chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization.  Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Vaccination site pain
Clinical narrative: had the worst backache; muscle soreness; muscle soreness at the injection site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid.  A contactable consumer (patient) reported that an 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration at the right arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (reported as immune system attacks red blood cells). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Concomitant medications included prednisone for red blood cells from Dec2020 and ongoing, folic acid from Dec2020, and omeprazole from 05Nov2020. The patient did not have any symptoms the day she received it except for muscle soreness at the injection site on 21Jan2021. On the night of 26Jan2021, she had the worst backache. Her son went to the store and bought Lidocaine patches for it. Clinical outcome of the event muscle soreness at the injection site was recovered on 22Jan2021 while for the worst backache was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Left axillary lymph node swelling, pain, and tenderness; Left axillary lymph node swelling, pain, and tenderness; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 09Jan2021 (18:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the public health clinic/veterans administration facility. Medical history included asthma. Concomitant medication included etonogestrel (NEXPLANON). The patient was not pregnant at the time of vaccination. On 10Jan2021 (18:00), the patient had left axillary lymph node swelling, pain and tenderness. The patient did not receive any treatment for the reported events. The outcome of the events, 'left axillary lymph node swelling, pain and tenderness', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, had nasal swab test for COVID-19 on 12Jan2021 which was negative.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Headache, Heart rate
Clinical narrative: stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers.  A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization.  Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year).  The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021),  she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers.  A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization.  Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year).  The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021),  she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tongue dry
Clinical narrative: stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers.  A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization.  Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year).  The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021),  she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysstasia, Gait disturbance, SARS-CoV-2 test, Sitting disability
Clinical narrative: severe low back pain; difficulty walking; difficulty standing; difficulty sitting; This is a spontaneous report from a contactable Other Health Professional.  A 50-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140), intramuscularly in the left arm on 30Dec2020 at 15:30 at 50-years-old at a single dose for COVID-19 immunization; administered in a living facility. The patient did not have COVID-19 prior to the vaccination. The patient's medical history was reported as NONE. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication from an unspecified date to an unspecified date; and an unspecified vaccine (SEQIRUS; Lot Number: P 100242861) taken for an unspecified indication on 01Dec2020. On 03Jan2021 at 10:00, the patient experienced severe low back pain (non-serious), difficulty walking (non-serious), difficulty standing (non-serious), difficulty sitting (non-serious); for which no treatment was given. Four days after the injection, the patient had severe low back pain. The patient had difficulty walking, standing, sitting. After the first injection the pain was bad for 3-4 days, and then was gone after 7 days. The patient underwent lab tests and procedures which included COVID test: negative on 21Jan2021. The clinical outcome of the events was recovered on an unspecified date (as reported). The patient received the second dose of the bnt162b2 (Lot Number: 123302), on 20Jan2021 in the left arm.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: The patient "felt tired and ache"; The patient "felt tired and ache"; This is a spontaneous report from a contactable physician via a Pfizer sales representative.  A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 in Dec20202 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient "felt tired and ache" on Jan2021 The outcome of events was recovered.  The patient did not received treatment due to the events. The events were considered as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: headaches; Sore throat; This is a spontaneous report from a contactable consumer (reporting for a patient).  A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),lot number unknown, via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported.  The patient experienced headaches and sore throat on 24Jan2021 (also reported as "headaches days 3-6 post-vaccination, Sore throat starting day 6"). The outcome of events was not recovered. Patient did not receive any treatment due to the events.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasal congestion, Pruritus, Pyrexia
Clinical narrative: Uncontrolled itchiness - body; Headaches; Mild fever; Nasal congestion; This is a spontaneous report from a contactable other hcp.  A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL1283, intramuscular, in the left arm, on 24Jan2021 12:00 at SINGLE DOSE for covid-19 immunization.  Medical history included diabetes mellitus, asthma and hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EJ1685, intramuscular, in the left arm, on 03Jan2021, 12:00 for covid-19 immunization.  The patient's concomitant medications were not reported.  On 25Jan2021 19:00, the patient experienced uncontrolled itchiness - body, headaches, mild fever and nasal congestion. The patient underwent lab tests and procedures on 25Jan2021 which included fever: mild and nasal swab: negative.  The outcome of events was unknown. Patient did not received treatment due to the events. The events were considered as non-serious.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Uncontrolled itchiness - body; Headaches; Mild fever; Nasal congestion; This is a spontaneous report from a contactable other hcp.  A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL1283, intramuscular, in the left arm, on 24Jan2021 12:00 at SINGLE DOSE for covid-19 immunization.  Medical history included diabetes mellitus, asthma and hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EJ1685, intramuscular, in the left arm, on 03Jan2021, 12:00 for covid-19 immunization.  The patient's concomitant medications were not reported.  On 25Jan2021 19:00, the patient experienced uncontrolled itchiness - body, headaches, mild fever and nasal congestion. The patient underwent lab tests and procedures on 25Jan2021 which included fever: mild and nasal swab: negative.  The outcome of events was unknown. Patient did not received treatment due to the events. The events were considered as non-serious.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site pain
Clinical narrative: Slight shoulder pain around injection sight; Mild discomfort; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 22Jan2021 (10:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. On 22Jan2021 (12:30), the patient had slight shoulder pain around the injection "sight" (site) and mild discomfort. The pain around the injection site had lasted roughly 48 hours, and then was getting more painful over time, then slowly getting better. The patient did not receive any treatment for the reported events. The outcome of the events, pain around the injection site and discomfort, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia oral, SARS-CoV-2 test, Swelling face, Tongue discomfort
Clinical narrative: Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date.  Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pain, Swelling
Clinical narrative: slight left armpit swelling and pain; slight left armpit swelling and pain; chills and slight aches 12 hours after 2nd injection; chills and slight aches 12 hours after 2nd injection; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 24Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously received first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 04Jan2021 07:45 AM at single dose for COVID-19 immunization. On 24Jan2021 22:30, the patient experienced chills and slight aches 12 hours after 2nd injection. On 25Jan2021, 24 hours after 2nd injection, the patient experienced slight left armpit swelling and pain. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; fever; muscle ache; headache; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 10:45 at a single dose for COVID-19 immunization. The first dose was received on an unspecified date. The patient medical history was not reported. Patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEXA).  The patient experienced chills, fever, muscle ache and headache on 26Jan2021 23:00. Outcome of the events was not recovered and no treatment was received for the events. Events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain, Vaccination site pain
Clinical narrative: Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), intramuscular in the left arm, on 26Jan2021 14:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included migraine and diabetes mellitus (diabetic). The patient has no allergies to medications, food or other products. Concomitant medication included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-10 post vaccination. The patient experienced migraine headaches, chills, body aches and sore arm on 26Jan2021 at 14:00. No treatment was given for the events. The outcome of the events was unknown. The events were assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pain
Clinical narrative: Body aches; fever - 100.8 degrees; chills; nausea; tired; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9263) on his left arm, via an unspecified route of administration on 25Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and covid. The patient's concomitant medications were not reported. The patient experienced Body aches, fever - 100.8 degrees, chills, nausea, tired; all on 26Jan2021 06:30 AM. No treatment was received for the events. The outcome of the events was recovered on unspecified dates.  No follow up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches; fever - 100.8 degrees; chills; nausea; tired; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9263) on his left arm, via an unspecified route of administration on 25Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and covid. The patient's concomitant medications were not reported. The patient experienced Body aches, fever - 100.8 degrees, chills, nausea, tired; all on 26Jan2021 06:30 AM. No treatment was received for the events. The outcome of the events was recovered on unspecified dates.  No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in hands; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 26Jan2021 at 11:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient previously took codeine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 at 01:30 AM (approximately 14 hours after injection), the patient experienced joint pain in hands. The event was considered non-serious. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on 27Jan2021.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain
Clinical narrative: Nausea; Severe headache; Body/joint aches; Body/joint aches; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL4238; Expiration date was not reported) on 25Jan2021 (14:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included hypertension (HTN), asthma and allergies. The patient had unspecified concomitant medications. The patient was not pregnant at the time of vaccination. On 26Jan2021 (09:00), the patient had nausea; severe headache; and body/joint aches. The patient did not receive any treatment for the reported events. The outcome of the events, nausea, severe headache and body/joint aches, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (11:00) at a single dose on the left arm for COVID-19 immunization. Medical history included orthostatic hypotension. The patient had unspecified concomitant medications. On 26Jan2021 (16:00), the patient had chills. The patient did not receive any treatment for the reported adverse event. The outcome of the event, chills, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible/needed; information about lot/batch number cannot be obtained.?
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Vaccine arm is a little tired; Vaccine arm is a little sore; This is a spontaneous report from a contactable consumer. A non-pregnant 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 26Jan2021 at 14:45 (02:45 PM), at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient was taking quite a few unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a clinic facility. On 27Jan2021, the patient's vaccine arm was a little tired and sore - typical of a shot. No problem, however. No treatment was administered for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: my face started to get red; my cheeks were swollen; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262, expiration date May2021), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got her first injection yesterday at 5pm. At 7pm, her face started to get red and her cheeks were swollen. At 1:30AM, she took some Benadryl. The outcome of the events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: chills; fever; aching arms; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK 4176) via an unspecified route of administration on the left arm on 22Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included allergies, high blood and cholesterol; and diagnosed with COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. On 23Jan2021, the patient experienced chills, fever and aching arms. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red at the injection site; This is a spontaneous report from a contactable consumer who reported for her husband, a male patient of an unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if there had been percentages surfaced on adverse reactions or continued studies on that with why some people were reacting and some were not as far as getting anaphylactic shock. The reporter heard that one doctor had a severe anaphylactic reaction and a lot of her nurse friends were afraid to receive the vaccine after hearing about it. The reporter also stated her husband who received the vaccine also got really red at the injection site on an unspecified date. The reporter was asking if there have been studies on dosage for all body masses for all health conditions and where information on the list of ingredients were posted. The reporter also asked if Pfizer's COVID vaccine use lipids as a carrier for the mRNA just like Moderna, and how does that affect people with heart disease. The reporter also asked if there was any problem with mixing vaccines with other vaccines such as use with the shingles, pneumonia, or whooping cough vaccine. The outcome of the event was unknown.   Information on Lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness, Pyrexia
Clinical narrative: light-headed; muscle weakness; fever; This is a spontaneous report from a patient. A 35-year-old male patient at same age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 26Jan2021 05:00 PM on left arm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 on left arm for covid-19 immunisation. The patient experienced light-headed, muscle weakness, and fever, all on 26Jan2021. The outcomes of events were not recovered. Treatment were not received. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Information about lot and batch number was requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5318, expiration date not reported), via an unspecified route of administration on the left arm, on 26Jan2021 at 09:45 at a single dose for Covid-19 immunization. The patient has no medical history and concomitant medications were not reported. The patient has no known allergies, not pregnant and no other vaccines in four weeks. The patient has no Covid prior to vaccination and not Covid tested post vaccination. The patient had chills on 27Jan2021. The patient did not receive treatment for the event. Outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe pains in his legs from the thigh down to the toes; This is a spontaneous report from a contactable consumer (patient).  A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL9262, expiration date not reported), via an unspecified route of administration from 22Jan2021 to 22Jan2021 at a single dose for Covid-19 immunization.  Medical history included 2 knee operations.  The patient's concomitant medications were not reported.  The patient received the first vaccine on Friday, 22Jan2021. He was fine on Friday and had sent reports with a text notification. On 23Jan2021, Saturday night, he was woken up by severe pains in his legs from the thigh down to the toes. He took an acetaminophen (TYLENOL) about 20 minutes after the pain and about 30-45 minutes the pain went away. The next day, he was fine during the day, but the same thing occurred to him at night, and he took another acetaminophen and it went away. He had 2 knee operations with new knees and thought it was something to do with that. Outcome of the events was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Tonsillar hypertrophy, Vaccination site pain
Clinical narrative: Soreness at injection site; headache; fatigue; slightly swollen tonsils; This is a spontaneous report from a contactable consumer. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 26Jan2021 09:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of the vaccination. The patient had no covid prior to vaccination. Concomitant medication included loratadine and unspecified hormonal birth control. The patient had no other vaccine in four weeks. On 27Dec2021 06:00 AM, the patient experienced soreness at injection site, headache, fatigue, and slightly swollen tonsils. No treatments received in response to the events reported. The patient was not tested for covid post vaccination. The outcome of the events soreness at injection site, headache, fatigue, and slightly swollen tonsils was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side/Doctor's diagnosis was angioedema secondary to vaccination; This is a spontaneous report from a contactable Other HCP (patient). This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose on 22Jan2021 09:00 in left arm for COVID-19 immunisation. The first dose (Lot#: EK9231) was received on 04Jan2021 at 02:30 PM in left arm. Medical history included known allergies to penicillin. Patient also had known allergies to cefalexin monohydrate (KEFLEX) in the past. There was no other medications in two weeks. There was no other vaccine in four weeks. There was no covid prior vaccination, no covid tested post vaccination. Patient experienced angioedema extending from the right side lower lip back to my ear and under my jaw on the right side on 25Jan2021 at 03:00 AM. It resulted in emergency room (ER)/department or urgent care and treatment included epinephrine, steroids, and diphenhydramine hydrochloride (BENADRYL). She went to ER due to side effect of the vaccine - Doctor's diagnosis was angioedema secondary to vaccination. The outcome of event was resolved in Jan2021.; Sender's Comments: Based on the compatible time association and drug's safe profile, the angioedema is possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Vaccination site pain
Clinical narrative: under her arm hurts and she has swelling in her armpit; under her arm hurts and she has swelling in her armpit; injection site pain; This is a spontaneous report from a contactable Nurse reported for herself.   A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 23Jan2021 around 10 a.m. at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Before she went to the appointment, she stated that she took ibuprofen without knowing it was not recommended. Then around 8 of the day of the vaccination she took more ibuprofen because she was experiencing injection site pain. Caller stated that under her arm hurts and she has swelling in her armpit. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Hypoaesthesia, Limb discomfort, Muscular weakness
Clinical narrative: Tingling/numbness throughout my left hand and some in forearm / Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; tingling/numbness throughout her left hand and some in forearm; tingling/numbness throughout her left hand and some in forearm; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Intermittent discomfort in forearm; winging of her left scapula; weakness of serrates anterior; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration in the right arm on 06Jan2021 07:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, raynaud's symptom, orthopedic surgeries. Concomitant medication included levothyroxine (unknown manufacturer). The patient previously took aspirin and gabapentin and experienced drug hypersensitivity. On 18Jan2021 13:00 the patient experienced tingling/numbness throughout her left hand and some in forearm, sudden onset of pretty severe diffuse pain 1.5-2 days later (Jan2021) in left shoulder, axilla, anterior chest wall, persistent and consistent significant pain that does not change with position, ROM, or much with palpation, intermittent discomfort in forearm, evolving into the progressive weakness phase with significant winging of her left scapula and weakness of serrates anterior. Events resulted in emergency room visit and physician office visit. The events were evaluated by an MD who has given the patient a tentative diagnosis of Neuralgic Amyotrophy. Seeing a neurologist on 02Jan2021. The outcome of the events was not recovered. The patient received mediation to manage pain. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.