chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, COVID-19, Chills
Clinical narrative: lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none.  The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight.  Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills.  Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.  The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Dyspnoea, Headache, Myalgia, Sinus disorder
Clinical narrative: lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none.  The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight.  Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills.  Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.  The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none.  The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight.  Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills.  Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.  The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested (SARS-CoV-2 test) positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated he got the first dose and tested (SARS-CoV-2 test) positive. Outcome of the event was unknown.    Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 20Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2021, the patient experienced headache, became nauseous and was tested positive. She wanted to know if she could continue with her second dose. Clinical outcome of the events was unknown at time of this report.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Not Provided), via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization.  On an unknown the patient received the vaccine and now after 2 weeks he was experiencing nausea. Outcome was unknown. Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Euphoric mood, Insomnia
Clinical narrative: Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself.  A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine.  The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect.   The case will be reassessed if additional information becomes available.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nightmare, Ocular hyperaemia, Pharyngeal mass, Polymerase chain reaction
Clinical narrative: Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself.  A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine.  The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect.   The case will be reassessed if additional information becomes available.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself.  A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine.  The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect.   The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient is done with the first dose and tested positive after; patient is done with the first dose and tested positive after; This is a spontaneous report from a Pfizer-sponsored program, by a contactable physician.   A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was done with the first dose and tested positive after on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient is about to be done with quarantine and asking if it's okay to take the second dose.  Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sales representative. A female patient of an unspecified age received 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) on unspecified date at a single dose for COVID-19 immunization. The patient was fine with the 1st dose, but the patient had muscle aches about 12 hours after the 2nd dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; vomiting; Headache; she could not even move her head without feeling like it would fall off her body; Fever/It is off and on; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included type 2 diabetes mellitus from 2014 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 03Jan2021 for COVID-19 immunization. On 24Jan2021, the patient experienced fever. It is off and on. On 25Jan2021, the patient experienced headache. Today (26Jan2021), she has had vomiting, nausea, and has still had a fever. Headache has improved. She could not even move her head yesterday (25Jan2021) without feeling like it would fall off her body. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL), ibuprofen (ADVIL), and drank some drinks. Outcome of the fever was not recovered while of the remaining events was recovering.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: sore muscles; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that. a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as first dose (Batch/lot number: unknown) via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that in Jan2021 patient experienced sore muscles, headache and felt like she's dying. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Sneezing
Clinical narrative: shortness of breath; cough; sneezing; Headache; This is a spontaneous report from a contactable consumer (patient) reported that a 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shortness of breath, cough, sneezing, and headache. The patient also mentioned that he had to go to the emergency room. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program by a contactable consumer (patient).   This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 22Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient resulted positive to COVID-19 after vaccination on 28Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 28Jan2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she tested positive for covid virus.; she tested positive for covid virus.; This is a Spontaneous report from a Pfizer Sponsored Program from a contactable consumer who reported for herself. A female patient of an unspecified age received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 12Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Jan2021, patient tested positive for covid virus. She was supposed to get #2 covax on 02Feb2021 but was told she had to wait 14 days after the virus test. The outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; body ache; stomach ache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 25Jan2021 10:45 at single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had unknown allergies to medications, food, or other products. Concomitant medication included hydrocodone. On 26Jan2021 01:30, the patient experienced fever, chills, body ache and stomach ache. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Clinical outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Minor soreness at injection site; This is a spontaneous report from a contactable consumer (patient). An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 25Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included hypertension and known allergies with penicillin. The patient's concomitant medications were not reported. The patient experienced minor soreness at injection site on 25Jan2021. No treatment was given to the patient. The patient did not have prior covid vaccination and was not tested for covid post vaccination. The patient recovered from the event on an unspecified date.    Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Muscle aches; swollen lymph nodes; generalized fatigue; nausea; This is a spontaneous report from a non-contactable nurse. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the right arm on 23Jan2021 10:00 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 to vaccination and had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On 25Jan2021, the patient experienced muscle aches, swollen lymph nodes, generalized fatigue, and nausea. No treatment was received for the adverse events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: approximately 3 inch red circle around injection site.  Slight itchiness and soreness at site.  Very slight swelling at site.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). This 23-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiry date unknown), via an unspecified route of administration on the left arm on an unspecified date (09:15) at a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosed prior to vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 03:00, the patient experienced chills and body aches. No treatment was received. Outcome of the events was recovering. Events were reported as non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling Lymph node on left arm pit; This is a spontaneous report from a contactable Healthcare Professional reporting for himself. A 34-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL3247, in Hospital, via intramuscular route in left arm on 25Jan2021 at 11:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EL0142, via intramuscular route in left arm on 05Jan2021 at 11:00. The patient was not tested for COVID-19 after the vaccination. There were no concomitant medications. On 27Jan2021 at 02:00 AM the patient experienced swelling lymph node on left arm pit. No treatment was received for the event. The reported event had not resolved yet at the time of the report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Dizziness
Clinical narrative: Not sure if delayed reaction because it was a week out.  Symptoms included delayed injection site pain, fatigue, headache, muscle pain, chills, joint pain, 99.2 temp, injection site red (delayed and only on 7th day), nausea, feeling unwell, dizziness, weakness, and hives which were relieved with Benedryl.    Most of the symptoms began on Monday, February 8th and worsened on Tuesday, February 9th with hives.  There was no shortness of breath or respiratory issues.  Injection site was only tender on day of injection but tender and red on the 9th only.  Fatigue, headache,  hives continued on February 10th along with a slight bout of diarrhea.  Called clinic and they requested he go in and be tested for Covid-19 and results should be known in 2 days.  February 11th seemed to be better and as of 10:00 a.m. PST no hives but still itching and slight fatigue.  Again,  didn't know if it could be a reaction since it is a week out or something else.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Not sure if delayed reaction because it was a week out.  Symptoms included delayed injection site pain, fatigue, headache, muscle pain, chills, joint pain, 99.2 temp, injection site red (delayed and only on 7th day), nausea, feeling unwell, dizziness, weakness, and hives which were relieved with Benedryl.    Most of the symptoms began on Monday, February 8th and worsened on Tuesday, February 9th with hives.  There was no shortness of breath or respiratory issues.  Injection site was only tender on day of injection but tender and red on the 9th only.  Fatigue, headache,  hives continued on February 10th along with a slight bout of diarrhea.  Called clinic and they requested he go in and be tested for Covid-19 and results should be known in 2 days.  February 11th seemed to be better and as of 10:00 a.m. PST no hives but still itching and slight fatigue.  Again,  didn't know if it could be a reaction since it is a week out or something else.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: Not sure if delayed reaction because it was a week out.  Symptoms included delayed injection site pain, fatigue, headache, muscle pain, chills, joint pain, 99.2 temp, injection site red (delayed and only on 7th day), nausea, feeling unwell, dizziness, weakness, and hives which were relieved with Benedryl.    Most of the symptoms began on Monday, February 8th and worsened on Tuesday, February 9th with hives.  There was no shortness of breath or respiratory issues.  Injection site was only tender on day of injection but tender and red on the 9th only.  Fatigue, headache,  hives continued on February 10th along with a slight bout of diarrhea.  Called clinic and they requested he go in and be tested for Covid-19 and results should be known in 2 days.  February 11th seemed to be better and as of 10:00 a.m. PST no hives but still itching and slight fatigue.  Again,  didn't know if it could be a reaction since it is a week out or something else.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal
Clinical narrative: heart beat was ranging from 53-155; This is a spontaneous report from a contactable consumer (patient).   This 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL1283  on 19Jan2021 at SINGLE DOSE for immunisation .Medical history :none.There were no concomitant medications.  The patient experienced heart beat was ranging from 53-155 on 26Jan2021 15:30 and by midnight She was better. She said she was perfect now her readings were basically normal. she has never had that problems as long as she has lived. She did not know if it was related to vaccine. She was worried about getting the second dose. Lab data included heart rate (26Jan2021): 53-155  on 26Jan2021. Outcome of the event was recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Odynophagia
Clinical narrative: Painful cervical adenopathy; overlying erythema of skin; Painful swallowing on side of vaccine; This is a spontaneous report from a contactable physician.  A 59-year-old female patient received first dose of intramuscular (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021 at 14:45 at a single dose in left arm for Covid-19 immunisation at the age of 59-year-old. Lot number was EL0142. Medical history included Hashimoto's thyroiditis, Gastrooesophageal reflux disease (GERD), obesity, anxiety, Known allergies (Seasonal pollen, dust, dander). The patient was not pregnant. Historical vaccination included influenza vaccine on 21Dce2020 for immunization. Concomitant medications included aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), sertraline hydrochloride (Zoloft) and lorazepam. On 18Jan2021, the patient experienced painful cervical adenopathy, overlying erythema of skin, painful swallowing on side of vaccine with onset day 1 post vaccine, start of improvement on day 5, the patient was still with adenopathy on day 10. The patient was treated with ibuprofen and acetaminophen. The patient recovered from the events with lasting effects. Prior to vaccination the patient did not have Covid-19; since vaccination the patient was not tested for Covid-19.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Crying, Fatigue, Heart rate increased, Oxygen saturation decreased
Clinical narrative: Congestion,  breathing abnormal,  elevated heartrate , 02 lower then usual , tired , exhausted,  fatigue,  not usual self , fussy , incosebale.  Patient is a non verbal child
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal, Upper respiratory tract congestion
Clinical narrative: Congestion,  breathing abnormal,  elevated heartrate , 02 lower then usual , tired , exhausted,  fatigue,  not usual self , fussy , incosebale.  Patient is a non verbal child
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: felt really super dizzy; Fatigue; This is a spontaneous report from a contactable consumer 8patient).  A 65-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:00 at single dose in left arm for COVID-19 immunisation. Lot number was EL3247. Medical history and concomitant medications were none. On 27Jan2021 at 11:00, the patient experienced feeling really super dizzy (used walker of wife to get around) and fatigue; the patient had to go to sleep after that, he could not walk around, he was so dizzy and tired, he went to bed after 11AM and did not wake until 3PM. Then, the patient recovered from the events on 27Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: Severe body pains and aches; Headache; Chills; Nausea; Fever (100 degrees F); This is a spontaneous report from a contactable consumer (patient) reported that a 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262), second dose via an unspecified route of administration in left arm on 03Feb2021 at 03:15 PM at single dose for COVID-19 immunization. The patient's medical history was none. Patient has no known allergies. Concomitant medication included ibuprofen for minor pains (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) in left arm on 13Jan2021 at 03:15 PM at the age of 26 years for COVID-19 immunization. No other vaccines were given on the same date. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 04Feb2021 at 12:30 AM, 10 hours post injection, the patient experienced severe body pains and aches, headache, chills, nausea, and fever (100 degrees F). No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe body pains and aches; Headache; Chills; Nausea; Fever (100 degrees F); This is a spontaneous report from a contactable consumer (patient) reported that a 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262), second dose via an unspecified route of administration in left arm on 03Feb2021 at 03:15 PM at single dose for COVID-19 immunization. The patient's medical history was none. Patient has no known allergies. Concomitant medication included ibuprofen for minor pains (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) in left arm on 13Jan2021 at 03:15 PM at the age of 26 years for COVID-19 immunization. No other vaccines were given on the same date. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 04Feb2021 at 12:30 AM, 10 hours post injection, the patient experienced severe body pains and aches, headache, chills, nausea, and fever (100 degrees F). No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date was not reported), via an unspecified route of administration on 21Jan2021 at single for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. Patient reported that she had her first dose of the vaccine on Thursday (21Jan2021) and she experienced facial swelling on her right cheek. She got it that night and it still has not gone down. She went to the doctor yesterday and the dermatologist to ask them what she can do about it and they told her to report the side effects. The patient was advised by the doctor to try Zyrtec for a whole week and patient already took the first pill at the time of the report. The patient had not recovered from the event at the time of the report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fatigue, Mild Grade Fever, Muscle Soreness, Severe Headache  Fatigue started at 7am on 2/10/21  Muscle soreness started at 9am on 2/10/21 Fever and headache started at 2pm on 2/10/21 Nausea started at 9pm on 2/10/21  All symptoms except the headache resolved on 2/11/21 at 7am
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle spasms
Clinical narrative: Muscle spasms; Could barely walk; This is a spontaneous report from a contactable consumer (patient's child). A female patient of an unspecified age (reported as 77, unit unknown) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had muscle spasms the next day (16Jan2021). The reporter is trying to find out if this is still a side effect, because she had the vaccine the first day (15Jan2021), then on the second day (16Jan2021) she was fine when she woke up that morning but then had muscle spasms and she could barely walk. The outcome of the event muscle spasms was not recovered, while for the other event was unknown.  Information about the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm; Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had his/her 1st Pfizer vaccine on 08Jan2021, and the reaction is just sore on the arm (on unspecified date in Jan2021). And then last week on unspecified date in Jan2021 (started a week ago), it came out like rash. The patient is asking whether there is anybody reported that they start looking out in rash, couple weeks later. The patient reported that he/she is not sure whether this rash is from the vaccine. The patient is also asking if he/she should get the 2nd vaccine, because his/her 2nd vaccine is this Friday. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: right arm hurts when she raises it; This is a spontaneous report from a contactable consumer (patient)  A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL5262) on 26Jan2021 at 16:15 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history and concomitant medications were none. On 26Jan2021 about 1 hour after vaccination at 17:15 the patient experienced  right arm hurts when she raises it. At the time of the reporting the patient had not yet recovered from the event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: Lump on her left shoulder; This is a spontaneous report from a contactable consumer(patient).   A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL9261) on 21Jan2021 at single dose in the left arm for COVID-19 immunization.  Medical history was none.  There were no concomitant medications.  Patient got her first dose of vaccine on 21Jan2021. She woke up on 27Jan2021 with a lump on her left shoulder. Her doctor said to inform the center where she got the vaccine, this may be related to the vaccine. Patient stated she was not sure if it was related. She said she was so nervous hopefully it was nothing. The final outcome of the event was reported as not recovered. Patient is supposed to get her second vaccination between 07Feb2021-11Feb2021.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Not being able to sleep; This is a spontaneous report from a non-contactable consumer. A patient (reporter) of an unspecified age and gender received first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was unable to sleep after taking the vaccine. The start date of the event was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report from a contactable consumer. This consumer reported for a 57-year-old female patient (reporter's grandmother) that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. Medical history was reported as 'no'.  Concomitant medications were not reported. The patient had a vaccine appointment on the 30th but she tested positive on the 11Jan2021 and she was wondering if she went to get her vaccine or did she wait until other guys call her. Treatment received for the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be fully excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Diarrhoea, Fatigue, Investigation
Clinical narrative: sore arm / arm hurts and is painful at the site of the vaccine; upset stomach; diarrhea; upset stomach; diarrhea; Muscle weakness; Tiredness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.    A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9263) solution for injection, intramuscular in left arm on 26Jan2021 11:00 at a single dose for Covid-19 immunization. Medical history included Covid-19 from 2020 (patient had Covid 3 months ago; he was in the hospital for 9 days and his wife received treatment at home), ongoing urination problem (it was an ongoing issue and again nothing to do with this (to the vaccine)). The patient's concomitant medications were not reported. The patient experienced sore arm/arm hurts and was painful at the site of the vaccine, upset stomach, diarrhea, muscle weakness, and tiredness on 26Jan2021. Patient reported that he and his wife got their first Covid-19 shots on 26Jan2021. Patient wanted to know what the window was for the second shot. He later mentioned he had a sore arm, upset stomach, and muscle weakness in the body. The arm hurts and was painful at the site of the vaccine given and they both were tired that night. Has had diarrhea, but it's not terrible. His wife also had symptoms. Mentioned he went to the hospital yesterday (27Jan2021) for some testing, but it's not related to this (vaccine). No further details provided. They did book an appointment for the second shot and it was actually 4 weeks from the first one, but they thought Pfizer's vaccine was supposed to be 3 weeks and wants information about that. No further details provided. Patient stated he had full blood work done about 2 weeks ago (Jan2021) and everything was okay, except a urination problem he has. That was an ongoing issue and again nothing to do with this. He and his wife both had the Covid virus over 3 months ago and he was in the hospital for 9 days and his wife received treatment at home. No further details provided. Patient reported he weighs 250-255 lbs. Outcome of the event was not recovered.  No follow-up activities are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117404 Same reporter, drug, and event, different patient