chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Connective tissue disorder, Pain in extremity
Clinical narrative: since the 2nd vaccine I've had pain in both hands; since the 2nd vaccine I've had pain in my fingers, in the joints; since the 2nd vaccine I've had pain in my fingers, in the joints; tendons and connective tissue like pain; general pain in my feet; This is a spontaneous report from contactable consumer (patient) reported for herself. A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6208, Expiration Date: 30Jun2021) intramuscular, administered at an unspecified anatomical location on 12Mar2021 (age at vaccination was 75 years) as 2nd dose, single for COVID-19 immunization. The patient's medical history included back pain. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6200, Expiration Date: 30Jun2021) intramuscular, administered at an unspecified anatomical location on 19Feb2021 (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. The caller reported that she always had back pain, but since the 2nd vaccine she had pain in both hands, fingers in the joints. But the finger pain wasn't like arthritis pain it felt more tendons and connective tissue like pain. She has also had general pain in her feet and have had no pain management. Side effects were ongoing. The caller stated she was going to a pain management physician for the pain today. The caller stated that she took ibuprofen and Aspirin to help relieve side effects. Verified with caller that vaccine received was Pfizer. The caller inquired whether the side effects experienced be a result of the Vaccine. The caller inquired how long the side effects would last and seeked medical recommendations. The caller was informed that they were unable to provide any medical recommendation and advised patient to follow up with HCP for additional medical recommendations or concerns and to follow up with Pfizer to report side effect and for further medial inquires. The outcome of the events was not resolved.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure increased, Blood pressure measurement, Body temperature increased, Chest discomfort
Clinical narrative: asthma flare up; migraine (12 days); muscle pain; swollen forearms (also reported as "both arms woke up looking like popeye"); fatigue; heart palpitations; heavy feeling in chest; severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe muscle spasms; entire body felt like been run over by a truck very painful to touch anywhere on my body; blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"); This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot: EW0170), via an unspecified route of administration on the left arm on 14May2021 10:00 (at the age of 37-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included asthma, migraines, hypotension/ low blood pressure (patient's normal blood pressure was 90/60), allergy to sulfa drugs and latex allergy. The patient's concomitant medications were not reported. The patient previously took azithromycin and was allergic to it. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 14May2021 11:15, the patient had asthma flare up, migraine (12 days), muscle pain, swollen forearms (also reported as "both arms woke up looking like popeye"), fatigue, heart palpitations, heavy feeling in chest, severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"), severe muscle spasms, entire body felt like been run over by a truck very painful to touch anywhere on my body, and blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"). The adverse events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The patient was put on steroids which made the reactions worse. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Hyperhidrosis, Migraine, Muscle spasms
Clinical narrative: asthma flare up; migraine (12 days); muscle pain; swollen forearms (also reported as "both arms woke up looking like popeye"); fatigue; heart palpitations; heavy feeling in chest; severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe muscle spasms; entire body felt like been run over by a truck very painful to touch anywhere on my body; blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"); This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot: EW0170), via an unspecified route of administration on the left arm on 14May2021 10:00 (at the age of 37-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included asthma, migraines, hypotension/ low blood pressure (patient's normal blood pressure was 90/60), allergy to sulfa drugs and latex allergy. The patient's concomitant medications were not reported. The patient previously took azithromycin and was allergic to it. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 14May2021 11:15, the patient had asthma flare up, migraine (12 days), muscle pain, swollen forearms (also reported as "both arms woke up looking like popeye"), fatigue, heart palpitations, heavy feeling in chest, severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"), severe muscle spasms, entire body felt like been run over by a truck very painful to touch anywhere on my body, and blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"). The adverse events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The patient was put on steroids which made the reactions worse. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Palpitations, Peripheral swelling
Clinical narrative: asthma flare up; migraine (12 days); muscle pain; swollen forearms (also reported as "both arms woke up looking like popeye"); fatigue; heart palpitations; heavy feeling in chest; severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe muscle spasms; entire body felt like been run over by a truck very painful to touch anywhere on my body; blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"); This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot: EW0170), via an unspecified route of administration on the left arm on 14May2021 10:00 (at the age of 37-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included asthma, migraines, hypotension/ low blood pressure (patient's normal blood pressure was 90/60), allergy to sulfa drugs and latex allergy. The patient's concomitant medications were not reported. The patient previously took azithromycin and was allergic to it. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 14May2021 11:15, the patient had asthma flare up, migraine (12 days), muscle pain, swollen forearms (also reported as "both arms woke up looking like popeye"), fatigue, heart palpitations, heavy feeling in chest, severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"), severe muscle spasms, entire body felt like been run over by a truck very painful to touch anywhere on my body, and blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"). The adverse events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The patient was put on steroids which made the reactions worse. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: Ran 103 to 104 fever; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171; Expiration date was not reported) on the right arm on 04Jun2021 (13:30) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the public health clinic. Medical history included attention deficit hyperactivity disorder (ADHD) and asthma. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0171; Expiration date was not reported) on 14May2021 (13:30) (when the patient was 18 years old) for COVID-19 immunization. On 05Jun2021 (12:00 AM), the patient had run a 103 to 104 fever. The event had resulted into an emergency room/department or urgent care visit. High dose of Motrin and intravenous (IV) fluids were administered to the patient as treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination; and had been tested for COVID-19 since the vaccination. The patient had a negative COVID-19 nasal swab (post-vaccination) on 05Jun2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Bradykinesia, Dysstasia, Fall, Pain
Clinical narrative: shoulders weakness , knees and hip weakness; fell once already stepping down a curve; had pain, every day and had to take pain medication each day; unable to stand for a long period of time; walking is slow; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 12:45 (Batch/Lot number was not reported) at the age of 66 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. The patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included atorvastatin; and amlodipine; both taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient had shoulders weakness, knees and hip weakness. She was unable to stand for a long period of time. Her walking was slow. She fell once already stepping down a curve. She had pain, every day and had to take pain medication each day. The patient used to be a very active person. The events occurred on 02Mar2021 12:45 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized due to shoulders weakness, knees and hip weakness for 3 days. Treatment for the events included IV, and pain medicine. The patient has not recovered from the events. The patient was tested for COVID-19 post vaccination on 16Mar2021 and result was negative. Prior to vaccination, the patient was not diagnosed with COVID-19.   Information on the batch/lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: shoulders weakness , knees and hip weakness; fell once already stepping down a curve; had pain, every day and had to take pain medication each day; unable to stand for a long period of time; walking is slow; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 12:45 (Batch/Lot number was not reported) at the age of 66 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. The patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included atorvastatin; and amlodipine; both taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient had shoulders weakness, knees and hip weakness. She was unable to stand for a long period of time. Her walking was slow. She fell once already stepping down a curve. She had pain, every day and had to take pain medication each day. The patient used to be a very active person. The events occurred on 02Mar2021 12:45 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized due to shoulders weakness, knees and hip weakness for 3 days. Treatment for the events included IV, and pain medicine. The patient has not recovered from the events. The patient was tested for COVID-19 post vaccination on 16Mar2021 and result was negative. Prior to vaccination, the patient was not diagnosed with COVID-19.   Information on the batch/lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bartholin's cyst, Infected cyst
Clinical narrative: developed a Bartholin cyst; the cyst got infected; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration on 17May2021 (at the age of 25 years old) (Lot number was not reported) as unknown, single for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took penicillin and experienced hypersensitivity. On 20May2021 (3 days after receiving the vaccine), the patient developed a Bartholin cyst. It was the first time this has happened to the patient and the cyst got infected. Patient had to go to the ER to drain the cyst. Patient said It seemed too much of a coincidence. Patient is a healthy young lady that almost never has health issues. As soon as she took the vaccine, she needed to go to the ER for a Bartholin cyst. Treatment received was Surgical drainage and antibiotics. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling abnormal, Heart rate
Clinical narrative: O2 was 74/with new batteries, it was 88/has been hovering at 93 and 94 for the last hour 1/2; This evening quite suddenly was not feeling right similar to when I had Covid; Breathless; lightheaded; very weak; heart rate was 54 (normally 80); pulse was 113; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Jun2021 11:30 at 52 years of age (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 08May2021 12:00 administered in arm left. Medical history included tachycardia, paroxysmal supraventricular tachycardia (PAT), severe joint pain from 06May2021, fatigue from 06May2021, fever from 06May2021, COVID-19. Patient was not pregnant at the time of  vaccination. Concomitant medications included ibuprofen taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; paracetamol (TYNOL) taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; atomoxetine hydrochloride (STRATTERA); bupropion hydrochloride (WELLBUTRIN); levothyroxine; and atorvastatin. The patient previously took prednisone and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination included Stratera, Wellbutrin, levothyroxine, and atorvastatin. On 06Jun2021 20:45, patient, quite suddenly, was not feeling right, similar to when she had COVID. Patient was breathless, lightheaded, and very weak. Patient got up and got her pulse oximeter. Her heart rate was 54, normally 80. O2 was 74 . Patient changed the batteries just to be sure. With new batteries it was 88, pulse was 113 . O2 steadily climbed to 97 but had been hovering at 93 and 94 for the last hour 1/2. Patient was recovering from the events. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The case was reported as non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Heart rate increased, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: O2 was 74/with new batteries, it was 88/has been hovering at 93 and 94 for the last hour 1/2; This evening quite suddenly was not feeling right similar to when I had Covid; Breathless; lightheaded; very weak; heart rate was 54 (normally 80); pulse was 113; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Jun2021 11:30 at 52 years of age (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 08May2021 12:00 administered in arm left. Medical history included tachycardia, paroxysmal supraventricular tachycardia (PAT), severe joint pain from 06May2021, fatigue from 06May2021, fever from 06May2021, COVID-19. Patient was not pregnant at the time of  vaccination. Concomitant medications included ibuprofen taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; paracetamol (TYNOL) taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; atomoxetine hydrochloride (STRATTERA); bupropion hydrochloride (WELLBUTRIN); levothyroxine; and atorvastatin. The patient previously took prednisone and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination included Stratera, Wellbutrin, levothyroxine, and atorvastatin. On 06Jun2021 20:45, patient, quite suddenly, was not feeling right, similar to when she had COVID. Patient was breathless, lightheaded, and very weak. Patient got up and got her pulse oximeter. Her heart rate was 54, normally 80. O2 was 74 . Patient changed the batteries just to be sure. With new batteries it was 88, pulse was 113 . O2 steadily climbed to 97 but had been hovering at 93 and 94 for the last hour 1/2. Patient was recovering from the events. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The case was reported as non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Ear discomfort, SARS-CoV-2 test, Somnolence, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; blocked nose and ears; drowsy, sleepy; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 16:00 (lot number: EP7534), at the age of 55-years-old, at 1st dose, single in the left arm, and second dose on 05Apr2021 16:45 (lot number: EP7533), at the age of 55-years-old, via an unspecified route of administration at 2nd dose, single in the left arm; both for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies and had no COVID prior to vaccination. Concomitant medications included linum usitatissimum seed oil (FLAX), multivitamin, and plant steroids. The patient had no other vaccines in four weeks. On 31May2021 22:00, the patient experienced body ache, cough, blocked nose and ears, drowsy, sleepy, feeling tired, and exhausted with talking and working. On 02Jun2021, the patient was tested for COVID via COVID-19 nasal swab test, and result came out positive on 04Jun2021. Despite having the two doses of the vaccine 8 weeks prior, the patient still tested positive. The patient was vaccinated in a pharmacy or drug store. Treatments such as home quarantine and care for COVID were given to the patient. Outcome of all the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Choking sensation, Dizziness, Oropharyngeal discomfort, Ventricular tachycardia
Clinical narrative: Ventricular tachycardia; He is getting light headed/dizzy; he feels like there is either a lump or something in his throat or somebody has their thumb on his Adam's apple; feel like somebody choked me and stuff like this; This is a spontaneous report from a contactable consumer (patient's parent). A male patient of unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 26May2021 (at an unspecified age) at 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 received on 03May2021 for COVID-19 immunization for which he started developing a cough, started not being able to sleep, started insomnia and tried to go to sleep and within an hour or two and his body jerks and wakes him back up. The patient has never had that before. It was reported that when the patient received his second vaccine, things stated to get worse and was getting lightheaded. The patient feels like there was either a lump or something in his throat or somebody has their thumb on his Adams apple and keeps pressing in. The patient woke up this morning and stated that he was dizzy, and he felt like somebody choked him and stuff like this. The patient can swallow okay but still feels like somebody was choking him with a thumb. Due to these, the patient went to the emergency room and they didn't do anything to the patient. Basically, the patient was just told to take 'breathing pills', which the patient cannot take because of ventricular tachycardia for which the patient was on special medicine. They did look up online and said that there was one side effect to the vaccine where somebody developed insomnia, so the doctor sent the patient home. The patient's parent called his family doctor and his heart doctor. The patient was supposed to have a test first thing in the morning for nuclear with nuclear medicine for a stress test since the patient cannot do the treadmill. They were concerned if the patient was having a side effect from the vaccine and if the patient should or should not have the nuclear medicine for the stress test. The way the patient's heart was, he must have that test. So, the reporter needs to know if this was a side effect and what they should do concerning the testing that he was supposed to have. The patient's test will be done on Sunday (unspecified date). Outcome of all the events was unknown.   Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, SARS-CoV-2 test, Tinnitus
Clinical narrative: ringing in left ear and some hearing loss in left ear; ringing in left ear and some hearing loss in left ear; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm, on 03Jun2021 12:00 (batch/lot number: Ew0181), as 2nd dose, single, at age 39 years old, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 on an unknown date (diagnosed prior to vaccination). There were no concomitant medications. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm, on 05May2021 10:00 (batch/lot number: Ew0173), at age 39 years old, for COVID-19 immunisation. On 04Jun2021 13:00, the patient started to have ringing in left hear and some hearing loss in left ear. No treatment was given for the events. The patient underwent laboratory tests which included SARS-CoV-2 test: Positive on an unspecified date (prior to vaccination), and COVID-19 Rapid Nasal Swab: Negative on 04Jun2021. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: The patient had COVID-19 infection prior to vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  Based on information available, the reported event ringing in left hear and hearing loss in left ear was unlikely causally related to BNT162B2.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot, Pain, Syncope
Clinical narrative: fainted in my kitchen; she is very clammy and very hot; she is very clammy and very hot; She is been very tired all day and been very achy; She is been very tired all day and been very achy; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (reporter's daughter) of an unspecified age received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient fainted in my kitchen, she is very clammy and very hot, she is been very tired all day and been very achy. Reporter stated, "My daughter had the Pfizer shot yesterday and she just fainted in my kitchen and I am curious if this is the side effect that is common. She is awaken now. She is very clammy and very hot." Reporter added "She is been very tired all day and been very achy and now she just fainted in my kitchen. She had her second shot yesterday about 24 hours ago. I am just trying to see if this is the medical emergency enough to take her to the hospital or if this is the common side effect she is been dealing." Outcome of the events was unknown. The patient received first dose of BNT162B2 on an unspecified date.  Information on the lot/batch number has been requested
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion missed, Fatigue, Pain in extremity, Ultrasound foetal
Clinical narrative: My pregnancy symptom s started disappearing gradually and after a week I didn't feel pregnant at all/missed abortion; My arm was sore; I felt mild fatigue; This is spontaneous report from contactable consumer.  A 28 year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), on 03May2021 (at the age of 28-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on 13Apr2021 (lot EW0164). The patient had no known allergies and had not other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that she got her 2nd dose of vaccination when she was 7 weeks pregnant. The LMP was on 21Mar2021. Her arm was sore and she felt mild fatigue. Her pregnancy symptoms started disappearing gradually and after a week she didn't feel pregnant at all. When she went in for her first ultrasound appointment at 9 weeks, the doctor said that the growth stopped at 7 weeks 4 days and there was no heartbeat. She declared it missed abortion.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Respiration abnormal, Vision blurred
Clinical narrative: blurriness of her eyes/ it got worse; blurriness of her eyes/ it got worse; Side effects like breathing things; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EWO177; Expiration Date: 31Aug2021), intramuscular, administered in left arm on an unspecified date as first dose, single for COVID-19 immunization. Medical history included Blood pressure abnormal (blood pressure), osteoporosis, ongoing blurriness of her eyes, and macular degeneration. Concomitant medication included carvedilol for blood pressure abnormal (blood pressure). The patient has not taken any vaccine 4 weeks prior to the COVID-19 vaccine. The patient stated that 2 weeks ago (unspecified date), she has gotten the first dose of the Pfizer COVID 19 vaccine. She said she did get most of the side effects and until now she is experiencing blurriness of her eyes. She also has a history of Macular Degeneration. She is experiencing blurriness before but after getting the Pfizer COVID 19 vaccine, she said that it seems like it got worse. The patient said that she won't be getting the second COVID 19 vaccine dose. She asked if Pfizer has an antidote and if it will continue to progress. When probed for the concern, she stated that she had the first shot vaccine two weeks before and just had a side effects with this. She stated she has macular degeneration and she sees blurry because of the macular degeneration. She wanted to know its side effect, her vision changed and it got worst. She wanted to know if other people had gone through this blurry vision. She wanted to know the side effects, if it's the side effect or what. When paraphrased the concern, the patient stated, "Yes, I have the other things. I have the side effects like breathing things and such type of things and I want to report it. Hold on I want to get the paper." The patient stated that she had the first shot of the vaccine 2 weeks before and she was afraid on the first day actually that the shot she got had side effects. As she got it, it got more blurry, as her eye, her vision. The vision changed on it on an unspecified date. It wasn't blurry prior to because she has macular degeneration however, ongoing symptoms, her eyes become more blurry and now it seems to be more blurry and she wanted to now if this is gonna last. She asked if this is going to continue and what she can take or do to stop it. The vaccine is in her system now. She said she get 2 treatment for macular degeneration, 3 days later, she got injection in her eye and it's called Eylea. The outcome for the events vision blurred and condition aggravated was not recovered while the outcome of the event respiration abnormal was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Eructation, Ophthalmic migraine, Panic attack, Photopsia
Clinical narrative: heart feeling like a fist when tighten it for a blood draw/heart squeeze; burpy; ocular migraine; seeing the black and white flashy snake thing that makes it hard to focus; seeing the black and white flashy snake thing that makes it hard to focus; almost like a panic attack/Panic; This is a spontaneous report from a contactable consumer (patient) reported that a 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167), via an unspecified route of administration, administered in arm right on 03Jun2021 18:30 (at the age of 41-years-old) as 1st dose, single for covid-19 immunization. The vaccine was administered at the Pharmacy/drugstore. The patient was not pregnant at the time of vaccination. The patient medical history included situational anxiety and melanoma. Concomitant medications included escitalopram; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); and clonazepam (ZICAM [CLONAZEPAM]); all were taken for an unspecified indication, start and stop date were not reported. It was reported that 2 mornings after (05Jun2021), she woke up at 5:45 am (after a really good sleep) with her heart feeling like a fist when tighten it for a blood draw. She also was burpy. She did meditative breathing and sat up. It helped, but kept coming back that day (almost like a panic attack -- but the patient never experienced that feeling). A few hours later she got an ocular migraine (no pain, just seeing the black and white flashy snake thing that makes it hard to focus). The visual went away within 30 minutes or so with no lights/eyes covered and in reclining position. Panic/heart squeeze continued on and off --- but underlying feeling -- all day. The next day, (today) heart is feeling a tad tight but no where like yesterday. Plan on talking to doctor tomorrow. She spoke to a medical friend and didn't feel it was life threatening, so didn't seek medical care over the weekend. It was unknown if the patient received any treatment for the events. The outcome of the events was recovered with sequel.   Information on lot/batch number was available. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: heart feeling like a fist when tighten it for a blood draw/heart squeeze; burpy; ocular migraine; seeing the black and white flashy snake thing that makes it hard to focus; seeing the black and white flashy snake thing that makes it hard to focus; almost like a panic attack/Panic; This is a spontaneous report from a contactable consumer (patient) reported that a 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167), via an unspecified route of administration, administered in arm right on 03Jun2021 18:30 (at the age of 41-years-old) as 1st dose, single for covid-19 immunization. The vaccine was administered at the Pharmacy/drugstore. The patient was not pregnant at the time of vaccination. The patient medical history included situational anxiety and melanoma. Concomitant medications included escitalopram; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); and clonazepam (ZICAM [CLONAZEPAM]); all were taken for an unspecified indication, start and stop date were not reported. It was reported that 2 mornings after (05Jun2021), she woke up at 5:45 am (after a really good sleep) with her heart feeling like a fist when tighten it for a blood draw. She also was burpy. She did meditative breathing and sat up. It helped, but kept coming back that day (almost like a panic attack -- but the patient never experienced that feeling). A few hours later she got an ocular migraine (no pain, just seeing the black and white flashy snake thing that makes it hard to focus). The visual went away within 30 minutes or so with no lights/eyes covered and in reclining position. Panic/heart squeeze continued on and off --- but underlying feeling -- all day. The next day, (today) heart is feeling a tad tight but no where like yesterday. Plan on talking to doctor tomorrow. She spoke to a medical friend and didn't feel it was life threatening, so didn't seek medical care over the weekend. It was unknown if the patient received any treatment for the events. The outcome of the events was recovered with sequel.   Information on lot/batch number was available. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Pericarditis
Clinical narrative: Multiple hospitalizations for pericarditis leading up up to a pericardectomy on May2021; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:30 (Batch/Lot Number: EL3246), age at vaccination of 64 years-old, as single dose, for covid-19 immunisation. Medical history included scarlet fever from an unknown date and unknown if ongoing, rheumatic fever from an unknown date and unknown if ongoing (as a child). The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medication included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis (hospitalization, medically significant) on 17Feb2021 19:30 with emergency room/department or urgent care visit as well as multiple hospitalizations leading up to a pericardectomy in May2021. Therapeutic measure was taken as a result of the event and included a course of Prednisone for 5 weeks/ followed by a co (as reported). Facility where the most recent COVID-19 vaccine was administered: Other.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included covid-19 negative on 19May2021. Outcome of the event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspiration pleural cavity, Atrial fibrillation, Cardiac operation, Chest discomfort, Echocardiogram abnormal
Clinical narrative: Multiple hospitalizations for pericarditis leading up up to a pericardectomy on May2021; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:30 (Batch/Lot Number: EL3246), age at vaccination of 64 years-old, as single dose, for covid-19 immunisation. Medical history included scarlet fever from an unknown date and unknown if ongoing, rheumatic fever from an unknown date and unknown if ongoing (as a child). The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medication included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis (hospitalization, medically significant) on 17Feb2021 19:30 with emergency room/department or urgent care visit as well as multiple hospitalizations leading up to a pericardectomy in May2021. Therapeutic measure was taken as a result of the event and included a course of Prednisone for 5 weeks/ followed by a co (as reported). Facility where the most recent COVID-19 vaccine was administered: Other.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included covid-19 negative on 19May2021. Outcome of the event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Implantable cardiac monitor insertion, Inflammation, Laboratory test, Pain, Pericarditis
Clinical narrative: Multiple hospitalizations for pericarditis leading up up to a pericardectomy on May2021; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:30 (Batch/Lot Number: EL3246), age at vaccination of 64 years-old, as single dose, for covid-19 immunisation. Medical history included scarlet fever from an unknown date and unknown if ongoing, rheumatic fever from an unknown date and unknown if ongoing (as a child). The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medication included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis (hospitalization, medically significant) on 17Feb2021 19:30 with emergency room/department or urgent care visit as well as multiple hospitalizations leading up to a pericardectomy in May2021. Therapeutic measure was taken as a result of the event and included a course of Prednisone for 5 weeks/ followed by a co (as reported). Facility where the most recent COVID-19 vaccine was administered: Other.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included covid-19 negative on 19May2021. Outcome of the event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pleural effusion, Pyrexia, Scan, X-ray
Clinical narrative: Multiple hospitalizations for pericarditis leading up up to a pericardectomy on May2021; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:30 (Batch/Lot Number: EL3246), age at vaccination of 64 years-old, as single dose, for covid-19 immunisation. Medical history included scarlet fever from an unknown date and unknown if ongoing, rheumatic fever from an unknown date and unknown if ongoing (as a child). The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medication included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis (hospitalization, medically significant) on 17Feb2021 19:30 with emergency room/department or urgent care visit as well as multiple hospitalizations leading up to a pericardectomy in May2021. Therapeutic measure was taken as a result of the event and included a course of Prednisone for 5 weeks/ followed by a co (as reported). Facility where the most recent COVID-19 vaccine was administered: Other.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included covid-19 negative on 19May2021. Outcome of the event was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haematochezia
Clinical narrative: Bloody stool; patient was very tired/ he got extremely exhausted; This is a spontaneous report from a contactable consumer (patient's wife). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), intramuscular on the right arm on 04Jun2021 13:00 (at the age of 53-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The reporter didn't know the lot number. The reporter called because last night (on 05Jun2021), at 09:00 PM, the patient was very tired and also had a bloody stool. The patient now hadn't gone to the bathroom again. Since that time, he hadn't had the bloody stool, but he got extremely exhausted after having the bloody stool. The reporter stated that the patient was a healthy person, so they needed to look out for any possible side effects once he got the vaccine. The reporter then added that's everything and they were just following up because the instructions that he was given was to reach out to the company if they had side effects and reiterated that the patient had exhausted and blood stool at 9 pm last night. The outcome of the events was unknown. Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Oropharyngeal pain, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: expiratory wheezing and coughs; my spo2 was 92/94; expiratory wheezing and coughs; throat ache; shortness of breath; tachycardia; This is a spontaneous report from a contactable consumer.  A 39 year old female consumer (patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ew0185), in the right arm on 30May2021 at 12:30 (at the age of 39-years-old) at single dose for COVID-19 immunization. The patient was not pregnant. patient's history included seasonal allergy with rhinorrhea and sneezing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant drugs included cromolyn sodium nasal spray. The patient reported on 03Jun2021 throat ache started after vaccine, then she woke up midnight with shortness of breath and tachycardia. She had expiratory wheezing and coughs. The next night the same thing happened and this time wheezing was pronounced and her husband could easily hear it. She was not asthmatic. She had to use cromolyn, psedoephedrine, fluticasone to reduce the symptoms. Her SPO2 was 92/94 and her husband 98. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.