chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1686), via an unspecified route of administration in the left arm on 14Jan2021 10:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with covid-19 prior vaccination. The patient was not tested for covid-19 post vaccination. The patient had no known allergies. On 14Jan2021 11:00, the patient's face starting itching and developed a rash. No treatment was received for the events. Outcome of the events was recovering.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial pain, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: I had right upper arm pain with right neck pain with right sided facial pain, right jaw pain that persisited for 5 days at the site of a wisdom tooth that had not caused pain previously.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I had right upper arm pain with right neck pain with right sided facial pain, right jaw pain that persisited for 5 days at the site of a wisdom tooth that had not caused pain previously.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of bnt162b2 ( COVID-19 VACCINE; lot EK9231, expiration date unspecified), via an unspecified route of administration on 08Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mild sleep apnea. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. On 09Jan2021, the patient experienced injection site pain and arm soreness on day 1 and day 2, patient was also very tired on day 1. Patient also had occasional sneezing and mild headache since day 1. On day 2, energy level was back to normal. However, on 11Jan2021, on day 3, the patient started to develop occasional shortness of breath and continued today, day 7. The shortness of breath comes and goes. On 14Jan2021, on day 6, the patient experienced occasional coughing and continued today, day 7. Since the patient was working in a pharmacy, she cannot rule out if symptoms were from vaccine or Covid exposure, so patient decided to get Covid test done today, day 7. The patient had no treatment received for the events. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Patient had no Covid prior vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with pending results on 14Jan2021. Outcome of events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Sneezing
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of bnt162b2 ( COVID-19 VACCINE; lot EK9231, expiration date unspecified), via an unspecified route of administration on 08Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mild sleep apnea. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. On 09Jan2021, the patient experienced injection site pain and arm soreness on day 1 and day 2, patient was also very tired on day 1. Patient also had occasional sneezing and mild headache since day 1. On day 2, energy level was back to normal. However, on 11Jan2021, on day 3, the patient started to develop occasional shortness of breath and continued today, day 7. The shortness of breath comes and goes. On 14Jan2021, on day 6, the patient experienced occasional coughing and continued today, day 7. Since the patient was working in a pharmacy, she cannot rule out if symptoms were from vaccine or Covid exposure, so patient decided to get Covid test done today, day 7. The patient had no treatment received for the events. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Patient had no Covid prior vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with pending results on 14Jan2021. Outcome of events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Injection site pain, Lymphadenopathy, Malaise
Clinical narrative: I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Lymphadenopathy, Malaise
Clinical narrative: I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: tinnitus; loss of hearing on Left side; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization at hospital facility. Medical history included benign prostatic hyperplasia (BPH) and hypothyroidism. The patient had no known allergies and did not have COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), tamsulosin hydrochloride (FLOMAX), and finasteride taken within two weeks of vaccination. The patient had no other vaccine in four weeks. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK8330) via intramuscular route on the left arm on 16Dec2020 at 6:15AM. The patient experienced tinnitus and loss of hearing on left side on 13Jan2021, 7 days post 2nd dose. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Prednisone taper was given as treatment for the events. The patient had not been tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the possible contribution of suspect BNT162B2 to the events tinnitus and loss of hearing cannot be totally excluded given the time association. The detailed clinical course about these events would be helpful for further assessment. 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: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Dizziness, high blood pressure
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the left arm on an unspecified date in Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. He was not tested for Covid post vaccination. The patient's injection arm and entire upper body was sore for roughly 3 days on an unspecified date in Dec2020. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Contraindication to vaccination, Urticaria
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) solution for injection, intramuscular on right arm 14Jan2021 12:30 at a single dose for Covid-19 immunization. Medical history included chronic sinusitis due to allergies, asthma; allergies to corn, wheat, Penicillin, Sulfa, and cephalosporins. The patient was not pregnant. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (AUROVELA FE 1/20), and salbutamol (ALBUTEROL HFA). The patient experienced hives - full body on 14Jan2021 17:00 (as reported), experienced it approximately 4-6 hours after receiving vaccine. It was resolved with Benadryl. Patient stated that to be fair, she has a lot of allergies and she does occasionally experience full body hives on days when she has not received a vaccine or changed her diet/detergents. Patient did not have COVID prior vaccination. Patient has not been tested for COVID-19 after receiving the vaccine. Outcome of the events was recovered.  No follow-up activities are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain, Vaccination site erythema, Vaccination site mass
Clinical narrative: the vaccine was administered too far up and may have been given subcutaneously; developed a lump and redness in the injection site; developed a lump and redness in the injection site; Pain; This is a spontaneous report from a contactable nurse reporting for herself. A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), subcutaneous on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified medications (patient take medications). She received on Wednesday (on 13Jan2021) the second dose of the Covid vaccine and she developed a lump and redness in the injection site. In her opinion the vaccine was administered too far up and may have been given subcutaneously, the patient did not know if the injection was too far up while getting on the muscle. She would like to know if this was a side effect of the medication. The patient also experienced pain on 13Jan2021. The patient tried taking Tylenol for pain and took a dose of Motrin for pain, but that was it, the nurse assessed causal relationship between pain and COVID Vaccine was Yes. The outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Initial insomnia, Pain
Clinical narrative: When she woke up at 1/28/21 had the general body aches, headache, and chills.  Then today that has resolved, but is having a stabbing, throbbing head pain in one spot.  Had been taking regular Tylenol but took Tylenol with Codeine as it is limiting her to what she can do.  Had trouble sleeping last night due to it.  Just hoping that it goes away.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: Atrial Fibrillation; his heart was racing and was something very unusual; This is a spontaneous report from a contactable consumer (patient himself). An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient mentioned that he was a pretty healthy at 80 years old. He and his wife got vaccinated for the 1st shot last 05Jan2021. He experienced no side effects for a week. On 12Jan2021, he experienced his first ever episode of atrial fibrillation and said that his heart was racing and was something very unusual. He mentioned that his I-watch first notified him of this and he went to consult his doctor who confirmed this. He was prescribed with baby aspirin but had not taken it yet. Outcome of events were unknown.   Information about batch/lot number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: injected way below her deltoid and at the time of the report it had been a red hot bump; injected way below her deltoid and at the time of the report it had been a red hot bump; injected way below her deltoid and at the time of the report it had been a red hot bump; it was inadvertently administered subcutaneously; This is a spontaneous report from a contactable physician (patient). A 48-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via subcutaneous on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for birth control. The patient had the second dose of the COVID-19 vaccine yesterday (14Jan2021) and it was inadvertently administered subcutaneously. She said that the vaccine was injected way below her deltoid and at the time of the report it had been a red hot bump. She also mentioned that she had 0 symptoms and no muscle paint. She was wondering whether there were recommendations for her disposition. The patient also stated that it was subcutaneous, it was way off, it was not her deltoid at all. The outcome of the event was unknown.  Information about Lot/Batch number is requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms, headache, chills, joint pain, nausea, fatigue, sore arm. Aspirin helped symptoms. Started 8:00 pm 1/27 over by 10:00pm 1/28
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Flu like symptoms, headache, chills, joint pain, nausea, fatigue, sore arm. Aspirin helped symptoms. Started 8:00 pm 1/27 over by 10:00pm 1/28
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: His Arm had a little bump on it; he was experiencing tiredness; headache; fever; nauseous; muscle pains/muscle aches; couldn't sleep last night, and a general feeling of unwellness; couldn't sleep last night, and a general feeling of unwellness; joint pain; chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3302, expiration date: 05Feb2021) via an unspecified route of administration on the left arm on 14Jan2021 09:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetes, ongoing heart stent from Nov2019, COVID-19 in Mar2020 and blood thinner. Concomitant medication included ongoing metformin for diabetes, ticagrelor (BRILINTA) for blood thinner and carvedilol as beta blocker related to heart stent. The patient received the first of the vaccine yesterday and experienced all of the side effects on the fact sheet. On 14Jan2021, the patient experienced that his arm had a little bump on it, he was experiencing tiredness, a headache, a fever, nauseous, muscle pains, couldn't sleep last night, and a general feeling of unwellness. He was asking asking how long these side effects should last. He was fine all morning and afternoon after getting the vaccine until around 11:30pm-12:00am when he started hurting; talking about a headache; muscle aches; chills; fevers; joint pain; he could not sleep. Outcome of the events was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vaccination site mass
Clinical narrative: His Arm had a little bump on it; he was experiencing tiredness; headache; fever; nauseous; muscle pains/muscle aches; couldn't sleep last night, and a general feeling of unwellness; couldn't sleep last night, and a general feeling of unwellness; joint pain; chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3302, expiration date: 05Feb2021) via an unspecified route of administration on the left arm on 14Jan2021 09:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetes, ongoing heart stent from Nov2019, COVID-19 in Mar2020 and blood thinner. Concomitant medication included ongoing metformin for diabetes, ticagrelor (BRILINTA) for blood thinner and carvedilol as beta blocker related to heart stent. The patient received the first of the vaccine yesterday and experienced all of the side effects on the fact sheet. On 14Jan2021, the patient experienced that his arm had a little bump on it, he was experiencing tiredness, a headache, a fever, nauseous, muscle pains, couldn't sleep last night, and a general feeling of unwellness. He was asking asking how long these side effects should last. He was fine all morning and afternoon after getting the vaccine until around 11:30pm-12:00am when he started hurting; talking about a headache; muscle aches; chills; fevers; joint pain; he could not sleep. Outcome of the events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Pt states she has left arm muscle pain, chills, mild headache, and upset stomach
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Eye haemorrhage, Headache, Hypoaesthesia, Oedema peripheral
Clinical narrative: fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation.  Medical history included End-Diastolic Heart Failure, osteopenia and arthritis.  Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. 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, COVID19
Symptoms: Oxygen saturation decreased, Pain, Pyrexia
Clinical narrative: fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation.  Medical history included End-Diastolic Heart Failure, osteopenia and arthritis.  Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. 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, COVID19
Symptoms: Bone pain, Chromaturia, Haematuria, Headache, Mobility decreased
Clinical narrative: fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation.  Medical history included End-Diastolic Heart Failure, osteopenia and arthritis.  Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. 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, COVID19
Symptoms: Muscle spasms, Neuralgia, Oxygen saturation decreased, Pyrexia, Rash erythematous
Clinical narrative: fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation.  Medical history included End-Diastolic Heart Failure, osteopenia and arthritis.  Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. 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, COVID19
Symptoms: Rash papular, SARS-CoV-2 test negative, Tetany
Clinical narrative: fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation.  Medical history included End-Diastolic Heart Failure, osteopenia and arthritis.  Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. 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: Lymph node pain, Lymphadenopathy
Clinical narrative: supraclavicular lymphnode swelling/mobile; lymph node is not as painful, but is still tender and is mobile.; This is a spontaneous report from a contactable physician (patient).  A 28-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) in the hospital via intramuscular route of administration on 04Jan2021 at 10:00 AM at a single dose on the right deltoid for COVID-19 prophylaxis.  The patient medical history was not reported and there were no concomitant medications. The patient was previously administered a flu vaccine on an unspecified date for immunization and experienced sore arm. The patient had no prior vaccinations within 4 weeks. It was reported that the patient developed supraclavicular lymphnode swelling on 11Jan2021 and was calling to see if this is normal or if it was something others have experienced. She noticed that last week or about 5 days (also reported as 11Jan2021) after receiving the vaccine her supraclavicular lymph node was swollen.  She stated that it was just that one lymph node on the same side that she received the injection. She added that the lymph node is not as painful, but is still tender and is mobile. She said that it is tender if she pushes on it. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: my blood pressure, it was up to 217; This is a spontaneous report from a contactable consumer (patient). A 80-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 an unspecified route of administration on 13Jan2021 at 12:00 PM at a single dose for COVID-19 immunization .  The patient's medical history and concomitant medications were not reported.  On 13Jan2021, the patient  received the first shot then had no problems. On 14Jan2021, 24 hours afterwards, the patient had two doctors supposed to get her iron injections and they checked her blood pressure, it was up to 217, they got it down a little and finally gave the iron. They recommended the patient went over the ER and be checked. The patient spent a good 10 hours there having medications to get it down. Finally, it went down: 187/92 and everything fine there. The patient was given injection through the IV and finally got one that worked; got the lowest it would come. The patient came home on 15Jan2021 at 3:00 AM, went to bed then got up and her husband took her blood pressure: 127/65 and informed that it has not been taken since 8:00 AM. The patient was told by doctors that they did not think it was related to the COVID-19 vaccine. The outcome of the event was recovered on 15Jan2021.  Information on lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Eight days after my vaccination, the injection site became red and slightly itchy. This only seemed to last for about 12 hours as I noticed it at night and when I woke up, while my arm was still slightly red, it was reduced.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EL0142), via an unspecified route of administration on 12Jan2021 at a single dose on the right arm because she doesn't want to get Covid. Medical history includes the patient being sick before she got the shot, she had the flu since an unspecified date in Dec2020 during Christmas time. She didn't feel well before. She thought it was Covid and her friend was also sick that time and did have Covid. She stated that her own symptoms were like the flu, no fever, just regular flu symptoms. There were no concomitant medications. The patient reported that got her first vaccine this past Tuesday, 12Jan2021. She has been fine, but her arm is quite red since an unspecified date in Jan2021, and was tender since 13Jan2021 but was not hurting. When she took off the band aid the next day to take a shower, everything was okay. On Thursday, 14Jan2021 when she woke up she noticed redness and it was tender. SHe added that her arm is quite red and tender to the touch. She was asking if she should put hear or ice on it or just leave it alone. She wanted to know if this was normal. She stated that she has had a dull headache since an unspecified date after receiving the vaccine. Her arm was also swollen on an unspecified date after receiving the vaccine  and sore. The patient wants to know if there are any recommendations for treatment. The outcome of the event vaccination site erythema was not recovered, the outcome of the event vaccination site pain was recovering the outcome of the other events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cluster headache, Pruritus
Clinical narrative: developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint itching all over her body/mild itching today 'like when a nerve lights up'; she felt her left outer ear was burning until around 22:00 at night; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL0142 and expiry date:Mar2021) , via an unspecified route of administration on 13Jan2021 16:15 at a single dose in left arm for covid-19 immunization.  There were no medical history and concomitant medications reported. She states that she had the first dose of the vaccine on Wed 13Jan2021 at 16:15 together with her husband, right after receiving the dose on left arm she felt her left outer ear was burning until around 22:00 at night and was milder the next day. She states that last night 14Jan2021 around 20:00, she developed a cluster type headache that lasted all night, she took ibuprofen (ADVIL) and around 22:00 the same night she developed pinpoint itching all over her body. She reported she still has some mild itching today 'like when a nerve lights up' and still has a 'little bit of a headache.' She wants to know if these were common side effects. The outcome of the event burning sensation recovered on 14Jan2021, while cluster headache and itching were recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: Left arm was so sore I could barely lift it, which was expected but later in the day I experienced extreme fatigue, aches in my muscles and joints, severe headache, nausea and fever of 100.5 for several hours.  Tylenol did help alleviate some of the symptoms. Some symptoms persist today, 2nd day post vaccine, such as headache, fatigue  and arm soreness.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Left arm was so sore I could barely lift it, which was expected but later in the day I experienced extreme fatigue, aches in my muscles and joints, severe headache, nausea and fever of 100.5 for several hours.  Tylenol did help alleviate some of the symptoms. Some symptoms persist today, 2nd day post vaccine, such as headache, fatigue  and arm soreness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza, Lymph node pain, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscular (left arm) on 08Jan2021 15:00 at single dose for Covid-19 immunization. The patient's medical history included skin cancer removal in September and Covid (reported as prior vaccination); no known allergies. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), desvenlafaxine succinate (PRISTIQ), escitalopram, sambucus nigra (ELDERBERRY), and apple cider vinegar (gummies), and daily vitamin (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient is not pregnant. The patient reported that she had flu symptoms all weekend after she got the vaccine. It included chills, fatigue, headache, dizziness and she had bad muscle cramps in calves. She then started having pain in lymph nodes under left arm a couple days ago. The adverse events start date was reported as 09Jan2021. There was no treatment received for the adverse events. The outcome of events was recovered with sequel (reported as recovered with lasting effects) on an unspecified date. The patient has not been tested for COVID-19 since the vaccination.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Dizziness, Electrocardiogram
Clinical narrative: He woke up could not walk; dizziness; lots of difficulty walking; This is a spontaneous report from a contactable consumer (patient's daughter)   A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 13Jan2021 at 15:00  at single dose via an unspecified route of administration  on right arm for COVID-19 immunization. Relevant medical history included borderline diabetic. It was also informed that patient had a little bit of cognitive decline predating the vaccine and he didn't drive. Concomitant medications were not reported. On 14Jan2021 the patient woke up and could not walk. On the same day (14Jan2021) the patient also experienced dizziness and lots of difficulty walking. He was admitted to hospital on 14Jan2021. Reported the CT was clean, chest x ray was clean and blood work was fine. Patient was planning to receive the next dose of vaccine on 03Feb2021. At the time of the reporting the patient was recovering from dizziness and had not yet recovered from other reported events.   Information about lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Gait inability
Clinical narrative: He woke up could not walk; dizziness; lots of difficulty walking; This is a spontaneous report from a contactable consumer (patient's daughter)   A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 13Jan2021 at 15:00  at single dose via an unspecified route of administration  on right arm for COVID-19 immunization. Relevant medical history included borderline diabetic. It was also informed that patient had a little bit of cognitive decline predating the vaccine and he didn't drive. Concomitant medications were not reported. On 14Jan2021 the patient woke up and could not walk. On the same day (14Jan2021) the patient also experienced dizziness and lots of difficulty walking. He was admitted to hospital on 14Jan2021. Reported the CT was clean, chest x ray was clean and blood work was fine. Patient was planning to receive the next dose of vaccine on 03Feb2021. At the time of the reporting the patient was recovering from dizziness and had not yet recovered from other reported events.   Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: 1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist.  RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: had arm pain that radiated up that side to my neck; had arm pain that radiated up that side to my neck; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that in Dec2020 following the first dose the patient had arm pain that radiated up that side to her neck. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Device breakage, Dyspnoea, Laboratory test, Malaise, X-ray
Clinical narrative: Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; This is a spontaneous report from a contactable Physician.  A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 13Jan2021 10:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. Vaccine location was right arm. No prior vaccinations within 4 weeks. Patient called stating she wasn't feeling well. She was in the resident lounge and all of a sudden, the right breast implant just popped. Silicone in her breast implant spread into her neck where patient was having difficulty breathing on 14Jan2021. The patient was hospitalized on 14Jan2021, with pain medication and will have to have the implants removed. They think it is vaccine related. Patient was waiting for general surgery. The outcome of right breast implant exploded was unknown. The outcome of difficulty breathing was not recovered.  Information on the Lot/batch number has been requested.; Sender's Comments: The reported breast implant rupture and associated difficulty breathing were more likely due to breast implant surgery and the quality of implant, 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Node on left side of lower neck; This is a spontaneous report from a contactable healthcare professional (patient herself). A 39-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies and was not pregnant. She had no COVID prior her vaccination. Concomitant medication in two weeks included intrauterine contraceptive device (IUD). The patient had no other vaccine in four weeks. She received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route of administration in the left arm on 28Dec2020 02:15 PM. The patient experienced swollen lymph node on left side of lower neck on 14Jan2021 that resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered due to the event. The patient was not Covid tested post vaccination. The outcome of the event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Pregnancy test positive, Progesterone decreased
Clinical narrative: Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage.