chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hot flush, Nausea, Tinnitus
Clinical narrative: Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, COVID-19. It was reported that the patient had a mild case before she got COVID on 12Jan2020, and before either vaccine. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included trazodone (MANUFACTURER UNKNOWN) and phentermine (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 06:00, beginning one week after the second dose, the patient had felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus. 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 beginning one week after the second dose, the patient had felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; Beginning 1 week after the second dose Ive felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, COVID-19. It was reported that the patient had a mild case before she got COVID on 12Jan2020, and before either vaccine. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included trazodone (MANUFACTURER UNKNOWN) and phentermine (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 06:00, beginning one week after the second dose, the patient had felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus. 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 beginning one week after the second dose, the patient had felt nauseous with vomiting, dizziness, intense hot flashes, fatigue, and increased tinnitus was not resolved 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: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness and pain at injection site for two days; Redness and pain at injection site for two days; 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: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 11:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. Concomitant medications included vitamin d nos (VITAMIN D), lecithin (MANUFACTURER UNKNOWN) and norethisterone (NORETHINDRONE) all from an unknown date for unspecified indications. 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 20:00 the patient experienced redness and pain at injection site for two days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcomes of the events redness and pain at injection site were recovered on an unknown date in Apr2021 .   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pain
Clinical narrative: Body aches; Tired; Upset stomach; This is a spontaneous report from a contactable consumer. A 53-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 in the right arm on 12Apr2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Patient received other medications in two weeks, names were unspecified. 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 15Mar2021 at 10:45 (at the age of 53-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 13Apr2021 at 09:00, the patient experienced body aches, tired, upset stomach. 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 events. The clinical outcome of the events body aches, tired, upset stomach was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 34, via an unspecified route of administration, on Apr 14, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history: none. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient does not have any allergies to medications, food or other products. On Apr 15, 2021, patient experienced pain in lymph node under armpit. Therapeutic measures were not taken as a result of the event. The outcome of pain in lymph node under armpit: not recovered (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: Chills; General malaise; This is a spontaneous report from a non contactable consumer, the patient. A 44-year-old 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 arm right on 13Apr2021 at 09:30(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any relevant medical history. Concomitant medications included meloxicam for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 23Mar2021 at 15:15 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 14Apr2021 at 01:00 the patient experienced chills and general malaise. Therapeutic measures  were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event chills and general malaise was recovering at the time of the report.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body aches; chills; headache; This is a spontaneous report from a contactable pharmacist, the patient. A 44-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 13Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy nonsteroidal anti inflammatory drugs (NSAIDS). Concomitant medications included vitamin d NOS (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 as a single dose for COVID-19 immunisation. The patient previously also received paracetamol (APAP) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 06:00, the patient experienced body aches, chills and headache. 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, and emergency room/department or urgent care. The clinical outcome of the body aches, chills and headache was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: Tiredness day after vaccine; Also next day, lymph node inflammation (left armpit swollen) and also in front under collar bone (left side); Overall pain on left side nothing on the right side; This is a spontaneous report from a contactable consumer, the patient. A 48-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 arm left on 14Apr2021 at 17:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included birth control, seafood allergy, shellfish allergy, mushrooms allergy and pistachios allergy. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) and birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 24Mar2021 at 17:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 16:00, day after vaccine the patient experienced tiredness.  Also, next day the patient experienced lymph node inflammation (left armpit swollen) and also in front under collar bone (left side). The patient had overall pain on left side nothing on the right side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, lymph node inflammation and overall pain on left side were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Peripheral swelling, Ultrasound scan
Clinical narrative: Right leg started swelling (below knee) for some weeks; having difficulty breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9262), via an unspecified route of administration in arm left on 28Jan2021 at 09:00 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included known allergies of penicillin. The concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EJ1686), via an unspecified route of administration in arm left on an unspecified date in Jan2021 at 10:15 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient experienced right leg started swelling (below knee) for some weeks and having difficulty breathing on an unspecified date in Feb2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included chest x-ray: unknown results on an unspecified date and ultrasound of leg: unknown results on an unspecified date. Therapeutic measures were taken as a result of events that included ultrasound of leg and chest Xray. The outcome of the events was reported as resolving.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Oral pain, Paraesthesia oral
Clinical narrative: Cold sore; Cold sore started with tingling on both sides of mouth 7 days after vaccination; developed into full sore on right side; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles in 2015. The patient did not receive any medication within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) 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 14Apr2021 at 17:00 the patient experienced cold sore, started with tingling on both sides of mouth 7 days after vaccination, then developed into full sore on right side. The patient had no cold sore in over 10 years. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event cold sore, started with tingling on both sides of mouth 7 days after vaccination, then developed into full sore on right side was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Eructation
Clinical narrative: Had unbearable indigestion and heartburn and belching/ excessive burping; The evening of the shot, started having bad indigestion and heartburn; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on 11Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and coronary artery disease (CAD). The patient did not have 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 rosuvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPRIN), lansoprazole (LANSOPRAZOL) and sambucus nigra (ELDERBERRY); all taken for unknown indication 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 an unknown date, as a single dose for COVID-19 immunisation. On 11Apr2021 at 20:00, the evening of the shot, the patient started having bad indigestion and heartburn. The following day, on 12Apr2021, it worsened and persisted and was really quite awful and the patient had unbearable indigestion heart burn and belching. The symptoms finally dissipated about 48 hours later. The patient had no nausea, it was strictly heartburn and indigestion excessive burping. 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 event the evening of the shot, started having bad indigestion and heartburn was recovered on an unknown date in Apr2021. The clinical outcome of the event unbearable indigestion and heartburn and belching/excessive burping was recovered on 12Apr2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Vaccination site pain
Clinical narrative: Sore muscle at injection site; Inflammation in both hands and wrists; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot 8731) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) for unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 12:30 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 COVID vaccine. On 16Apr2021 at 14:00 the patient experienced sore muscle at injection site and inflammation in both hands and wrists. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was unknown. The clinical outcome of the event inflammation was recovered on 16Apr2021 at 14:00.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Fatigue, Feeling hot, Lymphadenopathy
Clinical narrative: Swollen lymph nodes under right arm; Armpit swelled up considerably and experienced lots of pain; Armpit swelled up considerably and experienced lots of pain; Hot to the touch; Soreness in arm; Aches and pains; 99 plus fever; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 55-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 13Apr2021 at 17:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, hypothyroidism, overweight and prior to the vaccination, the patient was diagnosed with COVID-19. The patient was allergic to sulfur meds (drug allergy). Concomitant medications included celecoxib (CELEBREX), levothyroxine sodium (SYNTHROID), vitamin d nos (VITAMIN D), sertraline (MANUFACTURER UNKNOWN) and phendimetrazine tartrate (PHENTRA) all 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 14Apr2021, after shot, the patient had soreness in arm, aches and pains, 99 plus (unspecified units) fever and tiredness; about 24 hours after shot at 18:00, the patient developed swollen lymph nodes under right arm, armpit swelled up considerably and experienced lots of pain and it was hot to the touch. At the time of this report (still), it was very swollen and painful 3 days after shot, no longer hot to the touch and the patient still experienced slight aches as well. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the event hot to the touch was resolved on an unknown date in Apr2021, whereas the clinical outcome of the events soreness in arm, aches and pains, 99 plus fever, tiredness, swollen lymph nodes under right arm, armpit swelled up considerably and experienced lots of were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Swollen lymph nodes under right arm; Armpit swelled up considerably and experienced lots of pain; Armpit swelled up considerably and experienced lots of pain; Hot to the touch; Soreness in arm; Aches and pains; 99 plus fever; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 55-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 13Apr2021 at 17:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, hypothyroidism, overweight and prior to the vaccination, the patient was diagnosed with COVID-19. The patient was allergic to sulfur meds (drug allergy). Concomitant medications included celecoxib (CELEBREX), levothyroxine sodium (SYNTHROID), vitamin d nos (VITAMIN D), sertraline (MANUFACTURER UNKNOWN) and phendimetrazine tartrate (PHENTRA) all 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 14Apr2021, after shot, the patient had soreness in arm, aches and pains, 99 plus (unspecified units) fever and tiredness; about 24 hours after shot at 18:00, the patient developed swollen lymph nodes under right arm, armpit swelled up considerably and experienced lots of pain and it was hot to the touch. At the time of this report (still), it was very swollen and painful 3 days after shot, no longer hot to the touch and the patient still experienced slight aches as well. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the event hot to the touch was resolved on an unknown date in Apr2021, whereas the clinical outcome of the events soreness in arm, aches and pains, 99 plus fever, tiredness, swollen lymph nodes under right arm, armpit swelled up considerably and experienced lots of were 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: Dysgeusia, Insomnia
Clinical narrative: Insomnia; Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 36-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 13Apr2021 at 17:15 (at the age of 36-years-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 previously took cefazolin sodium (ANCEF) for an unknown indication on an unknown date and experienced allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 00:00, the patient experienced insomnia and metallic taste. The patient did not receive any treatment for the adverse events. 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. The clinical outcome of the events of insomnia and metallic taste was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Palpitations, Pyrexia
Clinical narrative: Fever; Chills; Headache; Nausea; Racing heart; This is a spontaneous report from a contactable consumer. A 51-year-old male 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 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history not reported. Concomitant medications included atenolol (MANUFACTURER UNKNOWN); from unknown date for unknown indication and unknown if on going. The patient had no known allergies to medications, food, or other products. 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 22Mar2021 at 14:00 (at the age of 51-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 13Apr2021, the patient experienced fever, chills, headache, nausea and racing heart. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. . The patient did not receive any treatment for the reported event. The clinical outcome of the events of fever, chills, headache, nausea and racing heart was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; 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: EW0150) via an unspecified route of administration in the left arm on 06Apr2021(at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had known allergy to Sulfa. The patient did not receive any other medication within 2 weeks of vaccination. 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 16Mar2021(at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 the patient experienced fever of 100.4 (unspecified units) and chills and continue to have these symptoms till 14Apr2021. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021, the patient underwent rapid test (nasal swab) and the result was negative. The clinical outcome of the event fever and chills was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Rash
Clinical narrative: I had mild temperature; Fatigue; Body ache; Rashes throughout my body; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 12:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had known allergies to Ibuprofen (MANUFACTURER UNKNOWN). Concomitant medications included escitalopram oxalate (LEXAPRO) for unknown indication, on unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Apr2021, the patient experienced mild temperature, fatigue, body ache for about 36 hours after getting the dose, which was expected and rashes throughout body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse event. The clinical outcome of the event's mild temperature, fatigue, body ache and rashes throughout body was recovering at the time of this report.      No follow up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received an unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7533), at the age of 46, via an unspecified route of administration, left arm, on Apr 6, 2021, at 18:15, 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 vaccine within four weeks prior to the COVID-19 vaccine. On Apr 10, 2021, patient's left arm ached too much from last 3 days. He could not carry even a pound. Since the vaccination, patient has not been tested for COVID-19. The event 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 event. The clinical outcome of the left arm ached too much from last 3 days 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: Hypoaesthesia, Paraesthesia oral, Vaccination site pain
Clinical narrative: experiencing some numbness; tingling in tongue; tingling in lips on the left side; site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old 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 left arm on 14Apr2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Allergies to medications, food, or other products were reported as not applicable. 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 levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. Patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) in the left arm on 19Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 Vaccination. On 14Apr2021 the patient experienced 4 hours after the stick, experienced some numbness/ tingling in tongue and lips on the left side only. Only other side effect is site soreness. Therapeutic measures were taken as a result of the events, numbness/ tingling in tongue and lips on the left side only. Only other side effect is site soreness which included treatment with dyphenhydramine. The adverse event 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 event experiencing some numbness/tingling in my tongue and lips on the left side only and only other side effect is site soreness was unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Malaise, Pain
Clinical narrative: Felt flush in face; Headache; Achy; Tired; General feeling of being unwell.; Sore arm at the site of the injection.; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin nos (DAILY MULTIVITAMIN), colecalciferol (VITAMIN D3) 5000 IU, all for unknown indication, for unknown period of time. 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 19Mar2021, at 16:30 as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 14:30, the patient reported that she received second dose of the Pfizer BioNTech vaccine at 12 noon on 12Apr2021 and by 2:30 pm felt flush in her face, headache, achy, tired and general feeling of being unwell. She also experienced sore arm at the site of the injection. These symptoms continued on 12Apr2021 and 13Apr2021. On 14Apr2021 she felt better upon waking up. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events achy, tired, general feeling of being unwell, sore arm at the site of the injection were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt flush in face; Headache; Achy; Tired; General feeling of being unwell.; Sore arm at the site of the injection.; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin nos (DAILY MULTIVITAMIN), colecalciferol (VITAMIN D3) 5000 IU, all for unknown indication, for unknown period of time. 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 19Mar2021, at 16:30 as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 14:30, the patient reported that she received second dose of the Pfizer BioNTech vaccine at 12 noon on 12Apr2021 and by 2:30 pm felt flush in her face, headache, achy, tired and general feeling of being unwell. She also experienced sore arm at the site of the injection. These symptoms continued on 12Apr2021 and 13Apr2021. On 14Apr2021 she felt better upon waking up. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events achy, tired, general feeling of being unwell, sore arm at the site of the injection were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Myalgia, Palpitations
Clinical narrative: Heart racing; Dizziness; Bad muscle aches; Fatigue; Felt absolutely terrible; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 26Mar2021 at 13:30 (at the age of 50-years-old) as a 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. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 26Mar2021 at 13:45, the patient reported that she had bad side effects which included heart racing, dizziness initially and then bad muscle aches, fatigue; the patient felt absolutely terrible for the next 3 days. Since the vaccination, the patient had not been tested for COVID-19. The adverse events 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 outcomes of the events heart racing, dizziness initially, bad muscle aches, fatigue and felt absolutely terrible were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Immune system disorder, Intertrigo
Clinical narrative: Painful Intertrigo on waist and lower abdomen/ intertrigo rash; Painful herpes outbreak all over mylower left arm and lower back; immune system was compromised; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old 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 left on 08Apr2021 at 11:00 (at the age of 68-year-old) at single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included herpes infection in 1975, bad back issues, high cholesterol, adhesive tape allergy. Concomitant medications included unspecified vitamins and eye drops. The patient previously took cefalexin (KEFLEX) on an unknown date and experienced constipation. The patient previously  received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 18Mar2021 at 10:30 (at the age of 68-year-old) as single dose for COVID-19 immunization; no issues after first injection. 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 09Apr2021 at 20:30 (also reported as between 29-30 hours after her second shot), patient experienced very painful intertrigo on waist and lower abdomen (which she have never had) and had a painful herpes outbreak all over lower left arm and lower back. These happened at the same time. She has not had a herpes outbreak in over 30 years. She had no issues after her 1st injection and she have not heard of this occurrence happening as a side effect, but she cannot overlook the timing that both of these concurrent skin rashes happened within 28-30 hours of 2nd Pfizer shot. She went to her PCP and it was confirmed that she had a herpes outbreak and an intertrigo rash and that it's possible that her immune system was compromised somehow that caused this to occur. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of these events which included treatment with valacyclovir and ketoconazole cream. The clinical outcome of the events (very painful intertrigo on waist and lower abdomen (which she have never had)/ intertrigo rash, and had a painful herpes outbreak all over lower left arm and lower back, immune system was compromised) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: "Whooshing"/rushing sound in my left ear for 2 days; 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: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 12:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included oxybutynin hydrochloride (OXYBUTININ ACCORD) from an unknown date for unknown indication and unknown if its ongoing. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 08:00, the patient experienced "whooshing"/rushing sound in her left ear for 2 days. No therapeutic measures were taken as a result of the reported event. The adverse event 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. The clinical outcome of the event "whooshing"/rushing sound in her left ear for 2 days was recovered on 17Apr2021.   No follow-up attempts are needed. No further information is expected.