chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Dysgeusia, Dysphagia, Injection site pain, Lethargy, Nasopharyngitis
Clinical narrative: On Saturday 1/16/21 at approximately 4:15 pm my wife and I received the Moderna vaccine, lot number 041L20A. We waited the required 15 minutes to see if we had any reaction, we did not. After checking out we drove directly home. At approximately 5:10 pm, while driving to our home, about 45 minutes after receiving the injection, we both noticed that we were having difficulty swallowing and felt a swelling in the back of our throats. I experienced a metallic taste. The feeling of the swelling in our throats was similar to when a dentist uses a topical numbing gel prior to a dental procedure. The difficulty swallowing and the thickness in our throats lasted about 30 - 45 minutes. We monitored ourselves at home and did not feel that we needed medical attention. Because of my wife?s angioedema we had 2 Epipens at the ready. We both experienced soreness at the injection site (left arm), my arm sorer than my wife?s   The swollen throat and difficulty swallowing is the only reaction my wife had. I woke on Sunday morning and my arm was very sore, more so than what I had experienced with a flu shot. At approximately 12:15 pm on Sunday, 1/17/21, and about 21 hours after the vaccine was administered, I began to feel achy, like l was getting a cold. I took a nap and upon waking did not feel any better. My temperature was 97.6. I felt lethargic the rest of the day and went to bed early and sleep ok but woke up not feeling any better. I used a finger pulse oximeter and it registered 94/94. My temperature remains normal.  I am registering these reactions after reading about the adverse and severe reactions of persons at the site who received the same Moderna lot 041L201 as we did.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pharyngeal swelling
Clinical narrative: On Saturday 1/16/21 at approximately 4:15 pm my wife and I received the Moderna vaccine, lot number 041L20A. We waited the required 15 minutes to see if we had any reaction, we did not. After checking out we drove directly home. At approximately 5:10 pm, while driving to our home, about 45 minutes after receiving the injection, we both noticed that we were having difficulty swallowing and felt a swelling in the back of our throats. I experienced a metallic taste. The feeling of the swelling in our throats was similar to when a dentist uses a topical numbing gel prior to a dental procedure. The difficulty swallowing and the thickness in our throats lasted about 30 - 45 minutes. We monitored ourselves at home and did not feel that we needed medical attention. Because of my wife?s angioedema we had 2 Epipens at the ready. We both experienced soreness at the injection site (left arm), my arm sorer than my wife?s   The swollen throat and difficulty swallowing is the only reaction my wife had. I woke on Sunday morning and my arm was very sore, more so than what I had experienced with a flu shot. At approximately 12:15 pm on Sunday, 1/17/21, and about 21 hours after the vaccine was administered, I began to feel achy, like l was getting a cold. I took a nap and upon waking did not feel any better. My temperature was 97.6. I felt lethargic the rest of the day and went to bed early and sleep ok but woke up not feeling any better. I used a finger pulse oximeter and it registered 94/94. My temperature remains normal.  I am registering these reactions after reading about the adverse and severe reactions of persons at the site who received the same Moderna lot 041L201 as we did.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: The day following vaccination I began to have abdominal pains with nausea, and diarrhea. I have been very tired only able to stay up approx. 3 hours then must lay down. Diarrhea quit after 4 days but am still nauseated and feel cold all over.  No fever, no vomiting. Very shaky. I have been keeping hydrated by drinking ginger tea, green tea, ginger snaps.  I am hungry and can eat small amounts which makes me feel better for a couple of hours but then back comes the abdomen discomfort. I am a cardiac patient and a diabetic.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: The day following vaccination I began to have abdominal pains with nausea, and diarrhea. I have been very tired only able to stay up approx. 3 hours then must lay down. Diarrhea quit after 4 days but am still nauseated and feel cold all over.  No fever, no vomiting. Very shaky. I have been keeping hydrated by drinking ginger tea, green tea, ginger snaps.  I am hungry and can eat small amounts which makes me feel better for a couple of hours but then back comes the abdomen discomfort. I am a cardiac patient and a diabetic.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Tremor
Clinical narrative: She was fine for the first 4 hours. Started to hurt at the inj site. Did not take diabetic meds with dinner that night. Around 11pm didn't feel well. was shaking. Took diabetic number, 65.  Normal count 115.  Thinks that the covid inj lowered her numbers. After eating cookies with milk it went up to 112. She felt better. If she had taken her meds, her numbers would have been around 50.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Neck pain
Clinical narrative: Felt a little out of it about an hour after but that wasn't bad. My neck started getting sore and headache that night. Next morning joints are sore, slight headache and slight chills.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: The right side of my face (cheek) began to tingle, and the my left hand was tingling as well. This is not normal for me. It feels like my cheek is going to sleep. So I've been rubbing it. As for my left hand, I've been opening and closing it.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Lymphadenopathy, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Took Motrin after receiving vaccine on 1/5/21 and felt fine until the evening of 1/6/21 felt like was freezing with temp 100.4 and body aches.  On 1/7/21 continued to have body aches, sweaty, afebrile and that evening felt nauseous requiring medication (zofran).   On 1/8 @ 1300 after waking up felt body aches and stiffness on right side of body, right side of face felt tingly, right underarm lymph node swollen.  Went to urgent care to be examined and had xray of neck that was negative for acute process and was informed to take motrin and return in 3 days if not better.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, X-ray
Clinical narrative: Took Motrin after receiving vaccine on 1/5/21 and felt fine until the evening of 1/6/21 felt like was freezing with temp 100.4 and body aches.  On 1/7/21 continued to have body aches, sweaty, afebrile and that evening felt nauseous requiring medication (zofran).   On 1/8 @ 1300 after waking up felt body aches and stiffness on right side of body, right side of face felt tingly, right underarm lymph node swollen.  Went to urgent care to be examined and had xray of neck that was negative for acute process and was informed to take motrin and return in 3 days if not better.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: local skin reaction (warm, red, swollen); local skin reaction (warm, red, swollen); local skin reaction (warm, red, swollen); local skin reaction (warm, red, swollen); This spontaneous report was received from a patient of unknown age and gender reporting on him/herself, through Pfizer. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  In approximately 2016 (reported as "some 5 years ago"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  On an unknown date, the patient experienced local skin reaction reported as warm, red and swollen (skin reaction, injection site erythema, injection site swelling and injection site warmth). The primary care physician advised the patient not to obtain the Pneumococcal Vaccine, Polyvalent (23-valent) anymore.  The outcome of skin reaction, injection site erythema, injection site swelling, and injection site warmth was unknown. Additionally, the causality assessment between skin reaction, injection site erythema, injection site swelling and injection site warmth with pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Erythema, Paraesthesia, Peripheral swelling, Productive cough
Clinical narrative: Day 8 after covid Madera injection red hot swollen itchy arm/bronci spasms and coughing flem clear thick/ also tingling in face right side took benedryl felt better /day 16 same thing happend.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm
Clinical narrative: Day 8 after covid Madera injection red hot swollen itchy arm/bronci spasms and coughing flem clear thick/ also tingling in face right side took benedryl felt better /day 16 same thing happend.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in right ear persisting since second injection
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: hives on her face; This is a spontaneous report from a contactable healthcare professional (physician assistant). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration, on 24Dec2020 as a single dose (reported as 0.3) for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced hives on her face in Dec2020, which was reported as medically significant. It was reported that within 24 hours of vaccination, the patient had hives for 48 hours. The event was reported as a moderate systemic reaction. The clinical outcome of hives on her face was recovered in Dec2020.; Sender's Comments: Based on the compatible time association, the event hives on her face is possibly related to suspect BNT162B2 administration. 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Injection site pain, Malaise, Pyrexia
Clinical narrative: a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine was given; This is a spontaneous report from a contactable Nurse (reporting for herself).  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, bacth/lot no: EK9231 while expiry date was unknown), intramuscular on left deltoid on 07Jan2021 16:45 at a single dose for covid-19 immunization.  There were no medical history and concomitant medications reported. Patient has no prior vaccination within 4 weeks.The patient got her first dose of the  COVID 19 vaccine yesterday (07Jan2021) from her employer.  She started "feeling yucky" today (08Jan2021) around noon with a low grade fever,and developed a cough that was not persistent. Patient has soreness in the arm where vaccine was given. She was asking what should she do about it? Outcome of the events low grade fever, cough, feeling unwell, feeling abnormal were not recovered while vaccination site pain was unknown. The events low grade fever, cough, feeling unwell were considered serious medically significant and related to vaccine.; Sender's Comments: Based on the time association, the events fever, cough and malaise are possibly related to suspect BNT162B2 administration. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cholangiogram, Complement factor, Dysphagia, Fibrin D dimer
Clinical narrative: Body pain, headache, difficulty swallowing
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test, Tryptase
Clinical narrative: Body pain, headache, difficulty swallowing
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Flushing
Clinical narrative: generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan2021; This is a spontaneous report from a contactable pharmacist. A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular in left arm on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic HTN and allergies to baclofen and statins. The patient's concomitant medications were unspecified medications taken for hypertension. The patient previously received the first dose of bnt162b2 on 19Dec2020 via intramuscular in left arm, lot EL0140. On 08Jan2021, the patient was brought into ER as code MET. Patient was receiving her second vaccine for COVID-19 when she experienced generalized weakness and flushing. She stated that she knew her BP was high. Endorses hx chronic HTN, reports she took all three medications this AM. The patient denied any headache, new visual change, CP, SOB, or focal weakness. The events recovered on an unknown date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.; Sender's Comments: Based on the time association, the events asthenia, flushing and hypertension are possibly related to suspect BNT162B2 administration. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Intra-uterine contraceptive device removal, Pelvic fluid collection, Ultrasound pelvis abnormal, Vaginal haemorrhage
Clinical narrative: Profuse watery vaginal bleeding 12 hrs after injection. Bleeding lasted approximately six hours. After first injection and vaginal bleeding, gynecology exam completed for abnormalities; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 22Dec2020 at 16:00 at a single dose; and the second dose via intramuscular in the left arm on 08Jan2021 at 08:00 at a single dose as COVID-19 vaccine. Medical history included a known latex allergy and previous spontaneous cerebral artery dissection x 3 ( nonspecific connective tissue disease). The patient was not pregnant at the time of vaccination and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications (reported as other medications within two weeks of vaccination) included estrogens conjugated (PREMARIN), micronized progesterone, colecalciferol (Vitamin D), folic acid (FOLATE), and diphenhydramine hydrochloride (BENADRYL). On 23Dec2020, the patient experienced profuse watery vaginal bleeding 12 hours after the injection. The bleeding lasted approximately six hours. After the first injection and vaginal bleeding, a gynecology exam was completed for abnormalities. Previously diagnosed uterine fibroids present and some free fluid in the pelvis by ultrasound. Bleeding resolved by the end of post-vaccine day 1. After the second vaccine, heavy vaginal bleeding started 10 hours after a injection. It was reported that the adverse event result in a doctor or other healthcare professional office/clinic visit. Treatment for the event involved removal of the IUD. Outcome of the event was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).  Information about the lot/batch number has been requested.; Sender's Comments: There is reasonable possibility that the event vaginal hemorrhage is related to suspect drug BNT162B2 based on a compatible temporal relation between vaccination and the onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Blood test normal, Exposure during pregnancy, Lymphadenopathy, Tenderness
Clinical narrative: few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the time of vaccination; large mass appeared in right axilla; mass was painful to touch; large mass appeared in right axilla; mass was painful to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of bnt162b2 (COVID 19, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 23Dec2020 07:15 at a single dose for COVID-19 immunization in a hospital. The patient had no relevant medical history and no known allergies. The patient was pregnant at the time of vaccination, last menstrual date was on 05Oct2020, delivery date will be on 12Jun2021, gestation period: 11.  Concomitant medication includes daily multivitamin. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 30Dec2020 04:00 am, 7 days after vaccine (as reported), a large mass appeared in right axilla. The mass was painful to touch. Overnight mass more than doubled in size on 31Dec2020 the mass took up her entire arm pit, went to immediate care and was given antibiotics. The mass decreased in size but has not gone away. She followed up with primary care. She had bloodwork and ultrasound of axilla and right breast. Blood work was normal. Ultrasound showed a few enlarged and abnormal lymph nodes believed to be reactive in nature. Largest lymph node as of 08Dec2020 2.5 x 0.9 x 2.2 cm. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast abnormal, Ultrasound scan abnormal
Clinical narrative: few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the time of vaccination; large mass appeared in right axilla; mass was painful to touch; large mass appeared in right axilla; mass was painful to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of bnt162b2 (COVID 19, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 23Dec2020 07:15 at a single dose for COVID-19 immunization in a hospital. The patient had no relevant medical history and no known allergies. The patient was pregnant at the time of vaccination, last menstrual date was on 05Oct2020, delivery date will be on 12Jun2021, gestation period: 11.  Concomitant medication includes daily multivitamin. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 30Dec2020 04:00 am, 7 days after vaccine (as reported), a large mass appeared in right axilla. The mass was painful to touch. Overnight mass more than doubled in size on 31Dec2020 the mass took up her entire arm pit, went to immediate care and was given antibiotics. The mass decreased in size but has not gone away. She followed up with primary care. She had bloodwork and ultrasound of axilla and right breast. Blood work was normal. Ultrasound showed a few enlarged and abnormal lymph nodes believed to be reactive in nature. Largest lymph node as of 08Dec2020 2.5 x 0.9 x 2.2 cm. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Syncope, Vomiting
Clinical narrative: Syncopal event; Nausea; Vomiting; This is a spontaneous report from a contactable nurse.  A 29-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), via an unspecified route of administration on the right arm on 08Jan2021 12:15 at single dose for COVID-19 immunisation. The patient medical history was not reported.  Concomitant medication included influenza vaccine (INFLUENZA VACCINE) on 13Dec2020. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 18Dec2021 12:15. The patient experienced syncopal event, nausea and vomiting on 09Jan2021 05:00. The patient received no treatment. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the event syncope is possibly related to suspect drug BNT162B2 administration. 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: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over my body
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Heart rate increased
Clinical narrative: Injection @ 9am.  Fever (100°),  chills/ shivering,  fatigue,  sore muscles (lower back,  hips,  thighs) began around 8:30 - 9pm.  Woke at 12am & HR was 160bpm, still had fever. Woke at 6am & took temp several times until 8am..Had fever/temperature between 102°-103.8°. Felt fatigued throughout the day, HR ran between 125-135 & temp ran between 100° -102°. Temp broke sometime in the am hours of Jan 8. Woke up at 6am and temperature was 98.0 & HR was 85bpm. My left shoulder muscle was swollen & itchy through Jan 15th. The soreness in my left arm disappeared on Jan 13th. I took Tylenol for temperature and drank plenty of fluids.  Was very concerned about increased heart rate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Myalgia, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Injection @ 9am.  Fever (100°),  chills/ shivering,  fatigue,  sore muscles (lower back,  hips,  thighs) began around 8:30 - 9pm.  Woke at 12am & HR was 160bpm, still had fever. Woke at 6am & took temp several times until 8am..Had fever/temperature between 102°-103.8°. Felt fatigued throughout the day, HR ran between 125-135 & temp ran between 100° -102°. Temp broke sometime in the am hours of Jan 8. Woke up at 6am and temperature was 98.0 & HR was 85bpm. My left shoulder muscle was swollen & itchy through Jan 15th. The soreness in my left arm disappeared on Jan 13th. I took Tylenol for temperature and drank plenty of fluids.  Was very concerned about increased heart rate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort
Clinical narrative: Heart fluttering; chest pressure; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EK5730; expiration date: not known), via an unspecified route of administration in the left arm at hospital on 31Dec2020 10:00 at at single dose for COVID-19 immunization. Medical history included known allergies with sulfa. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took clarithromycin (BIAXIN), metronidazole benzoate (FLAGYL), and sulfamethoxazole, trimethoprim (BACTRIM), and all but experienced allergies (reported as "known allergies: Biaxin, Flagyl, sulfa, Bactrim"). No COVID prior to vaccination and no COVID tested post vaccination. The patient experienced heart fluttering and chest pressure on 04Jan2021. There was no treatment received for the reported events. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between the reported heart fluttering and the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded due to temporal relationship.  The case will be reassessed should additional information become 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity
Clinical narrative: Sore arm first 3 days, reported on V-Safe. That was only reaction.  The after 1 week, Fri. arm started to hurt again, then itch and turned red around injection area for several days.  Took Photo if needed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Migraine, Nausea
Clinical narrative: Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tachycardia, Vomiting
Clinical narrative: Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Neuralgia, Pain in extremity, Pruritus
Clinical narrative: Red ring around area where vaccine was given approximately 7cm x 7cm. Skin is hot to touch, swollen, itchy, nerve pain up and down shoulder and arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Skin warm
Clinical narrative: Red ring around area where vaccine was given approximately 7cm x 7cm. Skin is hot to touch, swollen, itchy, nerve pain up and down shoulder and arm.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Malaise, Pneumonia, SARS-CoV-2 test
Clinical narrative: 7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tired; confused; unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on the left arm on 28Dec2020 12:00PM at a single dose for COVID-19 immunization at hospital facility. Medical history included Hashimotos disease. The patient had no known allergies and has not had COVID prior to vaccination. The patient's concomitant medications were not reported. The patient reported that she felt tired and confused and unwell on day of injection, 28Dec2020. After three days (31Dec2020), she developed hives on her stomach and arm and seven days later (04Jan2021), she was diagnosed with pneumonia and continued to have hives all over her legs and arms to this day. The patient was treated with antibiotics for pneumonia. She underwent Covid test/ Nasal swab post vaccination on 09Jan2021, pending result. The outcome of the events was not recovered.; Sender's Comments: The reported pneumonia was more likely an intercurrent disease, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become 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: Urticaria
Clinical narrative: 7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tired; confused; unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on the left arm on 28Dec2020 12:00PM at a single dose for COVID-19 immunization at hospital facility. Medical history included Hashimotos disease. The patient had no known allergies and has not had COVID prior to vaccination. The patient's concomitant medications were not reported. The patient reported that she felt tired and confused and unwell on day of injection, 28Dec2020. After three days (31Dec2020), she developed hives on her stomach and arm and seven days later (04Jan2021), she was diagnosed with pneumonia and continued to have hives all over her legs and arms to this day. The patient was treated with antibiotics for pneumonia. She underwent Covid test/ Nasal swab post vaccination on 09Jan2021, pending result. The outcome of the events was not recovered.; Sender's Comments: The reported pneumonia was more likely an intercurrent disease, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chest pain, Depression, Dizziness
Clinical narrative: difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation.  Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Loss of consciousness, Mobility decreased, Pruritus
Clinical narrative: difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation.  Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Dizzy, nauseous, fainted, emesis, severe sweating  from 6am-8:30am
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; This is a spontaneous report from a contactable Physician (patient). A 31-year-old female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJI685) intramuscular at arm right on 19Dec2020 06:30 at single dose for covid-19 immunization. Facility type vaccine was hospital. Medical history was none. The patient had no known allergies or other medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced a very early miscarriage at five weeks on 01Jan2021. The event result in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event miscarriage was recovered in Jan2021. No covid prior vaccination and no covid tested post vaccination.; Sender's Comments: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The data on BNT162B2 administered to pregnant women is insufficient to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Cold sweat, Culture negative, Diarrhoea
Clinical narrative: almost pass out; Chills; nausea; diarrhea; abdominal pain; clammy; elevated heart rate; dizzy; This is a spontaneous report from a contactable consumer (patient's parent). A 24-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The relevant medical history included asthma, migraines and anxiety all from an unspecified date. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING), topiramate (TOPAMAX), verapamil and sertraline hydrochloride (ZOLOFT). The patient experienced chills, nausea, diarrhea, abdominal pain, clammy, elevated heart rate, almost pass out, dizzy, all on 05Jan2021. The patient had no treatment for the events. No covid prior vaccination. The patient underwent lab test included heart rate showed elevated on 05Jan2021, Nasal Swab showed negative on 06Jan2021. The outcome of the events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Heart rate increased, Nausea
Clinical narrative: almost pass out; Chills; nausea; diarrhea; abdominal pain; clammy; elevated heart rate; dizzy; This is a spontaneous report from a contactable consumer (patient's parent). A 24-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The relevant medical history included asthma, migraines and anxiety all from an unspecified date. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING), topiramate (TOPAMAX), verapamil and sertraline hydrochloride (ZOLOFT). The patient experienced chills, nausea, diarrhea, abdominal pain, clammy, elevated heart rate, almost pass out, dizzy, all on 05Jan2021. The patient had no treatment for the events. No covid prior vaccination. The patient underwent lab test included heart rate showed elevated on 05Jan2021, Nasal Swab showed negative on 06Jan2021. The outcome of the events was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got covid after 10days, with signs and symptoms
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Thrombocytopenia
Clinical narrative: Rash on lower legs similar to that seen with Thrombocytopenia.; Rash on lower legs similar to that seen with Thrombocytopenia.; This is a spontaneous report from a contactable Other HCP (patient). A 21-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number= EJ1686), via an unspecified route of administration at Left arm on 05Jan2021 10:00 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on lower legs similar to that seen with thrombocytopenia on 09Jan2021 at time of 12:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A possible contributory effect of suspect drug on reported thrombocytopenia 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.