chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Tachypnoea, White blood cell count
Clinical narrative: hypoxic; shortness of breath; opacity in the mid and lower L lung; tachypnoea; tachycardia; This is a spontaneous report from a non-contactable other healthcare professional. A 65-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Mar2021 (Lot Number: ER8734) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2), dose 2 on an unspecified date for covid-19 immunization but reported to have had DOE for the past 3-4 days, has felt fatigued for the past week and his taste seems different over the past couple of days. It was reported that during the 15-minute waiting period after the injection, the patient began to experience shortness of breath as he was walking out to the front. He reports no issues with the vaccine as he was waiting. He denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient complaints of shortness of breath. There was no treatment therapy provided. Follow up response to treatment was excellent (also reported as no treatment provided). The patient was discharged as stable to go home and follow up with PCP (primary care physician). He completed his second dose of Covid vaccine yesterday (29Mar2021). He presented to respiratory clinic earlier today (30Mar2021) and was noted to be hypoxic and was sent to ED. He reported DOE (dyspnea on exertion) for the past 3-4 days and has felt fatigued for the past week. He notes that his taste seems different over the past couple of days. CXR (chest x-ray) on an unspecified date in 2021 shows opacity in the mid and lower left lung. He is tachypnea, tachycardia, high normal WBC and afebrile on an unspecified date in 2021. The patient underwent lab tests and procedures which included chest x-ray showed opacity in the mid and lower L lung and white blood cell count was high normal on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further Information is expected.; Sender's Comments: Based on the close temporal association, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of hypoxic cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Mental status changes, Nasal abscess
Clinical narrative: Hallucinations, altered mental status; Hallucinations, altered mental status; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on Jan2021 and on 21Feb2021 both via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included aplastic anaemia and allergies pencillin. Concomitant medications included eltrombopag olamine (PROMACTA) and darbepoetin alfa. The patient experienced hallucinations, altered mental status on 01Feb2021 12:00. The patient underwent lab tests and procedures which included nasal swab: negative on 02Feb2021. Therapeutic measures were taken as a result of hallucinations, altered mental status included Antibiotics and was in observation. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Fluid retention, Headache
Clinical narrative: heart attack; underling condition neurologic condition not diagnosed yet but she gets migraines often; pain; dizziness; headache; chest, arm pain; chest, arm pain; fatigue; water retention; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported. The patient was taking a lot of concomitant medications (unspecified). The patient reported that she has an underling condition neurologic condition which was not diagnosed yet but she gets migraines often on an unspecified date. It was also reported that patient had extreme episodes of tightness, pain, dizziness, headache, chest, arm pain that led her thought had a heart attack and also extreme fatigue on an unspecified date. She mentioned that she was taking a lot of medicines at the time this happened. The patient also experienced water retention on an unspecified date. She said that if she would know what the vaccine would do to her, she would have not been vaccinated wit the Pfizer vaccine. She wanted to know how does the vaccine work so to know if "it overrides your system to product antibodies." The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myocardial infarction, Pain, Pain in extremity
Clinical narrative: heart attack; underling condition neurologic condition not diagnosed yet but she gets migraines often; pain; dizziness; headache; chest, arm pain; chest, arm pain; fatigue; water retention; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported. The patient was taking a lot of concomitant medications (unspecified). The patient reported that she has an underling condition neurologic condition which was not diagnosed yet but she gets migraines often on an unspecified date. It was also reported that patient had extreme episodes of tightness, pain, dizziness, headache, chest, arm pain that led her thought had a heart attack and also extreme fatigue on an unspecified date. She mentioned that she was taking a lot of medicines at the time this happened. The patient also experienced water retention on an unspecified date. She said that if she would know what the vaccine would do to her, she would have not been vaccinated wit the Pfizer vaccine. She wanted to know how does the vaccine work so to know if "it overrides your system to product antibodies." The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, COVID-19, Rash, Rhinorrhoea
Clinical narrative: broke out with a body rash all over the body; nasal drip; I Tested positive on 23rd, in bed for 16 days; I Tested positive on 23rd, in bed for 16 days; This is a spontaneous report from a non-contactable consumer. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunization. Medical history included asthma and Covid-19 from same time a year ago, 15Mar2020 to middle of Apr2020 and it was worse the first time in 2020. The patient's concomitant medications were not reported. The patient had first dose of the vaccine on 15Mar2020, and she was due for the 2nd dose on 12Apr2020. On 23Mar2021, the patient tested positive, and was in bed for 16 days. The patient reported that she felt better, but broke out with a body rash all over the body on an unspecified date. The patient also had a nasal drip but that's because she had asthma. She reported she had no fever for the last 5 days, now this viral thing came up, her primary care doctor thought it was reaction to something she ate, her dermatologist said that they were seeing covid cases that were  presenting with rashes throughout their body. Her dermatologist said that this rash was the body's way of getting rid of the virus and was trying to get out of her system. This rash comes and goes when she woke up it wasn't there, but with activity it picked up again. She don't know what the whole time frame may be it could take up to 6 weeks to get out of the body. The patient was wondering if she can get the second dose of the vaccine and if there was a guidance on time frame for the second dose. Outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood glucose, Blood glucose increased, Chest pain, Diabetes mellitus
Clinical narrative: he was a "full-blown diabetic" in an emergency situation/he wasn't diabetic until he got the shot; his sugar was "400 something"; chest pain; abdominal pain; felt awful; if he closed his eyes he would just go to sleep; This is a spontaneous report from a contactable consumer (patient's parent). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was calling in behalf of her son. The patient had the first dose of Pfizer's COVID-19 vaccine on Saturday about 2 weeks ago, does not know exact date. The next Monday, on an unspecified date, he was a "full-blown diabetic" in an emergency situation and his sugar was "400 something". The patient also experienced chest pain, abdominal pain, felt awful, and if he closed his eyes he would just go to sleep on an unspecified date. Back in Dec (year not reported), his blood sugar was 88 in a general check-up, but he was not a diabetic as far as they knew. The reporter stated that he wasn't diabetic until he got the shot. They think it was caused by the COVID shot, he was told in the emergency room not to take the 2nd shot. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: he was a "full-blown diabetic" in an emergency situation/he wasn't diabetic until he got the shot; his sugar was "400 something"; chest pain; abdominal pain; felt awful; if he closed his eyes he would just go to sleep; This is a spontaneous report from a contactable consumer (patient's parent). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was calling in behalf of her son. The patient had the first dose of Pfizer's COVID-19 vaccine on Saturday about 2 weeks ago, does not know exact date. The next Monday, on an unspecified date, he was a "full-blown diabetic" in an emergency situation and his sugar was "400 something". The patient also experienced chest pain, abdominal pain, felt awful, and if he closed his eyes he would just go to sleep on an unspecified date. Back in Dec (year not reported), his blood sugar was 88 in a general check-up, but he was not a diabetic as far as they knew. The reporter stated that he wasn't diabetic until he got the shot. They think it was caused by the COVID shot, he was told in the emergency room not to take the 2nd shot. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 antibody test
Clinical narrative: feeling funny; if a person got vaccinated with the first dose of PFIZER BIONTECH COVID19 Vaccine and got COVID symptoms and tested positive for COVID after 3 days; This is a spontaneous report from a contactable consumer (the patient's mother). A male patient of an unspecified age received the first dose of BNT162B2 (BNT162B2,PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via an unspecified route of administration on 18Mar2021 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history concomitant medications were not reported. The patient started feeling funny on 22Mar2021. The patient was tested positive for COVID virus on 27Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 27March2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation/she has this prior to getting the first dose of the vaccine; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age (unknown if pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included atrial fibrillation. Concomitant medications were not reported. Pharmacist stated that his patient had Atrial Fibrillation 10 mins after getting the first dose of the vaccine. Asking if this would be a counter indication for her second dose. Also added that she has this prior to getting the first dose of the vaccine. The outcome of the event atrial fibrillation was unknown. The event is considered as serious (medically significant).  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug profile and available information the reported  atrial fibrillation is unrelated to bnt162b2.  This is an intercurrent  medical  history in a patient with a history of  atrial fibrillation.  Case will be reassessed if additional information is received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immune system disorder, Myocardial infarction
Clinical narrative: immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consumer (patient) via Medical Information, also received via Pfizer-sponsored program. A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 5 hours after receiving the dose, she developed shingles on 23Mar2021. She stated the pain was so bad she thought she was having a heart attack on an unspecified date in 2021. Her medical doctor (MD) told her that she should get the second dose of the vaccine and that the shingles was dormant in her system and because her "immune system was low" she developed the shingles outbreak. The patient further stated that she developed shingles 4 hours later after receiving the first dose. She stated that the eruptions have stopped but it was still painful. She was asking if she should get the second covax or wait. The patient had not yet recovered from shingles while outcome of the rest of the events was unknown.  Follow-up attempts are needed. Further information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; Elevated liver enzymes; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 76-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced rheumatoid arthritis and elevated liver enzymes on an unspecified date in 2021. It was reported that patient had second dose of Pfizer Covid vaccine on 28Feb2021. Patient have recently been diagnosed with Rheumatoid Arthritis. Patient have never had RA before. Patient also have elevated liver enzymes. Patient will have a workup by a Rheumatologist as soon as patient can get an appointment. Patient would like any information regarding the onset or flare-up of RA after the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile colitis, Pseudomonas infection, SARS-CoV-2 test, Subcutaneous abscess
Clinical narrative: Pseudomonas aeruginosa abscess of her face; Pseudomonas aeruginosa abscess of her face; C diff coliits; This is a spontaneous report from a contactable physician (patient). A non-pregnant 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9231), via an unspecified route of administration in left arm, on 14Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included paracetamol (TYLENOL), ibuprofen (MOTRIN), and aciclovir (ACYCLOVIR). The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 22Dec2020 at 09:00 AM at the age of 61 years for COVID-19 immunization (intramuscular in right arm); and triamcinolone acetonide (KENALOG) and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 14Jan2021 at 12:00 PM, the patient developed a Pseudomonas aeruginosa abscess of her face for which she needed interventions including drainage, antibiotics, and eventually surgery. As a result of needing repeated doses of antibiotics, the patient developed Clostridium difficile (C diff) colitis in 2021 for which she was still taking oral vancomycin of a tapered dose as of 05Apr2021 (about to end by 07Apr2021). The patient received antibiotics including clindamycin, amoxicillin/ clavulanic acid (AUGMENTIN), and levofloxacin (LEVAQUIN) for at least 2 months for the abscess in her face due to its recurring nature. The patient was able to be operated on 17Mar2021 (resection of abscess). The abscess was gone, and the patient felt better. C diff colitis was better, but the patient's gut has not gone yet without antibiotics to ensure the colitis is gone. The patient underwent COVID-19 nasal swab test post vaccination that was negative on 16Mar2021. The patient was recovering from "C diff colitis". The patient recovered from the other events in 2021.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events.  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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Dizziness, Eye disorder, Feeling abnormal, Laboratory test
Clinical narrative: Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in her head; Eye shutting; Weakness in her left arm and leg; This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular on 23Mar2021 as single dose for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. Concomitant medication included fluoxetine 60 mg taken for an unspecified indication, and an unspecified oral contraceptive. It was reported that on 23Mar2021, the patient received Pfizer Covid vaccine and felt a little dizzy on 11:00. She also started noting mumbling, slurred speech, passed out for about 15 (unspecified) after using the bathroom, developed a "static" feeling in her head and then noted her left eye shutting and then weakness in her left arm and leg. She was taken to the Emergency Room (ER) for evaluation. Symptoms lasted about 5 hours. She fell asleep in the ER. Symptoms seemed to clear by about 8:30 PM. She had lab and head CT at the hospital which were essentially normal. She felt okay the next day, but had some nausea for a couple days starting on the 3rd day on 25Mar2021. She stated she feels fine at the time of report in the Student Health Clinic and asked whether she should receive her second Pfizer dose scheduled on 20Apr2021. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse events. The outcome of the event nausea was recovered in Mar2021, and for other events was recovered on 23Mar2021 20:30.   Information about lot/batch number was requested.; Sender's Comments: Based on the information currently available and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Passed out. 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscular weakness, Nausea, Speech disorder
Clinical narrative: Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in her head; Eye shutting; Weakness in her left arm and leg; This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular on 23Mar2021 as single dose for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. Concomitant medication included fluoxetine 60 mg taken for an unspecified indication, and an unspecified oral contraceptive. It was reported that on 23Mar2021, the patient received Pfizer Covid vaccine and felt a little dizzy on 11:00. She also started noting mumbling, slurred speech, passed out for about 15 (unspecified) after using the bathroom, developed a "static" feeling in her head and then noted her left eye shutting and then weakness in her left arm and leg. She was taken to the Emergency Room (ER) for evaluation. Symptoms lasted about 5 hours. She fell asleep in the ER. Symptoms seemed to clear by about 8:30 PM. She had lab and head CT at the hospital which were essentially normal. She felt okay the next day, but had some nausea for a couple days starting on the 3rd day on 25Mar2021. She stated she feels fine at the time of report in the Student Health Clinic and asked whether she should receive her second Pfizer dose scheduled on 20Apr2021. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse events. The outcome of the event nausea was recovered in Mar2021, and for other events was recovered on 23Mar2021 20:30.   Information about lot/batch number was requested.; Sender's Comments: Based on the information currently available and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Passed out. 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Omphalitis, Weight, Weight increased
Clinical narrative: belly button was infected; a lump under my chin; weight gain/started gaining a pound a day; This is a spontaneous report received from a contactable consumer (patient) received from a Pfizer sponsored program. A 67-years-old female patient received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 09:15 (Batch/Lot Number: EN6209) as SINGLE DOSE for covid-19 immunisation, 67 years old. Medical history included bipolar disorder and attention deficit hyperactivity disorder from Jun2016 which were controlled by unspecified medications. The patient's concomitant medications were not reported. She has not had any other recent vaccinations or started any new medications. The patient experienced belly button was infected and a lump under the chin on 18Mar2021; weight gain/started gaining a pound a day on Mar2021. Patient had her first shot on 17Mar2021, and all was well and there were no problems. Patient woke up the next morning with a lump under her chin and her belly button was infected. She was able to take care of the belly button but the lump under her chin has not gone away. She was going to seek medical advice for that. For the lump under her chin, she has done no treatment. For the belly button she has used hydrogen peroxide and some special stuff she has, an antibiotic cream, and took a Q-tip, which she is doing it on a daily basis and has not quit yet. She says it is fine not, now like in the beginning, which was pretty nasty. She says for the chin it was like "when you have bumped something, you usually know it is going to have a bump there or you would see something there, but she didn't bump anything, which is why she was confused". She stated she would think she had made it up in her head, but she did not. She stated she hasn't seen doctor yet; she will be going to the new facility to see a doctor to get his opinion.  The second dose would be given on 07Apr2021. The patient asked if others reported that quite odd side effect, what happens if she does not get the second dose, if there were reported issues of weight gain, it has never been an issue with her and she started gaining a pound a day, were there pre-historic animals used in the vaccine, and that she read that there is a chip in the vaccine. Outcome of the event "belly button was infected" was recovering, "a lump under the chin" was not recovered and "weight gain/started gaining a pound a day" was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy, Chills, Dizziness, Headache
Clinical narrative: Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  More information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Swollen tongue
Clinical narrative: Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  More information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Deep vein thrombosis, Fibrin D dimer increased, Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: left arm swelling started from 4/18, extended from upper arm to lower arm in the afternoon. went to Urgent care on 4/19 morning, the NP reviewed my blood report and referred me to do ultrasound and also ask me to go to ER if the swell extend. as the swell extend, i went to ER in the afternoon. blood test shows high D-dimer and then ultrasound finds blood clot in the vessel near left neck. diagonised to be Deep Vein Thrombosis. no family history of such problem. in the hospital, they gave me a shot of blood thinner and also prescript oral blood thinner to be take at home.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: left arm swelling started from 4/18, extended from upper arm to lower arm in the afternoon. went to Urgent care on 4/19 morning, the NP reviewed my blood report and referred me to do ultrasound and also ask me to go to ER if the swell extend. as the swell extend, i went to ER in the afternoon. blood test shows high D-dimer and then ultrasound finds blood clot in the vessel near left neck. diagonised to be Deep Vein Thrombosis. no family history of such problem. in the hospital, they gave me a shot of blood thinner and also prescript oral blood thinner to be take at home.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Dyspnoea, Eye pain, Headache, Nausea
Clinical narrative: headache in my eyes so bad i couldn?t open them. terrible nausea that resulted in vomiting at 6:30 A.M. the next morning. Internal bleeding in kidneys that resulted in blood and foam in urine - blood cleared in 4 days; foam cleared in 4 days. Back pain where kidneys are located. Shortness of breath when lying down for 3 nights; had to sleep propped up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Urine analysis abnormal, Vomiting
Clinical narrative: headache in my eyes so bad i couldn?t open them. terrible nausea that resulted in vomiting at 6:30 A.M. the next morning. Internal bleeding in kidneys that resulted in blood and foam in urine - blood cleared in 4 days; foam cleared in 4 days. Back pain where kidneys are located. Shortness of breath when lying down for 3 nights; had to sleep propped up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills throughout night after vaccine, fever and headache for about 4 hours the day after vaccine, fatigue the day after vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever - 108 F
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Red rash circle on arm at injection site. Hard to touch. Itchy.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Bad headache for 2 days  then ringing a few days later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Urticaria
Clinical narrative: 7 days after the injection, large welt on my left arm surrounding the injection site (6cm high, 5cm wide)
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Itching at site of injection that presist  until today's date  04 20 2021 No rash no swelling just itching. Intense at times.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Sluggishness, Tonsillitis
Clinical narrative: None for first dose, second dose day after aches, sluggish, two days after low grade fever, aches sluggish,throat ache that turned to infected tonsil, needed antibiotic
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Left arm was painful around the injection site, pain was peaked during night, until next day, and start to subdue after 2 days.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Feeling abnormal, Headache, Injection site pain
Clinical narrative: After approximately 8 hours, initially very lethargic and expected left arm pain at injection site. A few hours later developed Severe headache, light headedness nearly fainting, motion sickness, mild cough, general fogginess, tingling of head (possibly nerves  & related to severe headache ). Left arm pain & lethargy are not active.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Motion sickness, Paraesthesia
Clinical narrative: After approximately 8 hours, initially very lethargic and expected left arm pain at injection site. A few hours later developed Severe headache, light headedness nearly fainting, motion sickness, mild cough, general fogginess, tingling of head (possibly nerves  & related to severe headache ). Left arm pain & lethargy are not active.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Severe fatigue, body aches and head aches. Swollen lymph nodes under arm and in neck. Low grade fever. Sore throat. Insomnia.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severe fatigue, body aches and head aches. Swollen lymph nodes under arm and in neck. Low grade fever. Sore throat. Insomnia.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site soreness and redness. Chills, body ache headache and fever. Ski  Hurt to the touch. Very uncomfortable.  Low grade Fever of 99.5 started around 5 am approx 13 hours after vaccination. 16 hours later  at 8 am, it was 101.4, then  101.9, 102.1. I took Tylenol 2 tablets 500mg every 4 hours. By 3 pm it was 102.9. I took ibuprofen. 800mg 1 tablet. Fever went down to 101.4 and by 7 pm it was 98.6. By 11 pm it was 99.5 and climbing again. Took 2 Tylenol 500 mg each. 100.3 by midnight
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sensitive skin
Clinical narrative: Injection site soreness and redness. Chills, body ache headache and fever. Ski  Hurt to the touch. Very uncomfortable.  Low grade Fever of 99.5 started around 5 am approx 13 hours after vaccination. 16 hours later  at 8 am, it was 101.4, then  101.9, 102.1. I took Tylenol 2 tablets 500mg every 4 hours. By 3 pm it was 102.9. I took ibuprofen. 800mg 1 tablet. Fever went down to 101.4 and by 7 pm it was 98.6. By 11 pm it was 99.5 and climbing again. Took 2 Tylenol 500 mg each. 100.3 by midnight
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye swelling, Facial pain, Headache, Nausea
Clinical narrative: Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient).  A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose  for covid-19 immunisation  .  Medical history included migraine, demyelination , post-traumatic stress disorder.     The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  The patient experienced immediate left side (injection side) headache.  on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour  on 03Apr2021 11:45 with outcome of not recovered , loose stool  on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting  on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives  on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events.  Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53.  Extreme vertigo within 1 hour, persisting now at hour 53.  Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53.  Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53.    No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pruritus, Swelling, Urticaria, Vertigo
Clinical narrative: Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient).  A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose  for covid-19 immunisation  .  Medical history included migraine, demyelination , post-traumatic stress disorder.     The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  The patient experienced immediate left side (injection side) headache.  on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour  on 03Apr2021 11:45 with outcome of not recovered , loose stool  on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting  on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives  on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events.  Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53.  Extreme vertigo within 1 hour, persisting now at hour 53.  Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53.  Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53.    No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient).  A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose  for covid-19 immunisation  .  Medical history included migraine, demyelination , post-traumatic stress disorder.     The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  The patient experienced immediate left side (injection side) headache.  on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour  on 03Apr2021 11:45 with outcome of not recovered , loose stool  on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting  on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives  on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events.  Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53.  Extreme vertigo within 1 hour, persisting now at hour 53.  Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53.  Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53.    No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Blood pressure jumped to 220/140; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208),  via an unspecified route of administration on 18Mar2021 (at the age of 65 years) at a single dose in the left arm for COVID-19 immunization. Medical history included atrial fibrillation, high blood pressure, and stage 3 kidney disease. No allergies to medications, food, or other products. Concomitant medications included atenolol; losartan; allopurinol and multivitamins. The patient previously took the first dose of BNT162B2 (lot number: CN6198) on 25Feb2021 at 12:00 pm (age: 65 years) in the left arm for COVID-19 immunization. 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. On 30Mar2021 at 11:00, the patient blood pressure jumped to 220/140. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 4 days. Therapeutic measures were taken as a result of the event which included lab tests and medications. The outcome of the event was recovered with sequel in Apr2021.