chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Constant heart ach/discomfort for 5 days, fatigue, shortness of breath at night.; Constant heart ach/discomfort for 5 days, fatigue, shortness of breath at night.; Constant heart ach/discomfort for 5 days, fatigue, shortness of breath at night.; Constant heart ach/discomfort for 5 days, fatigue, shortness of breath at night; This is a spontaneous report from a contactable consumer. A 37-year-old male consumer (patient) reported for himself that a 37-years-old male patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: unspecified), (at the age of 37-years-old) via an unspecified route of administration on 22May2021 at 11 am on left arm as unknown, single dose for COVID-19 immunisation. The patient' medical history included high cholesterol. She had no known allergies. The concomitant medications were not reported. No other vaccine and medications were received in respectively four weeks and two weeks. No vaccination prior to covid vaccination. Post vaccination covid tested not performed. The patient experienced heart ache or discomfort for 5 days, fatigue and shortness of breath at night on 03Jun2021. Events resulted in Emergency room visit. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Heavy menstrual bleeding, Muscle spasms
Clinical narrative: Constant menstrual bleeding/spotting since April 24 2021. Goes between spotting and extreme bleeding.; Pelvic pain; Lower back pain; Fatigue; Cramping; some Lightheadedness; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8729), via an unspecified route of administration at left arm on 09Apr2021 as single dose for covid-19 immunisation. The patient's medical history included Hashimotos, Migraine, anxiety and Sleep apnea. Concomitant medications included levothyroxine sodium; gabapentin; topiramate and cefalexin monohydrate (LEXIPRON). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm (at the age of 44-year-old) on 19Mar2021 as single dose for covid-19 immunisation. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since the vaccination. On 24Apr2021, the patient experienced constant menstrual bleeding/spotting, goes between spotting and extreme bleeding, pelvic pain, lower back pain, fatigue, cramping, some light-headedness. The patient visits to the clinic for the event. The outcome of all the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain
Clinical narrative: Constant menstrual bleeding/spotting since April 24 2021. Goes between spotting and extreme bleeding.; Pelvic pain; Lower back pain; Fatigue; Cramping; some Lightheadedness; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8729), via an unspecified route of administration at left arm on 09Apr2021 as single dose for covid-19 immunisation. The patient's medical history included Hashimotos, Migraine, anxiety and Sleep apnea. Concomitant medications included levothyroxine sodium; gabapentin; topiramate and cefalexin monohydrate (LEXIPRON). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm (at the age of 44-year-old) on 19Mar2021 as single dose for covid-19 immunisation. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since the vaccination. On 24Apr2021, the patient experienced constant menstrual bleeding/spotting, goes between spotting and extreme bleeding, pelvic pain, lower back pain, fatigue, cramping, some light-headedness. The patient visits to the clinic for the event. The outcome of all the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia, Vaccination site haemorrhage
Clinical narrative: slight "numbness and tingling" in bilateral arms and legs; slight "numbness and tingling" in bilateral arms and legs; they punctured her vessel with the vaccine with some heavy bleeding; slight chest tightness; This is a spontaneous report from a contactable other health care professional. A 26-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EW0217, brand: Pfizer), via intramuscular route of administration, administered in arm right on 12Jun2021 14:00 (at the age of 26-year-old) at 1st dose, single dose for covid-19 immunization. Medical history included Autoimmune disorder (Sjorgen), Boils, GERD (Gastrooesophageal reflux disease). Patient was allergic to Sulfa drugs, Latex, Bactrim, Environmental. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (which the patient received within 2 weeks of vaccination) included pantoprazole; cetirizine; xylometazoline hydrochloride (NASAL SPRAY II); aluminium hydroxide, magnesium hydroxide (MYLANTA SIMPLE); dupilumab (DUPIXENT); doxycycline. The patient received their first vaccine on 12Jun2021 at name. The patient stated they punctured her vessel with the vaccine with some heavy bleeding that resolved after several minutes. Then after 10 minutes complained of slight chest tightness but after 30 minutes symptoms subsided. The patient stated that at 4 am on 13Jun2021, experienced slight "numbness and tingling" in bilateral arms and legs. States it feels like when your feet just waking up. Patient did not receive treatment for the adverse event. Outcome of the events slight "numbness and tingling" in bilateral arms and legs was resolving and the events punctured her vessel with the vaccine with some heavy bleeding, slight chest tightness was resolved on 12Jun2021.  Information on Lot/Batch number is available; Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's grandmother) reported for a female patient (reporter's granddaughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as a 1st dose, single dose for COVID-19 immunization on unspecified date. The patient experienced joint pain on an unspecified date. It was reported that she was reporting her own symptoms after the Pfizer Covid 19 vaccine and mentioned that her granddaughter had experienced joint pain after the second shot. Her granddaughter got the Pfizer vaccine as well. Stated that her granddaughter and had other issues. She just kept telling her granddaughter that they got spoiled with the first one. The outcome of the event was reported as unknown.  Information on the lot/batch, further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dry mouth, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; Pain in arm; Dry mouth; a little headache; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unspecified, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in right arm on 20Jan2021 at 12:00 as 1st dose, single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unspecified, Expire Date: unknown) via an unspecified route of administration, administered in right arm on 12Feb2021 at 19:00 (at the age of 45-year-old) for COVID-19 immunization. The patient' medical history included former smoker; Verbatim: she used to smoke before, so she was a former smoker and high Prolactin; Verbatim: At that time, she had, high Prolactin and does not think she was on medication at that time. The family medical history reported as none. The prior Vaccinations within 4 weeks was reported as none. Additional Vaccines was not administered on same date of the Pfizer suspect. Concomitant medication(s) included gabapentin (GABAPENTIN) (Lot number: unknown, Expiry date: Discard after 30Apr2022) as 300 mg, 3x/day and Patient stopped taking it maybe 2 months ago. She does not think she was taking it even 3 months. She got tired of took it because she did not saw any improvement and bromocriptine (BROMOCRIPTINE) taken for high prolactin, as 2.5 mg, 1x/day with ongoing, she was taking this now but does not recall if she was taking this prior to the COVID-19 vaccine. On 21Jan2021, the patient experienced pain in arm, dry mouth, a little headache. On 24May2021, the patient had COVID-19 positive. 07Jun2021, Monday, the patient went back for a test again and it was negative. She stated that, she had 2 kids. She was scared of COVID-19 and wanted to be secure and safer. At that time, she had, high Prolactin and does not think she was on medication at that time. Maybe, she was not too sure. She could not recall if she was taking Bromocriptine, she was taking it now. She stated that the only side effect she had was pain in her arm for the first dose, and dry mouth and a little headache. It started the next day and lasted only one day. The patient underwent lab tests and procedures which included COVID-19 test: positive on 24May2021 and COVID-19 test: negative on 07Jun2021. Patient was not received treatment for the adverse event. The outcome of the event tested positive for COVID-19 was recovered on 07Jun2021, all other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Movement disorder
Clinical narrative: Felt like she'd been hit by a truck; couldn't move; This is a spontaneous report from a contactable consumer. This Female consumer (patient) reported that a female patient of unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW0179), via unspecified route, on 08Jun2021 as 2nd dose, single dose for covid-19 immunization. The patient received historical vaccine bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW0179), via unspecified route, on 18May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were not reported. The patient stated that they all got the second shot on Tuesday, 08Jun2021 and waited 15 minutes, also stated that after first time they made them wait for 30 minutes but the second time it was 15 minutes. She stated on Wednesday, she felt like she'd been hit by a truck and said she couldn't move and took Flu Dayquil, went to bed, said they gave her some food, and she was ok in the afternoon. Caller stated she stopped the paramedic in the middle of the road, and they took her wife and mother to the hospital, they asked her if she was ok. Caller said she was fine and to worry about them. Caller stated her mom was swelled and her wife. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site urticaria, Pain in extremity, Vaccination site pruritus
Clinical narrative: I got just one hive on my arm and it itches and hurts; I got just one hive on my arm and it itches and hurts; I got just one hive on my arm and it itches and hurts; This is a spontaneous report from a contactable consumer (patient). A 43-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0182, Expiration Date: 31Aug2021), via an unspecified route of administration in the left arm on 10Jun2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced just one hive on arm, and it itches and hurts on 11Jun2021. He wanted to know if he can take Benadryl or Claritin as treatment. The patient's second dose vaccine shot due date on 03Jul2021. The outcome of the events was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. This is the one of 4 reports from the same reporter. A 57-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Lot# and expiration date were not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 as SINGLE DOSE for COVID-19 immunization. Concomitant medication included VITAMIN D. He did not take any other medications. The patient medical history was not reported. It was reported that, he received his first dose 01Apr2021, and had mild pain in left arm on the same day. It was nothing bad and improved. The outcome of event was reported as resolving. Follow-up attempts are possible. Further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: He woke up in the middle of the night and felt like he got punched in the left arm. It really hurt; Fever; headache; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6209, expiration date: unknown), intramuscularly in the left arm on 22Apr2021, as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patients concomitant medication included calcium carbonate, colecalciferol (VITAMIN D 2000) for unspecified indications (start and stop date were not reported). Historical vaccination included patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number was not reported) via in tramuscularly in the Arm left on 01Apr2021, as a single dose for COVID-19 immunization.  After vaccination the patient experienced pain in extremities. On 22Apr2021, the patient stated that he woke up in the middle of the night and felt like he got punched in the left arm.  It really hurt. On an unspecified date in Apr2021, that patient experienced fever and headache and he stayed home that Friday. By that evening, he felt better. The next morning, he was 100% better.  He felt so great, he went for a really long bike ride.  All the events were non-serious. The outcome of the event pain in extremity was recovering. The outcome of the events fever and headache was recovered on an unspecified date in the Apr2021.   No follow-up attempts are possible; Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Aphasia
Clinical narrative: aphasia; This is a spontaneous report from a non-contactable consumer (a patient family member or friend), based on information received by Pfizer. This case was split from master case #2021689327 for a male patient taking COVID-19 vaccine and experienced aphasia.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient medical history included PE (pulmonary embolism), started from 2010 and unknown if ongoing. Concomitant medications were not reported. The patient previously took warfarin sodium for clot blood (started from 2010 and unknown if ongoing). The patient experienced aphasia on an unspecified date. The outcome of the event was unknown.   Follow up not performed as no contact information available.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Inflammation, Pain, Pyrexia
Clinical narrative: Arm doesn't feel normal, I feel like I'm getting some inflammation at the place where I got the shot; Fever symptoms; Feel very weak; Headache, getting a bit stronger; Fingers I feel like I'm getting some feelings of inflammation going down from my arm to my fingers; Arm was getting weak; My arm swell and I kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when I'm driving the car; Arm was getting weak; My arm swell and I kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when I'm driving the car; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported) dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date at first dose single dose for covid-19 immunisation and experienced arm was, felt like it swell. On an unspecified date the patient experienced arm doesn't feel normal, I feel like  getting some inflammation at the place where  got the shot, fever symptoms, feel very weak, headache, getting a bit stronger, fingers I feel like I am getting some feelings of inflammation going down from my arm to my fingers, arm was getting weak; my arm swell and i kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when i'm driving the car. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site inflammation
Clinical narrative: Arm doesn't feel normal, I feel like I'm getting some inflammation at the place where I got the shot; Fever symptoms; Feel very weak; Headache, getting a bit stronger; Fingers I feel like I'm getting some feelings of inflammation going down from my arm to my fingers; Arm was getting weak; My arm swell and I kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when I'm driving the car; Arm was getting weak; My arm swell and I kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when I'm driving the car; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported) dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date at first dose single dose for covid-19 immunisation and experienced arm was, felt like it swell. On an unspecified date the patient experienced arm doesn't feel normal, I feel like  getting some inflammation at the place where  got the shot, fever symptoms, feel very weak, headache, getting a bit stronger, fingers I feel like I am getting some feelings of inflammation going down from my arm to my fingers, arm was getting weak; my arm swell and i kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when i'm driving the car. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: his right arm started to have a problem where he could not use longer it; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program.   A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as 1st single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that he was done with the two doses of the Pfizer vaccine BNT162B2. The patient reported that after a month of getting the first dose, his right arm started to have a problem where he could not use longer it. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Bump; broke out into rash; This is a spontaneous report from a contactable consumer (patients mother). This is report 3 of 3. A 47 years old female patient received bnt162b2 (solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced bump and broke out into a rash and bump with the first shot. The patient was fine later. The outcome of the events was recovered on an unknown date.  information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: After getting my first shot my arm was, felt like it swell which is normal; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after getting my first shot my arm was, felt like it swell which is normal. Consumer stated, "Ok, so what happened is after I got my COVID Vaccine technically is that when I got to feel like my arm was getting weak which is normal. What happened was after getting my first shot my arm was, felt like it swell which is normal but everything was kind of like okay, after 2 or 3 days my arm was kind of like okay, everybody was like it's going to go away. The clinical outcome of the after getting my first shot my arm was, felt like it swell which is normal as recovered.  Further information could not be probed as the consumer was unwilling to share any further information. Hence limited information available over the call.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling; This is a spontaneous report received from a contactable consumer. This consumer (Patient's wife) reported for a patient (Reporter's husband) that:  The male patient of unspecified age received bnt162b2 ( solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling due to the vaccination. At the time of reporting, the outcome of event was  unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mass
Clinical narrative: Marble sized lump above clavicle; lump right above his collar bone from on the same arm that he had the vaccine; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer Sponsored Program COVAX US Support.   A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration on an unspecified date (at the age of 15 year old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 of BNT162B2 for COVID-19 immunization and no reaction on previous exposure to vaccine. On an unspecified date, the patient experienced marble sized lump above clavicle and lump right above his collar bone from on the same arm that he had the vaccine. Seriousness of the event was provided as unspecified. NDC and UPC number was unknown. It was reported that the patient (reporter's son) has received his second vaccine of the Pfizer COVID dose on Tuesday and he has since developed a marble sized lump above his clavicle and right above his collar bone from on the same arm that he had the vaccine and reporter was wondering if that was normal and if there was anything that she should do for it. Reporter informed that she is going to call the number and take care of her son first unless Medical information department away to connect her there faster. Outcome of the events were unknown.  Follow-up attempts are possible. Information about batch no/lot no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: She got a cyst on her like a its a lymph node swollen; This is a spontaneous report from a contactable consumer or other non-health care professional. This consumer (patient's parent) reported for a female patient (reporter daughter) that a female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the patient received vaccine she got a cyst on her like a its a lymph node swollen and then they went to the emergency room and they told that they have to call that number to report this, so reporter calling just to report. The outcome of event was unknown.  Information on the lot/batch, further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration, administered in right arm on 10Jun2021 15:09 (Batch/Lot number: EW0187) (age at time of vaccination) as single dose for COVID-19 immunization. The patient took the Pfizer COVID-19 Shot as she did not want to get COVID-19 and too many people were dying. Vaccination Facility Type: Other, please specify: Clarified as the racetrack. The patient's medical history included ongoing asthma (20 something years ago), ongoing sleep apnea (20 something years ago), ongoing diabetes (20 something years ago), ongoing chronic obstructive pulmonary disease (COPD) (20 something years ago), ongoing blood pressure high (20 something years ago) and ongoing heart condition (20 something years ago). Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at the age of 49-year-old) administered in right arm on 27 May 2021 (Lot number: EN6199, NDC number: Not provided, Expiry date: Unknown) as single dose (exact dose unknown) for COVID-19 immunization. On an unspecified date in June 2021, the patient experienced body aches, throwing up, tired, fever and chills. Yesterday, 10Jun2021 she got her last COVID-19 shot. She mentioned she was fine yesterday after getting the shot, but at some point while sleeping sometime between 10Jun2021 and 11Jun2021 she had body aches, throwing up, was tired, had a fever with a temperature of 100.7, and chills. She mentioned that events could have happened after midnight. All she knows was when she woke up in the morning, she had the events. It hurt her to sit. She was rocking back and forth not wanting to throw up again. She confirmed they all started around same time. She questioned if it was part of the side effects from the vaccine. She commented she would rather have this than go have COVID-19. Outcome of events: She confirmed as unknown. She cannot tell at this time. She mentioned if it gets worse she will call back and go to the Emergency Room. She hoped it gets better, but she could not tell if it was better, worse, or same at this point. Outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration, administered in right arm on 10Jun2021 15:09 (Batch/Lot number: EW0187) (age at time of vaccination) as single dose for COVID-19 immunization. The patient took the Pfizer COVID-19 Shot as she did not want to get COVID-19 and too many people were dying. Vaccination Facility Type: Other, please specify: Clarified as the racetrack. The patient's medical history included ongoing asthma (20 something years ago), ongoing sleep apnea (20 something years ago), ongoing diabetes (20 something years ago), ongoing chronic obstructive pulmonary disease (COPD) (20 something years ago), ongoing blood pressure high (20 something years ago) and ongoing heart condition (20 something years ago). Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at the age of 49-year-old) administered in right arm on 27 May 2021 (Lot number: EN6199, NDC number: Not provided, Expiry date: Unknown) as single dose (exact dose unknown) for COVID-19 immunization. On an unspecified date in June 2021, the patient experienced body aches, throwing up, tired, fever and chills. Yesterday, 10Jun2021 she got her last COVID-19 shot. She mentioned she was fine yesterday after getting the shot, but at some point while sleeping sometime between 10Jun2021 and 11Jun2021 she had body aches, throwing up, was tired, had a fever with a temperature of 100.7, and chills. She mentioned that events could have happened after midnight. All she knows was when she woke up in the morning, she had the events. It hurt her to sit. She was rocking back and forth not wanting to throw up again. She confirmed they all started around same time. She questioned if it was part of the side effects from the vaccine. She commented she would rather have this than go have COVID-19. Outcome of events: She confirmed as unknown. She cannot tell at this time. She mentioned if it gets worse she will call back and go to the Emergency Room. She hoped it gets better, but she could not tell if it was better, worse, or same at this point. Outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: illness/I was sick; This is a spontaneous report from contactable consumer. This consumer (patient) reported.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date in Feb2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was ill. The patient received Pfizer first vaccine in February but due to illness not able to received second shot. The reporter wanted to know can I receive second. will it be starting all over again because it's been quite a while since February and now we already into June." There was something, nothing to do with this covid or anything. Patient also wants to know can receive second shot. Will it be starting all over again because it's been quite a while since February and now already into June. The patient was referred Pfizer Medical Information for further guidance. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: This is a spontaneous report from a contactable consumer. A contactable consumer (Patients mother)reported that a 15-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, lot: EW0178) via unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. the patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunization. Reporter stated, her 15 years old had his 2nd Pfizer Vaccine on Tuesday. He has developed a marble size lump above his collar bone, and she don't know whether she need, was it dangerous, a problem, does she need to seek medical attention. she doesn't know how to proceed. Reporter stated, she just wanted to talk to somebody to know whether she need to do something about this reaction please. Outcome of the event was unknown. No follow-up attempts possible. No further information expected. Information on the lot/ batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 100.4; This is a spontaneous report from a contactable consumer or other non hcp (Patient's father). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217 and expiration date was not given), via an unspecified route of administration on 10Jun2021, as 2nd dose, single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not given) for COVID-19 immunisation on an unspecified date. On 11Jun2021 patient experienced fever of 100.4. It was reported that, the reporter enquired My daughter got the second dose of the Pfizer on Thursday and today she has a fever of 100.4 and I was wondering if she could take Aleve. The patient underwent lab tests and procedures which included body temperature: 100.4 on 11Jun2021. The outcome of the event was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling drunk, Gait inability
Clinical narrative: Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my face; 'Swollen' face; Don't feel good; Dizzy; I am weak, if you look into my eyes I look I am really sick; I am tired; Headache; Sick; can not even speak; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP.   A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Jun2021 11:00 (at the age of 51-years-old) as first dose single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On 12Jun2021, the patient experienced heart since beating really very fast, cannot even speak, feel really drunk, also numbness in face, swollen face, don't feel good, dizzy, weak, tired, headache, sick and can't even walk. Patient had some side effects from the shot today. Got the first dose this morning, since then her heart beating really very fast throughout the day, she actually felt really drunk, she cannot even speak to you, cannot even walk, she was out of it. Consumer stated, that was not worrying, she did not feel good, she did not really feel very good (voice not clear). She was tired, had a headache, her face was like either swollen or numb, she was dizzy, she was weak, she told that if someone look into her eyes, she looked like she was really sick, she can hardly even walk, felt like she drunk. The patient underwent lab tests and procedures which included heart rate: fast on 12Jun2021.The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hypoaesthesia, Illness
Clinical narrative: Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my face; 'Swollen' face; Don't feel good; Dizzy; I am weak, if you look into my eyes I look I am really sick; I am tired; Headache; Sick; can not even speak; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP.   A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Jun2021 11:00 (at the age of 51-years-old) as first dose single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On 12Jun2021, the patient experienced heart since beating really very fast, cannot even speak, feel really drunk, also numbness in face, swollen face, don't feel good, dizzy, weak, tired, headache, sick and can't even walk. Patient had some side effects from the shot today. Got the first dose this morning, since then her heart beating really very fast throughout the day, she actually felt really drunk, she cannot even speak to you, cannot even walk, she was out of it. Consumer stated, that was not worrying, she did not feel good, she did not really feel very good (voice not clear). She was tired, had a headache, her face was like either swollen or numb, she was dizzy, she was weak, she told that if someone look into her eyes, she looked like she was really sick, she can hardly even walk, felt like she drunk. The patient underwent lab tests and procedures which included heart rate: fast on 12Jun2021.The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Speech disorder, Swelling face
Clinical narrative: Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my face; 'Swollen' face; Don't feel good; Dizzy; I am weak, if you look into my eyes I look I am really sick; I am tired; Headache; Sick; can not even speak; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP.   A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Jun2021 11:00 (at the age of 51-years-old) as first dose single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On 12Jun2021, the patient experienced heart since beating really very fast, cannot even speak, feel really drunk, also numbness in face, swollen face, don't feel good, dizzy, weak, tired, headache, sick and can't even walk. Patient had some side effects from the shot today. Got the first dose this morning, since then her heart beating really very fast throughout the day, she actually felt really drunk, she cannot even speak to you, cannot even walk, she was out of it. Consumer stated, that was not worrying, she did not feel good, she did not really feel very good (voice not clear). She was tired, had a headache, her face was like either swollen or numb, she was dizzy, she was weak, she told that if someone look into her eyes, she looked like she was really sick, she can hardly even walk, felt like she drunk. The patient underwent lab tests and procedures which included heart rate: fast on 12Jun2021.The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: did not have too much side effects from the first dose of the Pfizer Covid-19 Vaccine, maybe a little tiredness; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, she did not have too much side effects from the first dose of the Pfizer Covid-19 Vaccine, maybe a little tiredness. She did not need this in her life; she had no expectation of it being this bad considering the first one was maybe a little tiredness. The patient was administered her second dose of Pfizer Covid-19 Vaccine On 11Jun2021. The outcome of event was unknown.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Too like Sore for the Arm; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received second dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 09Jun2021( at the age of 16-year-old) as Second dose ,SINGLE DOSE for covid-19 immunisation. The patients Medical history and Concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination. Patient's historical vaccine include first dose of BNT162B2 via intramuscular, administered in Arm Right (It was like 3 weeks before) for COVID-19 immunisation. On 10Jun2021 The patient experienced too like sore for the arm . Reporter stated, I am just calling because this past Wednesday when my son took the second dose of the Pfizer vaccine, but my son is too like Sore for the Arm . Reporter stated, it was started yesterday, and he just called us a little while ago and told that he was still having it in his right arm. Well, it started yesterday, and we noticed that from what he is telling is it is getting worse. he hasn't taken anything. That's why we were calling to see if we could give him some Ibuprofen. Therapeutic measures were not taken as a result of the events. The outcome of the event was reported as not recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Seasonal allergy, Throat irritation
Clinical narrative: its almost like seasonal allergy that she never had before; Nose is stuffed, she cannot really breath from her nose; Very itchy throat; she cannot really breathe from the nose; This is a spontaneous report from a contactable consumer (patients husband). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179), via an unspecified route of admin-istration on an unspecified date as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, the reporter stated for his wife that it almost like 3 weeks now that they did the vaccine and like the Pfizer vaccine, the second one and then the very next day after that she started with, it was almost like seasonal allergy that she never had before and her nose was stuffed on an unspecified date, she could not really breathe from the nose and she had a very itchy throat, very very itchy throat on an unspecified date. And she went to the doctor, they gave her some kind of medication like a Cortisone but it did not do nothing. So, it was almost a month now that she was like that, she could not really breathe from her nose and they tried to find out what they could do or if that was going to be permanent. Therapeutic measures were taken with drug cortisone as a result of the adverse events. The adverse events resulted physician office visit. The outcome for the events was not recovered.