chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Lethargy, Nausea, Oropharyngeal pain
Clinical narrative: Decreased heart rate of 43; Increased blood pressure; He woke up got out of the bed to pick things up and down he falls; He was dizzy lethargic; He was dizzy lethargic; Chills; Fever; Nausea; Sore throat; This is a spontaneous report from a contactable Consumer or other non health professional.  This consumer (Wife) reported that a male patient (Husband) of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Lot number: EN6208, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included colon cancer stage IV from an unknown date and unknown if ongoing (He has stage 4 Colon cancer and the cancer has metastasized to his lungs). The patient woke up, got out of bed to pick things up and down he fell, he was dizzy lethargic, chills, fever, nausea, sore throat, increased blood pressure and decreased heart rate of 43. After receiving the vaccine on 09Mar2021, the patient came home and everything was normal. The next morning he had an appointment with his Oncologist. He had stage 4 Colon cancer and the cancer had metastasized to his lungs. He was supposed to see his oncologist the following morning. He woke up got out of the bed to pick things up and down he fell. He was dizzy lethargic. He was experiencing severe chills, fever, nausea and lethargic and also had a sore throat. 18:00 that night, it seemed got a lot better than Friday he was still having a sore throat and had to take a couple pills but he seemed like he was on the road to recovery. That morning they woke up and he started with severe chills again and he had increased blood pressure and he was on blood pressure medicine as well. Friday his blood pressure was up to 173 over 93 and gave him a 100 mg of losartan, today or Saturday his blood pressure was at 161 over 109 with a heart rate of 77, gave him 200 mg of losartan. Couple hours after that started coming down 145/99 with so increased heart rate later on 148/97 and 155/100 with the decreased heart rate of 43. The patient underwent lab tests and procedures which included blood pressure measurement: 173/93 mmhg on 12Mar2021 Friday his blood pressure was up to 173 over 93, blood pressure measurement: 161/109 mmhg on 13Mar2021 Saturday his blood pressure was at 161 over 109, blood pressure measurement: 145/99 mmhg on 13Mar2021 Couple hours after that started coming down 145/99, blood pressure measurement: 148/97 mmhg on 13Mar2021 later on 148/97 and 155/100, blood pressure measurement: 155/100 mmhg on 13Mar2021 later on 148/97 and 155/100, heart rate: 77 on 13Mar2021 Saturday his blood pressure was at 161 over 109 with a heart rate of 77, heart rate: 43 on 13Mar2021 later on 148/97 and 155/100 with the decreased heart rate of 43. Therapeutic measures taken as a result of, increased blood pressure included Losartan. The outcome of the events sore throat was not recovered and remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Decreased heart rate of 43; Increased blood pressure; He woke up got out of the bed to pick things up and down he falls; He was dizzy lethargic; He was dizzy lethargic; Chills; Fever; Nausea; Sore throat; This is a spontaneous report from a contactable Consumer or other non health professional.  This consumer (Wife) reported that a male patient (Husband) of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Lot number: EN6208, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included colon cancer stage IV from an unknown date and unknown if ongoing (He has stage 4 Colon cancer and the cancer has metastasized to his lungs). The patient woke up, got out of bed to pick things up and down he fell, he was dizzy lethargic, chills, fever, nausea, sore throat, increased blood pressure and decreased heart rate of 43. After receiving the vaccine on 09Mar2021, the patient came home and everything was normal. The next morning he had an appointment with his Oncologist. He had stage 4 Colon cancer and the cancer had metastasized to his lungs. He was supposed to see his oncologist the following morning. He woke up got out of the bed to pick things up and down he fell. He was dizzy lethargic. He was experiencing severe chills, fever, nausea and lethargic and also had a sore throat. 18:00 that night, it seemed got a lot better than Friday he was still having a sore throat and had to take a couple pills but he seemed like he was on the road to recovery. That morning they woke up and he started with severe chills again and he had increased blood pressure and he was on blood pressure medicine as well. Friday his blood pressure was up to 173 over 93 and gave him a 100 mg of losartan, today or Saturday his blood pressure was at 161 over 109 with a heart rate of 77, gave him 200 mg of losartan. Couple hours after that started coming down 145/99 with so increased heart rate later on 148/97 and 155/100 with the decreased heart rate of 43. The patient underwent lab tests and procedures which included blood pressure measurement: 173/93 mmhg on 12Mar2021 Friday his blood pressure was up to 173 over 93, blood pressure measurement: 161/109 mmhg on 13Mar2021 Saturday his blood pressure was at 161 over 109, blood pressure measurement: 145/99 mmhg on 13Mar2021 Couple hours after that started coming down 145/99, blood pressure measurement: 148/97 mmhg on 13Mar2021 later on 148/97 and 155/100, blood pressure measurement: 155/100 mmhg on 13Mar2021 later on 148/97 and 155/100, heart rate: 77 on 13Mar2021 Saturday his blood pressure was at 161 over 109 with a heart rate of 77, heart rate: 43 on 13Mar2021 later on 148/97 and 155/100 with the decreased heart rate of 43. Therapeutic measures taken as a result of, increased blood pressure included Losartan. The outcome of the events sore throat was not recovered and remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tingling of her tongue; This is a Spontaneous report based on the information received by Pfizer (Reference No: CH-2021000074-00) from a contactable consumer (patient). A female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and Expire Date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included actinic keratosis. Concomitant medications were not reported. On an unspecified date, the patient experienced tingling of her tongue. She mentioned that she had COVID shot from Pfizer and might be the tingling of her tongue was the reaction of her body. Additionally, the patient confirmed that the product (unspecified) was prescribed for her Actinic Keratosis. She explained that she only got the tingling when she used the product at night. She mentioned that the dermatologist instructed her to use it five nights a week for six weeks; however, on the third week, she realized that she used it seven days a week. She asked if overusing it could do any harm. She added that her tongue tingled a little bit; however, the spots on her face cleared-up. She did not have the tingling all day on her tongue. It was only when she put it on and then it started to go and then during the morning it wore off. During the call, she mentioned that she was still experiencing the tingling on the tongue but very little. She experienced it when she used the product more to 7 days than the 5 days. The consumer refused to provide her email address. She provided the consent to call her back for follow-up questions. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Second dose that made him pretty sick.; This is a spontaneous report from a contactable consumer. A 52 years male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single Dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single Dose for covid-19 immunisation. The patient experienced second dose that made him pretty sick on an unspecified date. Caller stated what does it mean that vaccine may not protect everyone. Caller wanted to know if the second dose is same as first dose. And also ( 78 years old female) stated she received the first dose of the Pfizer covid vaccine on the Feb 25 and her second dose is scheduled on the March 25, 4 weeks later instead of the 3 weeks later. Caller stated the first dose did not bothered her but she wanted to know if its ok to take it 4 weeks later then the 3 weeks later and wanted to know if she experienced headache after the second shot can she take Tylenol for it. Caller stated her doctor told her that the first dose of the covid vaccine caller was not sure if that was Pfizer or moderna made him a little bit sick but its the second dose that made him pretty sick and also there is another male patient 52 years old stated the covid vaccine made him a little bit sick and more on the second dose caller was not sure if that was Pfizer or moderna. Several other people told her that the first dose did not bother them but they felt sick with the second dose caller was not sure if that was Pfizer or moderna. The events were assessed as Non serious by health authority. The clinical outcome of the event second dose that made him pretty sick was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Chest pain, Flushing, Hot flush
Clinical narrative: Feeling flushed; Hot flashes almost; Chest tight; Tight side arm and chest sharp pain; Right ear feeling full and tinnitus; Site pain soreness; Stiffness and all over body aches and muscle stiffness/tight side arm; All over body aches; Feeing generally not well; Scratchy throat but no swelling or otherwise allergic reaction.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER2613) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included blood clots, postpartum depression, overweight and sulfonamide allergy. Concomitant medications included Fluoxetine hydrochloride (PROZAC), ibuprofen (MOTRIN), paracetamol (TYLENOL), and fluticasone (FLONASE); all on unknown dates for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received levothyroxin(MANUFACTURER UNKNOWN) and metronidazole (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 18:00, the patient was feeling flushed, hot flashes almost, chest tight, tight side arm and chest sharp pain, right ear feeling full and tinnitus, that lasted off and on until the patient went to bed. The shot was completely painless but 20-30 minutes after vaccination, the patient had site pain soreness, stiffness and all over body aches and muscle stiffness. The patient was feeling generally not well and flushed, was by skin with no rash and had scratchy throat but no swelling or otherwise allergic reaction. The patient received treatment for the reported events and blood pressure was examined and observed for 45 minutes. 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 feeling flushed, hot flashes, chest tight, chest sharp pain, tinnitus, vaccination site pain, stiffness, body aches, feeling unwell and scratchy throat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal stiffness, Pain, Throat irritation, Tinnitus
Clinical narrative: Feeling flushed; Hot flashes almost; Chest tight; Tight side arm and chest sharp pain; Right ear feeling full and tinnitus; Site pain soreness; Stiffness and all over body aches and muscle stiffness/tight side arm; All over body aches; Feeing generally not well; Scratchy throat but no swelling or otherwise allergic reaction.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER2613) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included blood clots, postpartum depression, overweight and sulfonamide allergy. Concomitant medications included Fluoxetine hydrochloride (PROZAC), ibuprofen (MOTRIN), paracetamol (TYLENOL), and fluticasone (FLONASE); all on unknown dates for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received levothyroxin(MANUFACTURER UNKNOWN) and metronidazole (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 18:00, the patient was feeling flushed, hot flashes almost, chest tight, tight side arm and chest sharp pain, right ear feeling full and tinnitus, that lasted off and on until the patient went to bed. The shot was completely painless but 20-30 minutes after vaccination, the patient had site pain soreness, stiffness and all over body aches and muscle stiffness. The patient was feeling generally not well and flushed, was by skin with no rash and had scratchy throat but no swelling or otherwise allergic reaction. The patient received treatment for the reported events and blood pressure was examined and observed for 45 minutes. 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 feeling flushed, hot flashes, chest tight, chest sharp pain, tinnitus, vaccination site pain, stiffness, body aches, feeling unwell and scratchy throat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Feeling flushed; Hot flashes almost; Chest tight; Tight side arm and chest sharp pain; Right ear feeling full and tinnitus; Site pain soreness; Stiffness and all over body aches and muscle stiffness/tight side arm; All over body aches; Feeing generally not well; Scratchy throat but no swelling or otherwise allergic reaction.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER2613) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included blood clots, postpartum depression, overweight and sulfonamide allergy. Concomitant medications included Fluoxetine hydrochloride (PROZAC), ibuprofen (MOTRIN), paracetamol (TYLENOL), and fluticasone (FLONASE); all on unknown dates for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received levothyroxin(MANUFACTURER UNKNOWN) and metronidazole (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 18:00, the patient was feeling flushed, hot flashes almost, chest tight, tight side arm and chest sharp pain, right ear feeling full and tinnitus, that lasted off and on until the patient went to bed. The shot was completely painless but 20-30 minutes after vaccination, the patient had site pain soreness, stiffness and all over body aches and muscle stiffness. The patient was feeling generally not well and flushed, was by skin with no rash and had scratchy throat but no swelling or otherwise allergic reaction. The patient received treatment for the reported events and blood pressure was examined and observed for 45 minutes. 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 feeling flushed, hot flashes, chest tight, chest sharp pain, tinnitus, vaccination site pain, stiffness, body aches, feeling unwell and scratchy throat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling face
Clinical narrative: Headache; Face swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 08:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to tree nuts and coconut. The concomitant medications included prednisone (MANUFACTURER UNKNOWN),SINGULAIR, CLARINEX and Metoprolol (MANUFACTURER UNKNOWN) for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 25Feb2021 at 08:45 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had tested positive for COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 09.45, the patient experienced headache within hour of vaccination and on 18Mar2021 face swollen in the morning after vaccine. Therapeutic measures were taken with ice and Tylenol for the reported events. The clinical outcome of the event headache and face swollen face were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Swollen tongue
Clinical narrative: Strange taste in my mouth; My tongue and lower lip was tingling; My tongue was swelling and it did not feel normal; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported, Expiry date: unknown, Age at the vaccination: 73-year-old), via an unspecified route of administration in Arm Left on 17Mar2021 17:15 as dose 1, single for covid-19 immunization at pharmacy or drug store. Medical history included diabetes, lots of allergies, Anaphylactic attacks due to Sulfa, Erythromycin and penicillin. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE; SITAGLIPTIN]) at 50/1000 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient reported, within 1-2 minutes from the injection, strange taste in mouth, waited 25 min and went home at which time her tongue and lower lip was tingling. At that time, she had to go to ER because her tongue was swelling, and it did not feel normal. Treatment received was at hospital the doctor gave her Benadryl 50 mg, Prednisone 20 mg, 3 times a day (total 60 mg per day) and Pepcid 20mg twice daily for 3 days all of them. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 was no. Outcome of events was recovering.  Information on the lot/batch number had been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstrual disorder, Pain
Clinical narrative: Dull headache, bad body aches, very tired, my periods became very very heavy.; Dull headache, bad body aches, very tired, my periods became very very heavy.; Dull headache, bad body aches, very tired, my periods became very very heavy.; Dull headache, bad body aches, very tired, my periods became very very heavy.; This is a spontaneous report from a contactable consumer. This 46-Year-Old female consumer reported for herself, a 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 11:30 (age at the time of vaccination was 46-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); biotin (BIOTIN); ubidecarenone (COQ-10); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) (all concomitant medications) was taken for an unspecified indication, start and stop date was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 02:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported by the patient that she experienced dull headache, bad body aches, very tired, my periods became very very heavy on 19Mar2021 01:00. No treatment was received for all the events. Outcome of all the events was reported as recovering. No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: nausea; vomiting; Achy; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration in arm left on 19Mar2021 17:15 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to food, medication or other products. Since the vaccination, the patient had not been tested for COVID-19. Patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. On 19Mar2021 at 22:30, the patient experienced nausea, vomiting and achy. The patient did not receive any treatment for the events. The outcome of the events nausea, vomiting and pain was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.  Amendment (DSU) (28Jun2021): This follow-up report was being submitted to amend previously reported information: Dose description was updated from UNKNOWN DOSE NUMBER, SINGLE to DOSE NUMBER UNKNOWN, SINGLE. Event headache was deleted and updated as vomiting since source not reported headache as event per source event field adverse event nausea, vomiting, achy were updated. Event occurred country updated from UK to US for event Achy. Lead sentence updated as "This is a spontaneous report received from a contactable consumer to add word contactable".  Narrative sentence the patient did not have symptoms associated with COVID-19. Removed previously not reported on source. Narrative sentence Since the vaccination, the patient had not been tested positive for COVID-19 updated as Since the vaccination, the patient had not been tested for COVID-19. Narrative sentence the patient was treated with any medication for the events. Updated as the patient was not treated with any medication for the events. Final sentence updated as No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Chills; Nausea; Low grade fever; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old female (non-pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration on the left arm on 19Mar2021 at 12:00 (at the age of 51 years), as a single dose for COVID-19 immunisation. Patient medical history included COVID-19. Patient concomitant medication included vitamin D (MANUFACTURER UNKNOWN) and armour/thyroid (MANUFACTURER UNKNOWN) for unknown indications from unknown date. The Patient did not have any allergies to medications, food, or other products. No known allergies ware reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccintion. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient experienced sore arm, chills, nausea, low grade fever and headache on on Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of sore arm, chills, nausea, low grade fever and headache was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in both ears; This is a spontaneous report received from a non-contactable consumer, the patient. An adult patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 25Feb2021, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, the patient experienced ringing in both ears. The patient did not receive any treatment for the event ringing in both ears. The clinical outcome of the event ringing in ears was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information:Patient initials updated from "PRIVACY" to "UNKNOWN". Relevant Med History: None added. Final sentnence was updated from "Information about lot/batch number cannot be obtained.   No further information is expected." as "No follow-up attempts are needed; information about lot/batch number cannot be obtained."
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Obstructive airways disorder, Oropharyngeal discomfort, Pharyngeal swelling
Clinical narrative: went to sleep and woke up with slight breathing problems.She adjusted sleeping position went back to sleep and the same occurred again. She awoke with breathing problems.; After adjusting the sleeping position again, the patient woke up with a closed throat and no air at all; Breathing returned after a few seconds, Patient stayed awake, and about ten mins later, throat closed and breathing stopped briefly again.; adjusting the sleeping position again, the patient woke up  with a closed throat and no air; She had some redness on the chest; swollen throat; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: 195518-06399, Pfizer NTEC), via an unspecified route of administration, administered in right arm on 19Mar2021 14:15 (at the age of 54-year-old, non-pregnant) as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis. The had not allergies to medications, food, or other products but had allergic reactions to vaccines prior. Concomitant medications included prednisone taken for an unspecified indication, start and stop date were not reported. 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 had not been tested for COVID-19. It was reported that nine hours after the vaccine patient went to sleep and woke up with slight breathing problems. She adjusted sleeping position went back to sleep and the same occurred again. She awoke with breathing problems. After adjusting the sleeping position again, the patient woke up with a closed throat and no air at all. Breathing returned after a few seconds, Patient stayed awake, and about ten mins later, throat closed and breathing stopped briefly again. The patient went to the local emergency room at the hospital where they examined her. She had some redness on the chest, a slightly swollen throat and in order to reduce the swelling and to stop the breathing issues, the doctor administered Benedryl by injection and some steroids. The patient relaxed and returned to normal sleep within a short period of time- 30 minutes. The patient was fine today (as reported). The clinical outcome for the events was recovered on an unspecified date.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory arrest
Clinical narrative: went to sleep and woke up with slight breathing problems.She adjusted sleeping position went back to sleep and the same occurred again. She awoke with breathing problems.; After adjusting the sleeping position again, the patient woke up with a closed throat and no air at all; Breathing returned after a few seconds, Patient stayed awake, and about ten mins later, throat closed and breathing stopped briefly again.; adjusting the sleeping position again, the patient woke up  with a closed throat and no air; She had some redness on the chest; swollen throat; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: 195518-06399, Pfizer NTEC), via an unspecified route of administration, administered in right arm on 19Mar2021 14:15 (at the age of 54-year-old, non-pregnant) as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis. The had not allergies to medications, food, or other products but had allergic reactions to vaccines prior. Concomitant medications included prednisone taken for an unspecified indication, start and stop date were not reported. 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 had not been tested for COVID-19. It was reported that nine hours after the vaccine patient went to sleep and woke up with slight breathing problems. She adjusted sleeping position went back to sleep and the same occurred again. She awoke with breathing problems. After adjusting the sleeping position again, the patient woke up with a closed throat and no air at all. Breathing returned after a few seconds, Patient stayed awake, and about ten mins later, throat closed and breathing stopped briefly again. The patient went to the local emergency room at the hospital where they examined her. She had some redness on the chest, a slightly swollen throat and in order to reduce the swelling and to stop the breathing issues, the doctor administered Benedryl by injection and some steroids. The patient relaxed and returned to normal sleep within a short period of time- 30 minutes. The patient was fine today (as reported). The clinical outcome for the events was recovered on an unspecified date.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Burning sensation on the right hand; Sudden rash on the right hand; Itching sensations on the right hand; This is a spontaneous report received from a contactable healthcare professional, the nurse. A 42-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: EP6955) via intramuscular route in left arm on 19Mar2021 at 11:45(at the age of 42 years) as single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history reported as none. 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. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks prior to the vaccination. The patient experienced burning sensation on the right hand, sudden rash on the right hand, and itching sensations on the right hand on 20Mar2021 at 02:00. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events burning sensation, rash and pruritus was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Medical history captured as None in patient tab; patient age updated as 42 years old per source; facility name captured.Verbatim updated as "Since the vaccination, the patient had not been tested for COVID-19" in narrative.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular pain, Vasodilatation
Clinical narrative: veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes; veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 21Mar2021 (at the age of 44-years) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was not allergic to medications, food, or other products. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN). The patient previously received unknown dose unspecified Pfizer vaccine via an unspecified route of administration on an unspecified date for immunization. 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 21Mar2021 at 16:00, the patients veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes. The patient did not receive any treatment for these 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 veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes was recovered on 21Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country captured ; patient's information was captured; for relevant med history#1, the verbatim was updated as High blood pressure; final sentence updated; dose number leave blank, dose description captured as DOSE NUMBER UNKNOWN, SINGLE; historical vaccine was deleted; narrative updated and start date and stop date of SD updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: Pain/heaviness in left arm; Sweats; Chills; Diahrea; Nausea; Weakness; Fatigue for 3 weeks; This is a spontaneous report received from a contactable health care professional (patient). This is the 1st of 2 reports, for the 1st dose. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration on the left arm on 07Jan2021 at 17:00, as single dose for COVID-19 immunisation (age at vaccination 60-years-old). Medical history was reported as asthma, hypothyroidism, neuro damage in spine and wrists, vertigo, migraines (none in past 5-6 years), arthritis, and mood disorder. Concomitant medications included bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); paliperidone; valproate semisodium (DEPAKOTE). The patient previously took Darvon [dextropropoxyphene hydrochloride] and was allergic to it.  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 did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Jan2021 at 14:00, the patient experienced pain/heaviness in left arm, sweats, chills, diarrhea, nausea (nausea for 3 days), weakness, and fatigue (fatigue for 3 weeks). The patient received treatment for the reported events as an injection of a medication with high NSAID (non-steroidal anti-inflammatory drugs) levels. Patient visited the doctor or other healthcare professional office/clinic visit for adverse event. The events outcome were recovered with sequalae.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Pain/heaviness in left arm; Sweats; Chills; Diahrea; Nausea; Weakness; Fatigue for 3 weeks; This is a spontaneous report received from a contactable health care professional (patient). This is the 1st of 2 reports, for the 1st dose. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration on the left arm on 07Jan2021 at 17:00, as single dose for COVID-19 immunisation (age at vaccination 60-years-old). Medical history was reported as asthma, hypothyroidism, neuro damage in spine and wrists, vertigo, migraines (none in past 5-6 years), arthritis, and mood disorder. Concomitant medications included bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); paliperidone; valproate semisodium (DEPAKOTE). The patient previously took Darvon [dextropropoxyphene hydrochloride] and was allergic to it.  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 did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Jan2021 at 14:00, the patient experienced pain/heaviness in left arm, sweats, chills, diarrhea, nausea (nausea for 3 days), weakness, and fatigue (fatigue for 3 weeks). The patient received treatment for the reported events as an injection of a medication with high NSAID (non-steroidal anti-inflammatory drugs) levels. Patient visited the doctor or other healthcare professional office/clinic visit for adverse event. The events outcome were recovered with sequalae.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain in extremity
Clinical narrative: extreme, ongoing pain in left arm, shoulder, neck and top of back; extreme, ongoing pain in left arm, shoulder, neck and top of back; extreme, ongoing pain in left arm, shoulder, neck and top of back; extreme, ongoing pain in left arm, shoulder, neck and top of back; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration, in the left arm on 19Mar2021 as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On unknown date in Mar2021, the patient experienced extreme, ongoing pain in left arm, shoulder, neck and top of back, not subsiding with Tylenol or Advil. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL or ADVIL. The clinical outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information. For all events: Term updated as "extreme, ongoing pain in left arm, shoulder, neck and top of back" per source reported; Onset Date captured as "Mar2021" per vaccination date=19Mar2021 and PRD=22Mar2021. Event's Coding "Pain in arm" updated as "Painful L arm" per MedDRA. Initial information need review: adverse event: extreme, ongoing pain in left arm, shoulder, neck and top of back, not subsiding with Tylenol or Advil. If patient recovered: Not recovered. Final sentence "Information about lot number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained."
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Lip swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Immediate allergic reaction after vaccine; lip swelling; swollen lymph node under chin/lymph node under left armpit was extremely swollen, formed a large bump and was still swollen; hard to swallow; racing heart; lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 26Feb2021 18:45 (at the age of 29-year-old, Batch/Lot Number: EN6202) at arm left as single dose for COVID-19 immunisation. The patient previously took minocycline and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with or tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications taken in two weeks included: ashwaganda gummies and botulinum toxin type A (BOTOX) for forehead 1 week prior. The patient experienced immediate allergic reaction after vaccine including lip swelling, swollen lymph node under chin, hard to swallow, racing heart. Next day lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later. All events started on 05Mar2021 18:15 (as reported, pending clarification) and were serious due to medically significant. The events resulted in doctor or other healthcare professional office/clinic visit. Diphenhydramine hydrochloride (BENADRYL) taken as treatment. The patient received second dose of BNT162B2 on 19Mar2021 18:15 (at the age of 29-year-old, Batch/Lot Number: EN6207) at arm left as single dose. The outcome of all the events was not recovered.  Follow-up attempts are possible. Further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Immediate allergic reaction after vaccine; lip swelling; swollen lymph node under chin/lymph node under left armpit was extremely swollen, formed a large bump and was still swollen; hard to swallow; racing heart; lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 26Feb2021 18:45 (at the age of 29-year-old, Batch/Lot Number: EN6202) at arm left as single dose for COVID-19 immunisation. The patient previously took minocycline and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with or tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications taken in two weeks included: ashwaganda gummies and botulinum toxin type A (BOTOX) for forehead 1 week prior. The patient experienced immediate allergic reaction after vaccine including lip swelling, swollen lymph node under chin, hard to swallow, racing heart. Next day lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later. All events started on 05Mar2021 18:15 (as reported, pending clarification) and were serious due to medically significant. The events resulted in doctor or other healthcare professional office/clinic visit. Diphenhydramine hydrochloride (BENADRYL) taken as treatment. The patient received second dose of BNT162B2 on 19Mar2021 18:15 (at the age of 29-year-old, Batch/Lot Number: EN6207) at arm left as single dose. The outcome of all the events was not recovered.  Follow-up attempts are possible. Further information is expected.