chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: achy joints; mild sore throat; nausea; Fever; chills; shaking; Headache; This is a spontaneous report from a contactable consumer (patient).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18Feb2021 11:45 (Batch/Lot Number: EL3247) as age at vaccination of 31-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient had no allergy. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 03:00 PM (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. Starting at 2 AM on 19Feb2021, the patient experienced achy joints then fever, chills, shaking, headache, nausea and mild sore throat were all experienced.  Therapeutic measures were taken as a result of the events and included administration of ibuprofen. The patient had not covid prior vaccination and was not covid tested post vaccination.  The patient was recovering from the events.   Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: swelling of my lymph node under my armpit on the same arm as my shot; chest started to tighten a bit; body aches; chills; fever persisted for 24 hours and surpassed 100.4; lymph node pain; headache; fatigue; This is a spontaneous report from a non-contactable consumer.   A 23-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 10:45 (Batch/Lot number was not reported) (at the age of 23) as single dose for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. The patient experienced swelling of my lymph node under my armpit on the same arm as my shot on 17Feb2021 22:00, chest started to tighten a bit on 17Feb2021 22:00 with, body aches on 17Feb2021 22:00, chills on 17Feb2021 22:00, fever persisted for 24 hours and surpassed 100.4 on 17Feb2021 22:00, lymph node pain on 17Feb2021 22:00, headache on 17Feb2021 22:00, fatigue on 17Feb2021 22:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Most symptoms subsided after 36 hours, but lymph node pain, headache, and fatigue persisted for a bit longer. The outcome of fever was unknown, of the other events was recovered on an unknown date  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: swelling of my lymph node under my armpit on the same arm as my shot; chest started to tighten a bit; body aches; chills; fever persisted for 24 hours and surpassed 100.4; lymph node pain; headache; fatigue; This is a spontaneous report from a non-contactable consumer.   A 23-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 10:45 (Batch/Lot number was not reported) (at the age of 23) as single dose for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. The patient experienced swelling of my lymph node under my armpit on the same arm as my shot on 17Feb2021 22:00, chest started to tighten a bit on 17Feb2021 22:00 with, body aches on 17Feb2021 22:00, chills on 17Feb2021 22:00, fever persisted for 24 hours and surpassed 100.4 on 17Feb2021 22:00, lymph node pain on 17Feb2021 22:00, headache on 17Feb2021 22:00, fatigue on 17Feb2021 22:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Most symptoms subsided after 36 hours, but lymph node pain, headache, and fatigue persisted for a bit longer. The outcome of fever was unknown, of the other events was recovered on an unknown date  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; I had chills, muscle aches and ran a temperature between 101.7 and 100.1 for 30 hours; ran a temperature between 101.7 and 100.1 for 30 hours; This is a spontaneous report from a contactable consumer (patient) A 61-Years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en6210) on 17Feb2021 at 02:30 at single dose via an unspecified route of administration on left arm  for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (lot #: en5318) on 27Jn2021 at 02:30 am on left arm.  On 17Feb2021 at 12:00 am the patient presented chills, muscle aches and ran a temperature between 101.7 and 100.1 for 30 hours. No treatment was administered for the events. The patient recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue
Clinical narrative: feeling of light headedness for 3 straight days; felt fatigue; hard to focus; This is a spontaneous report from a contactable consumer or other non hcp.A 65-years-old male patient received second dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 10:30 as SINGLE DOSE for covid-19 immunisation.The patient medical history and concomitant medications were not reported.  Historical vaccine includes patient received first dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 11:00 as SINGLE DOSE for covid-19 immunization. Patient did not get other vaccine in four weeks and no other medications in two weeks. Patient does not have covid prior vaccination and does not tested covid post vaccination. Patient does not have any other allergies. On 14Feb2021 12:00, after 2 days of the second vaccine patient felt fatigue and a feeling of light headedness for 3 straight days hard to focus. The outcome of the events was resolved.  Information about lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: sore throat; runny nose; sneezing; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sore throat, runny nose and sneezing on 18Feb2021. On 19Feb2021, his throat felt better, but he had random throbbing pains in the throat throughout the day and still had runny nose and sneezing. The patient was recovering from the event sore throat while was not recovered from the other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eating disorder, Fatigue, Nausea, Pain
Clinical narrative: fatigue/feeling tired; achy; nausea; diarrhea; she's only eaten twice being vaccinated due to the diarrhea; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 16Feb2021, 2 hours after the vaccination, the patient had fatigue and hasn't "been able to get myself situated since then", feeling tired and achy along with nausea and diarrhea. She also noted "she's only eaten twice being vaccinated due to the diarrhea" in Feb2021. The events were considered as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Somnolence
Clinical narrative: slept for 11 hours; felt fairly ill; This is a spontaneous report from a non-contactable consumer. An adult patient of an unspecified gender received the 2nd dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The day after vaccination the patient experienced slept for 11 hours (non-serious) with outcome of recovered, felt fairly ill (non-serious) with outcome of recovered. It was unknown if therapeutic measures were taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Heart rate was about 10 points higher than normal; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Feb2021 at 03:30 AM (Lot Number: En9810), as single dose, for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included lisinopril (unknown manufacturer) and allopurinol (unknown manufacturer). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced heart rate was about 10 points higher than normal (non-serious) on unknown date with outcome of recovered in Feb2021 after 1 week. The patient underwent lab tests and procedures which included heart rate: about 10 points higher than normal on unknown date. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: Fever; coughing; This is a spontaneous report from a contactable consumer (patient).   An 83-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration, in right arm, at single dose, on 17Feb2021, at 09:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  Relevant medical history included asthma. Allergies to medications, food, or other products: penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medications within 2 weeks of vaccination: blood pressure and memory medications (unspecified). On 18Feb2021, at 09:00 PM, the patient experienced fever and coughing. No treatment received. The case was assessed as non-serious (Seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no, seriousness criteria-congenital anomaly/birth defect: no). The patient did not recover from the events at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  The lot number is not available despite follow-up attempts made. Follow-up attempt have been completed and no further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pruritus
Clinical narrative: Left armpit had deep itching sensation; left lower leg and foot cramps (charley horse); This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 12Feb2021 at 09:45 (Lot Number: EN6201; Expiration Date: 30Jun2021) (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included chronic obstructive pulmonary disease (COPD), asthma, obesity, pre-diabetic, leg cramps, all from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19.  Concomitant medications included diphenhydramine hydrochloride/paracetamol (TYLENOL PM) taken for an unspecified indication, start and stop date were not reported and second dose of varicella zoster vaccine rge (cho) (SHINGRIX) at 50 ug single dose (Lot Number: 7354R) taken for immunization on 14Jan2021. On 12Feb2021 at 15:00, the patient experienced left armpit had deep itching sensation for 2 days and left lower leg and foot cramps (charley horse). No therapeutic measures were taken as a result of the events. The patient outcome of the event was recovered in Feb2021.     Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; full body aches; headache; This is a spontaneous report from a non-contactable consumer (patient).   A 25-year-old non-pregnant female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration, in right arm, at single dose, on 16Feb2021, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication, received within 2 weeks of vaccination, included melatonin. The patient previously, on 27Jan2021, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration, in right arm, at single dose, for COVID-19 immunisation. On 16Feb2021, the patient experienced sore arm, full body aches and headache for 24-48 hours after shot. No treatment received. The case was assessed as non-serious (Seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no, seriousness criteria-congenital anomaly/birth defect: no). The patient recovered from the events on an unspecified date, in Feb2021. Post the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Hyperventilation
Clinical narrative: tiredness; weakness; headache; muscle pains; feeling unwell; stomachache; heavy breathing; This is a spontaneous report from a contactable consumer (patient).   A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 19Feb2021 at 10:45 (Lot Number: EL9266) (at the age of 29-year-old) as single dose for COVID-19 immunisation.  Medical history included type 1 diabetes and penicillin allergy, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not tested positive for COVID-19. Concomitant medications included insulin and sertraline hydrochloride (ZOLOFT), both taken for an unspecified indication, start and stop date were not reported.  On 19Feb2021 at 11:30, the patient experienced tiredness, weakness, headache, muscle pains, feeling unwell, stomachache and heavy breathing. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: tiredness; weakness; headache; muscle pains; feeling unwell; stomachache; heavy breathing; This is a spontaneous report from a contactable consumer (patient).   A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 19Feb2021 at 10:45 (Lot Number: EL9266) (at the age of 29-year-old) as single dose for COVID-19 immunisation.  Medical history included type 1 diabetes and penicillin allergy, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not tested positive for COVID-19. Concomitant medications included insulin and sertraline hydrochloride (ZOLOFT), both taken for an unspecified indication, start and stop date were not reported.  On 19Feb2021 at 11:30, the patient experienced tiredness, weakness, headache, muscle pains, feeling unwell, stomachache and heavy breathing. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful & Swollen axillary lymph nodes on armpit side of injection site; Painful & Swollen axillary lymph nodes on armpit side of injection site; This is a spontaneous report from a non-contactable nurse reported for herself.   This 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in left arm on 17Feb2021 13:00 (Lot Number: EL9267) as single dose (at 22 years old) for COVID-19 immunisation. Medical history included COVID-19 prior vaccination on an unknown date, known allergies: Penicillin. There were no concomitant medications. The patient experienced painful & swollen axillary lymph nodes on armpit side of injection site on 18Feb2021 with outcome of unknown. No treatment required. The patient had not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild intermittent headache; This is a spontaneous report from a contactable Pharmacist reporting for a patient. A 46-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 02Jan2021 10:00 (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced mild intermittent headache on an unspecified date with outcome of recovered.  The event was treated with ibuprofen and subsided after 24 hours.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable other hcp. A 58-years-old no pregnant  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Feb2021 08:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation. Medical history included asthma, meniere's, hypoactive thyroid, syncope, allergies: Penicillin. There were no concomitant medications. No covid prior vaccination, no covid tested post vaccination. The patient experienced loss of taste (non-serious) on 20Feb2021 07:00 with outcome of not recovered.  The case is non serious.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Swelling, Vaccination site pain
Clinical narrative: left shoulder muscle and upper chest swelling; pain on side of injection; left shoulder muscle and upper chest swelling; This is a spontaneous report from a contactable consumer.   A 35-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 17Feb2021 10:15 (Batch/Lot Number: En6201) as single dose at the age of 35-year-old for COVID-19 immunisation, administered at Public Health Clinic.  Medical history included born with Poland syndrome: no left pectoral muscle, known allergies: Pencilin. No COVID prior vaccination. Concomitant medication(s) included verapamil (manufacturer unknown); escitalopram (manufacturer unknown); lamotrigine (manufacturer unknown); calcium (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 27Jan2021 10:30 (Batch/Lot Number: El9262) as single dose at the age of 35-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced left shoulder muscle and upper chest swelling, and pain on side of injection on 19Feb2021 07:00 am. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The events were considered non serious. COVID was not tested post vaccination. The outcome of events was recovering.    Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 14Jan2021 at 15:30 (at the age of 70-year-old) (Lot Number: EK9231) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced diarrhea on 27Jan2021 at 07:00 with outcome of not recovered. The event was considered as non-serious and resulted in Doctor or other healthcare professional office/clinic visit. The patient stated that "two weeks to the day of the first vaccine diarrhea started and it has continued for three weeks". The patient did not receive corrective treatments.  The patient was not pregnant. The patient had not had COVID-19 prior to vaccination and she was not tested for COVID-19 after the vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Tender & swelling of shot site; Tender & swelling of shot site; Headache; Chills; fever - 102.3; Whole body achy; This is a spontaneous report from a contactable consumer (patient). This 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Feb2021 12:30 (Batch/Lot number was not available) (age at vaccination was 50 years old) as single dose for covid-19 immunisation. Medical history included anaemia from an unknown date and unknown if ongoing. No known allergies. There were no concomitant medications. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient experienced whole body achy, tender and swelling of shot site, chills and fever - 102.3 and headache on 19Feb2021. No treatment was received for the events. The patient was recovering from the events. The patient was tested positive for COVID-19 in Jul2020 and was sick for 4-5 days and was concerned the first dose of the vaccine having this much impact to body immune system. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Tender & swelling of shot site; Tender & swelling of shot site; Headache; Chills; fever - 102.3; Whole body achy; This is a spontaneous report from a contactable consumer (patient). This 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Feb2021 12:30 (Batch/Lot number was not available) (age at vaccination was 50 years old) as single dose for covid-19 immunisation. Medical history included anaemia from an unknown date and unknown if ongoing. No known allergies. There were no concomitant medications. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient experienced whole body achy, tender and swelling of shot site, chills and fever - 102.3 and headache on 19Feb2021. No treatment was received for the events. The patient was recovering from the events. The patient was tested positive for COVID-19 in Jul2020 and was sick for 4-5 days and was concerned the first dose of the vaccine having this much impact to body immune system. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pyrexia
Clinical narrative: Headache; chills; fever of 101.8 for about 24 hours then fever of 99.8 for 2 days; lethargy; This is a spontaneous case from a contactable consumer (patient). This 66-years-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6200) on 17Feb2021 at 14:30, at single dose, for COVID-19 immunisation. No other vaccine was given in 4 weeks. Medical history included asthma, COVID and allergy to amoxicillin. Concomitant medications were not reported. On 18Feb2021 at 14:30 the patient experienced headache, chills, fever of 101.8 for about 24 hours, then fever of 99.8 for 2 days and lethargy. The events did not require any treatment and were resolving. COVID was not tested post vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeds; This is a spontaneous report received from a non-contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in right arm on 03Feb2021 09:00 (at the age of 70-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included lymphoma. No known drug allergies (NKDA) and no COVID prior vaccination reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in 4 weeks. On 19Feb2021 the patient experienced nose bleeds. No treatment was received due to the event. The patient was not tested for COVID post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: 102 fever, tiredness
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache; chills; Body ache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 11:45 at 53 years old (Lot Number: EL3247) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination. No other vaccine were administered in four weeks. The patient previously received the first dose of bnt162b2 administered in Arm Left on 29Jan2021 01:30 PM at 53 years old (Lot Number: EL3247) as single dose for covid-19 immunization. The patient experienced headache, chills, body aches on 20Feb2021 02:00AM. No treatment was received for the events. The outcome of the events was recovering. COVID was not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: joint pain; Back stiffness; This is a spontaneous report from a contactable nurse (patient). This nurse reported events after first and second dose of the vaccine. This case is for events after the first dose. A 48-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 29Jan2021 10:00 (Lot Number: EL9264) as single dose (at age of 48-year-old) for covid-19 immunisation. Medical history included non-hodgkin's lymphoma. The patient had no known allergies. Concomitant medications included st. john's wort (ST. JOHN'S WORT), fluoxetine hydrochloride (PROZAC), cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). Patient did not receive any other vaccine in four weeks. On 29Jan2021 12:00 patient experienced joint pain all over with back stiffness. No treatment was received. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events, at the time of the report. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021212605 same patient, same drug different dose, different event
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Very sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm right, on 19Feb2021 at 08:30 AM (Lot Number: EN6203), as single dose, for COVID-19 immunisation. The patient's medical history was none. Patient had no known allergies. Patient did not have COVID-19 prior to vaccination. Concomitant medications included loratadine (unknown manufacturer), vitamin d3 (unknown manufacturer) and men multivitamin 1x/day. The patient experienced very sore arm (non-serious) in Feb2021 at 12:00 PM with outcome of unknown and nausea (non-serious) in Feb2021 at 12:00 PM with outcome of unknown. Patient has not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: My lymph node above my left shoulder blade was swollen.; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), administered in left arm, on 27Jan2021 at 09:30 AM (at the age of 25-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included known allergies: pollen. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were not reported. No other vaccine received in four weeks and no other medications in two weeks. The patient reported that his lymph node above the left shoulder blade was swollen on 30Jan2021 at 08:30 AM. He went to receive an ultrasound in 2021 to confirm. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received due to the event. The patient then received the second dose of BNT162b2 (lot number: EL3247) on 17Feb2021 at 08:30 AM, administered in left arm for COVID-19 immunisation. The patient was recovering from the event.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Enlarged uvula
Clinical narrative: Swollen uvula; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 19Feb2021 14:45 (Lot number was not reported) as single dose (at age of 59-year-old) for covid-19 immunisation. Medical history was not reported. The patient had no known allergies. First dose of bnt162b2 (BNT162B2) was administered on 28Jan2021 04:15 PM in right arm (at age of 59-year-old) for covid-19 immunisation. Concomitant medication in two weeks included quetiapine fumarate (SEROQUEL). Patient did not receive any other vaccine in four weeks. On 20Feb2021 07:00 patient experienced swollen uvula. Patient was treated with paracetamol (TYLENOL). Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient was recovering from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Upper arm pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 19Feb2021 at 08:30 AM (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history was none. Patient had no known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included rosuvastatin (unknown manufacturer) and colecalciferol (VITAMIN D). Patient did not receive any other vaccine in four weeks. The patient experienced upper arm pain (non-serious) on 19Feb2021 at 07:00 PM with outcome of recovered. Patient has not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; muscle soreness; This is a spontaneous report from non-contactable consumer (patient).  A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date as single dose for Covid-19 immunisation at the age of 72-year-old . Medical history included headache. Concomitant medications included IBUPROFEN (IBUPROFEN ABECE). Historical vaccine included first dose of COVID-19 VACCINE on unknown date for covid-19 immunisation. On unknown date, the patient experienced muscle soreness in arm and headache. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support, received from a contactable consumer (patient). A male patient with age of 81 (unit unknown) received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history included quadruple bypass and diabetic. The patient was taking unspecified concomitant medication, it was reported that he took a pill not insulin. The reporter stated that he got his second dose 2 hours before the present report (20Feb2021) and he wanted to know when he will be protected because he wanted to go the restaurant and eat. He had no side effects after this dose, and after the first dose he only had tingling in his arm for a few hours. It was very mild. He got his shot before lunch and midafternoon his symptoms were gone. He had had a quadruple bypass and he was a diabetic. He took a pill not insulin. The event was reported as non-serious. The outcome of the event was resolved.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 19Feb2021 at 14:30 at 68 years (Lot Number: EM9809), as single dose, for COVID-19 immunisation. Medical history included drug hypersensitivity. Patient was not pregnant and was not pregnant at time of vaccination. Patient did not experience COVID-19 prior to vaccination. Concomitant medications included omeprazole (unknown manufacturer), amlodipine (unknown manufacturer); biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX), vitamin d3 (unknown manufacturer). Patient did not receive any other vaccine in four weeks. The patient experienced sore arm (non-serious) on 19Feb2021 at 21:00 with outcome of recovered.  The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 03Dec2020.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Burning/tingling sensation on tops of hands, and after mostly subsiding, returned in a week on the tops of my feet and hands, on my left arm and occasionally on my face.; Burning/tingling sensation on tops of hands, and after mostly subsiding, returned in a week on the tops of my feet and hands, on my left arm and occasionally on my face.; This is a spontaneous report from a contactable other healthcare professional (HCP, patient).  A 60-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, in left arm on 11Feb2021 at 13:00 at single dose for covid-19 immunisation.  Medical history included grave's disease, hypertension, high cholesterol, previously Ramsay Hunt Syndrome with bell's palsy, struma ovaria. Patient had no covid prior vaccination and was not covid tested post vaccination. No known allergies.Previously on Jan2021 at 13:00 (at 60 years) patient received the first dose of the vaccine administered in left arm covid-19 immunisation. Concomitant medications included hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ), levothyroxine sodium (LEVOXYL) and colecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported.  On 12Feb2021 at 20:00 the patient experienced burning/tingling sensation on tops of hands, and after mostly subsiding, returned in a week on the tops of her feet and hands, on her left arm and occasionally on her face. No treatment given; the final outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach pain for 4 hours after injection.; This is a spontaneous report from a contactable consumer (patient herself).  This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3429), via an unknown route in the left arm, on 19Feb2021 10:30 (at the age of 75-year-old) at single doe for COVID-19 immunisation. No other vaccine was received in four weeks. Medical history included lyme disease and allergy to NSAID. Past drug history included allergy to acetylsalicylic acid (ASPIRIN), penicilin, doxycycline, ceftriaxone, tramadol, trandolapril, prochlorperazine maleate (COMPAZINE), and ceftriaxone sodium (ROCEPHIN). Relevant concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE), azithromycin (ZITHROMAX) and estradiol. On 19Feb2021 11:00, the patient experienced severe stomach pain for 4 hours. No treatments were given for the patient. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had recovered from the event on 19Feb2021 15:00.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Physical examination, Vaccination site pain, Vein discolouration
Clinical narrative: mild arm pain at injection site; mild intermittent abdominal discomfort; veins radiating from right arm to shoulder, chest, and breast were bright blueish purple and very pronounced; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20Feb2021 at 07:30 (Lot Number: EN6198) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included asthma, celiac disease, Isaacs syndrome, allergy to contrast dye and gluten. Concomitant medications included immunoglobulin human normal (IVIGLOB-EX); diphenhydramine hydrochloride (BENADRYL); paracetamol (TYLENOL); ascorbic acid (VITCEE); colecalciferol (VITDE); and salbutamol (ALBUTEROL HFA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient reported that the shot was in right arm and at around 12 hours post injection (20Feb2021 at 19:30), the patient did a body scan for any changes and she noticed that the veins radiating from right arm to shoulder, chest, and breast were bright blueish purple and very pronounced. They are not usually visible and there were no signs of similar effect on the left side. The left side was unaffected. The patient had no fever. The patient also experienced mild arm pain at injection site and mild intermittent abdominal discomfort on an unspecified date. The patient did not receive treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oral discomfort, Swelling
Clinical narrative: swelling of my lips and nose; sensation of having an allergic reaction; my lips are red and feel as if they are burning; This is a spontaneous report from a contactable consumer (patient)  A 55 year old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730) on 13Feb2021 at 12:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included venlafaxine, levothyroxine sodium and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient received first dose of BNT162B2 on 23Jan2021 on left arm. On 15Feb2021 at 09:30 the patient experienced  had slight swelling of her lips and nose. She had the sensation of having an allergic reaction but can breath fine. The edge of her lips were red and feel as if they were burning as does the skin adjacent to the lips. Consumption of most foods makes it feel as if her lips are on fire (as reported). At the time of the reporting the patient had not yet recovered from reported events.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: vomiting (2:00 pm, 19Feb2021); Severe abdominal cramping; nausea (9:00 am, 19Feb2021); This is a spontaneous case from a non-contactable consumer (patient)   A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 15:00 (Batch/Lot Number: EL9266) age at vaccination of 23-years-old, as single dose, for covid-19 immunisation.  Medical history was none; patient had no allergy; patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on 28Jan2021 (Batch/Lot Number: EL3248) age at vaccination of 23-years-old, for covid-19 immunisation. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient experienced severe abdominal cramping on 19Feb2021 (9:00 AM),  nausea on 19Feb2021 (9:00 AM) and vomiting on 19Feb2021 (14:00). No treatment were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccinations the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; Pruiritis; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in right arm on 18Feb2021 04:00PM (at the age of 50-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination and did not have other vaccine in four weeks. Relevant medical history included cervical cancer (1995) and bladder atony. The patient had not COVID prior vaccination and was not tested post vaccination. She had no known allergy. Concomitant medications included macrogol 3350 (PEG 3350). On 20Feb2021 10:00PM the patient had pruritus and rash anterior midsection. No treatment was received. The events were not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: chills; fever of 100.4 degrees Fahrenheit; Sweating; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Feb2021 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included joint pain from an unknown date and unknown if ongoing. Concomitant medications included naproxen taken for joint pain, start and stop date were not reported. The patient experienced mild side effects of chills and a fever of 100.4 degrees Fahrenheit. The patient stated that on unspecified date, "I am having chills overnight, I am sweating and I am running a low grade fever of 100.4. I am due to have a small family gathering this afternoon. Am I putting my family at risk if I go to that gathering?" When asked for event treatment, the patient stated, "No that is what the other part of the question that I wanted to ask but I have to call this other number and ask them what I have to." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 10:30 as 2nd dose, single for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. The patient has no history of covid prior vaccination and was not covid tested post vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date, for COVID-19 immunization. The patient experienced dizziness worsening daily and fatigue on 08Feb2021 with outcome of not recovered. The events resulted in a doctor or other healthcare professional office/clinic visit. No treatment was received for the events.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.