was recovering 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.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair has been shedding and falling out; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9266) via an unspecified route of administration, administered in left arm on 25Feb2021 10:00 as single dose for covid-19 immunisation. The patient's medical history included stroke, aneurysm, high blood pressure from an unknown date and unknown if ongoing. The patient previously took statins and experienced allergies. The patient's concomitant medications included telmisartan, amlodipine, omeprazole and aspirin at 81 mg. On 24Apr2021 10:30 AM, the patient experienced hair has been shedding and falling out. Patient reported that from end of Apr2021 through now, her hair has been shedding and falling out. Currently she was taking good hair high power synergistical food supplements, but it still sheds and falls out. Patient was wondering if Pfizer with her medicine has cause an issue and she trying to find out why her hair is shedding since it had never happened in the past. Therapeutic measures were taken as a result of my hair has been shedding and falling out. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: fluid filled blisters at vaccination site; have fluid filled blisters at injection site, they itch; have fluid filled blisters at injection site, they itch, red in area as well; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Jun2021 at 16:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient was allergic to penicillin. Concomitant medications included ciprofloxacin (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously took emycin and clindamycin and experienced drug allergy. 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 an unknown date in Jun2021, the patient had fluid filled blisters at injection site, they itched and the area was red. Therapeutic measures were taken as a result of the events and included treatment with benadryl. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events fluid filled blisters at injection site, itchy and red were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: sever pain in my left elbow; Pain is going all the way to my hands and is making me drop things; Sever pain in left sholder; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within two weeks of vaccination. 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 an unknown date the patient experienced severe pain in left elbow and left shoulder and the pain was going all the way to hands and was making the patient to drop things. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in left elbow and left shoulder and pain was going all the way to hands and was making the patient to drop things was not recovered at the time of this report.     The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling of the lips; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Jun2021 at 11:45 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jun2021 at 12:45, the patient experienced swelling of the lips.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of the lips was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Rashes and hives all over my arms, legs, and stomach.; Rashes and hives all over my arms, legs, and stomach.; Skin very itchy; Forearms especially were swollen; The arm which got the vaccine on was very sore and painful to raise; The arm which I got the vaccine on is very sore and painful to raise.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 19Jun2021 at 12:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to vaccination, it was unknown whether 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 19Jun2021 at 13:00 the patient experienced rashes and hives all over the arms, legs, and stomach. The patient skin was very itchy and forearms especially were swollen. The arm which the patient got the vaccine on was very sore and painful to raise. 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 rashes all over arms, legs and stomach, hives all over arms, legs and stomach, skin very itchy, forearms especially was swollen, the arm which got the vaccine on was very sore and painful to raise was not recovered at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Rashes and hives all over my arms, legs, and stomach.; Rashes and hives all over my arms, legs, and stomach.; Skin very itchy; Forearms especially were swollen; The arm which got the vaccine on was very sore and painful to raise; The arm which I got the vaccine on is very sore and painful to raise.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 19Jun2021 at 12:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to vaccination, it was unknown whether 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 19Jun2021 at 13:00 the patient experienced rashes and hives all over the arms, legs, and stomach. The patient skin was very itchy and forearms especially were swollen. The arm which the patient got the vaccine on was very sore and painful to raise. 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 rashes all over arms, legs and stomach, hives all over arms, legs and stomach, skin very itchy, forearms especially was swollen, the arm which got the vaccine on was very sore and painful to raise was not recovered at the time of this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Severely swollen eye lid; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Jun2021 at 17:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. The patient took unspecified other medication in two weeks. 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 20Jun2021 at 21:00, the patient experienced severely swollen eye lid. 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 event swollen eye lid was not recovered.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node left armpit; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: Blm0196) via an unspecified route of administration, administered in Arm Left on 18Jun2021 15:00 as single dose for covid-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications was not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Blm0176) via an unspecified route of administration, administered in Arm Left on 27May2021 15:00 as single dose for covid-19 immunization. Patient had not Known allergies. The patient experienced swollen lymph node left armpit on 19Jun2021. Patient did not COVID prior vaccination. Patient did not COVID tested post vaccination. No other vaccine in four weeks. Patient had no treatment. The outcome of the event was unknown.   Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Migraine, Sinusitis
Clinical narrative: Suffering severe migraines that won't go away; Heart beat spikes; Sinus infection; General feeling of unwell; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01Jun2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known 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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021, three weeks since first dose the patient was suffering with severe migraines "that won't go away", heart beat spikes, had sinus infection migraines and general feeling of unwell. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with antibiotics. On 11Jun2021, the patient underwent COVID-19 Nasal Swab test and the result was negative.  The clinical outcome of the events severe migraines, heart beat spikes, sinus infection migraines and general feeling of unwell were not recovered at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash erythematous
Clinical narrative: Red spot on arm; Sore; Itchy; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and Expiry date were not reported) via an unspecified route of administration in the right arm on an unspecified date in 15:45 and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and Expiry date were not reported) via an unspecified route of administration in the right arm on 17Jun2021 14:45 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included meniers disease, obesity. The patient concomitant medications were not reported. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took morphine (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 17May2021 at 15:45, the patient had experienced red spot-on arm, sore and itchy and stayed that way for 2 weeks. The patient receive treatment for the adverse event Spot still on arm, but soreness and itchiness gone with the first dose used cortisone cream. Got the second dose on 17Jun2021 same thing happened but much more intense. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included cortisone cream but not helping on second dose. The outcome of the events was not recovered.  Information on Lot/Batch number was not available. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood test
Clinical narrative: Now i am very anemic for the first time in my life; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Jan2021 at 18:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included liraglutide (SAXENDA) and dicycloverine (DICYCLOMINE) for unknown indications from unknown start date and unknown if ongoing. 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 COVID vaccine. On 01Apr2021 at 00:00 the patient had new blood work (blood test) in June 2021, then patient was very anemic for the first time in her life. patient thought it had something to do with the vaccine. On an unknown date in Dec2020, the patient underwent Blood test and the result was normal results. On an unknown date in Jun2021, the patient underwent Blood test and the result was diagnosed with anemia. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the reported event. The clinical outcome of the events very anemic for the first-time in-patient life was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: The patient developed a low fever a day after the second dose of vaccination.  The fever lasted for a day.; The patient continued to feel fatigue for six days.; This is a spontaneous report from a contactable consumer. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Feb2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 32-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, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 20Feb2021, the patient experienced a low fever a day after the second dose of vaccination. The fever lasted for a day. The patient continued to feel fatigue for six days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the events. The clinical outcome of the event a low fever after the second dose of vaccination recovered on 21Feb2021. While that of felt fatigue was recovered on 26Feb2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Pain in extremity
Clinical narrative: Arm pain; Very low, depressed thoughts that are very much out of the ordinary; This is a spontaneous report from a non-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: UNKNOWN) via an unspecified route of administration in the left arm on 18Jun2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included colon cancer and depressive state. 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 18Jun2021 at 16:00 the patient experienced very low, depressed thoughts that are very much out of the ordinary and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events very low, depressed thoughts that are very much out of the ordinary and arm pain was not recovered.   Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Dizziness, Sleep disorder, Tinnitus, Tympanometry
Clinical narrative: Unilateral tinnitus (right ear) on 16May21 at 21:00 turned into bilateral tinnitus on 17May2021 at 07:00 (~12kHz tone and slight ~4kHz tone both in both ears).; Sleep was interrupted; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the arm left on 13May2021 at 12:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY) for unspecified indication since unspecified date within two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took prednisone (MANUFACTURER UNKNOWN), asprin (MANUFACTURER UNKNOWN); both were taken for unspecified indication since an unspecified date and experienced drug allergy. The patient experienced unilateral tinnitus (right ear) on 16May21 at 21:00 turned into bilateral tinnitus on 17May2021 at 07:00; it was (~12kHz tone and slight ~4kHz tone both in both ears). On 16May2021 at 21:00, the patient's sleep was interrupted and had slight dizziness accompanied the unilateral tinnitus only. The events resulted in doctor or other healthcare professional office/clinic visit. It was reported that, the patient had primary care visit on 25May2021. Therapeutic measures were not taken as a result of events. On 27May2021, the patient underwent audiogram, tympanometry and the results were unknown. The events bilateral tinnitus and sleep interrupted was persisted. The event resulted in ENT visit on 10Jun2021 . The clinical outcome of the event unilateral tinnitus , sleep was interrupted; slight dizziness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Genital ulceration
Clinical narrative: Genital ulcers; This is a spontaneous report from a contactable physician. A 15-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 on 04Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jun2021, 2 days after the second COVID vaccine, the patient had genital ulcers. It was also reported that it was unclear if related to vaccine but didn't have another explanation. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of genital ulcers and included treatment with antifungal creams, fluconazole (MANUFACTURER UNKNOWN), triamcinolone (MANUFACTURER UNKNOWN) ointment. The clinical outcome of the event genital ulcers was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.