chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate after second dose. Will not go back to normal.; This is a spontaneous report from a contactable consumer or other non HCP (patient reported for self). An elderly male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EE9265, Expiry date: unknown), via an unspecified route of administration, administered in Left arm on 27Feb2021 as dose 2, single for COVID-19 immunization. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EE9265), via an unspecified route of administration, administered in Left arm on 05Feb2021 as dose 1, single for COVID-19 immunization. Medical history reported as none. Patient had no known allergies. The concomitant medications. was not reported. On 27Feb2021, the patient experienced elevated heart rate after second dose, will not go back to normal. The patient underwent lab tests and procedures which included heart rate was elevated on 27Feb2021. Patient was not tested for COVID post vaccination. Patient did not receive any treatment. The clinical outcome of event was reported as not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 test
Clinical narrative: Chest pain. Been 30 days; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 67-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 07Feb2021 12:00 AM (Age at vaccination: 67-years-old) as single dose for covid-19 immunization. Medical history included Factor V, allergies to Sulpha all from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 in arm right on 17Jan2021 12:00 AM (Age at vaccination: 67-years-old) for covid-19 immunization, patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. On 08Feb2021 12:00 AM patient experienced Chest pain. Been 30 days. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. Patient was tested for covid since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. The outcome for the event was reported as not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Pain
Clinical narrative: Her heart rate high and was fast paced; aggravation from the vaccine went down her arm across her shoulder to her other shoulder and arm; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date was not reported), dose 1 via unspecified route of administration on left arm on 24Feb2021 as single dose for COVID-19 immunization. The patient's medical history Diabetes, Triple bypass since 2019 (Ongoing) were reported. The patient concomitant medications were not reported. Reported stated that her first dose was on 24Feb2021. She said that she did not even feel the shot that she had on Wednesday 24Feb2021 and said that by Thursday, the aggravation from the vaccine went down her arm across her shoulder to her other shoulder and arm. It was really strong. On Friday 26Feb2021, her heart started to act up and act wonky. She clarified that her heart rate was high and was fast paced on the pulse ox. She tried to call her primary care physician but could not get a hold of them. She said that she controlled it herself. Caller said that she has had a triple heart bypass in the past. She was due on 24Mar2021 to get her second dose. She said that everyone says that it was worse. With her history of the AFib, was this going to cause undue episode or what is the experiences that have been reported. She said that she never had aggravation that travelled from one arm to her shoulder and across to her other shoulder and arm before with any other vaccine. Caller stated that she took aspirin to treat her heart rate. The patient developed aggravation from the vaccine went down her arm across her shoulder to her other shoulder and arm started on 24Feb2021 and stopped on 25Feb2021 and Her heart rate high and was fast paced start date 26Feb2021 and stopped on 26Feb2021 was updated. The outcome of the event was recovered.   No follow-up attempts are possible. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Approximately 5 minutes post vaccination patient had numbness from shoulder to hand; This is a spontaneous report from a contactable other healthcare professional. A 53-years-old female patient (pregnant: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203), via intramuscular on 26Feb2021 at 15:30 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization at public health clinic/veterans administration facility. Medical history included MS (multiple sclerosis). The patient's concomitant medications were not reported. No known allergies. It was unknown if the patient received any other vaccine in four weeks or other medications in two weeks. It was unknown if the patient had COVID prior to vaccination and unknown if tested for COVID post vaccination. On 26Feb2021 at 15:35, approximately 5 minutes post vaccination patient had numbness from shoulder to hand. Numbness improved approximately 15 minutes post vaccination. Continued observation for additional 15 minutes. The patient was discharged at 15:38. The patient did not receive treatment for the adverse event. The outcome of event was resolved on an unspecified date in 2021.  No follow up attempts are possible; no further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Chronic Knee pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient would like to know if it was fine for him to take Aleve or aspirin. The patient had chronic Knee pain in Mar2021. The patient would also wanted to know if she could take steroid injection for knee pain. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate increased, Tinnitus
Clinical narrative: Strong pulse; Tinnitus; Elevated blood pressure; This is a spontaneous report from a contactable consumer (Patient). A 63-year-old female patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: Unknown, Expiration date: was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included high blood pressure, anxiety and overweight. Concomitant medications were not reported. On an unspecified date, patient experienced strong pulse, tinnitus and elevated blood pressure. The patient underwent lab tests and procedures which included Blood pressure: High on an unspecified date. Patient also reported she didn't know if the symptoms could be because she was nervous. Before getting the vaccine, she asked her doctor if it was okay for her to get it, since she has high blood pressure (caller stated she takes medication for this and it is under control), anxiety and overweight, and doctor said it was okay. If the second dose is stronger than the first one, should she still get the second dose?. The outcome of events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Nausea, Urticaria, Vomiting
Clinical narrative: Nausea; had little hives here and there; vomiting; redness on wrists, hands; inflammation; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 15:00 hours (Batch/Lot Number: EN6204) as DOSE 1, SINGLE (at the age of 22-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. The patient's medical History (including any illness at time of vaccination) was not reported. The patient's family History was not reported. On 11Mar2021, the patient experienced nausea, on an unspecified date in Mar2021 experienced vomiting, redness on wrists, hands, and inflammation. It was not reported whether the patient had admission to the hospital or received any treatment due to the events nausea, vomiting and redness on wrists, hands. On 11Mar2021, the patient started to feel nauseated and then had little hives here and there. The patient had not seen any new ones on the day of reporting and the inflammation seemed to have gone down; they were not as red on the day of reporting. The patient was more nauseated on the day of reporting. The patient queried for how long these side effects tend to last and Mentioned that this was the first vaccine reaction he has ever had and the first time he has had to call in to report anything without his parents doing it for him. The patient also queried whether he should still get his 2nd dose and for any recommendations on treatment for the symptoms. The patient had no relevant tests reported. The adverse events did not require a visit to physician or emergency room. The patient had no prior Vaccinations (within 4 weeks). The patient was recovering from the events inflammation and had little hives here and there; had not recovered from the event nausea and the clinical outcome for other events was unknown.  Follow-up attempts are needed.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Breast mass, Breast pain, Breast swelling, Nipple pain
Clinical narrative: Medical Information Potential AE; Pain and swelling in her breast; Pain and swelling in her breast; Stated that her right nipple was uncomfortable; Stated that her right nipple was swollen; It feels like a lymph node; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 27Feb2021 (at the age of 65-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced medical information potential AE on an unspecified date. The patient reported that she developed pain and swelling in her breast that has been ongoing for 3 days. She stated that she knew there are lymph nodes in the area but wanted to know if this was normal and how to treat the same. Caller also stated that a couple of days ago her right nipple was uncomfortable and was now swollen. Stated that it felt like a lymph node. She wanted to know if possible if it could be a lymph node. Seriousness of the events was reported as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nipple swelling
Clinical narrative: Medical Information Potential AE; Pain and swelling in her breast; Pain and swelling in her breast; Stated that her right nipple was uncomfortable; Stated that her right nipple was swollen; It feels like a lymph node; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 27Feb2021 (at the age of 65-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced medical information potential AE on an unspecified date. The patient reported that she developed pain and swelling in her breast that has been ongoing for 3 days. She stated that she knew there are lymph nodes in the area but wanted to know if this was normal and how to treat the same. Caller also stated that a couple of days ago her right nipple was uncomfortable and was now swollen. Stated that it felt like a lymph node. She wanted to know if possible if it could be a lymph node. Seriousness of the events was reported as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Urinary tract infection
Clinical narrative: Urinary Tract infection; arms was sore in that area; headache; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unknown date in 2021 (age at vaccination: 90-year-old) as dose 1, single for covid-19 immunisation. Medical history included macular degeneration from an unknown date and unknown if ongoing (he was almost blind and don't drive because of his macular degeneration, he had for years. His eye problem started 30 something years ago when he was 50) and kidney stones (has tendency to get kidney stones). The patient's concomitant medications were not reported. The patient received his first dose 2 weeks ago on an unknown date and it took him a long time to get the vaccine. Next Friday on 19Mar2021 he was scheduled for his 2nd dose. Caller stated, he went to his doctor and got antibiotics which he would start today. He got an urinary tract infection. He has tendency to get kidney stones, so he has to watch what he eat. This was not unusual. She had quite a few. The first was the worst; almost all of them he has passed. Normally he drink water and he would pass, none were the same, he would to get an ultrasound. It took him a long and long time to get the vaccine. His side effects: first day his arms was sore in that area (it hurt a little bit in the morning and 6-7 hours later he didn't even know it was there). Before he got his flu shot he needed to exercise the arm. He had a little headache and that went away. His pharmacist said it would be alright with his antibiotic but he wanted to make sure. The outcome of the event urinary tract infection was unknown and other events recovered on an unspecified date in 2021.   No follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Chills, Decreased appetite, Dizziness
Clinical narrative: drastic deteriation of eye sight; extreme chest pain; extreme lungs pain; hard to breathe; loss of appetite; feeling of numbness in limbs; extreme anxiety; insomnia; dizziness; mild headaches; mild chills; mild brain fog; stiff neck; stiff  jaws; feeling hyper activated; This is a spontaneous report from a contactable other hcp (patient) reported for herself that . A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021 (Age at vaccination 57-years-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included mitral valve prolapse, anxiety, presyncope from an unknown date and unknown if ongoing. Patient had no known allergy. Concomitant medications included estradiol (VIVELLE DOT), estradiol (ESTRACE) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (Lot number=EL9262), in Arm Left, on 25Jan2021 at 08:15 (Age at vaccination 57-years-old), for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. On 16Feb2021 the patient experienced drastic deteriation of eyesight, extreme chest/lungs pain, hard to breathe, loss of appetite, feeling of numbness in limbs, extreme anxiety, insomnia, dizziness, for 10 days of second dose of vaccine. its almost one month, I am still experiencing, extreme anxiety, mild headaches, odd mild chills, mild brain fog, numbness in limbs, stiff neck, jaws, feeling hyper activated. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Mar2021. No treatment received for adverse events. Outcome of the events was not recovered,  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Hypoaesthesia, Insomnia
Clinical narrative: drastic deteriation of eye sight; extreme chest pain; extreme lungs pain; hard to breathe; loss of appetite; feeling of numbness in limbs; extreme anxiety; insomnia; dizziness; mild headaches; mild chills; mild brain fog; stiff neck; stiff  jaws; feeling hyper activated; This is a spontaneous report from a contactable other hcp (patient) reported for herself that . A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021 (Age at vaccination 57-years-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included mitral valve prolapse, anxiety, presyncope from an unknown date and unknown if ongoing. Patient had no known allergy. Concomitant medications included estradiol (VIVELLE DOT), estradiol (ESTRACE) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (Lot number=EL9262), in Arm Left, on 25Jan2021 at 08:15 (Age at vaccination 57-years-old), for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. On 16Feb2021 the patient experienced drastic deteriation of eyesight, extreme chest/lungs pain, hard to breathe, loss of appetite, feeling of numbness in limbs, extreme anxiety, insomnia, dizziness, for 10 days of second dose of vaccine. its almost one month, I am still experiencing, extreme anxiety, mild headaches, odd mild chills, mild brain fog, numbness in limbs, stiff neck, jaws, feeling hyper activated. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Mar2021. No treatment received for adverse events. Outcome of the events was not recovered,  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Musculoskeletal stiffness, Psychomotor hyperactivity, Pulmonary pain, SARS-CoV-2 test
Clinical narrative: drastic deteriation of eye sight; extreme chest pain; extreme lungs pain; hard to breathe; loss of appetite; feeling of numbness in limbs; extreme anxiety; insomnia; dizziness; mild headaches; mild chills; mild brain fog; stiff neck; stiff  jaws; feeling hyper activated; This is a spontaneous report from a contactable other hcp (patient) reported for herself that . A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021 (Age at vaccination 57-years-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included mitral valve prolapse, anxiety, presyncope from an unknown date and unknown if ongoing. Patient had no known allergy. Concomitant medications included estradiol (VIVELLE DOT), estradiol (ESTRACE) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (Lot number=EL9262), in Arm Left, on 25Jan2021 at 08:15 (Age at vaccination 57-years-old), for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. On 16Feb2021 the patient experienced drastic deteriation of eyesight, extreme chest/lungs pain, hard to breathe, loss of appetite, feeling of numbness in limbs, extreme anxiety, insomnia, dizziness, for 10 days of second dose of vaccine. its almost one month, I am still experiencing, extreme anxiety, mild headaches, odd mild chills, mild brain fog, numbness in limbs, stiff neck, jaws, feeling hyper activated. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Mar2021. No treatment received for adverse events. Outcome of the events was not recovered,  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: drastic deteriation of eye sight; extreme chest pain; extreme lungs pain; hard to breathe; loss of appetite; feeling of numbness in limbs; extreme anxiety; insomnia; dizziness; mild headaches; mild chills; mild brain fog; stiff neck; stiff  jaws; feeling hyper activated; This is a spontaneous report from a contactable other hcp (patient) reported for herself that . A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021 (Age at vaccination 57-years-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included mitral valve prolapse, anxiety, presyncope from an unknown date and unknown if ongoing. Patient had no known allergy. Concomitant medications included estradiol (VIVELLE DOT), estradiol (ESTRACE) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (Lot number=EL9262), in Arm Left, on 25Jan2021 at 08:15 (Age at vaccination 57-years-old), for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. On 16Feb2021 the patient experienced drastic deteriation of eyesight, extreme chest/lungs pain, hard to breathe, loss of appetite, feeling of numbness in limbs, extreme anxiety, insomnia, dizziness, for 10 days of second dose of vaccine. its almost one month, I am still experiencing, extreme anxiety, mild headaches, odd mild chills, mild brain fog, numbness in limbs, stiff neck, jaws, feeling hyper activated. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Mar2021. No treatment received for adverse events. Outcome of the events was not recovered,  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: heart pulse was racing; dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6203, expiry date: unknown) via unspecified route of administration, in left arm on 26Feb2021 14:30 (age at vaccination: 66-years) as dose 1, single for Covid- 19 immunisation. Facility type vaccine was public health clinic/veterans administration facility. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with covid prior to vaccination. She was not tested for covid since vaccination. Patients medical history included asthma, thyroid and known allergies of citrus and mold from an unspecified date and unknown if ongoing. Concomitant medication included flu vaccine as single dose on 10Feb2021 (in 4 weeks of covid vaccine), for unspecified indication. On 26Feb2021 2:30PM, immediately after receiving the Covid 19 vaccine, her heart pulse was racing, and she started to feel dizzy. The patient underwent lab test for heart rate on 26Feb2021, with results as racing. No treatment was given as a result of the adverse events. The outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Urticaria
Clinical narrative: Severe hives that started on my ears and then spread to face, neck and arms. It's continuing to spread down my legs; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EL 9264, expiry date: unknown), via an unspecified route of administration in the right arm on 01Feb2021 at 11:00 (at the age of 33-year-old), at dose 2, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. the patient had no known allergies to medications, food, or other products. The historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302) on right arm on 12Jan2021 (at the age of 33-year-old) at 12:00 PM as dose 1 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine within 4 weeks prior to BNT162B2 vaccine. The patient experienced severe hives that started on her ears and then spread to face, neck and arms. It was continuing to spread down her legs. It started on 02Feb2021 and is still going on 11Feb2021. The patient was pregnant at the time of vaccination on 01Feb2021. The date of last menstrual period was on 01Jan2021 and the gestation period was 4 week. The patient is due to deliver on 08Oct2021. The reporter assessed the events as non-serious. The adverse event resulted in the emergency room/department or urgent care. The patient received topical steroids and antihistamines for the events. Outcome of the event Pregnant at the time of vaccination: yes was not resolved and for other event was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Disturbance in attention, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: Full body numbness; Lack of coordination; Extreme exhaustion; Inability to focus; feel a faint generalized numbness but it is fading; This is a spontaneous report from a contactable consumer (patient).A 43-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6208),via an unspecified route of administration on 12Mar2021 at 08:15 (at the age of 43-years-old) as a dose 1, single for COVID-19 immunization. Medical history included HEDS (Hypermobile type Ehlers-Danlos syndrome) and scoliosis. The patient was not allergic, but sensitive to eggs, dairy, steroids, aspirin, ibuprofen. Concomitant medication(s) included cyanocobalamin (B12 [CYANOCOBALAMIN]); vitamin d [vitamin d nos] and ascorbic acid (VIT C). The patient previously took aspirin [acetylsalicylic acid] and ibuprofen and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 12Mar2021 at 20:00, the patient experienced lack of coordination, extreme exhaustion, inability to focus, on 13Mar2021, around 2pm the patient experienced full body numbness and on an unspecified date in Mar2021, she experienced feel a faint generalized numbness, but it was fading. The patient reported that she experienced full body numbness climaxing around 2pm on 13Mar2021, the day after the injection. Also, lack of coordination, extreme exhaustion, inability to focus. It was 14Mar2021 and she still feel a faint generalized numbness, but it was fading, thankfully. The patient did not receive any treatment for adverse events. The patient was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Pyrexia
Clinical narrative: Temp of 102.8 a few hours after injection.  This temp was relieved after a couple of hours without any medication.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A adult female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included unknown from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported. The patient experienced temperature of 102.8 a few hours after injection.  this temperature was relieved after a couple of hours without any medication on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included body temperature at 102.8.  Follow-up (15Mar2021): This is a follow-up spontaneous report received from contactable consumer. This consumer reporting for female patient that, She became aware of the event on 8Mar2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbing and tingling sensation in my thumb, pointer, and middle finger of my right hand.; Numbing and tingling sensation in my thumb, pointer, and middle finger of my right hand.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date not reported) via an unspecified route of administration in Arm Right on 13Mar2021 11:00 (at the age of 39 years old) as dose 2, single for COVID-19 immunization. Medical history included bipolar 2 disorder, allergy to penicillin. Patient was not tested for COVID post vaccination Concomitant medication taken within two weeks of COVID vaccine included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date not reported) via an unspecified route of administration in Arm Left on 20Feb2021 11:00 (at the age of 38 years old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccine in four weeks of COVID vaccine. The patient experienced numbing and tingling sensation in my thumb, pointer, and middle finger of my right hand on 13Mar2021 11:45. No treatment were received for the adverse events. Outcome of the events were unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Neuralgia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: tingling and numbness down my right leg, into my left leg; tingling and numbness down my right leg, into my left leg/tingling sensation in my right lateral thigh; weakness in both legs from back of the buttocks into hamstrings; nerve pain down the back of my hamstrings; This is a spontaneous report from a contactable Other HCP (nurse reported for herself). A 54-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EL9262), dose 2 via an unspecified route of administration, administered in Arm Right on 28Jan2021 11:00 AM (at the age of 54-year-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient other medical history was none. The patient had no Known allergies. The patient did not have COVID prior vaccination. Concomitant medication(s) included Estradiol (ESTROGEN) and Progesterone (PROGESTERONE), all taken for an unspecified indication, start and stop date were not reported. The patient previously received her first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EL01470), via an unspecified route of administration, administered in Left arm on 07Jan2021 11:00 AM, as single for covid-19 immunisation and about 1 1/2 weeks after the first dose of the COVID vaccine, she had a numb/tingly tingling down her right leg into the foot. No other vaccine in four weeks. On 28Jan2021, within several minutes after receiving the 2nd dose of the COVID vaccine, the patient experienced tingling and numbness down her right leg, into her left leg/tingling sensation in her right lateral thigh, weakness in both legs from back of the buttocks into hamstrings and nerve pain down the back of her hamstrings. The clinical details of the events as follows: Within several minutes after receiving the 2nd dose of the COVID vaccine, she had a rush of tingling and numbness down her right leg, into her left leg and weakness in both legs from back of the buttocks into hamstrings which was lasting about 1 1/2 weeks after the vaccine. She had nerve pain down the back of her hamstrings for about 1 1/2 weeks. It was reported that she had to be seen by a neurologist and have an MRI the days following. She had been referred to a spine Dr. to discuss the findings, but she has to get workman comp approval before she can make this appointment. She continued to have a tingling sensation in her right lateral thigh. The sensations in her buttocks, hamstrings and left leg had resolved. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received to treat the events. The patient underwent lab tests and procedures which included antigen test (Nasal Swab) was negative on 09Feb2021. The patient outcome of the events was Resolved with Sequel (resolved with lasting effects).   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Experiencing some numbness; This is a spontaneous report from a contactable consumer (patient) received via an automated system. This automated system responded via telephonic activity.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient experienced experiencing some numbness and was not sure if patient should call Pfizer,  or go to Doctor. Patient received the vaccine and was experiencing symptoms that patient had not heard about and was not sure if patient should go to the doctor or call Pfizer. Patient stated that he has been having numbness. The outcome of the event was unknown.   Information on Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: Face numbed up on the left side; All her joints on the left side from her knee all the way to her neck bothered her; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (daughter) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the reporter was calling in regard for daughter, she had a reaction, reporter was just helping her out to try and find all these things to get the information. She had the Pfizer, and approximately on unknown date in Mar2021, she got a side effect of her like her face numbed up on the left side and then all her joints on the left side from her knee all the way to her neck bothered her. She was getting better now, they took the BENADRYL, and she took like Ibuprofen, but the problem they were having was they could not get any answers from doctors or anything, did she go for the second shot, or will this cause more of a serious condition with the face of numbing; asked by reporter. Reporter was trying to get information for daughter. Reporter stated, daughter will take care of herself. Reporter wanted to try and find out where she can call, as she wants to call that number and that was about it, because this was going to be frustrating for her. Outcome of both the events was recovering at the time of reporting.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Lymphadenopathy, Pain
Clinical narrative: Rapid heart rate that hasn't stopped; Chills; Fever; body aches for 5 days; Swallen lymph node under left arm pit for 5 days and still there; This is a spontaneous report from a non-contactable consumer. This 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at arm Left on 02Mar2021 12:30 (at the age of 32-years-old) as a single dose for covid-19 immunisation. Medical history included thyroid disorder. Patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. In two weeks, Other medications used Birth control and thyroid medicine. Historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) dose 1 (Lot number and expiry date was not reported) via unspecified route of administration at Left arm on 09Feb2021 12:00 PM as a single dose for covid-19 immunisation. On 02Mar2021 16:30 the patient experienced rapid heart rate that hasn't stopped, chills, fever, body aches, swollen lymph node under left arm pit for 5 days and still there. The patient underwent lab tests and procedures which included heart rate: rapid on 02Mar2021. Treatment was not given for adverse events. Outcome of the events was recovered with Sequel on unspecified date in 2021  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Rapid heart rate that hasn't stopped; Chills; Fever; body aches for 5 days; Swallen lymph node under left arm pit for 5 days and still there; This is a spontaneous report from a non-contactable consumer. This 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at arm Left on 02Mar2021 12:30 (at the age of 32-years-old) as a single dose for covid-19 immunisation. Medical history included thyroid disorder. Patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. In two weeks, Other medications used Birth control and thyroid medicine. Historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) dose 1 (Lot number and expiry date was not reported) via unspecified route of administration at Left arm on 09Feb2021 12:00 PM as a single dose for covid-19 immunisation. On 02Mar2021 16:30 the patient experienced rapid heart rate that hasn't stopped, chills, fever, body aches, swollen lymph node under left arm pit for 5 days and still there. The patient underwent lab tests and procedures which included heart rate: rapid on 02Mar2021. Treatment was not given for adverse events. Outcome of the events was recovered with Sequel on unspecified date in 2021  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Fatigue, Headache, Pain
Clinical narrative: Extreme heartburn; sinus pressure with headache; sinus pressure with headache; body aches; loose bowels; fatigue.; This is a spontaneous report from a Non-contactable consumer. This consumer reported for male patient that a 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 11Mar2021 (at the age of 45 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) for covid-19 immunisation. The patient did not receive any other vaccines within four weeks. It was unknown that the patient had covid prior vaccination. It was unknown that the patient had tested for COVID-19 since having the vaccine. On 11Mar2021, patient experienced extreme heartburn, sinus pressure with headache, body aches, loose bowels, fatigue. It was unknown that the patient had received any treatment for events. The outcome of events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: Extreme heartburn; sinus pressure with headache; sinus pressure with headache; body aches; loose bowels; fatigue.; This is a spontaneous report from a Non-contactable consumer. This consumer reported for male patient that a 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 11Mar2021 (at the age of 45 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) for covid-19 immunisation. The patient did not receive any other vaccines within four weeks. It was unknown that the patient had covid prior vaccination. It was unknown that the patient had tested for COVID-19 since having the vaccine. On 11Mar2021, patient experienced extreme heartburn, sinus pressure with headache, body aches, loose bowels, fatigue. It was unknown that the patient had received any treatment for events. The outcome of events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeding disorder, Headache, Vomiting
Clinical narrative: I awoke with a terrible headache and vomited for several hours.; vomited for several hours; I was dizzy; unable to eat with a lingering headache all weekend; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 16:30 (at the age of 39-years-old) as a single dose for covid-19 immunization. Medical history included asthma, hypertension, hypersensitivity, allergies with aspirin, burlap. Concomitant medication(s) in two weeks included mefenamic acid (ADVIL [MEFENAMIC ACID]). The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, Saturday, 4 days after vaccination, the patient awoke with a terrible headache and vomited for several hours. She was dizzy, unable to eat with a lingering headache all weekend. The patient did not receive any treatment. Outcome of the event was recovered on Mar2021, at the time of this report. No follow-up attempt are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeding disorder, Feeling abnormal, Hypersomnia
Clinical narrative: Unable to eat; very tired; unable to get out; feeling so bad; Sleeping a lot; Aching; very weak; This is a spontaneous report from a contactable consumer or other non hcp.   A elderly female patient received bnt162b2 (BNT162B2 Solution for solution), via an unspecified route of administration on 08Mar2021 12:30 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included clindamycin taken for an unspecified indication, start and stop date were not reported; meloxicam taken for an unspecified indication, start and stop date were not reported; metformin hcl taken for an unspecified indication, start and stop date were not reported. The patient experienced unable to eat, very tired, unable to get out, feeling so bad, sleeping a lot, aching and very weak.  The not received any treatment for the events. The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.