chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Insomnia, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: pain and discomfort is greater with the post-vaccination side effects; pain and discomfort is greater with the post-vaccination side effects; she has not being able to sleep in two nights.; throat inflammation; nasal congestion; coughing; she developed headache / forehead pain; throat pain; pain in the internal ear; some mild allergies; she developed pain on her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route on 28Feb2021 (reported as Sunday) as first dose, single dose for COVID-19 immunisation. Medical history included COVID-19 with the following symptoms: mild flu, sneezing, headache and body aches from an unknown date (reported as near February 5th) and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pain on her arm on 28Feb2021; some mild allergies (reported as suffers from "common allergies") on 01Mar2021 (reported as Monday); headache, throat pain and pain in the internal ear on 04Mar2021 (reported as Thursday); forehead pain, throat inflammation, nasal congestion and coughing on 05Mar2021 (reported as today); and pain and discomfort (reported as greater with the post-vaccination side effects than with the COVID-19 infection) and not being able to sleep in two nights on an unspecified date. Therapeutic measure, paracetamol (TYLENOL), was taken as a result of the events. The patient underwent lab tests and procedures which included COVID-19: Positive on an unspecified date (reported as near February 5th). The outcome of the events pain on her arm, pain and discomfort is greater with the post-vaccination side effects and not being able to sleep in two nights was unknown; while the outcome of events some mild allergies, headache, throat pain, pain in the internal ear, forehead pain, throat inflammation, nasal congestion and coughing was not recovered. The patient has not presented fever, stopped working on Wednesday and wanted to know if these were reported side effects of the vaccine and how long could these side effects last. The patient has an appointment with her physician on March 17th.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal inflammation
Clinical narrative: pain and discomfort is greater with the post-vaccination side effects; pain and discomfort is greater with the post-vaccination side effects; she has not being able to sleep in two nights.; throat inflammation; nasal congestion; coughing; she developed headache / forehead pain; throat pain; pain in the internal ear; some mild allergies; she developed pain on her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route on 28Feb2021 (reported as Sunday) as first dose, single dose for COVID-19 immunisation. Medical history included COVID-19 with the following symptoms: mild flu, sneezing, headache and body aches from an unknown date (reported as near February 5th) and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pain on her arm on 28Feb2021; some mild allergies (reported as suffers from "common allergies") on 01Mar2021 (reported as Monday); headache, throat pain and pain in the internal ear on 04Mar2021 (reported as Thursday); forehead pain, throat inflammation, nasal congestion and coughing on 05Mar2021 (reported as today); and pain and discomfort (reported as greater with the post-vaccination side effects than with the COVID-19 infection) and not being able to sleep in two nights on an unspecified date. Therapeutic measure, paracetamol (TYLENOL), was taken as a result of the events. The patient underwent lab tests and procedures which included COVID-19: Positive on an unspecified date (reported as near February 5th). The outcome of the events pain on her arm, pain and discomfort is greater with the post-vaccination side effects and not being able to sleep in two nights was unknown; while the outcome of events some mild allergies, headache, throat pain, pain in the internal ear, forehead pain, throat inflammation, nasal congestion and coughing was not recovered. The patient has not presented fever, stopped working on Wednesday and wanted to know if these were reported side effects of the vaccine and how long could these side effects last. The patient has an appointment with her physician on March 17th.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain, swelling, tenderness and redness in my left arm; Pain, swelling, tenderness and redness in my left arm; Pain, swelling, tenderness and redness in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6204, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 02Mar2021 at 11:15 (at the age of 39 years old) as second dose, single for COVID-19 immunization in a Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient has known allergies with sulfamethoxazole, trimethoprim (SEPTRA), minoxidil (BIOXCININ) and Mendel's solution on an unspecified date. The patient previously received the first dose of BNT162B2 (lot number: EL9267), via unspecified route of administration, administered in right arm on 09Feb2021 at 11:15 AM (at the age of 39 years) as first dose, single for COVID-19 immunisation. Patient was not pregnant, did not receive other vaccines in 4 weeks and no other medications in 2 weeks. On 03Mar2021 at 09:00, the patient experienced pain, swelling, tenderness and redness in my left arm. No treatment was received for the adverse event and since vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Drug eruption, Inappropriate schedule of product administration
Clinical narrative: first dose on 02Feb2021 and second dose on 20Feb2021 (18 days apart); developed a rash all over my body/rash got worse/ rash was drug related; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 02Feb2021 (at the age of 72-years-old; lot number: EN5318, expiration date not reported) as first dose, single dose and via an unspecified route of administration, administered on the left arm on 20Feb2021 09:30 (at the age of 72-years-old; lot number: el3246, expiration date not reported) as second dose, single dose both for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included amlodipine and simvastatin; both taken for an unspecified indication, start and stop dates were not reported. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 10Feb2021, about a week after the first vaccine, the patient experienced rash all over her body and after the second shot, on an unspecified date after about a week, the rash got worse. The patient also experienced inappropriate schedule of vaccine administered on 20Feb2021 as the first dose was given on 02Feb2021 and second dose on 20Feb2021 (18 days apart). The patient underwent lab tests and procedures which included biopsy: the rash was drug related on an unspecified date in Feb2021. Treatment with topical steroidal cream was taken as a result of the event rash all over her body/ rash got worse/ rash was drug related. The event rash all over her body/ rash got worse/ rash was drug related resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event rash all over her body/ rash got worse/ rash was drug related was not recovered and the patient still have it.  No follow up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy red patch around injection site with pain and swelling; Itchy red patch around injection site with pain and swelling; Itchy red patch around injection site with pain and swelling; Itchy red patch around injection site with pain and swelling; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL9262, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 02Mar2021 at 10:00 (at the age of 71 years old) as second dose, single for COVID-19 immunisation. Medical history included thyroid disorder. Patient had other medications in 2 weeks. Patient was not pregnant at the time of vaccination and did not receive any other vaccines in 4 weeks and prior to vaccine the patient was not diagnosed with COVID-19. Patient has known allergies to unspecified medications, food, or other products.The patient previously received the first dose of BNT162B2 (lot number: EL9264), via an unspecified route of administration, administered in right arm on 09Feb2021 at 10:00 (reported as 10:00AM) (at the age of 71 years old) for COVID-19 immunisation. On 03Mar2021, the patient experienced itchy red patch around injection site with pain and swelling. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea, Vomiting
Clinical narrative: Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; This is a spontaneous report from a contactable consumer.  An 89-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 15:00 at single dose in left arm for COVID-19 immunisation at the age of 89-year-old. Medical history included dementia, breast cancer, high blood pressure, high cholesterol, depression, thyroid disease, Allergy. Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she was coughing. The patient did not receive any treatment for the events. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in armpits; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 20Feb2021 11:00 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included unspecified blood thinner, taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously took DEMEROL and experienced allergy. The patient experienced swollen lymph nodes in armpits on 03Mar2021. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Increase Heart Rate of 148 BPM about 15 minutes after injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 09:45AM (at the age of 43-years-old) as first dose, single dose for COVID-19 immunisation at a workplace clinic. Medical history included Sulfa allergy from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug allergy. No other vaccine was given to the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 26Feb2021 10:00AM, about 15 minutes after injection, the patient experienced an increase in heart rate of 148 beats per minute. No treatment was taken as a result of the event. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included heart rate: 148 beats per minute (increase in heart rate) on 26Feb2021. The outcome of the event, which lasted for three hours, was recovered on 26Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Mild Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 12:30 (Lot Number: EL3247) as single dose (at age of 43-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medication in two weeks included salbutamol sulfate (VENTOLIN HFA) inhaler. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild diarrhea on 05Mar2021 06:00. No treatment was received. Patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination, on 05Mar2021 underwent polymerase chain reaction (PCR) test (Nasal Swab): unknown result (pending). Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bursitis, Fatigue, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Suspected bursitis with prolonged arm pain and weakness 2 weeks after first Pfizer dose. On the day of vaccination, I had a panic attack and nearly blacked out after vaccination, something that had never happened to me after a vaccination. Once the pain started a few hours after vaccination, it significantly increased. I experienced excruciating pain in my left arm like I had never felt after any other vaccination. Complete inability to move my arm without pain; the pain persisted even with zero movement whatsoever. Within the first 12 hours the pain spread to my entire left shoulder, and within 24 hours the pain spread to my neck, and general upper left quadrant of my body to the point where inhaling deeply would cause chest pain on my left side. This extreme pain persisted for about 3-4 days. After about the 5th day, my left arm still felt different and weaker than my right arm but little pain remained. After the 7th day, pain started back up whenever I tried to use my arm in any way. The days went on and the pain and arm weakness is not passing. It is minor pains, aches, and occasional throbbing compared to those first few days after vaccination but chronic pain nonetheless. My left arm continues to feel weak and I have a concentrated area of pain directly where the vaccination site was, it's as if I could still feel exactly where the needle went through my body. My arm feels okay pain-wise upon waking most days but I am unable to do anything as simple as chopping vegetables or washing dishes without feeling pain for the rest of the day. I am unable to even wear a backpack for more than 10 minutes without my left shoulder hurting and feeling fatigued.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Muscular weakness, Pain, Pain in extremity, Panic attack
Clinical narrative: Suspected bursitis with prolonged arm pain and weakness 2 weeks after first Pfizer dose. On the day of vaccination, I had a panic attack and nearly blacked out after vaccination, something that had never happened to me after a vaccination. Once the pain started a few hours after vaccination, it significantly increased. I experienced excruciating pain in my left arm like I had never felt after any other vaccination. Complete inability to move my arm without pain; the pain persisted even with zero movement whatsoever. Within the first 12 hours the pain spread to my entire left shoulder, and within 24 hours the pain spread to my neck, and general upper left quadrant of my body to the point where inhaling deeply would cause chest pain on my left side. This extreme pain persisted for about 3-4 days. After about the 5th day, my left arm still felt different and weaker than my right arm but little pain remained. After the 7th day, pain started back up whenever I tried to use my arm in any way. The days went on and the pain and arm weakness is not passing. It is minor pains, aches, and occasional throbbing compared to those first few days after vaccination but chronic pain nonetheless. My left arm continues to feel weak and I have a concentrated area of pain directly where the vaccination site was, it's as if I could still feel exactly where the needle went through my body. My arm feels okay pain-wise upon waking most days but I am unable to do anything as simple as chopping vegetables or washing dishes without feeling pain for the rest of the day. I am unable to even wear a backpack for more than 10 minutes without my left shoulder hurting and feeling fatigued.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Small bruises 2mm  1st on inside upper left  next day 2nd bruise 5? lower same arm few days later 3rd bruise  opposite inside forearm few days later 4th bruise  on right shoulder/neck on 6/2/2021
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria of lower (lumbar region) back 5 hours after vaccination. Pruritic. Improved the next day and resolved completely after 2 days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Nasal congestion, Pain, Pyrexia
Clinical narrative: Severe flushing of face and ears; Body rash; Aches; Chills; Low grade fever; Stuffy nose; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via unspecified route of administration in right arm on 03Mar2021 11:45 AM (at the age of 65-year-old) as 2nd dose, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient was not pregnant at the of the event and at the time of vaccination. The patient's medical history included antihypertensive (unspecified concomitant medication) and allergies to shrimp and sulfites in food. It was unknown if patient was diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within 2 weeks of vaccination included levothyroxine, antihypertensive (unspecified) and anti-allergy (unspecified). The patient previously received nitrofurantoin and she experienced allergy. She also previously received first dose of BNT162B2 (lot number not reported), via unspecified route of administration in right arm on 10Feb2021 11:00 AM (at the age of 65-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 at 12:00 PM within 15 minutes (as reported) of second injection the patient experienced severe flushing of face and ears treated with 50 mg diphenhydramine oral, self-prescribed. On unspecified date in Mar2021 the patient also experienced aches, chills and low-grade fever, all within 18 hours, stuffy nose within 36 hours and body rash within 48 hours. Treatment of events aches, chills, low-grade fever, stuffy nose and body rash was reported as over the counter (OTC) allergy pill. All the events were reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe flushing of face and ears; Body rash; Aches; Chills; Low grade fever; Stuffy nose; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via unspecified route of administration in right arm on 03Mar2021 11:45 AM (at the age of 65-year-old) as 2nd dose, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient was not pregnant at the of the event and at the time of vaccination. The patient's medical history included antihypertensive (unspecified concomitant medication) and allergies to shrimp and sulfites in food. It was unknown if patient was diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within 2 weeks of vaccination included levothyroxine, antihypertensive (unspecified) and anti-allergy (unspecified). The patient previously received nitrofurantoin and she experienced allergy. She also previously received first dose of BNT162B2 (lot number not reported), via unspecified route of administration in right arm on 10Feb2021 11:00 AM (at the age of 65-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 at 12:00 PM within 15 minutes (as reported) of second injection the patient experienced severe flushing of face and ears treated with 50 mg diphenhydramine oral, self-prescribed. On unspecified date in Mar2021 the patient also experienced aches, chills and low-grade fever, all within 18 hours, stuffy nose within 36 hours and body rash within 48 hours. Treatment of events aches, chills, low-grade fever, stuffy nose and body rash was reported as over the counter (OTC) allergy pill. All the events were reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in arm  at sight of injection still to this day
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: the right side of my face became numb/tingly; the right side of my face became numb/tingly; This is a spontaneous report from a contactable consumer.  A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Mar2021 at 17:30 at single dose in right arm for COVID-19 immunisation at the age of 51-year-old. Lot number EN6202. Medical history included sleep apnea, asthma, allergy to sulfa, grass allergy, allergy to molds, Pollen allergy. The patient was not pregnant. Historical vaccine included TDAP on 18Feb2021 in right arm. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone furoate (ARNUITY ELLIPTA), montelukast sodium (SINGULAIR), ergocalciferol (VIT D). The patient waited 30 minutes after injection because she did do get allergy injections so the patient was just being extra cautious. On 04Mar2021, at 18:15, after we left the right side of face became numb/ tingly. It lasted probably an hour. The patient was not treated due to the events. The patient recovered from the events on unknown date. No follow-up attempts are needed. No further information is expected
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: shortness of breath; high heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm on 04Mar2021 at 15:00 (at the age of 29-years-old) at 2nd dose, single for COVID-19 immunisation. The patient was not pregnant. Medical history was not reported. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications in two weeks included fluoxetine hydrochloride (PROZAC), propranolol. No other vaccine received in four weeks. The patient previously received the first dose of BNT162B2 on 11Feb2021 at 01:00 AM (at the age of 29-years-old) administered in the right arm for COVID-19 immunisation. The patient previously took codeine and experienced known allergies. The patient experienced high heart rate and shortness of breath on 04Mar2021 at 21:00. No treatment was received for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Headache, Nausea, Paraesthesia oral
Clinical narrative: metallic taste in her mouth; lightheadedness; headache; nausea; tingling lips; This is a spontaneous report received from a non-contactable health care professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205), on unspecified date (at the age of 41-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included that patient mentioned having a history of anxiety and she took her duloxetine and WELLBUTRIN the day of the present report (05Mar2021). The patient's concomitant medications included duloxetine and bupropion hydrochloride (WELLBUTRIN), both from unspecified date for anxiety. She denied use of her lorazepam (ATIVAN) recently. It was reported that during her 15 minutes waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. Treatment included paracetamol (TYLENOL) and water. Response to treatment was good. She noted some lightheadedness prior to discharge but other symptoms were improved. Reporter walked patient around the bay area and she was feeling okay. Her vitals were stable. Patient was escorted out of the facility. As per patient discharge it was reported stable to go home and follow-up with primary care physician (PCP). The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I realized my left ear was ringing loudly with an additional metallic, repetative clinking noise. I am hardly able to hear out of that ear.; This is a spontaneous report from a contactable consumer.  A 63-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 13:00 at single dose in left arm for COVID-19 immunisation at the age of 63-year-old. Lot number was EN6205. Medical history included levothyroxine sodium (Hypothyroidism), Sjogrens. The patient was not pregnant. Concomitant medications included Synthroid, Amplodipine, hydroxychloroquine sulfate (PLAQUENIL), cyanocobalamin (Vit b12) and multiVi. On 02Mar2021 at 13:00, the patient realized that left ear was ringing loudly with an additional metallic, repetitive clinking noise. He was hardly able to hear out of that ear. The patient was not able to determine if right ear was affected. The patient did not recover from the events. No follow-up attempts are possible; No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: nausea; Swollen lymph nodes; chills; fatigue; muscle aches; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 02Mar2021 12:00 (Lot number was not reported) as SINGLE DOSE (at age of 65-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. On 04Mar2021 13:15 patient experienced nausea, swollen lymph nodes, chills, fatigue, muscle aches. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events. No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: massive headache; All over aches; nausea; severe dizziness; This is a spontaneous report from a contactable consumer, reporting for herself. A 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in right arm on 03Mar2021 01:45PM (at the age of 65-year-old) at single dose for COVID-19 immunisation. The patient had COVID prior to vaccination and known allergies (unspecified). She did not have other vaccine in four weeks and was taking other medications (unspecified) in two weeks. On the day of first dose of vaccine, at about 07:00PM, the patient had severe dizziness, then around 01:00AM on 04Mar2021 massive headache. On 04Mar2021 she felt all over aches, headache and later nausea. On 05Mar2021 she was feeling better but headache persisted. No treatment was received. The patient was not tested for COVID after vaccination. Headache was not resolved, while other events were resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dysgeusia, Feeling of body temperature change, Headache
Clinical narrative: she got sick which lasted a day and a half and now 8 days later, she got sick again; She has a fever; feels hot and cold; severe headaches; has thrown up 5 times; bad taste in her mouth; feels dizzy; This is a spontaneous report from a contactable consumer (patient).  This 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) administered on unknown date at single dose for COVID-19 immunisation. She got her second vaccine and a couple of days after it, she got sick which lasted a day and a half and now 8 days later, she got sick again.  She had a fever, feels hot and cold, severe headaches, had thrown up 5 times and had a bad taste in her mouth and felt dizzy. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: she got sick which lasted a day and a half and now 8 days later, she got sick again; She has a fever; feels hot and cold; severe headaches; has thrown up 5 times; bad taste in her mouth; feels dizzy; This is a spontaneous report from a contactable consumer (patient).  This 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) administered on unknown date at single dose for COVID-19 immunisation. She got her second vaccine and a couple of days after it, she got sick which lasted a day and a half and now 8 days later, she got sick again.  She had a fever, feels hot and cold, severe headaches, had thrown up 5 times and had a bad taste in her mouth and felt dizzy. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: One sided like a migraine; Bad headache; This is a spontaneous report from a contactable consumer (patient).  A 74-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Feb2021 14:30 (at the age of 74-years-old) as single dose for covid-19 immunisation.  Medical history included panic disorder from an unknown date and unknown if ongoing, food allergy (Shellfish allergy) from an unknown date and unknown if ongoing. Concomitant medications included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported.   The patient experienced one sided like a migraine (migraine) (non-serious) on 01Mar2021 10:30 with outcome of recovered on 05Mar2021, bad headache (headache) (non-serious) on 01Mar2021 10:30 with outcome of recovered 05Mar2021.  Therapeutic measures were taken as a result of one sided like a migraine (migraine), bad headache (headache) included tylenol for 4-5 days and and lots of caffeine.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tenderness, Vaccination site pain
Clinical narrative: his arm was sore; little tired; arm is just tender to touch; This is a spontaneous report from a contactable consumer (patient) by a  Pfizer sponsored program.   A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received vaccine for pneumonia (shot too) and experienced sore arm and tiredness. The patient stated that his arm was sore, he felt a little tired (as for pneumonia shot) and arm is just tender to touch. Patient would like to know if taking amoxicillin would have any effect on the vaccine. Outcome of the event arm is just tender to touch was unknown while outcome of the other events was recovered (he is fine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: felt dizzy; a fuzzy feeling; This is a spontaneous report from a contactable consumer.   A 65-years-old female patient received first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200) on 01Mar2021 at 14:00 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included high blood pressure. On 04Feb2021 the patient received pneumococcal vaccine in right arm. Concomitant medications included metroprolol, losartan, VITAMIN D3, psyllium hydrophilic mucilloid (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID). The patient informed that on 01Mar2011 after taking Vitamin D3-2000IU approximately 5 hours after vaccination felt dizzy and a fuzzy feeling for about 10 minutes, drank 2 glasses of water and the feeling stopped. The patient reported she had not taken the vitamin D3 since. The patient recovered from the event on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: have soreness, it's real tender around the site of injection; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date (at the age of 69-year-old) as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced soreness, it's real tender around the site of injection. The patient asked whether she could take an aspirin. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Flushing, Salivary hypersecretion, Sensory disturbance
Clinical narrative: odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing.  On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Few days after 2nd vaccine started having sever itching on torso has been lasting for about a week so far; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 23Feb2021, at 67 years of age, (Batch/Lot Number: EN6203) as single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included hypothyroidism and hypertension, both from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 03Feb2021 01:00 PM, at 67 years of age, (Batch/Lot Number: El3246) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine in the previous 4 weeks. Concomitant medications included levothyroxine, amlodipine besilate (NORVASC) and hydrochlorothiazide and "TINIMOL", all taken for an unspecified indication since an unknown date. The patient reported that on 26Feb2021, few days after the 2nd vaccine dose, she started having severe itching on torso, which has been lasting for about a week so far. The patient was treated with topical ointments as a result of the event. At the time of the report the event had not resolved yet.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Vitreous floaters, Vomiting
Clinical narrative: eyes were showing bright silver snowflakes; severe abdominal pain; diarrhea; vomited3x in 15 min; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 24Feb2021 14:00 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included high blood pressure, kidney stones (controlled), penicillin allergy, allergy to antibiotics, allergy to trees, allergy to grass and sulfa and cataracts and surg to replace retina 6 years ago (as reported). Concomitant medications included simvastatin, metoprolol, amlodipinum, lisinopril and paracetamol (TYLENOL),all  taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 15:00 the patient experienced severe abdominal pain followed by diarrhea and vomited 3x in 15 min. On 26Feb2021 16:30 the patient had eye problem: she was not able to see because her eyes were showing bright silver snowflakes. Lasted about 15 minutes. Tearing and water made it go away. The patient did not received treatment for the other events. The patient did not have COVID prior vaccination and she was not tested post vaccination. The events were resolved on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: experiencing left hand/fingers- redness; experiencing left hand/fingers- tingling; experiencing left hand/fingers- numb/burning/pain; experiencing left hand/fingers- numb/burning/pain; experiencing left hand/fingers- numb/burning/pain; This is a spontaneous report from a contactable consumer (patient's boyfriend).   A 25 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 05Mar2021 at 09:40 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Mar2021 at 09:40. About 2 hours after she was administered the vaccine she started to develop symptoms of 2 or 3 of her left fingers started to feel tingling, burning, numb and having redness. At the time of the reporting events outcome was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Malaise, Pain, Pain in extremity
Clinical narrative: slight fever; body pains; arm soreness; feeling unwell; fast heartrate (97); This is a spontaneous report from contactable consumer (patient's friend). A 52-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The patient experienced side effects such as (as reported) slight fever, body pains, arm soreness, feeling unwell and fast heartrate (97) on an unspecified date in Mar2021 (04Mar2021 or 05Mar2021). She spoke to her HCP regarding these side effects. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slight fever; body pains; arm soreness; feeling unwell; fast heartrate (97); This is a spontaneous report from contactable consumer (patient's friend). A 52-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The patient experienced side effects such as (as reported) slight fever, body pains, arm soreness, feeling unwell and fast heartrate (97) on an unspecified date in Mar2021 (04Mar2021 or 05Mar2021). She spoke to her HCP regarding these side effects. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.