chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache
Clinical narrative: Headache; Higher temperature than normal; This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on 15Mar2021 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 22Feb2021 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization and patient experienced I get a arm soreness after the first dose. On an unspecified date Mar2021, the patient experienced Headache, and Higher temperature than normal. Caller stated it is possible for people to have no side effects after either dose of the vaccine. Caller wants to know how she can know for sure the vaccine was mixed and administered properly. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: felt nauseous again at times; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EV0178), via an unspecified route of administration on 13Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in July2021, the patient felt nauseous again at times. The patient went to the hospital they just gave her pain medicines (Further clarification unknown) and some like fluids and then she felt better. The patient was scheduled for second dose on 03Aug2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Computerised tomogram, Endoscopy upper gastrointestinal tract, Erythema, Heart rate
Clinical narrative: Date of start of drug (1st dose): 15Apr2021, 2nd dose, Dose received - 06Jun2021; broke out on her chest, face, and  everything turned beat red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167, NDC, Expiration date - unknown) via an unspecified route of administration on 06Jun2021 (at the age of 42-year-old) at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in right arm on 15Apr2021 (at the age of 42-year-old) at dose 1, single for covid-19 immunisation. Patient experienced did not feel well (Didn't feel well: start - beginning of Mar, she thought she had an infection in her hand, and she went to the local urgent care and her doctor ruled that out. She wasn't feeling great and had a hard burning ear drainage and got a covid test on 28Mar2021, the end of Mar it came back negative. Caller stated she is not sure if it was 28Mar2021, she clarified it was the last week in Mar), she was shaking and her heart rate went up to 185 and dropped pretty suddenly down to 36, lost a significant amount of weight, neurological and muscle problems, GI problems, difficult time walking, muscles are very weak, back and spine pain and neck, broke out on her chest, face, and everything turned beat red, shaking after taking first dose. On an unspecified date the patient experienced date of start of drug (1st dose): 15apr2021, 2nd dose, dose received - 06jun2021 and on an unspecified date in Jun2021 the patient experienced broke out on her chest, face, and everything turned beat red. The patient underwent lab tests and procedures which included on an unspecified date colonoscopy result was unknown, 3 CT scans result was unknown, scope result was unknown, Heart rate was 185 dropped pretty suddenly down to 36, MRI of neck and head Everything came back normal and on 28Mar2021 covid test was negative. She got 3 CT scans but does not know the dates or the results. She had a colonoscopy and a scope, and has a scheduled EMG (muscle, nerve study) can't get in until Oct. She had the CT scan a day before one of the vaccines. Treatment - She has been going to the doctors almost four or five a week, blood work like crazy and the ER nine times. Two times were prior to her first vaccine. Outcome of the event broke out on her chest, face, and everything turned beat red was resolved with sequel and another event was unknow.   Follow up (PRD/SRD 02Aug2021): No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: Date of start of drug (1st dose): 15Apr2021, 2nd dose, Dose received - 06Jun2021; broke out on her chest, face, and  everything turned beat red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167, NDC, Expiration date - unknown) via an unspecified route of administration on 06Jun2021 (at the age of 42-year-old) at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in right arm on 15Apr2021 (at the age of 42-year-old) at dose 1, single for covid-19 immunisation. Patient experienced did not feel well (Didn't feel well: start - beginning of Mar, she thought she had an infection in her hand, and she went to the local urgent care and her doctor ruled that out. She wasn't feeling great and had a hard burning ear drainage and got a covid test on 28Mar2021, the end of Mar it came back negative. Caller stated she is not sure if it was 28Mar2021, she clarified it was the last week in Mar), she was shaking and her heart rate went up to 185 and dropped pretty suddenly down to 36, lost a significant amount of weight, neurological and muscle problems, GI problems, difficult time walking, muscles are very weak, back and spine pain and neck, broke out on her chest, face, and everything turned beat red, shaking after taking first dose. On an unspecified date the patient experienced date of start of drug (1st dose): 15apr2021, 2nd dose, dose received - 06jun2021 and on an unspecified date in Jun2021 the patient experienced broke out on her chest, face, and everything turned beat red. The patient underwent lab tests and procedures which included on an unspecified date colonoscopy result was unknown, 3 CT scans result was unknown, scope result was unknown, Heart rate was 185 dropped pretty suddenly down to 36, MRI of neck and head Everything came back normal and on 28Mar2021 covid test was negative. She got 3 CT scans but does not know the dates or the results. She had a colonoscopy and a scope, and has a scheduled EMG (muscle, nerve study) can't get in until Oct. She had the CT scan a day before one of the vaccines. Treatment - She has been going to the doctors almost four or five a week, blood work like crazy and the ER nine times. Two times were prior to her first vaccine. Outcome of the event broke out on her chest, face, and everything turned beat red was resolved with sequel and another event was unknow.   Follow up (PRD/SRD 02Aug2021): No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Loss of consciousness, Pain
Clinical narrative: Practically unconscious the first day and a half; fever; practically in immense pain from head to toe, including the kidneys./aches; practically in immense pain from head to toe, including the kidneys.; with chills like never before.; His knee and back felt as if someone shot a hole and left him there./back pain; His knee and back felt as if someone shot a hole and left him there./knee pain; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0217), via an unspecified route of administration on 21Jun2021 12:00 (at the age of 21-years-old) at dose 2, single in the left arm for COVID-19 immunisation. The patient has no medical history. The patient has no known allergies. 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's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0186) received on 31May2021 at 13:00 in the left arm for COVID-19 immunisation. On 22Jul2021 11:00, the patient was practically in immense pain from head to toe, including the kidneys, and had fever. On 22Jul2021 11:00 the patient was practically unconscious from the first day and a half, with chills like never before. On the same day, on 22Jul2021 11:00, The patient's knee and back felt like as if someone shot a hole and left him there. They weren't sure if the patient was going to make it. The chills, fever, and aches left but the knee pain and back pain still sits with the patient until today. The events were assessed as serious due to disability or permanent damage. The patient was not given any treatment for the events. Outcome of the event unconscious was recovered on 23Jul2021 23:00, for back pain and knee pain was not recovered, and for other events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Renal pain
Clinical narrative: Practically unconscious the first day and a half; fever; practically in immense pain from head to toe, including the kidneys./aches; practically in immense pain from head to toe, including the kidneys.; with chills like never before.; His knee and back felt as if someone shot a hole and left him there./back pain; His knee and back felt as if someone shot a hole and left him there./knee pain; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0217), via an unspecified route of administration on 21Jun2021 12:00 (at the age of 21-years-old) at dose 2, single in the left arm for COVID-19 immunisation. The patient has no medical history. The patient has no known allergies. 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's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0186) received on 31May2021 at 13:00 in the left arm for COVID-19 immunisation. On 22Jul2021 11:00, the patient was practically in immense pain from head to toe, including the kidneys, and had fever. On 22Jul2021 11:00 the patient was practically unconscious from the first day and a half, with chills like never before. On the same day, on 22Jul2021 11:00, The patient's knee and back felt like as if someone shot a hole and left him there. They weren't sure if the patient was going to make it. The chills, fever, and aches left but the knee pain and back pain still sits with the patient until today. The events were assessed as serious due to disability or permanent damage. The patient was not given any treatment for the events. Outcome of the event unconscious was recovered on 23Jul2021 23:00, for back pain and knee pain was not recovered, and for other events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site haemorrhage
Clinical narrative: Anatomical site of injection: her left elbow; when patient received the second vaccine dose, she sometimes like "bleed"; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored Program, a Regulatory Authority. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly, administered in the left elbow(pending clarification) on 08Jul2021 (batch/lot number: FA6780 and expiration date: 30Jul2021) at 62 years old as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 intramuscularly, administered in the left elbow on 14Jun2021 (batch/lot number and expiration date were unknown) at 62 years old, as DOSE 1, SINGLE for COVID-19 immunization and experienced hematoma in the area of administration. It was reported that when patient received the second vaccine dose, she sometimes like "bleed' (vaccination site bleeding) since an unknown date in Jul2021. Reporter stated, "you inject, obviously you use needle and so apparently patient has like hematoma." The reporter did not see it and the other problem was, patient was not present during the call. Reporter had not seen if patient was developing a hematoma. But, the nurse of 40 years, in the summary thoughts, was wondering, If the vaccine did not go into the vein therefore was not effective because it did not land in the muscles or should she get another vaccine. Patient wanted to know if she can get another vaccine. She felt like, if it did go into the veins instead of muscles and therefore, she wanted to get another vaccine. The outcome of the event "she sometimes like "bleed' (vaccination site bleeding)" was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site haematoma
Clinical narrative: hematoma in the area of administration; Anatomical site of injection: Her left elbow; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored Program. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in the left elbow on 14Jun2021 (at the age of 62 years) (Batch/Lot Number: FA6780) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. When the patient received the first dose, she had a hematoma in the area of administration on an unspecified date. Anatomical site of injection was reported as "her left elbow" (pending clarification). Outcome of the event "hematoma in the area of administration" was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: shot itself was "very painful."; her arm remains very painful./quite painful in the arm and has been hurting ever since; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date was not provided), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. Patient had questions about side effects of arm pain lasting 2 weeks. Patient had both doses of her Pfizer COVID-19 vaccinations. The 1st dose she had "zero pain and zero complications." She stated the 2nd injection was given 2 weeks ago (full 2 weeks noted to be at 15:00 today) was "substantially different in relation to the initial." Patient stated the shot itself was "very painful." She thought she would give it the "full 2 weeks" however her arm remains very painful. Patient would like to know had we heard of this, had projection of days it should go away and also wanted to know what can be done about her symptoms. Patient noted that she will be seeing a new doctor for the 1st time next week. Advised patient adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain and muscle pain. Adverse Reactions in Post Authorization Experience. pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials. Encouraged patient to contact her HCP due to ongoing bothersome side effects. Advised the patient that yes, we have heard of these side effects in clinical trials and through self-reporting. Patient again stated, the second dose was with a different person and when they gave the shot, it was quite painful in the arm and been hurting ever since. She was not quite sure how this had anything to do with the pain in her arm. She needs to run out the door in a few minutes. Waited until today to call. Just wants to know what was suggested, given this company was who provided the vaccine. The outcome of event her arm remains very painful/quite painful in the arm and has been hurting ever since was not recovered and another event outcome was unknown.  Information on lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing
Clinical narrative: flushing on my arms, face, neck and chest; Warm to touch and very red; Warm to touch and very red; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EY0584, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Jul2021 at 12:00 hours as dose 1, single (at the age of 57-years-old) for covid-19 immunisation.  Medical history included high blood pressure (BP) from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication(s) within 2 weeks of vaccination included levothyroxine; benazepril and omeprazole (all taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. On 08Jul2021 at 13:00 hours, on day 6 after my vaccination, patient experienced flushing on her arms, face, neck and chest, warm to touch and very red. Patient received no treatment for the events. All events were reported as non-serious by the reporter. The outcome of all the events was recovered on Jul2021  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: right under her jawline, on the side where she got her shot, like her lymph node or whatever it is, is swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 12Jul2021 as DOSE 1, SINGLE for covid-19 immun-isation. Medical history included heart issues from an unknown date and unknown if ongoing I have heart issues. The patient's concomitant medications were not reported. On Jul2021 caller reports I am not doing too good stating that she received her first covid vaccine dose on 12Jul2021, she reports that I was kind of not feeling good before that because I have heart issues and she say her doctor. Caller reports that she started feeling better but now, starting about 1 hour ago, on the right side (the same side as my shot) in front her right ear, my lymph node under her jaw line she started noticing a swollen area that is big. Caller reports that she called her HCP, but they didn't want to address it, but they said she could come in, but she reports that her car is broken down and she isn't able to get to the office. Caller now asking should I be worried about this, should I go to the ER. Caller reports that she didn't know if her symptom is from the vaccine or if it is related to the heart monitor she has been wearing since Tuesday that she just took off today at 3:00 reporting that she may be having a reaction to the stickers that come with the heart monitor. Also asking It's not going to cut off my breathing right, it's been like an hour now if something bad was going to happen it would have already happened right. Caller reports I just wish this hadn't have happened because now I don't want the second dose. The caller is calling regarding COVID-19 vaccine. The caller states she had the vaccine on 12Jul2021, and her second dose is not until 02Aug2021. She mentions she is a heart patient. She wasn't feeling so good, but she explains that kind of happened before the shot. She is calling regarding what happened in the past 30 minutes. Right under her jawline, on the side where she got her shot, like her lymph node or whatever it is, is swollen. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Rash, Tinnitus
Clinical narrative: Non itchy Rash on torso, upper legs and upper arms; Difficulty breathing; Fever; Ringing in ears; This is a spontaneous report from a contactable consumer (patient). A 71-years-old patient of an unspecified gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was nor reported, patient was 71-year at the time of vaccination), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 at 11:00 AM as single dose for covid-19 immunisation. Medical history included lupus, asthma, Knonw allergies: Yes. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL); allopurinol (ELAVIL); colecalciferol (VIT D3); chondroitin sulfate, glucosamine (GLUCOSAMIN & CHONDROITIN) all are taken for an unspecified indication, within two weeks of vaccination. No other vaccine received in four weeks. No covid reported prior vaccination and patient was not tested for covid post vaccination. On an unspecified date in May2021 at 12:00 AM, the patient experienced non itchy rash on torso, upper legs and upper arms, difficulty breathing, fever, ringing in ears. No seriousness criteria were reported for events. No treatments were received for events. The outcomes of events (non itchy rash on torso, upper legs and upper arms, difficulty breathing, fever) were recovered on an unspecified date in 2021 and the outcome of event (ringing in ears) was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: broke out on upper torso with a rash or hives and spread overnight to lower torso and legs/ rash spread all over his body except that of his face; broke out on upper torso with a rash or hives and spread overnight to lower torso and legs; This is a spontaneous report from a contactable consumer (patient's wife). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0180 [also reported as EWD180]), via an unspecified route of administration in arm on 02Jul2021 (at the age of 62-years-old) at dose 1, single for COVID-19 immunization. Medical history included latent TB from at least 15 years ago and digestive problems, which were both and ongoing. Concomitant medications were reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, and prior vaccinations within 4 weeks were reported as none. The vaccine was administered at a pharmacy. The patient received his first dose of PFIZER-BIONTECH COVID-19 VACCINE on 02Jul2021. However, 4 days ago, on 19Jul2021, he broke out in rash or hives that started from his upper torso and spread to his lower torso and legs overnight. And right now, the patient's wife confirmed that the rash spread all over his body except that of his face. Even though they have been giving him BENADRYL 25 mg capsules which he already took four pills, probably two at a time and using a topical lotion (triamcinolone acetonide 1% 30 grams) from the doctor, he has still broken out. She would like to get some advice as to whether the patient should get the second dose of the vaccine considering this side effect experienced. The events required physician office visit. It also required an emergency phone call from the doctor's office, they did a tele-med. The outcome of the events was not recovered.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Lacrimation increased, Periorbital swelling
Clinical narrative: watery eyes and are kind of puffy; watery eyes and are kind of puffy; watery eyes and are kind of puffy was reported as worsened; headache; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported; expiry date: unknown) via an unspecified route of administration on 23Jul2021 (at the age of 12-years-old) in right arm as a single dose for covid-19 immunization. The patient's medical history, concomitant medications and investigation assessment were not reported. The patient experienced headache 30 minutes after the vaccination and had watery eyes and were kind of puffy on 23Jul2021. The events of watery eyes and were kind of puffy was reported as worsened. She was treated with Zyrtec. Her mother asked if it was okay about the events and should she take the patient to the emergency room. The outcome of all the events was not resolved.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: Chills; Fever of 102.3 °F; Nausea; This is a spontaneous report from a contactable conumer (patient's daughter) reported for a 56-year-old female patient (reporter's mother) via Medical Information Team.  A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FA7484), via an unspecified route of administration in left arm on 22Jul2021 at 18:55 (at the age of 56 years old) as single for covid-19 immunisation.  Medical history included ongoing thyroid issue, unknown when she was diagnosed. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. On 23Jul2021, patient experienced chills, fever of 102.3 Celsius F and nausea. She had chills all day. The reporter wanted to know if these side effects are normal. Wants to know if they should be concerned. The patient underwent lab tests and procedures which included body temperature: 102.3 fahrenheit on 23Jul2021. No family medical history relevant to adverse events was provided and no relevant tests were performed. The events not resulted in a visit to emergency room or physician office. The outcome of nausea was unknown, while with other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Eye disorder, Headache
Clinical narrative: body aches; headache; chills; Came down with this fever; fever is on 100.7 right now.; feeling weak; Nausea; eye pressure; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's mother). A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration on 19Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date in Jul2021, the patient experienced eye pressure. On 22Jul2021, experienced body aches, headache, chills, came down with this fever; fever is on 100.7 right now, feeling weak and nausea. Reporter reported that the patient received his first dose of the Pfizer BioNtech covid 19 vaccine on Monday on 19Jul2021 and he did not have no side effects on Tuesday, Wednesday, so yesterday on thursday he began to experienced side effects such as fever, body aches, headache, and feeling weak on 22Jul2021. So on thursday he came down with this fever, chills, headache and same today. His fever is 100.7 right now and he had headache and eye pressure and body ache. Reporter wondering if it is normal to have these side effects four days after the vaccine. Reporter also reported that she experienced side effects within the first two days of receiving her covid vaccine. The patient underwent lab tests and procedures which included body temperature: 100.7 on 23Jul2021. The clinical outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: body aches; headache; chills; Came down with this fever; fever is on 100.7 right now.; feeling weak; Nausea; eye pressure; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's mother). A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration on 19Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date in Jul2021, the patient experienced eye pressure. On 22Jul2021, experienced body aches, headache, chills, came down with this fever; fever is on 100.7 right now, feeling weak and nausea. Reporter reported that the patient received his first dose of the Pfizer BioNtech covid 19 vaccine on Monday on 19Jul2021 and he did not have no side effects on Tuesday, Wednesday, so yesterday on thursday he began to experienced side effects such as fever, body aches, headache, and feeling weak on 22Jul2021. So on thursday he came down with this fever, chills, headache and same today. His fever is 100.7 right now and he had headache and eye pressure and body ache. Reporter wondering if it is normal to have these side effects four days after the vaccine. Reporter also reported that she experienced side effects within the first two days of receiving her covid vaccine. The patient underwent lab tests and procedures which included body temperature: 100.7 on 23Jul2021. The clinical outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Vertigo
Clinical narrative: I felt very dizzy for 2 following days; I got vertigo attacks next day after vaccination; This is a spontaneous report from a contactable other healthcare professional (patient). A 68-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER2613), via an unspecified route of administration in the right arm on 06Jul2021 at 10:30 as dose number unknown, single for COVID-19 immunization (at the age of 68-years-old). Medical history included meniere's disease from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient previously took ampicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient stated that she got vertigo attacks next day after vaccination (07Jul2021) and she felt very dizzy for 2 following days. The events were assessed as non-serious as per reporter. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): negative on 12Jul2021 and 21Jul2021. The patient received meclizine 25mg X 3/day and hydrochlorothiazide 12.5mg within 2 weeks of vaccination. The clinical outcome for the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: felt very ill; sustained fever of 100.6-100.8; I am very weakened; exhausted; I have headaches; Muscle aches; Nasal congestion; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 12Jul2021 12:30 (Lot Number: EW0173) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Jul2021 18:45, approximately 4 -5 days after the first Covid vaccine, the patient felt very ill and had a sustained fever of 100.6-100.8 now for 6 full days that does not go away. Patient was very weakened and exhausted; also had headaches, muscle aches, and nasal congestion. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 100.6-100.8 on 17Jul2021; Covid-19 test: inconclusive on 20Jul2021 and unknown results (pending)on 23Jul2021. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: felt very ill; sustained fever of 100.6-100.8; I am very weakened; exhausted; I have headaches; Muscle aches; Nasal congestion; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 12Jul2021 12:30 (Lot Number: EW0173) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Jul2021 18:45, approximately 4 -5 days after the first Covid vaccine, the patient felt very ill and had a sustained fever of 100.6-100.8 now for 6 full days that does not go away. Patient was very weakened and exhausted; also had headaches, muscle aches, and nasal congestion. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 100.6-100.8 on 17Jul2021; Covid-19 test: inconclusive on 20Jul2021 and unknown results (pending)on 23Jul2021. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Swelling face
Clinical narrative: noticed that her chin was getting fatter and not reducing; This is a spontaneous report from a contactable pharmacist (patient).    A 56-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported),via intramuscular route of administration, administered in left Arm on 18Apr2021 at 15:00 as Dose 2,Single (at the age of 56-years-old) for COVID-19 immunization and deoxycholic acid (KYBELLA) taken for fat tissue increased, start and stop date were not reported. The patient previously received Shingrix to prevent shingles in Nov-2020 and first dose of bnt162b2 vaccine on an unspecified date in Mar-2021 (26th or 27th) administered via intramuscular route of administration in left arm as Dose 1, Single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced they remove fat from the chin/I am having an opposite effect where before I as showing a positive outcome and then along came the pfizer vaccine and noticed that her chin was getting fatter and not reducing. Reporter stated that she had both shots of our shots of Covid vaccine, she was undergoing Kybella treatment which is an injection to reduce chin fat. Wanted to know if they have had reports of problems with the vaccine with Kybella. Stated that she should have had chin reduction and is experiencing the direct opposite.  Both having negative outcomes and believes it is related to product.  A review of interim safety data from the clinical program did not identify adverse events specifically associated with Botox or cosmetic fillers. The outcome of the events is unknown at the time of this report.  Follow-up attempts needed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reporter's Comments: Reporter causality: She thinks it is RELATED to the product.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100945497 Same reporter/drug/event, different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rach all over my body; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received (also reported as 45-year-old, pending clarification) bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: FA7484, expiration date was not reported), via an unspecified route of administration, in left arm, on 23Jul2021 09:45, at the age of 25-year-old (also reported as 45-year-old, pending clarification), at dose 1, single, for covid-19 immunization. Medical history included environmental allergies and COVID-19. The patient was not having other known allergies and was not pregnant during the time of report. Concomitant medications included diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not tested after the vaccination. The patient experienced rash all over body on 23Jul2021 16:00. The reporter assessed the case as non-serious. No treatment was administered for the event. The outcome of the event was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasms
Clinical narrative: calf muscle cramps in both legs; leg discomfort during day time hours; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO151), via an unspecified route of administration, administered in Arm Right on 20Apr2021 09:45 as dose number unknown, single for covid-19 immunization. Medical history included sinus and known allergy: yes from an unknown date. Concomitant medications included mometasone furoate (NASONEX) taken for an unspecified indication; azelastine hydrochloride (ASTELIN) taken for an unspecified indication; and montelukast sodium (SINGULAIR) taken for sinus and allergy related, all start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. On 28May2021 06:30, the patient experienced calf muscle cramps in both legs and no treatment was taken. The patient reported that she never had experienced cramps prior. On an unspecified date in 2021, the patient had experience leg discomfort during day time hours and began consuming tonic water containing quinine. This has been part of her daily routine for weeks now since the lower leg discomfort was worsening. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Limb discomfort, Nausea, Pain in extremity
Clinical narrative: both my arms began to tingle and become numb/left arm is still numb and tingling its been almost 24 hours/having trouble with my arm being numb and tingling; both my arms began to tingle and become numb/left arm is still numb and tingling its been almost 24 hours/having trouble with my arm being numb and tingling; left arm is still hurting very bad and feels very heavy; left arm is still hurting very bad and feels very heavy; heart palpitations; felt very tired/overall feel run down; nausea; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA6780, expiry date not reported), via an unspecified route of administration, in left arm, on an unspecified date, at the age of 55-year-old, at dose number unknown, single for covid-19 immunization. Medical history included high blood pressure and heart issues. The patient was not pregnant during the time of report. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient experienced heart palpitations, tired and nausea with overall feel run down on 23Jul2021 01:00. Two hours later (23Jul2021 03:00), both the arms began to tingle and became numb. The patient's left arm is still hurting, felt heavy, numb, tingling and it's been almost 24 hours from the time of report. The reporter assessed the events as non-serious. No treatment was administered for the events. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: both my arms began to tingle and become numb/left arm is still numb and tingling its been almost 24 hours/having trouble with my arm being numb and tingling; both my arms began to tingle and become numb/left arm is still numb and tingling its been almost 24 hours/having trouble with my arm being numb and tingling; left arm is still hurting very bad and feels very heavy; left arm is still hurting very bad and feels very heavy; heart palpitations; felt very tired/overall feel run down; nausea; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA6780, expiry date not reported), via an unspecified route of administration, in left arm, on an unspecified date, at the age of 55-year-old, at dose number unknown, single for covid-19 immunization. Medical history included high blood pressure and heart issues. The patient was not pregnant during the time of report. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient experienced heart palpitations, tired and nausea with overall feel run down on 23Jul2021 01:00. Two hours later (23Jul2021 03:00), both the arms began to tingle and became numb. The patient's left arm is still hurting, felt heavy, numb, tingling and it's been almost 24 hours from the time of report. The reporter assessed the events as non-serious. No treatment was administered for the events. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Body temperature, Pyrexia, Tinnitus
Clinical narrative: Fever at 101 Fahrenheit; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 09Jun2021 15:00 (Lot Number: EW0217) as single dose, for COVID-19 immunisation. Medical history included torticollis, post-traumatic stress disorder, depression, cyp2b6 gene status assay, cyp2c19 gene status assay, cyp2d6 gene status assay, hysterectomy, menopause, food allergy, hypersensitivity, rubber sensitivity (to latex and latex foods), allergy to surgical sutures, food allergy, seasonal allergy, drug hypersensitivity (to gabapentinoids, SSRI's, SNRI's), COVID-19. Patient was not pregnant and was not pregnant at time of vaccination. Concomitant medications included trazodone (unknown manufacturer), diphenhydramine hydrochloride (BENADRYL), cyclobenzaprine (unknown manufacturer), erenumab aooe (AIMOVIG). Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EW0182), in right arm, on 17May2021 at 01:00 PM at 53 years, for COVID-19 immunisation and miconazole nitrate (MONISTAT) and experience drug allergy. Patient did not receive other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced fever at 101 Fahrenheit (disability) on 16Jun2021 07:00 with outcome of not recovered, tinnitus (disability) on 16Jun2021 07:00 with outcome of not recovered. The patient underwent lab tests and procedures which included acoustic stimulation tests: no hearing loss on 16Jun2021, body temperature: 101 Fahrenheit on 16Jun2021. The events required physician office visit. No treatment has been administered as a result of the events. The patient has not been tested for COVID-19 since the vaccination.