chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site pain; Tired; Mild headache; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right on 10Apr2021 at 14:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included seizures, white blood cell count low and had sulfa allergy. The patient did not receive any medication within two weeks of vaccination. Concomitant medication included phenobarbital (MANUFACTURER UNKNOWN), phenytoin (DILANTIN) all for unknown indication, from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 20Mar2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.Since, 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 11Apr2021 at 09:00 the patient experienced injection site pain, tired, mild headache, fever, chills the day after 2nd dose. The chills were due to fever. The patient took Tylenol 1000mg, every 6 hours, fever was gone and the  patient was drinking plenty of fluids. Therapeutic measures were taken as a result of adverse events and included treatment with Tylenol (1000mg, every 6 hours). The clinical outcome of the events injection site pain, tired, mild headache, chills was recovering at the time of this report. The clinical outcome of the event fever was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
I became extremely cold and could not get warm.. Bundled up and went to bed for the night. The next morning, 08/25/2018 I awoke and was not cold. Within five minutes after waking up I once again became extremely cold. I also started feeling poorly, (a mild headache, extreme bodily aches and pains). As the day progressed, I went from extreme cold to extreme sweating. The bodily aches and pains continue and presently I am once again sweating. The time is now 5:24 central time. If this continues, I will see my physician Monday morning.
The pharmacist gave me this shot subcutaneous when it is supposed to be an IM. As a result I have had significant swelling, itching and pain at the site of the injection that seems worse that what would be expected. The size of the reaction area is 6 inches up and down by 5 inches around my arm. Even today, 3 days later, the discomfort and swelling still exists. I am also concerned about whether the shot is still effective or if I now have to get another shot.
Patients left arm from injection site down to elbow is black and blue (appears to be bruised, possibly hematoma).  Skin has a yellow tinge.  No itching or pain.  No swelling.  Reaction occurred 2 days after vaccination.
pt c/o lightheadedness p/vax & immed stiffened then twitched, general & unresponsive x10sec;pt c/o diaphoresis, warm feeling, lightheadedness;observed pt x 30min;
tiny bit of a sore throat only first thing in the mornings; Stuffy nose; cough; a little bit of a headache off and on; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (tiny bit of a sore throat only first thing in the mornings), NASOPHARYNGITIS (Stuffy nose), COUGH (a bit of a cough, which is not bad cough) and HEADACHE (a little bit of a headache off and on) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MONTELUKAST SODIUM (SINGULAIR) and BARIATRIC ADVANTAGE ULTRA MULTI WITH IRON for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (tiny bit of a sore throat only first thing in the mornings), NASOPHARYNGITIS (Stuffy nose), COUGH (a bit of a cough, which is not bad cough) and HEADACHE (a little bit of a headache off and on). At the time of the report, OROPHARYNGEAL PAIN (tiny bit of a sore throat only first thing in the mornings), NASOPHARYNGITIS (Stuffy nose), COUGH (a bit of a cough, which is not bad cough) and HEADACHE (a little bit of a headache off and on) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient got exposed from his 19 year old son & tested positive for Covid-19 . He thinks the symptoms are not related to first dose. Patient prefers to be contacted by phone.
I got the vaccine, I feel bad; I got ball rolled under my armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I got the vaccine, I feel bad) and AXILLARY MASS (I got ball rolled under my armpit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I got the vaccine, I feel bad) and AXILLARY MASS (I got ball rolled under my armpit). At the time of the report, FEELING ABNORMAL (I got the vaccine, I feel bad) and AXILLARY MASS (I got ball rolled under my armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications were reported.
Upper extremity dysfunction; Eye disorder; This is a spontaneous report from a non-contactable consumer based on the information received by Pfizer.   A elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced upper extremity dysfunction on an unspecified date with outcome of not recovered , eye disorder on an unspecified date with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was unknown.  No follow-up attempts are needed. No further information is expected.
Swelling at the injection site; Red at the injection site; Itchy at the injection site; Low grade fever which she managed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever which she managed), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product DENOSUMAB (PROLIA) for an unknown indication.    No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient started DENOSUMAB (PROLIA) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced PYREXIA (Low grade fever which she managed). On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site). On 10-Feb-2021, PYREXIA (Low grade fever which she managed) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the low grade fever included ibuprofen.
event that occurred the evening she got the second shot. It has been re-occurring since then; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (event that occurred the evening she got the second shot. It has been re-occurring since then) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (event that occurred the evening she got the second shot. It has been re-occurring since then). At the time of the report, ADVERSE EVENT (event that occurred the evening she got the second shot. It has been re-occurring since then) outcome was unknown.            This case was linked to MOD-2021-030826 (Patient Link).
extreme aching, confusion, anorexia, weakness, jaundice, lt arm very tender; dec urine output;nausea/o vomiting;no BM today;mom thought it was flu waited 3 days a/taking child to ER by that time pt was dehydrated;tx w/fluids;
I was diagnosed 3 days after the second dose of vaccine with acute pancreatitis, and I had a paralytic ileus associated with the pancreatitis.
heart murmur; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart problems" (unspecified if ongoing), notes: in the past. The patient took concomitant medications. The following information was reported: CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur". Additional information: Caller mentioned she saw an advertisements of the new Moderna COVID-19 vaccine for new variants, but the advertisements mentioned that it could cause heart inflammation and inflammation lining of the heart. She wanted to know if the Pfizer 2023-2024 formulation also had this side effect. She mentioned she wanted to know because in the past she already experienced heart problems and wants to know whether or not to get the vaccine. Upon learning that the Pfizer COVID-19 Vaccine does have reports of myocarditis and pericarditis, she mentioned she did experienced a heart murmur after having 3 previous Pfizer COVID-19 Vaccine doses last year and the year before. She mentioned she experienced this murmur after previous doses, but she never thought it could be related to the vaccine as she changed her treating physician. However, she never had any problem and the only thing she's done different was getting the vaccine. She mentioned she does take a low dose of blood pressure medication, but she had been taking it before and didn't change anything in what she does, and she has the same diet. She didn't report it because she never thought it could be related. Caller mentioned she was scared of the side effects and had to balance what is worse if the side effects or COVID-19, mentioning she was specially  scared of the blood clots and the heart inflammation. She stated she was concerned on this information as she has a holiday dinner next week and doesn't want to risk it, as many of her friends have used Moderna and have gotten very sick. She mentioned she still wears a mask and people look ugly at her and proceeded to mention that she lives in where people are ignorant and many didn't even get the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300392535 same patient/product/events.;
Tolerated vaccine well but woke up next morning and noticed a bald spot on her head. To see dermatologist on 12/11/21.
Pt felt fine had shingles shot Next day began to have acute abdominal pain found to have blocksage in ER
On 10/18/18, morning after vaccination, parents noticed redness at vaccination site, but didn't think much of it because child has had pretty strong localized reactions to other vaccines in the past. Child's skin is also very sensitive to other things. Swelling and warmth at site started later that day at school and progressed throughout the day. After school child was seen by primary care provider, who advised that this was likely an inflammatory response and told parents to give child ibuprofen. Parent reports that ibuprofen helped with inflammation. Symptoms started to disappear on Saturday, 10/20 and were completely gone by Wednesday, 10/24.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 7 month old infant patient of unknown gender. On 04-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Patient received her Pfizer Covid-19  shot on Wednesday April 14th at 5:30 pm. She stayed at the pharmacy area for 15 minutes with no symptoms and  went home.  Three days later on Saturday April 17th, she woke up and not being able to feel her right side of her face. She went to Emergency room  and doctor told her that she has bell's palsy due to covid-19  shot. She was prescribed Prednisone 20mg  and Valtrex 1g.
24 hours after taking the vaccine, I experienced firm and tender lymph nodes (behind both ears). Approximately 24-48 hours later, my neck and ears developed a bumpy rash. The rash turned into hives on both ears. Taking ZYRTEC 10mg bid x 24 hours, no resolution to symptoms yet.
COVID-19 breakthrough. 83-year-old with PMHx dementia, HTN, HLD, alcohol abuse and urinary incontinence s/p nerve stimulator presents to ED via EMS. Symptoms worsening per patient's husband. CT abdomen/pelvis with patchy bibasilar ground glass opacities. Patient afebrile. Room air SAT 96%.
This study case was received from the investigator on 27 August 2012. A male subject with a medical history of penicillin allergy had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 28 July 2010 (also with a reported date of 30 July 2010) an elevated central laboratory Troponin level of 0.15 ng/ml and on 03 August 2010 a central laboratory Troponin level of 0.11 ng/ml. The subject had a rapid Troponin I level on 28 July 2010 that was within normal limits (negative). Treatment (other than medication) was given. On 26 July 2010 (also a reported date of 28 July 2010), the patient experienced swollen glands in the clavicle area on the right injection site. On 03 August 2010, the subject had a normal ECG reading. There was no other reported visit. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was ongoing. According to the Investigator, the event of elevated central lab troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. *List of docs held by sender: medical records.
This case was reported by a physician via call center representative and described the occurrence of squamous cell carcinoma in a 54-year-old male patient who received ENGERIX B (batch number AHBVC064CA, expiry date 22nd March 2014). Previously administered products included ENGERIX B (1st dose - AHBVC018BA - left deltoid) and Hepatitis B vaccine (2nd dose - H010965 (Merck) - the left deltoid). Concomitant products included omeprazole, ramipril and simvastatin. On 20th November 2013, the patient received the 3rd dose of ENGERIX B. On 24th November 2013, 4 days after receiving ENGERIX B, the patient experienced squamous cell carcinoma (serious criteria GSK medically significant and other). On 8th January 2014, the outcome of the squamous cell carcinoma was recovered/resolved. It was unknown if the reporter considered the squamous cell carcinoma to be related to ENGERIX B. Additional information was received: 4 days after receiving the 3rd dose of vaccine, the patient reported a growth near the injection site. The growth was on the left deltoid. As per the patient, the growth grew rapidly. On 10 December 2013, the patient went to his PCP (different doctor) and had the growth removed. On 17 December 2013, the pathology report came back stating that the growth was squamous cell carcinoma. On 8 January 2014, the plastic surgeon confirmed that the carcinoma had been removed in total.
Wife reported 103 temp-body aches and chills. TYLENOL relieved symptoms. RPh told to give TYLENOL q 4-6h prn symptoms; symptoms persisted for approx 48 hours before resolution.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF LEFT PERONEAL VEIN
This woman is an employee who is a case worker for the developmentally disabled. She recieved Engerix on August 15th 2006, as a first immunization in a preventative series of three. She developed headache, nausea and upper body muscular skeletal aches and pains and chills. She was seen by a physician on August 17 and it was determined to be an allergic reaction. She has recovered completely but she has been counciled that in the event of an exposure to Hepatitis B she will need to get HBIG initially and again in 4 weeks.
Left arm swollen to wrist for 2-3 days. Pt. stayed in bed one day.
This spontaneous report was received from a physician refers to a 24 year old female patient. Physician stated that patients have been coming in with incomplete GARDASIL series. On an unknown date in 2010(reported as 3 years ago), the patient was vaccinated with dose 1 GARDASIL(lot#, expiry not reported). No concomitant medications were reported. She did not receive the subsequent doses of GARDASIL. Physician inquired if the series could be restarted or give the patient the remaining 2 in the GARDASIL series. Physician wanted to know where to find guide lines for incomplete series. Additional information has been requested.
CEREBRAL VENOUS SINUS THROMBOSIS; This spontaneous report was received from literature. This report concerned multiple female patients (6) of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced cerebral venous sinus thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cerebral venous sinus thrombosis was not reported. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210957986.; Sender's Comments: V0: 20211002675-covid-19 vaccine ad26.cov2.s-cerebral venous sinus thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a registered nurse (RN) concerning a 30 year old female with no allergies or medical history who was vaccinated with a dose of MMR II as a child (date and dose not reported). There was no concomitant medication. On 05-SEP-2008 the patient had a titer drawn (for school entrance) and was found not to have immunity for mumps. No adverse effects were reported. The patient sought medical attention at the office. There was no product quality complaint involved. Additional information has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW015B), on 01May2021 as dose 2, single (Lot number: EW0172) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 52 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "tested positive on 16May with rapid AG". The event "tested positive on 16May with rapid ag" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. No follow-up attempts are possible. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.