chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Dizzy; Nauseated; Headache; Chills; Feeling crappy; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (patient) reported for herself that.  A 74-years-old female consumer received bnt162b2 (COVID-19 Vaccine,  formulation: solution for injection, Batch/Lot Number: EN6201, expiration date was 30Jun2021) via intramuscular, administered in arm left on 17Feb2021 11:30 as dose 1, single for covid-19 immunisation (age at vaccination was 74 years). Medical history included Polycythemia Vera (reported as poly something vera), she had that gene, where her body makes more red blood cells than normal from an unknown date and unknown if ongoing and she gets phlebotomies every couple of months and seasonal allergy from an unknown date and unknown if ongoing and she did not know what they are but when there was pollen out, she gets all stuffed up and sneezes. The patients concomitant medications were not reported. She received her first Pfizer Covid-19 shot on 17Feb2021 and called to report her symptoms. About 2 hours after the shot on the same day 17Feb2021, she felt a little dizzy like she was going to pass out. However, it went away just as fast as it came, and she was fine. She had the shot around 11:30 A.M and at about 5:30-6:30 PM, she became a little nauseated. She had a headache, chills and was feeling crappy. She did not had fever or swelling of the face, none of that. However, these symptoms just came and went. One day before the day of report, at around 2:00pm which was about 24 hours later, she felt really good and fine. However, she got up in the morning and had a little nausea, headache, chills, and just felt crappy. Caller wanted to know how long these symptoms will last and declined to include a healthcare professional for this report. Vaccination facility type was a mall. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as not applicable. No other additional Vaccines received on same date of the Pfizer Suspect. Adverse events did not require a visit to emergency Room or physician Office. Prior Vaccinations within 4 weeks was reported as none. NDC number of COVID-19 Vaccine was reported as unknown. She did not receive any other products and had no history of investigation assessment done. Outcome of these symptoms was reported as either staying the same or improving. At the time of report, she did not have headache or nausea. The outcome of the events dizzy, chills and felt crappy was recovering and nauseated and headache was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Periorbital pain
Clinical narrative: headache; pain around her eyes; pain around her eyes and face; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the first and second shot, patient experienced headache, pain around her eyes and face. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: sore & tender at injection site; nausea; light-headedness; fever; chills; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 19Feb2021 12:30 (age at vaccination: 28 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 29Jan2021 (age at vaccination: 28 years) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced sore and tender at injection site, nausea, light-headedness, fever, chills and general fatigue, all on 20Feb2021 05:00. Treatment was not received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore & tender at injection site; nausea; light-headedness; fever; chills; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 19Feb2021 12:30 (age at vaccination: 28 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 29Jan2021 (age at vaccination: 28 years) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced sore and tender at injection site, nausea, light-headedness, fever, chills and general fatigue, all on 20Feb2021 05:00. Treatment was not received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Vaccination site mass
Clinical narrative: body aches; on and off chills; red lump on her shoulder on the same arm she received the vaccine; Headache; Dizziness; This is a spontaneous report from a contactable female consumer communicated to Pfizer sales representative. This consumer (patient) reported that, a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm on 11Feb2021 (Batch/Lot Number: EL9265) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3246) via unspecified route of administration on 20Jan2021 as single dose for covid-19 immunization. No side effects experienced after the first dose. The patient experienced body aches, on and off chills, red lump on her shoulder on the same arm she received the vaccine, headache, and dizziness on Feb2021. It was reported that, hour 12-24 post vaccine she had body aches, on and off chills, hour 36 post vaccine pounding headache and dizziness and she also noticed a red lump on her shoulder on the same arm she received the vaccine that has now subsided. The outcome of the event red lump on her shoulder on the same arm she received the vaccine was recovering while the outcome other events was unknown.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nervousness, Vertigo, Vomiting
Clinical narrative: When I wake up from my sleep, I felt like I was little dizzy; I woke up with really bad dizziness; Little shaky, my body was shaky; Little sweating; Throwing up; I end up going to ER and they think it could be Vertigo; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, lot number: EN6201), dose 1 via an unspecified route of administration on an unspecified date as dose 1,single for covid-19 immunisation. Medical history included ongoing asthma. The patient concomitant medications were not reported.Patient got first dose of vaccine on unknown date (on sunday) afternoon around 2 o clock and didn't have any side effects, also on same night, patient did not feel anything but the next night for a little while when patient wake up from sleep and felt like little dizzy but ignore it and went back to sleep. The next night it happened, the same thing, but on the third night (on the Wednesday night) patient woke up with bad dizziness, little shaky, body was shaky, a little sweating and then patient started throwing up. Patients end up going to ER and they think it could be Vertigo. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bite
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (wife), of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 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. Caller reported on Feb 16, 2021, his wife got either a spider or bat bite or something and needed a rabies shot. Caller needed to know if she can get the rabies shot or not. The clinical outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dyspepsia
Clinical narrative: woke to severe heartburn; very tired; weak; aching targeted lower back and knees; aches were getting more severe and over entire body/achy; had headache; aching in shoulders and neck; woke up hot; sweating; aching in shoulder joints/aching targeted lower back and knees; woke to chills; shaking; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient (age at vaccination: 39-year-old) received bnt162b2 (BNT162B2, lot EN 5318), via an unspecified route of administration inf left arm on 19Feb2021 16:45 as dose 2, single for Covid-19 immunisation. Medical history included high blood pressure, drug allergies to Amoxicillin, Lisinopril, Veropamil and Depo Provera, allergy to latex. She had her dose 1 of BNT162B2 (lot EN5318) on 29Jan2021 17:30 via unknown route in left arm. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient experienced woke to chills and shaking on 20Feb2021 03:00, aching in shoulder joints/aching knees on Feb2021 03:30, woke up hot and sweating on 20Feb2021 05:00, had aching in shoulders on 20Feb2021 06:30, headache on 20Feb2021 06:30, achy/aches were getting more severe and over entire body on 20Feb2021 07:20, aching targeted lower back on 20Feb2021 19:00. The patient took Ibuprofen. She also reported that on 21Feb2021, she felt very tired too ibuprofen routinely and had to continue taking lots of naps and was also weak (not treatment). On 21Feb2021 12:48 she woke to severe heartburn and took tums and pepto bismol over next 2 hours. The outcome of headache was recovered on 21Feb2021; for heartburn was recovered on unspecified date; for fatigue and weak was unknown; for other events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Hyperhidrosis, Neck pain
Clinical narrative: woke to severe heartburn; very tired; weak; aching targeted lower back and knees; aches were getting more severe and over entire body/achy; had headache; aching in shoulders and neck; woke up hot; sweating; aching in shoulder joints/aching targeted lower back and knees; woke to chills; shaking; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient (age at vaccination: 39-year-old) received bnt162b2 (BNT162B2, lot EN 5318), via an unspecified route of administration inf left arm on 19Feb2021 16:45 as dose 2, single for Covid-19 immunisation. Medical history included high blood pressure, drug allergies to Amoxicillin, Lisinopril, Veropamil and Depo Provera, allergy to latex. She had her dose 1 of BNT162B2 (lot EN5318) on 29Jan2021 17:30 via unknown route in left arm. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient experienced woke to chills and shaking on 20Feb2021 03:00, aching in shoulder joints/aching knees on Feb2021 03:30, woke up hot and sweating on 20Feb2021 05:00, had aching in shoulders on 20Feb2021 06:30, headache on 20Feb2021 06:30, achy/aches were getting more severe and over entire body on 20Feb2021 07:20, aching targeted lower back on 20Feb2021 19:00. The patient took Ibuprofen. She also reported that on 21Feb2021, she felt very tired too ibuprofen routinely and had to continue taking lots of naps and was also weak (not treatment). On 21Feb2021 12:48 she woke to severe heartburn and took tums and pepto bismol over next 2 hours. The outcome of headache was recovered on 21Feb2021; for heartburn was recovered on unspecified date; for fatigue and weak was unknown; for other events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tremor
Clinical narrative: woke to severe heartburn; very tired; weak; aching targeted lower back and knees; aches were getting more severe and over entire body/achy; had headache; aching in shoulders and neck; woke up hot; sweating; aching in shoulder joints/aching targeted lower back and knees; woke to chills; shaking; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient (age at vaccination: 39-year-old) received bnt162b2 (BNT162B2, lot EN 5318), via an unspecified route of administration inf left arm on 19Feb2021 16:45 as dose 2, single for Covid-19 immunisation. Medical history included high blood pressure, drug allergies to Amoxicillin, Lisinopril, Veropamil and Depo Provera, allergy to latex. She had her dose 1 of BNT162B2 (lot EN5318) on 29Jan2021 17:30 via unknown route in left arm. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient experienced woke to chills and shaking on 20Feb2021 03:00, aching in shoulder joints/aching knees on Feb2021 03:30, woke up hot and sweating on 20Feb2021 05:00, had aching in shoulders on 20Feb2021 06:30, headache on 20Feb2021 06:30, achy/aches were getting more severe and over entire body on 20Feb2021 07:20, aching targeted lower back on 20Feb2021 19:00. The patient took Ibuprofen. She also reported that on 21Feb2021, she felt very tired too ibuprofen routinely and had to continue taking lots of naps and was also weak (not treatment). On 21Feb2021 12:48 she woke to severe heartburn and took tums and pepto bismol over next 2 hours. The outcome of headache was recovered on 21Feb2021; for heartburn was recovered on unspecified date; for fatigue and weak was unknown; for other events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Infectious mononucleosis, Mononucleosis heterophile test, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; mononucleosis; she had a fever of 101.6; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 18 years) for covid-19 immunisation. Medical history included rash from unknown date, tired on 13Jan2021 (tired from 13Jan2021 until 14Feb2021 and she never fully recovered from that tiredness from January), sick in Jan2021, (sick middle of January for viral and was placed on Amoxicillin), and sore throat on unknown date. The patient's concomitant medications were not reported. The patient had a fever of 101.6 on 12Feb2021; experienced mononucleosis on 16Feb2021, and sore throat on an unspecified date. On12Feb2021, the patient came home and looked horrible, and they took her temperature and she had a fever of 101.6. Caller states that her daughter had a fever for the entire week, and they saw the doctor that Monday and Wednesday, and on Tuesday 16Feb2021, her daughter was tested for Mono and it came back on 18Feb2021, as positive for Mono. Caller states that she was not positive that her daughter did not have Mono back in January, because the doctors did not test for it back then. Caller states that the doctor called them today and the Strep test came back today positive for Strep S, but the doctor said that usually does not mean anything because people always have some strep in their throats, but maybe because of the Mono, it might be causing more problems. The reported states that Saturday(unspecified date), was her daughter's last day with a fever. Caller states that her daughter's fever was high on Friday, and Saturday it was lower, and Sunday was the first day with no fever. Caller states that Mono lasts a while, and she was wondering if it is okay for her daughter to get her second dose of the product tomorrow (23Feb2021), regardless of the Mono diagnosis. It was further mentioned that the patient was sick middle of January for viral and was placed on Amoxicillin, daughter does not have a fever as of yesterday. The patient underwent lab tests and procedures which included (fever) body temperature: 101.6  and strep test negative on an unknown date; on 16Feb2021, mono was positive; and on 22Feb2021, strep test was positive (Strep test came back today positive for Strep S). The outcome of the event fever was recovered on an unknown date and unknown outcome for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: sore throat; mononucleosis; she had a fever of 101.6; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 18 years) for covid-19 immunisation. Medical history included rash from unknown date, tired on 13Jan2021 (tired from 13Jan2021 until 14Feb2021 and she never fully recovered from that tiredness from January), sick in Jan2021, (sick middle of January for viral and was placed on Amoxicillin), and sore throat on unknown date. The patient's concomitant medications were not reported. The patient had a fever of 101.6 on 12Feb2021; experienced mononucleosis on 16Feb2021, and sore throat on an unspecified date. On12Feb2021, the patient came home and looked horrible, and they took her temperature and she had a fever of 101.6. Caller states that her daughter had a fever for the entire week, and they saw the doctor that Monday and Wednesday, and on Tuesday 16Feb2021, her daughter was tested for Mono and it came back on 18Feb2021, as positive for Mono. Caller states that she was not positive that her daughter did not have Mono back in January, because the doctors did not test for it back then. Caller states that the doctor called them today and the Strep test came back today positive for Strep S, but the doctor said that usually does not mean anything because people always have some strep in their throats, but maybe because of the Mono, it might be causing more problems. The reported states that Saturday(unspecified date), was her daughter's last day with a fever. Caller states that her daughter's fever was high on Friday, and Saturday it was lower, and Sunday was the first day with no fever. Caller states that Mono lasts a while, and she was wondering if it is okay for her daughter to get her second dose of the product tomorrow (23Feb2021), regardless of the Mono diagnosis. It was further mentioned that the patient was sick middle of January for viral and was placed on Amoxicillin, daughter does not have a fever as of yesterday. The patient underwent lab tests and procedures which included (fever) body temperature: 101.6  and strep test negative on an unknown date; on 16Feb2021, mono was positive; and on 22Feb2021, strep test was positive (Strep test came back today positive for Strep S). The outcome of the event fever was recovered on an unknown date and unknown outcome for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Somnolence
Clinical narrative: mild sleepiness; malaise; right upper arm pain developed; This is a spontaneous report from a contactable consumer (patient). A adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and from the night of the vaccination, right upper arm pain was developed. After the 2nd dose: On an unspecified date in Feb2021, a few hours after the vaccination, right upper arm pain developed. The pain was little stronger than the 1st dose. On the second day of the vaccination, in the afternoon, there were mild sleepiness and malaise. The outcome of the events was recovering as on the third day.  No follow-up attempts are possible. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Lacrimation increased, Pain in extremity, Swelling face
Clinical narrative: right side of her face was swollen/cheek were swollen; eye swelling; right arm was hurting; right eye was watery; Headache; This is a spontaneous report from a contactable consumer (patient's child). A 93-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on Feb2021 (at the age of 93 years old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. 5 days after receiving the Covid-19 Vaccine, patient had a headache over the weekend and took acetaminophen (TYLENOL). Patient didn't have anything else beside the headache. On 22Feb2021, patient woke up and the right side of her face was swollen. The patient's right eye and cheek were swollen, and her right arm was hurting. The reporter clarified that the patient's right eye was watery, as well, and the patient got her Covid-19 Vaccine in her left arm. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable Nurse. This 64-year-old female Nurse (patient) reported in response to Hcp letter sent in cross reference case which included that.  A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1284), dose 1 intramuscular, administered in Deltoid Left on 29Dec2020 as (At the age of 64-years) dose 1, single for covid-19 immunisation; ibuprofen (ADVIL 12 HOUR), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 1 hour after injection again 12 hours later. for an unspecified indication, paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 1 hour after injection again 12 hours later. for an unspecified indication. Medical history included sideroblastic anaemia from 1997 and ongoing, and haemochromatosis from 1999 and ongoing. Concomitant medication included epoetin alfa 40000 units SQ every other week (PROCRIT) taken for sideroblastic anaemia from 2000 and ongoing; deferasirox 720 mg Po daily (JADENU) taken for haemochromatosis from 2017 and ongoing. The patient experienced sore arm on an unspecified date. The action taken in response to the event(s) for bnt162b2 was not applicable, for ibuprofen was unknown , for paracetamol was unknown. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site haemorrhage
Clinical narrative: She is concerned because a small stream of blood came out afterward; has bruising under the skin that is larger than a half dollar; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age (reported as elderly) received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she is concerned because a small stream of blood came out afterward and has bruising under the skin that is larger than a half dollar on 18Feb2021. The patient received 2nd dose of Pfizer vaccine and wants to know if she received the full dose of the vaccine. She is concerned because a small stream of blood came out afterward. She estimates approximately 5 drops. She later developed a bruise in her arm approximately the size of a half dollar. Patient is elderly and denies being on a blood thinner. The outcome of the events was unknown. Patient received first dose of BNT162B2 on an unspecified date.  Follow-up attempts are completed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Nausea, Pyrexia
Clinical narrative: vomiting; fever of 99.9; diarrhea; nausea; weakness; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting, fever of 99.9, diarrhea, nausea and weakness on 09Feb2021 (reported as 2 days after receiving the vaccine). The outcome of the events was unknown. The patient would like to known whether he can get his second dose.   No follow-up attempts are possible. No further information is expected. Information about batch/lot number already obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; fever of 99.9; diarrhea; nausea; weakness; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting, fever of 99.9, diarrhea, nausea and weakness on 09Feb2021 (reported as 2 days after receiving the vaccine). The outcome of the events was unknown. The patient would like to known whether he can get his second dose.   No follow-up attempts are possible. No further information is expected. Information about batch/lot number already obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleeding; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 18Feb2021 (age at vaccination: 72-years) as single dose for COVID-19 immunisation. The patient's medical history (including any illness at time of vaccination) was none. The patient's concomitant medications were not reported. The patient experienced nose bleeding on 20Feb2021. The patient had his first dose of the vaccine last Thursday (18Feb2021) and since then he had 2 different episodes of nose bleeding. The patient stated that the 1st incident was 2 days after getting the vaccine and the 2nd incident was on Sunday. He mentioned that it wasn't that significant since he experienced bleeding on only 1 nostril and thought he had cut himself at first. When he noticed that it was coming from his nose, he tilted his head and put ice over it and 15 minutes later the bleeding stopped. He also added that he has not experienced this for 30-45 years now and what a coincidence it was that he had nose bleed again 2 days after getting the vaccine. He wants to know if there had been any reports of nose bleeding as a side effect of the vaccine because he wanted to call and check first before he calls and makes an appointment with his doctor. Therapeutic measures were taken as a result of nose bleeding. The outcome of the event was recovered on 22Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation, Underdose, Vaccination site bruising
Clinical narrative: at the time of the injection she had leakage at the site and thinks she did not get the whole amount of the vaccination; at the time of the injection she had leakage at the site and thinks she did not get the whole amount of the vaccination; bruise on that arm where she received the COVID-19 Vaccine; This is a spontaneous report from a contactable nurse. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot Number: EM9810), at the age of 73-years-old, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single for COVID-19 immunization. The patient had second dose of COVID-19 Vaccine two weeks ago today (at the time of report). The patient had no reaction to the second COVID-19 Vaccine. At the time of caller's injection, the nurse administering the COVID-19 Vaccine said "oops" or "uh oh" and stated there was leakage at the injection site. The nurse cleaned the site with alcohol and caller noticed there was no blood on the alcohol pad. She has been thinking over the past two weeks that she clearly didn't receive the whole amount of the COVID-19 Vaccine. She still has a bruise on that arm where she received the COVID-19 Vaccine. The bruise in 1.5 inches vertically and 1 inch horizontally. She wanted to know should she be concerned if she didn't get the full amount of the COVID-19 Vaccine and should she be tested for antibodies to see if she has full immunity. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headaches; fatigue/tiredness; body aches; feeling feverish without taking [her] temperature /she experienced fever; This is a spontaneous report from contactable consumers (including patient) from a Pfizer-sponsored program. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine last Wednesday (17Feb2021) and developed symptoms Sunday (Feb2021), which are persisting until today.  She specified she has been having headaches, fatigue, tiredness, and has been feeling feverish without taking her temperature. Yesterday to today (Feb2021), she has had a headache, fatigue/tiredness, and body aches. She did not know if she could have covid and if she should get tested since she has only been vaccinated with first dose. She experienced fever, headache and body aches today (unspecified date) after the first dose. She asked for recommendations on what to do next. She asked if she should get tested for COVID-19. The patient said that she will disconnect and will call her doctor after explaining that Pfizer is unable to make treatment recommendations for individual patients. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Erythema, Fatigue, Feeling hot, Loss of personal independence in daily activities
Clinical narrative: hands got warm and red; hands got warm and red; veins from hands and forearms were heavy; stomach feels tight; tired; can't make her normal routine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL9269), via an unspecified route of administration administered in arm left on 09Feb2021 08:45 as dose 2, single for covid-19 immunization. Medical history included Parkinson's disease. The patient was not pregnant. There were no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered in left arm on 19Jan2021 at 08:45 AM for covid-19 immunization at the age of 69-years-old and had no reaction. The patient previously took azithromycin (ZITHROMAX) and ciprofloxacin (CIPRO) and experienced allergies to both. The second covid-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. After the second dose, on 12Feb2021 12:00 PM, the patient's hands got warm and red, veins from hands and forearms were heavy, stomach feels tight, felt tired and the patient can't make her normal routine. No treatment was received for the said adverse events and at the time of the report, the patient had not recovered from them. Since the vaccination, the patient has not been tested for covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular pain
Clinical narrative: hands got warm and red; hands got warm and red; veins from hands and forearms were heavy; stomach feels tight; tired; can't make her normal routine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL9269), via an unspecified route of administration administered in arm left on 09Feb2021 08:45 as dose 2, single for covid-19 immunization. Medical history included Parkinson's disease. The patient was not pregnant. There were no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered in left arm on 19Jan2021 at 08:45 AM for covid-19 immunization at the age of 69-years-old and had no reaction. The patient previously took azithromycin (ZITHROMAX) and ciprofloxacin (CIPRO) and experienced allergies to both. The second covid-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. After the second dose, on 12Feb2021 12:00 PM, the patient's hands got warm and red, veins from hands and forearms were heavy, stomach feels tight, felt tired and the patient can't make her normal routine. No treatment was received for the said adverse events and at the time of the report, the patient had not recovered from them. Since the vaccination, the patient has not been tested for covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Thinking abnormal
Clinical narrative: she took the 1st dose yesterday and she took Ibuprofen because her mind is clouded and her voice has changed; she took the 1st dose yesterday and she took Ibuprofen because her mind is clouded and her voice has changed; This is a spontaneous report from a contactable consumer or other non health care professional (patient). This is a report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number and expiry date was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she took the 1st dose yesterday (19Feb2021) and she took ibuprofen because her mind was clouded and her voice had changed on an unspecified date in Feb2021. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: dizzy spells; Difficulty in walking; This is a spontaneous report based on the information received by Pfizer from Sanofi (Sanofi: 20210210000833) via a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included teriflunomide (AUBAGIO) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced dizzy spells, difficulty in walking. Patient wanted to know if she can take her Gabapentin due to the dizzy spells. The patient was advised to contact her neurologist to see what they would like her to do. The outcome for the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product preparation issue, Product use issue, Vaccination site rash
Clinical narrative: vial was shaken before and was injected half way down elbow/arm; she recieved a rash around the injection site; vial was shaken before and was injected half way down elbow/arm; vial was shaken before and was injected half way down elbow/arm; This is a spontaneous report from a contactable consumer (patient herself) via a Pfizer-sponsored program .   A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm on Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, an unspecified date for covid-19 immunization Caller stated worried about way second dose of    vaccine was administered 17 days ago (Jan2021); vial was shaken before and was injected half way down elbow/arm, caller stated 2-3 days (Feb2021) later she received a rash around the injection site. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Rash located only on his chest and shoulders, not itchy, but about 30 spots of pink light-colored dots; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on 26Jan2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, the patient had a rash. It was located only on his chest and shoulders, was not itchy, but was about 30 spots of pink light-colored dots. It was dots, a quarter inch to the size of a quarter that do not itch. They are not all round, they can be oblong, they are a lighter pink. The patient said that since they were where his suspenders go that the skin might just be getting irritated. The patient tried Neosporin which was not helpful, and Mellaluca oil which made it darker red. The patient reported that he called local clinic to schedule an appointment and they asked him to talk to Pfizer first to see what their recommendations were. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Sore arm; Fever blisters on and above my lip; Soreness at injection site a little itchy; Soreness at injection site a little itchy; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 22Feb2021 17:15 (Batch/Lot Number: EW6200) as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy from an unknown date. The patient's concomitant medications were reported as none. No COVID prior to vaccination. Not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 08:00, the patient experienced soreness at injection site a little itchy. On 03Mar2021, the patient had sore arm and fever blisters on and above my lip. No treatment was received for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pain
Clinical narrative: Sore throat; started to experience aches; Harsh dry cough; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received BNT162B2, via an unspecified route of administration, administered in Arm Right on 22Feb2021 11:00 (Lot Number: EN6200), at the age of 50-years-old, as dose 1, single for COVID-19 immunisation. Medical history included sinus drainage from allergies from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously had his flu vaccine about 8 weeks ago. On 23Feb2021 10:00, the patient experienced sore throat, started to experience aches and harsh dry cough. The clinical course was reported as follows: Patient received first dose of Pfizer Covid vaccine on 22Feb2021 about 11am. He woke up this morning about 10am with a sore throat and a harsh dry cough. On 23Feb2021 started to experience aches, sore throat, and dry cough. He knows these are not reported side effects in the clinical trials but wants to know if he could transmit the virus after receiving the vaccine. He is a caretaker for his mother who has respiratory issues and he wants to be safe for when she returns home from the hospital later this week. States that he is constantly keeping a Halls cough drop in his mouth and is trying to keep his throat moist so he doesn't hack so hard. Therapeutic measures were taken as a result of all the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: had trouble breathing; Laryngitis; Fatigue; headache; back aches; Coughing; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9264; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm right on 06Feb2021 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced coughing on Feb2021, had trouble breathing, laryngitis, fatigue, headache and back aches on an unspecified date. The clinical course was as follows: Reporter is a consumer, asking, should she get the second dose on Saturday? and should she quarantine with these symptoms? She received her first vaccine dose and about 4-5 days later she began "coughing real bad". Also reported experiencing fatigue, headache and back aches and was diagnosed with laryngitis. She went for her first vaccine with several other people, they had some symptoms but nothing like hers. She is supposed to be due for her second dose of the COVID vaccine on Saturday but is coughing and has fatigue and laryngitis and a headache. It was the coughing that really got to her. She did not develop side effects the same day as the vaccine, it was like 4 or 5 days later, and then she had trouble breathing, and that went away and then she got the laryngitis and then the fatigue. She had no other vaccines on the same day. The outcome of had trouble breathing was recovered on an unspecified date while of the rest was unknown.    No follow-up attempts are possible. No further information is expected.