chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: App. 1 hour ago I broke out in itchy; fat hives on my neck; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot Number: EN6207 expiry date was unknown) via an unspecified route of administration at arm right on 26Mar2021 10:00 (at the age of 67-years-old) as a single dose for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, depression, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide, levothyroxine, fluoxetine taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. Patient was not in pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. List of any other medications the patient received within 2 weeks of vaccination: Fluoxetine, hydrochlorothiazide, levothyroxine. Allergies to medications, food, or other products: cipro. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 12:00 the patient experienced app. 1 hour ago she broke out in itchy, fat hives on his neck. Outcome of the events was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Nasopharyngitis
Clinical narrative: vomiting; head ache; shortness of breath; dizziness; cold; My wife fell a little chill after the vaccine; This is a spontaneous report received from a contactable consumer. A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 at 01:30(at the age of 66-years-old) as SINGLE DOSE for covid-19 immunisation At Public health clinic/veterans administration facility. Medical history included Diabetic, covid-19 (all from an unknown date and unknown if ongoing). Concomitant medication(s) included carvedilol; atorvastatin calcium; amlodipine; canagliflozin (INVOKANA) (all taken for an unspecified indication, start and stop date were not reported). 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. Since the vaccination, the patient has not been tested for COVID-19.The patient did not allergies to medications, food, or other products. On 26Mar2021 at 15:45PM, the patient experienced a little chill after the vaccine. At around 1am 27Mar2021. She experienced chilled, vomiting, headache, shortness of breath, dizziness. Until 9am she still cold and chill. No treatment was given for the events. The outcome of the events was recovered with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; head ache; shortness of breath; dizziness; cold; My wife fell a little chill after the vaccine; This is a spontaneous report received from a contactable consumer. A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 at 01:30(at the age of 66-years-old) as SINGLE DOSE for covid-19 immunisation At Public health clinic/veterans administration facility. Medical history included Diabetic, covid-19 (all from an unknown date and unknown if ongoing). Concomitant medication(s) included carvedilol; atorvastatin calcium; amlodipine; canagliflozin (INVOKANA) (all taken for an unspecified indication, start and stop date were not reported). 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. Since the vaccination, the patient has not been tested for COVID-19.The patient did not allergies to medications, food, or other products. On 26Mar2021 at 15:45PM, the patient experienced a little chill after the vaccine. At around 1am 27Mar2021. She experienced chilled, vomiting, headache, shortness of breath, dizziness. Until 9am she still cold and chill. No treatment was given for the events. The outcome of the events was recovered with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I broke out in hives on my neck and chest and down my right arm. I did not get them on the arm I got the vaccine.; This is a spontaneous report received from a 64-year-old female contactable consumer reported for herself. A 64-year-old non-pregnant female patient received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/Lot number: Unknown), via an unspecified route in the left arm on 19Mar2021 at 10:15 (age at vaccination: 64-year-old) as a single dose for covid-19 immunization. Medical history was reported as none. The patient concomitant medications were not reported. No known allergies to medications, food, or other products were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unknown date, patient broke out in hives on her neck and chest and down her right arm. Patient did not get them on the arm she got the vaccine. Therapeutic measures taken as a result of the events included Prednisone. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unwell.; This is a spontaneous report from a contactable consumer (patient, reported for herself).  A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EH6208), via unspecified route of administration, in left arm on 24Mar2021 11:00 AM (at the age of 50-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no other medical history and no allergies to medications, food, or other products. The patient had not COVID prior to vaccination and not tested post COVID vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and not tested since the vaccination. On 24Mar2021 06:00 PM the patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever and was feeling unwell. Patient does not receive any treatment for all the reported events. Outcome of all the reported events was not recovered. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unwell.; This is a spontaneous report from a contactable consumer (patient, reported for herself).  A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EH6208), via unspecified route of administration, in left arm on 24Mar2021 11:00 AM (at the age of 50-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no other medical history and no allergies to medications, food, or other products. The patient had not COVID prior to vaccination and not tested post COVID vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and not tested since the vaccination. On 24Mar2021 06:00 PM the patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever and was feeling unwell. Patient does not receive any treatment for all the reported events. Outcome of all the reported events was not recovered. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: achiness; headache; pain in injection site arm that persists after 18 hrs; Chills overnight; fatigue; joint aches; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:30PM as DOSE 1,SINGLE for covid-19 immunisation (At the age 47 years). Medical history included hypothyroidism and depression from an unknown date and unknown if ongoing. Concomitant medication(s) included liraglutide (SAXENDA), levothyroxine 50mcg and liothyronine 5 taken for an unspecified indication, start and stop date were not reported. On 26Mar2021 20:00 the patient experienced achiness, headache, pain in injection site arm that persists after 18 hrs, chills overnight, fatigue, joint aches. Patient received no treatment for the event. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the event was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: achiness; headache; pain in injection site arm that persists after 18 hrs; Chills overnight; fatigue; joint aches; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:30PM as DOSE 1,SINGLE for covid-19 immunisation (At the age 47 years). Medical history included hypothyroidism and depression from an unknown date and unknown if ongoing. Concomitant medication(s) included liraglutide (SAXENDA), levothyroxine 50mcg and liothyronine 5 taken for an unspecified indication, start and stop date were not reported. On 26Mar2021 20:00 the patient experienced achiness, headache, pain in injection site arm that persists after 18 hrs, chills overnight, fatigue, joint aches. Patient received no treatment for the event. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the event was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Nausea
Clinical narrative: Fatigue; nausea; mild joint soreness; diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 26Mar2021 at 15:15 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation at workplace clinic. No medical history and concomitant medications were reported. No known allergies were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021 at 20:00, the patient experienced fatigue, nausea, mild joint soreness, diarrhea. No treatment was received for the events. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough
Clinical narrative: Feeling of a strange tightness and heaviness in the chest; Feeling like coughing; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 54-year) in right arm on 23Mar2021 at 02:45 PM as dose 2, single for COVID-19 immunization. Medical history reported none. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered in left arm on 01Mar2021 for COVID-19 immunization. No allergies to medications, food, or other products were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. Reported facility where the most recent COVID-19 vaccine was administered was not available. On 24Mar2021 the patient experienced feeling of a strange tightness and heaviness in the chest, feeling like coughing. Reported adverse event "Not super severe but feeling of a strange tightness and heaviness in the chest, described as ''moving up and down" through the upper chest midchest/surrounding esophagal region. Felt like coughing when the tightness was closer to the throat. Moderate tightness, not impacting daily activities but there was still a concern. Symptoms have been on/off since the vaccination date. Breathing is normal, no other symptoms experienced." The patient was not received any treatment for the adverse events. The seriousness of the events was reported as non-serious; seriousness criteria not results in death/Life threatening/Caused prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The clinical outcome of the events was not resolved.  Information about Lot/Batch number is requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Pain, Pain in extremity, Pruritus
Clinical narrative: Day 4 right under arm lymph node swollen and itching; Day 4 right under arm lymph node swollen and itching; Day 3 more pain/stiffness; Day 3 more pain/stiffness; Day 2 after shot right arm soreness - medium pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-year-old (non-pregnant) female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 25Mar2021 08:45 (at the age of 46-year-old) at dose 1, single for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination). Concomitant medications were not reported. 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. Since the vaccination, the patient has not been tested for COVID-19. Patient was not tested for covid post vaccination. On 26Mar2021 the patient experienced day 2 after shot right arm soreness - medium pain, on 27Mar2021 day 3 more pain/stiffness, on 28Mar2021 day 4 right under arm lymph node swollen and itching. Adverse event: Day 2 after shot right arm soreness - medium pain. Day 3 more pain/stiffness. Day 4 right under arm lymph node swollen and itching. Outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Chills; Very high fever (several hours each day at 104F); Pain in the body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as unknown, a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes. Concomitant medications were not reported. It was unknown if the patient received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The reporter reported that on an unspecified date in Mar2021, the patient experienced chills, very high fever (several hours each day at 104F) and pain in the body. The reporter became aware of the adverse event on Saturday evening, sometime around 8 PM after reading friends message on a group chat. The patient did not receive treatment for the adverse event. The patient underwent lab test and procedure Body temperature with fever 104F on an unspecified date in Mar2021. Outcome of the events was re-covered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number can-not be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Influenza like illness, Lymphadenopathy, Nasopharyngitis
Clinical narrative: a really bad sore throat; like strep throat; it is hard to swallow; swollen lymph nodes; it is like she has a nasty flu or cold; it is like she has a nasty flu or cold; Feel bad; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received Flu shot for immunization where he felt sick after it, like a cold. On an unspecified date in Mar2021, patient experienced feel bad. Patient reported that he got the first dose of the vaccine on 24Mar2021 and was having some side effects. He had a really bad sore throat, like strep throat, and it was hard to swallow (Mar2021). He said he saw swollen lymph nodes (Mar2021) was one of the side effects and did not know what that was. He said it was like he had a nasty flu or cold and it started about a day and a half after the vaccine (Mar2021). He asked if it was a side effect, how long will it last, and what he should do about it. He stated he tried to call the (clinic name) and they told him they would not give him anything for it. He did not want to go to the Emergency room just for a sore throat. He went to the pharmacy and got some over the counter medication. Patient again wanted to know if he should follow up with his doctor or buy something over the counter. Patient wanted to know how long the symptoms would last or should he take antibiotics. Patient read swollen lymph nodes were a side effect. He just wanted to know what he needs to do about his sore throat. Patient again stated he had flu shots in the past that made him sick after, like a cold. He stated he has never had Strep before. The clinical outcome of events was unknown.  No follow-up attempts needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngitis streptococcal
Clinical narrative: a really bad sore throat; like strep throat; it is hard to swallow; swollen lymph nodes; it is like she has a nasty flu or cold; it is like she has a nasty flu or cold; Feel bad; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received Flu shot for immunization where he felt sick after it, like a cold. On an unspecified date in Mar2021, patient experienced feel bad. Patient reported that he got the first dose of the vaccine on 24Mar2021 and was having some side effects. He had a really bad sore throat, like strep throat, and it was hard to swallow (Mar2021). He said he saw swollen lymph nodes (Mar2021) was one of the side effects and did not know what that was. He said it was like he had a nasty flu or cold and it started about a day and a half after the vaccine (Mar2021). He asked if it was a side effect, how long will it last, and what he should do about it. He stated he tried to call the (clinic name) and they told him they would not give him anything for it. He did not want to go to the Emergency room just for a sore throat. He went to the pharmacy and got some over the counter medication. Patient again wanted to know if he should follow up with his doctor or buy something over the counter. Patient wanted to know how long the symptoms would last or should he take antibiotics. Patient read swollen lymph nodes were a side effect. He just wanted to know what he needs to do about his sore throat. Patient again stated he had flu shots in the past that made him sick after, like a cold. He stated he has never had Strep before. The clinical outcome of events was unknown.  No follow-up attempts needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypoaesthesia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: she woke up around 4:30-5:00am this morning with right sided chest pain; tingling in her body including her feet/Right arm was very numb and tingly/Tingly and numb all over head and face; her head feels numb/ Tingly and numb all over head and face/Right arm was very numb and tingly; her lips feel like she has had novacaine; having some arm pain later that evening; Had a little headache; This is a spontaneous report from a contactable consumer (Patient).   A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 73-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient received first dose of BNT162B2 for covid-19 immunisation. Patient reported she had a little headache and some arm pain later that evening (on 29Mar2021) for which she took Tylenol PM. She states she woke up around 4:30-5:00am this morning (on 30Mar2021) with right sided chest pain, tingling in her body including her feet, her head feels numb, and her lips feel like she has had novacaine, right arm was very numb and tingly and for tingly and numb all over head and face. As a therapeutic measure patient took Tylenol PM for some arm pain and headache. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: she woke up around 4:30-5:00am this morning with right sided chest pain; tingling in her body including her feet/Right arm was very numb and tingly/Tingly and numb all over head and face; her head feels numb/ Tingly and numb all over head and face/Right arm was very numb and tingly; her lips feel like she has had novacaine; having some arm pain later that evening; Had a little headache; This is a spontaneous report from a contactable consumer (Patient).   A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 73-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient received first dose of BNT162B2 for covid-19 immunisation. Patient reported she had a little headache and some arm pain later that evening (on 29Mar2021) for which she took Tylenol PM. She states she woke up around 4:30-5:00am this morning (on 30Mar2021) with right sided chest pain, tingling in her body including her feet, her head feels numb, and her lips feel like she has had novacaine, right arm was very numb and tingly and for tingly and numb all over head and face. As a therapeutic measure patient took Tylenol PM for some arm pain and headache. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first dose just sore arm for 1 day; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:30 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was none. Concomitant medication included escitalopram oxalate (LEXAPRO), rosuvastatin, ezetimibe all drugs were taken for an unspecified indication, start and stop date were not reported. Patient received dose 2 of bnt162b2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:15 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced sore arm after first dose for 1 day on an unspecified date in Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have any allergies to medications, food, or other products. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient did not receive treatment for the adverse event. Outcome of the event was recovered on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: blood on his urine after he got the 1st dose; This is a spontaneous report received from contactable consumer (patient himself) via Pfizer sponsored program COVAX US Support. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: un-known, expiry date: unknown) via unspecified route of administration on 23Mar2021, as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. On an unspecified date, patient experienced blood on his urine after he got the 1st dose. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to plants, Chest pain, Dyspnoea, Hypersensitivity, Pneumonitis
Clinical narrative: irritated lungs; hard time breathing; it was hurting my chest; it 'urges' inflammation of the lining around the lungs/ Get too much allergens so I have an inflammation of the lungs, irritation; got this allergy from ground, wind, tree and grasses/Inflammation; allergies from wind, leaves and trees; allergies from wind, leaves and trees; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6199, Expiration Date: not reported), via an unspecified route of administration in left deltoid on an unspecified date as dose 1, single for COVID-19 immunization (at the age of 70-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient experienced congestion, irritated lungs and hard time breathing. Patient was scheduled to receive the second dose this Friday 02Apr2021. Over the weekend he had allergies from wind, leaves and trees and his lungs got inflamed and this caused irritation of the lining of his lungs, he was not on medication. Patient got too much allergens from air which had a lot of dust, grasses coming out while working on the field, so he had an inflammation of the lungs, irritation and on the Saturday he went to the doctor because it was hurting his chest and it 'urges' inflammation of the lining around the lungs probably from air allergens or something like that and they checked everything and did not prescribed any medication. Everything was normal, everything was good. Patient had no problem with the vaccine and got this allergy from ground, wind, tree and grasses. He consulted his doctor and pharmacist and had no answer, they did not know well but they did not think there would be any problem but it might not be as effective; patient mentioned that he would hate to cancel his appointment for the second dose this weekend, because it was very difficult to reschedule it. Patient wanted to know if his irritated lungs would interfere with the second dose of the vaccine (efficacy) whether he should take it or not. The patient underwent lab tests and procedures which included blood test, chest x-ray and electrocardiogram was normal on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract irritation
Clinical narrative: irritated lungs; hard time breathing; it was hurting my chest; it 'urges' inflammation of the lining around the lungs/ Get too much allergens so I have an inflammation of the lungs, irritation; got this allergy from ground, wind, tree and grasses/Inflammation; allergies from wind, leaves and trees; allergies from wind, leaves and trees; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6199, Expiration Date: not reported), via an unspecified route of administration in left deltoid on an unspecified date as dose 1, single for COVID-19 immunization (at the age of 70-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient experienced congestion, irritated lungs and hard time breathing. Patient was scheduled to receive the second dose this Friday 02Apr2021. Over the weekend he had allergies from wind, leaves and trees and his lungs got inflamed and this caused irritation of the lining of his lungs, he was not on medication. Patient got too much allergens from air which had a lot of dust, grasses coming out while working on the field, so he had an inflammation of the lungs, irritation and on the Saturday he went to the doctor because it was hurting his chest and it 'urges' inflammation of the lining around the lungs probably from air allergens or something like that and they checked everything and did not prescribed any medication. Everything was normal, everything was good. Patient had no problem with the vaccine and got this allergy from ground, wind, tree and grasses. He consulted his doctor and pharmacist and had no answer, they did not know well but they did not think there would be any problem but it might not be as effective; patient mentioned that he would hate to cancel his appointment for the second dose this weekend, because it was very difficult to reschedule it. Patient wanted to know if his irritated lungs would interfere with the second dose of the vaccine (efficacy) whether he should take it or not. The patient underwent lab tests and procedures which included blood test, chest x-ray and electrocardiogram was normal on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Emotional disorder, Epistaxis
Clinical narrative: arm soreness; stiffened; temp. went from 98.2F to 100.3F; nose bleed/nose bleed without trauma; blood pressure has been spiking up about 5 to 10.5 times higher than normal; haven't sleep for last 2 nights; big emotional upset; heart rate is abnormal, it is irregular; feels lousy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6202, Expiry date: not reported, age at vaccination 57-year-old), via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included chronic fatigue syndrome (This all started 19 months ago. I mean the chronic fatigue syndrome was in 89 or 91. I started getting symptoms in 89. I did not get diagnosed at that time), fibromyalgia, venous disease, migraine, seizure, stroke, irritable bowel syndrome, vertigo (The vertigo has been going on from 3 different sources, I have allergies issues, oh yes that is part of it too, allergic rhinitis and Eczema. All the immune hyperactivity issues but there is probably some part of my immune system that is depressed in some way), weakness, allergy, dizziness, Bell's palsy (I was born with Bell's palsy), allergic rhinitis and eczema. Concomitant medications included clonazepam (0.25 in evening and 0.125 in the morning), diazepam (5 mg at night), diclofenac (10 mg at night, unsure), claritin (loratadine 10 mg), gabapentin (100 mg), levetiracetam; aimovig taken for migraine, sudafed (pseudoephedrine hydrochloride 120 mg), cardizem (diltiazem, 30 mg). The patient reported, stated with the stress of her father passing away, she feels lousy and already has immune system issues and was supposed to get a blood panel done today because she may have a vascular disorder but had to reschedule. Added after the 1st dose she had arm soreness that was worse than tetanus shot. She was really surprised but she drove for 1 hour after the vaccine so she thinks she was stiffened up. Also her temp. went from 98.2F to 100.3F in last 10 yrs haven't gone this high. She also had a nosebleed without trauma. She had not sleep for last 2 nights and its very big emotional upset. Right now her heart rate is abnormal, it is irregular. Her blood pressure has been spiking up about 5 to 10.5 times higher than normal, mostly top number and it is high and lows so even 10 point higher is still not consider High Blood Pressure but its huge change for her because something is causing it to jump 10 points. Due date of next shot was 2Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: increased, body temperature: 100.3 fahrenheit, heart rate: irregular on an unspecified date. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Insomnia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: arm soreness; stiffened; temp. went from 98.2F to 100.3F; nose bleed/nose bleed without trauma; blood pressure has been spiking up about 5 to 10.5 times higher than normal; haven't sleep for last 2 nights; big emotional upset; heart rate is abnormal, it is irregular; feels lousy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6202, Expiry date: not reported, age at vaccination 57-year-old), via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included chronic fatigue syndrome (This all started 19 months ago. I mean the chronic fatigue syndrome was in 89 or 91. I started getting symptoms in 89. I did not get diagnosed at that time), fibromyalgia, venous disease, migraine, seizure, stroke, irritable bowel syndrome, vertigo (The vertigo has been going on from 3 different sources, I have allergies issues, oh yes that is part of it too, allergic rhinitis and Eczema. All the immune hyperactivity issues but there is probably some part of my immune system that is depressed in some way), weakness, allergy, dizziness, Bell's palsy (I was born with Bell's palsy), allergic rhinitis and eczema. Concomitant medications included clonazepam (0.25 in evening and 0.125 in the morning), diazepam (5 mg at night), diclofenac (10 mg at night, unsure), claritin (loratadine 10 mg), gabapentin (100 mg), levetiracetam; aimovig taken for migraine, sudafed (pseudoephedrine hydrochloride 120 mg), cardizem (diltiazem, 30 mg). The patient reported, stated with the stress of her father passing away, she feels lousy and already has immune system issues and was supposed to get a blood panel done today because she may have a vascular disorder but had to reschedule. Added after the 1st dose she had arm soreness that was worse than tetanus shot. She was really surprised but she drove for 1 hour after the vaccine so she thinks she was stiffened up. Also her temp. went from 98.2F to 100.3F in last 10 yrs haven't gone this high. She also had a nosebleed without trauma. She had not sleep for last 2 nights and its very big emotional upset. Right now her heart rate is abnormal, it is irregular. Her blood pressure has been spiking up about 5 to 10.5 times higher than normal, mostly top number and it is high and lows so even 10 point higher is still not consider High Blood Pressure but its huge change for her because something is causing it to jump 10 points. Due date of next shot was 2Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: increased, body temperature: 100.3 fahrenheit, heart rate: irregular on an unspecified date. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: arm soreness; stiffened; temp. went from 98.2F to 100.3F; nose bleed/nose bleed without trauma; blood pressure has been spiking up about 5 to 10.5 times higher than normal; haven't sleep for last 2 nights; big emotional upset; heart rate is abnormal, it is irregular; feels lousy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6202, Expiry date: not reported, age at vaccination 57-year-old), via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included chronic fatigue syndrome (This all started 19 months ago. I mean the chronic fatigue syndrome was in 89 or 91. I started getting symptoms in 89. I did not get diagnosed at that time), fibromyalgia, venous disease, migraine, seizure, stroke, irritable bowel syndrome, vertigo (The vertigo has been going on from 3 different sources, I have allergies issues, oh yes that is part of it too, allergic rhinitis and Eczema. All the immune hyperactivity issues but there is probably some part of my immune system that is depressed in some way), weakness, allergy, dizziness, Bell's palsy (I was born with Bell's palsy), allergic rhinitis and eczema. Concomitant medications included clonazepam (0.25 in evening and 0.125 in the morning), diazepam (5 mg at night), diclofenac (10 mg at night, unsure), claritin (loratadine 10 mg), gabapentin (100 mg), levetiracetam; aimovig taken for migraine, sudafed (pseudoephedrine hydrochloride 120 mg), cardizem (diltiazem, 30 mg). The patient reported, stated with the stress of her father passing away, she feels lousy and already has immune system issues and was supposed to get a blood panel done today because she may have a vascular disorder but had to reschedule. Added after the 1st dose she had arm soreness that was worse than tetanus shot. She was really surprised but she drove for 1 hour after the vaccine so she thinks she was stiffened up. Also her temp. went from 98.2F to 100.3F in last 10 yrs haven't gone this high. She also had a nosebleed without trauma. She had not sleep for last 2 nights and its very big emotional upset. Right now her heart rate is abnormal, it is irregular. Her blood pressure has been spiking up about 5 to 10.5 times higher than normal, mostly top number and it is high and lows so even 10 point higher is still not consider High Blood Pressure but its huge change for her because something is causing it to jump 10 points. Due date of next shot was 2Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: increased, body temperature: 100.3 fahrenheit, heart rate: irregular on an unspecified date. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: runny nose; sneezing; This is a spontaneous report from a contactable consumer (patient) received from a Regulatory Authority. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, the caller received second dose today on an unspecified date, has runny nose and sneezing on an unspecified date in Mar2021. The temperature was normal but concerned about efficacy of vaccine. Any unaddressed medical questions referred or forwarded to Medical Information was reported as no. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: because of having Bronchitis that she got recently after she took 1st dose.; This is a spontaneous report from a Pfizer Sponsored Program a contactable consumer or other non hcp(patient). A female patient of an unspecified age received bnt162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 09Mar2021 as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced because of having bronchitis that she got recently after she took 1st dose on Mar2021. Patient was advised by her doctor that don't take the 2nd dose vaccine be-cause of having Bronchitis that she got recently after she took 1st dose.Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over her body.; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program  Support.A 85-years-old female patient received bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date,at the age of 85 years old, as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced rash all over her body on an unspecified date.The patient wanted to know whether it happened due to vaccine.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Infection, Influenza like illness
Clinical narrative: Flu-like symptoms; fever; pain in joints; infection site pain warm; General tiredness and soreness; loss of appetite; General tiredness and soreness; This is a spontaneous case received from a consumer (Patient). A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration in right arm on 29Mar2021 at 09:45 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history included COVID 19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 01:00, the patient experienced flu-like symptoms, fever, pain in joints, infection site pain warm, general tiredness and soreness, loss of appetite, general tiredness, and soreness. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.