chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Night sweats, Pain in extremity, Swelling
Clinical narrative: pain in left arm; night sweats; a slight headache which as subsided; swelling and tenderness under left armpit; tenderness under left armpit; pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW 0150) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included ubidecarenone (COQ10), amlodipine (MANUFACTURER UNKNOWN), D3 and K2; all taken on an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the right arm on 16Mar2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient previously received BACTRIM, PREVPAC and hydrocodone (MANUFACTURER UNKNOWN) taken for unknown indication 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 08Apr2021 at 10:00, on day 2 of vaccine, the patient noticed swelling and tenderness under her left armpit and pain at the injection site. The patient was so afraid that she researched the side affects of the second dose of Pfizer vaccine. On 13Apr2021, on seventh day, the patient still have tenderness and swelling under left arm and pain in left arm where vaccine was administered. The patient also go night sweats and a slight headache which has subsided. 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. The clinical outcome of the events swelling and tenderness under left armpit, pain at the injection site, pain in left arm, night sweats, a slight headache which has subsided were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in left arm; night sweats; a slight headache which as subsided; swelling and tenderness under left armpit; tenderness under left armpit; pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW 0150) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included ubidecarenone (COQ10), amlodipine (MANUFACTURER UNKNOWN), D3 and K2; all taken on an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the right arm on 16Mar2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient previously received BACTRIM, PREVPAC and hydrocodone (MANUFACTURER UNKNOWN) taken for unknown indication 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 08Apr2021 at 10:00, on day 2 of vaccine, the patient noticed swelling and tenderness under her left armpit and pain at the injection site. The patient was so afraid that she researched the side affects of the second dose of Pfizer vaccine. On 13Apr2021, on seventh day, the patient still have tenderness and swelling under left arm and pain in left arm where vaccine was administered. The patient also go night sweats and a slight headache which has subsided. 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. The clinical outcome of the events swelling and tenderness under left armpit, pain at the injection site, pain in left arm, night sweats, a slight headache which has subsided were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Limb discomfort
Clinical narrative: Light headedness/ dizziness; Wobbly; Heavy limb feeling; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease and coil in carotid artery for aneurysm from unknown dates. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and triamterene (MANUFACTURER UNKNOWN); both from an unknown date and for unknown indications; unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 08Feb2021 at 14:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient had no 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 07Mar2021 at 00:00, the patient experienced light headedness/ dizziness, wobbly and heavy limb feeling after second shot and had not gone away. No therapeutic measures were taken for the reported events. 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 light headedness, dizziness, wobbly and heavy limb feeling were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Flushing, Headache, Paraesthesia oral
Clinical narrative: Tingling lips; Red hot face; Fever of 99-102; Headache; Chills; 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: Unknown) via an unspecified route of administration in the  left arm on 08Apr2021 at 17:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Other medical history included multiple sclerosis (MS). Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diroximel fumarate (VUMERITY) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient underwent body temperature check and the result was 99-102 with unspecified units. On 10Apr2021 at 16:00, the patient experienced tingling lips, red hot face, fever of 99-102, headache and chills. Therapeutic measures were taken as a result of the events of fever, headache and chills which included drinking lots of fluids and taking Tylenol but the fever does not break. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of tingling lips, red hot face, fever, headache and chills were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tingling lips; Red hot face; Fever of 99-102; Headache; Chills; 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: Unknown) via an unspecified route of administration in the  left arm on 08Apr2021 at 17:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Other medical history included multiple sclerosis (MS). Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diroximel fumarate (VUMERITY) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient underwent body temperature check and the result was 99-102 with unspecified units. On 10Apr2021 at 16:00, the patient experienced tingling lips, red hot face, fever of 99-102, headache and chills. Therapeutic measures were taken as a result of the events of fever, headache and chills which included drinking lots of fluids and taking Tylenol but the fever does not break. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of tingling lips, red hot face, fever, headache and chills were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Headache, Herpes zoster, Pain
Clinical narrative: blister; chills; headache; Shingles; aches; rash; fever; This is a spontaneous report from a contactable consumer (patient himself). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533), via an unspecified route of administration, administered in right arm, on 09Apr2021 at 10:00 A.M (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient has no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN6207) administered at the right arm, on 12Mar2021 at 10:00 A.M, as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 09Apr2021 (also reported on 03Apr2021), it was reported that within 24 hours, the patient experienced chills and aches, then fever on Saturday night through Monday morning. A rash and headache started on his left but cheek and back it continued to spread and blister. The patient couldn't stand the pain from the rash that he went to a clinic, and urgent care was reported. The patient was diagnosed with the Shingles and the doctor there gave him a medicine and the next day he went to my primary care doctor for follow up treatment. The patient had to see her every week now for check up on the Shingles. The patient received steroid shot, valacyclovir and a pain medicine as the treatment for the events. The events have resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered. The events were considered serious (medically significant).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: blister; chills; headache; Shingles; aches; rash; fever; This is a spontaneous report from a contactable consumer (patient himself). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533), via an unspecified route of administration, administered in right arm, on 09Apr2021 at 10:00 A.M (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient has no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN6207) administered at the right arm, on 12Mar2021 at 10:00 A.M, as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 09Apr2021 (also reported on 03Apr2021), it was reported that within 24 hours, the patient experienced chills and aches, then fever on Saturday night through Monday morning. A rash and headache started on his left but cheek and back it continued to spread and blister. The patient couldn't stand the pain from the rash that he went to a clinic, and urgent care was reported. The patient was diagnosed with the Shingles and the doctor there gave him a medicine and the next day he went to my primary care doctor for follow up treatment. The patient had to see her every week now for check up on the Shingles. The patient received steroid shot, valacyclovir and a pain medicine as the treatment for the events. The events have resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered. The events were considered serious (medically significant).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Flushing, Hypoaesthesia oral, Lip swelling, Paraesthesia
Clinical narrative: Flushed face; Hives; Numb and swelling tongue; Numb and swelling tongue; Numb and swelling tongue and lips; Numb and swelling tongue and lips; Residual tingling in hands and mouth; Residual tingling in hands and mouth; A fear of the allergic reaction rebounding; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 18:30 (at the age of 46 years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, hypermobile and Ehlers-Danlos. The patient had known allergies to shellfish. Prior to the COVID vaccination, the patient did not received any other vaccines within four weeks. The patient did not received 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: ER2613) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 17:45 (at the age of 46 years-old) as a single dose for COVID-19 immunisation and also received erythromycin (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication 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. On an unknown date in Apr2021 at 19:15, within 40 minutes of shot, the patient experienced flushed face, hives, numb and swelling tongue and lips. The patient had already left the hospital and was at home. Benadryl resolved the problem, but the patient needed a second dose due to residual tingling in hands and mouth, and a fear of the allergic reaction rebounding. Therapeutic measure were taken as a result of the events that included treatment with BENADRYL. 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 flushed face, hives, numb and swelling tongue and lips, residual tingling in hands and mouth, and a fear of the allergic reaction rebounding was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue, Urticaria
Clinical narrative: Flushed face; Hives; Numb and swelling tongue; Numb and swelling tongue; Numb and swelling tongue and lips; Numb and swelling tongue and lips; Residual tingling in hands and mouth; Residual tingling in hands and mouth; A fear of the allergic reaction rebounding; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 18:30 (at the age of 46 years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, hypermobile and Ehlers-Danlos. The patient had known allergies to shellfish. Prior to the COVID vaccination, the patient did not received any other vaccines within four weeks. The patient did not received 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: ER2613) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 17:45 (at the age of 46 years-old) as a single dose for COVID-19 immunisation and also received erythromycin (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication 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. On an unknown date in Apr2021 at 19:15, within 40 minutes of shot, the patient experienced flushed face, hives, numb and swelling tongue and lips. The patient had already left the hospital and was at home. Benadryl resolved the problem, but the patient needed a second dose due to residual tingling in hands and mouth, and a fear of the allergic reaction rebounding. Therapeutic measure were taken as a result of the events that included treatment with BENADRYL. 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 flushed face, hives, numb and swelling tongue and lips, residual tingling in hands and mouth, and a fear of the allergic reaction rebounding was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Fatigue; injection site pain; muscle ache; acute pain in lower back; This is a spontaneous report from a non-contactable consumer. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 33-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: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 33-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. On 12Apr2021 at 18:00, the patient experienced fatigue, injection site pain, muscle ache with acute pain in lower back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fatigue, injection site pain, muscle ache with acute pain in lower back and included treatment with TYLENOL. The clinical outcome of the events fatigue, injection site pain, muscle ache with acute pain in lower back were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast discomfort, Hot flush, Pain, Pruritus
Clinical narrative: Itching; joint pain; hot flashes; body pain; heavy breasts; throbbing all over; This is a spontaneous report from a contactable healthcare professional, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Mar2021 at 10:00(at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included drug allergy (quinolone) and hashimoto's disease. Concomitant medications included levothyroxine sodium (SYNTHROID), losartan (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. The patient previously took ciprofloxacin (CIPRO) on an unknown date and for an unknown indication 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 COVID vaccine. On 05Mar2021 the patient experienced itching, joint pain, hot flashes, body pain heavy breasts, and throbbing all over. The adverse events resulted 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 event itching, joint pain, hot flashes, body pain, heavy breasts, and throbbing all over was not recovered at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Severe pain in injection site; do not feel well; 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: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and back pain. Patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included paracetamol (TYLENOL), menthol; capsaicin (ALLEVESS) and calcium carbonate; magnesium carbonate (TUMS); all for an unknown indication from an unknown start 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 COVID vaccine. On 15Apr2021, the patient experienced severe pain in injection site and did not feel well. 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 adverse events. The clinical outcome of the event severe pain in injection site and do not feel well was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Slight headache; Chills; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8738) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis c. The patient had known allergies to bee stings. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: paa165469) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:00, the patient experienced slight headache, chills and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight headache, chills and tiredness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Upper right arm swollen,; skin hot; skin hot and red; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 10:30(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and stroke. The patient received medication(unspecified) within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Mar2021 at 10:30(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies.  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 10Apr2021, the patient experienced upper right arm swollen, skin hot and red. The adverse 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 events. The clinical outcome of the event upper right arm swollen, skin hot and red was not recovered at this time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles 17 days after first vaccine; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the left arm on 10Mar2021 at 00:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had unknown history of allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks of vaccination, but the medications were unknown. On 26Mar2021 at 12:00, the patient developed shingles 17 days after first vaccine. The patient had to postpone second vaccine. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with Valtrex. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Hyperhidrosis, Lymphadenopathy
Clinical narrative: Arm pit pain; sweats for days; Serve swollen lymph nodes.; Chills; 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: EP6955) via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nickel. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via an unspecified route of administration in the left arm on 22Mar2021 at 09:00 (at the age of 21-year-old) as a single dose 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 12Apr2021 at 22:00, the patient experienced serve swollen lymph nodes, arm pit pain, chills and sweats for days. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes, arm pit pain, chills and sweating was recovering 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: Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever over 100; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-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 05Apr2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021 at 02:00, the patient experienced fever over 100 (unspecified units) for two full days and headache for three days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 14Apr2021, the patient underwent a PCR test (nasal swab) and tested negative. The clinical outcome of the event fever over 100 (unspecified units) was resolved on 08Apr2021 at 02:00 and the clinical outcome of the event headache was resolved on 09Apr2021 at 02:00.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy. The patient had no known allergies to medications, food, or other products. Concomitant medications included cetirizine hydrochloride (CETRIZINE) and levothyroxine sodium (UNITHROID); taken 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: Unknown) via an unspecified route of administration on 22Feb2021 at 12:00 (at the age of 38-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. On 07Apr2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with VALTREX, naproxen (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN). The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Ultrasound Doppler
Clinical narrative: 11 days after 1st shot an EKG showed Irregular Heart beats; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 10:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and gastroesophageal reflux disease (GERD). The patient received unspecified medications within two weeks of vaccination. The patient previously received Morphine and experienced drug 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 22Feb2021, the patient underwent lab test and procedures which included stress test and carotid artery test and everything was good. On 28Mar2021 at 16:00, 11 days after 1st shot, an electrocardiogram (EKG) showed irregular heartbeats. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 11 days after 1st shot an EKG showed Irregular Heart beats 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: Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 43-year-old (non-pregnant) female patient received an unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0150), at the age of 43, via an unspecified route of administration, left arm, on Apr 2, 2021, at 11:15, single dose, for COVID-19 immunisation. The patient has not reported any other health issues. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 13, 2021, at 12:00, 11 days after vaccine, patient had a constant numbness in her toes and on the top of her feet. Each day the numbness spread a little bit more. The patient had it in the ankles, calves, fingers and tops of hands. The patient was at day 14 from the day of vaccine. Her primary doctor referred her to a neurologist; who she is seeing in 4 days. If symptoms worsened, she was supposed to go to the emergency room. Since the vaccination, patient has not tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures taken as a result of the reported event. The clinical outcome of numbness in toes and on the tops of feet, ankles, calves, fingers and tops of hands: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise
Clinical narrative: I just dont feel well.; Headaches; brain fog continuing; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date in Jul2020. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in right arm on 12Mar2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 01:00, the patient did not feel well, headaches and brain fog continued (at the time of this report). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events did not feel well, headaches and brain fog continued were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on body trunk that spread to arms, pubic area and neck; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced rash on body trunk that spread to arms, pubic area and neck. 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 triamcinolone. The clinical outcome of the event rash on body trunk that spread to arms, pubic area and neck was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: the pain is terrible, it hurts a lot to move my arm; the pain is terrible, it hurts a lot to move my arm; arm started to hurt; pain is were the vaccine was injected; This is a spontaneous report from a contactable consumer, the patient. A 53-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 25Mar2021 at 13:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient's arm started to hurt (pain was where the vaccine was injected) and on 16Apr2021, the pain was terrible and it hurt a lot to move arm. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event arm started to hurt, the pain was terrible, it hurt a lot to move arm, pain was where the vaccine was injected were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Urticaria
Clinical narrative: Sore Throat; Chills; Hives; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 30Mar2021 at 17:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and arthritis. The patient was not aware of any known allergies to medications, food or other products. Concomitant medications included acetylsalicylic acid (ASPRIN), meloxicam (MANUFACTURER UNKNOWN) and vitamins plus 50 (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknow if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021 at 02:00, the patient experienced chills, sore throat and hives. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events chills, sore throat and hives was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Bad taste in my mouth; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 12:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient had no known allergies to food, medication or other products. The patient did not receive any other medication within two 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced bad taste in mouth. The event 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 event. The clinical outcome of the event bad taste in mouth was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Local arm rash at injection site, itchy, red and swollen; Local arm rash at injection site, itchy, red and swollen; Local arm rash at injection site, itchy, red and swollen; Local arm rash at injection site, itchy, red and swollen; This is a spontaneous report from a contactable consumer, the patient. A 26-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 08Apr2021 at 13:30 (at the age of 26-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 14Apr2021 at 16:00, the patient experienced local arm rash at injection site which was itchy, swollen and red. 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. The clinical outcome of the events local arm rash at injection site, itchy, red and swollen were 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Nausea, Pain
Clinical narrative: fever; chills; body ache; nasal congestion; nausea; Headache; This is a spontaneous report from a contactable nurse. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and hypercholesterolemia. Concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unspecified date in 2021 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 03:30, the patient experienced fever, chills, body aches, nasal congestion, nausea and headache. The patient reported that it was more severe than expected and was only confined to bed. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, nasal congestion, nausea and headache lasted for 12 hours before subsiding and was recovered on 16Apr2021.   No follow-up attempts are needed. No further information is expected.