chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Ear injury, Epistaxis, Haemoglobin
Clinical narrative: nosebleed for 4.5 hours; blood pressure was 218/170; left side ear also split on the outside and bled the next day; left side ear also split on the outside and bled the next day; This is a spontaneous report from a contactable consumer (the patient). This 41-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 05Mar2021 19:15 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included nasal polyps and high blood pressure. Concomitant medications included losartan (manufacturer unknown), loratadine (CLARITINE), mometasone furoate (FLONASE), amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and ibuprofen (ADVIL); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 20:00, the patient experienced "nosebleed for 4.5 hours" requiring an emergency room visit and treatment of 'Rhino Rocket' (nasal packing kit). On 07Mar2021, her "blood pressure was 218/170". On an unspecified date in Mar2021, her "left side ear also split on the outside and bled the next day". The clinical course was described as follows: "my nosebleed was so bad that I had to go in an ambulance to the hospital. My blood pressure was 218/170.  All bloodwork was good, platelets/hemoglobins/etc. My nose bled for 4.5 hours. I had to get a 'Rhino Rocket' to stop the bleeding. I have never had a bloody nose like this before. I do have nasal polyps. A nurse I work with, who also has nasal polyps, had the same thing happen after her second dose. This happened to me 48 hours, to the hour, after my first dose. It was my left nostril and I had the first dose in my left arm. My left side ear also split on the outside and bled the next day. There was no cut. I did second dose, 31Mar2021, in right arm and had no reactions. I have had no issues since. I am a huge advocate of your vaccine." The clinical outcome of the events "nosebleed for 4.5 hours", "blood pressure was 218/170", and "left side ear also split on the outside and bled the next day" was resolved in Mar2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Platelet count, Wound haemorrhage
Clinical narrative: nosebleed for 4.5 hours; blood pressure was 218/170; left side ear also split on the outside and bled the next day; left side ear also split on the outside and bled the next day; This is a spontaneous report from a contactable consumer (the patient). This 41-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 05Mar2021 19:15 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included nasal polyps and high blood pressure. Concomitant medications included losartan (manufacturer unknown), loratadine (CLARITINE), mometasone furoate (FLONASE), amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and ibuprofen (ADVIL); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 20:00, the patient experienced "nosebleed for 4.5 hours" requiring an emergency room visit and treatment of 'Rhino Rocket' (nasal packing kit). On 07Mar2021, her "blood pressure was 218/170". On an unspecified date in Mar2021, her "left side ear also split on the outside and bled the next day". The clinical course was described as follows: "my nosebleed was so bad that I had to go in an ambulance to the hospital. My blood pressure was 218/170.  All bloodwork was good, platelets/hemoglobins/etc. My nose bled for 4.5 hours. I had to get a 'Rhino Rocket' to stop the bleeding. I have never had a bloody nose like this before. I do have nasal polyps. A nurse I work with, who also has nasal polyps, had the same thing happen after her second dose. This happened to me 48 hours, to the hour, after my first dose. It was my left nostril and I had the first dose in my left arm. My left side ear also split on the outside and bled the next day. There was no cut. I did second dose, 31Mar2021, in right arm and had no reactions. I have had no issues since. I am a huge advocate of your vaccine." The clinical outcome of the events "nosebleed for 4.5 hours", "blood pressure was 218/170", and "left side ear also split on the outside and bled the next day" was resolved in Mar2021.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Her heart was racing for 3 hours in the middle of the night.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced her heart was racing for 3 hours in the middle of the night. Patient stated she received the first shot on Thursday, 01Apr2021. Then on 02Apr2021 and 03Apr2021 her heart was racing for 3 hours in the middle of the night. She had this again on Sunday and Wednesday. This was early in the morning at like 5:00 in the morning. She had 2 events Sunday going into Monday. She went to see her GP but he said she needed to see a cardiologist. She had to go to the ER that Wednesday night but it was gone by the time she got there. That was the last event. It has not happened since then. She stated she has to assume it was from the shot. She exercises every morning, has never had any heart problems and has low blood pressure so this is out of character and thinks it is linked to the vaccine. She has a history of a pretty robust immune system. She stated she had a heart monitor and nothing happened. She was supposed to take the second dose on 22Apr2021 but delayed it and would prefer to wait to get more testing done before she gets the second dose. She stated she could probably get it past the 42 days if she needed to. She stated she wanted to take it but does not want to have a heart attack. She stated she knows we are collecting safety data and we have to have some information. She stated she knows she was not the only one reporting cardiac symptoms. She stated there is an article of heart muscle inflammation after the Pfizer Covid vaccine. She asked for more information on these types of symptoms and reports of it. She asked how long would it take until an antibody test would show up positive so she can see if she is protected after one dose? CDC stated that antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. The adverse event resulted in emergency room visit. The outcome of the event was reported as recovered on unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Palpitations
Clinical narrative: heart palpitations; shortness of breath; headaches; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer sponsored program regulatory authority.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that it has been over two weeks since his/her second dose of the Covid 19 vaccination and from an unspecified date he/she continued to have heart palpitations, headaches and fatigue as well as shortness of breath. Patient was concerned that these side effects are lasting so long and wanted advise. The outcome of all the events was not recovered.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Toothache
Clinical narrative: terrible taste/some odd taste on her mouth (salty like)/mouth taste really strange/bad taste in my mouth; also aching in her tooth and tingling on her lips; also aching in her tooth and tingling on her lips; This is a spontaneous report from a contactable retired nurse (patient). A 71-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8732; Expiration Date: 31Jul2021, NDC and UPC number was unknown), via an unspecified route of administration on 31Mar2021 as dose 2, single (at the age of 71-years-old) for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included tamoxifene citrate taken for cancer, start and stop date were not reported. Historical vaccine included patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206 and Expiration Date: 30Jul2021, NDC and UPC number was unknown), via an unspecified route of administration on 10Mar2021, as dose 1, single (at the age of 71-years-old) for covid-19 immunisation. Patient stated she saw on the news a couple days before she received the second dose that people had been complaining of their mouth being full of metal and nickel after the vaccine. On 31Mar2021, since her vaccination, patient had terrible taste, odd taste in her mouth (salty like), really bad taste in my mouth, mouth taste really strange, her lips kind of like salty all the time and also had aching in her tooth and tingling on her lips. Patient had no idea what to do, she gone to infectious disease doctor, she had no idea no idea, she mentioned that she had just gotten her vaccine, doctor said well it might be but you knows nobody knows we were in pandemic. Patient stated that she also had an endoscopy this past Wednesday (28Apr2021) at the hospital. Patient stated that odd taste in her mouth was still persisting today (04May2021), and she doesn't know when it will go away. Causality reported by the patient, patient stated that it must be, it had to be, because nothing else in her life had changed, and when she got the second dose then she had this odd taste in her mouth, that she thought it will go away and it had not yet. Patient would like to know if these side effects had been reported before, like to know if her side effects were caused by the vaccine how long will it last. Patient stated that it was not fun to eat anymore due to the taste in her mouth and was concerned about an odd taste in her mouth. The outcome of terrible taste/some odd taste on her mouth (salty like)/mouth taste really strange/bad taste in my mouth was not recovered and unknown for rest of the events.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Lymphadenopathy, Mass, Pain
Clinical narrative: Underneath my ear and in front of my ear like a gland swollen; Huge lump in front of ear goes from middle of ear down to jaw where bottom of gland have pain; Huge lump in front of ear goes from middle of ear down to jaw where bottom of gland have pain; Pain in cheek; This is a spontaneous report from a contactable consumer or other non hcp.     A 55-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8729), dose 1 via an unspecified route of administration on 03Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included omeprazole (PRILOSEC). It was Reported, consumer stated, got my first vaccine on (03Apr2021) and after my first vaccine I had my, underneath my ear and in front of my ear, had like a gland that was swollen, so she thought like and it is said that you know that it's like normal that your gland swell. Gone for my second vaccine today actually had to leave right now had to drove for three hours and also had pain again and it's like a huge lump in front of my ear goes from the middle of my ear down to my jaw and where my jaw is like where your gland at the bottom of jaw there that's where the pain. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus inadequate control
Clinical narrative: Uncontrollable blood sugar for several weeks since getting initial shot.; This is a spontaneous report from a contactable consumer or other non hcp.  A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: Unknown) at the age of 24 years, as DOSE 1, SINGLE for COVID-19 immunization.  Medical history included Juvenile Diabetes (Type I). It was unknown if the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It was reported that the patient experienced uncontrollable blood sugar for several weeks since getting initial shot, on an unspecified date. The event was reported as non-serious. No treatment was received for the event. The clinical outcome of the event was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in left hand; numbness/tingling in face; numbness/tingling in face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0173) via an unspecified route of administration in the left arm on 01May2021 at 10:00 (at the age of 55-years-old) 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 at 10:15, the patient experienced numbness in left hand immediately after shot and numbness/tingling in face for 1 hour after shot. The clinical outcome of the event numbness in left hand was resolved on an unknown date in May2021; while that of numbness/tingling in face was resolved on 01May2021 at 11:15, after the duration of 1 hour.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Palpitations
Clinical narrative: Exhausted; Heart was racing so bad, it was ridiculous; heart was racing terrible; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself.  A 63-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW01770, Expiration date: unknown), via intramuscular, administered in left arm on 24Apr2021 (at the age of 63-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history includes thyroid disorder and concomitant medications include levothyroxine.  On 27Apr2021, 3 days after the vaccination, the patient experienced heart racing so bad, it was ridiculous, and she knew it does like afterwards that heart could be raising but she had no idea that is the only thing that she could attribute. She was there in the bed and her heart was racing terrible. In the next morning she woke up she was exhausted. Consumer said she wanted to report because there was no other reason for heart would be racing like that, so she just thought it had to be a side effect from Pfizer and she never had this before. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nerve compression, Neuralgia
Clinical narrative: extreme nerve pain  in lower spine/back while sitting.; left leg became extremely weak and could not lift it; spinal nerve compression; This is a spontaneous report from a non-contactable consumer (patient). This 56-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8735) via an unspecified route of administration on 28Apr2021 at 10:00 (at the age of 56-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included autoimmune disorder, chronic kidney disease stage 2 (CKD2), anemia, peanut allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number ER8734) on 05Apr2021 as a single dose for COVID-19 immunization. The patient previously received penicillin and prochlorperazine (COMPAZINE) from unknown dates for  unknown indications and experienced allergy. On the third day after the shot (01May2021) at 07:00 the patient experienced extreme nerve pain in lower spine/back while sitting. It got worse over several days and the left leg became extremely weak. She could not lift it. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited urgent care as a result of the events and was diagnosed with spinal nerve compression of unknown cause. The patient received treatment with an anti-inflammatory shot, prednisone, and pain reliever. The outcome of spinal nerve compression of unknown cause was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: her sister received the pfizer covid-19 vaccine and began to experience palpitations; This is a spontaneous report from a contactable Other Health Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported her sister received the pfizer covid-19 vaccine and began to experience palpitations on an unspecified date. She declined to provide her sister's name and contact information. The outcome of event was outcome.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Bad body aches, particularly bottoms of feet; Bad body aches, particularly bottoms of feet; This is a spontaneous report from a contactable consumer. A female patient of unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in 2021, the patient had very bad body aches, particularly the bottoms of feet for 2 days. The clinical outcome of the events bad body aches, particularly bottoms of feet were resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Discharge
Clinical narrative: brown and red discharge; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04May2021(at the age of 32-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient previously took first dose of Covid-19 Vaccine(Covid-19 vaccine-Manufacturer Unknown: Lot number-unknown) as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 21:00 the patient experienced brown and red discharge. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event brown and red discharge was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Palpitations
Clinical narrative: Palpitation/Little bit of heart palpitations; Chest pain and pressure that lasted for a day; Chest pain and pressure that lasted for a day/Chest pressure; This is a spontaneous report received from a contactable consumer (Patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), Solution for injection, via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at the age of 51-year-old) as single dose for covid-19 immunisation. Medical history was reported as none. Family history was reported as none. The patient's concomitant medications were not reported. Patient did not receive any vaccine within four weeks prior to receiving Pfizer vaccine. Patient did not administer any additional Vaccines on Same Date of the Pfizer Suspect. On 16Apr2021, the patient experienced palpitation/little bit of heart palpitations, chest pain and pressure that lasted for a day. 51-year-old female stated that one day after receiving the first dose of the Pfizer Covid-19 vaccine on 15Apr2021 she experienced palpitation, chest pain and pressure that lasted for a day. She read an article that there were reports of heart enlargement after taking the second dose. Stated that after the first dose of the vaccine she was having a little bit of heart palpitations and chest pain. It went away the next day. She did not know if this was related to the vaccine. She stated that more than palpitations it was a chest pressure feeling. The symptoms began the morning after her first dose of the vaccine. They were gone the day following that. She waited 15 minutes at the vaccination site after the vaccine to see if she had a reaction. She wasn't really expecting anything related to the vaccine to happen the day after the vaccine. Her second dose was scheduled for this Monday, 10May2021. The events were recovered on 17Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling cold, Nausea, Pain in extremity
Clinical narrative: The following morn I woke up with pain in my hips and legs. Lasted all day.; The following morn I woke up with pain in my hips and legs. Lasted all day.; By after dinner I was freezing, nauseous and weak.; By after dinner I was freezing, nauseous and weak.; By after dinner I was freezing, nauseous and weak. The next 2 days I was very weak.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 12:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy. The patients past drug was reported as no. Concomitant medications taken within two weeks prior to vaccination included Multi vitamin (unspecified), allergy pill (unspecified), vitamin d nos (VITAMIN D) and calcium (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following morning, on 30Apr2021 at 07:00, the patient woke up with pain in hips and legs. Lasted all day. By after dinner she was freezing, nauseous and weak. The next two days the patient was very weak. On the day of report, 04May2021, was the first day she felt fine since getting the shot. The clinical outcome of the event woke up with pain in hips and legs, by dinner was freezing, nauseous and weak was resolved on 04May2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dry mouth, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient was symptomatic tested positive for Covid-19 on 7/25 via Rapid Antigen Test; Patient was symptomatic tested positive for Covid-19 on 7/25 via Rapid Antigen Test; persistent dry mouth; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, administered in Arm Left on 14Apr2021 10:00 (at the age of 46yeas old, Lot Number: ER8730),and the second dose administered in Arm Left on 05May2021 10:00 (at the age of 46yeas old, Lot Number: EW0153) as single dose for covid-19 immunisation.  Medical history included Elevated prolactin. The patient was not pregnant.Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient previously took sulfa drugs and codeine and experienced Allergy.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination the patient was not diagnosed with COVID-19.The patient experienced persistent dry mouth on 09May2021 (21:00). She was not admitted to hospital and did not receive any treatment. As of 25Jul2021,it was reported that patient was symptomatic tested positive for Covid-19 on 25Jul2021(23:30) via Rapid Antigen Test. She received steroids, azithromycin as treatment due to it.Hospitalization Prolonged: No.It resulted in Doctor or other healthcare professional office/clinic visit.Since the vaccination, she has been tested for COVID-19, covid  test type post vaccination=Nasal Swab,and Negative on 26Jun2021, Positive on 25Jul2021. The outcome of the events was resolving.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got Covid after having the vaccine; Got Covid after having the vaccine; The initial case was missing the following minimum criteria: suspect product is not reported or specified. Upon receipt of follow-up information on 22Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's friend). An 84-year-old male age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6200), via an unspecified route of administration on an unspecified date (at the age of 84-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test and results unknown. On an unspecified date it was reported as the 84-year-old patient got COVID after having the vaccine. Reporter stated that the patient was tested for COVID the following week after the vaccine was administered. He was home for about 1 month and he was glad. Then After 1 month he went and got antibodies, they injected him with the antibody infusion as outpatient in unknown hospital. He was waiting to get the second dose of vaccine. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Having really intense heart palpitations yesterday and today; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: unknown, NDC number: unknown) via an unspecified route of administration on 04May2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 on an unspecified date at dose 1, single for covid-19 immunisation. On 06May2021 the patient experienced having really intense heart palpitations yesterday and today. Reporter stated, reporter had second shot on Tuesday reporter not sure if this is the right extension but reporter having really intense heart palpitations yesterday and today. And reporter just wondering if that's the normal side effect. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Feeling abnormal, Headache
Clinical narrative: Exactly after 2 hours after receiving the shot I became very dizzy and my body tingled.  The dizziness was the most concerning because I knew I would fall if I got up.  I was sitting down eating lunch; Exactly after 2 hours after receiving the shot I became very dizzy and my body tingled.  The dizziness was the most concerning because I knew I would fall if I got up.  I was sitting down eating lunch; The nausea came a little later and has stayed with me; feltsplotchy; States she felt herblood pressure lowering; she wouldn't have strength to stand up; She felt very weak; had a mildheadache; splotchy visIon; This is a spontaneous report from a contactable other HCP, the patient. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736) via intramuscular in left Arm on 09May2021 12:15 as DOSE 1, SINGLE (age at time of vaccination 54 years) for COVID-19 immunization. Medical history included migraines and mild arthritis. The patient had allergy to Sulfa. Concomitant medications included Betamethasone Dipropionate capsules (DIMETASONE) to level out hormone 20mg once to twice a day (taking this for years), Cetirizine Hydrochloride (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE], Zinc chloride and Multivitamin and Vitamin D. The patient previously received heptavax vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 (exactly after 2 hours after receiving the shot), the patient became very dizzy, and her body tingled. The dizziness was the most concerning because she knew she would fall if got up. The nausea came a little later, the severe dizziness was off and on for about an hour and a half, was lightheaded, had splotchy vision, felt her blood pressure lowering and not doing well, could not stand up, did not have the strength, mild headache and arms and legs tingled. The patient relevant test was none. The outcome of (Felt very weak, Nauseated and Arms and legs tingled, felt very weak) was recovered completely in 2021 and (paresthesia and dizzy) was recovering and (felt splotchy, Hypotension, headache and splotchy vision) was unknown.  Additional information has been requested and will be provided as it becomes available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Nausea, Paraesthesia, Visual impairment
Clinical narrative: Exactly after 2 hours after receiving the shot I became very dizzy and my body tingled.  The dizziness was the most concerning because I knew I would fall if I got up.  I was sitting down eating lunch; Exactly after 2 hours after receiving the shot I became very dizzy and my body tingled.  The dizziness was the most concerning because I knew I would fall if I got up.  I was sitting down eating lunch; The nausea came a little later and has stayed with me; feltsplotchy; States she felt herblood pressure lowering; she wouldn't have strength to stand up; She felt very weak; had a mildheadache; splotchy visIon; This is a spontaneous report from a contactable other HCP, the patient. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736) via intramuscular in left Arm on 09May2021 12:15 as DOSE 1, SINGLE (age at time of vaccination 54 years) for COVID-19 immunization. Medical history included migraines and mild arthritis. The patient had allergy to Sulfa. Concomitant medications included Betamethasone Dipropionate capsules (DIMETASONE) to level out hormone 20mg once to twice a day (taking this for years), Cetirizine Hydrochloride (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE], Zinc chloride and Multivitamin and Vitamin D. The patient previously received heptavax vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 (exactly after 2 hours after receiving the shot), the patient became very dizzy, and her body tingled. The dizziness was the most concerning because she knew she would fall if got up. The nausea came a little later, the severe dizziness was off and on for about an hour and a half, was lightheaded, had splotchy vision, felt her blood pressure lowering and not doing well, could not stand up, did not have the strength, mild headache and arms and legs tingled. The patient relevant test was none. The outcome of (Felt very weak, Nauseated and Arms and legs tingled, felt very weak) was recovered completely in 2021 and (paresthesia and dizzy) was recovering and (felt splotchy, Hypotension, headache and splotchy vision) was unknown.  Additional information has been requested and will be provided as it becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07May2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 07May2021 the patient experienced fever, chills, nauseated, diarrhea. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Itching/Rash and itching moved up legs, onto stomach and back.; Rash/Rash and itching moved up legs, onto stomach and back.; feet and hands red and swollen; feet and hands red; Throat tightness; Swallowing felt tight; This is a spontaneous report from a contactable other healthcare professional reporting for himself. A 46-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 12May2021 (Batch/Lot Number: EW0168) as single dose (at age of 46-years old) for covid-19 immunization. The patient concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot Number EW0153) via an unspecified route of administration, administered in Arm Right on 21Apr2021 as single dose for covid immunization. No other vaccine in four weeks, and no other Medications in two weeks. Patient was not diagnosed COVID prior to vaccination. No covid tested post vaccination. Known allergies reported none known. Other medical History was none. On 13May2021, the patient experienced less than 24 hours post 2nd shot, feet and hands red and swollen and itching. Rash and itching moved up legs, onto stomach and back. Throat tightness and swallowing felt tight. Continued for several days and had to seek medical treatment with steroids and hydroxyzine. Therapeutic measures were taken as a result of all events. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Itching/Rash and itching moved up legs, onto stomach and back.; Rash/Rash and itching moved up legs, onto stomach and back.; feet and hands red and swollen; feet and hands red; Throat tightness; Swallowing felt tight; This is a spontaneous report from a contactable other healthcare professional reporting for himself. A 46-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 12May2021 (Batch/Lot Number: EW0168) as single dose (at age of 46-years old) for covid-19 immunization. The patient concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot Number EW0153) via an unspecified route of administration, administered in Arm Right on 21Apr2021 as single dose for covid immunization. No other vaccine in four weeks, and no other Medications in two weeks. Patient was not diagnosed COVID prior to vaccination. No covid tested post vaccination. Known allergies reported none known. Other medical History was none. On 13May2021, the patient experienced less than 24 hours post 2nd shot, feet and hands red and swollen and itching. Rash and itching moved up legs, onto stomach and back. Throat tightness and swallowing felt tight. Continued for several days and had to seek medical treatment with steroids and hydroxyzine. Therapeutic measures were taken as a result of all events. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: Feeling lightheadedness and High Blood Pressure even after 10 days of 2nd dose; Feeling lightheadedness and High Blood Pressure even after 10 days of 2nd dose; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 06May2021 08:30 (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 15Apr2021 08:30 (at the age of 36-year-old) as dose 1, single for covid-19 immunisation and experienced hypertension. On an unspecified date in 2021, the patient experienced feeling lightheadedness and high blood pressure even after 10 days of 2nd dose. The patient underwent lab tests and procedures which included blood pressure measurement: 140/94 on 17May2021; Today my BP is around 140/94. The outcome of the events were not recovered.   Device Date : 17May2021  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Wrong product administered
Clinical narrative: second dose: really high fevers; She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 001C21A), via an unspecified route of administration on 21Apr2021 as dose 2, single for COVID-19 immunization. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273), Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included COVID-19 from on an unspecified date in Nov2020 to an unknown date (patient got the COVID virus from her brother in Nov2020). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 046A21A), via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced second dose: really high fevers on 21Apr2021, She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable on an unspecified date in 2021. Reporter is calling about the COVID 19 vaccine. She calling on behalf of her brother. While patient is reporting on her brother's experience with the Pfizer COVID 19 vaccine, caller states, it maybe be helpful. She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable but she was she was sick, only for the common 48-72 hours, she had really high fevers with both vaccine doses. Primary Care: She says the primary care doctor's information is the same for her as she provided for her brother. She did not go see him related to this but Pfizer would be welcome to contact him. Event details: Her first dose was given on 24Mar2021. Second dose given on 21Apr2021. With the first dose her fever started on 24Mar2021 and it has recovered completely at this point. She also got the COVID virus from her brother in Nov2020. She says the fever with her first dose went away on the third day, so it went away 27Mar2021. The second dose was 21Apr2021 and the fever began that night same day and lasted until 23Apr. It was high like 104 at multiple occasions. She confirm she has recovered completely from that fever. Product details: She reports lot number from her first dose 046A21A. Lot number from her second dose 001C21A. She does not see NDC or expiration dates. The patient underwent lab tests and procedures which included fever was 104 (high like 104 at multiple occasions) on 21Apr2021. Outcome of the event was recovered on 23Apr2021.  Follow-up (PRD/SRD 29Jul2021): No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-2021560230 similar report from same reporter
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fungal skin infection, Pruritus, Urticaria
Clinical narrative: bruise on my left upper thigh; fungal rash; itch; hives; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old male patient received bnt162b2 (PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered in Arm Left on 21Apr2021 09:15 (age at vaccination: 36-years-old) as dose2, single for covid-19 immunization. Medical history included asthma. Concomitant medication received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), loratadine, pseudoephedrine sulfate (CLARITIN D 12 HOUR) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within 4 weeks prior to the Covid vaccine. Prior to vaccination patient was not diagnosed with Covid-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 24Mar2021 01:15 PM for covid-19 immunization (age at vaccination: 36-years-old). It was reported that a day after second dose, on 22Apr2021 17:30 patient noticed a quarter size bruise on his left upper thigh. A few days later that bruise started to itch. About a week and a half there was bright red hive and bruising that spread all over his upper leg that had an extreme itch then same hives and bruising appeared on his right leg in same general area. His general physician doctor thought it was a fungal rash his treatment did not work then went to dermatologist there treatment of a steroid cream and antihistimine did not work then went to Emergency room where he was prescribed an oral steriod which has helped the itch but the rash/hives have still not gone away. We are going on 3.5 weeks and waiting on a biopsy. Patent was not tested for covid-19 Since the vaccination. Patient was not hospitalized for the event. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Steroid cream, Antihistamines, Oral steroid. Outcome for the events was not resolved at the time of this report.   Follow-up (19Jul2021 and 23Jul2021): Follow-up attempts completed. No further information expected.