chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Wheezing
Clinical narrative: she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1  via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm  from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work  due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Pain in extremity
Clinical narrative: extreme arm pain; shoulder pain; arm and shoulder pain/it was not really a soreness, it was an injury; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left shoulder or arm on 16Mar2021 15:00 (Lot Number: EN6200; Expiration Date: 30Jun2021) at single dose for COVID-19 immunization.  Medical history included sports injuries. Patient said he has had sports injuries, when he used to play tennis, but nothing on his left side. The patient's concomitant medication was none. Patient said they have not had any other recent vaccinations or started any new medications. He said there was a new med he thought he started before getting the first vaccine, it said March 30th, so it had to be in February that he started this, this was date for second dose, so he didn't think that there was anything close to second vaccine dose. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 58-year-old, administration on 23Feb2021 4:00 PM in left shoulder or arm (Lot number: EN6200, Expiration date: 30Jun2021) for COVID-19 Immunization. Patient has had vaccines all his life with no problems. He has had extreme arm pain mostly to his shoulder into his arm after he took the second shot dose roughly three weeks ago. He said that his arm and shoulder pain began 17Mar2021, and had lasted to today. He said it was not really a soreness, it was an injury. He said it had gotten a little worse the last couple of days. He said he stopped taking Aleve since you are not supposed to take that long because of bleeding problems. He was taking 4 a day for a week then stopped taking it. He said he was taking two in the morning and two at night, strength unknown. He said his pain was almost getting better, but it seemed worse since he stopped taking the Aleve. He said the pain affect what he normally did like tennis and yard work, it woke him in the middle of the night with pain, he was right handed. He said he also tried Bengay and things that didn't seem to work. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoaesthesia, Tinnitus
Clinical narrative: Loss of hearing in left ear; tinnitus/echoing; numbness around area of left ear; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old male patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: El3248), via an unspecified route of administration, administered in the left arm on 18Jan2021 as a single dose for COVID-19 immunization.  Medical history included Hashimoto's disease, high cholesterol and is prediabetic all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient did not have COVID prior to vaccintion and has not been tested for COVID post vaccination. Concomitant medications included empagliflozin (JARDIANCE); levothyroxine (manufacturer unknown); metoprolol (manufacturer unknown); rosuvastatin (manufacturer unknown) and fish oil (OMEGA 3 [FISH OIL]), all taken for an unspecified indication, start and stop date were not reported.  The patient previously received the first dose of bnt162b2 (lot number: Es1685) on 28Dec2020 at 12:00 PM via intramuscular route on the right arm for COVID-19 immunization. The patient experienced loss of hearing in left ear, tinnitus/echoing and numbness around area of left ear all on 22Mar2021 at 12:00. The ENT prescribed prednisone 10mg as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Loss of personal independence in daily activities, Myalgia, Off label use, Pain
Clinical narrative: muscle pain; generalized pain in left side of body mainly; doesn't allow her to walk or move; second dose on March 28th, 14 days after first dose; second dose on March 28th, 14 days after first dose; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 28Mar2021 at single dose for COVID-19 immunisation. She previously received the first dose on 14Mar2021 for COVID-19 immunisation and experienced injection site pain. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient called in requesting information about the symptoms she experienced post second dose administration of Pfizer's COVID-19 vaccine. She received the first dose on 14Mar2021 and second dose on 28Mar2021, 14 days after first dose. She only had injection site pain after vaccine first dose. After second dose she had muscle pain and generalized pain in left side of body mainly, described as deep pain that doesn't allow her to walk or move. She hasn't been able to communicate with physician. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed hives; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported same event for two patients.This is the second of two reports.  A 64-year-old female patient received first dose of BNT162B2via an unspecified route of administration in her arm (unknown know if right or left) on 26Mar2021 11:00 AM (Batch/Lot number and expiriaton date were not reported) as single dose for covid-19 immunisation. The patient medical history (including any illness at time of vaccination), family medical history relevant to event were none.     The patient's concomitant medications were not reported. Patient did not receive any prior vaccine within 4 weeks. In the middle of the night on 26Mar2021, patient experienced hives. Both she and her mother got BNT162B2 and both got hive. She had been taking Benadryl and the hives are ongoing. They had worsened for her. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) :  same reporter/event/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy
Clinical narrative: sick; lethargic; This is a spontaneous report from a contactable consumer via a company representative This is the first report for one of two female patients. A female patient received Pfizer COVID-19 Vaccine BNT162B2 on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced sick and feeling lethargic. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384159 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy
Clinical narrative: sick; lethargic; This is a spontaneous report from a contactable consumer via a company representative. This is the second report for one of two female patients. A female patient received Pfizer COVID-19 Vaccine BNT162B2 on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced sick and feeling lethargic. She did get to a doctor. No Emergency Room visit. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021384123 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Burning pain in back; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via an unspecified route of administration on unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced Burning pain in back. The outcome of the event was Unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Paraesthesia, Pruritus
Clinical narrative: they were extremely tired; felt their skin was itchy/tingly; felt their skin was itchy/tingly; They felt that they were having cold like symptoms; This is a spontaneous report from contactable consumer. An adult female patient received BNT162B2 second dose on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Pregnant at the time of vaccination was No. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient previously receive first dose of BNT162B2 on unspecified date for Covid-19 Immunisation. After the second dose was received, the patient mentioned that they were extremely tired and felt their skin was itchy/tingly in Mar2021. They felt that they were having cold like symptoms in Mar2021. The patient did not have any fever and the event only last a day or two. No treatment received for the adverse event. The outcome of the events was recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Insomnia, Lymph node pain, Mobility decreased
Clinical narrative: It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest; It is not comfortable and cannot rest; Pain and Soreness in left shoulder; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Right arm swollen/arm was swelling/right arm is swollen underneath and on top; her arm was swelling and really hurting; has not been able to sleep in about 2 days because of this; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0150) intramuscularly in left arm on 01Apr2021 10:00 at single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes diagnosed 3-4 years ago, blood pressure abnormal, and hiatal hernia. She has to take Prilosec for a hiatal hernia but has been taking it for years. Concomitant medications included omeprazole magnesium (PRILOSEC) for hiatal hernia, and blood pressure medication and diabetes medication. She previously received the first dose of BNT162B2 on 04Mar2021 (Lot EN6202) in right arm in the muscle for COVID-19 immunisation. She took the second one on Thursday and it was not bothering her until Friday night until Saturday morning. On 03Apr2021 05:00, it woke her up and it felt like it went in the muscle under her arm. It was real sore like lymph nodes are sore and she cannot lift her arm. She got the second shot on Thursday morning and that is what caused it. Sometime toward daybreak on Saturday morning is when she first felt that her arm was swelling and really hurting on 03Apr2021 05:00. Her right arm is swollen underneath and on top. On 04Apr2021 08:00, pain in left shoulder is like when old people say they have pleurisy in the back. She has not been able to sleep in about 2 days (Apr2021) because of this. No ER or physician's office required. She felt like going but did not took Ibuprofen. She thought it was going to be great because she did not have any symptoms, but this has whooped her. It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest. She read over the paperwork and saw that there were Lymph nodes and she wanted to know if there was anything she can do for it.  She is just taking blood pressure medication and diabetes medication and has been on them for several years. Event outcome of not comfortable and cannot rest, insomnia was unknown, while for others was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Restlessness
Clinical narrative: It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest; It is not comfortable and cannot rest; Pain and Soreness in left shoulder; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Right arm swollen/arm was swelling/right arm is swollen underneath and on top; her arm was swelling and really hurting; has not been able to sleep in about 2 days because of this; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0150) intramuscularly in left arm on 01Apr2021 10:00 at single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes diagnosed 3-4 years ago, blood pressure abnormal, and hiatal hernia. She has to take Prilosec for a hiatal hernia but has been taking it for years. Concomitant medications included omeprazole magnesium (PRILOSEC) for hiatal hernia, and blood pressure medication and diabetes medication. She previously received the first dose of BNT162B2 on 04Mar2021 (Lot EN6202) in right arm in the muscle for COVID-19 immunisation. She took the second one on Thursday and it was not bothering her until Friday night until Saturday morning. On 03Apr2021 05:00, it woke her up and it felt like it went in the muscle under her arm. It was real sore like lymph nodes are sore and she cannot lift her arm. She got the second shot on Thursday morning and that is what caused it. Sometime toward daybreak on Saturday morning is when she first felt that her arm was swelling and really hurting on 03Apr2021 05:00. Her right arm is swollen underneath and on top. On 04Apr2021 08:00, pain in left shoulder is like when old people say they have pleurisy in the back. She has not been able to sleep in about 2 days (Apr2021) because of this. No ER or physician's office required. She felt like going but did not took Ibuprofen. She thought it was going to be great because she did not have any symptoms, but this has whooped her. It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest. She read over the paperwork and saw that there were Lymph nodes and she wanted to know if there was anything she can do for it.  She is just taking blood pressure medication and diabetes medication and has been on them for several years. Event outcome of not comfortable and cannot rest, insomnia was unknown, while for others was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: temperature of 102/still has a fever of 101; This is a spontaneous report from a contactable female consumer (Patient) via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included breast cancer (breast cancer survivor) and concomitant medications were not reported. On an unspecified date, the patient had temperature of 102. She took Advil and still has a fever of 101 and wants to know since she isn't allowed to have Advil how does she bring down her temperature. The patient underwent lab tests and procedures which included Body temperature: 102 and 101. The outcome of the events was not recovered.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Felt like was fainting; Five to ten minutes after receiving the first dose I started feeling dizzy; numb (tingling) in my fingers.; numb (tingling) in my fingers.; I also started to sweat; my BP fell when the nurse checked.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Apr2021 12:45 (Lot Number: ER8737) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks or in two weeks.  There was no known allergies. The patient has no Covid prior vaccination and has no Covid tested post vaccination. After receiving the first dose, on 06Apr2021 13:00, the patient started feeling dizzy and numb (tingling) in his fingers. Felt like him was fainting. He also started to sweat and his BP fell when the nurse checked. The patient did not have a full breakfast or lunch before getting the dose. The patient had coffee in the morning with some dates and later had two oranges and a Kind Nut Bar. Drank some water and juice after the dizziness subsided. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken as a result of all the events. The outcome of events was resolved on unknown date.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Syncope
Clinical narrative: Felt like was fainting; Five to ten minutes after receiving the first dose I started feeling dizzy; numb (tingling) in my fingers.; numb (tingling) in my fingers.; I also started to sweat; my BP fell when the nurse checked.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Apr2021 12:45 (Lot Number: ER8737) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks or in two weeks.  There was no known allergies. The patient has no Covid prior vaccination and has no Covid tested post vaccination. After receiving the first dose, on 06Apr2021 13:00, the patient started feeling dizzy and numb (tingling) in his fingers. Felt like him was fainting. He also started to sweat and his BP fell when the nurse checked. The patient did not have a full breakfast or lunch before getting the dose. The patient had coffee in the morning with some dates and later had two oranges and a Kind Nut Bar. Drank some water and juice after the dizziness subsided. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken as a result of all the events. The outcome of events was resolved on unknown date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she came down with symptoms of covid and tested positive for covid; she came down with symptoms of covid and tested positive for covid; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. she had her 1st dose on 25Mar2021. she came down with symptoms of covid and tested positive for covid in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Wicked tired; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that on an unspecified patient received his first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown) on an unspecified route as a single dose for covid 19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient was wicked tired. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sinus disorder
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; he started with sinus issues but had no fever or chills; This is a spontaneous report from a contactable consumer (spouse). A male patient of an unspecified age, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 31Mar2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) on an unknown date. Reporter stated that she and her husband both received the second shot on 31Mar2021, right before noon. Her husband didn't get much, in regards to symptoms, and was feeling fine before the shot. 2 Days later (in Apr2021), he started with sinus issues but had no fever or chills and stated that these symptoms were expected. It was reported that her husband went to the walk in clinic on 5Apr2021 because he was worried it was Covid. He tested positive for COVID-19 but, it was not even 5 days after the shot. Went to the doctor's office yesterday (06Apr2021) and got another test at the doctor's office. That test came back positive as well and got the results on 07Apr2021. The patient went to the walk in clinic on Sunday because he didn't know if he should go to work on Monday. Stated that she does not know if the antibodies from the Pfizer vaccine are showing up on the test. It has been 5 days since the second test. Outcome of the events was unknown.  Information on lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the husband is positive for Covid; the husband is positive for Covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 16Mar2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Reporter stated that the mother-in-law had her first vaccine on 14Mar2021 and the mother-in-law's husband (patient) had his vaccine on 16Mar2021. Patient received first dose 16Mar2021 and tested positive for COVID, 2 days ago (05Apr2021). Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her husband tested negative for covid twice and then tested positive but has no symptoms; her husband tested negative for covid twice and then tested positive but has no symptoms; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated she was calling and could not find another number to call but her husband and she had their 1st doses of the Pfizer Vaccine; states her husband had his 1st dose on 19Mar2021 and she had her 1st dose on 25Mar2021. The consumer stated her husband tested negative for covid twice and then tested positive but has no symptoms in 2021. The consumer stated her husband has his appointment for the 2nd dose of the Pfizer Vaccine scheduled for Friday 09Apr2021 and he wants to change that. The patient underwent lab tests and procedures which included Covid which showed negative for twice and positive but has no symptoms on an unknown date in 2021. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Thrombosis, Ultrasound scan, Varicose vein
Clinical narrative: blood clot in her right ankle; varicose vein in her right ankle and it started to hurt; varicose vein in her right ankle and it started to hurt; ankle on her right side started swelling; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on arm left on 26Feb2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiry date: 30Jun2021) on left arm on 05Feb2021 for covid-19 immunisation. The patient experienced blood clot in her right ankle, varicose vein in her right ankle and it started to hurt, ankle on her right side started swelling, all on an unknown date. All events caused patient physician office visit. Treatment received for all events. It is reported that she is calling about the Covid 19 vaccine. She wanted to report that she developed a blood clot in her right ankle. She went to the doctor yesterday on 06Apr2021. She would like to add she has no prior history of any type of blood issues. The doctor she saw thought that the blood clot and the Covid 19 vaccine could be related but would not commit to saying so directly. She started having issues about 6 days after the second Covid 19 vaccine. She doesn't exactly remember when, maybe the 04Mar2021 or 05Mar2021. She ignored the issues attributing them to over exercising. She reached a point where she couldn't ignore the issues anymore and went to the doctor. Caller clarifies she has a varicose vein in her right ankle and it started to hurt then her ankle on her right side started swelling. She only payed attention to her ankle when it got worse. The last 3 weeks have been awful. She would like it known that she does not lead a sedimentary lifestyle. She rides her bike 60 miles a week and walks 10 miles a week. She's always moving. This is unusual for her. The doctor she saw diagnosed her with a blood clot and he did a sonogram in his office. She has been prescribed Xarelto 15mg tablets. Take 2 tablets twice daily for the first 21 days then on the 22nd day start taking one 20mg tablet once daily. The patient underwent lab tests and procedures which included sonogram: unknown result on 06Apr2021. The outcome of the all events was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Muscular weakness, Musculoskeletal discomfort, Pain
Clinical narrative: Pain started in left knee, and left hip; discomfort in left ankle; Left leg still weak and feels unstable; still achy; Left leg still weak and feels unstable/unstable; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 55-year-old on 26Mar2021 09:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included Restless Legs Syndrome. No known allergies. No covid prior vaccination. Concomitant medications included ropinirole and statin. The patient experienced pain started in left knee, and left hip. Very severe at times. Some lighter discomfort in left ankle. Left leg still weak and feels unstable. It's gotten a bit better, but still achy and unstable. Events onset date was all on 27Mar2021 11:00. AE resulted in Disability or permanent damage. No treatment received for the events. The outcome of events was reported as resolved with sequel.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope
Clinical narrative: Syncope and collapse 3 times; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 02Mar2021 (Batch/Lot Number: EN6199) as single dose for covid-19 immunization. Medical history included allergy to penicillin. Concomitant medication included amlodipine accept in two weeks. There was no other vaccine in four weeks. The patient experienced syncope and collapse 3 times on 06Mar2021, resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for syncope and collapse 3 times for 3 days. The patient has not covid prior vaccination, tested covid post vaccination. covid test type post vaccination was Nasal Swab, covid test date on 31Mar2021 with negative result. Therapeutic measures included potassium replenishment, rest and monitor were taken as a result of syncope and collapse 3 times. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer reporting for herself.  This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced a sore arm after her first dose, on an unknown date. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot.  Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,.  The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021.  The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Tremor
Clinical narrative: She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot.  Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,.  The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021.  The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Oral herpes
Clinical narrative: After the first shot/just a small cold sore/she got the second shot, she had cold sores all over her mouth/it was a pretty bad outbreak; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:00 as single dose, and second dose (Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 30Mar2021 13:15 as single dose for covid-19 immunisation. Medical history included cold sores ever since she was a little girl. The patient's concomitant medications were not reported. Patient thought she had a side effect from her COVID vaccine and she wanted to know if anyone else had it and then to report. After receiving the first shot, she got a cold sore the day after, on 09Mar2021, she didn't remember exactly how long it lasted, it was just a small cold sore, just a normal 7-10 day one, that's all it lasted. She never thought anything of it because she has gotten cold sores ever since she was a little girl. She recovered completely from the first one in Mar2021. Then she got the second shot, she had cold sores all over her mouth, this one was huge, on her bottom and top lip, tongue, like they were still there. It began 31Mar2021 and it's ongoing. The cold sore got worse when it started, then started to dry out and heal. Patient stated that it's in the drying and healing stage, as cold sores go. She supposed it is getting better, it still hurts and itches though. Since it is a pretty bad outbreak and so she's wondering if this is a side effect of this vaccine because she understands there will be boosters and perhaps will have to take it again next year. Patient had blood work done in between the first dose and the second dose in Mar2021. She is unsure of the blood tests or results, just the standard blood work. The event did not require a visit to emergency room or physician office. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks.  Outcome of the event was recovered in Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: both tested positive with Covid-19; both tested positive with Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number: Unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer mentioned that she and her husband had the first dose on 24Mar2021, and both tested positive with Covid-19. The patient tested positive on 06Apr2021. The consumer would like to know if it is okay for them to take the second dose on 14Apr2021. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal
Clinical narrative: my numbers went up; This is a spontaneous report received from a Pfizer sponsored program a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiry Date: Not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient administered Ibrance 100mg with an unknown start date and stop date: Not applicable. Patient verbally stated my numbers went up. Patient verbally stated I think it may be due to taking the COVID vaccine. Therapeutic measures taken as a result of events were not reported. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced shortness of breath with her second dose and had to go to the hospital for a week. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: she had the chills, fever; not feeling good at all; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) right before noon as single dose for covid-19 immunisation. Medical history included emphysema, blood clot issues and breast cancer. Patient also stated that it is that time of years, so thought it would be allergies. Concomitant medications were not reported. On 31Mar2021, after 8 hours of vaccination patient had fever chills and was not feeling good at all and that she expected this. Patient had heard from family members that it still could be from Covid in the body and do not know what to expect. She was confused and would like some help and guidance for "what should she expect" and "what should she do and the family members they have been around". She also clarified that this could be caused by the antibodies from the vaccine and declined to provide any further details for full report. The patient stated that she just wants side effects, want to know what to expect and to prevent the Covid virus. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Swollen Lymph node (under right armpit); Fever (up to at least 102); Muscle Aches; Fatigue; Headache (mild); This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 11:30 (Lot Number: EP-6955) at SINGLE DOSE in Arm Right for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 in Arm Right on 18Mar2021 11:00 (Lot Number: EP-6955) as SINGLE DOSE for covid-19 immunisation. The patient experienced Fever (up to at least 102), Muscle Aches, Fatigue, Headache (mild), Swollen Lymph node (under right armpit) from 06Apr2021 11:45 PM. The outcome was Recovering. No treatment received. No covid prior vaccination. No covid tested post vaccination. The events were assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Other. 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 has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen Lymph node (under right armpit); Fever (up to at least 102); Muscle Aches; Fatigue; Headache (mild); This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 11:30 (Lot Number: EP-6955) at SINGLE DOSE in Arm Right for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 in Arm Right on 18Mar2021 11:00 (Lot Number: EP-6955) as SINGLE DOSE for covid-19 immunisation. The patient experienced Fever (up to at least 102), Muscle Aches, Fatigue, Headache (mild), Swollen Lymph node (under right armpit) from 06Apr2021 11:45 PM. The outcome was Recovering. No treatment received. No covid prior vaccination. No covid tested post vaccination. The events were assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Other. 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 has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Mobility decreased
Clinical narrative: left knee started to ache/ bend my left knee fully without it paining.; Swelling/swelled up; was not able to bend the knee/cannot bend my left knee fully without it paining; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm as single dose for covid-19 immunisation, dose 1 on 28Feb2021 13:45 (Lot number EN6198), dose 2 on 21Mar2021 14:00 (Lot Number: EP-7534). Medical history included allergic to shell fish and pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 1st dose (outside the normal side effects), his left knee started to ache, swelled up and he was not able to bend the knee. Did not effect his right knee. The patient took Ibuprofen and iced to reduce swelling. The ache reduced but was still persistent. After the 2nd shot the situation worsened a bit and was still there. The patient could not bend his left knee fully without it paining. No treatment was received for the adverse event after second dose. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.