chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: High fever; High headache; Feeling like coming down with the flu; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (age 68 unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization and did not have any kind of reaction or anything. The patient reported that after receiving the second dose of vaccine on an unknown date in Feb2021 she experienced high fever, headache and feeling like coming down with the flu. The reporter wanted to ask if it was normal. The patient did not have lot number at the time of report in hand since she has her granddaughter, so she said she will have to call back. The outcome of the events was unknown.   Information about lot/batch no. has been requested.   Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypoaesthesia
Clinical narrative: With in few minutes of having the injections administered  my face started getting numbed. I notify one of the workers from the park. Medic came to check me out to my blood pressure everything; This is a spontaneous report from a contactable other HCP, the patient. A 42-year-old female (unknown if pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EL9267) via an unspecified route of administration (Age at vaccination 42-year) in Right Arm on 02Mar2021 at 09:00 AM as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Thyroidectomy of the right side, bilateral hernia, right humerus metal rod surgeries; all from an unknown date and unknown if ongoing. Concomitant medications included thyroid NP 30 mg; ethinylestradiol, levonorgestrel (SEASONIQUE); both taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination was reported. The patient has not been tested for COVID, post vaccination. The patient has not received any other vaccine in four weeks. On 02Mar2021 at 09:00 AM, within few minutes of having the injection administered patient's face started getting numbed. Patient notified one of the workers from the park. Medic came to check patient's blood pressure, and everything seemed ok. Patient just could feel the face. Now almost 24 hours later patient still feel some parts of the face numbed. No treatment was received for the adverse event. The clinical outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: Approx. 12 hours after 2nd dose started experiencing chills then  sweating.  Fever ~102F; Fatigue; headache; minor body aches; chills; sweating; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received second dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 AM as DOSE 2, SINGLE for covid-19 immunisation (at the age of 39 years). The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 10 Feb2021 10:00 AM (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. On 01Mar2021 22:30 patient experienced approx. 12 hours after 2nd dose started experiencing chills then sweating. Fever 102F. Fatigue, headache, minor body aches. Fever lasted 36 hours. The patient was not received treatment medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Approx. 12 hours after 2nd dose started experiencing chills then  sweating.  Fever ~102F; Fatigue; headache; minor body aches; chills; sweating; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received second dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 AM as DOSE 2, SINGLE for covid-19 immunisation (at the age of 39 years). The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 10 Feb2021 10:00 AM (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. On 01Mar2021 22:30 patient experienced approx. 12 hours after 2nd dose started experiencing chills then sweating. Fever 102F. Fatigue, headache, minor body aches. Fever lasted 36 hours. The patient was not received treatment medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever 101.4; Injection sight pain; Headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el3247, patient was 50-year and not pregnant at th time of vaccination), via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 04:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin allergy, covid-19 prior vaccination. Concomitant medication(s) included naproxen sodium (ALEVE); ibuprofen (ADVIL [IBUPROFEN]); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL]) all taken within two weeks of vaccination. No other vaccine received in four weeks. No covid tested post vaccination. On 26Feb2021 at 11:00, the patient experienced fever 101.4, injection sight pain, headache. No treatment received for events. The patient underwent lab tests and procedures which included body temperature resulted as 101.4 on 26Feb2021. The outcomes of reported events were not recovered.  No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Erythema, Pain, Pain in extremity
Clinical narrative: Fever of 101; flush face; sick to my stomach; achy; Sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 3N6201), via an unspecified route of administration (at the age of 67-years), administered in arm right on 02Mar2021 at 12:30 as dose 2, single for COVID-19 immunization. Medical history included migraines from and known allergies- yes lots mostly sulfa based from an unknown date and unknown if ongoing. Concomitant medications included topiramate (TOPIRAMATE) taken as 50 mg x 3, amitriptyline hydrochloride (AMITRIPTYL.HCL BRISTOL MYERS) and levothyroxine sodium (THYROXINE) taken as 112 mcg for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration (at the age of 67-years), administered in arm right on 10Feb2021 at 12:15 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 03Mar2021 at 18:00, the patient experienced fever of 101, flush face, sick to my stomach, achy and sore arm. The treatment was received for all the adverse events with advil. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The facility type was reported as hospital. The clinical outcome for all the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101; flush face; sick to my stomach; achy; Sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 3N6201), via an unspecified route of administration (at the age of 67-years), administered in arm right on 02Mar2021 at 12:30 as dose 2, single for COVID-19 immunization. Medical history included migraines from and known allergies- yes lots mostly sulfa based from an unknown date and unknown if ongoing. Concomitant medications included topiramate (TOPIRAMATE) taken as 50 mg x 3, amitriptyline hydrochloride (AMITRIPTYL.HCL BRISTOL MYERS) and levothyroxine sodium (THYROXINE) taken as 112 mcg for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration (at the age of 67-years), administered in arm right on 10Feb2021 at 12:15 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 03Mar2021 at 18:00, the patient experienced fever of 101, flush face, sick to my stomach, achy and sore arm. The treatment was received for all the adverse events with advil. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The facility type was reported as hospital. The clinical outcome for all the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rash, Swelling
Clinical narrative: a fever that spiked up to 103°F; a rash that broke out; neck was swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported by the patient that after receiving the first dose of vaccine the patient experienced a rash that broke out, neck was swollen and a fever that spiked up to 103 degree Fahrenheit. The patient underwent lab tests and procedures which included body temperature which was spiked up to 103 degree Fahrenheit. The outcome of the event was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain in extremity, Sitting disability
Clinical narrative: tongue/face numb; tongue/face numb; Shaky/dizzy while sitting; reported arm pain; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3302), via intramuscular route of administration, administered in left arm on 20Jan2021 at 12:30 (at the age of 26-years-old) as dose 2, single for COVID-19 immunization in hospital. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) (Strength 0.25mg-0.35mcg) taken for an unspecified indication. It was unknown if the patient was pregnant at the time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el1284), via intramuscular route of administration, administered in left arm on 30Dec2020 at 10:00 as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no known allergies and other medical history was none. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccination. On 20Jan2021 at 12:30, the patient experienced tongue/face numb, shaky/dizzy while sitting and reported arm pain. Refused ED. The rapid response evaluated and the patient ambulated from cafeteria to home. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the events. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: my right cheek began feeling numb/ travelled up to my left temple, then later to my right temple and across my forehead. Later that night went across the top of my head; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 23Feb2021 17:45 as dose 1, single for covid-19 immunization at pharmacy or drug store. The patient medical history included high BP, thyroid. Concomitant medications included atenolol, l-thyroxine [levothyroxine], calcium carbonate (CALTRATE [CALCIUM CARBONATE]), all taken for unknown indications from an unknown date. Other medications received in two weeks included atenolol, L-Thyroxine, Caltrate, supplements. The patient previously took codeine and experienced allergies. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient has not been tested for covid. It was reported that, on 23Feb2021 at 18:30, within 1 hour of dose her right cheek began feeling numb. She liken the feeling to right after Dentist gave a shot of Nova Caine, that first numb feeling. The numbness remained in the cheek for approx 2 hours, travelled up to her left temple, then later to my right temple and across her forehead. Later that night went across the top of her head. It was gone the next morning, she would say it lasted 5-6 hours. No treatment was received for adverse event (AE). The outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable pharmacist (patient). A 42-years-old patient of an unspecified gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 02Mar2021 at 11:00 hours as dose 1, single (at the age of 42-years-old) for covid-19 immunisation. Patient had no known allergies and medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 02Mar2021, at around 18:00 hours, patient began getting some fever and chills. These symptoms were gone by next morning when patient woke up. Patient received no treatment for the events. Patient reported these symptoms on 03Mar2021 once patient felt much better. The outcome of the events was recovered on 03Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a sponsored program. A contactable female consumer reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. patient experienced arm pain after first dose. The patient medical history and concomitant medications were not reported.  On 24Feb2021, after the vaccination, the patient experienced fever. The event assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (14May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up at-tempts have been completed and no further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever; nausea; fatigue for 24 hours; headache (week); This is a spontaneous report from a contactable consumer, the patient. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 11:00 (at the age of 46-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm left on 18Jan2021 10:30 (at the age of 46-years-old) as a single dose for covid-19 immunization. The patient had allergies with codeine. The patient had no other vaccine within four weeks. 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 15Feb2021 18:00, the patient experienced fever, nausea, fatigue for 24 hours, headache (week). The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report.  Information about lot/batch number have been requested. Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeding disorder, Hypertension, Malaise, Mood swings
Clinical narrative: Unable to eat; food tastes bad; has been having weird episodes that he is unsure if it is anxiety or hypertension; has been having weird episodes that he is unsure if it is anxiety or hypertension; thoughts have been cloudy; has been feeling like total crap; This is a spontaneous report from a contactable consumer or other non-health care professional ( patient). A 56-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration (at the age of 56-years), administered in arm left on 24Feb2021 at 14:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, the patient experienced has been feeling like total crap. On 25Feb2021, experienced thoughts have been cloudy, has been having weird episodes that he is unsure if it is anxiety or hypertension. On 26Feb2021, experienced unable to eat, food tastes bad. Patient received the Covid-19 vaccine a couple of days an ago. and it was not doing too good. He received the vaccine at the hospital . He is having some bad side effects. He wants to make sure nothing is wrong with him. He has just moved to the area and does not have a doctor. For most of his life he does not even take aspirin. He was in pretty decent shape. For the past two days he has been feeling like total crap. His thoughts have been cloudy. He has not been able to eat. Food tastes bad. He has been having weird episodes that he is unsure if he is anxious or has hypertension. He is in perfect health. What does he do? This is crazy. Is there something that will make this go away? The events has been feeling like total crap, thoughts have been cloudy and has been having weird episodes that he is unsure if it is anxiety or hypertension was reported as worsened. The patient was taking Covid-19 vaccine for Covid protection. The adverse event did not required any emergency room and physician office. The vaccination facility type was hospital. The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Unable to eat; food tastes bad; has been having weird episodes that he is unsure if it is anxiety or hypertension; has been having weird episodes that he is unsure if it is anxiety or hypertension; thoughts have been cloudy; has been feeling like total crap; This is a spontaneous report from a contactable consumer or other non-health care professional ( patient). A 56-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration (at the age of 56-years), administered in arm left on 24Feb2021 at 14:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, the patient experienced has been feeling like total crap. On 25Feb2021, experienced thoughts have been cloudy, has been having weird episodes that he is unsure if it is anxiety or hypertension. On 26Feb2021, experienced unable to eat, food tastes bad. Patient received the Covid-19 vaccine a couple of days an ago. and it was not doing too good. He received the vaccine at the hospital . He is having some bad side effects. He wants to make sure nothing is wrong with him. He has just moved to the area and does not have a doctor. For most of his life he does not even take aspirin. He was in pretty decent shape. For the past two days he has been feeling like total crap. His thoughts have been cloudy. He has not been able to eat. Food tastes bad. He has been having weird episodes that he is unsure if he is anxious or has hypertension. He is in perfect health. What does he do? This is crazy. Is there something that will make this go away? The events has been feeling like total crap, thoughts have been cloudy and has been having weird episodes that he is unsure if it is anxiety or hypertension was reported as worsened. The patient was taking Covid-19 vaccine for Covid protection. The adverse event did not required any emergency room and physician office. The vaccination facility type was hospital. The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Feb2021 (Sunday) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Feb2021, the patient experienced fever and number of other symptoms. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever; joint and muscle pain; joint and muscle pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:02 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. Medical history included spine issues and car accident from 2003 to an unknown date (she had spine issues from a car accident she had in 2003. She said she had been medicating with CBD oil and medical marijuana for the past 3 years. No further details provided), fibromyalgia from an unknown date and unknown if ongoing (she has had Fibromyalgia for 30 years), knee arthroplasty from an unknown date and unknown if ongoing (she had both knees replaced about 5 years ago). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Expiry Date: Unknown), via intramuscular, administered in Arm Left (at the age of 66-year-old) on 10Feb2021 for COVID-19 immunisation and experienced knees got so stiff/both her knees have stayed stiff. Facility where the vaccination was given unknown. Vaccine was not administered at Military facility. Number of previous doses was none. Patient did not receive any additional vaccines administered on same date of the Pfizer suspect. Patient prior vaccinations (within 4 weeks) were none reported. Patient reported that she had a reaction to her second Pfizer COVID-19 Vaccine. She clarified since 10:00AM this morning 03Mar2021 she has had a fever, joint pain, muscle pain, chills, and a severe headache. She clarified she got her second COVID-19 Vaccine shot yesterday 02Mar2021 at 2:00PM. She said her side effects started around 20 hours after she received her second COVID-19 Vaccine. Patient said she wanted to know what the usual time frame was for the COVID-19 side effects to go away. Reported she took 2 Rapid Release Acetaminophen 500mg capsules at 10:00AM this morning 03Mar2021: NDC Number: #, Lot Number: P120450, Expiration Date: Jun2022. Reported after she received her first COVID-19 Vaccine 10Feb2021, her knees got so stiff. She said she had both of her knees replaced about 5 years ago. She said both her knees have stayed stiff since she received her first COVID-19 Vaccine dose. Patient did not visit emergency room and physician office. There was no investigation assessment and no relevant tests. Therapeutic measures were taken as a result of fever, joint and muscle pain, chills, headache. The clinical outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: fever; body aches; not feeling good; This is a spontaneous report received from a contactable consumer (Patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 24Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced fever, body aches and not feeling good. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: 48 hrs after injection experienced temp of 102 for 2 days; chills; body aches; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in right arm on 23Feb2021 10:30 pm (68-year-old at the time of vaccination) as dose number unknown, single for covid-19 immunisation. Medical history included Osteoarthritis, osteoporosis, small vessel disease from an unknown date and unknown if ongoing. The patient previously took Imitrex (IMITREX) and Toradol (TORADOL) and experienced allergy. The concomitant medications were reported as none. The patient had not received any vaccine within four weeks. The patient did not have COVID prior to vaccination. The patient was not tested since vaccination. On 25Feb2021 02:00 pm, 48 hrs after vaccination, the patient experienced temperature of 102 for 2 days with chills and body aches and headache. No treatment was received for the events. The outcome of the events were recovered on an unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Feeling abnormal, Hyperhidrosis
Clinical narrative: fever; sweats; rash; weak; BP dropped; cold sore; bumps on the roof of her mouth; sore throat; Body aches and pains; brain fog; lots of nausea; itching palms; This is a spontaneous report from a contactable consumer (patient's daughter). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry 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 orthostatic issues (we have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The reporter calling for her mother. The patient got a shot on Saturday. This was her second shot. The first round had a fair amount of side effects and this time she had fever, sweats, rash on an unspecified date. One thing starts and then moves to the next. She has been very weak. She felt heavy headed and felt like she should sit down. We have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119 which was a Potts like reaction and asked side effect you have heard of before. She woke up today with a cold sore, bumps on the roof of her mouth and a sore throat, body aches and pains, brain fog and lots of nausea, and itching palms. She had about a half cup of saltwater that made the nausea go away, but she hasn't been up and around. She took a couple of Tylenol. We our on day 4 1/2. The patient underwent lab tests and procedure included Blood pressure measurement 138 to 119 (normal range 90 to 120) on an unspecified date. Outcome of the event lots of nausea was recovered on an unspecified date and for all other events, it was unknown.  No follow-up attempts are possible; Information about lot/batch number can not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral disorder, Oral herpes, Oropharyngeal pain, Pain
Clinical narrative: fever; sweats; rash; weak; BP dropped; cold sore; bumps on the roof of her mouth; sore throat; Body aches and pains; brain fog; lots of nausea; itching palms; This is a spontaneous report from a contactable consumer (patient's daughter). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry 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 orthostatic issues (we have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The reporter calling for her mother. The patient got a shot on Saturday. This was her second shot. The first round had a fair amount of side effects and this time she had fever, sweats, rash on an unspecified date. One thing starts and then moves to the next. She has been very weak. She felt heavy headed and felt like she should sit down. We have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119 which was a Potts like reaction and asked side effect you have heard of before. She woke up today with a cold sore, bumps on the roof of her mouth and a sore throat, body aches and pains, brain fog and lots of nausea, and itching palms. She had about a half cup of saltwater that made the nausea go away, but she hasn't been up and around. She took a couple of Tylenol. We our on day 4 1/2. The patient underwent lab tests and procedure included Blood pressure measurement 138 to 119 (normal range 90 to 120) on an unspecified date. Outcome of the event lots of nausea was recovered on an unspecified date and for all other events, it was unknown.  No follow-up attempts are possible; Information about lot/batch number can not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: fever; sweats; rash; weak; BP dropped; cold sore; bumps on the roof of her mouth; sore throat; Body aches and pains; brain fog; lots of nausea; itching palms; This is a spontaneous report from a contactable consumer (patient's daughter). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry 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 orthostatic issues (we have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The reporter calling for her mother. The patient got a shot on Saturday. This was her second shot. The first round had a fair amount of side effects and this time she had fever, sweats, rash on an unspecified date. One thing starts and then moves to the next. She has been very weak. She felt heavy headed and felt like she should sit down. We have orthostatic issues in our family (Potts) Her BP dropped from 138 to 119 which was a Potts like reaction and asked side effect you have heard of before. She woke up today with a cold sore, bumps on the roof of her mouth and a sore throat, body aches and pains, brain fog and lots of nausea, and itching palms. She had about a half cup of saltwater that made the nausea go away, but she hasn't been up and around. She took a couple of Tylenol. We our on day 4 1/2. The patient underwent lab tests and procedure included Blood pressure measurement 138 to 119 (normal range 90 to 120) on an unspecified date. Outcome of the event lots of nausea was recovered on an unspecified date and for all other events, it was unknown.  No follow-up attempts are possible; Information about lot/batch number can not be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Heart rate increased
Clinical narrative: itching; headache; fatigue; redness; swelling; fever; chills; Bodu aches; Heart rate; injection site pain; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter sent in cross-referenced case. A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Feb2021 at 08:00 (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital clinic. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1485 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 21Dec2020 (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital clinic. Vaccine was not administered at Facility. On 05Feb2021 at 08:00, the patient experienced injection site pain. At 10:45, the patient had fever, chills, bodu aches, and heart rate. On 07Feb2021, the patient experienced redness and swelling. On 08Feb2021, the patient experienced itching, headache, and fatigue. On 28Feb2021, the patient diagnosed with covid-19. The patient underwent lab test and procedure included covid test-24HR: negative on 30Dec2020, covid quick test #2: negative on 31Dce2020, covid quick test#3, and Covid quick test#4: both negative on 02Feb2021. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: itching; headache; fatigue; redness; swelling; fever; chills; Bodu aches; Heart rate; injection site pain; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter sent in cross-referenced case. A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Feb2021 at 08:00 (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital clinic. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1485 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 21Dec2020 (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital clinic. Vaccine was not administered at Facility. On 05Feb2021 at 08:00, the patient experienced injection site pain. At 10:45, the patient had fever, chills, bodu aches, and heart rate. On 07Feb2021, the patient experienced redness and swelling. On 08Feb2021, the patient experienced itching, headache, and fatigue. On 28Feb2021, the patient diagnosed with covid-19. The patient underwent lab test and procedure included covid test-24HR: negative on 30Dec2020, covid quick test #2: negative on 31Dce2020, covid quick test#3, and Covid quick test#4: both negative on 02Feb2021. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A 76-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), at vaccination age of 76, via an unspecified route, left arm, on Feb 26, 2021, at 15:30, single dose, for COVID-19 immunization. Medical history included quadriplegic. The patient concomitant medications not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No known allergies reported. On Feb 28, 2021, at 16:00, patient experienced fever 101.5ºF for 36 hours. Patient did not receive any treatment for the events. The patient underwent lab test and procedure, which included fever of 101.5ºF, with outcome of recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: tongue and roof of her mouth went numb; tingly feeling around lips and face; This is a spontaneous report from a contactable consumer. A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Feb2021 (at the age of 54-year-old) as dose 1, single for covid-19 immunisation. Facility type vaccine was unknown. The patient medical history and concomitant medications were not reported. Known allergies were unknown. Unknown allergies to medications, food, or other products. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received any vaccines within four weeks prior to the vaccination was unknown. No prior vaccination. On Feb2021, patient experienced tongue and roof of her mouth went numb and had a tingly feeling around lips and face. No idea on timing of the event, almost immediately after the 1st dose. Patient then went into ER Emergency room (unknown location) for 3 hours after the shot (1st dose). Reporter was informed that patient was waiting on an infectious disease specialist to contact her. Her 2nd shot was supposed to occur 02Apr2021, no idea on specific date on 1st dose. The patient received any treatment for the event was unknown. Reporter did not have additional details like ER hospital location, location of dose 1, batch number etc. The outcome of all events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient/self-reported). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included flu vaccine; she had previous allergic reaction to flu vaccine on an unknown date. The patient reported she received the first dose of the Pfizer COVID-19 vaccine three weeks ago from today. She stated right after the vaccine, her tongue went numb and was swollen a little. She was tingling a little bit on an unspecified date. She stated the emergency team checked her out and noticed some hives on her neck. They told her to take some Benadryl and she went home. She experienced neurological symptoms for five days after the vaccine at the same time of day. She felt no pain in facial nerve but tingling all over the trigeminal nerve in her face and all over her head in a pattern. She also experienced severe itching of the lymph nodes (from her jawbone to her neck) off and on and in the lymph nodes under her armpit and groin. She had small hives on her lymph nodes and also experienced severe headaches and soreness in her muscles. She had a rash that comes and goes in her midriff area and cheeks. She had a fever over a 24-hour period and her whole body was wet. She would like to know if her symptoms were normal and if she should receive the second dose. She stated she was scheduled for the second dose of the vaccine today, but she did not receive it due to her adverse reactions. She would like to know how long she could put off receiving the second dose. Outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient/self-reported). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included flu vaccine; she had previous allergic reaction to flu vaccine on an unknown date. The patient reported she received the first dose of the Pfizer COVID-19 vaccine three weeks ago from today. She stated right after the vaccine, her tongue went numb and was swollen a little. She was tingling a little bit on an unspecified date. She stated the emergency team checked her out and noticed some hives on her neck. They told her to take some Benadryl and she went home. She experienced neurological symptoms for five days after the vaccine at the same time of day. She felt no pain in facial nerve but tingling all over the trigeminal nerve in her face and all over her head in a pattern. She also experienced severe itching of the lymph nodes (from her jawbone to her neck) off and on and in the lymph nodes under her armpit and groin. She had small hives on her lymph nodes and also experienced severe headaches and soreness in her muscles. She had a rash that comes and goes in her midriff area and cheeks. She had a fever over a 24-hour period and her whole body was wet. She would like to know if her symptoms were normal and if she should receive the second dose. She stated she was scheduled for the second dose of the vaccine today, but she did not receive it due to her adverse reactions. She would like to know how long she could put off receiving the second dose. Outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.