chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Facial discomfort
Clinical narrative: "funny feeling in his face"; difficulties breathing; This is a spontaneous report received from a non-contactable other healthcare professional. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration on 24Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had experienced funny feeling in his face and difficulties in breathing during his 15 minutes waiting period after vaccination on 24Mar2021. The patient denied rash, difficulty swallowing, wheezing, throat tightness, dizziness and facial swelling. The patient received treatment with antihistamines and had taken water and snacks. The follow up response after treatment was good. The patient was stable to go home and follow up with primary care physician (PCP). The clinical outcome of the events funny feeling in his face and difficulties breathing was resolved on 24Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Leg muscle pain and stiffness the day after treatment. The condition has persisted for two weeks.; Leg muscle pain and stiffness the day after treatment. The condition has persisted for two weeks.; This is a spontaneous report received from contactable consumer, the patient. A 78-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in right arm on 11Mar2021 at 09:00 (at the age of 78-year-old), as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 15:00, the patient experienced leg muscle pain and stiffness the day after treatment. The condition had persisted for two weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the adverse events. The clinical outcome of leg muscle pain and muscle stiffness was not resolved at the time of report.                  No follow-up attempts possible. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Major headache; Sore back; Sore arms; Very stiff; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL) for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient previously took azithromycin (Z PACK) for an unspecified indication and experienced allergy. It was unknown whether the patient was diagnosed with COVID-19, prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 20:00, the patient experienced major headache, sore arms, sore back, very stiff, fever and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the major headache, sore arms, sore back, very stiff, fever and chills were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Major headache; Sore back; Sore arms; Very stiff; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL) for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient previously took azithromycin (Z PACK) for an unspecified indication and experienced allergy. It was unknown whether the patient was diagnosed with COVID-19, prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 20:00, the patient experienced major headache, sore arms, sore back, very stiff, fever and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the major headache, sore arms, sore back, very stiff, fever and chills were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore lower throat/trachea on outsidenot really on inside; Hurts whencoughing.; Voice sounds gravel-y and a little hoarse; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration on left arm on 22Mar2021 at 16:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications included spirolactone 50 mg (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), unspecified multivitamin (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 24Mar2021 at 12:00, the patient had sore lower throat/trachea on outside not really on inside. started at noon and worsened over afternoon. Felt like the patient need to cough. Hurts when coughing. Hurts when press on throat. Voice sounds gravel-y and a little hoarse. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore lower throat/trachea on outside not really on inside, hurts when coughing. and voice sounds gravel-y and a little hoarse was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: Body aches; joint pain; severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 51-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 23Mar2021 at 12:00 (at an age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously took his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified anatomical site on an unknown date as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced body aches, joint pain, severe headache. The clinical outcome of body aches, joint pain, severe headache was unknown at the time of report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria, Vaccination site erythema
Clinical narrative: Red hives on left hip, cheek, eye lid and nose; Painful arm; Red around injection spot; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2((PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number-ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer 13 years ago. The patient had a history of allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive medications within 2 weeks of vaccination. On 22Mar2021 at 20:00, the patient had experienced painful arm and redness around injection spot. On 23Mar2021 in the second day morning, the patient had red hives first on left hip, then on cheek, eye lid and nose in the afternoon. No therapeutic measures were taken. Adverse event resulted in emergency room/department or urgent care. The clinical outcome of the events painful arm, red around injection site and red hives on left hip, cheek, eye lid and nose were not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Mild and constant headache; Pain over injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ELO140), via an unspecified route of administration in left arm on 17Mar2021 at 17:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included headache. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021, the patient experienced pain over injection site. On 20Mar2021 and 23Mar2021, the patient experienced mild and constant headache. The patient had headache several times a month even before the vaccination. It was reported that the real concern of the patient was when the pharmacist gave the injection, was that she noticed an intact pack of Pfizer vials (probably two dozen of them) left on the table. The patient did not complain and was not sure how the vaccine should be handled until afterwards she seriously doubted the vaccine vials were handled properly because there were fewer than 10 people waiting only, so there was no need to keep a pack of dozens on the table. The patient was concerned that the vaccine she had might have gotten compromised. The patient did not know how long the pack of those vaccines was left on the table. The patients friend who got her shot at another Walgreens said the same. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the pain over injection site and headache were resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under right arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and acid reflux. The patient had known sulfa allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received other medications (unspecified) within 2 weeks of vaccination. On 20Mar2021 at 10:00, after one week of vaccination, the patient experienced swollen lymph nodes under right arm. The patient did not receive any treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of swollen lymph nodes under right arm was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Pruritus, Vaccination site pain
Clinical narrative: METALLIC TASTE IN MOUTH; Itching of ears and face; INJECTION SITE PAIN; TIREDNESS; HEADACHE; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 24Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and chronic pain. The patient had no allergies to medications, food or other products. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 12:30, the patient experienced metallic taste in mouth, itching of ears and face, injection site pain, tiredness and headache. 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 treatment for the events. The clinical outcome of the events metallic taste in mouth, itching of ears and face, injection site pain, tiredness and headache were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: bone joint pain; right upper arm muscle pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in the left arm on 13Mar2021 at 14:00, (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021, the patient experienced headache, right upper arm muscle pain and bone joint pain. The patient did not receive any treatment for the events. The clinical outcome of the events headache, right upper arm muscle pain and bone joint pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Pruritus
Clinical narrative: Itching all over; Slight headache; Throat felt funny, it was hard to swallow; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8732) via unspecified route of administration in the left arm on 24Mar2021 at 12:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient had allergy to morphine, iodine, latex, most generic medicine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d3 (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), enalapril (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) for unknown indication. On 24Mar2021 at 12:30, the patient experienced itching all over, slight headache and throat felt funny, it was hard to swallow. The patient received benadryl (MANUFACTURER UNKNOWN) as treatment for the events The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itching all over, slight headache and dysphagia were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Parosmia
Clinical narrative: hands and feet turned dark red; incredibly bizarre sense ofsmell I can smellThings others cant very very acute; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208)via unspecified route of administration (at the age of 46-year-old) on 18Mar2021 at 11:00 as a single dose for COVID-19 immunisation. The patient medical history was reported but not specified. Patient had Allergies to medications, food, or other products which are not specified. Concomitant medications included  natural thyroid extract( ARMOUR THYROID) Fexofenadine hydrochloride (ALLEGRA), Dextromethorphan hydrobromide, Diphenhydramine hydrochloride, Pseudoephedrine (BENADRYL CHILDREN), ibuprofen (IBUPROG) all for unknown indication and date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021 the patient had an incredibly bizarre sense of smell she can smell things others cannot very very acute. On18Mar2021 When she got the shot her hands and feet turned dark red and she had to be monitored for an hour. No treatment was taken for adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of incredibly bizarre sense of smell and hands and feet turned dark red was not resolved.   No follow-up attempts possible. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Nausea, Thirst
Clinical narrative: Within 1 hour of receiving the 1st of 2 vaccine doses my mouth became extremely dry; Extremely thirsty; Suffered from a mild headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on left arm 20Mar2021 at 12:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient medical history included colon issues. The patient had allergies which included codeine, cipro and flu meds. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 at 13:30 the patient reported her mouth became extremely dry and extremely thirsty within 1 hour of receiving the first of 2 vaccine doses. Patient did not get enough to drink. Later on the same day patient suffered from a mild headache and nausea. Therapeutic measures were not taken as a result of the events. The outcome of the events mouth became extremely dry, extremely thirsty, mild headache and nausea were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Fatigue, Menstruation irregular, Pain in extremity
Clinical narrative: period - 1 week earlier than expected.; Aching and pain in right wrist; feels bruised and hurt to move; Extreme fatigue; arm pain/aches; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8727) via an unspecified route of administration in the right arm on 23Mar2021 at 20:00 (at the age of 39-years-old) for COVID-19 immunisation. The patient medical history was not reported. The patient reported there were no allergies to medications, food or other products. The patient concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), vit-d (MANUFACTURER UNKNOWN)  (MANUFACTURER UNKNOWN, Org bound minerals (MANUFACTURER UNKNOWN. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, within an hour of receiving the vaccine the patient got her period - 1 week earlier than expected. Within 20 hours, the patient began experiencing aching and pain in right wrist which feels bruised and hurts to move and is a bit swollen. No injury has been reported. Also, the patient experienced extreme fatigue immediately following the vaccine and through today and arm pain/aches as expected. It was reported that there were no treatment medications taken for the reported events. The clinical outcome of the events irregular periods, wrist pain, extreme fatigue, pain in arm, feels bruised hurt to move the wrist was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Viral test
Clinical narrative: Delayed menstrual period by 6 days.; This is a spontaneous report received from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in left arm on 20Feb2021 at 14:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The medical history was not reported. The patient was allergic to latex, gabapentin and scopolamine. Concomitant medications included ondansetron (ZOFRAN) and oxycodone (MANUFACTURER UNKNOWN) from an unspecified date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via unspecified route of administration on left arm on 01Feb2021 at 10:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient was tested for COVID-19. On 18Mar2021, the patient experienced delayed menstrual period by 6 days. The patient heard from other friends that this was also the case for them. The patient had looked online and saw more reports from other women on forums. The patient thinks this should be investigated or warned about as its pretty worrisome for many women when their periods were late, especially when trying to conceive. The patient underwent lab tests and procedures, which included COVID-19 virus test (nasal swab) on 04Mar2021 and was tested negative. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not received treatment for the reported event. The clinical outcome of the event menstruation delayed was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Lymphoedema
Clinical narrative: Lymphedema in right arm and also right chest; more swelling and not just right arm but also right chest, and there was pain.; more swelling and not just right arm but also right chest; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer (treated for several year ago, generally good health), mild lymphedema due to resection of several lymph nodes, and seasonal allergies. Concomitant medications included levothyroxine sodium (EUTHYROID), cholestyramine (MANUFACTURER UNKNOWN) from unknown dates for unknown indications. The patient had not received 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 had not been tested for COVID-19. The patient experienced lymphedema in right arm, lymph node pain and swollen lymph nodes on 13Mar2021. It was further reported that this episode involved more swelling and not just right arm but also right chest, and there was pain. Amelioration after a few days, but some of the problems was persisting. The patient would visit specialist eventually and would likely refuse second shot unless much smaller dose could be administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lymphedema in right arm, lymph node pain and swollen lymph nodes were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Vaccination site pain
Clinical narrative: Intense pain throughout my left arm from the shoulder through the fingers of my left hand; Tenderness in the vaccine site; Tenderness in the vaccine site andmuscle to shoulder.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration in the left arm on 09Mar2021 at 14:00 (at the age 67-years old), as a single dose for COVID-19 immunisation. Medical history included hypertension and pre-diabetes. The patient had no known allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 02:00, the patient experienced intense pain throughout the left arm from shoulder through the fingers of the left hand, pain lasted for 2 days and had resolved into tenderness in the vaccination site and muscle to shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the painful left arm was recovered on 19Mar2021 and of the vaccination site tenderness and tenderness to muscle and shoulder was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruising around injection site on upper left arm; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 at 08:30 (at the age of 51 years) as a single dose for COVID-19 immunisation. Medical history included asthma, left ventricular hypertrophy (LVH), and the patient was allergic to norco, aspirin, penicillin,  latex and bananas. Concomitant medications included metoprolol succinate (TOPROL XL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), all since an unknown date for an unknown indication. 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 was not tested for COVID-19. On 22Mar2021, the patient experienced bruising around the injection site on the upper left arm. The event resulted in a doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the event reported. The clinical outcome of the event bruising around the injection site on the upper left arm was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache; Nausea; Body ache; Muscle soreness; Joint pain; Fatigue; This is spontaneous report from contactable consumer, the patient. A 37-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified route of administration in the right arm on 16Mar2021 at 15:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The Patient had allergic to Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21Mar2021 at 13:00, the patient experienced headache, nausea, body ache, muscle soreness, joint pain and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had nasal swab (COVID-19 virus test) on 22Mar2021 and the result was pending. The patient did not receive any treatment for the events. The clinical outcome of the events headache, nausea, body ache, muscle soreness, joint pain, and fatigue were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Headache; Nausea; Body ache; Muscle soreness; Joint pain; Fatigue; This is spontaneous report from contactable consumer, the patient. A 37-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified route of administration in the right arm on 16Mar2021 at 15:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The Patient had allergic to Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21Mar2021 at 13:00, the patient experienced headache, nausea, body ache, muscle soreness, joint pain and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had nasal swab (COVID-19 virus test) on 22Mar2021 and the result was pending. The patient did not receive any treatment for the events. The clinical outcome of the events headache, nausea, body ache, muscle soreness, joint pain, and fatigue were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Body ache; Headache; Fever (101); This is a spontaneous report from a contactable consumer, the patient. A 54-years old non-pregnant female patient received second dose of dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via unknown route of administration in the left arm on 23Mar2021 at 10:00, (at the age of 54-years-old) as a single dose for Covid-19 immunisation. Medical history was not reported. The patient previously received clarithromycin (BIAXIN) and unspecified sulfa for unspecified indication and experienced drug allergy. Concomitant medication included Levothyroxine (MANUFACTURER UNKNOWN) and unspecified vitamins (MANUFACTURER UNKNOWN) both for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via unknown route of administration in the left arm on 02Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for Covid-19 immunisation. On 24Mar2021 at 12:00, the patient experienced headache, body aches and fever (101). The patient did not receive any treatment medication for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body aches and fever (101) were recovered on an unknown date at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Left arm pain at point of insertion; Headcahe; extreme fatigue; This is a spontaneous report received from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient medical history included diabetes, blood clotting disorder and obesity. Patient had no allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced left arm pain at point of insertion, headache and extreme fatigue. The events did not result in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the events. The clinical outcome of all the events was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added age at vaccination, vaccine facility country, revised narrative (added sentence: Patient had no allergies to medications, food, or other products).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Nausea, Pharyngeal swelling
Clinical narrative: Throat swelling; Difficulty swallowing; Nausea; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 06Mar2021 (at an age of 39-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of known allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. On 06Mar2021, the patient had experienced throat swelling, difficulty swallowing, nausea and dizzy. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events throat swelling, difficulty swallowing, nausea and dizzy were resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Irritability, Pain, Pyrexia
Clinical narrative: Severe headache, the day following the administration of the second dose.; Fever, the day following the administration of the second dose.; Joint pain, the day following the administration of the second dose.; Body aches, the day following the administration of the second dose.; Radical change in my temperament/ Intense rage, the following week.; Irritable; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in right arm in Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19 since the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date in Feb2021 as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the day following the second dose, the patient had experienced severe headache, fever, join pain and body aches. The following week, the patient had experienced anger/rage and irritability. The patient had noticed a radical change in his temperament. The patient was then very irritable, and prone to fits of intense rage. The patient never had anger issues in the past, or and any other psychiatric issues. The patient was hoping this as temporary issue, but right then, it was quite debilitating. The patient did not receive any treatment for the events. The clinical outcome of all the events headache, fever, join pain body aches, anger/rage and irritability was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test
Clinical narrative: circular hair loss; This is a spontaneous report received from a non-contactable nurse. A 36-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 19Mar2021 (at the age of 36-year-old), as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown, if the patient had been tested for COVID-19 since the vaccination. Concomitant medications were reported. On 20Mar2021 about 24 hours after the vaccination, the patient had circular hair loss (chunk fell out). Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent unspecified blood tests and the results were not reported. Therapeutic measures were taken as a result of hair loss included steroid cream. The patient was referred to dermatology. The clinical outcome of the event hair loss was not resolved at the time of this report.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Balance was greatly impaired; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via unspecified route of administration in left arm on 15Mar2021 at 14:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetic. The patients concomitant medications included glimepiride (MANUFRACTURER UNKNOWN), pioglitazone (MANUFRACTURER UNKNOWN) and crestor (MANUFRACTURER UNKNOWN) all for unknown indications and since unknown dates. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021 (two days after vaccine) at 03:30, the patient woke up to go the bathroom and balance was greatly impaired. The patient had to hold onto the wall to get in the room and it was going on for a week now. The patient had no symptoms of anything before the vaccine, so she was wondering if this is a side effect and have others been affected this way. The patient was concerned about contacting her doctor regarding what was happening and how long will it be continuing and was also concerned to get the second round of the vaccine scheduled on 5Apr2021. No treatment was received for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event balance was greatly impaired was not recovered at the time of this report.   No follow-up attempts are needed. No further information expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Chills, Fatigue, Headache
Clinical narrative: tiredness; headache; muscle pain; chills; un-controlled shaking; fever; nausea; loss of balance; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered on Arm Left on 24Mar2021 08:15 as dose 1, single for COVID-19 immunization at hospital. Medical history included prostate cancer. The patient had no known allergies to medications, food, or other products. Concomitant medications included Escitalopram at 10 mg; Pantoprazole 40 mg; Metoprolol Tartrate; all are received within four weeks of vaccination. The patient did not receive any other vaccines within four weeks. On 24Mar2021 19:30, the patient experienced tiredness, headache, muscle pain, chills, un-controlled shaking, fever (102 degrees), nausea, loss of balance and ringing in the ears. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. No treatment was received for the events. The outcome of events was recovered in Mar2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Tinnitus, Tremor
Clinical narrative: tiredness; headache; muscle pain; chills; un-controlled shaking; fever; nausea; loss of balance; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered on Arm Left on 24Mar2021 08:15 as dose 1, single for COVID-19 immunization at hospital. Medical history included prostate cancer. The patient had no known allergies to medications, food, or other products. Concomitant medications included Escitalopram at 10 mg; Pantoprazole 40 mg; Metoprolol Tartrate; all are received within four weeks of vaccination. The patient did not receive any other vaccines within four weeks. On 24Mar2021 19:30, the patient experienced tiredness, headache, muscle pain, chills, un-controlled shaking, fever (102 degrees), nausea, loss of balance and ringing in the ears. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. No treatment was received for the events. The outcome of events was recovered in Mar2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.