chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: swelling of the throat; This is a spontaneous report from a contactable pharmacist. A 20-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0217, Expiration date: Unknown), via intramuscular route of administration in Left arm on 02Jun2021 at 16:00 as dose 1, single (at the age of 20-years-old) for COVID-19 immunization. It was unknown if the patient received any medications in four weeks of vaccination. The patient's medical history included asthma and pollen allergy from an unknown date and unknown if ongoing. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication in two weeks of vaccination. It was reported that the patient received his vaccination around 4:00 PM and then he waited for 15 minutes post-vaccination. On 02Jun2021, after going home, the patient experienced swelling of the throat around 20 minutes after they left the pharmacy. The patient and his mother then proceeded with the Emergency room visit. The outcome of the event was recovered on an unspecified date 2021.   Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypoaesthesia, Pyrexia, Somnolence
Clinical narrative: fever as high as 102; sleeping all day; headache; body feels weird like its numb; soreness at injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191; Expiration Date: 30Sep2021), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 14-year-old) as DOSE 2, SINGLE for covid-19 immunisation. No prior Vaccinations (within 4 weeks). Medical history included ongoing intellectual disability Verbatim: Intellectual disability Affects her memory mostly. The patient's concomitant medications were not reported. On 10Jun2021 05:00 the patient experienced fever as high as 102, sleeping all day, headache, body feels weird like its numb. On 09Jun2021, soreness at injection site. The patient underwent lab tests and procedures which included body temperature: 102 on Jun2021 She is running a temperature as high as 102. The patient was treated with Tylenol two 500mg tablets every 4-6 hours, ice pack for the arm soreness. The outcome of events not recovered.  Therapeutic measures were taken as a result of fever as high as 102 (pyrexia), sleeping all day (somnolence), headache (headache), soreness at injection site (vaccination site pain), body feels weird like its numb (hypoaesthesia).   Information on lot/batch number was available. Additional information has been requested.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fever as high as 102; sleeping all day; headache; body feels weird like its numb; soreness at injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191; Expiration Date: 30Sep2021), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 14-year-old) as DOSE 2, SINGLE for covid-19 immunisation. No prior Vaccinations (within 4 weeks). Medical history included ongoing intellectual disability Verbatim: Intellectual disability Affects her memory mostly. The patient's concomitant medications were not reported. On 10Jun2021 05:00 the patient experienced fever as high as 102, sleeping all day, headache, body feels weird like its numb. On 09Jun2021, soreness at injection site. The patient underwent lab tests and procedures which included body temperature: 102 on Jun2021 She is running a temperature as high as 102. The patient was treated with Tylenol two 500mg tablets every 4-6 hours, ice pack for the arm soreness. The outcome of events not recovered.  Therapeutic measures were taken as a result of fever as high as 102 (pyrexia), sleeping all day (somnolence), headache (headache), soreness at injection site (vaccination site pain), body feels weird like its numb (hypoaesthesia).   Information on lot/batch number was available. Additional information has been requested.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal discomfort
Clinical narrative: "breathing weird which comes and goes" and it "feels like she can't breath"; pressing on her neck for about a minute; This is a spontaneous report from a contactable consumer or other non hcp. A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181) via an unspecified route of administration, administered in Arm Left on 09Jun2021 17:45 (Age at Vaccination 14-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included prednisone acetate (PREDNISONE [PREDNISONE ACETATE]) taken for an unspecified indication from 02Jun2021 and ongoing. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171) via an unspecified route of administration, administered in Arm Left on 14May2021 (Age at Vaccination 14-years-old) as DOSE 1, SINGLE for COVID-19 immunization. She had no other vaccines that day or 4 weeks prior. On 10Jun2021 11:00 the patient experienced breathing weird which comes and goes, and it feels like she can't breath and pressing on her neck for about a minute. It was reported that Caller was the mother of the Patient. Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last night, 09Jun2021. Caller reported that today at 11AM, Patient started breathing weird which comes and goes, and it feels like she can't breath. Caller described it as pressing on her neck for about a minute. Callers daughter who is 14 years old had her second COVID shot last night. The caller just picked her daughter up from school because her breathing felt weird. Her daughter says it comes and goes. She said she was sitting there at desk and felt like her sweatshirt was pushing on her neck a little. It lasted a minute and stopped. The outcome of the events was not recovered. pressing on her neck for about a minute was recovered on 10Jun2021.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Dizziness, Fatigue
Clinical narrative: Chest pressure; nerve pain; headache; chills; fever; numbness in thumb; nausea; dizziness; joint pain; tired; sore arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0777), via an unspecified route of administration, administered in left arm on 09Jun2021 at 03:00 PM (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation in Pharmacy or Drug Store. The patient medical history included arthritis and high blood pressure and had no known allergies. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and venlafaxine HCL ER (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 19May2021 at 03:00 PM (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was not a pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jun2021 at 03:30PM, the patient experienced chest pressure, nerve pain, headache, chills, fever, numbness in thumb, nausea, dizziness, joint pain, tired and sore arm. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea, Neuralgia, Pain in extremity
Clinical narrative: Chest pressure; nerve pain; headache; chills; fever; numbness in thumb; nausea; dizziness; joint pain; tired; sore arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0777), via an unspecified route of administration, administered in left arm on 09Jun2021 at 03:00 PM (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation in Pharmacy or Drug Store. The patient medical history included arthritis and high blood pressure and had no known allergies. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and venlafaxine HCL ER (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 19May2021 at 03:00 PM (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was not a pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jun2021 at 03:30PM, the patient experienced chest pressure, nerve pain, headache, chills, fever, numbness in thumb, nausea, dizziness, joint pain, tired and sore arm. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chest pressure; nerve pain; headache; chills; fever; numbness in thumb; nausea; dizziness; joint pain; tired; sore arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0777), via an unspecified route of administration, administered in left arm on 09Jun2021 at 03:00 PM (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation in Pharmacy or Drug Store. The patient medical history included arthritis and high blood pressure and had no known allergies. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and venlafaxine HCL ER (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 19May2021 at 03:00 PM (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was not a pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jun2021 at 03:30PM, the patient experienced chest pressure, nerve pain, headache, chills, fever, numbness in thumb, nausea, dizziness, joint pain, tired and sore arm. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Large welt at injection site; Area is hot and arm is very sore.; Area is hot and arm is very sore.; This is a spontaneous report from a contactable consumer. This consumer reported for himself that,  A 15-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0191) (at the age of 15 years old), dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 17:45 as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0185), dose 1 via an unspecified route of administration, administered in arm left on 19May2021 16:45 as dose 1, single for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, tourette's disorder from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, bursitis from an unknown date and unknown if ongoing. Concomitant medication(s) included Multi-Vitamins, methylphenidate hydrochloride (CONCERTA) taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. It was reported that on 10Jun2021 at 12:15 patient experienced large welt at injection site, area was hot and arm was very sore. No treatment was received for events. Patient did not have covid prior to vaccination. He was not tested for covid post vaccination. The outcome for the events was not recovered.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Pyrexia, Vomiting
Clinical narrative: Fever; Vomiting; Been Sick All Day; Felt like Garbage All Day; Been Sick All Day; Felt like Garbage All Day; This is a spontaneous report received from a contactable consumer (mother) Parent reported behalf of her daughter. A 12-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0180) via an unspecified route of administration at left arm on 09Jun2021 14:00 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other Products and patient history reported as No. Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Patient's Medical History was not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0168) via an unspecified route of administration at left arm on 18May2021 (at the age of 12-year-old) as dose 1, single for COVID-19 immunisation. It was reported that caller states she was calling about her daughter. Caller states her daughter got her second Covid shot yesterday 09Jun2021 at 2:00p.m and she woke up today around 4:00 p.m to 5:00p.m. with a fever and vomiting and she just vomited again. Caller states she has been sick all day. Caller states this was ongoing, her daughter has felt like garbage all day. The patient experienced fever, vomiting, been sick all day; felt like garbage all day on 10Jun2021. Patient did not visit physician office and emergency room for the events. Patient received treatment for the events Tylenol about an hour or two after her shot. Outcome of events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: feel ache and achy, during the day like all my world, I felt like I have been  hit with, from my head to toe; Lymph node underneath my armpit going into my breast is swollen and enlarged; Bad headache; I have a rash; I have a knot where the shot was; my arm that I have the shot is really being aching; I was really Fluish/still felt very Fluish; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old patient of an unspecified gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0191) via an unspecified route of administration, administered in arm on 07Jun2021 (at the age of 52-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter stated, Yes. What I need today, I called the number yesterday. I had my first shot of the Pfizer vaccine on Monday afternoon. Tuesday, well Monday evening, I was kind of feel ache and achy but right Tuesday, during the day like all my world, I felt like I have been hit with, from my head to toe and yesterday morning, All into the evening my arm that I have the shot is really being aching and I have a knot where the shot was and then I have a rash up above it and then the lymph node under meet my armpit going into my breast is swollen and enlarged. Needless to say, I am a pretty miserable person right now and have bad headache also. Reporter stated, Yes, I was still feeling that Tuesday also, I was really Fluish, then yesterday not as that but still felt very Fluish and then that's when the rash started and then then lymph nodes under my arm into my breast started swelling. Age: Reporter stated, Okay. When I started feeling it, was have been Monday evening. It could have been 8 I Believe. Start date: Consumer stated, I started showing that on Monday June 8. UPC and NDC: Reporter stated, I do not have it. It is the LOT number they gave me and the date. I had it. First shot: Monday, 07Jun2021 and then I have to return on 28Jun2021 also. Condition of event: Reporter stated, they had improved a little, not much. Treatment: Reporter stated, I have just been taking Tylenol. Outcome of the events was resolving.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site nodule
Clinical narrative: feel ache and achy, during the day like all my world, I felt like I have been  hit with, from my head to toe; Lymph node underneath my armpit going into my breast is swollen and enlarged; Bad headache; I have a rash; I have a knot where the shot was; my arm that I have the shot is really being aching; I was really Fluish/still felt very Fluish; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old patient of an unspecified gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0191) via an unspecified route of administration, administered in arm on 07Jun2021 (at the age of 52-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter stated, Yes. What I need today, I called the number yesterday. I had my first shot of the Pfizer vaccine on Monday afternoon. Tuesday, well Monday evening, I was kind of feel ache and achy but right Tuesday, during the day like all my world, I felt like I have been hit with, from my head to toe and yesterday morning, All into the evening my arm that I have the shot is really being aching and I have a knot where the shot was and then I have a rash up above it and then the lymph node under meet my armpit going into my breast is swollen and enlarged. Needless to say, I am a pretty miserable person right now and have bad headache also. Reporter stated, Yes, I was still feeling that Tuesday also, I was really Fluish, then yesterday not as that but still felt very Fluish and then that's when the rash started and then then lymph nodes under my arm into my breast started swelling. Age: Reporter stated, Okay. When I started feeling it, was have been Monday evening. It could have been 8 I Believe. Start date: Consumer stated, I started showing that on Monday June 8. UPC and NDC: Reporter stated, I do not have it. It is the LOT number they gave me and the date. I had it. First shot: Monday, 07Jun2021 and then I have to return on 28Jun2021 also. Condition of event: Reporter stated, they had improved a little, not much. Treatment: Reporter stated, I have just been taking Tylenol. Outcome of the events was resolving.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Headache, Joint swelling, Joint warmth
Clinical narrative: Left knee is swollen; sore head; Knee is all swollen and sore and red; Knee is all swollen and sore and red; knee is all swollen and sore and red, kind of warm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) reported for self. A 61-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced left knee is swollen, sore head, knee is all swollen and sore and red, knee is all swollen and sore and red, knee is all swollen and sore and red, kind of warm on an unspecified date. Patient stated "well had this shot a couple days ago, in right arm and patient's left knee was swollen, and sore head. So, would that be a concern from that COVID shot. The patient stated never had knee problems before and now patient's knee was all swollen and sore and red, kind of warm." Consumer stated, "Yes I want to know why I got a swollen knee." Further information could not be probed as the consumer was unwilling to share any further in-formation. Hence limited information available over the call. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date 14 hours after second dose the patient experienced fever and chills. It was reported that event took place after use of product. Outcome of fever and chills was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Heavy menstrual bleeding, Nasopharyngitis
Clinical narrative: dizzy; The bleeding has increased from the next day but ended in a week; headaches; cold-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp.   A 31-years-old female patient received bnt162b2 (BNT162B2) (Formulation: Solution for injection, Batch/Lot Number: EW0171; Expiration Date: Unknown), dose 2 Single, via an unspecified route of administration, administered in Arm Right on 27May2021 13:30 (age at vaccination was 31 years) for covid-19 immunisation. Medical history included seasonal (hay fever) from an unknown date and unknown if ongoing. Historical vaccine was (Formulation: Solution for injection, Batch/Lot Number: EW0153; Expiration Date: Unknown) dose 1 Single, via an unspecified route of administration, administered in Arm Right on 07May2021, 01:30 PM (age at vaccination 31 years) for covid-19 immunisation. After dose 1 patient experienced Abnormal bleeding from uterus. My period started on the day I took my 1st dose as a normal cycle, and instead of ending in 1 week,occasional heavy bleeding, anaemia like dizziness, fatigue, bloating, less appetite. The patient's concomitant medications were not reported. No Covid prior to vaccination. No covid tested post vaccination. No other vaccine in received within four weeks. On 27May 2021 the patient experienced headaches, cold-like symptoms, on 28May2021  the bleeding has increased from the next day but ended in a week, on Jun2021 patient experienced dizzy. The patient underwent lab tests and procedures which included blood test normal region   on 2021 I took a blood test, but results were all in normal region.  The outcome of events headaches, cold-like symptoms,  the bleeding has increased from the next day but ended in a week, was recovered on unknown date in 2021, but the outcome of event dizzy was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Injection site swelling; Fever; Feeling unwell; Swollen lymph nodes in the left axilla; This is a spontaneous report from a contactable other health care professional (nurse), the patient. A 59-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0164), via an unspecified route of administration, administered in arm left on 09Jun2021 09:00 as dose 2, single (at the age of 59-years-old) for covid-19 immunization. The patient was non-pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. There were no known allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration, administered in arm left on 19May2021 09:00 as dose 1, single for covid-19 immunization. On 10Jun2021 06:00, the patient experienced injection site pain, injection site swelling, fever, feeling unwell and swollen lymph nodes in the left axilla. The patient did not receive any treatment for the events. The patient did not receive any other vaccine in four weeks and not received other medications in two weeks. The patient did not had any other vaccine prior to the vaccination and did not test for covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: headache; Fever; chills/uncontrolable shivering; Sweats; Hot Feeeling; Fatigue; This is a spontaneous report from a contactable consumer or other non HCP. A 44-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number was EW0180, Expiry date was not reported), dose 2 via intramuscular route of administration, administered in arm left on 11Jun2021 08:45 (Age at vaccination: 44-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history were not reported. Concomitant medications were reported as none. Patient had no known allergies. The patient previously received bnt162b2 (BNT162B2, solution for injection, Lot Number was EW0183,expiry date was not reported), dose 1 via an intramuscular route of administration, administered in arm left on 21May2021 (Age at vaccination: 44-years-old) 09:00 AM as dose 1, single for COVID-19 immunization. On 11Jun2021 22:45 the patient experienced headache, fever, chills/uncontrolable shivering and on 11Jun2021  the patient experienced sweats, hot feeling and fatigue. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received no treatment for the events. The clinical outcome of the events headache, fever, chills/uncontrolable shivering was recovering, and unknown for other events.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; Fever; chills/uncontrolable shivering; Sweats; Hot Feeeling; Fatigue; This is a spontaneous report from a contactable consumer or other non HCP. A 44-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number was EW0180, Expiry date was not reported), dose 2 via intramuscular route of administration, administered in arm left on 11Jun2021 08:45 (Age at vaccination: 44-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history were not reported. Concomitant medications were reported as none. Patient had no known allergies. The patient previously received bnt162b2 (BNT162B2, solution for injection, Lot Number was EW0183,expiry date was not reported), dose 1 via an intramuscular route of administration, administered in arm left on 21May2021 (Age at vaccination: 44-years-old) 09:00 AM as dose 1, single for COVID-19 immunization. On 11Jun2021 22:45 the patient experienced headache, fever, chills/uncontrolable shivering and on 11Jun2021  the patient experienced sweats, hot feeling and fatigue. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received no treatment for the events. The clinical outcome of the events headache, fever, chills/uncontrolable shivering was recovering, and unknown for other events.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lethargy, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: 24 hours after injection: dizziness; lethargy; nausea; pain at injection sight.; swelling at injection sight; This is a spontaneous report from a contactable consumer or other non hcp  (patient) reporting for herself. A 38-years-old female non-pregnant patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0182, expiry date: unknown) via an unspecified route of administration in Arm Left on 10Jun2021 at 08:30 (at the age of 38-year-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported no known allergies. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EWO175, expiry date: unknown) via an unspecified route of administration in Arm Left on 21May2021 at 03:45 PM at the age of 38-year-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. 24 hours after injection, on 11Jun2021 at 06:00 AM patient experienced dizziness, lethargy, nausea, pain and swelling at injection site. No treatment was received by the patient for AEs. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Polymerase chain reaction, Rash, Rash pruritic
Clinical narrative: The day after vaccination rash appeared on my legs. The following day the rash was all over my legs and arms and my shoulders and left cheek; It was itchy and painful; It was itchy and painful; It was itchy and red; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0183) via an unspecified route of administration, administered in left arm on 05Jun2021 11:45 (at the age of 29 years old) as dose 1, single for COVID-19 immunization (Workplace clinic). The patient medical history included asthmatic from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was diagnosed with COVID prior vaccination. The patient was tested COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient concomitant medications were not reported. On 06Jun2021 at 19:00, the patient experienced the day after vaccination rash appeared on my legs. The following day the rash was all over my legs and arms and my shoulders and left cheek, it was itchy and painful and it was itchy and red. The patient reported that it was itchy and red for two days and then started to go away. Now it was seventh day after vaccine and the patient still had rash on legs although it seems to be going away on it's own. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included PCR (Nasal swab) on 09Jun2021 which result negative. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Urticaria, Vomiting
Clinical narrative: vomiting; high fever of 103.5; Low grade fever up to 100; All over red dots/hives; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 13-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 16May2021 at 13:00 pm (age at vaccination was 13 years) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma. The patient had known allergies to eggs, tree nuts, peanuts and penicillin. Concomitant medications the patient received in two weeks included fluoxetine, sulfamethoxazole, beclometasone dipropionate (QVAR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Hospital. 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. On 01Jun2021, Tuesday at 20:30 pm, the patient had all over red dots/hives. The patient took 2 doses of Benadryl to calm down. On 03Jun2021, Thursday night at 2:00 am, the patient had vomiting and high fever of 103.5. The patient was given Tylenol too and it reduced the fever to 101. Low grade fever up to 100 was persistent until Saturday at 15:00 pm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0164, Expiration date: unknown) via an unspecified route of administration, administered at in left arm on 06Jun2021 at 13:15 pm (age at vaccination was 13 years) as dose 2, single for COVID-19 immunization. The outcome of the event low grade fever was resolved on 05Jun2021 at 15:00 pm. The outcome of the other events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Chest pain; racing heart; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EN6207, Expiry date: unknown) (age at the time of vaccination was 37 years), administered in Arm Right on 25Mar2021 at 13:15 as dose 2, single for COVID-19 immunization. The patient's medical history included type 2 diabetes. The patient's concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Ep6955), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for COVID-19 immunization. On 20Apr202 at 12:00, the patient had chest pain and racing heart. No treatment received. The outcome of the events was recovering.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Disturbance in attention, Frustration tolerance decreased, Potentiating drug interaction
Clinical narrative: Frustrated; could not focus after getting vaccine shot; Patient reported taking Tylenol at time of having vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that an individual said she was frustrated because could not focus after getting vaccine shot, implied this was due to vaccine. The patient reported taking Tylenol at time of having vaccine (This would imply that they potentially had side effects.) No other information was provided. Seriousness of the events was reported as non-serious. The outcome of events was recovered.  No follow up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills; Fever; Extreme fatigue; Headache; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER8736), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jun2021 17:30 (Batch/Lot Number: ER8736) as dose 2, single for covid-19 immunisation (at the age of 49-year-old). Medical history included covid-19 and arthritis from an unknown date and unknown if ongoing. Not known allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 on 20May2021 05:30 PM in arm left as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 11Jun2021 01:00 AM patient experienced chills and fever with extreme fatigue and headache. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; feverish; fatigue; swollen lymph node in armpit of left arm; This is a spontaneous report from a contactable consumer (Patient).  57-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179, Expiration date: not reported) via an unspecified route of administration, administered at hospital in Left arm on 11Jun2021at 08:30 (at the age of 57-years-old) as dose 2, single, for covid-19 immunization. The medical history was not reported .There was no known allergies. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN); methimazole (METHIMAZOLE), multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EW0172, Expiration date: not reported), via an unspecified route of administration in the left arm on 06May2021at12:00 (at the age of 57-years-old) AM as dose 1, single for COVID-19 immunization. On12Jun2021 at 00:30, patient experienced vaccination site pain, feverish, fatigue, swollen lymph node in armpit of left arm. Patient did not receive any treatment. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was recovered in Jun2021.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chest pain, Myalgia
Clinical narrative: Expected soreness in arm muscle the next morning; pain and soreness in my Right armpit and down into my chest/breast tissue.; pain and soreness in my Right armpit and down into my chest/breast tissue.; pain and soreness in my Right armpit and down into my chest/breast tissue.; This is a spontaneous report from a contactable other health care practitioner (patient herself) COVID-19 Adverse Event Self-Reporting Solution. A 50 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0191), via an unspecified route, administered in Right Arm on 11Jun2021 15:30 (at the age of 50 years old) as Dose 1, Single for Covid -19 immunization at Pharmacy or Drug store. The patient's medical history included type 2 diabetes mellitus, intraductal proliferative breast lesion, Ductal carcinoma in situ both breasts. treated with mastectomies on both sides, COVID -19 (prior to vaccination), drug hypersensitivity, mastectomy. The patient was allergic to penicillin. The patient received other medication (unspecified) 2 weeks. The patient did not receive any other vaccine four weeks. The patient had COVID infection prior to vaccination. The patient was not tested for COVID infection post vaccination. The patient was not pregnant at the time of vaccination. On 12Jun201 (next morning after first dose of vaccination), the patient expected soreness in arm muscle the next morning. On 13Jun2021 05:00 (2 days later after vaccination) the patient experienced pain and soreness in her right armpit and down into her chest/breast tissue. Device date was mentioned as 13Jun2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue, Taste disorder
Clinical narrative: A wide range of food has been tasting bland to me, and sometimes has no taste at all.; My tongue tingles on both sides and on the top, near the front.; bumps in the back of my tongue, on both sides; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:00 (at the age of 36-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included norethisterone (NORA BE) for birth control. The patient previously took oxycodone and experienced allergies to oxycodone, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EP6455) via an unspecified route of administration at Left arm as dose 1, single on 26Mar2021 09:00 (at the age of 36-year-old) for covid-19 immunisation. No other vaccine in four weeks. May2021 at 09:00, the patient experienced a wide range of food has been tasting bland to me, and sometimes has no taste at all. These are foods I typically enjoy very much. My tongue tingles on both sides and on the top, near the front. The tingling sensation happens whether I am eating or not. The tingling at the top of my tongue is amplified when I press my tongue to the roof of my mouth, or put pressure on my tongue with food (such as when eating an ice cream cone, for instance). There are also bumps in the back of my tongue, on both sides, though they seem to have no feeling and I'm not sure if they are normal or not (I don't usually inspect my tongue to that degree). It has been going on for at least a month. I am very concerned that I may be losing my sense of taste, which definitely dampens (and in some cases completely removes) my enjoyment of food. No treatment received. No covid prior vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Rash papular, Rash pruritic
Clinical narrative: Itchy red bumpy rash around neck, stomach and back.; Itchy red bumpy rash around neck, stomach and back.; Itchy red bumpy rash around neck, stomach and back.; first dose 30Apr2021, second dose on 11Jun2021; This is a spontaneous case received from a contactable consumer (patient). A 49-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0217), via an unspecified route of administration, administered in left arm on 11Jun2021 at 14:00 as DOSE 2, SINGLE and first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration, administered in left arm on 30Apr2021 as DOSE 1, SINGLE (age at vaccination 49-year-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included hypothyroid. Concomitant medications included anti-anxiety and thyroid meds. The patient previously took erythromycin and experienced allergies. Prior vaccination within 4 weeks was reported as none. On 14Jun2021, the patient experienced itchy red bumpy rash around neck, stomach and back. The patient reported that the events happened with the first vaccine as well. The patient was administered inappropriate schedule of vaccine. The patient did not receive any treatment for the event. COVID prior vaccination and COVID tested post vaccination was reported as none. The outcome of the events was recovering.  Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe nosebleed lasting a little over 45 minutes; This is a spontaneous report from a contactable consumer (Patient). A 13-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186, Expiry Date was not provided), via an unspecified route of administration, administered in right arm, on 13Jun2021 at 11:15 AM (age at vaccination was 13 Years) as DOSE 2, SINGLE for COVID-19 immunization in other facility. The patient's medical history was not reported. Concomitant medications included Clonidine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Batch/Lot Number: EW0186, Expiry Date was not provided), via an unspecified route of administration, administered in right arm, on 22May2021 at 02:15 PM (age at vaccination was 13 Years) as DOSE 1, SINGLE for COVID-19 immunization in other facility. The patient did not have known allergies. The patient did not receive any other vaccines in four weeks. The patient received 0.1mg clonidine (been taking it for about 4 years) in two weeks. Patient did not have COVID prior vaccination. Patient has not been tested post vaccination. On 14Jun2021 at 8:00 AM, patient experienced severe nose-bleed lasting a little over. Patient did not receive any treatment for events. The outcome of event was recovering.  No follow up attempts are possible. No further information is expected.