chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Feb2021 at 14:45 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date in 2005 and allergy to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and Vitamin (MANUFACTURER UNKNOWN); all for an unspecified indication from unknown date and unknown if ongoing. On 22Feb2021 monday at 02:30, the patient woke up with vertigo which she never had before. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 17:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included wheat allergy, corn allergy, chocolate allergy and tomatoes allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269) via an unspecified route of administration in the left arm on 23Feb2021 at 18:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 25Feb2021 at 05:00, the patient experienced severe headache, body aches, chills and sore throat. 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 adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache, body aches, chills and sore throat were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node 3-7 days after injection; This is a spontaneous report from a contactable consumer. A 27-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left on an unspecified date (age at vaccination 27-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Feb2021, patient experienced swollen lymph node 3-7 days after injection. No treatment received for the AE. Patient has no Allergies to medications, food, or other products and patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Aching body; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Feb2021, the patient experienced aching body. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event aching body was unknown 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: Pain in extremity
Clinical narrative: Mild pain in the arm that lasted for about 36 hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced mild pain in the arm that lasted for about 36 hours. The clinical outcome of the event mild pain in the arm was resolved on an unknown date after 36 hours (details unspecified).  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 1 intramuscular on 16Feb2021 (at the age of 76 years) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date of Feb2021 the patient experienced sore arm. Patient was calling because she got her 1st dose last Tuesday and wanted to know when she can start to see people again. She also wanted to know what the percentage rate of people that have a sore arm after injection. The Patient was due to get the second shot of the COVID-19 vaccine, and she would like to know how long will the maximum protection kick in once she receives the second vaccine? She was 76 years old and was returning to work. Patient just wanted to know when it's safer to go back. The outcome of the event was unknown.  Follow-up (19Feb2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 19Feb2021, this case now contains all required information to be considered valid.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported for reporter's sister-in-law. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, The patient experienced nausea. The reporter while talking her nephew on the phone and she told him that she just does not feel right, and it was when she was reading that she would get the nausea. She said that in the background, she heard her sister-in-law say that she also had nausea after the vaccine, but hers went away. The reporter declined to complete a report for her sister-in-law. She said that it seems like every time she puts something into her body, she does not react well to it. She said that if the nausea is something that will go away, she will not go to the doctor for it, but if it does not go away, she will need to see her doctor. The outcome of the event was resolved.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182870 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: chills; headache; nausea; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as a DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unknown date as a DOSE 1, SINGLE for covid-19 immunization. It was reported that, the patient was calling about her husband but stated she received the second dose of her Pfizer vaccine on 10Jan2021 (may have meant 10Feb2021, noticed after call was complete) and on an unspecified date in 2021, the patient experienced chills, headache and nausea. The clinical outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness; arm pain; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient experienced dizziness and arm pain about 6-8 hrs after receiving COVID-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site pain
Clinical narrative: Soreness in upper left arm (injection site) which became noticeable about 11 hours after injection; The discomfort was minor; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received flu vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the upper left arm for an unknown indication from an unknown date. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Feb2021 at 23:00, the patient experienced soreness in upper left arm (injection site) which became noticeable about 11 hours after injection. The discomfort was minor. However, he usually had not been this reaction to other shots (i.e. flu vaccine) was given in the same location. The patient was a Pfizer employee and received the shot at his normal work location. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness in upper left arm (injection site) which became noticeable about 11 hours after injection and the discomfort was minor was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Off label use
Clinical narrative: 2nd dose 01Mar2021, 17 days after 1st dose; stuffy nose; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (BNT162B2 Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received 1st dose of Covid vaccine on 12Feb2021 and is scheduled for 2nd dose 01Mar2021, 17 days after 1st dose which led to Off label dosing frequency. On an unspecified date, she was developing stuffy nose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient herself) of (Age: 68; Unit: Unspecified) reported that she received BNT162B2 (BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included CEPHALEXIN [CEFALEXIN] and COLCHICINE. She stated that, she received first vaccination 4 weeks ago, and was due for second dose but she was taking medications for gout. She took a methyl prednisolone dose pack which she finished a week ago, cephalexin that she just finished last night, and colchicine 0.6 mg one twice daily, that she finished yesterday as well. She was on Methyl Prednisolone and will finish it on Sunday. She was scheduled to take 2nd dose of vaccine on Tuesday and she was wondering if the medication will affect the vaccine On unspecified date, the patient received 1st dose of Covid vaccine and then developed gout. Therapeutic measures were taken as a result of event and treatment included with took a methyl prednisolone dose pack. The outcome of event was unknown   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EN6200, Expiry date: unknown) via an unspecified route of administration on 21Feb2021 as dose 1, single for COVID-19 immunization. Medical history included headache from an unspecified date and unknown if ongoing (patient reported that before she got her first shot of vaccination, she had headache). The patient's concomitant medications were not reported. On an unspecified date the patient experienced headache. Patient called to know if she can take Aleve as she was experiencing headache. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Mild to moderate pain at the injection site; Muscle aches in legs and arms; Mild headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 at 13:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included bicuspid aortic valve and pre-hypertension. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included propanolol (MANUFACTURER UNKNOWN) 20 mg twice daily (BID) and losartan (MANUFACTURER UNKNOWN) 50 mg four times daily (QD); both from unknown date, for unknown indications and unknown if ongoing. On 25Feb2021, the patient experienced mild to moderate pain at the injection site, muscle aches in legs and arms and mild headache. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild to moderate pain at the injection site, muscle aches in legs and arms and mild headache was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 24Feb2021 at 05:30 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID vaccine. Concomitant medications included blood thinners since an unknown date an unknown if ongoing. On 24Feb2021 at 23:00, the patient experienced sore arm. Therapeutic measures were not taken as a result of the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was recovered on unknown date in Feb2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Feeling cold, Influenza
Clinical narrative: I started feeling extremely nauseous/ The rest of the night I felt horrible like a bad case of the flu with nausea; weak/no energy; The rest of the night felt horrible like a bad case of the flu with nausea; No appetite; Chills; Couldn't get warm; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 23Feb2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN); all started from unknown date for unspecified indication and unknown if ongoing. On 24Feb2021 at 09:30, the patient started feeling extremely nauseous, weak, no energy. The nausea went away around 112:00, but came back worse around 16:30. The rest of the night she felt horrible like a bad case of the flu with nausea, no appetite, no energy, chills, couldn't get warm. She did not have a fever though. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events nausea, weak/no energy which included treatment with Pepto bismol and saltine crackers. No therapeutic measures were taken as a result of the other events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events I started feeling extremely nauseous/ the rest of the night I felt horrible like a bad case of the flu with nausea, weak/no energy, the rest of the night felt horrible like a bad case of the flu with nausea, no appetite, chills and couldn't get warm was recovered on an unknown date in Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: I started feeling extremely nauseous/ The rest of the night I felt horrible like a bad case of the flu with nausea; weak/no energy; The rest of the night felt horrible like a bad case of the flu with nausea; No appetite; Chills; Couldn't get warm; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 23Feb2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN); all started from unknown date for unspecified indication and unknown if ongoing. On 24Feb2021 at 09:30, the patient started feeling extremely nauseous, weak, no energy. The nausea went away around 112:00, but came back worse around 16:30. The rest of the night she felt horrible like a bad case of the flu with nausea, no appetite, no energy, chills, couldn't get warm. She did not have a fever though. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events nausea, weak/no energy which included treatment with Pepto bismol and saltine crackers. No therapeutic measures were taken as a result of the other events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events I started feeling extremely nauseous/ the rest of the night I felt horrible like a bad case of the flu with nausea, weak/no energy, the rest of the night felt horrible like a bad case of the flu with nausea, no appetite, chills and couldn't get warm was recovered on an unknown date in Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Warm arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). This report is for first dose. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported) via an unspecified route of administration, on 26Jan2021 (at the age of 77 years), as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included ongoing Metoprolol succinate for hypertension, ongoing Alprazolam (XANAX) for anxiety, Albuterol for chronic obstructive pulmonary disease, ongoing Budesonide for chronic obstructive pulmonary disease, ongoing Arformoterol tartrate (BROVANA) for chronic obstructive pulmonary disease, Tiotropium bromide (SPIRIVA) as a bronchodilator, Aspirin for unspecified indication, Omeprazole (PROTONIX) for Acid reflux, ongoing Diltiazem for hypertension, Prednisone and unspecified Vitamins. The patient stated first vaccine dose had no reaction, just a little warm arm on unspecified date. The event accessed as a non serious. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6200, expiration date: not reported), at the age of 39, via an unspecified route of administration, in right arm, on Feb 19, 2021, at 11:15, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN5318, expiration date: not reported), via an unspecified route of administration, in the right arm, on Jan 29, 2021, at 01:00, single dose, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks. The patient's past drug included aspirin, which she experienced known allergies. It was unknown whether the patient had COVID-19 prior vaccination. Patient has not tested for COVID-19 post vaccination. On Feb 20, 2021, patient experienced swollen lymph nodes in right underarm causing pain and discomfort. Patient did not take treatment for the events. The outcome of all events: resolving. Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 21Feb2021 at 10:30 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and allergic to lobster. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), eicosapentaenoic acid ethyl ester (VASCEPA) and metformin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient  received unspecified vaccines within four weeks prior to the vaccination. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 01Feb2021, the patient underwent COVID test via nasal swab and the result was negative. On 24Feb2021 at 06:00, the patient experienced dizziness which had not started until 3 days after the vaccination and persisted for 3 days so far. 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 was tested for COVID-19. Therapeutic measures were not taken as a result of the events reported. The clinical outcome of the event dizziness was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea and nausea ~ 36 hours after administration; Diarrhea and nausea ~ 36 hours afteradministration; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 14:45 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included eosinophilic asthma and chronic obstructive pulmonary disease (COPD). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included benralizumab (FASENRA) for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 03Feb2021 at 03:00 (at the age of 37-year-old), as a single dose for COVID-19 immunisation.  On 25Feb2021 at 21:00, reported as 36 hours after vaccination, the patient experienced diarrhea and nausea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and nausea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Nausea, Pain
Clinical narrative: Extremely high eosinophil counts for over 1 month; Elevated white blood count; Extreme upper abdomen bloating; Pain; Nausea; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231, expiration date: 30Apr2021 ) via an unspecified route of administration in the right arm on 30Dec2020 at 07:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, asthma, high-density lipoprotein (HDL) and vitamin deficiency. The patient had allergy to medications, food, or other products which are not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking concomitant medications within 2 weeks of vaccination which are not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 the patient experienced extremely high eosinophil counts for over 1-month, elevated white blood count, extreme upper abdomen bloating, pain, nausea and extreme fatigue with a trip to urgent care and Emergency room and with multiple Dr's, testing, imagine, and specialists, no one was able to figure out what was wrong with her. Therapeutic measures were taken as a result of the events with different medications (name not specified), tests, imaging and specialists; (unspecified) . The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely high eosinophil counts, elevated white blood count, extreme upper abdomen bloating, pain, nausea and extreme fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm near injection site; Headache; This is a spontaneous report from a contactable healthcare professional. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an intramuscular route of administration in the right arm on 24Feb2021 at 07:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 24Feb2021, at 12:15, the patient experienced a sore arm near the injection site and headache for approximately 16 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm near the injection site and headache was resolved on 24Feb2021 at 23:30, approximately 16 hours after the vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Headache, Pain
Clinical narrative: Chills,; Cold sweat; Body aches; Headache; Injection site soreness; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 14:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pill (MANUFACTURE UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN); all taken for unknown indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Feb2021 at 05:00 the patient experienced chills, cold sweat, body aches, headache, injection site soreness, dizziness. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with paracetamol (ACETAMINOPHEN) at home. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, cold sweat, body aches, headache, injection site soreness, dizziness was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills,; Cold sweat; Body aches; Headache; Injection site soreness; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 14:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pill (MANUFACTURE UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN); all taken for unknown indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Feb2021 at 05:00 the patient experienced chills, cold sweat, body aches, headache, injection site soreness, dizziness. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with paracetamol (ACETAMINOPHEN) at home. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, cold sweat, body aches, headache, injection site soreness, dizziness was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: 45 hours after injection felt dizzy.  Slightly at first and it progressed to room spinning.; 45 hours after injection felt dizzy.  Slightly at first and it progressed to room spinning.; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 19Feb2021 at 15:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included hay fever, arthritis, GERD and allergy to shellfish and adhesives. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included many supplements, loratadine (CLARITIN) and omeprazole (PRILOSEC); all for unknown indication from unknown date and unknown if ongoing. . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021 at 10:30, 45 hours after vaccination, the patient felt dizzy, slightly at first and it progressed to room spinning. Took to bed and took a nap and awoke 3 hours later and felt fine and no more dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt dizzy, slightly at first and it progressed to room spinning was recovered on 21Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Influenza like illness, Lymph node pain
Clinical narrative: Flu-like symptoms; Extremely bad headache; Armpit/glands in shot arm very sore; Armpit/glands in shot arm very sore; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Feb2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroidosis. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Feb2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 23Feb2021 at 23:00, the patient experienced flu-like symptoms for 24 hrs (no congestion), extremely bad headache and armpit/glands in shot arm very sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events flu-like symptoms was resolved on 24Feb2021; while that of the events extremely bad headache and armpit/glands in shot arm very sore were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Paraesthesia
Clinical narrative: Slight hot flash; Back,butt and down right thigh feel like a thousand needles are pricking skin; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration on 22Feb2021 at 08:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afibrulation), chronic obstructive pulmonary disease (COPD), chronic sinusitis and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included celecoxib (CELEBREX), salbutamol (ALBUTEROL), theophylline (MANUFACTURER UNKNOWN), estrogens conjugated/medroxyprogesterone acetateprempro (PREMPRO) and gabape (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing for an unknown indication. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 01Feb2021 at 08:30 AM for COVID-19 immunisation. On 23Feb2021 at 20:00, the patient experienced a slight hot flash, then the patient's back, butt and down her right thigh felt like a thousand needles were pricking her skin which was hurt for about 5 to 10 seconds. Therapeutic measures were taken as a result of the events and included treatment with unspecified pain medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight hot flash and back, butt and downright thigh felt like a thousand needles pricking the skin were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue discomfort
Clinical narrative: Tip of tongue tingling; Tip of tongue burning; This is a spontaneous report from a non-contactable other healthcare professional. A 58-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on an unknown date (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, during 15 minutes waiting period after the vaccination, the patient began to experience tip of tongue tingling and burning. The patient reported that, she might have burned the tip of the tongue after eating hot oatmeal. The patient wanted to be evaluated to be sure if that was the issue and not an allergic reaction. Therapeutic measures were taken as a result of events and included treatment with water. It was reported that the patient's response to treatment was good. The patient was discharged and stable to go home and was asked to follow up with primary care physician (PCP). The clinical outcome of the events tip of tongue tingling/burning was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in upper right arm around injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 25Feb2021 at 13:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 22:00, the patient experienced soreness in upper right arm around injection site. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness in upper right arm around injection site was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Decreased appetite, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Loss of appetite; Severe stomach cramps; Severe abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes type 2, HTN (hypertension) and obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received codeine (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medication within two weeks of vaccination. On 23Feb2021, the patient experienced nausea, vomiting, loss of appetite, severe stomach cramps and severe abdominal pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, loss of appetite, severe stomach cramps and severe abdominal pain were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.