chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic, Blood pressure systolic increased, Body temperature, Dizziness, Nausea
Clinical narrative: blood pressure was as high as 155 (systolic); got up sluggish; nausea related to high BP; lightheaded; Low grade fever, his temperature went from 97.3 up to 99.2; Soreness in arm; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced blood pressure was as high as 155 (unit not provided) (systolic), got up sluggish and, nausea related to high BP on 07Mar2021, low grade fever, his temperature went from 97.3 up to 99.2, soreness in arm, lightheaded on an unspecified date in Mar2021. It was reported that, patient received his first dose of Pfizer-Biontech Covid19 vaccine on Saturday 06Mar2021. His blood pressure (BP) was as high as 155 (systolic) on Sunday (07Mar2021). Patient asked that had it been reported that being vaccinated can increase your blood pressure. Other adverse events reported included nausea related to high BP which resolved after taking his blood pressure medications, sore arm that had since resolved, and a low-grade fever of 99-degree Fahrenheit. Took BP med and down to 146; 138/117 on the day of this report. Low grade fever as well. 99F- nauseated then took BP med and went down. Soreness in arm, kind of went away. Patient was unwilling to complete the report and lot number was not provided. It was reported that he was curious. He woke up the day before this report and his blood pressure was up to 155. Patient asked that could the vaccine cause the blood pressure to go up and just wanted to know if it was a possibility. It was 137 on 06Mar2021 before he got the vaccine. The day before this report he got up sluggish. The home monitor didn't monitor like the doctors. After taking his blood pressure medication it went down to 146 (systolic). In the morning of the day of this report, it was like 138/117 (unit not provided). He didn't write it down, but he thought that was what it as. He was really lightheaded the day before this report. His temperature went from 97.3 up to 99.2 and it was not bad. Patient stated he would have gone to his doctor this morning, but he wanted to see if it was possibly related. Therapeutic measures taken as the result of the event blood pressure was as high as 155 (systolic); BP medication (unspecified). Clinical outcome of events soreness in arm, nausea related to high BP was recovered on unspecified date in Mar2021, outcome of the events blood pressure was as high as 155 (systolic), and low-grade fever was recovering, and outcome of the event got up sluggish, lightheaded was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sluggishness
Clinical narrative: blood pressure was as high as 155 (systolic); got up sluggish; nausea related to high BP; lightheaded; Low grade fever, his temperature went from 97.3 up to 99.2; Soreness in arm; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced blood pressure was as high as 155 (unit not provided) (systolic), got up sluggish and, nausea related to high BP on 07Mar2021, low grade fever, his temperature went from 97.3 up to 99.2, soreness in arm, lightheaded on an unspecified date in Mar2021. It was reported that, patient received his first dose of Pfizer-Biontech Covid19 vaccine on Saturday 06Mar2021. His blood pressure (BP) was as high as 155 (systolic) on Sunday (07Mar2021). Patient asked that had it been reported that being vaccinated can increase your blood pressure. Other adverse events reported included nausea related to high BP which resolved after taking his blood pressure medications, sore arm that had since resolved, and a low-grade fever of 99-degree Fahrenheit. Took BP med and down to 146; 138/117 on the day of this report. Low grade fever as well. 99F- nauseated then took BP med and went down. Soreness in arm, kind of went away. Patient was unwilling to complete the report and lot number was not provided. It was reported that he was curious. He woke up the day before this report and his blood pressure was up to 155. Patient asked that could the vaccine cause the blood pressure to go up and just wanted to know if it was a possibility. It was 137 on 06Mar2021 before he got the vaccine. The day before this report he got up sluggish. The home monitor didn't monitor like the doctors. After taking his blood pressure medication it went down to 146 (systolic). In the morning of the day of this report, it was like 138/117 (unit not provided). He didn't write it down, but he thought that was what it as. He was really lightheaded the day before this report. His temperature went from 97.3 up to 99.2 and it was not bad. Patient stated he would have gone to his doctor this morning, but he wanted to see if it was possibly related. Therapeutic measures taken as the result of the event blood pressure was as high as 155 (systolic); BP medication (unspecified). Clinical outcome of events soreness in arm, nausea related to high BP was recovered on unspecified date in Mar2021, outcome of the events blood pressure was as high as 155 (systolic), and low-grade fever was recovering, and outcome of the event got up sluggish, lightheaded was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: I have a tingling sensation on my fingertips 3 days after shot.  My face is tingling, my lips tingle.; I have a tingling sensation on my fingertips 3 days after shot.  My face is tingling, my lips tingle.; This is a spontaneous report from a contactable consumer(patient). A 55-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number not provided), via an unspecified route of administration on 06Mar2021 at 10:45 (at the age of 55-years-old) into right arm as a single dose for COVID-19 immunization at pharmacy or Drug Store. The patient medical history included high blood pressure, prediabetic, high cholesterol, rosacea. Prior the vaccination, patient was not diagnosed with COVID. Post vaccination, patient was not tested for COVID. The concomitant medications were farxiga, victoza, doxyclycline. Patient had allergies to codiene, shrimp. Patient did not receive any other vaccine in four weeks. On 07Mar2021 at 06:00 am, the patient experienced tingling sensation on my fingertips 3 days after shot. His face was tingling, lips tingle. No treatment was given for the events. The outcome of the events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paraesthesia
Clinical narrative: the back of my neck became occasionally tender/painful to the touch.; I had pins and needles/tingling feeling in my right arm all day Friday./ There was a brief time I thought it was on the right side of my face as well.; This is a spontaneous report from a contactable Consumer (patient). A 56-Year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot number: EN6202) via an unspecified route of administration on 04Mar2021 at 15:00 (Thursday) in the right arm as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included Penicillin allergy, Cutaneous T Cell Lymphoma, Mal de debarquement Syndrome. The patient's concomitant in two weeks included Zyrtec Allergy. Prior to vaccination, no other vaccine in four weeks and did not had COVID. On 05Mar2021 (Friday), patient had pins and needles/tingling feeling in her right arm all day. There was a brief time she thought it was on the right side of her face as well which went away the next day. On 06Mar2021 (Saturday evening), the back of her neck became occasionally tender/painful to the touch. The patient was unable to tell whether it was swollen. Patient stated that It was feeling better today (Monday). No COVID post vaccination. No treatment received for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Eating disorder, Fatigue
Clinical narrative: Really bad chest pains; fever; chills; feeling achy; feeling really bad; achy body; does not want to eat; feel like she is having COVID; This is a spontaneous report from a contactable consumer. A 56-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ERL6202 and expiry date unknown) via an unspecified route of administration in arm Left on 07Mar2021 12:00 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, hypersensitivity, respiratory disorder, cytogenetic abnormality, obesity, immunosuppression and endocrine disorder from an unknown date and unknown if ongoing. Patient had COVID-19 from 01Jul2020 to 25Jul2020. Patient was hospitalized for 14 days in the ICU for this event. Patient was discharged from the hospital on 25Jul2020 which was the date she provided for recovered from event date to date. This condition hit her severely bad. Concomitant medications included sitagliptin (JANUVIA [SITAGLIPTIN]), dapagliflozin propanediol monohydrate (FARXIGA), ongoing metformin HCL (METFORMIN HCL) taken for diabetes mellitus from Oct2020; ongoing levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from Oct2020 and ongoing atorvastatin (ATORVASTATIN) taken for an unspecified indication from Oct2020. Patient previously received Shingles and Flu vaccine in Nov2020 and had same kind of symptoms as ongoing event of COVID-19 like symptoms but without really bad chest pain. On 08Mar2021 09:30, patient had series of symptoms, including bad chest pain, achy body, feeling really bad, body temperature was at 101.7 degrees Fahrenheit today, and she just took her body temperature again which was 101 degrees Fahrenheit so it seemed like it might be going down; she is still having the chills and stuff but improved. She was feeling achy and just wanted to lay down and did not want to eat. Patient stated that these symptoms made her feel like she was having COVID all over again. The patient did not visit emergency room and physician office. She finally took an Ibuprofen for the event Really bad chest pains about 12:30-13:00 08Mar2021 and this event seems to have improved, eased up. She did not have this kind of event when she had COVID-19 in Jul2020. The patient underwent lab tests and procedures which included body temperature 101 Fahrenheit on an unspecified date and body temperature 101.7 Fahrenheit on 08Mar2021. The outcome of the events chest pain, fever, chills and feel like she is having COVID was recovering while events did not want to eat, achy body, feeling really bad and feeling achy was unknown.   No follow up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia, Suspected COVID-19
Clinical narrative: Really bad chest pains; fever; chills; feeling achy; feeling really bad; achy body; does not want to eat; feel like she is having COVID; This is a spontaneous report from a contactable consumer. A 56-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ERL6202 and expiry date unknown) via an unspecified route of administration in arm Left on 07Mar2021 12:00 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, hypersensitivity, respiratory disorder, cytogenetic abnormality, obesity, immunosuppression and endocrine disorder from an unknown date and unknown if ongoing. Patient had COVID-19 from 01Jul2020 to 25Jul2020. Patient was hospitalized for 14 days in the ICU for this event. Patient was discharged from the hospital on 25Jul2020 which was the date she provided for recovered from event date to date. This condition hit her severely bad. Concomitant medications included sitagliptin (JANUVIA [SITAGLIPTIN]), dapagliflozin propanediol monohydrate (FARXIGA), ongoing metformin HCL (METFORMIN HCL) taken for diabetes mellitus from Oct2020; ongoing levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from Oct2020 and ongoing atorvastatin (ATORVASTATIN) taken for an unspecified indication from Oct2020. Patient previously received Shingles and Flu vaccine in Nov2020 and had same kind of symptoms as ongoing event of COVID-19 like symptoms but without really bad chest pain. On 08Mar2021 09:30, patient had series of symptoms, including bad chest pain, achy body, feeling really bad, body temperature was at 101.7 degrees Fahrenheit today, and she just took her body temperature again which was 101 degrees Fahrenheit so it seemed like it might be going down; she is still having the chills and stuff but improved. She was feeling achy and just wanted to lay down and did not want to eat. Patient stated that these symptoms made her feel like she was having COVID all over again. The patient did not visit emergency room and physician office. She finally took an Ibuprofen for the event Really bad chest pains about 12:30-13:00 08Mar2021 and this event seems to have improved, eased up. She did not have this kind of event when she had COVID-19 in Jul2020. The patient underwent lab tests and procedures which included body temperature 101 Fahrenheit on an unspecified date and body temperature 101.7 Fahrenheit on 08Mar2021. The outcome of the events chest pain, fever, chills and feel like she is having COVID was recovering while events did not want to eat, achy body, feeling really bad and feeling achy was unknown.   No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Dysgeusia, Flushing
Clinical narrative: My blood pressure and it was 200/124; My tongue started to have spots on it; two spots, red spot; I got very flushed; I got metallic taste in my mouth; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 27Feb2021 (at the age of 72 years) as dose 1 single for COVID-19 immunization. Medical history included "Just Vaginal Hormones", allergic to hornet sting. The patient's concomitant medications were not reported. Patient informed since she was allergic to hornet sting. When she went to the clinic to get shot, instead of waiting 15 minutes, they had waited her 30 minutes after the shot well she waited 30 minutes and then she left to go to the parking lot to her truck and while she was walking she got very flushed and got metallic taste in mouth and her tongue started to have spots on it, two spots, red spot so she went back in the clinic and told them and blood pressure was taken and it was 200/124 and that was what alarm them so she have to go in to urgent care then she have to go emergency room (ER) on 27Feb201. The patient underwent lab tests and procedures which included blood pressure measurement which was 200/124 and blood test: normal on 27Feb2021. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: My blood pressure and it was 200/124; My tongue started to have spots on it; two spots, red spot; I got very flushed; I got metallic taste in my mouth; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 27Feb2021 (at the age of 72 years) as dose 1 single for COVID-19 immunization. Medical history included "Just Vaginal Hormones", allergic to hornet sting. The patient's concomitant medications were not reported. Patient informed since she was allergic to hornet sting. When she went to the clinic to get shot, instead of waiting 15 minutes, they had waited her 30 minutes after the shot well she waited 30 minutes and then she left to go to the parking lot to her truck and while she was walking she got very flushed and got metallic taste in mouth and her tongue started to have spots on it, two spots, red spot so she went back in the clinic and told them and blood pressure was taken and it was 200/124 and that was what alarm them so she have to go in to urgent care then she have to go emergency room (ER) on 27Feb201. The patient underwent lab tests and procedures which included blood pressure measurement which was 200/124 and blood test: normal on 27Feb2021. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: lips and tongue tingling; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: was not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (age at the time of vaccination 64-years-old), as a dose 1, single for COVID-19 immunization. The patient's medical history included fibromyalgia, and she has chronic pains that were diagnosed 20 years ago. There were no concomitant medications. On 03Mar2021, the patient experienced lips and tongue tingling. No treatment was received for the adverse event. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Reflux gastritis, Throat tightness
Clinical narrative: It felt like it was kind of closing; reflux; swelling under her upper lip; swelling of her throat; This is a spontaneous report from a contactable consumer or other non health care professional from a Pfizer-sponsored program  . A 78 year old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EL0140 ), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jan2021 13:00 (Age at vaccination: 77 years) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included she has a lot of food a lot of food allergies including nuts, and seeds. She was very allergic to poppy seeds and would like to know if any ingredients have been derived from poppy seeds. Patient did not received prior vaccination in 4 weeks. There were no concomitant medications. The patient experienced swelling of her throat and swelling under her upper lip in Jan2021. Patient reported, it felt like it was kind of closing, reflux, on an unspecified date. within 24-48 hours felt a little feeling of swelling of her throat. It felt like it was kind of closing. She got an EMT Scope and they saw that her throat was swollen. They thought that it was because of reflux and gave her reflux medications which did not help. ENT said her throat was swollen and she has some swelling under her upper lip. She thinks it was something to do with the vaccination. Then she received the second 28Jan2021 13:00PM in the right arm. After the second dose she continued to feel like her throat was swollen and her upper lip underneath feels swollen. Adds you can't see it but if you lift up her lip you can see it was swollen. She saw an ENT and an allergist who confirmed everything. It was further reported that after 1 month she finished the 2 doses of Pfizer covid-19 vaccine, she stated that she received the 1st dose last 07Jan2021 and started feeling like there's a pressure on the back of her throat, since she was feeling that she visited a physician and telling her that it's just a reflux. but since she was feeling that her throat was closing she started taking medication for reflux. (3 weeks) and she noticed that she's swelling/tingling in her upper interior lips. but she was advised that there's no medical intervention but until now she had all the reactions after 1 month. The outcome of throat is swollen and swelling under her upper lip was not recovered. The outcome of the rest of the events was unknown.   No follow up attempts are possible. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Development of right index finger tingling; left leg numbness; left great toe tingling/Faint tingling right great toe; Developed lower lip and tip of tongue tingling post vaccination; Developed lower lip and tip of tongue tingling post vaccination; This is a spontaneous report from a contactable Nurse (patient). A 39-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: EL-3247), via an unspecified route of administration, administered in Arm Left on 23Jan2021 09:30 (age the age of 39-year-old) as single dose, for covid-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient sis did not receive any other vaccine in four weeks. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (MICROGESTIN FE); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), and multivitamin. On 23Jan2021 10:00 (after receiving vaccine at 09:33 am), the patient experienced developed lower lip and tip of tongue tingling post vaccination. On 25Jan2021 20:30, the patient experienced left leg numbness and left great toe tingling/faint tingling right great toe while development of right index finger tingling on 26Jan2021. At 10:00 am, Developed lower lip and tip of tongue tingling post vaccination. Lower lip tingling resolved 5 minutes later, and tip of tongue tingling continued. Tip of tongue tingling resolved on 24Jan2021. On 25Jan2021 at 20:30 pm; developed sudden left leg numbness and left great toe tingling but at 21:00 pm left leg numbness decreased and left great toe continued to have tingling sensation. She also had faint tingling right great toe. 26Jan2021 08:00 am; left leg numbness improved but left great toe continued to tingle and Right great toe tingling was intermittent. On 26Jan2021, she had new development of right index finger intermittent tingling but at 10:00; Left leg numbness was resolved. As of 27Jan2021, she remained with intermittent left and right great toe tingling and right index finger tingling. In week of 08Feb, the above remaining symptoms were resolved. The adverse events resulted into doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The outcome of the event Tingling lips was resolved on an unspecified date in 2021, Tingling tongue resolved on 24Jan2021, numbness in leg resolved on 26Jan2021; and left great toe tingling/Faint tingling right great toe and development of right index finger tingling resolved on 08Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Sight tingling in both arms; Feels like arms are cold; This is a spontaneous report from a contactable consumer reported for himself. A 37-year-old male patient received BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EN6199), via an unspecified route on 05Mar2021 (age at 37-year-old male), as a single dose for covid-19 immunization. Medical history included hypertension. The patient concomitant medications were not reported. No known allergies were reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, patient experienced sight tingling in both arms. Feels like arms are cold. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat tightness
Clinical narrative: throat swelling; tightness; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 08:15 (at the age of 56-years-old) as dose 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, anxiety depression, chronic fatigue and fibromyalgia. The patient received other unspecified medications in two weeks. The patient had unspecified known allergies. The patient received the vaccine in a hospital. The patient did not receive other vaccine in four weeks. On 04Mar2021 12:00 (reported as mid-day today), the patient experienced throat swelling, felt it around her neck in the evening and tightness but no sore throat. There was no treatment received for the adverse event. The patient did not experience covid prior vaccination nor was tested for covid post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site bruising
Clinical narrative: feels like her hand fell asleep; bruise at the injection site; arm felt numb like it was falling asleep; This is a spontaneous report from a contactable Consumer. This 70-year-old female Consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not report-ed. The patient reported that she received her first Pfizer COVID vaccine in her left arm 1 week ago Monday (on an unspecified date). The patient looked up the side effects. About a half hour later (on an unspecified date) after receiving the vaccine her arm it "feels like her hand fell asleep". The patient was asking if this was a side effect. She also reported having a bruise at the injection site (the size of a nickel). The patient was concerned as no one she talked to had bruising at the injections site. She asked if this was a common occurrence and if so what was the percentage of people who experienced this. The patient reported that "no one cares". The patient was curious "what do I do about the second dose, do I get it. What happens if I don't get it are there any harmful side effects to not getting the second dose" and was asking "if the first and second doses are the same medicine and dose" The patient was asking if there were any harmful effects if someone received only 1 dose of the vaccine series and was asking for guidance on if she should get the second dose. Stated "there must be some people who can't take the second dose so what happened to them" The patient wondered "once you have the first dose do you have to have the second dose". The patient was curious, what percentage of people got the first shot and it felt like their hand on the side of the vaccine injection falls asleep, was that common. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Day 3 started experience facial tingling, and it has persisted to now day 5.; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN6199, and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 04Mar2021 at 07:45 (at the age of 32-year-old, non-pregnant) as dose 1, single for COVID-19 immunisation. Medical history included chronic headaches and anxiety. The patient's known allergies were unknown. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. The patient's concomitant medications were not reported. On 06Mar2021 at 12:00, day 3, the patient experienced facial tingling, and it had persisted to now day 5. The patient did not received treatment for reported event. The outcome of the event was not resolved.    No follow-up attempts are possible; No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue pruritus
Clinical narrative: Back of Tongue tingly and itchy; Back of Tongue tingly and itchy; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiration date not reported), via an unspecified route of administration in arm left on 09Mar2021 09:00 (at the age of 37-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. patient had no known allergies. Patient did not had covid prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.25 mcg taken for an unspecified indication, start and stop date were not reported and was taken within 2 weeks of vaccine administration. Patient did not receive any other vaccinations with in 4weeks prior to vaccination. Patient was not tested for covid post vaccination. On 10Mar2021 12:00 the patient experienced back of tongue tingly and itchy the day after vaccination on and off for 2 days. The patient did not receive any treatment for the event. The outcome of back of tongue tingly and itchy was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: Tingling on the Tongue; numbness on lower left half of face; This is a spontaneous report from two contactable consumers. These consumers [patient's husband and 58-year-old female consumer (patient)] reported that she received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6201, Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Right on 10Mar2021 13:15(at the age of 58-years-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes mellitus Diagnosed 19 years ago. Concomitant medications included insulin (INSULIN),States it is split in to two; for a total of 65 units a day, injection, one morning and one evening. No prior vaccinations (within 4 weeks). Family Medical History Relevant to AE(s) states she has no family medical records because she was adopted. AEs following prior vaccinations includes Arm Soreness from prior annual flu vaccinations. On 10Mar2021 at 13:30 within 15 minutes post vaccination, the patient experienced tingling on the tongue with outcome of recovering, numbness on lower left half of face. Her husband wanted to know if this is normal and what they should do about it. No shortness of breath, no throat swelling. No Emergency Room or Physician Office visit required.The outcome for event tingling on the tongue was recovering and for event numbness on lower left half of face was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: blood pressure which is usually 79/120 rage to over 200; My resting heart rate went from 79 up to almost 150; lightheaded and dizzy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 43 years of age), dose 1 via an unspecified route of administration, administered in arm left on 07Mar2021 12:00 (Batch/Lot Number: EN 6199) as dose 1, single for covid-19 immunisation. Medical history included an autoimmune disease called indolent systemic mastocytosis, soy allergy, dairy allergy, gluten allergy, bee venom allergy and alcohol allergy.  Concomitant medications included cimetidine; fexofenadine; molybdenum and gemfibrozil (LOWDOWN). The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid-19 vaccine. The patient previously took and had allergy to codeine. The patient had no covid prior vaccination. She had not been covid tested post vaccination. It was reported that the within 16 minutes of the vaccine shot, the patient's resting heart rate went from 79 up to almost 150, she was lightheaded and dizzy, and his blood pressure which was usually 79/120 rage to over 200. The events occurred on 07Mar2021 12:30 PM. The patient recovered from the events on an unspecified date with sequelae. No treatment received for the events. The patient had nasal swab (SARS-CoV-2 test) on 10Jun2020 with negative result.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: blood pressure which is usually 79/120 rage to over 200; My resting heart rate went from 79 up to almost 150; lightheaded and dizzy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 43 years of age), dose 1 via an unspecified route of administration, administered in arm left on 07Mar2021 12:00 (Batch/Lot Number: EN 6199) as dose 1, single for covid-19 immunisation. Medical history included an autoimmune disease called indolent systemic mastocytosis, soy allergy, dairy allergy, gluten allergy, bee venom allergy and alcohol allergy.  Concomitant medications included cimetidine; fexofenadine; molybdenum and gemfibrozil (LOWDOWN). The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid-19 vaccine. The patient previously took and had allergy to codeine. The patient had no covid prior vaccination. She had not been covid tested post vaccination. It was reported that the within 16 minutes of the vaccine shot, the patient's resting heart rate went from 79 up to almost 150, she was lightheaded and dizzy, and his blood pressure which was usually 79/120 rage to over 200. The events occurred on 07Mar2021 12:30 PM. The patient recovered from the events on an unspecified date with sequelae. No treatment received for the events. The patient had nasal swab (SARS-CoV-2 test) on 10Jun2020 with negative result.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Mid-cycle bleeding resembling a full flow full duration (5 day) period on day 14 of my cycle.; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (at the age of 43-years-old) (Batch/Lot Number: EN531) as single dose for COVID-19 immunisation. Medical history included covid prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccine in four weeks and other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 01Feb2021 (at the age of 43-years-old) (Batch/Lot Number: EL3248) for COVID-19 immunisation. Since 06Mar2021 09:00 AM, the patient had mid-cycle bleeding resembling a full flow full duration (5 day) period on day14 of her cycle. The patient did not receive treatment for AE. The patient had not tested covid post vaccination. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Vomiting
Clinical narrative: headache; chills; vomiting; diarrhea; I was light headed about 10 minutes; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient (no pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 01Mar2021 07:00 (Lot Number: EN6200) at age of 69-years-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  Medical history included hypothyroidism, allergies: sulfur. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); ergocalciferol (VIT D); calcium; fish oil.  The patient previously took amoxicillin and experienced allergies, clindamycin and experienced allergies.  The patient experienced headache, chills, vomiting, diarrhea on 04Mar2021 05:30 with outcome of recovered in Mar2021, light headed about 10 minutes on 04Mar2021 05:30 with outcome of recovered on 04Mar2021.  The patient took 1000 mg of Tylenol & sumatriptan. AE resulted in Doctor or other healthcare professional office/clinic visit.  No follow up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia oral, Paraesthesia oral, Throat tightness
Clinical narrative: tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; flushed face; slight constricting of throat; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer reported.   A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:15 (age at the time of vaccination was 42-year-old) as dose 1, single for COVID-19 immunization. Medical history included urticaria and dermatitis contact from an unknown date and unknown if ongoing, I get hives from dermal contact with certain plants/animals/chemicals from an unknown date and unknown if ongoing, allergy to chemicals and allergy to animals from an unknown date and unknown if ongoing. The patient's concomitant medications was not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other medication prior to COVID-19 Vaccine. The patient reported that after 15 minutes of injection, the patient experienced tingling/numbness of lips and tip of tongue, flushed face and slight constricting of throat on 30Mar2021 12:45. Drove to emergency but did not go in, effects began to subside 30 minutes later. No treatment was received for all the events. Outcome of all the events was reported as recovered on 30Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dysphagia, Paraesthesia oral
Clinical narrative: Tingling lips; mild difficulty swallowing for a short period of time; strange taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: en6208), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 12:45 (at the age of 49 years old) as a dose 1, single for covid-19 immunisation at Hospital. Medical history included Addison's disease. Concomitant medications in two weeks included cortisone, levothyroxine, fludrocortisone and vitamin, all were taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. No other vaccine was received in four weeks. Patient did not have Covid prior vaccination. On 12Mar2021 at 12:45, the patient experienced tingling lips, mild difficulty swallowing for a short period of time and strange taste in mouth. Patient did not receive any treatment for the events. He had not been tested for covid post vaccination and no covid post vaccination. Outcome of the events were recovered on unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Dizziness, Fall
Clinical narrative: Decreased heart rate of 43; Increased blood pressure; He woke up got out of the bed to pick things up and down he falls; He was dizzy lethargic; He was dizzy lethargic; Chills; Fever; Nausea; Sore throat; This is a spontaneous report from a contactable Consumer or other non health professional.  This consumer (Wife) reported that a male patient (Husband) of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Lot number: EN6208, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included colon cancer stage IV from an unknown date and unknown if ongoing (He has stage 4 Colon cancer and the cancer has metastasized to his lungs). The patient woke up, got out of bed to pick things up and down he fell, he was dizzy lethargic, chills, fever, nausea, sore throat, increased blood pressure and decreased heart rate of 43. After receiving the vaccine on 09Mar2021, the patient came home and everything was normal. The next morning he had an appointment with his Oncologist. He had stage 4 Colon cancer and the cancer had metastasized to his lungs. He was supposed to see his oncologist the following morning. He woke up got out of the bed to pick things up and down he fell. He was dizzy lethargic. He was experiencing severe chills, fever, nausea and lethargic and also had a sore throat. 18:00 that night, it seemed got a lot better than Friday he was still having a sore throat and had to take a couple pills but he seemed like he was on the road to recovery. That morning they woke up and he started with severe chills again and he had increased blood pressure and he was on blood pressure medicine as well. Friday his blood pressure was up to 173 over 93 and gave him a 100 mg of losartan, today or Saturday his blood pressure was at 161 over 109 with a heart rate of 77, gave him 200 mg of losartan. Couple hours after that started coming down 145/99 with so increased heart rate later on 148/97 and 155/100 with the decreased heart rate of 43. The patient underwent lab tests and procedures which included blood pressure measurement: 173/93 mmhg on 12Mar2021 Friday his blood pressure was up to 173 over 93, blood pressure measurement: 161/109 mmhg on 13Mar2021 Saturday his blood pressure was at 161 over 109, blood pressure measurement: 145/99 mmhg on 13Mar2021 Couple hours after that started coming down 145/99, blood pressure measurement: 148/97 mmhg on 13Mar2021 later on 148/97 and 155/100, blood pressure measurement: 155/100 mmhg on 13Mar2021 later on 148/97 and 155/100, heart rate: 77 on 13Mar2021 Saturday his blood pressure was at 161 over 109 with a heart rate of 77, heart rate: 43 on 13Mar2021 later on 148/97 and 155/100 with the decreased heart rate of 43. Therapeutic measures taken as a result of, increased blood pressure included Losartan. The outcome of the events sore throat was not recovered and remaining events was unknown.  No follow-up attempts are possible. No further information is expected.