chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Pain in extremity, Rash
Clinical narrative: bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/neck rash; fatigue; dizzy.; Sore arm; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 23Mar2021 12:00 (Batch/Lot number was not reported), at the age of 62-years at vaccination, as SINGLE DOSE for COVID-19 immunization.  Medical history included enlarged aorta, high blood pressure, asthma, eggs and corn allergy. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; budesonide (PULMICORT) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin, ferrous sulfate, folic acid, serine (RESCUE) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 12:00, the patient experienced mild allergic reaction, started with metallic taste in mouth and pounding headache before leaving (pharmacy name withheld) after 15 min wait period, red ears, face/neck rash, "bulging eyes". No respiratory issues. Subsided after <1 hour but still feeling fatigue and dizzy. The patient also had sore arm. Still thrilled to get it. The outcome of the events was recovering.  No treatment was received for the events.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Head discomfort, Hypertension, Hypoaesthesia
Clinical narrative: fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021.  Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face, Syncope, Tachycardia
Clinical narrative: fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021.  Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. 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.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Computerised tomogram, Fall, Gait disturbance, Headache
Clinical narrative: seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anxiety, Chest discomfort, Chest pain, Periorbital swelling
Clinical narrative: anxiety attack/she did get pretty anxious easily and that probably exacerbated it; Chest pain; Chest heaviness; Abdominal pain; eyelid got puffy/puffiness mostly on her upper eyelid of her left eye; had eye puffiness in her left eye; This is a spontaneous report received from a contactable nurse (patient). This 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 10:15 (Batch/Lot number was not reported, reported as "one number on there is EN and then she does not know if it is a G or 6 and then 204") as a single dose for COVID-19 immunization. Medical history included ongoing anxiety from 2020, ongoing acid problems from 2020, high cholesterol levels from 2020 (she was not prescribed any medication and the advice given was just for diet and exercise), and ongoing gallbladder problem for years. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 10Mar2021, patient had eye puffiness in her left eye. Patient asked if it is safe to take the second dose. Her eyelid got puffy which began 30 minutes after having the Pfizer COVID Vaccine and it is not ongoing but resolved completely after a few minutes. She did not require treatment for the eye puffiness and the puffiness was mostly on her upper eyelid of her left eye. Patient stated that she does not know in terms of causality if the Pfizer COVID vaccine is related to the reported events and was worried because a week after she got the vaccine, she had other symptoms and was not sure if they are connected with the vaccine. She also reported that she does not think the eye puffiness itself is that serious but it is medically significant and the other symptoms she had were chest pain, chest heaviness, and abdominal pain. These symptoms are not ongoing anymore and began around Friday, 19Mar2021 and resolved after a couple of hours of when they began. For the chest pain, chest heaviness and abdominal pain, she just took an antacid Prilosec for treatment. She thought about going to the emergency room but also thought she was having an anxiety attack and was close to having to go to the emergency room that night. She did get pretty anxious easily and that probably exacerbated it. AEs did not require a visit to emergency room or physician office. Outcome of the events had eye puffiness in her left eye and eyelid got puffy/puffiness mostly on her upper eyelid of her left eye was recovered on 10Mar2021, of the event "anxiety attack/she did get pretty anxious easily and that probably exacerbated it" was unknown, and of the other events was recovered in Mar2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the contributory role of the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported events is possible.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: anxiety attack/she did get pretty anxious easily and that probably exacerbated it; Chest pain; Chest heaviness; Abdominal pain; eyelid got puffy/puffiness mostly on her upper eyelid of her left eye; had eye puffiness in her left eye; This is a spontaneous report received from a contactable nurse (patient). This 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 10:15 (Batch/Lot number was not reported, reported as "one number on there is EN and then she does not know if it is a G or 6 and then 204") as a single dose for COVID-19 immunization. Medical history included ongoing anxiety from 2020, ongoing acid problems from 2020, high cholesterol levels from 2020 (she was not prescribed any medication and the advice given was just for diet and exercise), and ongoing gallbladder problem for years. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 10Mar2021, patient had eye puffiness in her left eye. Patient asked if it is safe to take the second dose. Her eyelid got puffy which began 30 minutes after having the Pfizer COVID Vaccine and it is not ongoing but resolved completely after a few minutes. She did not require treatment for the eye puffiness and the puffiness was mostly on her upper eyelid of her left eye. Patient stated that she does not know in terms of causality if the Pfizer COVID vaccine is related to the reported events and was worried because a week after she got the vaccine, she had other symptoms and was not sure if they are connected with the vaccine. She also reported that she does not think the eye puffiness itself is that serious but it is medically significant and the other symptoms she had were chest pain, chest heaviness, and abdominal pain. These symptoms are not ongoing anymore and began around Friday, 19Mar2021 and resolved after a couple of hours of when they began. For the chest pain, chest heaviness and abdominal pain, she just took an antacid Prilosec for treatment. She thought about going to the emergency room but also thought she was having an anxiety attack and was close to having to go to the emergency room that night. She did get pretty anxious easily and that probably exacerbated it. AEs did not require a visit to emergency room or physician office. Outcome of the events had eye puffiness in her left eye and eyelid got puffy/puffiness mostly on her upper eyelid of her left eye was recovered on 10Mar2021, of the event "anxiety attack/she did get pretty anxious easily and that probably exacerbated it" was unknown, and of the other events was recovered in Mar2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the contributory role of the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported events is possible.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, SARS-CoV-2 test, Thrombosis
Clinical narrative: experiencing passing a ton of clots; I washed my face, it got extremely red; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 20-year-old, via an unspecified route of administration, administered in the left arm on 19Jan2021 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included lupus and idiopathic thrombocytopenic purpura (ITP). Concomitant medications included mycophenolate mofetil (CELLCEPT), esomeprazole magnesium (NEXIUM), medroxyprogesterone acetate (DEPOPROVERA), and propranolol; all taken for an unspecified indication, start and stop date were not reported. The patient has known allergies to rituximab and amoxicillin. As a woman, the patient was having a lot of blood clots being passed. The patient doesn't get a period because of depo, but for some reason, she was experiencing passing a ton of clots on an unspecified date. Also, after the first dose, when she washed her face, it got extremely red on an unspecified date in 2021 (She did the same in the days before and that didn't happen). The patient underwent lab tests and procedures which included Covid test: negative on an unspecified date. The outcome of the events was unknown. No treatment was received for the events. The patient received the second dose of BNT162B2 on 11Feb2021 for COVID-19 immunisation administered at the left arm.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: was on the phone then loss conscious and collapsed; was on the phone then loss conscious and collapsed; This is a spontaneous report from a contactable consumer(patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EP7534) via an unspecified route of administration into the left arm on 20Mar2021 08:30 as single dose for COVID-19 immunisation. Medical history included heart disorder and blood pressure abnormal. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EN6203) via an unspecified route of administration into the left arm on 26Feb2021 02:30 PM as single dose for COVID-19 immunisation. On 21Mar2021 12:00, patient was on the phone then experienced loss conscious and collapsed. The patient was brought to the emergency department and was given treatment (unspecified). Outcome of events recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: contracted COVID-19 3 days after being vaccinated/developed pneumonia due to the COVID-19 infection; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID -19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient contracted COVID-19 3 days after being vaccinated, she has preexisting medical conditions (including rheumatoid arthritis) and is still in the hospital. She developed pneumonia due to the COVID-19 infection. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Dyspnoea, Lip swelling, Pulmonary congestion
Clinical narrative: felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Upset stomach; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:00 (Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (TIROSINT) taken for thyroid, start and stop date were not reported. The patient previously took thiomersal and experienced allergy to thiomersal. On 22Mar2021, the patient had some reactions to BNT162B2, the patient was curious if she should take the second one, knowing how the patient's body. The patient waited for 30 minutes after the vaccine to make sure something didn't happen. The patient started to have lip swelling so she went back into the facility and waited a little longer, the swelling subsided on their own but then she started having shortness of breath through the evening, but not to the point to go to the emergency room. The patient felt like there was a lot of pressure on her chest, congestion and upset stomach. The main symptom was the heaviness in the chest. The outcome of congestion, lip swelling and upset stomach was recovering and the outcome of the rest of the events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess, Wound
Clinical narrative: Open wound; Abscess; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 14: 30 (Batch/Lot number was not reported), at the age of 75-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included black lung and COPD, he fell about three weeks before they got the vaccine. He was swollen in his back with infection where he fell on a rock, back was hurting in the hip area due to the fall. Family history includes: Sister has had an abscess 20 years ago. The patient's concomitant medications were not reported. Reports he fell about three weeks before they got the vaccine. He was swollen in his back with infection where he fell on a rock. He received the first dose of the Pfizer COVID 19 vaccine on 5MAR2021 at 1430 in the left arm. On the 12MAR2021, there was a knot across his back. The doctor said the bruise didn't come to the outside; it started bleeding inside and turned his back red across the bottom. He went to the doctor who put him in the hospital and they drained out all the infection from the wound. Patient was admitted to the hospital 12MAR2021 and discharged 16MAR2021. Mentions you have to check in at the front and then they send you around to the ER to see the doctor. When he was admitted they diagnosed an abscess. They cut it and lanced it and put in a drain tube that is still draining. Now the wound is still an open wound. He has an appointment with the surgeon and his regular doctor soon. The swelling is gone now and the wound was actually in the hip. Adds he had the infection when he got the first shot but he never ran a fever. Adds they are treating him with the generic for Levaquin and he has four more days. Adds when he was in the hospital he was given two types of strong IV antibiotics but she does not know the names or anything else about them.  The outcome of the event abscess was recovering with sequalae; open wound was recovering.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Pyrexia, Syncope
Clinical narrative: Faint; Fever; Dizzy; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 20Mar2021 12:00 (Lot Number: EP7534) as single dose for covid-19 immunization at age 76 years old. Not pregnant at the time of vaccination. The patient medical history was not reported. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included lisinopril; amlodipine besylate; and carvedilol; all taken for product used for unknown indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 26Feb2021 12:00 PM (lot no: EN6202) for COVID-19 immunization at age 76 years old. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced faint, fever, dizzy, and diarrhea. The events were reported as non-serious. No treatment received for the adverse events. The patient had not recovered from the events.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Hypotension, Immediate post-injection reaction
Clinical narrative: Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in trendelburg position
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Ran low temp (99.4), achey, tired, nausea.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bad Tinnitus
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Tremor
Clinical narrative: Severe joint pain in every part of body, more than ever had before during a ?normal flare up? of joint pain. Uncontrollable shaking and chills. Muscle pain in every part of body. Sensitivity to touch, just as when I am sick with some type of cold virus.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Hyperhidrosis, Injection site pain
Clinical narrative: Sore arm and shoulder - lifting and pressure were painful for about 36 hours Lack of appetite - lasting 36-48 hours Severe lower back pain, beginning 12 hours following shot, currently experiencing Low grade fever - resulting in fits of overactive sweating - 24 hours post shot Swollen arm pit resulting in severe pain in injection arm - iced and took acetaminophen- relieved superficial pain, but still very sore.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Sore arm and shoulder - lifting and pressure were painful for about 36 hours Lack of appetite - lasting 36-48 hours Severe lower back pain, beginning 12 hours following shot, currently experiencing Low grade fever - resulting in fits of overactive sweating - 24 hours post shot Swollen arm pit resulting in severe pain in injection arm - iced and took acetaminophen- relieved superficial pain, but still very sore.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Neck pain, Sleep disorder
Clinical narrative: Horrific pain in left arm, shoulder, neck  every day since the first injection.  Pain is 24/7, ongoing, causes lack of sleep, severe discomfort, inability to function
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pruritus
Clinical narrative: large red skin reaction around the injection site. First noticed it 4 days after injection. red an warm with slight itchiness
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Somnolence, Tremor
Clinical narrative: Extreme chills causing full body shaking Extreme fatigue to the point that holding head up and staying conscious was difficult Mild Fever  All started about 12hrs after the vaccine and lasted about 32hrs
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, fever (99.9), congestion, muscle aches.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vertigo
Clinical narrative: Fever started the night from the day Of administration and the next morning I woke up with severe vertigo and dizziness. I waited  10 days for it go away on its own. Then on April 4 and 5th tried Meclizine to see of that helps but seen very minimum relief from Meclizine. Going to see the ENT or Neuro today or tomorrow depending on the availability of the appointments
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Haematemesis, Headache, Malaise
Clinical narrative: pt states that her arm was very sore after getting the vax.  Her arm is still sore today but was severely sore for a week and half.  She gets a chronic migraine every day since taking this vax.  She says the headache comes on about 10 AM everyday and it may last about 30 minutes or it may last a couple of hours.  She has bouts of vomiting that comes and goes.  she says the vomit contains blood.  When she vomits her face breaks out into a rash.  Pt says she is not feeling well, has chills and very fatigued.  These symptoms have been going on for almost 2 weeks.  Pt will see her PCP next week for symptoms on 4/14 @ 10AM.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Rash, Vomiting
Clinical narrative: pt states that her arm was very sore after getting the vax.  Her arm is still sore today but was severely sore for a week and half.  She gets a chronic migraine every day since taking this vax.  She says the headache comes on about 10 AM everyday and it may last about 30 minutes or it may last a couple of hours.  She has bouts of vomiting that comes and goes.  she says the vomit contains blood.  When she vomits her face breaks out into a rash.  Pt says she is not feeling well, has chills and very fatigued.  These symptoms have been going on for almost 2 weeks.  Pt will see her PCP next week for symptoms on 4/14 @ 10AM.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: TWENTY-FIVE MINUTES AFTER ADMINISTERING VACCINE PATIENT STARTED TO ITCH AND SKIN TURNED RED. BENEDRYL WAS ADMINISTERED AND PATIENT WAS ASKED TO STAY AN ADDITIONAL 5-10 MINUTES (TOTAL 35 MINUTES)  PATIENT STARTED TO FEEL BETTER BUT WAS STILL SOMEWHAT ITCHY AT TIME OF DEPARTURE.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Shortness of breath, wheezing were the symptoms. They prescribed me prednisone and gave me a pump.  This was on February 14, 2021 around 10:00 a.m.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Significant amount of hair loss on a daily basis
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Approximately 18 hrs Chills, Tired, headache on and off
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Exfoliative rash, Herpes zoster, Nerve block
Clinical narrative: Shingles with a few rash spots and horrible nerve pain on the same side as injection site (left). Burning, stinging, stabbing, extremely achy.  Very painful that I needed pain meds lyrica and tramadol.  rash could take up to 100 days to appear and postherpetic neuralgia can last from a few days to a few months.  Its been 3 weeks. Getting a nerve block. Also, it starts on left upper back, wrapping around torso to under my breast.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Post herpetic neuralgia
Clinical narrative: Shingles with a few rash spots and horrible nerve pain on the same side as injection site (left). Burning, stinging, stabbing, extremely achy.  Very painful that I needed pain meds lyrica and tramadol.  rash could take up to 100 days to appear and postherpetic neuralgia can last from a few days to a few months.  Its been 3 weeks. Getting a nerve block. Also, it starts on left upper back, wrapping around torso to under my breast.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: I started to notice mouth ulcers on the lips the morning after I got vaccinated with the first Pfizer dose
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: A few days after receiving my shot on 3/22, I experienced soreness and itchiness. No rash, from what I could tell but my injection was through a tattoo so it might?ve been hard to see. The itchiness was subdermal and almost felt like the muscle itself was itching.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: 12:08PM LIGHTHEADED AND DIAPHORETIC. BP 80/50. JUICE GIVEN.  'FEELS BETTER NOW'. PLACED ON COT PER WHEEL CHAIR.12:14PM 'FEELS BETTER'. BP 98/60, HR 91, R 16, 02 SAT 95%. 12:19PM SITTING UP BP 104/78. PT STATES '100% BETTER'.  AMBULATORY TO EXIT - GAIT BRISK AND STEADY. A/O, PINK, W/D, RESP REG WITH EASE. 4-7-21 9AM TC: PT STATES HE 'FEELS GREAT'.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo, Vitreous floaters
Clinical narrative: DIZZINESS AND VERTIGO AND APPEAR TO SEE FLOATERS / HAVE NOT HAD THIS AFFECT SINCE i WAS FIRDT DIAGNOSED WITH TINNITUS AND COMLETE RIGHT EAR HEARING LOSS vestibular disorder in 1985
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucinations lasting approximately 1.5 hours
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fall, Fatigue, Head injury
Clinical narrative: these symptoms began around 8 pm on 4/5/21 - Headache - severe; chills; muscle aches in neck and upper back; nausea;  dizziness upon awakening on 4/6/21 such that when brushing teeth in morning, I blacked out and fell to the floor hitting my head. fatigue all day on 4/6/21  above symptoms resolved at 11:00 pm on 4/6/21
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Myalgia, Nausea
Clinical narrative: these symptoms began around 8 pm on 4/5/21 - Headache - severe; chills; muscle aches in neck and upper back; nausea;  dizziness upon awakening on 4/6/21 such that when brushing teeth in morning, I blacked out and fell to the floor hitting my head. fatigue all day on 4/6/21  above symptoms resolved at 11:00 pm on 4/6/21
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in my right side of my face and right arm.  Went to Urgent Care but symptoms were gone.  Suggestion was to take baby aspirin.  The next day the symptoms came back and I went to the ER.  They drew blood samples and did a CT scan.  Everything appeared to be normal.  Referred to a neurologist but couldn?t get in until July.  Follow up the following week with my Dr.  She said since the CT scan showed no sign of stroke, cancer or tumor, there really wasn?t a need to get an MRI.  No further outbreak of symptoms.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Eye swelling, Fatigue, Lip swelling, Pruritus
Clinical narrative: 24hrs after - tired and minimal tenderness where shot was administered.  4 days after - woke at 1am with itchy scalp, swollen ears and hives mostly upper body. Called Dr. and sent pictures and was told to take Benadryl. 5th day - woke to swollen eyes, upper lip and full body hives.  Went to ER and was given IV, Benadryl and steroid and continued to take Benadryl and Prednisone for 5 day.  Day 3 of Prednisone, hives had subsided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 24hrs after - tired and minimal tenderness where shot was administered.  4 days after - woke at 1am with itchy scalp, swollen ears and hives mostly upper body. Called Dr. and sent pictures and was told to take Benadryl. 5th day - woke to swollen eyes, upper lip and full body hives.  Went to ER and was given IV, Benadryl and steroid and continued to take Benadryl and Prednisone for 5 day.  Day 3 of Prednisone, hives had subsided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Migraine with aura, Myalgia, Pyrexia, Syncope
Clinical narrative: Shortness of breath 5 minutes after, fainting, and severe migraine with aura 1.5 hours after.  Muscle pain and aches for 24 hours after. low-grade fever.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Chest X-ray abnormal, Haemoglobin decreased, Pneumonia, Unevaluable event
Clinical narrative: Admitted to hospital 4/5/21 with DX pneumonia & anemia ( Hgb 6.7). Visit to PCP 4/3/21, chest X ray done, showing developing pneumonia. Abx prescribed but not filled by pt. Pt remains inpatient.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Interchange of vaccine products, Overdose, Product name confusion
Clinical narrative: Pt is a 12-month old girl, was seen in office for the first time for WCC. She only had her 2-month old shots, behind with her IZs, discussed with parents and decided to give her Pentacel, HepB, Hep A, PVC 13, MMR and VAR. I wanted pt to get MMR and VAR vaccines separately. However, MMRV proquad was given by mistake instead of just MMR alone and patient also received VAR alone. I did not verify the vaccine name correctly. Parents were informed that pt received a double dose of varicella, Tylenol was prescribed in case she has a fever. Parents are aware all vaccines have potential adverse reactions with most common being injection site reaction and rarely low grade fever. Parent understood if fever develops, the patient should be given Tylenol to relieve symptoms with ER precautions given. I consulted my supervisor. I also sent an email to the CDC for any recommendations or precautions to take. Per CDC, child might experience a more severe local reaction that usual, but not expecting any other safety concerns.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness bilateral
Clinical narrative: Hearing loss left ear
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Fevered 100f hit at midnight. Joints and muscle aches. Upset stomach. Very tired. Headache.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fevered 100f hit at midnight. Joints and muscle aches. Upset stomach. Very tired. Headache.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Post vaccine patients felt itchy on her arms and legs. Given 25 mg PO diphenhydramine and felt better
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: headache, sore throat, arm pain, fever, runny nose, fatigue, brain fog, nausea, vomiting, constipation, diarrhea, muscle aches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: headache, sore throat, arm pain, fever, runny nose, fatigue, brain fog, nausea, vomiting, constipation, diarrhea, muscle aches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: headache, sore throat, arm pain, fever, runny nose, fatigue, brain fog, nausea, vomiting, constipation, diarrhea, muscle aches
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness  in fingers and hands- mostly in left arm (injection arm)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pruritus, Sleep disorder
Clinical narrative: Body aches beginning in the middle of the night, in process of subsiding now but back and body is still sore Intense itching/burning of hands and feet, beginning about midnight and waking me about every twenty minutes until dawn.  Gone now.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Was vaccinated at 9:30 am, and started reacting to it at 10:45 pm.   Fever, chills, muscle aches, head ache, nausea, weakness, fatigue.   Reactions started lessening about 5 am, still have a headache, and some nausea, but the other side effects are gone.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Was vaccinated at 9:30 am, and started reacting to it at 10:45 pm.   Fever, chills, muscle aches, head ache, nausea, weakness, fatigue.   Reactions started lessening about 5 am, still have a headache, and some nausea, but the other side effects are gone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: c/o light headache after the 2nd dose of Pfizer.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Tinnitus
Clinical narrative: Ringing in the right ear.  Ear Pain,  WORST HEAD ACHE I have ever had in my life.  The head ache has lasted over a week.  The ear pain has lasted over a week.  The ringing in the ear comes and goes.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia
Clinical narrative: other than muscle aches, also shows redness at site of injection
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, headache and body aches starting about 18 hours after the 2nd shot.  Took aspirin to attempt to mediate all issues. Temperature reached over 102 by 10:00am the morning of 4/6.  Temperature dropped to 101 by 14:00 and below 100 by 14:30.  Felt normal the morning of 4/7.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on torso, legs that lasted over a week
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 2:25PM 'FEELS LIGHTHEADED' PINK, W/D. NO SOB, NO ITCHING. BP 118/90, HR 98, R 16, 02 SAT 99%, BS 87MG/DL. 2:32PM 'FEELS BETTER'. PT DECLINES JUICE/CRACKERS. 2:40PM AMBULATORY TO EXIT- GAIT BRISK AND STEADY. A/O, PINK, W/D, RESP WITH EASE.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Headache, Nausea
Clinical narrative: Arm and shoulder pain, headache, cough, fever 101-102, chills, body aches, nausea the day after
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm and shoulder pain, headache, cough, fever 101-102, chills, body aches, nausea the day after
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cranial nerve disorder, Eye pain, Ophthalmological examination, Vision blurred
Clinical narrative: Cranial nerve VI partial palsy, blurred vision/eye pain, blurred vision within 24 hours after vaccination time
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Diplopia, Eye movement disorder, Headache, Magnetic resonance imaging
Clinical narrative: Cranial nerve VI partial palsy, blurred vision/eye pain, blurred vision within 24 hours after vaccination time
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Venogram, Vision blurred
Clinical narrative: Cranial nerve VI partial palsy, blurred vision/eye pain, blurred vision within 24 hours after vaccination time
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: I was feeling fine for a couple of hours after the shot. I started getting a headache at around 11:00am. By noon, I was feeling fatigued and started feeling confusion and lightheadedness. I had to leave work by 3:00pm. by 5:00pm, I was very concerned about the way I was feeling. The headache was severe and I was lethargic. I slept for most of the next 24 hours. 48 hours after the injection, I am still fairly lightheaded and have a headache, but I am improving.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Lethargy
Clinical narrative: I was feeling fine for a couple of hours after the shot. I started getting a headache at around 11:00am. By noon, I was feeling fatigued and started feeling confusion and lightheadedness. I had to leave work by 3:00pm. by 5:00pm, I was very concerned about the way I was feeling. The headache was severe and I was lethargic. I slept for most of the next 24 hours. 48 hours after the injection, I am still fairly lightheaded and have a headache, but I am improving.