chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Memory impairment, Pain, Pyrexia
Clinical narrative: Forgetful; Detached; Stomach still feels strange; Dizzy; Stomach hurt; Felt miserable; Fever; Chills; Headache; Body aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 12:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine sodium (SYNTHROID) and esomeprazole (NEXIUM); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 26Mar2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 17:00 (reported as the following day), the patient experienced fever, chills, headache, body aches and she knew "rhoa" was typical. On 19Apr2021 (Monday), the patient tried to go to work and could not, she was dizzy, her stomach hurt and she felt miserable. The patient did go back to work on Wednesday (on 21Apr2021) after spending 48 hours in bed. On 21Apr2021, the patient was still feeling dizzy, forgetful and detached. Her stomach still felt strange. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, body aches, dizzy, stomach hurt, felt miserable, forgetful, detached and stomach still feels strange were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Haematuria, Pain, Pyrexia
Clinical narrative: Hematuria; fever; chills; fatigue; achiness; This is a spontaneous report from a contactable nurse. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication from an unknown date and unknown if ongoing. On 20Apr2021, the patient experienced hematuria which began the evening of having received the Pfizer COVID vaccine along with fever, chills, fatigue, and achiness. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events and included treatment with antibiotics (unspecified). The clinical outcome of the event hematuria, fever, chills, fatigue, and achiness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Arthralgia, Chills, Fatigue, Gait disturbance
Clinical narrative: Sore arm; Chills; Fever; Joint pain; Fatigue; Headache; Canker sores in mouth; Left knee swollen; Difficultly walking; Sores on genitals; Hives/welts on legs; ulcer in mouth; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products.. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included ethinylestradiol; norgestimate (TRINESSA LO) from an unknown date for birth control. On 14Apr2021 at 14:00, the patient experienced sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent SARS-COV-2 test (Nasal Swab) and the result was Negative. Therapeutic measures were taken as a result of the event joint swelling which included treatment with oral steroids. The clinical outcome of the events sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Genital lesion, Headache, Joint swelling, Mouth ulceration, Pain in extremity
Clinical narrative: Sore arm; Chills; Fever; Joint pain; Fatigue; Headache; Canker sores in mouth; Left knee swollen; Difficultly walking; Sores on genitals; Hives/welts on legs; ulcer in mouth; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products.. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included ethinylestradiol; norgestimate (TRINESSA LO) from an unknown date for birth control. On 14Apr2021 at 14:00, the patient experienced sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent SARS-COV-2 test (Nasal Swab) and the result was Negative. Therapeutic measures were taken as a result of the event joint swelling which included treatment with oral steroids. The clinical outcome of the events sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: Sore arm; Chills; Fever; Joint pain; Fatigue; Headache; Canker sores in mouth; Left knee swollen; Difficultly walking; Sores on genitals; Hives/welts on legs; ulcer in mouth; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products.. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included ethinylestradiol; norgestimate (TRINESSA LO) from an unknown date for birth control. On 14Apr2021 at 14:00, the patient experienced sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent SARS-COV-2 test (Nasal Swab) and the result was Negative. Therapeutic measures were taken as a result of the event joint swelling which included treatment with oral steroids. The clinical outcome of the events sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 14Apr2021 at 21:00, a little over after 48 hours after the 2nd dose of the vaccination,  the patient began to show symptoms of shingles. The patient was then diagnosed with shingles a day later. Therapeutic measures were taken as a result of adverse events and included treatment with VALTREX. The events resulted in doctor or other healthcare professional office/clinic visit.  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; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Pain, Pruritus, Skin warm
Clinical narrative: Warm; Sore to touch; Redness developed around the injection site; Itchy; Dose 1 start date on 20210322 and dose 2 start date on 20210408; This is a spontaneous report from a non-contactable nurse. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021 at 09:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and unknown if ongoing. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW8727) via an unspecified route of administration in the left arm on 22Mar2021 at 09:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced redness which developed around the injection site, warm, itchy and sore to touch. The patient had received the second dose outside the range of 19-42 days after the first dose and hence there was a medication error (inappropriate scheduling of vaccine administered). 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site redness, warm, itchy and pain were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: Daily intense vivid dreams; This is a spontaneous report from a contactable consumer, the patient. An male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history included allergies to some artificial sweeteners. 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 unspecified date in 2021, pretty much after the first shot, the patient experienced daily intense vivid dreams. Usually 2 plus a night, for every night. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event daily intense vivid dreams was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait inability
Clinical narrative: Feeling fatigue; Unable to safely walk for long distances; Pain in knee; pain in all joints.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 03Apr2021 at 08:15 (at the age of 37-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 the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (PRILOSEC), on an unknown date for an unknown indication and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took and paracetamol (TYLENOL) and NSAIDs on an unknown date in Apr2021 for joint pain, pain in the knee and fatigue and the patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm right on 13Mar2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 20:00, the patient experienced pain in his knee. The following morning, he experienced pain in all of his joints. He was unable to safely walk for long distances for the remainder of the day. He was also feeling fatigue. On Thursday, his joint pain started to subside but not end completely. He was still feeling fatigue. On Friday, he felt much less fatigue but still had some joint pain. The event resulted in doctor or other healthcare professional office/clinic visit. 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 pain in joint, fatigue, and inability to safely walk were recovering 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: Flushing, Headache, Hot flush, Neck pain, Pain in extremity
Clinical narrative: Headache; Neck pain; Bilateral arm pain; Hot/cold flashes; Hot/cold flashes; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 22Apr2021 at 09:45 (at the age of 44-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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 01Apr2021 at 11:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 21:00, the patient experienced headache, neck pain, bilateral arm pain and hot/cold flashes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, neck pain, bilateral arm pain and hot/cold flashes was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Sick; Aches; Tiredness; Muscle pain; Swollen lymph nodes; Not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included parkinson's. The patient had known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA), clopidogrel bisulfate (PLAVIX) and carbidopa (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPRIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 15:30, after 1 week of 2nd vaccine, the patient experienced sick, aches, tiredness, muscle pain, swollen lymph nodes and not feeling well. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcomes of sick, aches, tiredness, muscle pain, swollen lymph nodes and not feeling well were recovered with lasting effects.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sick; Aches; Tiredness; Muscle pain; Swollen lymph nodes; Not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included parkinson's. The patient had known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA), clopidogrel bisulfate (PLAVIX) and carbidopa (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPRIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 15:30, after 1 week of 2nd vaccine, the patient experienced sick, aches, tiredness, muscle pain, swollen lymph nodes and not feeling well. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcomes of sick, aches, tiredness, muscle pain, swollen lymph nodes and not feeling well were recovered with lasting effects.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness, Musculoskeletal discomfort
Clinical narrative: Prolonged discomfort in left arm and knot in bicep; Joint discomfort in wrist, elbow and shoulder; Slight fatigue in hand; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8934) via an unspecified route of administration in the left arm on 07Apr2021 at 00:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, 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 vaccines within four weeks prior to the vaccination. On 07Apr2021 at 00:30, the patient experienced prolonged discomfort in left arm and knot in bicep, joint discomfort in wrist, elbow and shoulder and slight fatigue in hand. All lasted over 2 weeks to the current day. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events prolonged discomfort in left arm and knot in bicep, joint discomfort in wrist, elbow and shoulder and slight fatigue in hand was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine headaches daily since day after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 59-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 24Mar2021 at 11:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included history of periodic migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Mar2021 at 12:00, since day after vaccine, daily the patient experienced migraine headaches. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of migraine headaches and the treatment was reported as medication refill (unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine headaches was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Numbness/tingling in entire face; Numbness/tingling in entire face, tongue and legs.; Numbness/tingling in entire face, tongue and legs.; Tingling in entire face and legs; Numbness/tingling in entire face, tongue and legs.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the arm right on an unknown date in Apr2021 at 14:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism and polycystic ovarian syndrome (PCOS). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levothyroxine sodium (SYNTHROID), fexofenadine hydrochloride (ALLEGRA), chromium (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the arm right on an unknown date in Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 16:00, the patient experienced numbness/tingling in entire face, tongue and legs. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events numbness/tingling in entire face, tongue and legs were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Lymphadenopathy, Nausea, Paraesthesia
Clinical narrative: swollen lymph nodes; nausea; feverish; flu-like symptoms; numbness; tingling in right arm; This is a spontaneous report from a contactable consumer, the patient. A 36-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 20Apr2021 at 15:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, fish allergy, fruit allergy (blueberries, cherries), food allergy (italian seasoning) and allergy to plants (flowers). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and methylphenidate hydrochloride (RITALIN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (MONO-LINYAH) on 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 right arm  on 30Mar2021 at 15:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 the patient experienced swollen lymph nodes, nausea, feverish, flu-like symptoms, numbness and tingling in right arm. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events that included Doctor visit, labs, and ultrasound. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes, nausea, feverish, flu-like symptoms, numbness and tingling in right arm was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: swollen lymph nodes; nausea; feverish; flu-like symptoms; numbness; tingling in right arm; This is a spontaneous report from a contactable consumer, the patient. A 36-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 20Apr2021 at 15:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, fish allergy, fruit allergy (blueberries, cherries), food allergy (italian seasoning) and allergy to plants (flowers). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and methylphenidate hydrochloride (RITALIN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (MONO-LINYAH) on 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 right arm  on 30Mar2021 at 15:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 the patient experienced swollen lymph nodes, nausea, feverish, flu-like symptoms, numbness and tingling in right arm. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events that included Doctor visit, labs, and ultrasound. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes, nausea, feverish, flu-like symptoms, numbness and tingling in right arm was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; The initial case was missing the following minimum criteria: unspecified event and number of patients. Upon receipt of follow-up information on 23Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient's colleague). A male patient of unspecified age and gender received BNT162B2, (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. After second dose, on an unspecified date in 2021, the patient experienced cold. The outcome of the event was unknown.  The lot number for [BNT162B2] was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Urticaria
Clinical narrative: Hives on head, arms for brief period; Now appear to be having a shingles outbreak; This is a spontaneous report from a contactable consumer, the patient. A 64-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 06Apr2021 at 10:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included dermatomyositis, atrial fibrillation (Afib) and thyroid. The patient had known allergies to trazodone and statins. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included mycophenolate mofetil (MYCOPHENOLATE), bisoprolol (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); all from an unknown dates for unknown indications and unknown if ongoing. On 06Apr2021 at 20:00, the patient experienced hives on head, arms for brief period and appeared to be having a shingles outbreak. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives on head, arms for brief period and appeared to be having a shingles outbreak 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: Neck pain, Pain in extremity
Clinical narrative: Intense pain in neck and arms; Intense pain in neck and arms; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Concomitant medications received within two weeks of vaccination were not reported. The patient previously took azithromycin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. The patient previously also took doxycycline (MANUFACTURER UNKNOWN) for unknown indication on unknown date 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 22Apr2021 at 19:00, the patient experienced intense pain in neck and arms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events intense pain in neck and arms was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Frequent and sometimes persistent dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-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 19Apr2021 at 10:15 (at the age of 25-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN) and Birth control pill; all for unknown indication from an unknown date and unknown if ongoing. On 22Apr2021 at 10:00, the patient experienced frequent and sometimes persistent dizziness. The event did not result in doctor 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.Therapeutic measures were not taken as a result of the event. The clinical outcome of the event dizziness 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Lymphadenopathy
Clinical narrative: upset stomach; Headache; fatigue; swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 41-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 21Apr2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts and avocado allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 21Apr2021 at 22:30, the patient experienced upset stomach, headache, fatigue and swollen lymph node in left armpit. The events did not result in doctor 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 patient did not receive any treatment for the events. The clinical outcome of the events upset stomach, headache, fatigue and swollen lymph node in left armpit was resolving 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 23Apr2021 at 14:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to NSAIDS (non-steroidal anti-inflammatory drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) for unknown indication on unknown date and experienced drug allergy. On 23Apr2021 at 16:00, the patient experienced light headed. 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 event light headed was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Malaise, SARS-CoV-2 test
Clinical narrative: Numb skin; Dizzy; Very unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient also received first dose of measles, mumps and rubella vaccine (MMR) (MANUFACTURER UNKNOWN) via an unspecified route of administration on 03Mar2021 for an unknown indication. Medical history included asthma and allergy to seafood. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. On 01Apr2021 at 19:00, the patient experienced numb skin, dizzy and very unwell. On 16Apr2021, the patient underwent rapid test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events numb skin, dizzy and very unwell were resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Fatigue, Headache, Hyperhidrosis, Limb discomfort
Clinical narrative: Arm pain; Sweating; Shaky hands; Loss of coordination; Heaviness of limbs; Fatigue; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 15:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing and testosterone phenylpropionate (TESTOSTERONE) taken for hormone replacement therapy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 15:45, about a minute after the first shot, the patient experienced the following: arm pain, sweating, shaky hands, loss of coordination, heaviness of limbs, fatigue and also experienced a headache and nausea. 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 arm pain, sweating, shaky hands, loss of coordination, heaviness of limbs, fatigue, headache and nausea was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Tremor
Clinical narrative: Arm pain; Sweating; Shaky hands; Loss of coordination; Heaviness of limbs; Fatigue; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 15:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing and testosterone phenylpropionate (TESTOSTERONE) taken for hormone replacement therapy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 15:45, about a minute after the first shot, the patient experienced the following: arm pain, sweating, shaky hands, loss of coordination, heaviness of limbs, fatigue and also experienced a headache and nausea. 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 arm pain, sweating, shaky hands, loss of coordination, heaviness of limbs, fatigue, headache and nausea was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor, Vaccination site pain, Vision blurred
Clinical narrative: Tremors in left arm occasionally; Blurred vision; Area above the injection site hurt when took a deep breath, felt an occasional stabbing pain in that area (4/10 pain scale); Arm also hurts; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 17:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient previously received acetylsalicylic acid (ASPIRIN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if it was ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she felt tremors in left arm occasionally. It happened when she pressed it against the edge of my laptop while it was on her lap today, on 19Apr2021 (day 2). Also, on the first day, 18Apr2021, the area above the injection site hurt when she took a deep breath, and she felt an occasional stabbing pain in that area (4/10 pain scale). This was no longer happening. Today, 19Apr2021(day 2), the patient was  experiencing some blurred vision, but might be unrelated (e.g. tired) and she was  able to blink it away. Her arm also hurts but nothing unbearable or strange. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events arm also hurts, area above the injection site hurt when she took a deep breath, felt an occasional stabbing pain in that area (4/10 pain scale), tremors in left arm occasionally and blurred vision. The clinical outcome of events area above the injection site hurt when she took a deep breath, felt an occasional stabbing pain in that area (4/10 pain scale) was recovered on an unknown date in Apr2021, while the clinical outcome of the events arm also hurts, tremors in left arm occasionally and blurred vision were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Hot flush
Clinical narrative: menstrual cramping; breakthrough hot flashes; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the left arm on 02Mar2021 at 11:15 (at 57-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to anticonvulsants from an unknown date; and post-menopausal for 7-years from an unknown date. Concomitant medications were unspecified. Prior to vaccination the patient had not received any other vaccines in 4 weeks and had not been diagnosed with COVID-19. On 02Mar2021 at 20:00 the patient experienced menstrual cramping and breakthrough hot flashes; she reported she was post-menopausal by 7 years and was on hormone replacement therapy. No treatment was received for the events. The patient received the second dose of BNT162B2 (ER87340) in the left arm on 23Mar2021 for COVID-19 immunisation. The outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.