chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Dyspnoea, Oral discomfort, Oxygen saturation
Clinical narrative: patient became light-headed  10 minutes after Moderna vaccine. then complained of burning down mouth and jaw, and then right leg.  then became short of breath. O2 applied, oximeter at 100%.  Benadryl 50 mg given IM to left deltoid. called 911.  Dr. notified
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Headache, Malaise, Oral pruritus, Paraesthesia oral
Clinical narrative: Patient received COVID-19 Pfizer vaccine today. She has a hx of allergies and was being monitored for 30 minutes. She alerted staff after approx 25 min that she was feeling unwell.    Reported that she developed generalized headache, ear fullness and tingling in the upper lip soon after receiving vaccine. Denied symptoms of anaphylaxis.   She was brought into the triage area. She appeared well, in no distress, no evidence of angioedema or hives. VS were taken: BP 114/70, HR 87 bpm, SpO2 97%.    She was given zyrtec 10 mg PO once. After approx 10 minutes she reported that she was experiencing new mild itching in the roof of her mouth and back of throat. She was then given benadryl 25 mg PO once.    VS taken again: BP 112/74, HR 86 BPM, SpO2 98%. Continued to appear well. There was no observed difficulty breathing. No hives or evidence of angioedema.   After approx 10-15 minutes she reported significant improvement of symptoms. She reported resolution of headache, ear fullness, tingling of the upper lip, and 90% resolution of itching of roof of mouth and back of throat. She denied feelings of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness.    She was monitored for an additional 30 minutes after reporting feeling improved. During that time she reported resolution of symptoms. She continued to appear well.   Prior to leaving she was counseled that should she develop any recurrent tingling in the lip, itching in the throat/mouth, feeling of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness she should seek urgent medical attention.   Her daughter is waiting outside and will escort her home. Encouraged her to call with questions or concerns. She verbalized understanding of and agreement with plan
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Patient received COVID-19 Pfizer vaccine today. She has a hx of allergies and was being monitored for 30 minutes. She alerted staff after approx 25 min that she was feeling unwell.    Reported that she developed generalized headache, ear fullness and tingling in the upper lip soon after receiving vaccine. Denied symptoms of anaphylaxis.   She was brought into the triage area. She appeared well, in no distress, no evidence of angioedema or hives. VS were taken: BP 114/70, HR 87 bpm, SpO2 97%.    She was given zyrtec 10 mg PO once. After approx 10 minutes she reported that she was experiencing new mild itching in the roof of her mouth and back of throat. She was then given benadryl 25 mg PO once.    VS taken again: BP 112/74, HR 86 BPM, SpO2 98%. Continued to appear well. There was no observed difficulty breathing. No hives or evidence of angioedema.   After approx 10-15 minutes she reported significant improvement of symptoms. She reported resolution of headache, ear fullness, tingling of the upper lip, and 90% resolution of itching of roof of mouth and back of throat. She denied feelings of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness.    She was monitored for an additional 30 minutes after reporting feeling improved. During that time she reported resolution of symptoms. She continued to appear well.   Prior to leaving she was counseled that should she develop any recurrent tingling in the lip, itching in the throat/mouth, feeling of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness she should seek urgent medical attention.   Her daughter is waiting outside and will escort her home. Encouraged her to call with questions or concerns. She verbalized understanding of and agreement with plan
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Oral herpes, Pyrexia
Clinical narrative: Mouth developed cold sores, fever, chills, fatigue HA
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Pneumonia, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: pneumonia; urinary tract infection; Shortness of breath; Currently critically ill; This is a spontaneous report from a contactable consumer reporting for himself. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6203/expiration date: not provided), via an unspecified route of administration, on 03Mar2021 at 10:00 (at the age of 92 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included congestive heart failure, pace-maker to treat congestive heart failure, ongoing and consistent treatment for high cholesterol, high blood pressure, and shell fish allergy. Concomitant medication included levotyroxine, atrovastatine, amniodarone, and wafarin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 at 04:15, the patient experienced shortness of breath and needed to be hospitalized with pneumonia and urinary tract infection. The patient was currently critically ill. The events required an emergency room visit and hospitalization. It was unknown if any treatment was received. The outcome of the events shortness of breath, pneumonia, urinary tract infection, and ill was unknown. Since the vaccination, the patient had been tested for COVID-19 on 06Mar2021, with a negative result.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac failure, Chest discomfort, Confusional state, Dizziness
Clinical narrative: shortness of breath; weakness; diffuse chest tightness; confusion; dizziness; cardiac failure; pulmonary failure; A spontaneous report was received from a consumer concerning a 51-year-old, male patient who developed cardiac failure, pulmonary failure/respiratory failure and died.  The patient's medical history included hypertension, obesity, bee allergy and bipolar disorder. Concomitant product use was not provided by the reporter.   Patient received first dose of vaccine prior to two weeks to his death (died on 09 Mar 2021).   A week prior to his vaccination as shortness of breath, weakness, diffuse chest tightness, confusion, and dizziness. These symptoms progressed following his vaccination and he was hospitalzed for two days prior to his death on 09 Mar 2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 09 Mar 2021 The cause of death was reported as cardio/pulmonary failure with secondary and tertiary causes of hypertension and obesity. Plans for an autopsy were not provided.  The outcome of the events, cardiac failure and pulmonary failure were fatal.; Reporter's Comments: This is a case of death in a 51-year-old male subject with a medical history of HTN, obesity, bee allergy and bipolar disorder,who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac failure; pulmonary failure
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Respiratory failure
Clinical narrative: shortness of breath; weakness; diffuse chest tightness; confusion; dizziness; cardiac failure; pulmonary failure; A spontaneous report was received from a consumer concerning a 51-year-old, male patient who developed cardiac failure, pulmonary failure/respiratory failure and died.  The patient's medical history included hypertension, obesity, bee allergy and bipolar disorder. Concomitant product use was not provided by the reporter.   Patient received first dose of vaccine prior to two weeks to his death (died on 09 Mar 2021).   A week prior to his vaccination as shortness of breath, weakness, diffuse chest tightness, confusion, and dizziness. These symptoms progressed following his vaccination and he was hospitalzed for two days prior to his death on 09 Mar 2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 09 Mar 2021 The cause of death was reported as cardio/pulmonary failure with secondary and tertiary causes of hypertension and obesity. Plans for an autopsy were not provided.  The outcome of the events, cardiac failure and pulmonary failure were fatal.; Reporter's Comments: This is a case of death in a 51-year-old male subject with a medical history of HTN, obesity, bee allergy and bipolar disorder,who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac failure; pulmonary failure
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Muscle strain, Pain in extremity, Peripheral swelling
Clinical narrative: Diagnosed with DVT; Leg got really swollen/swelling of the lower calf area; Sore arm; Sore arm; Pulled a muscle; A spontaneous report was received from a consumer concerning a 57-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, DVT/ deep vein thrombosis, pulled a muscle/myalgia, swelling of the lower calf area(leg got really swollen)/peripheral swelling and calf pain(sore arm)/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 FEB 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Jan 2021, after receiving the vaccine the patient had sore arm. On an unspecified date in Jan 2021, the patient had experienced a pull in his muscle in his calf and lower calf area got swollen. On 09 Feb 2021, after receiving the second dose of vaccine he had experienced a sore arm. On 11 Mar 2021, his leg got really swollen and on 12 Mar 2021, he visited hospital where it got diagnosed as DVT in his right lower calf. Treatment for the events included blood thinner Apixaban. Patient is concerned about possibility of indirect relation of events to the vaccine.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The outcome of the event DVT, leg got really swollen, swelling of the lower calf area and calf pain were unknown at the time of this report. The event pulled a muscle is not resolved. The event sore arm which the patient experienced for both the doses got resolved on 13 Jan and 14 Jan 2021, respectively.; Reporter's Comments: Based on the information provided which includes a strong temporal association a causal association between the event of sore arm and the administration of mRNA-1273 cannot be excluded.  The evens of DVT , pulled muscle and swelling of lower calf is assessed as unlikely related to mRNA-1273. Events were all attributed to muscle strain.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cerebrovascular accident, Discomfort, Facial paralysis, Feeling abnormal
Clinical narrative: muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/"dropping face"; felt like she was going to have a stroke; feeling "tingles" and numbness all over her body; feeling "tingles" and numbness all over her body; belly pain; going to throw up; feeling that heaviness; bad feelings; "heavy" headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient would like to know if it is safe for her to receive her second dose following the symptoms she experienced after the first dose. The patient reported that 17 hours after the first dose, she had the muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/dropping face. The patient added that before that she was feeling "tingles" and numbness all over her body, including going to her head and "very strong" in her left side, stating it felt like she was going to have a stroke. The patient also states she experienced these feelings in her hand as well. Caller also reports belly pain, was going to throw up. She states that after 2 hours, the "dropping face" was a lot better and had "bad feelings" but slowly disappeared. She states the only thing she experienced after that was a "heavy" headache, but not constantly. She reports that since an unspecified date she has just been "feeling that heaviness." The outcome of the event feeling "tingles" and numbness all over her body, "bad feelings" was recovered, for the event muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/"dropping face" was recovering while for the rest of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Vomiting
Clinical narrative: muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/"dropping face"; felt like she was going to have a stroke; feeling "tingles" and numbness all over her body; feeling "tingles" and numbness all over her body; belly pain; going to throw up; feeling that heaviness; bad feelings; "heavy" headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient would like to know if it is safe for her to receive her second dose following the symptoms she experienced after the first dose. The patient reported that 17 hours after the first dose, she had the muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/dropping face. The patient added that before that she was feeling "tingles" and numbness all over her body, including going to her head and "very strong" in her left side, stating it felt like she was going to have a stroke. The patient also states she experienced these feelings in her hand as well. Caller also reports belly pain, was going to throw up. She states that after 2 hours, the "dropping face" was a lot better and had "bad feelings" but slowly disappeared. She states the only thing she experienced after that was a "heavy" headache, but not constantly. She reports that since an unspecified date she has just been "feeling that heaviness." The outcome of the event feeling "tingles" and numbness all over her body, "bad feelings" was recovered, for the event muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/"dropping face" was recovering while for the rest of the events was unknown.  Information about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: got covid (tested positive); got covid (tested positive); GI issues; weak; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient's daughter) that an 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 (at the age of 84 years) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was daughter, her mom (patient) got 1st dose on 04Feb2021, then patient got covid (tested positive) on 23Feb2021, patient had GI (gastrointestinal) issues and weak in Ferb2021. Patient took antiviral treatment and had to be in hospital in 2021. Patient was currently out of hospital, recovered, and in rehab place. Caller was asking for information about 2nd dose past 21 days. Caller was asking if her mother should restart the series. The case was reported as non-serious. Outcome of events was recovered in 2021.   Information about batch/lot number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia, Nausea, Syncope, Vomiting
Clinical narrative: fainting spells; Metallic taste in the mouth; weakness; nausea; vomiting; This is a spontaneous report from a contactable consumer.   A 20-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, as single dose in in left arm on 08Mar2021 12:30 AM for COVID-19 immunisation, administered at drive thru site.   Medical history included hypertension, COVID-19 prior vaccination, no known allergies. Concomitant medications in two weeks included lisinopril (manufacturer unknown); methylphenidate (manufacturer unknown), both taken for an unspecified indication, start and stop date were not reported.  No other vaccine in four weeks. On 08Mar2021 13:00 the patient experienced fainting spells, metallic taste in the mouth, weakness, nausea, vomiting. No treatment received. COVID-19 was not tested post vaccination. The outcome of events was unknown.    Information about lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Cellulitis, Peripheral swelling
Clinical narrative: cellulitis; right lower leg was swollen  and bright pink; tiny blisters; 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), via an unspecified route of administration on 05Mar2021 at 14:30 (Lot number was not reported) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took sulfa and experienced drug allergy. On 05Mar2021 at 19:00, the patient experienced cellulitis, right lower leg was swollen and bright pink and tiny blisters seeping fluid. The events required physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Blister rupture, Culture, Culture positive, Dry skin
Clinical narrative: cellulitis; right lower leg was swollen  and bright pink; tiny blisters; 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), via an unspecified route of administration on 05Mar2021 at 14:30 (Lot number was not reported) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took sulfa and experienced drug allergy. On 05Mar2021 at 19:00, the patient experienced cellulitis, right lower leg was swollen and bright pink and tiny blisters seeping fluid. The events required physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: cellulitis; right lower leg was swollen  and bright pink; tiny blisters; 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), via an unspecified route of administration on 05Mar2021 at 14:30 (Lot number was not reported) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took sulfa and experienced drug allergy. On 05Mar2021 at 19:00, the patient experienced cellulitis, right lower leg was swollen and bright pink and tiny blisters seeping fluid. The events required physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage subcutaneous, Pain in extremity, Paraesthesia
Clinical narrative: Hands getting brown spots, like potentially blood; Hands felt achy; Hands tingly; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 at 13:00 (at the age of 46-years-old), at single dose for COVID-19 immunisation.  Medical history included congestive heart failure (CHF), dilated cardiomyopathy, psoriatic arthritis and airborne allergies. Concomitant medications included carvedilol, sacubitril valsartan sodium hydrate (ENTRESTO), eplerenone and allopurinol. It was reported that on 25Feb2021 patient hands were getting brown spots, looked like potentially blood. Hands felt achy and tingly. Spots went away in a day then came back. They first appeared on day 6 post vaccine and occurred on day 6, 7 then not again until day 16 but it's the worst at time of reporting. Started on 1 finger, at the time of reporting on several and palm. Mostly occurring on left hand, same arm as shot. The patient did not receive treatment for events. The events were not recovered.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Illness, Migraine, Near death experience, Pyrexia
Clinical narrative: deathly sick; deathly sick; high fever; throwing up; massive migraine; dehydration; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the parent, reported that a 28-year-old male patient (son) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 vaccination. Medical history included Crohns disease (caller concerned because HUMIRA causes immunosuppression). Concomitant medication included adalimumab (HUMIRA) for Crohns disease. After the first dose, the patient became "deathly sick" with the following: high fever, throwing up, massive migraine. These symptoms occurred approximately 5-7 days post vaccination. The patient went to ER (emergency room) and was given IV fluid for dehydration, no other diagnosis, but was told it could be related to the dose of vaccine. The outcome of the events deathly sick, high fever, throwing up, massive migraine and dehydration was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: deathly sick; deathly sick; high fever; throwing up; massive migraine; dehydration; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the parent, reported that a 28-year-old male patient (son) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 vaccination. Medical history included Crohns disease (caller concerned because HUMIRA causes immunosuppression). Concomitant medication included adalimumab (HUMIRA) for Crohns disease. After the first dose, the patient became "deathly sick" with the following: high fever, throwing up, massive migraine. These symptoms occurred approximately 5-7 days post vaccination. The patient went to ER (emergency room) and was given IV fluid for dehydration, no other diagnosis, but was told it could be related to the dose of vaccine. The outcome of the events deathly sick, high fever, throwing up, massive migraine and dehydration was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: she is diabetic; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 7Mar2021 as a single dose for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. On an unspecified date, after receiving the vaccine, the patient reported that she has an appointment with her physician next week and needs to get an A1 blood test done, as she is diabetic. She wants to know if the vaccination could interfere with the lab results. The outcome of the event diabetic was unknown.   Information about lot/batch has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Anaphylactic reaction, Fatigue, Headache, Lip pruritus
Clinical narrative: severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pruritus, Pyrexia, Skin discolouration, Throat irritation
Clinical narrative: severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Generalised tonic-clonic seizure, Malaise, Nausea, Slow speech
Clinical narrative: Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech and gait; still a little slow in speech and gait; This is a spontaneous report from a contactable consumer (patient).  A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in arm right on 05Mar2021 08:00 as a single dose (at the age of 28-years-old) for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included epilepsy, hypopituitarism, central diabetes insipidus, neoplasm of brain, irregular menses, short-term memory loss, elevated LDL, and myopia w/ astigmatism. The patient had known allergies to surgical tape and contrast dyes. Concomitant medications included desmopressin acetate (DDAVP), lamotrigine (LAMICTAL), levetiracetam, and zonisamide; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug allergy. On 08Mar2021 at 06:15 PM, the patient experienced generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait. Therapeutic measures were taken as a result of generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait as Nayzilam 5 mg two doses was administered. Clinical course details as reported: the patient finished dinner and evening medications before 6 pm and started feeling unwell and slightly nauseous soon after. Laid on sofa, started to sit up at 6:20 pm, and went into a Generalized Tonic-Clonic Seizure. The patient's father administered Nayzilam 5 mg (2 doses); seizure ended and the patient went into a deep sleep until 8:00 pm. The patient was largely recovered, but still a little slow in speech and gait. The outcome of the events was recovering as reported.  Information on the lot/batch number has been requested.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Facial pain, Swelling face
Clinical narrative: Cellulitis; face was weeping serous fluid; sores; Swelling; face was so swollen; swollen cheeks; Pain in face; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), intramuscular in left arm, on 25Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included Alzheimer's and other conditions, but family did not disclose. The patient was taking unspecified concomitant medications. The patient previously took piroxicam (FELDENE) and experienced allergies. The vaccine was administered in a public health clinic or Veterans administration facility. On 25Feb2021, the patient noticed pain in face in the evening of day he was vaccinated and then the patient developed swelling by the next morning (26Feb2021). On 27Feb2021, the patient's face was so swollen that his face was weeping serous fluid and family took him to the ER. The swollen cheeks bilaterally progressed to cellulitis (27Feb2021) requiring oral steroids, famotidine (PEPCID), and antibiotics including cefalexin (CEPHALEXIN). The patient remains on steroids and creams to treat swelling and sores. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of cellulitis due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Urinary tract infection
Clinical narrative: confused; suspected UTI; This is a spontaneous report from a non contactable consumer. This consumer (daughter) reported for a 77-year-old female patient that  A 77 years old female patient (not pregnant) received  second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Mar2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medications were not reported. On 09Mar2021 at 09:00 patient was taken to ER as was confused and not herself. The patient was being held overnight. The patient was hospitalized and UTI. was suspected.  At the time of the reporting the patient was unknown.  No follow-up attempts are possible; Information on the batch/lot number could not be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes; numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes.; she was getting intermittent headaches; This is a spontaneous report from a contactable Physician reported for a patient. A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 17Feb2021 (Lot Number: EN6201) at age of 69-year-old at single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medication(s) included atorvastatin (LIPITOR). The patient previously took first dose of bnt162b2 on 27Jan2021 (Lot number=EL3262) at single dose for COVID-19 immunization. On 20Feb2021, she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands. She reported after few days he started noticing in her bilateral toes. Patient also reported that she was getting intermittent headaches on 20Feb2021. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for 1 day. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab SARS-CoV-2 Antigen: negative  on 08Mar2021.  The outcome of the events was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events paraesthesia, hypoaesthesia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Discomfort, Feeling abnormal, Foreign body sensation in eyes
Clinical narrative: ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started feeling funny and weak; Eye is watering, feels like there is grit in there; Eye is watering, feels like there is grit; Uncomfortable.; This is a spontaneous report from a contactable consumer, the patient.   A 60-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 12:15 (at the age of 60 years old)  as SINGLE DOSE for covid-19 immunisation.  Historical Vaccine includes BNT162b2  Dose 1, 10Feb2021 at 14:00 , Lot number=EL9263 in Left arm  Medical history included diabetes mellitus. There were no concomitant medications. The patient has no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19 Facility where the most recent COVID-19 vaccine was administered was a Hospital. On 04Mar2021 at 13:15, The patient experienced Bell's palsy. left side facial paralysis  (medically significant), started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable. The adverse events resulted in an Emergency Room Visit.  Treatment was given for the events.  The clinical course is as follows the day after I went to the (Withheld).  Patient started feeling funny and weak. Since he was close to a local Hospital Emergency room. ER Doctor said 'I have Bell's Palsy. Left side facial paralysis'. He prescribed prednisone. Have to wear eye patch on left eye. Eye wont close. Can't eat or drink on left side. I was told by my primary care doctor that this could last up to 6 months. And that 85 percent of cases clear up. Eye is watering, feels like there is grit in there. Uncomfortable. Treatment (Prednisone therapy) was given for the events. The clinical outcome of the events Bell's palsy. left side facial paralysis, started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased
Clinical narrative: ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started feeling funny and weak; Eye is watering, feels like there is grit in there; Eye is watering, feels like there is grit; Uncomfortable.; This is a spontaneous report from a contactable consumer, the patient.   A 60-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 12:15 (at the age of 60 years old)  as SINGLE DOSE for covid-19 immunisation.  Historical Vaccine includes BNT162b2  Dose 1, 10Feb2021 at 14:00 , Lot number=EL9263 in Left arm  Medical history included diabetes mellitus. There were no concomitant medications. The patient has no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19 Facility where the most recent COVID-19 vaccine was administered was a Hospital. On 04Mar2021 at 13:15, The patient experienced Bell's palsy. left side facial paralysis  (medically significant), started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable. The adverse events resulted in an Emergency Room Visit.  Treatment was given for the events.  The clinical course is as follows the day after I went to the (Withheld).  Patient started feeling funny and weak. Since he was close to a local Hospital Emergency room. ER Doctor said 'I have Bell's Palsy. Left side facial paralysis'. He prescribed prednisone. Have to wear eye patch on left eye. Eye wont close. Can't eat or drink on left side. I was told by my primary care doctor that this could last up to 6 months. And that 85 percent of cases clear up. Eye is watering, feels like there is grit in there. Uncomfortable. Treatment (Prednisone therapy) was given for the events. The clinical outcome of the events Bell's palsy. left side facial paralysis, started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable was not recovered.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Fatigue, Hypersensitivity, Rhinorrhoea
Clinical narrative: uncontrollable sneezing; runny nose; tired; allergies; calcium was very high; creatine high; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: em9809) via an unspecified route of administration, administered in left arm on 08Feb2021 at 08:15 at a single dose for COVID-19 immunization.  Medical history included being deaf, glaucoma, left bundle branch block and osteoarthritis all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not tested for COVID prior to vaccination. The patient had unspecified concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: el38982) on 18Jan2021 at 08:15 AM on the left arm for COVID-19 immunization after which the patient could not hear anything. It was reported that on an unspecified date in 02Mar2021, about 2 and 1/2 weeks after receiving the second dose, the patient had uncontrollable sneezing and runny nose and was very tired. The doctor said it was allergies. The patient had a nasal swab test for COVID on 27Feb2021 and flu test on 02Mar2021 which were both negative. The patient's blood work was taken and his calcium was very high and creatine was high on 02Mar2021. The events required an emergency room visit and a physician office visit. The patient was admitted to the hospital on 02Mar2021 to Mar2021, for 5 days due to the events. They took bone biopsy and the patient was waiting for the results. It was reported that the patient was fine after the first injection and now this. The patient wanted to inform Pfizer since it may be connected. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: uncontrollable sneezing; runny nose; tired; allergies; calcium was very high; creatine high; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: em9809) via an unspecified route of administration, administered in left arm on 08Feb2021 at 08:15 at a single dose for COVID-19 immunization.  Medical history included being deaf, glaucoma, left bundle branch block and osteoarthritis all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not tested for COVID prior to vaccination. The patient had unspecified concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: el38982) on 18Jan2021 at 08:15 AM on the left arm for COVID-19 immunization after which the patient could not hear anything. It was reported that on an unspecified date in 02Mar2021, about 2 and 1/2 weeks after receiving the second dose, the patient had uncontrollable sneezing and runny nose and was very tired. The doctor said it was allergies. The patient had a nasal swab test for COVID on 27Feb2021 and flu test on 02Mar2021 which were both negative. The patient's blood work was taken and his calcium was very high and creatine was high on 02Mar2021. The events required an emergency room visit and a physician office visit. The patient was admitted to the hospital on 02Mar2021 to Mar2021, for 5 days due to the events. They took bone biopsy and the patient was waiting for the results. It was reported that the patient was fine after the first injection and now this. The patient wanted to inform Pfizer since it may be connected. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.