chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid after 1st dose received on 03Jan2021; tested positive for covid after 1st dose received on 03Jan2021; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported similar events for 15 patients. This is 8th of 15 reports. A patient of an unspecified gender and age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. As per caller 15 residents tested positive for covid after 1st dose received on 03Jan2021. Would like to know if and when they should receive the second dose i.e. wait 10-14 days without symptoms.The second dose was scheduled for 24Jan2021. The outcome of events was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for covid after 1st dose".,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: had tested positive for the virus (COVID) after the first dose of the vaccine; had tested positive for the virus (COVID) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This report is for 11th of 15 residents.  A patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), at single dose for COVID-19 immunisation on 03Jan2021. The patient's medical history and concomitant medications were not reported. The patient had tested positive for the virus (COVID) after the first dose of the vaccine in Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 14th of 20 reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The second dose is scheduled for 24Jan2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested. Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 15th of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Nausea, Tachycardia, Vomiting
Clinical narrative: Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contactable consumer. A 50-years-old female patient started to receive  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 23Dec2020 11:30 to 23Dec2020 11:30 and from 13Jan2021 13:30 to 13Jan2021 13:30 both intramuscular arm right at SINGLE DOSE for covid-19 immunisation.  Medical history included migraine from Feb2015 and ongoing. There were no concomitant medications. The patient stated that she has chronic migraines and takes medications to keep her at a level where she can function.  She was on them prior to taking this and did not think they were relevant.  She was diagnosed in Feb2015. On 23Dec2020 at 12:00, the patient experienced nausea, blood pressure elevated, tachycardia and vomiting. The patient also stated that she had the same symptoms of events on her second dose. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Night sweats
Clinical narrative: Pain at injection site; Severe headache; Myalgias; Fever; Chills; Night sweats; Weakness; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK4176), via an unspecified route of administration in right arm, on 13Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EK9241) on 24Dec2020 at 12:15 PM for COVID-19 immunization (left arm) and developed pain at injection. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a hospital. On 13Jan2021 at 8 PM after the second dose, the patient developed pain at injection site similar to the first dose but also developed severe headache, myalgias, fever, chills, night sweats, and weakness about 8-10 hours after the injection that lasted throughout the night. The patient was currently more than (>) 24 hours after the second injection and while most symptoms have resolved, the patient still had significant weakness and myalgias. Treatment was received for the events including paracetamol (TYLENOL). Post-vaccination, the patient has not been tested for COVID-19. The patient was recovering from "Myalgias" and "Weakness". The patient recovered from the remaining events in Jan2021.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site; Severe headache; Myalgias; Fever; Chills; Night sweats; Weakness; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK4176), via an unspecified route of administration in right arm, on 13Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EK9241) on 24Dec2020 at 12:15 PM for COVID-19 immunization (left arm) and developed pain at injection. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a hospital. On 13Jan2021 at 8 PM after the second dose, the patient developed pain at injection site similar to the first dose but also developed severe headache, myalgias, fever, chills, night sweats, and weakness about 8-10 hours after the injection that lasted throughout the night. The patient was currently more than (>) 24 hours after the second injection and while most symptoms have resolved, the patient still had significant weakness and myalgias. Treatment was received for the events including paracetamol (TYLENOL). Post-vaccination, the patient has not been tested for COVID-19. The patient was recovering from "Myalgias" and "Weakness". The patient recovered from the remaining events in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Supraventricular tachycardia
Clinical narrative: Post COVID Vaccine SVT; This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients. This is 2nd of three reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced post COVID vaccine supraventricular tachycardia (SVT) (showed from an EKG) on an unspecified date. The patient had no known cardiac history at all. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same reporter, same drug and event, different patient.; same reporter, same drug and event, different patient.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9241, expiration date not reported) via an unspecified route of administration on the left arm on 24Dec2020 12:15 at a single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pain at injection site with the first dose. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: Post COVID Vaccine SVT; This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients. This is 3rd of three reports.   A female patient of an unspecified age received BNT162B2 (Lot/Batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced Post COVID Vaccine SVT on an unspecified date. The patient had no known cardiac history at all. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042313 same reporter, same drug and event, different patient.;US-PFIZER INC-2021042335 same reporter, same drug and event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm sore after first dose injection administered; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK5730; expiration date not provided), via an unspecified route of administration on 23Dec2020 09:00 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that she had first dose of Pfizer COVID-19 Vaccine on 23Dec2020; she reported left arm sore after first dose injection administered. The patient recovered completely from the event after about 4 days on 27Dec2020.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Vaccination site pain
Clinical narrative: Flu like symptoms; feeling achy; Left arm sore after second dose injection administered initially described as at the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second single dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, lot number: EK9231, exp date: Apr2021), via an unspecified route of administration (Injection to left upper arm ) on 13Jan2021 09:00 for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received first single dose of BNT162B2 (lot number: EK5730) on 23Dec2020 for COVID-19 immunization wherein she reported left arm sore after first dose injection administered which she recovered completely from after about 4 days (from 23Dec2020 to 27Dec2020). The patient called to ask if it was ok to take something like Ibuprofen or paracetamol (TYLENOL) after having been administered Pfizer COVID-19 Vaccine. She reported left arm sore after second dose injection administered on 13Jan2021 and flu like symptoms on an unspecified date. The left arm sore after first dose injection administered was same reaction she had following the second dose: Left arm sore after second dose injection administered initially described as at the injection site; very sore; her arm being much better since she slept all last night with ice pack on her left arm; but then specified that outcome of that event and flu like symptoms have remained persistent with on and off pattern; The flu like symptoms include feeling achy which started on 14Jan2021 (day of reporting). The outcome of events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: allergies; positive for COVID 19; positive for COVID 19; This is a spontaneous report from a contactable consumer(patient) from Pfizer-sponsored program Pfizer First Connect. The 24-year-old female consumer received first dose of bnt162b2 (BNT162B2, lot number: 1686), unknown on 05Jan2021 at SINGLE DOSE by injection once to left arm for covid-19 immunisation. Medical history and concomitant medications were none. The patient got the first dose of the COVID 19 vaccine and got positive for COVID 19 on 13Jan2021, and is asking if she will have to take the second dose as per her scheduled date. States she thought this was just allergies, since she takes Zyrtec and it clear up everything. No further details provided. The outcome of the event drug allergy was unknown and was not recovered for the rest events.  No follow-up attempts possible. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Flushed; Hot feeling; Numb back of tongue or throat; Numb back of tongue or throat; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0142), intramuscular in left arm, on 08Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included Bell's palsy from 2017. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 at 12 PM for COVID-19 immunization (intramuscular in right arm) and experienced flushed and hot feeling. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a hospital facility.  On 08Jan2021 (12:30 PM), the patient experienced flushed or hot feeling 30 minutes after the second dose, followed by numb back of tongue or throat (best described like swallowing a good amount of throat numbing spray) that lasted about 2 hours. No treatment was administered for the events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on 08Jan2021 (14:30).
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; headache; chills; body aches, especially in my back; body aches, especially in my back; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation and experienced painful, swollen axillary lymph node. It was reported that after the second dose, the patient had a rougher go of it with fever, headache, chills, body aches, especially in back. Clinical outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Headache, Insomnia, Restlessness
Clinical narrative: Stomach ache; Restless; Couldn't sleep; Headache; So hot she couldn't keep cool; This is a spontaneous report from a contactable consumer (patient). A 98-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982, expiration date not reported) via an unspecified route of administration at the left arm on 12Jan2021 15:45 at a single dose for COVID-19 immunization. The patient's medical history included arthritis, she is in a wheelchair (can't walk), gallbladder out a year ago (2020) and she her right hip replaced. No family medical history. There were no concomitant medications. The patient usually sleeps well. Clarified she received the first dose of the Pfizer COVID 19 vaccine 12Jan2021 15:45PM in the left arm. She was fine after the injection then 13Jan2021 in the afternoon she had a headache for two hours; that night she was restless and couldn't sleep; she was so hot she couldn't keep cool. Then this morning 14Jan2021 her headache is gone but she has a little stomach ache. Mentioned they haven't brought breakfast by yet and that might help. She was planning to get the next dose of the vaccine 02Feb2021. She has been living in an assisted living facility now for three years; and she can't get outside; and has not seen her family due to the virus. The facility where the vaccine was administered was in an assisted living facility. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events did not require a visit to physician or ER. No relevant tests done. Outcome of the events headache, feeling hot, restless was recovered on 14Jan2021; stomach ache was recovering and unknown for the other event.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Gait inability, Headache, Limb discomfort
Clinical narrative: Very cold; Headache; issues with his lower extremities; he cannot walk; Body does not work anymore; Throwing up; bad feeling; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: LE3301), via an unspecified route of administration in the right arm on 12Jan2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included belief that he had agent orange and tiredness. The patient did not have additional vaccines administered on the same date as the Pfizer vaccine and did not have vaccinations within four weeks. The patient's concomitant medications were not reported. The patient previously received a flu shot in October (year unspecified). On 12Jan2021, the patient was throwing up. The patient stated that his whole body has gone, it did not work anymore, his legs have gone out, and was having headaches on 13Jan2021. The patient initially stated that the feeling that his body did not work anymore started six hours after he got the vaccine. He later clarified and stated it started on 13Jan2021. He further clarified that what he meant by the body did not work was issues with his lower extremities, he cannot walk and he was having a lot of headaches. The throwing up started on the evening of 12Jan2021. He could not get up to go to the bathroom. He had a couple of episodes of throwing up. He confirmed the throwing up has resolved, but was unable to provide any additional details. He also added that he was feeling very cold on 13Jan2021. The headaches left him concerned. At end of the call, the patient indicated he wanted this bad feeling to go away. The events did not require any visit to the Emergency Room or Physician's office (patient stated he considered it, but he just stayed in bed). Outcome of the event throwing up was recovered, for the events body does not work anymore, very cold, and headache was not recovered, while for the other events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vomiting
Clinical narrative: Very cold; Headache; issues with his lower extremities; he cannot walk; Body does not work anymore; Throwing up; bad feeling; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: LE3301), via an unspecified route of administration in the right arm on 12Jan2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included belief that he had agent orange and tiredness. The patient did not have additional vaccines administered on the same date as the Pfizer vaccine and did not have vaccinations within four weeks. The patient's concomitant medications were not reported. The patient previously received a flu shot in October (year unspecified). On 12Jan2021, the patient was throwing up. The patient stated that his whole body has gone, it did not work anymore, his legs have gone out, and was having headaches on 13Jan2021. The patient initially stated that the feeling that his body did not work anymore started six hours after he got the vaccine. He later clarified and stated it started on 13Jan2021. He further clarified that what he meant by the body did not work was issues with his lower extremities, he cannot walk and he was having a lot of headaches. The throwing up started on the evening of 12Jan2021. He could not get up to go to the bathroom. He had a couple of episodes of throwing up. He confirmed the throwing up has resolved, but was unable to provide any additional details. He also added that he was feeling very cold on 13Jan2021. The headaches left him concerned. At end of the call, the patient indicated he wanted this bad feeling to go away. The events did not require any visit to the Emergency Room or Physician's office (patient stated he considered it, but he just stayed in bed). Outcome of the event throwing up was recovered, for the events body does not work anymore, very cold, and headache was not recovered, while for the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (reporting for herself).  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included headache during menses.  The patient's concomitant medications were not reported.  The patient experienced headache on an unspecified date.  During the time of vaccination, the patient was on her menses.  Therapeutic measures were taken as a result of headache and included over the counter (OTC) medication.  The clinical outcome of headache was recovered on an unspecified date.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: tingling in my throat; tingling on the tongue and bottom lip; Burning sensation in my throat, on the tongue and bottom lip and on the left side of the face as well; tingling sensation developed on the left side of the face; This is a spontaneous report from a non-contactable pharmacist reporting for herself. A 33-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El1283), via an unspecified route of administration on 14Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 33 years. The vaccine was administered in the Clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included migraine very infrequent. Concomitant medications included norethisterone (NORETHINDRONE). The patient had no known allergies. She reported that slightly over 48 hours post injection on 17Jan2021 she developed a tingling and burning sensation in throat, on the tongue and bottom lip. A burning or tingling sensation developed on the left side of the face as well. Treatment for the events included Benadryl. The patient had not recovered from the events at the time of the report. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms including body aches; Flu like symptoms including body aches; alternating fever and chills on the second dose; alternating fever and chills on the second dose; This is a spontaneous report received from a contactable consumer. A 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration, on 13Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient had COVID-19 prior to vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration, on 23Dec2020, for COVID-19 immunization and had a sore shoulder (at point of injection) and foggy head for the few hours. On 14Jan2021 at 06:30, the patient experienced flu like symptoms including body aches, alternating fever and chills on the second dose. Treatment was not given for the events. It was unknown if the patient was tested for COVID-19 post vaccination. The outcome of the events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Fever of 102.3; This is a spontaneous report from a contactable consumer(patient). A 36-year-old male received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3246), via an unspecified route of administration at Arm Right on 12Jan2021 17:00 at the 36 years old at single dose for COVID-19 immunization.  The medical history included High cholesterol. The concomitant medications were Hydroxychloroquine and azithromycin( ZITHROMAX Z-PACK). The Historical Vaccine was first dose BNT162B2 (Lot number=EL1284)on 22Dec2020 17:00  at 36 years old at Left arm for COVID-19 immunization and experienced Covid test result Positive on 30-DEC-2020. The patient previously took Codeine and experienced Allergy. On 13Jan2021 16:00 the patient experienced Flu like symptoms and fever of 102.3 Fahrenheit at 23 hours after the second dose. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 04Jan2021 15:45, at single dose, for COVID-19 immunization, in her workplace. Medical history included ongoing arthritis (has been cold there) and Crohn's disease so the patient has a tendency to have inflammation. Concomitant medication included vedolizumab (ENTYVIO). The patient experienced joint pain and had a little bit of pain in her finger on the left hand on an unspecified date in Jan2021. Treatment included Salonpas and Tylenol. The outcome of joint pain was recovering (reported as ongoing but a little better); and "has a little bit of pain in her finger on the left hand" was unknown.  Information on the batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19 pneumonia, Chills, Cough
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization.  Medical history was none and there were no concomitant medications.  The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021.  All the events were reported as being medically significant.  The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020.  Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX).  The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered.  The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Headache, Myalgia
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization.  Medical history was none and there were no concomitant medications.  The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021.  All the events were reported as being medically significant.  The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020.  Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX).  The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered.  The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization.  Medical history was none and there were no concomitant medications.  The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021.  All the events were reported as being medically significant.  The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020.  Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX).  The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered.  The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little sore on site on the first day; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, expiry date: 31Mar2021), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. Medical history included colitis, diverticulitis and allergies. Concomitant medications included chlordiazepoxide hydrochloride, clidinium bromide (LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE;CLIDINIUM BROMIDE]) for colitis, omeprazole (PROTONIX [OMEPRAZOLE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, and cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) for colitis. The patient experienced a little sore on site on the first day on 21Dec2020. Outcome of the event was recovered on 22Dec2020.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; chills; severe body aches; This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 13Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history and concomitant medications were none. Historical vaccines included first dose of BNT162B2 on 23Dec2020 for Covid-19 immunization and with a week (30Dec2020 16:15) he developed COVID positive test, had a mild to moderate illness. The patient received second dose and developed fever, chills and severe body aches on unspecified date in Jan2021. The outcome of the events fever, chills and severe body aches was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye irritation, Fatigue
Clinical narrative: felt really tired; eyes has a burning feeling behind them; joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient received her first dose of the COVID-19 vaccine yesterday, 13Jan2021. The patient informed that she felt really tired now, and her eyes has a burning feeling behind them, and she has joint pain (Jan2021). The patient wanted to know how long do the side effects last. The outcome of the events felt really tired, eyes has a burning feeling behind them, joint pain was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Extreme fatigue; Malaise; chills; Injection site pain and tenderness; muscular pain; This is a spontaneous report from a non-contactable physician (reporting for herself).  A non-pregnant 34-year-old 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 13Jan2021 6:00 PM at a single dose for COVID-19 immunization.  Medical history included: COVID-19 (prior to the vaccine).  The patient's concomitant medications were not reported. The patient had no known allergies.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 24Dec2020 3:00 PM in the left arm, at 34 years old for COVID-19 immunization.  The patient experienced extreme fatigue, malaise, chills, injection site pain and tenderness and muscular pain on 14Jan2021.  Therapeutic measures were taken as a result of the events which included ibprophen (ADVIL).  The outcome o the events was recovered in Jan2021.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via the Pfizer sponsored program Pfizer First Connect. An 88-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 to 28Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The reporter stated that the patient had tested positive for covid on 11Jan2021. Outcome of the event was unknown.   Information on the Lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: hasn't slept all night; Itching; This is a spontaneous report from a contactable consumer (patient).  An 84-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown and has been requested), via an unspecified route of administration on 10Jan2021 at single dose because COVID is getting worse and she is in a home. Medical history included 17 back surgeries, has lost a good bit of weight, ongoing pain, ongoing arthritis and ongoing sleep disorder.  Concomitant medication included hydrocodone bitartrate, paracetamol (manufacturer unknown) from an unknown date and unknown if ongoing and morphine pump (manufacturer unknown) for pain which she has had for eight years that is right under the skin. The patient was also taking something (unspecified) for arthritis and they give her something (unspecified) to help her sleep. The patient got her first shot on Sunday, 10Jan2021. She has not had effects or anything. However on 13Jan2021, she started itching. She stated that honest to God she hasn't slept all night on an unspecified date. She is itching all over. She wanted to know if this was something that comes with the vaccine. She thought if she would have something it would have happened on Monday or Tuesday and at the time of the report it was Thursday. She stated that she was not that concerned. She was just calling to pass this along. She added that she is in good shape structurally. She was not worried as someone might have the same effect. This could just be side effects.  The outcome of the event itching was recovering while the outcome of the event hasn't slept all night was unknown.   Information on the Batch/Lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Chills, Diarrhoea, Dysgeusia
Clinical narrative: tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hypersomnia, Malaise
Clinical narrative: tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.