chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Neck pain, Pain in extremity, Presyncope, Pyrexia
Clinical narrative: I thought I was going to pass out.; Fatigue; congestion and runny nose; congestion and runny nose; arm pain; head and neck pain/head started throbbing/headache; head and neck pain; chills; I had a puffy face post-vaccine; I wasn't feeling well; I had difficulty breathing; I felt dizzy when bending over and standing up; My heart rate also increased to 100-120 bpm; Arm injection site is very itchy; Arm injection site is very itchy, and now around 2 inches in size; Arm injection site swelling; Arm injection site swelling and redness; muscle aches; Fever maximum 100.5F; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration  in the arm on an unspecified date (Lot Number: EL3247; Expiration Date: May2021) as SINGLE DOSE for COVI-19 immunization. Medical history included allergy/contact dermatitis from latex, allergy/sensitivity to dairy, eczema in teens and IBS in 2018. The patient's concomitant medications were not reported. The patient previously took steroids and experienced allergies to steroids. The patient previously had first dose of BNT162B2 on unspecified date for COVID-19 immunisation and experienced site injection and shoulder pain in left arm, left hand pinky finger and ring finger tingling and ache and pain all day in left hand. The patient experienced fatigue, congestion and runny nose, arm pain, head and neck pain and chills on unspecified date. On 24Mar2021, the patient had arm injection site swelling and redness, headache, muscle aches, severe chills and fever maximum 100.5F and kept stable with Tylenol taken every 6 hours. The patient had a puffy face post-vaccine. This started 3 hours after vaccination dose 2, and resolved by evening of 24Mar2021. The patient wasn't feeling well on unspecified date. On 25Mar2021, the patient was still severely fatigued. The patient went downstairs to get takeout/delivery, and after coming up half a flight of stairs which would consider as minor exertion by the patient. The patient had difficulty breathing, stated, "my head started throbbing, and I thought I was going to pass out. This happened again when I was trying to load/unload the dishwasher and I felt dizzy when bending over and standing up. I developed a headache for around 1 hour. My heart rate also increased to 100-120 bpm." The patient had arm injection site was very itchy, and now around 2 inches in size. The events took place after use of product. Therapeutic measures were taken as a result of , arm injection site swelling and redness, muscle aches and fever maximum 100.5f. The outcome of the event fatigue was not recovered. The outcome of the event puffy face was recovered on 24Mar2021. The outcome of the rest of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Swelling face, Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: I thought I was going to pass out.; Fatigue; congestion and runny nose; congestion and runny nose; arm pain; head and neck pain/head started throbbing/headache; head and neck pain; chills; I had a puffy face post-vaccine; I wasn't feeling well; I had difficulty breathing; I felt dizzy when bending over and standing up; My heart rate also increased to 100-120 bpm; Arm injection site is very itchy; Arm injection site is very itchy, and now around 2 inches in size; Arm injection site swelling; Arm injection site swelling and redness; muscle aches; Fever maximum 100.5F; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration  in the arm on an unspecified date (Lot Number: EL3247; Expiration Date: May2021) as SINGLE DOSE for COVI-19 immunization. Medical history included allergy/contact dermatitis from latex, allergy/sensitivity to dairy, eczema in teens and IBS in 2018. The patient's concomitant medications were not reported. The patient previously took steroids and experienced allergies to steroids. The patient previously had first dose of BNT162B2 on unspecified date for COVID-19 immunisation and experienced site injection and shoulder pain in left arm, left hand pinky finger and ring finger tingling and ache and pain all day in left hand. The patient experienced fatigue, congestion and runny nose, arm pain, head and neck pain and chills on unspecified date. On 24Mar2021, the patient had arm injection site swelling and redness, headache, muscle aches, severe chills and fever maximum 100.5F and kept stable with Tylenol taken every 6 hours. The patient had a puffy face post-vaccine. This started 3 hours after vaccination dose 2, and resolved by evening of 24Mar2021. The patient wasn't feeling well on unspecified date. On 25Mar2021, the patient was still severely fatigued. The patient went downstairs to get takeout/delivery, and after coming up half a flight of stairs which would consider as minor exertion by the patient. The patient had difficulty breathing, stated, "my head started throbbing, and I thought I was going to pass out. This happened again when I was trying to load/unload the dishwasher and I felt dizzy when bending over and standing up. I developed a headache for around 1 hour. My heart rate also increased to 100-120 bpm." The patient had arm injection site was very itchy, and now around 2 inches in size. The events took place after use of product. Therapeutic measures were taken as a result of , arm injection site swelling and redness, muscle aches and fever maximum 100.5f. The outcome of the event fatigue was not recovered. The outcome of the event puffy face was recovered on 24Mar2021. The outcome of the rest of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: I thought I was going to pass out.; Fatigue; congestion and runny nose; congestion and runny nose; arm pain; head and neck pain/head started throbbing/headache; head and neck pain; chills; I had a puffy face post-vaccine; I wasn't feeling well; I had difficulty breathing; I felt dizzy when bending over and standing up; My heart rate also increased to 100-120 bpm; Arm injection site is very itchy; Arm injection site is very itchy, and now around 2 inches in size; Arm injection site swelling; Arm injection site swelling and redness; muscle aches; Fever maximum 100.5F; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration  in the arm on an unspecified date (Lot Number: EL3247; Expiration Date: May2021) as SINGLE DOSE for COVI-19 immunization. Medical history included allergy/contact dermatitis from latex, allergy/sensitivity to dairy, eczema in teens and IBS in 2018. The patient's concomitant medications were not reported. The patient previously took steroids and experienced allergies to steroids. The patient previously had first dose of BNT162B2 on unspecified date for COVID-19 immunisation and experienced site injection and shoulder pain in left arm, left hand pinky finger and ring finger tingling and ache and pain all day in left hand. The patient experienced fatigue, congestion and runny nose, arm pain, head and neck pain and chills on unspecified date. On 24Mar2021, the patient had arm injection site swelling and redness, headache, muscle aches, severe chills and fever maximum 100.5F and kept stable with Tylenol taken every 6 hours. The patient had a puffy face post-vaccine. This started 3 hours after vaccination dose 2, and resolved by evening of 24Mar2021. The patient wasn't feeling well on unspecified date. On 25Mar2021, the patient was still severely fatigued. The patient went downstairs to get takeout/delivery, and after coming up half a flight of stairs which would consider as minor exertion by the patient. The patient had difficulty breathing, stated, "my head started throbbing, and I thought I was going to pass out. This happened again when I was trying to load/unload the dishwasher and I felt dizzy when bending over and standing up. I developed a headache for around 1 hour. My heart rate also increased to 100-120 bpm." The patient had arm injection site was very itchy, and now around 2 inches in size. The events took place after use of product. Therapeutic measures were taken as a result of , arm injection site swelling and redness, muscle aches and fever maximum 100.5f. The outcome of the event fatigue was not recovered. The outcome of the event puffy face was recovered on 24Mar2021. The outcome of the rest of the events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: palpitations; High blood pressure; This is a spontaneous report from a non-contactable Nurse (Patient). A 70-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EP6955 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:30 AM as SINGLE DOSE for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history was not reported. Allergies to medications, food, or other products: Latex, bananas, melons, ragweed, tree pollen. Concomitant medications included spironolactone, propranolol, amlodipine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 21:00 The patient experienced high blood pressure and palpitations. The adverse event result: Emergency room/department or urgent care. No treatment received for the adverse event. The patient was not diagnosed with COVID 19, Prior to vaccination. The patient not has been tested for COVID19, Since the vaccination. The outcome of the events was recovering.  No follow-up attempts possible. As reporter denied to contact.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysstasia, Gait disturbance, Postural orthostatic tachycardia syndrome, Speech disorder
Clinical narrative: Complete flare of Postural orthostatic tachycardia syndrome; Complete flare of Postural orthostatic tachycardia syndrome; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; This is a spontaneous report from a contactable nurse (patient herself). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiration date: Unknown), via an unspecified route of administration in left arm on 25Mar2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included just POTS (postural orthostatic tachycardia syndrome) from 2 1/2 years prior. Concomitant medication included nadolol received in two weeks. The patient previously took cefepime and experienced known allergies: Cefepime. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID priori vaccination. The patient did not undergo COVID test post vaccination. The patient experienced complete flare of postural orthostatic tachycardia syndrome (last flare was 2 1/2 years prior), can't stand up, walk, talk without struggling to breath on 25Mar2021 at 16:30. The events were considered as serious (disability or permanent damage) by nurse. No treatment medications were received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the reportedly close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received  the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 14:30 (Batch/Lot Number: EM9809) as SINGLE DOSE for covid-19 immunisation.  Medical history included migraine and sulfa drug allergy. Concomitant medications included hypericum perforatum (ST JOHNS WORT) taken for an unspecified indication, start and stop date were not reported; magnesium  taken for an unspecified indication, start and stop date were not reported; and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported.  The patient experienced bell's palsy on 20Mar2021. The outcome of events was not recovered.  Therapeutic measures were taken as a result of bell's palsy.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event  Bell's palsy  due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: blacking out; Nausea; dizziness, feeling woozy and faint; This is a spontaneous report from a contactable consumer who reported for herself, a 37-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 12:30, at the age of 37 years old, at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL). The patient previously received the first dose of BNT162B2 in the left arm (Lot number: EL3248) on 02Mar2021 at 10:00 AM, at the age of 37 years, for COVID-19 immunization. The patient experienced nausea, dizziness, feeling woozy and faint as well as blacking out, all on 25Mar2021 at 08:00. The events were reported as non-serious. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Bloody Stool; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 25Mar2021 17:30 (batch/lot number: EP6955) at 31 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Workplace clinic. The patient's medical history included asthma, seasonal allergies, and tree nuts allergy; all from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL), salbutamol sulfate (PROAIR), and simeticone (GAS-X); therapy dates and indications for all were not reported. The patient received these medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:30, the patient experienced bloody stool (haematochezia). It was unknown if patient received treatment. Outcome of the event was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: My period had ended four days before the vaccine. I always have very regular periods. The night of the vaccine, I started bleeding heavily with large blood clots and continue to do so.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), via an unspecified route of administration administered in left arm on 03Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Medical history included long QT syndrome. The patient had no known allergies to medications, food, or other products. Concomitant medication included nadolol. On 03Mar2021  the patient experienced "My period had ended four days before the vaccine. I always have very regular periods. The night of the vaccine, I started bleeding heavily with large blood clots and continue to do so." The reporter considered the event as non-serious. There was no treatment received for the event. The patient was recovering from the event. The patient received the second dose of bnt162b2 (lot number: ER2613) on 24Mar2021 in the left arm.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: PT devolved occulsive DVT to left femoral vein; This is a spontaneous report received from a contactable physician. A 77-year-old male patient received second dose of BNT162B2 (Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 24Mar2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included azithromycin (Z-PAK) taken for an unspecified indication, start and stop date were not reported. The patient experienced "devolved occulsive DVT to left femoral vein" on 24Mar2021 with outcome of unknown. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of occulsive dvt to left femoral vein which included apixaban (ELIQUIS). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event "occlusive DVT to left femoral pain" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Erythema
Clinical narrative: face and chest turned "really red"/get real bright red like a tomato/her chest and face were bright red; felt some fluttering later in the evening/flutters in pacemakers; This is a spontaneous report from a contactable consumer (patient's husband). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via intramuscular route, administered in right arm on 05Mar2021 at 03:30, at the age of 57 years, at a single dose for COVID-19 immunization. Medical history included pacemaker placed 20 years ago to prevent her from easily passing out, during surgery they punctured heart wall and she started bleeding out into her heart wall and they had to do surgery and relief the bleeding in her heart, she has fought pericarditis ever since. The patient was allergic to sulfas. There were no concomitant medications. It was reported that 20 minutes after receiving the first dose of the vaccine, at 03:50, the patient's face and chest turned "really red." She had no other symptoms and did not notice the redness until her husband pointed it out. She was fine and then get real bright red like a tomato. They were concerned, stated there were no hives, just her chest and face were bright red. They called the paramedics and recommended Benadryl but she did not take any, states when they got home and settled down, it disappeared. As patient was allergic to sulfas, she waited 30 minutes not 15 minutes. Patient has had a pacemaker for 20 years, and felt some fluttering later in the evening after the first shot (05Mar2021) but it went away. The patient was nervous about this afternoon (26Mar2021) as she was getting the second shot, hence the reporter was seeking guidance on what do to about the second dose. The events were reported as non-serious, and did not require a visit to the emergency room nor the physician's office. The events recovered on 05Mar2021.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, Angina pectoris, Dyspnoea, Heart rate increased, Pulse abnormal
Clinical narrative: short pain in my heart; my heart feels like it beating faster than usual/pulse was 130 and today is 108; my pulse was 130 and today its 108; short of breath; agitated; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 24Mar2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that  2 hours after getting the vaccine she had a short pain in her heart and her heart feels like it beating faster than usual. Yesterday, her pulse was 130 and today is 108. The pain it comes and goes and sometimes she's a bit short of breath and agitated. She wanted to wait it out but how long should i wait before seeing a doctor. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Heart rate increased
Clinical narrative: short pain in my heart; my heart feels like it beating faster than usual/pulse was 130 and today is 108; my pulse was 130 and today its 108; short of breath; agitated; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 24Mar2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that  2 hours after getting the vaccine she had a short pain in her heart and her heart feels like it beating faster than usual. Yesterday, her pulse was 130 and today is 108. The pain it comes and goes and sometimes she's a bit short of breath and agitated. She wanted to wait it out but how long should i wait before seeing a doctor. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Agitation, Angina pectoris, Dyspnoea, Heart rate increased, Pulse abnormal
Clinical narrative: feeling my heart rate a little more faster than usual; getting little sharp pains in my heart; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program. This patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "Two days ago (24Mar2021) I got the Pfizer vaccine and after leaving the site I was fine but a couple of hours later I started getting little sharp pains in my heart. Ever since yesterday (25Mar2021), I've been feeling my heart rate a little more faster than usual." The clinical outcome of "getting little sharp pains in my heart" and "feeling my heart rate a little more faster than usual" was unknown.  No follow-up attempts are needed; information about batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Heart rate increased
Clinical narrative: feeling my heart rate a little more faster than usual; getting little sharp pains in my heart; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program. This patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "Two days ago (24Mar2021) I got the Pfizer vaccine and after leaving the site I was fine but a couple of hours later I started getting little sharp pains in my heart. Ever since yesterday (25Mar2021), I've been feeling my heart rate a little more faster than usual." The clinical outcome of "getting little sharp pains in my heart" and "feeling my heart rate a little more faster than usual" was unknown.  No follow-up attempts are needed; information about batch/lot number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature decreased, Feeling abnormal, Hypotension
Clinical narrative: Passed out; Blood pressure was low for him: 112/54; temp was also low: 96.6; thirsty; feel funny; This is a spontaneous report from a contactable consumer reported for self. This 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 14:45 PM on Arm left at single dose (Lot # ER8732) for covid-19 immunisation. Medical history included Sleep apnea, breathing issues, IBS, Hypertension; Anxiety/Depressive disorder. No known allergies. No covid prior vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. On 26Mar2021 08:00 AM, he went to the bathroom around 8 a.m. this morning and started to feel funny. He stood up and passed out onto the floor. Family members heard him and came to help. Blood pressure was low for him: 112/54. Temp was also low: 96.6. He was very thirsty. No treatments received. No covid tested post vaccination. Outcome of the events was recovering.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Thirst
Clinical narrative: Passed out; Blood pressure was low for him: 112/54; temp was also low: 96.6; thirsty; feel funny; This is a spontaneous report from a contactable consumer reported for self. This 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 14:45 PM on Arm left at single dose (Lot # ER8732) for covid-19 immunisation. Medical history included Sleep apnea, breathing issues, IBS, Hypertension; Anxiety/Depressive disorder. No known allergies. No covid prior vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. On 26Mar2021 08:00 AM, he went to the bathroom around 8 a.m. this morning and started to feel funny. He stood up and passed out onto the floor. Family members heard him and came to help. Blood pressure was low for him: 112/54. Temp was also low: 96.6. He was very thirsty. No treatments received. No covid tested post vaccination. Outcome of the events was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium decreased, Chills, Feeling cold, Muscular weakness, Pain in extremity
Clinical narrative: was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't want to work, I had to use a ladder to pull myself up out of the chair; checked his temperature and it was either 101 degree F or 100.1 degree F/running a fever now of 100.1 degrees Fahrenheit; he liked to froze to death in his house; his legs are so sore; chills; shaking; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6204), via an unspecified route of administration, administered in left arm on 23Mar2021 09:00 at single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (began years ago about 10 years ago, states he has no names or lot numbers of the blood pressure pill). The patient's concomitant medications were not reported. On 25Mar2021, the patient experienced chills and shaking. He stated he was probably running a fever but he don't know. On 26Mar2021, he woke up with extreme lower extremity weakness, stating his legs didn't want to work. He had to use a ladder to pull himself up out of the chair. He checked his temperature and it was either 101 degree F or 100.1 degree F. He was running a fever now of 100.1. Patient stated he had the 1st dose on 23Mar2021 and it was about three days ago and then yesterday (26Mar2021) he liked to froze to death in his house which was 80 degrees and he was covered up and had covers on him. He got ready for work today and when he got up his legs did not want to work and it would have been very easy to fall and when he came in, he fell in the door but his legs were so sore and he was running a fever now of 100.1 degrees Fahrenheit on 26Mar2021. Patient had the Pfizer COVID shot in his left arm and had no soreness or anything like that but stated he was in the hospital for three days trying to get his potassium up on an unspecified date and went through sixteen little bags of concentrated potassium and the first potassium bag was on a drip machine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't want to work, I had to use a ladder to pull myself up out of the chair; checked his temperature and it was either 101 degree F or 100.1 degree F/running a fever now of 100.1 degrees Fahrenheit; he liked to froze to death in his house; his legs are so sore; chills; shaking; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6204), via an unspecified route of administration, administered in left arm on 23Mar2021 09:00 at single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (began years ago about 10 years ago, states he has no names or lot numbers of the blood pressure pill). The patient's concomitant medications were not reported. On 25Mar2021, the patient experienced chills and shaking. He stated he was probably running a fever but he don't know. On 26Mar2021, he woke up with extreme lower extremity weakness, stating his legs didn't want to work. He had to use a ladder to pull himself up out of the chair. He checked his temperature and it was either 101 degree F or 100.1 degree F. He was running a fever now of 100.1. Patient stated he had the 1st dose on 23Mar2021 and it was about three days ago and then yesterday (26Mar2021) he liked to froze to death in his house which was 80 degrees and he was covered up and had covers on him. He got ready for work today and when he got up his legs did not want to work and it would have been very easy to fall and when he came in, he fell in the door but his legs were so sore and he was running a fever now of 100.1 degrees Fahrenheit on 26Mar2021. Patient had the Pfizer COVID shot in his left arm and had no soreness or anything like that but stated he was in the hospital for three days trying to get his potassium up on an unspecified date and went through sixteen little bags of concentrated potassium and the first potassium bag was on a drip machine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable healthcare professional (patient who was also reported as a consumer). A 66-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 28Jan2021 11:45 (Lot Number: EL3302) as a single dose for covid-19 immunisation. Medical history included aortic dissection, BP [blood pressure] (blood pressure abnormal), thyroid (thyroid disorder), heart (heart disorder) and cholesterol (blood cholesterol abnormal). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication includes unspecified BP, heart, thyroid and cholesterol medication. The patient previously took and had allergies with codeine (includes upset stomach) and lisinopril (includes cough). The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. On 09Mar2021 07:15 AM, the patient had Bell's palsy. The event resulted in a doctor or other healthcare professional office/clinic visit and received treatment which includes prednisone (ORASONE) 20mg Oral and valacyclovir (VALTREX). The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.; Sender's Comments: Based on available information, the event Bell's palsy most likely represents intercurrent medical condition and is unrelated to Bnt162b2 vaccine. 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Spontaneous subconjuntival hemorrhage; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration in left arm, on 08Mar2021 at 03:15 PM (15:15), at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included omeprazole. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 10Mar2021 at 10:15 AM, the patient experienced spontaneous subconjunctival hemorrhage that resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was received for the adverse event. The event was considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain
Clinical narrative: developed Bells Palsy on the left side of my face almost 2 months to the day from my last Covid vaccine; having a severe ear ache in the left ear; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 14:30 (Batch/Lot Number: EK5730) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 week prior to the COVID vaccine. The patient received first dose of bnt162b2 on 18Dec2020 10:00 in right arm for COVID-19 immunization. On 26Feb2021, the patient started having a severe ear ache in the left ear. On 06Mar2021, he developed Bells Palsy (medically significant) on the left side of his face almost 2 months to the day from his last Covid vaccine. The Palsy has since totally resolved and his facial. The patient received treatment for the events: prednisone and anti viral medication for 7 days. The patient was not diagnosed with COVID19 prior to vaccination, and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered.   Follow up needed, further information was requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Fatigue
Clinical narrative: Possibly an autoimmune disease; Possibly Fatigue; Experiencing exacerbation of pre-existing symptoms; This is a spontaneous report from a contactable consumer via the medical information team. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient exacerbation of pre-existing symptoms since she had the vaccine first dose. The reporter did not know the details of her pre-existing symptoms but stated that fatigue was included and possibly an autoimmune disease. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness, Dysphonia, Feeling abnormal, Pain in extremity
Clinical narrative: feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization.  There were no medical history and concomitant medications.  The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021.  On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day.  Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy.  Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear.  She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization.  There were no medical history and concomitant medications.  The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021.  On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day.  Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy.  Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear.  She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: Patient developed itching over chest and arms and stated she felt warm and mildly dizzy.  No hypotension, respiratory or GI symptoms to constitute anaphylaxis; deemed to have hives + mild vasovagal symptoms. Symptoms improved with administration of 25mg benadryl. Patient was given strict ER precautions given history of anaphylaxis to other medications in the past and patient was given rx for epi pen for home use if needed.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, temp of 103, muscle aches, fatigue, head ache. Lasted almost 24 hours.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Headache, fever 104 degrees, body and joint aches & pain.  Nausea,  Chills, diarrhea,  painful urination, throat swelling, light touching of torso is very painful.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Headache, Nausea, Pain, Pharyngeal swelling
Clinical narrative: Headache, fever 104 degrees, body and joint aches & pain.  Nausea,  Chills, diarrhea,  painful urination, throat swelling, light touching of torso is very painful.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Pallor
Clinical narrative: Client reported feeling "hot and light headed" approx 2 minutes after receiving vaccine. She was led by EMT to zero gravity chair.  12:31 V/S: HR 67, O2 99, BP 98/60. V/S  @ 12:46 BP 118/80, HR 82, O2 99, AOx3 EMT observed client's to have pallor color. V/S @ 12:56 BP 92/58, HR 72, O2 100, RR 20 and client report of "feeling much better." Client reported having hx of syncope with nose piercing. At 1312, client left site unassisted and with a steady gait.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: 12 hours afterwards I had a fever and a headache. I feel very weak and tired and my left arm hurts.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Sleep disorder, Sneezing, Somnolence
Clinical narrative: felt tired and sleepy on the same evening; then went to bed; woke up at night feeling a mild headache; took two pills of Acetaminophen; no fever; a few sneezes
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Urticaria
Clinical narrative: 12 minutes after vaccination onset of stomach upset followed by hives and bilateral upper extremity tingling. Denies SOB, wheeze, throat tightness.  PE: Urticaria right face, . neck, upper chest Rapid clearing of hives started under one minute after oral diphenhydramine