chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm at injection site (left arm), swollen lymph node  (under left arm), chills, low-grade fever, body and muscle aches, headache, nausea, fatigue for 24 hours
lot of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 67-year-old patient who received Herpes zoster (Shingrix) (batch number Mh67) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number Mh67) for prophylaxis.   The patient's past medical history included shingles (had shingles 9 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced pain (Verbatim: lot of pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 02-MAY-2023 The patient asked that, how come you did not let people know they could get shingles after having your vaccine? The patient asked somebody call him/her about your vaccine and the way it did not worked. The reporter thought that it should be made known when you get this vaccine that you will still get shingles, people believed they will never get shingles again this is just not true and also just the two vaccines were not enough if even that. The patient stated that he/she had never seen this information on your commercials everyone he/she know who had gotten the vaccine seems to think they were never going to get shingles and when they give you the vaccine they did not give you this information, so this should be made more well-known. The patient stated that could file a product feedback case with all of this should be made known to okay.  The patient had the both the vaccine 3 years ago and had a lot of pain. The patient stated that he/she could say the vaccine less and the effects of shingles but sadly it did not.
Patient was 17 years of age at the time the 1st dose of Moderna vaccine was given.
Information has been received from a lawyer regarding a case in litigation concerning a 65 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 21-MAR-2015, at age 62, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. In December 2017, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself and economic losses. Additional information has been requested.
Pt got GARDASIL # 3 given as injection; approximately 5 mins later stood up; was walking out of room and fainted. Pt also had blood drawn as well and hadn't eaten much that day.
12hr after shot I have experienced nausea, vomiting, headache, stiff neck, aches and pains, trouble sleeping, feeling like I have a fever but do not, sweating profusely
pt recvd vax & was swelling, redness w/ heat; t 102; pt seen at ER; swelling was on RL 7cmx4cm; tx apap, benadryl & cool packs on leg;
This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is sixth of eight reports. A patient of unspecified age, ethnicity and gender received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history and concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Next few days after vaccine: nauseous, dizzy, headache  On Friday the 22nd left arm was sore again  On Sunday the 24th firm, raised, mildly painful rash on upper left after under injection site. Gone in 48 hours.
shortness of breadth;chills;fever 101;muscle aches;neck stiffnes/;site soreness
01/18/22 presents to Birth Center Triage for "elevated BP". PMHx of "Environmental allergies, Weight disorder"
AG 25Mar2022, 26Mar2022; AG 25Mar2022, 26Mar2022; severe cold symptoms; myalgia; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3 (booster), single, administration date 30Mar2021 (Lot number: EP6955) as dose 2, single and administration date 11Mar2021 (Lot number: EN5318) as dose 1, single 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 25Mar2022, outcome "unknown" and all described as "AG 25Mar2022, 26Mar2022"; NASOPHARYNGITIS (non-serious) with onset 25Mar2022, outcome "unknown", described as "severe cold symptoms"; MYALGIA (non-serious) with onset 22Mar2022, outcome "unknown", described as "myalgia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Mar2022) positive; (26Mar2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasopharyngitis, myalgia.  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 Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
nausea; vomiting; body aches; lightheaded ness; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included hydrocephalus. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 22:00, the patient experienced nausea, vomiting, body aches and lightheaded ness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, body aches and lightheaded ness was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Patients mother attested child's birthday was , signed document stating birthday and filled out all paperwork with said birthdate. First covid vaccine given 11/20/2009. Upon second dose child's father confirms child's birthdate making his first dose before age 12.  Second dose given on 12/11, 21 days later as child had turned 12.
Exactly 1 year later, I was treated for submassive pulmonary embolism. I almost died due to having so many blood clots that I did not know I had. No prior medical history of blood clots or family history or injuries to cause it. Active and healthy and don?t smoke. I?m on eliquise for the rest of my life. Surgery removed the clots.
ill; flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a male patient (age unspecified) who felt ill (malaise) and had flu (influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was ill (malaise) and had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter's dad got very ill after getting the flu shot 3 years in a row. He came close to dieing the 3rd year. Family begged him not to get a flu shot the following year, he did not and he did not get the flu either. He never did get another flu shot after that and he never did get the flu again.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Information has been received from a physician concerning a 38 year old (now 52 year old) female patient with breast cancer and no drug reactions/allergies on 16-FEB-1996, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). In May 1996, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# not reported). On October 2009, the patient was vaccinated with the third dose of VARIVAX (Merck) (lot # 665025/0992Y). Concomitant therapy included AROMASIN, EFFEXOR and multivitamins (unspecified). The patient  had antibody titers test performed. The physician stated that the patient continued to have negative titer even after receiving three doses of VARIVAX (Merck). The patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician who reported that on 21-OCT-2009, the patient with bee sting allergy and osteopenia and a history of breast cancer, was vaccinated intramuscularly in the left arm with the second or third dose (not sure) of VARIVAX (Merck) (lot # 665025/0992Y). On 06-AUG-2010, a varicella zoster virus IgG test performed was <0.9. Failed to show immune response to vaccine. At the time of the report, the patient's outcome was unknown. No further information is available.
Localized redness and swelling  at shot site, Fussy, No flush or respiratory distress.
After 7-10 days after the second Pfizer shot, my existing Tinnitus worsened in my left ear.  The ringing grew louder and I felt a shock if someone yelled or if there was a loud noise.
Injection site pain; Rash; Itching; Hives area of about 6" wide and 8" long; Area was hot, had swelling; Redness; Warm pain; Slight fever of 100.7; Head pain; Neck pain; Muscle pain; Joint pain; Feeling of unwellness; Area was hot; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration, administered in the left arm on 14Apr2021 at 11:30 (at the age of 64-years-old) as a dose 2, single for COVID-19 immunization. Medical history included blood pressure high and had unspecified known allergies. The patient has taken unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration, administered in the left arm on an unspecified date in 2021 (at the age of 64-years-old) as a dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021, the patient experienced injection site pain, rash, itching, hives area of about 6" wide and 8" long, area was hot, had swelling, redness, warm pain, slight fever of 100.7, head pain, neck pain, muscle pain, joint pain and feeling of unwellness for about one week, after the second vaccine. The patient underwent lab tests and procedures which included body temperature: 100.7 (Slight fever) on an unspecified date. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for events. The clinical outcome of all the events was recovered on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At end of April began feeling very sick. Extreme fatigue, muscle aches. No explanation for this. Went to several doctors. Send to rheumatologist. Ended with probable lupus diagnosis on 8/11/21. Possible that vaccine triggered it.
I had no side effects from the vaccine. The week of 09/26/2022, I had muscle pain and cramps in the upper right side of my back. I also had cramps in the back of my thighs. It went down from my shoulder to my hand that made it difficult to use it. I also had cramps in the back of my thighs. I contacted my doctor, and we treated the symptoms with muscle relaxer, hot/cold compresses, MOTRIN and rest. As of today, I'm feeling better but being careful.
Information has been received from a physician concerning a 15 or 16 year old female with a history of "getting dizzy", who, on an unspecified date, was vaccinated with a 0.5mL dose of Gardasil. On 24-JUL-2007, the patient fainted. The patient sought unspecified medical attention. On 24-JUL-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Pink dots around injection site on right arm. No itching reported. Pink dots lasted about a week.
My arm was achy; Tired for day, or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was achy) and FATIGUE (Tired for day, or so) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was achy) and FATIGUE (Tired for day, or so). At the time of the report, PAIN IN EXTREMITY (My arm was achy) and FATIGUE (Tired for day, or so) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-360547 (Patient Link).
This case was reported by the mother of a consumer and described the occurrence of stiff neck in a 38-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included history of Lymes disease. In February 2011 the subject received 2nd dose of HAVRIX (unknown). On the day of HAVRIX vaccination, the subject experienced stiff neck, stiff back and stiffness in shoulder. At the time of reporting the outcome of the events was unspecified.
watery eyes, erythematous conjunctivitis, eyelids edema, cough;zyrtec;
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
headache; Had soreness in arm; This is a spontaneous report from a non-contactable consumer. A female patient in her 60s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 23Dec2020 to 23Dec2020 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced had soreness in arm and a headache on 24Dec2020. The outcome of the events was unknown.  Information about lot/batch number has been requested.
pt devel encephalomyelitis w/severe peripheral neuropathy; pt w/ weakness, tremors, shakes & somnolence; sore spot on rt lower to mid abd; necrotic tissue; t101.3; anorexia; 13 lb below nl weight, lethargy, dec hearing, tenderness, GBS
Very sleepy with joint pain.  Still have headache and joint pain, somewhat sleepy and mild nausea as 02/14/2016.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAY-2016, the patient was inadvertently vaccinated with a dose of improperly stored M-M-R II lot # L030162, expiration date reported as 11-AUG-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 50.9 degrees Fahrenheit for 1 hour 30 minutes. Data logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
Headache, Body Ache, Tired, soreness at injection site. Took Advil 24 hours after injection., started to feel better about 30 hours after injections.
Information has been received from a registered nurse concerning a 5 year old female who on 30-SEP-2002 was vaccinated in the right thigh with a SC first dose of Varivax (lot # 643084/0472M). There was no illness at the time of vaccination. On 30-MAY-2006 the patient developed a fever and a rash. Subsequently, the patient recovered. Additional information has been requested.
Patient with COVID vaccines who admitted with positive COVID PCR and COVID complications.  Provider d/c note:  "Patient presented to the emergency department on 10/12/2022 with a chief complaint of shortness of breath.  On arrival he was found to be COVID positive as well as be in DKA.  He was intubated, placed on pressors and put in the intensive care unit.  He was treated for septic shock for which infectious workup showed MSSA bacteremia as well as candida urinary tract infection.  He also had MSSA, Klebsiella and Enterobacter in his sputum.  He was seen by infectious disease during the course of his stay and completed a course of micafungin and meropenem in with a transition for an additional 6 weeks of oral antibiotics.  He also developed an AKI during the course of his stay and did require temporary hemodialysis  as well as the ureteral stent exchange with Urology.  He was seen by pulmonology for his pneumonia as there was concern for lung abscess but this was not large enough to require drainage.  His stay was also complicated by encephalopathy which did resolve over time.  He completed his treatment for MSSA bacteremia and had a negative TEE.  He will be discharged on oral Augmentin and Bactrim per Infectious Disease recommendations to complete his antibiotics.  He will need a repeat CT scan outpatient with Infectious Disease.  He was also found to have dysphagia during the course of his stay which resolved with eventual diet modification.  Patient was tolerating diet well on day of discharge.  Due to his persistent hypotension patient was placed on midodrine and blood pressure remained borderline low but stable.  His kidney function eventually returned to baseline.  Patient's symptoms continued to improve over the course of his stay and he will be discharged in stable and improved condition.  He will need to follow-up with Infectious Disease as well as Urology.  He will be discharged to facility.  "
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Positive, notes: Tested positive again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Office practice was to draw up all doses from vial at the beginning of the day. They discarded vial w/o a double check. They had bivalent NDC, lot and expiration on a sticky note and used this as source of data for EMR. At some point the realized that some days they had pulled monovalent vaccine and administered instead of the intended bivalent vaccine.
rash; This case was reported by a nurse and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included benadryl (nos) (Benadryl) for rash.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received in 27th August 2020 refer case US2020AMR215173).   On an unknown date, the patient received the 2nd dose of Shingrix and Benadryl at an unknown dose and frequency. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd injection of Shingrix. The physician advised to take Benadryl prior to receiving Shingrix. The patient developed rash 2 days after vaccine. The physician prescribed prednisone also. It was unknown if the reporter considered the rash to be related to Benadryl.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215173:Same patient
consumer devel shingles on 6JUN96, 42 days p/consumers child had been vaccinated w/varicella vaccine;consumer felt shingles were r/t child vax;pt child did not devel lesions or inj site complaints p/vax;
patient reported symptoms from receiving the covid vaccine on 12/30/2020. On 1/6/2021 she indicated that she developed symptoms at the vaccination site such as circumscribed, indurated, and erythema area at the injection site. She notes some discomfort. Currently denies fever, SOB, or sore throat. Patient reports NKA and that she has never had a reaction to immunizations before. Patient also reports that her symptoms are improving and the area is starting to look better as of 1/8/2021.
No known adverse reactions, but received (2) doses in 6 weeks. Initial given 09/01/2021