chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Her temperature it was 101.5; Crashing headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 13-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EW0217) via an unspecified route of administration on 25Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received historical vaccine of first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number not reported) via unspecified route of administration on unspecified date as a dose 1 single for covid-19 immunisation. The patient experienced crashing headache on Jun2021, her temperature it was 101.5 on 26Jun2021. Therapeutic measures were taken as a result of crashing headache, her temperature it was 101.5. The patient underwent lab tests and procedures which included body temperature 101.5 on 26Jun2021. The outcome of the event headache was not recovered, and the outcome of the events pyrexia was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Illness, Palpitations
Clinical narrative: I was sick for 3 days; now I have a lot of heart palpitations and irregular beats. Way more than prior to the vaccines.; I have a lot of heart palpitations and irregular beats.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 39-year-old female patient (Non-Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot Number: EW0178) via an unspecified route of administration in arm left on 28May2021 12:00PM (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. Medical history included cardiomyopathy from an unknown date and unknown if ongoing and known allergies included Penicillin from an unknown date and unknown if ongoing. Concomitant medications included patient received within 2 weeks of vaccination, metoprolol tartrate (METORPOLOLTARTRAAT A); ethinylestradiol, norgestimate (TRI-SPRINTEC); vitamins nos (DAILY VITAMINS); valeriana officinalis root, valeriana officinalis root extract (VALERIAN ROOT EXTRACT), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot Number: EW0175), administration on 07May2021 12:00 PM in Left arm as first dose, single for COVID-19 immunisation and experienced a very sore arm for the 1st shot, had aches in her bones which started like working out aches and turned into flu aches the next day. 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. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021 at 12:00 AM, it was reported that after the 2nd dose patient was sick for 3 days and now she had a lot of heart palpitations and irregular beats and was more than prior to the vaccines. Now it was a daily occurrence. No treatment was received. The clinical outcome of the event was not recovered. Case seriousness was reported as No.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Pain in my shoulder; Numbness in my arm; feel like tingling sensation moving to my arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose (Lot Number: EW0217) administered in arm left (left shoulder as reported) on 05Jun2021 as dose1, single and second dose (Lot Number: EW0191) administered in right arm (right shoulder as reported) on 26Jun2021 at 11:00 A.M, as dose 2 single both via an unspecified route of administration for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No prior vaccinations (Within 4 weeks). Patient stated, "I have like pain in my shoulder and numbness in my arm in Jun2021" Patient further stated, "So I basically taken the Pfizer vaccine Saturday afternoon and I really started feeling it Sunday morning but I didn't pay any attention to it because I felt the pain as when I got my first shot in my left arm so I didn't take any medication, but when I woke up in the morning I was like oh you know my arm, I can't feel it, it was really numb and it really feel like a tingling sensation moving to my arm in Jun2021. I just need a second opinion, because I called my doctor they told me to go to ER. I am kind of having same reaction in my right arm that I did have in my left arm it felt numb like if I like slept on it wrong or something and blood was trying to circulate through it. I got feel like any pain but it was really numb, I was just trying to figure is this like any side effect or I should go to ER like emergency room." No treatment received for events. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; This is a spontaneous report from a Pfizer sponsored program. This consumer reported adverse events with similar suspect for 4 patients. This report is One of four patients. This consumer (patient) reported that: 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 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated. Exposure could not have occurred before Monday 21Jun2021 and symptom onset (all positive tested individuals were symptomatic) was by 25Jun2021. We are all researchers and recognize the impossibility of this not being a variant. I am totally willing to participate in any studies that might help understand variants and the efficacy of the vaccine on them. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Jun2021. The outcome of the event Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; This is a spontaneous report from a contactable consumer via Pfizer sponsored program via contactable consumer reported for an unknown patient (colleague #1 of 3).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Jun2021, four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated. Exposure could not have occurred before Monday 21Jun2021 and symptom onset (all positive tested individuals were symptomatic) was by 25Jun2021. We were all researchers and recognized the impossibility of this not being a variant. Reporter was totally willing to participate in any studies that might help understand variants and the efficacy of the vaccine on them. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 25Jun2021.The clinical outcome of the events was reported as unknown.  Information about batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration on Jun2021 as unknown single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that four of my colleagues (including myself) reporter's colleagues (including reporter) have contracting COVID within a week despite all having been vaccinated. Exposure could not have occurred before Monday 21Jun2021 and symptom onset (all positive tested individuals were symptomatic) was by 25Jun2021. They all were researchers and recognize the impossibility of this not being a variant. Consumer was totally willing to participate in any studies that might help understand variants and the efficacy of the vaccine on them. The patient underwent lab tests and procedures which included SARS-COV-2 test which was positive on 25Jun2021. The outcome of event was unknown.   Information on the lot/batch number has been requested. .
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye swelling, Lip swelling
Clinical narrative: moderate swelling up into the eyes down to the oral commissures; moderate swelling up into the eyes down to the oral commissures; This is a spontaneous report from a contactable other hcp. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 43-year) on 29May2021 as dose 1, single for COVID-19 immunization. The patient was injected with 1mL Restylane to the nasolabial fold areas on 08Jun2021. The patient medical history and Concomitant medication were not reported. The patient previously took Desyrel and experienced drug hypersensitivity (allergy to Desyral). Patient has not had other vaccines or dental procedures in the past 6-12 months, and she did not have any illness the month prior to her treatment. On 08Jun2021 the patient experienced moderate swelling up into the eyes down to the oral commissures. She was prescribed Elocin 0.1% cream on 08Jun2021. The events were ongoing. The clinical outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Cough, Hiatus hernia, Hypoaesthesia, Pain in extremity
Clinical narrative: Dry cough; Arm down to his thumb it goes numb not all the time just happen 2 or 3 times a day/Numbness; Hiatal hernia; Arm where the injection went in, it hurt him; tingling; This is a spontaneous report received from a contactable consumer (patient fiancee) via Pfizer sponsored program. A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration, administered in right arm on 02Apr2021 13:00 as dose 2, single for COVID-19 immunization. Medical history and Concomitant medications were not reported. No prior vaccinations (within 4 weeks). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6199) in right arm on 12Mar2021 01:00 PM for COVID-19 immunization. It was reported that patient after having the second dose now has the dry cough and his arm bothers him and occasionally has numbness in Apr2021. Reporter stated the concern, "Ok, his arm where the injection went in, it hurt him for a while in Apr2021 I don't think it hurt him now, but what happen was he got this straight down the line on his arm down to his thumb it goes numb not all the time just happen 2 or 3 times a day may be and was tingling in Apr2021, but it only come back he was been to ours family physician and he got this dry cough it only happen after the second dose I don't think it happen immediately after and it was not a dry cough, it was not his lung or anything. He had a CAT (Computerised tomogram) scan the other day and that came back negative in Apr2021 except he has a high hiatal hernia in Apr2021 that was it but no cancer nothing else strong and he got this dry cough and I don't know it was associated with the vaccine." Later she says it was not really like a cough but having to clear his throat. He was given amoxicillin the first time he went to the doctor, 125mg on 29Apr2021 for 20 pills, he took them all, once a day. He was given something else next time he went to the doctor, which was 5 to 6 pills but it still didn't go away. Patient visited to Physician Office for adverse events. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Dry cough; Arm down to his thumb it goes numb not all the time just happen 2 or 3 times a day/Numbness; Hiatal hernia; Arm where the injection went in, it hurt him; tingling; This is a spontaneous report received from a contactable consumer (patient fiancee) via Pfizer sponsored program. A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration, administered in right arm on 02Apr2021 13:00 as dose 2, single for COVID-19 immunization. Medical history and Concomitant medications were not reported. No prior vaccinations (within 4 weeks). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6199) in right arm on 12Mar2021 01:00 PM for COVID-19 immunization. It was reported that patient after having the second dose now has the dry cough and his arm bothers him and occasionally has numbness in Apr2021. Reporter stated the concern, "Ok, his arm where the injection went in, it hurt him for a while in Apr2021 I don't think it hurt him now, but what happen was he got this straight down the line on his arm down to his thumb it goes numb not all the time just happen 2 or 3 times a day may be and was tingling in Apr2021, but it only come back he was been to ours family physician and he got this dry cough it only happen after the second dose I don't think it happen immediately after and it was not a dry cough, it was not his lung or anything. He had a CAT (Computerised tomogram) scan the other day and that came back negative in Apr2021 except he has a high hiatal hernia in Apr2021 that was it but no cancer nothing else strong and he got this dry cough and I don't know it was associated with the vaccine." Later she says it was not really like a cough but having to clear his throat. He was given amoxicillin the first time he went to the doctor, 125mg on 29Apr2021 for 20 pills, he took them all, once a day. He was given something else next time he went to the doctor, which was 5 to 6 pills but it still didn't go away. Patient visited to Physician Office for adverse events. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Sluggishness
Clinical narrative: it was just mild fever; Pain in arm; sluggishness lasted for two days/sluggish for two days; she is very tired; This is a spontaneous report from a contactable consumer (parent). A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196, 14-years-old at the time of vaccination), intramuscular, administered in arm left on 26Jun2021 10:30 as single for covid-19 immunisation. Medical history included asthmatic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma. Patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186, at the age of 14-year-old), intramuscular, administered in arm left on 21May2021 12:30 as single for covid-19 immunisation and experienced four days late for her monthly menstrual cycle. On an unknown date in 2021 patient experienced mild fever, pain in her arm, sluggishness lasted for two days and she was very tired and sluggish for two days. Patient did not receive any treatment for the events. On an unknown date in 2021 events were resolved.  Follow-up attempts are needed. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: patient was sick; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 02Jun2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. Patient got the first dose of the Pfizer vaccine 02Jun2021. However, the patient was sick on unspecified date in Jun2021 and was not able to get the second dose. Reporter's daughter (patient) missed the second dose. Second dose was scheduled 23Jun2021. 21 days after the 1st dose. Caller wanted to know when patient can get the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate increased
Clinical narrative: increased BP 148/102; having feeling of rapid heart beat; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6207, expiry date was not reported) via unspecified route of administration, in the left arm, on 25Jun2021 at 10:45 (at the age of 42-years-old) as a single dose, for COVID-19 immunization. The patient's medical history included hypothyroidism, relevant past drug history included Bactrim, allergies to Bactrim, unknown start and stop dates, unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN, strength: 88mcg) for unspecified indication. On 28Jun2021 at 03:00, patient started having feeling of rapid heartbeat and increased BP 148/102. Patient did not receive any treatment for events. Patient did require a visit to doctor or other healthcare professional office/clinic for events. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. Reporter assessed the events as non-serious. The patient underwent the lab tests and procedure included blood pressure measurement and was 148/102 on 29Jun2021. Outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood glucose, Blood pressure measurement, Headache, Inflammation, Pain
Clinical narrative: inflammation; extreme pain; headaches; This is a spontaneous report from a contactable consumer (patient) received from a Xelsoure. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for covid-19 immunisation; tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Lot number was not reported) to an unspecified date, at 5 mg tablets for an unspecified indication. Medical history included blood pressure - also taking a medication for blood pressure. On an unspecified date Apr2021, after the shot of vaccine the patient experienced inflammation and extreme pain. so, patient did go off of it for a while so she have some extra pills and also experienced headache so her doctor also told her to go off. The patient off it for about a week or also been monitoring her blood pressure. The doctor also put her on a diuretic for having to go to the bathroom a lot. She just started taking it, but she hasn't noticed much of a difference. She also taking a medication for blood pressure and what her doctor said was a water pill, and she had noticed that it has raised her blood sugar up a bit so she also watching that. The patient underwent lab tests and procedures which included blood sugar Level: raised- raised her blood sugar up a bit , blood pressure measurement: unknown -Monitoring blood pressure. Therapeutic measures were taken as a result of events. Outcome of events was unknown.   Information on Lot/Batch information has been requested
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruise from first dose; This is a spontaneous report received from a contactable consumer reported for a female patient. The consumer reported on two patients one is husband and one is wife. Report 1 of 2. This is the report on the wife. This report was not related to a study or programme. A 27-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0217; Expiration Date: Sep2021), via an unspecified route of administration, administered in Arm Left on 04Jun2021 (at the age of 27-year-old), as single for covid-19 immunisation. Medical history included anaemia. Family medical history relevant to events was none. The patient concomitant medications were not reported. Additional Vaccines administered on Same date of the Pfizer Suspect was none. The patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The events following prior vaccinations were none. On 18Jun2021, the patient experienced bruise from the first dose. Reporter stated that patient had a bruise from the first dose, but it was starting to fade, it was non concerning. The event did not require a visit to emergency Room and Physician office. The relevant tests were none. Reporter stated that the patient was in the hospital recently, but it was for a panic attack due to a paperwork issue as far as the reporter know. The patient was resolving from the event at the time of this report.  Follow up needed, further information has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021810425 Same reporter/ drug, different patient/ AE
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to vaccine; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (BNT162B2), first single dose intramuscularly on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation.  Medical history included inflammation and immune system attacks itself. The patient's concomitant medications were not reported. The patient previously used diphenhydramine hydrochloride (BENADRYL), calcitonin, losartan, smallpox vaccine. The patient experienced allergy to vaccine on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Muscle spasms, Peripheral swelling, Thrombosis, Ultrasound Doppler
Clinical narrative: blood clot right leg in groin area; cyst in left leg behind the knee; Both of her legs started swelling up; muscle spasms in her leg; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0182) via unspecified route of administration in in left upper arm on 09Jun2021 at 11:00am, at patient age of 58-year-old, as a single dose for COVID-19 immunisation. The patient medical history included Covid-19 in Oct2020.  The patient concomitant medications was none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number RA7886) via unspecified route of administration on 19May2021 at 11:00am, at patient age of 58-year-old as a single dose for COVID-19 immunisation and experienced diarrhea. In Jun2021, the patient experienced blood clot right leg in groin area, cyst in left leg behind the knee. This is affecting her health and she has a lot of bills racking up. She had not had any blood clots or anything like this till after the shots. Blood clot and Cyst occurred around the same time. Both of her legs started swelling up. She went to the doctor on 14Jun2021 since both legs were swollen and it would not go away. They did an ultrasound of the vein, a test called HCUS vein extremity was done. She had another test called a DUP scan and one called XTR vein complete. When querying results, she reported that one of the tests found the main clot and then went into check that there was nothing missed. She did not know exactly when the blood clot and cyst started but 14Jun2021 is when it started to take a toll on her body. She knew it did not feel right but did not know why.  She was fine before that. Regarding cyst outcome, she can see and feel it more. Sometimes it gets to where if someone were to put their hands around her leg and squeeze real tight with pressure, it is very odd. As treatment, she was on an acetylsalicylic acid (BABY ASPIRIN). She has an appointment made to see a specialist for medical oncology and hematology. Since the second shot she had muscle spasms in her leg so bad that even when she stood up, she could not get it to stop, it was so painful and never had anything like that before. The events did not require a visit to emergency room, but required a visit to physician office. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: blood clot right leg in groin area; cyst in left leg behind the knee; Both of her legs started swelling up; muscle spasms in her leg; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0182) via unspecified route of administration in in left upper arm on 09Jun2021 at 11:00am, at patient age of 58-year-old, as a single dose for COVID-19 immunisation. The patient medical history included Covid-19 in Oct2020.  The patient concomitant medications was none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number RA7886) via unspecified route of administration on 19May2021 at 11:00am, at patient age of 58-year-old as a single dose for COVID-19 immunisation and experienced diarrhea. In Jun2021, the patient experienced blood clot right leg in groin area, cyst in left leg behind the knee. This is affecting her health and she has a lot of bills racking up. She had not had any blood clots or anything like this till after the shots. Blood clot and Cyst occurred around the same time. Both of her legs started swelling up. She went to the doctor on 14Jun2021 since both legs were swollen and it would not go away. They did an ultrasound of the vein, a test called HCUS vein extremity was done. She had another test called a DUP scan and one called XTR vein complete. When querying results, she reported that one of the tests found the main clot and then went into check that there was nothing missed. She did not know exactly when the blood clot and cyst started but 14Jun2021 is when it started to take a toll on her body. She knew it did not feel right but did not know why.  She was fine before that. Regarding cyst outcome, she can see and feel it more. Sometimes it gets to where if someone were to put their hands around her leg and squeeze real tight with pressure, it is very odd. As treatment, she was on an acetylsalicylic acid (BABY ASPIRIN). She has an appointment made to see a specialist for medical oncology and hematology. Since the second shot she had muscle spasms in her leg so bad that even when she stood up, she could not get it to stop, it was so painful and never had anything like that before. The events did not require a visit to emergency room, but required a visit to physician office. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Palpitations
Clinical narrative: chest pain; racing heat and palpitation; elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. Medical history included flu every 5 to 7 years. Prior to the vaccine he never had chest or other issues. Patient had blood pressure was not high before. The patient's concomitant medications were not reported. After three days her first vaccine (on an unknown date) in the evening, patient had chest pain, racing heart and palpitation. He had his physical two days later he let my doctor know about it. At that time these side effects were not known. He told his doctor about racing heart rate and elevated blood pressure. The patient underwent lab tests and procedures which included blood pressure: elevated. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood magnesium, Blood pressure increased, Blood pressure measurement, Blood test, Cerebrovascular accident
Clinical narrative: Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram, Full blood count, Gait disturbance, Glycosylated haemoglobin increased
Clinical narrative: Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Heart rate, Heart rate increased, Hypoaesthesia, Limb discomfort
Clinical narrative: Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging neck, Metabolic function test, Troponin
Clinical narrative: Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Walking disability
Clinical narrative: Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Gait inability, Illness, Loss of personal independence in daily activities
Clinical narrative: Pericarditis; extreme chest pain; had to sleep sitting up; couldn't breath; couldn't walk or talk; couldn't walk or talk; fever; couldn't function for weeks; it was painful; She has been sick; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on 07Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 Immunization. On 11Mar2021, 4 days after second vaccination, the patient had extreme chest pain after walking on a flat walk that she normally does and she reports walking trail is nothing new to her. Patient also reports patient is 61-years-old, and she's going to have aches and pains and she has to get over it, and went home. It kind of passed. And then patient was diagnosed with Pericarditis. Patient states that she couldn't breath, couldn't walk or talk, and had a fever. She states she couldn't function for weeks, it was painful and she had to sleep sitting up. On an unspecified date in Mar2021, patient has been very very sick. It was reported patient used to work in clinical trials and she knows we need the information and it is important. Reporter does not wish to complete a safety report because she believes her husband might have completed one already and Reporter would like to know if are we receiving reports of women experiencing this or is it only adolescent boys. The outcome of event for Pericarditis was Not recovered, and rest of the events was taken as Unknown.   Information about lot/batch number cannot be obtained. Additional information has been requested.  Follow-up attempts are completed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pericarditis, Pyrexia, Sleep disorder, Speech disorder
Clinical narrative: Pericarditis; extreme chest pain; had to sleep sitting up; couldn't breath; couldn't walk or talk; couldn't walk or talk; fever; couldn't function for weeks; it was painful; She has been sick; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on 07Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 Immunization. On 11Mar2021, 4 days after second vaccination, the patient had extreme chest pain after walking on a flat walk that she normally does and she reports walking trail is nothing new to her. Patient also reports patient is 61-years-old, and she's going to have aches and pains and she has to get over it, and went home. It kind of passed. And then patient was diagnosed with Pericarditis. Patient states that she couldn't breath, couldn't walk or talk, and had a fever. She states she couldn't function for weeks, it was painful and she had to sleep sitting up. On an unspecified date in Mar2021, patient has been very very sick. It was reported patient used to work in clinical trials and she knows we need the information and it is important. Reporter does not wish to complete a safety report because she believes her husband might have completed one already and Reporter would like to know if are we receiving reports of women experiencing this or is it only adolescent boys. The outcome of event for Pericarditis was Not recovered, and rest of the events was taken as Unknown.   Information about lot/batch number cannot be obtained. Additional information has been requested.  Follow-up attempts are completed; information about lot/batch number cannot be obtained