chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Chest pain, Chills, Fatigue
Clinical narrative: Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain, Pain in extremity, Palpitations
Clinical narrative: Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: muscle aches; nausea; fever, Tmax 101.7; neck ache; soreness at sight of injection; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), intramuscularly on 21Jan2021 at 09:15 AM in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included hasimoto's, known allergies with peanuts. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscularly on 30Dec2020 at 08:15 AM in the Left arm at single dose for COVID-19 immunization at the age of 30-year-old. The patient experienced fever, Tmax 101.7, muscle aches, neck ache, soreness at sight of injection, nausea on 21Jan2021 at 23:30. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included mefenamic acid (ADVIL). The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle aches; nausea; fever, Tmax 101.7; neck ache; soreness at sight of injection; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), intramuscularly on 21Jan2021 at 09:15 AM in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included hasimoto's, known allergies with peanuts. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscularly on 30Dec2020 at 08:15 AM in the Left arm at single dose for COVID-19 immunization at the age of 30-year-old. The patient experienced fever, Tmax 101.7, muscle aches, neck ache, soreness at sight of injection, nausea on 21Jan2021 at 23:30. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included mefenamic acid (ADVIL). The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was very sore; This is a spontaneous report from a contactable consumer (patient's neighbor) reporting for a patient.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. On an unknown date the patient experienced their arm was very sore. It was reported the arm was sore, but after a couple of days, it was annoying, but it went away. The clinical outcome of the arm was very sore was recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Tremor
Clinical narrative: she couldn't sit down on the commode, she was shaking/knees and legs are shaking; she couldn't sit down on the commode, she was shaking/knees and legs are shaking; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 07Jan2021 as a single dose for COVID-19 vaccination.  Medical history included walking aid user from an unknown date and unknown if ongoing, wheelchair user from an unknown date and unknown if ongoing, back surgery from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.   The consumer reported his wife got up this morning and went to the bathroom. His wife uses walkers and wheelchairs, but she couldn't sit down on the commode, she was shaking, and she said that she can't get up since an unspecified date. His wife can't get up now, her knees and legs are shaking, he doesn't know if this is from the vaccination or not. The clinical outcome of he couldn't sit down on the commode, she was shaking/knees and legs are shaking was unknown  Information on Lot/Batch has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Head discomfort, Myalgia, Pyrexia
Clinical narrative: Muscle aches; fever; chills; bones hurting; pressure on head; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. It was unknown if the patient had any known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Jan2021, the patient experienced muscle aches, fever, chills, bones hurting and pressure on head. It was unknown if treatment was provided for the events muscle aches, fever, chills, bones hurting and pressure on head. The outcome of the events muscle aches, fever, chills, bones hurting and pressure on head was recovered in Jan2021. Since the vaccination, it was unknown if the patient had been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Mouth haemorrhage
Clinical narrative: bloody nose; spit from his mouth and there was blood; This is a spontaneous report from a contactable consumer (wife). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an injection in the left arm on 20Jan2021 at 14:00 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included diabetic from 2009 and unknown if ongoing. The patient had not had any other recent vaccinations or new medications. Concomitant medications included clopidogrel bisulfate (PLAVIX) from an unknown date (taken for about 10 years) at 75mg daily for blood thinner. On 21Jan2021, the patient experienced bloody nose and he spit from his mouth and there was blood. Reporter stated that the blood was coming from his nose and dripping out. No treatment was given for the events. The clinical outcome of the epistaxis was not recovered; for mouth hemorrhage was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient experienced sore arm  on an unspecified date with outcome of unknown.  The reported event was considered non serious.  Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dermatitis acneiform, Feeling abnormal, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Pimple-like rash; Anxiety; Felt a little odd; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma from 1993 to an unspecified date (diagnosed when she was 5). Concomitant medication included tetanus vaccine (Lot number: U6830A; Expiration date: 17Sep2022) on 06Jan2021. On 20Jan2021 (15:00), the patient had reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot. In Jan2021, the patient had pimple-like rash; anxiety; and had felt a little odd. The patient had received diphenhydramine (BENADRYL) as treatment for the events, 'reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot' and 'pimple-like rash'. The outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Pimple-like rash; Anxiety; Felt a little odd; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma from 1993 to an unspecified date (diagnosed when she was 5). Concomitant medication included tetanus vaccine (Lot number: U6830A; Expiration date: 17Sep2022) on 06Jan2021. On 20Jan2021 (15:00), the patient had reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot. In Jan2021, the patient had pimple-like rash; anxiety; and had felt a little odd. The patient had received diphenhydramine (BENADRYL) as treatment for the events, 'reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot' and 'pimple-like rash'. The outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Decreased appetite, Fatigue
Clinical narrative: husband is breaking out in cold chills, and his bones are still sore.; inflamed liver; arm is still sore; Nauseated; has no energy; sick; no appetite; he is sweating; he is tired.; husband is breaking out in cold chills, and his bones are still sore.; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration on 19Jan2021 08:00 at single dose on left arm for COVID-19 prevention. The medical history and concomitant medications were not reported. The patient got the shot on 19Jan2021. Since Jan2021, his arm was still sore, but he had been nauseated since then. He has no energy. He has had it almost four days. He was fine until he got it and his arm is sore and he is nauseated. He is usually on the go. The patient also has an inflamed liver. He has been sick since. The patient has no appetite, he is sweating, his bones are hurting, and he is tired. The consumer took her husband to his doctor, and they tested him for COVID, and it came back negative, but the consumer does not think the PA did the test right. The consumer doesn't know what to do with him, because he is still tired, and has no appetite. The patient is breaking out in cold chills, and his bones are still sore. When the patient got the vaccine, he was walking and talking, and by 11 AM that day, he was in bed. The patient had some labs done, and was being told that his liver is big, so the consumer did not know if the vaccine went to his liver. The outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis, Hyperhidrosis, Laboratory test, Nausea, Pain in extremity
Clinical narrative: husband is breaking out in cold chills, and his bones are still sore.; inflamed liver; arm is still sore; Nauseated; has no energy; sick; no appetite; he is sweating; he is tired.; husband is breaking out in cold chills, and his bones are still sore.; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration on 19Jan2021 08:00 at single dose on left arm for COVID-19 prevention. The medical history and concomitant medications were not reported. The patient got the shot on 19Jan2021. Since Jan2021, his arm was still sore, but he had been nauseated since then. He has no energy. He has had it almost four days. He was fine until he got it and his arm is sore and he is nauseated. He is usually on the go. The patient also has an inflamed liver. He has been sick since. The patient has no appetite, he is sweating, his bones are hurting, and he is tired. The consumer took her husband to his doctor, and they tested him for COVID, and it came back negative, but the consumer does not think the PA did the test right. The consumer doesn't know what to do with him, because he is still tired, and has no appetite. The patient is breaking out in cold chills, and his bones are still sore. When the patient got the vaccine, he was walking and talking, and by 11 AM that day, he was in bed. The patient had some labs done, and was being told that his liver is big, so the consumer did not know if the vaccine went to his liver. The outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: husband is breaking out in cold chills, and his bones are still sore.; inflamed liver; arm is still sore; Nauseated; has no energy; sick; no appetite; he is sweating; he is tired.; husband is breaking out in cold chills, and his bones are still sore.; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration on 19Jan2021 08:00 at single dose on left arm for COVID-19 prevention. The medical history and concomitant medications were not reported. The patient got the shot on 19Jan2021. Since Jan2021, his arm was still sore, but he had been nauseated since then. He has no energy. He has had it almost four days. He was fine until he got it and his arm is sore and he is nauseated. He is usually on the go. The patient also has an inflamed liver. He has been sick since. The patient has no appetite, he is sweating, his bones are hurting, and he is tired. The consumer took her husband to his doctor, and they tested him for COVID, and it came back negative, but the consumer does not think the PA did the test right. The consumer doesn't know what to do with him, because he is still tired, and has no appetite. The patient is breaking out in cold chills, and his bones are still sore. When the patient got the vaccine, he was walking and talking, and by 11 AM that day, he was in bed. The patient had some labs done, and was being told that his liver is big, so the consumer did not know if the vaccine went to his liver. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling hot, Palpitations
Clinical narrative: blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 21Jan2021 at 14:45 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included a history of asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination or additional vaccines on the same day. On 21Jan2021 around a half hour after administration (also reported as within 40 minutes) the patient started having symptoms of suddenly felt very warm, her blood pressure went up considerably and her heart was racing. The patient went to Urgent Care and Urgent Care advised to take her to the Emergency Room as they did not have an EpiPen. The patient was advised to go to the Emergency Room and was in transit to the ER. The clinical outcome of the events blood pressure increased and palpitations was not recovered; for feeling hot it was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt a little tender where the shot was; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported for two patients (herself and her husband). This is the second of two reports.   A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 09Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has not had any reaction at all, maybe felt a little tender where the shot was, also reported as felt nothing except maybe a little soreness on the arm in Jan2021. The outcome of event is unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057886 same reporter, suspect product, and event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Got the first dose of the COVID Vaccine, and then tested positive for the virus; Got the first dose of the COVID Vaccine, and then tested positive for the virus/developed covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable pharmacist reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacist on the line calling about a patient who got the first dose of the COVID Vaccine, and then tested positive for the virus, also reported as the patient received the first dose of vaccine and then developed covid after the first dose. She was asking if it was okay for the patient to get the second dose. The outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: felt lightheaded; a little bit of muscle pain and joint pain/ left bicep after got home had a pain in it; a little bit of muscle pain and joint pain; Took his blood pressure and it was really high like 150 something; bump at the injection; bump at the injection, it hurt if he pushed on it or bumped it; His joints felt weird. It was on the right and left which is unusual; Right forearm has slight pain in it; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) in the right arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included bad arthritis in right wrist. There were no concomitant medications. When shot, patient felt lightheaded and a little bit of muscle pain and joint pain. He told the nurse there and they sent over a Physician Assistant. He took his blood pressure and it was really high like 150 something. Patient was cleared after 30 minutes. Since being home he has noticed a couple of things. Mostly muscle pain or discomfort. He had a bump at the injection, it hurt if he pushed on it or bumped it. Four days later and there is no bump or pain there. The other thing is his joints. His joints felt weird. It was on the right and left which is unusual. His left bicep after he got home had a pain in it. The right forearm has slight pain in it. He is not sure if it is the muscle or ligament. If he rubs it doesn't bother him at all. The outcome of "blood pressure 150", "bump and pain at the injection" was recovered, of other events was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site mass, Vaccination site pain
Clinical narrative: felt lightheaded; a little bit of muscle pain and joint pain/ left bicep after got home had a pain in it; a little bit of muscle pain and joint pain; Took his blood pressure and it was really high like 150 something; bump at the injection; bump at the injection, it hurt if he pushed on it or bumped it; His joints felt weird. It was on the right and left which is unusual; Right forearm has slight pain in it; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) in the right arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included bad arthritis in right wrist. There were no concomitant medications. When shot, patient felt lightheaded and a little bit of muscle pain and joint pain. He told the nurse there and they sent over a Physician Assistant. He took his blood pressure and it was really high like 150 something. Patient was cleared after 30 minutes. Since being home he has noticed a couple of things. Mostly muscle pain or discomfort. He had a bump at the injection, it hurt if he pushed on it or bumped it. Four days later and there is no bump or pain there. The other thing is his joints. His joints felt weird. It was on the right and left which is unusual. His left bicep after he got home had a pain in it. The right forearm has slight pain in it. He is not sure if it is the muscle or ligament. If he rubs it doesn't bother him at all. The outcome of "blood pressure 150", "bump and pain at the injection" was recovered, of other events was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site haemorrhage
Clinical narrative: This is a spontaneous report from a contactable consumer. A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261) at right arm, via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history was none. Historical Vaccine included unspecified flu vaccine taken in Oct2020 for immunisation. The patient experienced bleeding after shot and bruise on 21Jan2021. The patient said she got her first dose last night and after the pharmacist finished and pulled the needle out there was quite a lot of blood after she pulled the needle out, and there was a bruise there. She didn't know if a blood vessel got nicked when all that happened. She would like to know if the dose was efficacious or if it is possible some of the vaccine came out with the blood. The patient said that the bleeding from the injection stopped probably within just a minute after she gave it or less, and there was no treatment given. The outcome of event bleeding after shot was recovered; of event bruise was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't smell; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 44-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Lot Number: ER5730 or EK5730), via an unspecified route of administration at Arm right on 18Dec2020 17:00 at the 44 years old at single dose for COVID-19 immunization.   The medical history was none. The Family Medical History Relevant to adverse events was none. The concomitant medication was none. The patient was supposed to work the day she tested positive but had a stuffy nose on 01Jan2021. She wasn't sure if that was what it was but when she took a shower she couldn't smell the body wash and so she knew she had COVID. She had a rapid test used for the positive test for COVID on 01Jan2021. There was no hospitalization due to testing positive. The events did not require a visit to Emergency Room and Physician Office, but she did go to the urgent care to get the rapid test.There was no Prior Vaccinations (within 4 weeks). There was none additional Vaccines Administered on Same Date of the product. The patient underwent lab tests and procedures, which included tested positive for COVID on 01Jan2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Crying
Clinical narrative: weeping; This is a spontaneous report from a contactable Other Health Professional. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. He was weeping. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired for a couple days; This is a spontaneous report from a contactable consumer reporting for the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tired for a couple days after the vaccine administration.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: felt flushed; This is a spontaneous report from a contactable Nurse.   A 29-year-old female patient received the first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247 with Expiration Date 31May2021), on 18Jan2021 (at 08:30) at 0.3 ml single dose on the left deltoid for COVID-19 immunisation. No relevant medical history was provided. The patient did not have relevant concomitant medications. She was vaccinated at COVID vaccine center where they are administering the Pfizer vaccine. On 18Jan2021 (at 09:05), she felt flushed. She took cetirizine hydrochloride (ZIRTEC) at home in preparation; she was given juice and cookies. At 9:20, patient was feeling better, she was monitored for 30 more minutes in observation area and stated she was feeling fine and left. The patient had recovered from the events on 18Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Immune system disorder, Off label use, Product use issue, Urinary tract infection
Clinical narrative: immune system to weaken; herpes reaction; Urinary tract infection; history included multiple sclerosis and immune system weakened; history included multiple sclerosis and immune system weakened; This is a spontaneous report from a contactable consumer reported for self. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not known) via an unspecified route of administration on 18Jan2021 at single dose in arm for COVID-19 immunization; and unspecified steroids via an unspecified route of administration from an unspecified date at unspecified dosage for unspecified indication. The patient medical history included multiple sclerosis and immune system weakened. The patient concomitant medications were not provided. The patient reported that she had multiple sclerosis, every time she went on steroids, her immune system was weakened, which is reported "unrelated". The patient received vaccination on 18Jan2021. When she was on steroids about 2-3 days later, she got a herpes reaction and urinary tract infection afterwards from 20Jan2021. The doctor told her it was because her immune system is weakened because of steroids. The patient was wondering if it is a normal reaction for her immune system to weaken due to the vaccine, if it is safe for her to get the second vaccine. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Confusional state, Malaise, Nausea, Speech disorder
Clinical narrative: Vomiting; Not feeling well; nausea; Confusion; Potential cognitive issues and having trouble finding words; Potential cognitive issues and having trouble finding words; This is a spontaneous report. A contactable consumer (patient's daughter) reported that a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history, concomitant medications and investigation assessment were not reported. It was reported that on 22Jan2021, patient was vomiting and not feeling well. Reporter wanted to see if this was a side effect or something different. It was more than just vomiting. The patient was vomiting and not feeling well, but was also having confusion and potential cognitive issues in Jan2021. Patient was having trouble finding her words in Jan2021. Reporter was trying to figure out how emergent the symptoms were and if it was related to the vaccine and also wanted to know if the nausea in Jan2021 was a side effect. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Not feeling well; nausea; Confusion; Potential cognitive issues and having trouble finding words; Potential cognitive issues and having trouble finding words; This is a spontaneous report. A contactable consumer (patient's daughter) reported that a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history, concomitant medications and investigation assessment were not reported. It was reported that on 22Jan2021, patient was vomiting and not feeling well. Reporter wanted to see if this was a side effect or something different. It was more than just vomiting. The patient was vomiting and not feeling well, but was also having confusion and potential cognitive issues in Jan2021. Patient was having trouble finding her words in Jan2021. Reporter was trying to figure out how emergent the symptoms were and if it was related to the vaccine and also wanted to know if the nausea in Jan2021 was a side effect. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: Extremely tired/fatigue; Low grade fever; chills; Dizziness; This is a spontaneous report from a contactable consumer reported for herself. This 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, Expiry date: 30Apr2021) in right arm on 21Jan2021 4:30pm for COVID-19 immunization. None medical history nor concomitant medications. Patient got her of the vaccine around 4:30pm. They made her stay there for about 15 minutes to make sure she didn't have any kind of reaction. She got home and went right to bed early around 10pm. The next day she was extremely tired, and had difficulty getting up in the morning; has fatigue. She also thinks she has a low grade fever because she has the chills, but she doesn't have a thermometer to check her temperature. She also has some dizziness. Her dizziness has improved, but she still doesn't feel comfortable driving. No emergency room or physician office visit. The outcome of fatigue was not recovered, of other events was recovering.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Chills, Pyrexia
Clinical narrative: Fever; Chills; his face was burning up; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via unspecified route of administration on left arm on 22Jan2021 at 08:15 AM at single dose for COVID-19 vaccination. The relevant medical history included three stents in his heart, allergy and medication for cholesterol (he just quit the medication, it was killing his legs). They have tried him on them 99 times but he cannot take statin drugs, they cripple him. Concomitant medications were reported as none. The patient previously took Claritin (doesn't know if he took this for food or medication allergies, he thought it was for sinus drainage most of it). The patient said he got his COVID shot and had a fever of 102 and he had chills with it too on 22Jan2021. He said he was wondering what he was supposed to do to get that fever down, which he clarified it was 102.4 degrees Fahrenheit. The fever started by the time he got back, it was a 2.5-3 hours drive, his wife checked his temperature about 5 minutes prior for the first time, because his face was burning up. He says that the NDC is not written on the vaccine card with the other handwritten information, it did say he went back 12Feb for the second one. He had not started any new medications or received any recent vaccinations. The patient underwent lab test included temperature elevation which showed 102.4 degrees Fahrenheiton on 22Jan2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Rhinorrhoea, Sneezing, Throat irritation, Vaccination site pain
Clinical narrative: felt scratchy in the throat; nose started running more/ nose was like a faucet, non stop, clear; sneezing non stop; injection site was sore; can't taste; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. An 80-year-old male 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 Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her Doctors PA told her that they got off the phone with another gentleman that was 80 y/o who had the same symptoms and he got the vaccine 1 week ago. On an unspecified date the patient experienced felt scratchy in the throat, nose started running more/ nose was like a faucet, non stop, clear, sneezing non stop, injection site was sore and can't taste. Outcome of the events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058185 same drug, similar events, different patients
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer. A 78 years old male consumer (patient) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Historical Vaccine was first dose of BNT162B2 and experienced sore arm. Patient had a wave of nausea 1 hour after the second shot. Outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Fatigue, Inflammation, Myalgia
Clinical narrative: sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went to bed and slept for 12 hours; muscle aches; nose was crusty; discharge from her nose, bloody/it was a little bloody; inflammation; cold; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received the first dose of  bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 15Jan2021 at single dose for covid-19 immunization. There were no concomitant medications and medical history. She had still has a sore throat, it has been a week since her first injection, and she immediately like got a sore throat straightaway, then drainage, and she was really tired and had to go to bed in about 4 hours. She couldn't stay awake 4 hours after, she went to bed and slept for 12 hours after the first shot. There was discharge from her nose, bloody, crusty like a cold, and she seldom ever has a cold and that continued, she didn't feel good until about maybe 4 or 5 days later. Sore throat was immediately after she thinks, it was certainly the next day (16Jan2021), and her date of vaccine was 15Jan2021. Now states and cough developed not until later. On 15Jan2021, she had the shot, she was really tired, muscle aches, the kind of things on the sheet, if not that evening, but the next day (16Jan2021), then drainage, it was white at first, it didn't turn yellow until a few days later, had a yellowish tinge, so she is sure there was inflammation, and her nose was crusty, in the morning it was a little bloody, and she had a sore throat, and probably by the Wednesday or Thursday, so 20 or 21Jan2021, there was a little cough, in the evening, and she is not experiencing that today. The outcome of the event sore throat was not recovered, cough was recovered on 22Jan2021, cold was recovering, other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal crusting, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, Somnolence
Clinical narrative: sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went to bed and slept for 12 hours; muscle aches; nose was crusty; discharge from her nose, bloody/it was a little bloody; inflammation; cold; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received the first dose of  bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 15Jan2021 at single dose for covid-19 immunization. There were no concomitant medications and medical history. She had still has a sore throat, it has been a week since her first injection, and she immediately like got a sore throat straightaway, then drainage, and she was really tired and had to go to bed in about 4 hours. She couldn't stay awake 4 hours after, she went to bed and slept for 12 hours after the first shot. There was discharge from her nose, bloody, crusty like a cold, and she seldom ever has a cold and that continued, she didn't feel good until about maybe 4 or 5 days later. Sore throat was immediately after she thinks, it was certainly the next day (16Jan2021), and her date of vaccine was 15Jan2021. Now states and cough developed not until later. On 15Jan2021, she had the shot, she was really tired, muscle aches, the kind of things on the sheet, if not that evening, but the next day (16Jan2021), then drainage, it was white at first, it didn't turn yellow until a few days later, had a yellowish tinge, so she is sure there was inflammation, and her nose was crusty, in the morning it was a little bloody, and she had a sore throat, and probably by the Wednesday or Thursday, so 20 or 21Jan2021, there was a little cough, in the evening, and she is not experiencing that today. The outcome of the event sore throat was not recovered, cough was recovered on 22Jan2021, cold was recovering, other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Fatigue, Headache
Clinical narrative: joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection site pain; Headache; Muscle pain; tired; This is a spontaneous report from a contactable consumer reporting for herself.    A 68-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm, on 13Jan2021 14:30 at single dose for Covid-19 immunisation .  Medical history included cyclic neutropenia from 1998, thyroid disorder from 2001.  There were no concomitant medications.  The patient experienced feeling sick  on 13Jan2021 with outcome of recovering , injection site pain  on 13Jan2021 with outcome of recovering , headache  on 13Jan2021 with outcome of recovering , muscle pain on 13Jan2021 with outcome of recovering , tired  on 13Jan2021 with outcome of recovering , splotches on both cheeks on 14Jan2021 with outcome of recovering , dizzy on 16Jan2021 with outcome of recovering , face a little swollen  on 16Jan2021 with outcome of recovering , joint pain  on an unspecified date with outcome of recovering , burned  on 13Jan2021 with outcome of recovering.   The patient received ibuprofen 400 mg to treat  headache,  muscle pain,  joint pain.  The patient is not sure if LOT number is EL1283 or EC1283.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.