chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: At around 10pm I began with nausea and headache. On April 14 the 1st dose shot. The following day April 15 I started with fevers, chills, body aches, tiredness and pain in my neck. On April 16 I had minor diarrhea.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: At around 10pm I began with nausea and headache. On April 14 the 1st dose shot. The following day April 15 I started with fevers, chills, body aches, tiredness and pain in my neck. On April 16 I had minor diarrhea.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Visual impairment
Clinical narrative: dizziness; brain fog; vision issues; balance issues; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraine from an unknown date and unknown if ongoing, kidney stones from an unknown date and unknown if ongoing. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included tizanidine hydrochloride (ZANAFLEX); amitriptilina [amitriptyline] (AMITRIPTILINA); and topiramate (TOPAMAX), all taken for an unspecified indication, start and stop date were not reported. Tizanidine, amitriptyline, and topiramate were taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 on 10Feb2021 at 12:00 (at the age of 42-years-old) for COVID-19 immunisation. On an unknown date after the second vaccination, the patient experienced dizziness, brain fog, vision issues, balance issues. Therapeutic measures were taken as a result of dizziness, brain fog, vision issues, balance issues included anti-inflammatory steroid. Clinical outcome of the events dizziness, brain fog, vision issues, balance issues was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021284020 same reporter/ patient, different drug dose/ AE.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Hard itchy red lump at injection site. Painful at the touch.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fatigue lasting 24 hours Headache lasting 24 hours Loss of appetite lasting 12 hours Chills lasting 3 hours
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain
Clinical narrative: My cheeks hurt.  One side first, now both sides.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, Skin sensitisation
Clinical narrative: Headache, chills, fever, arm soreness, skin sensitive to touch. Feels like i have covid again  waking up this morning.
Sex: F
Vaccine: COVID19
Symptoms: Excessive cerumen production, Palpitations, Pruritus, Throat irritation
Clinical narrative: This is a spontaneous report received from a contactable consumer(patient). This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. Medical history included mitral valve prolapse and itching, both from unknown dates and unknown if ongoing. Concomitant medications included propranolol from an unknown date for mitral valve prolapse. The patient reported she received the first dose of the vaccine on 04Mar2021 and about an hour later, after she got home, she had an itching in the throat and body and had no rashes. She mentioned that she was not sure if there was a correlation with the vaccine because her body sometimes itched up and she couldn't swear if it was cause and effect. She mentioned that she consulted with an emergency medical technician (EMT) yesterday for the wax in her ears and they said that her throat was not swelling up. She inquired if non-severe allergic reactions could still be recommended to take the second dose, as she was aware that only severe allergic reactions were contraindicated. She also asked if it was expected for her allergies to get worse by the second dose. She stated she would consult with her "allergologist" about her symptoms. She also mentioned that after the vaccination, she could feel the heart beat a little more, which she could feel through her body. She had a mitral valve prolapse and kept it under control with propranolol. She consulted her cardiologist that day and they mentioned that the vaccine might have revved up her system more and advised her that it was okay to take the second dose. She took a little bit more propranolol and her heartbeat got normal. The clinical outcomes of an itching in the throat and body, and wax in her ears were unknown. The outcome of she could feel heart beat a little more, which she could feel through her body/ revved up was recovered on an unspecified date. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Rhinorrhoea, Sneezing
Clinical narrative: body aches; chills; runny nose; coughing; sneezing; This is a spontaneous report from a contactable consumer (patient). This 28-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that last week he received BNT162B2 and yesterday (as of 16Mar2021) he started feeling body aches, a lot of chills, a runny nose, coughing and sneezing. The patient inquired if he could go to the doctor or what he should do. The clinical outcomes of body aches, chills, runny nose, coughing and sneezing were unknown.   Batch/Lot Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; slight headache; This is a spontaneous report from a contactable consumer or other Non-HCP (patient's son).   Follow-up (16Mar2021) received from contactable consumer via from a Pfizer Sponsored Program was processed together with initial information.   A 56-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date after the vaccination the patient had no symptoms however had a slight headache one day which went away. On 12Mar2021 the patient started having fever (around 100F). On an unspecified date the patient got tested for COVID-19, but it was negative. The patient was referred to their HCP. The patient's HCP told him that event was probably from covax. Patient asked if it was correct as he just started with a fever 4 days ago. Outcome of headache was resolved. Outcome of fever was not resolved.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: tooth infection; This is a spontaneous report received from a contactable consumer(patient). This 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient inquired if she should get the second dose of BNT162B2 as scheduled and what the maximum time she could wait before getting the second dose was. The patient received her first dose of BNT162B2 and was scheduled to receive her second dose on 25Mar2021. She stated she had a tooth infection, was on amoxicillin 500 mg every 8 hours until 13Mar2021 and was having a root canal on 22Mar2021. She asked if amoxicillin would interact or impact the efficacy of the vaccine. She stated she had no reaction to the first injection of the vaccine. The clinical outcome of tooth infection was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer(patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced generalized muscle pain on an unspecified date in Mar 2021 a few days after getting BNT162B2. She was due for the second dose soon but still had lingering generalized muscle pain. The outcome of generalized muscle pain was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sores on his lips; This is a spontaneous report received a contactable consumer, the patient. A male of unspecified age received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 13Mar2021, for COVID-19 immunisation. Relevant medical history included cold sores on his lips (not ongoing; quite a few years ago now; occasionally gets one or two at a time). There were no concomitant medications or past drug history reported. The patient reported that he received the first dose of the Pfizer vaccine on 13Mar2021, reported as last Saturday, and on 15Mar2021, reported as yesterday, he broke out with quite a few cold sores on his lips. The patient explained that the cold sores are almost 2/3rds around his lip. The patient explained that he has not had cold sores in quite a few years now and would occasionally only get one or two at a time. The patient inquired if this could be possibly related to the vaccine. The outcome of the event cold sores on his lip was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin fissures
Clinical narrative: chapped hands; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chapped hands on an unspecified date. Clinical outcome of the event chapped hands was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Injection site discomfort, Malaise, Myalgia, Pain
Clinical narrative: I feel like crap; raised mark on arm where the shot was given about the size of a quarter; sore; aches and pains across his chest and muscles; aches and pains across his chest and muscles; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was unknown), via an unspecified route of administration on 08Mar2021 (at the age of 72 years-of-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced i feel like crap, raised mark on arm where the shot was given about the size of a quarter, sore, aches and pains across his chest and muscles. The patient wants to know if it was unusual for it to take a week for a raised mark on his arm to show up which starting yesterday (unspecified date), and he does not have a temperature. The patient wishes to be transferred to ED. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Caller received her second Covax injection 2 1/2 weeks ago and the injection site still itches; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a female of unspecified age received the second dose of BNT162b2 (solution for injection; batch/lot and expiry information reported as not available) as a single dose via unspecified route on an unspecified date in Feb2021, described as two and a half weeks ago, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient reported that she received the second dose of the vaccine two and a half weeks ago and the injection site still itches. The patient inquired why that is and if the vaccination did not take or something that is causing it to still itch. The outcome of the event injection site still itches was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: 6 days later he was tested positive; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had his first dose of the covid vaccine last 26th of February. 6 days later he was tested positive. He was asking if he would be continuing his second dose of the vaccine on 19th of March after being tested positive. Outcome of the event was unknow.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 6 days later he was tested positive; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had his first dose of the covid vaccine last 26th of February. 6 days later he was tested positive. He was asking if he would be continuing his second dose of the vaccine on 19th of March after being tested positive. Outcome of the event was unknow.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diplopia, Magnetic resonance imaging
Clinical narrative: double vision; This is a spontaneous report from a contactable consumer (patient's daughter). An 81-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 81 years, administered in the arm on 09Mar2021 16:00 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) diagnosed from an unspecified date about 2 years ago but reporter was sure she had it before that. Patient did not have prior vaccinations within 4 weeks. There were no concomitant medications. Patient historically took the first dose of BNT162B2 (Lot: EL3302) on 09Feb2021 at around 12:00, at age 81 years on the arm for COVID-19 immunisation. Patient had a reaction to Pfizer's COVID vaccine where double vision happened 2- 3 days after her second vaccination, but clarified that it was on 11Mar2021. The patient did not initially mentioned double vision to reporter herself, patient told her daughter last Saturday that she had been having double vision but reporter did not find out about it until later. The reporter took her to the doctor regarding the double vision and the doctor sent the patient to the hospital emergency room for double vision on 15Mar2021. Patient was not admitted to the hospital, was kept under observation in the emergency room where she had testing performed. While in the emergency room the patient had a CAT scan, and MRI and bloodwork and all of those tests results came back clear on 15Mar2021. The patient was released home from the emergency room after probably about 5-6 hours. The reporter just thought the double vision seems to be a little suspect being that she had had the Pfizer-BioNTech COVID-19 Vaccines and they have nothing else to attribute the event to. The vaccine was not administered at military facility. Outcome was not recovered at the time of reporting. Case was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: slept a bit more than usual; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received the first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that on an unspecified date, her mother might have experienced some side effects (slept a bit more than usual) from the Pfizer Covid 19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombophlebitis
Clinical narrative: Thrombophlebitis Right Ankle; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the left arm on 05Feb2021 (batch/lot number: EM9809) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, hypothyroid and known allergies to mild seafood (oral sensitivity). The patient was not pregnant. Facility type vaccine was military base. No other vaccine in four weeks. Other unspecified medications in two weeks. Historical vaccine included BNT162B2 first dose on 15Jan2021 (batch/lot number: EL3302) administered in the left arm for COVID-19 immunisation. The patient experienced thrombophlebitis right ankle on 24Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of thrombophlebitis right ankle which included injection of meds, also taking oral meds. No COVID prior to vaccination and COVID tested post vaccination which included nasal swab on 08Mar2021 with negative test result. The outcome of the event was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Periorbital swelling
Clinical narrative: Puffy both eyelids and double vision.; Puffy both eyelids and double vision.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID 19, Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 16Mar2021 13:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history was none. No known allergies. Concomitant medications included metformin; levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR) and women one day sl.  No other vaccine in four weeks. On 17Mar2021 02:00 AM, the patient experienced puffy both eyelids and double vision. No Covid prior vaccination and not tested with Covid post vaccination. No treatment was received for the events. The outcome of the events was not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: Double vision; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported), via an unspecified route of administration, administered in arm left on 13Mar2021 15:30 as a single dose (at the age of 63-years-old) for covid-19 immunisation. The patient had known allergies with shellfish and ragweed both from an unknown date. Concomitant medications included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 15Mar2021 10:00, the patient experienced double vision 2 days after vaccine. The patient was seeing 2nd image vertically located from both eyes. Ongoing for 3 days. No treatment was received for the event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ageusia, Anosmia, Decreased appetite, Fatigue
Clinical narrative: lost her sense of taste; tired; lost her appetite; had an upset stomach; low grade fever 2 days later; Lost her sense of smell; she also had body aches; she had colds after the vaccine; This is a spontaneous report from a contactable consumer(patient herself)..   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205) via unknown route of administration on 03Mar2021 at single dose in left arm for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient got the first Covid vaccination on 03Mar2021, stated she had Covid, tested positive after the vaccine on 08Mar2021. stated she got symptoms 2 days afterwards she tested positive after the vaccine, patient stated she was assuming she had it when she got the vaccine. patient stated she tested positive on 08Mar2021, was asymptomatic at the time, started feeling symptoms, lost her sense of taste on Sun 07Mar2021, stated her other symptoms where she was really tired, she lost her appetite, had an upset stomach in Mar2021, stated she was feeling much better now, next vaccine was due on 24Mar2021, some people were saying she shouldn't get it should wait 90 days. Patient lost her sense of taste and sense of smell in Mar2021. she also had body aches and was feeling very tired and had a low-grade fever 2 days later after that in Mar2021. she had colds after the vaccine in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: lost her sense of taste; tired; lost her appetite; had an upset stomach; low grade fever 2 days later; Lost her sense of smell; she also had body aches; she had colds after the vaccine; This is a spontaneous report from a contactable consumer(patient herself)..   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205) via unknown route of administration on 03Mar2021 at single dose in left arm for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient got the first Covid vaccination on 03Mar2021, stated she had Covid, tested positive after the vaccine on 08Mar2021. stated she got symptoms 2 days afterwards she tested positive after the vaccine, patient stated she was assuming she had it when she got the vaccine. patient stated she tested positive on 08Mar2021, was asymptomatic at the time, started feeling symptoms, lost her sense of taste on Sun 07Mar2021, stated her other symptoms where she was really tired, she lost her appetite, had an upset stomach in Mar2021, stated she was feeling much better now, next vaccine was due on 24Mar2021, some people were saying she shouldn't get it should wait 90 days. Patient lost her sense of taste and sense of smell in Mar2021. she also had body aches and was feeling very tired and had a low-grade fever 2 days later after that in Mar2021. she had colds after the vaccine in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis superficial
Clinical narrative: symptoms and subsequent confirmation diagnosis of Mondor's disease; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 08Jan2021 15:30 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. The first dose was received on 18Dec2020 15:30 (lot number: EK5730) intramuscular on the left arm at age 26 years old. Medical history included hyperadrenergic postural orthostatic tachycardia syndrome. There were no concomitant medications (no vaccine in 4 weeks and no other medications in 2 weeks). The patient previously took bactrim and experienced allergies. Soon after the second dose, patient had symptoms and subsequent confirmation diagnosis (20Jan2021) of Mondor's disease. At the time, patient had thought maybe it was related, but chalked it up to a coincidence and did not decide to report until patient had recently heard of a possible blood clotting relation to the COVID-19 vaccine. The event was experienced on 09Jan2021 and resulted in physician's visit. Outcome of the event was recovered. Treatment was NSAID (unspecified) for 6 weeks. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYNELOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever on an unspecified date with outcome of recovering. Reporter seriousness for Fever was unspecified. The reporter stated, "I am calling someone else (consumer). They have a fever after taking this shot, the Covid shot first one, yesterday and they have a fever but I put a cold "wet" (not clarified) on and the fever went down a little bit. Can they take a Tylenol or they cannot take one." In response, reporter stated, "Do we need to go to the Hospital or talk to them first?"   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: irregular heart beat/his father in law experienced the exact same thing she did; pulse rate was high/his father in law experienced the exact same thing she did; would wake up in the middle of the night with her heart pounding like crazy/the same happened to his dad; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number; NDC number; Expiry Date: Unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced irregular heart beat/his father in law experienced the exact same thing she did, pulse rate was high/his father in law experienced the exact same thing she did, would wake up in the middle of the night with her heart pounding like crazy/the same happened to his dad. The patient underwent lab tests and procedures which included heart beat/pulse rate were irregular and high. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021294406 same drug/event, different patient; PFIZER INC-2021297869 same drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter inquired what pain medications the patient could take as the patient had experienced soreness after the first dose in Mar 2021. The clinical outcome of soreness was unknown. Follow-up attempts are completed. No further information is expected; information about the lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first dose she was experiencing pain on her arms; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient) reported a female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021 after receiving BNT162B2 the patient experienced pain on her arms. The outcome of pain on her arms was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Temp of 101; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. On an unspecified date, one day after the second dose of the COVID-19 vaccine, the patient experienced a temperature of 101, chills, and body aches. The clinical outcomes of temperature 101, chills and body aches were resolved on unspecified dates soon thereafter.  Follow-up attempts are completed. No further information is expected; information about the lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: Headache; Chest pain; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program,t. A female patient of unspecified age (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported the patient experienced headache and chest pain in Mar2021, and took acetaminophen (TYLENOL). The clinical outcomes of headache and chest pain were not recovered at the time of reporting (14Mar2021).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Gait disturbance, Insomnia, Pain in extremity
Clinical narrative: experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported.  The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombophlebitis superficial, Ultrasound scan
Clinical narrative: experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported.  The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 73-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as a single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient experienced sore arm a few hours after the first dose on an unspecified date. The outcome of event, sore arm, was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021102574 same patient, different dose/AE (second dose)
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She has a bit of soreness; This is a spontaneous report. A non-contactable consumer, the patient, reported a female of unspecified age received the first dose BNT162b2 (solution for injection; batch/lot and expiry information reported as not available) as a single dose via unspecified route on 15Mar2021, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient denied any allergies to medications, food, or other products. The patient denied being diagnosed with COVID prior to this vaccine. It was unknown if the patient was pregnant at the time of vaccination. The patient has not been tested for COVID since the vaccine. The patient reported that she received the first dose today and she wanted to know if she should take acetaminophen (TYLENOL). The patient explained that she has a bit of soreness. The outcome of the event soreness was unknown.  No follow-up attempts possible as reporter declined consent to further contact; No further information expected and information about batch /lot number(s) cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID-19  after the first dose; got COVID-19  after the first dose; This is a spontaneous report from Pfizer Sponsored Program by a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date, the patient experienced covid after the first dose. The patient wanted to know if she was able to get her 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: patient states she is 65 y/o. She had contact (rode in the car) with granddaughter briefly on 17Mar2021. her granddaughter (21 y/o) recently tested positive for Covid-19 virus.; This is a spontaneous report received from Pfizer-sponsored program A contactable 65-year-old female consumer reported that:  This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (BNT162B2; solution for injection), dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states she is 65 y/o. she had contact (rode in the car) with granddaughter briefly on 17mar2021. her granddaughter (21 y/o) recently tested positive for covid-19 virus. She states her grand daughter has a fever and sore throat. Will e-transmit as potential AE. Referred caller to HCP for further discussion. Spoke from attached document - post-vaccination precautions- wearing a mask and social distancing after receiving the vaccine. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid a week after she got her 1st dose of vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive for COVID a week after first dose of vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive two weeks after getting the first dose; tested positive two weeks after getting the first dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 26Feb2021, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive two weeks after getting the first dose (on 12Mar2021) in SARS-CoV-2 test. She reported as well that her second was scheduled on 26Mar2021, more than 21 days after her first dose. The outcome the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that, 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 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her 1st dose on 23Feb2021, and 2nd dose will be on 17Mar2021 that was more than the usual 21 days interval. The patient also said that her niece visited her and tested positive for COVID-19. The patient experienced caller also said that her niece visited her and tested positive for covid on an unspecified date. Outcome of the event was unknown. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body pain; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program,  A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 04Mar (2021) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she experienced body pain in Mar2021 and she was going to receive her second dose on 24Mar (2021). The clinical outcome of body pain was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: 3 days after my second dose, my hives increased severely/full body hives that are extremely itchy/full body itchiness; 3 days after my second dose, my hives increased severely/full body hives that are extremely itchy/full body itchiness; 3 days after my second dose, my hives increased severely/full body hives that are extremely itchy/full body itchiness; injection site got super red and itchy the day after my second injection; injection site got super red and itchy the day after my second injection; This is a spontaneous case received report from a contactable other hcp. A 23-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. Medical history included, seasonal allergy from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included fexofenadine hydrochloride (Allegra) taken for an unspecified indication, cetirizine hydrochloride (Zyrtec [cetirizine hydrochloride]) taken for an unspecified indication, isotretinoin (Accutane) taken for an unspecified indication, fluticasone propionate (Flonase [fluticasone propionate]) taken for an unspecified indication, ethinylestradiol, ferrous fumarate, norethisterone acetate (Minastrin 24 FE) taken for an unspecified indication. The patient reported injection site got super red and itchy the day after my second injection on 19Jan2021 that lasted several days as well. "The full body itchiness is unbearable and does not resolve with multiple antihistamines being taken. I have several pictures of the hives that I am willing to share if someone contacts me" Three days after her second dose, hives increased severely full body hives that are extremely itchy full body itchiness on 22Jan2021, injection site got super red and itchy the day after my second injection on 19Jan2021. The patient had recovered from the event of vaccination site erythema and not recovered from the events of vaccination site pruritus, pruritus, urticaria, while the outcome of the event condition aggravated was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site extravasation, Vaccination site haemorrhage
Clinical narrative: a leakage at her injection site occurred where she noticed that a clear liquid with blood leaked and dripped down her arm at about 5 inches; a leakage at her injection site occurred where she noticed that a clear liquid with blood leaked and dripped down her arm at about 5 inches; This is a spontaneous report from a contactable consumer (Caregiver). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Mar2021, the patient experienced a leakage at her injection site occurred where she noticed that a clear liquid with blood leaked and dripped down her arm at about 5 inches. The seriousness reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.