chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEHYDRATION; CANNOT EAT DUE TO BLISTERS AND INFLAMED GUMS; CANNOT DRINK DUE TO BLISTERS AND INFLAMED GUMS; DIZZY/LIGHTHEADED; INFLAMED GUMS; MOUTH BLISTERS; INFLAMED, SWOLLEN AND SORE THROAT; SWEATS; CHILLS; FEVER; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user (Social once in a month), and non smoker, and other pre-existing medical conditions included patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced sweats, chills, fever, muscle aches, nausea. On 12-MAR-2021, the patient experienced mouth blisters, inflamed, swollen and sore throat and the patient was given steroid shot. On 13-MAR-2021, the patient experienced dizzy/lightheaded, inflamed gums. On an unspecified date, the patient experienced dehydration, cannot eat due to blisters and inflamed gums, and cannot drink due to blisters and inflamed gums. The patient was given IV for dehydration. Laboratory data (dates unspecified) included: Streptococcal sore throat (NR: not provided) Negetive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed, swollen and sore throat on 13-MAR-2021, and sweats, chills, fever, muscle aches, and nausea on 12-MAR-2021, had not recovered from mouth blisters, dizzy/lightheaded, and inflamed gums, and the outcome of dehydration, cannot eat due to blisters and inflamed gums and cannot drink due to blisters and inflamed gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210329079-covid-19 vaccine ad26.cov2.s -Mouth blisters, Inflamed Swollen and sore throat, Cannot eat due to blister, Cannot drink due to blisters, Dizziness, Dehydration, Inflamed gums, Sweats, Chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210329079-covid-19 vaccine ad26.cov2.s -Fever, Muscle aches, Nausea. These events are labeled and are therefore considered potentially related.
My arm began to hurt about 10:30 am, then by evening I had headache, body chills, muscle spasms, fever, and nausea.  I could not left my left arm without pain for 3 days.  I did not feel well for about a week, very tired.
This spontaneous report as received from approximately 71 years male patient with "borderline" diabetic, refers to himself. The patient had no drug reactions or allergies. On an unknown date, 2-3 years ago, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, frequency and route of administration not reported). Concomitant therapies included metoprolol tartrate, losartan potassium (manufacturer unknown), omeprazole (manufacturer unknown), COLCRYS, ULORIC, metformin, pravastatin sodium, terazosin hydrochloride and warfarin sodium (manufacturer unknown). In February or March 2013, the patient developed shingles on his face. It was a "pimply" rash on one side of face near eye. Caller said that it "seems like" he had shingles prior to receiving vaccine but wasn't sure. In addition, the patient stated that he had developed a "possible problem" with his kidney while taking metformin and discontinued that medication. None lab diagnostics studies were performed. The patient did seek medical attention, he visited office but he was not hospitalized. No treatment was given for shingles. The outcome of shingles were reported as recovered/resolved on an unspecified date in 2013. The outcome of "possible problem" with kidney was unknown at the time of the report. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Diagnosed with rheumatoid arthritis; Tiny bump on her arm; A spontaneous report was received from a consumer concerning a 72-years-old  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rheumatoid arthritis, tiny bump on her arm/ lymphadenopathy.  The patient's medical history included was rheumatoid arthritis.  No relevant Concomitant medication was cortisone injection .   On 04FEB2021, approximately 11 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030l20a) through Intramuscular route for prophylaxis of COVID-19 infection.   On 04FEB2021, after vaccination patient experienced rheumatoid arthritis, tiny bump on her arm/ lymphadenopathy. The event rheumatoid arthritis was medically significant. Treatment for the rheumatoid arthritis included etanercept .Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, rheumatoid arthritis ,tiny bump on her arm/ lymphadenopathy  were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a 12-month-old male birth triplet with no known allergies who on 03-Feb-2004 was vaccinated in the left leg with a dose of varicella virus vaccine live (lot #644789/0329N). The nurse reported that on 03-Feb-2004, the patient experienced a local site reaction and developed hives at site immediately post vaccination. The patient was observed for 45 minutes and was treated with oral diphenhydramine hydrochloride (Benadryl). The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center of Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that the patient's brother and sister experienced a similar reaction after therapy with varicella virus vaccine live (WAES #0402USA01433 and 402USA01540). The nurse reported two other children who experienced a similar reaction after therapy with varicella virus vaccine live (WAES#0402USA01546 and 0402 USA01547). It was noted that the triplets had the worst reaction. The nurse also reported two other children who experienced a similar reaction after therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES #0402USA01554 and 0402US01555).
Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints. Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 40-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Aug2021 16:00 (Batch/Lot Number: FA7484) (at the age of 40-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no known allergies reported. Concomitant medications included hydroxyzine embonate (VISTARIL) as needed taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride daily (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jul2021 16:00 (Batch/Lot Number: EWA82) for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. On 04Aug2021 17:00, the patient experienced fingers swollen with redness and pain at the joints.severe discomfort of muscles and joints.raised hives covering most of body including eyelids.doctor gave steroids. The events resulted in emergency room visit. The patient received treatment with antihistamines and steroids. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
12 y.o  was mistakenly given Pediatric Pfizer dose instead of 12+ Pfizer dose
Reoccurring migraines - between 5-11 a month. From may to September 2021. Had to get onto medication for them. I believe this was caused by the modern vaccine. I did not have them like that before.
On 3-31-2021, administered dose ONE of the Pfizer Covid vaccine. the patient received  dose TWO, which was Moderna,  on 4-8-2021.
This report described the occurrence of back pain in a 39 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and was subsequently medically confirmed via medical treatment records received through the litigation process. The patient received injections of Lymerix on 7/17/00, 8/17/00, and 8/7/01 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered back pain according to the client. The onset of his symptoms is not clear at this time. Treatment and outcome of the alleged event were not reported. The following information was received via medical records. The patient's medical history included a vertebral fracture when he was in the seventh grade, and Lyme Disease in 1999 with associated joint pain in the hip and shoulder. The patient's family history was significant for arthritis in the patient's mother. On 7/17/00 and 8/17/00, the patient received his first and second Lymerix vaccinations. Subsequent to receiving his third Lymerix vaccination sometime in 2001, in the summer of 2001, the patient developed throbbing pain in either his upper or lower back, which awakened him early morning. The patient also experienced morning stiffness. The symptoms were noted to be worse when lying down, performing intense yard work, or with prolonged and repetitive bending. The pain in the back did not radiate, and the patient retained an excellent range of motion of his back, without obvious structural deformities, negative straight leg raising, and no neurologic deficit. He experienced no peripheral joint symptoms, synovitis, effusions, nor focal tenderness of the spine. His pain was assessed to be fairly localized and neuropathic in origin, without evidence of acute inflammatory arthritic process. Neurontin was initiated, but was subsequently discontinued due to lack of efficacy. Treatment included ibuprofen, and the patient was advised to perform stretches. Diagnostic tests showed the patient to be HLA-B27 positive, and sacroiliac films were negative without sing of an inflammatory process. MRI of the lumbosacral spine showed mild degenerative disc bulging. A bone scan showed mild degenerative changes of the thoracic spine without pathologic lesion. On 1/2/02, back pain was described as muscular. A consult letter from a rheumatologist dated 2/3/03 indicated that the patient's symptoms improved following treatment with Vioxx. Following the reported onset of back pain, the patient experienced chest pain and possible ischemia. These were not reported as adverse events due to vaccination administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events.
Body ache/ pain; fever of 101°F-102°F; Chills; Vomiting; Constipation; Really sick; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), ILLNESS (Really sick), MYALGIA (Body ache/ pain), PYREXIA (fever of 101°F-102°F) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced CONSTIPATION (Constipation), ILLNESS (Really sick), PYREXIA (fever of 101°F-102°F), CHILLS (Chills) and VOMITING (Vomiting). On an unknown date, the patient experienced MYALGIA (Body ache/ pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, CONSTIPATION (Constipation), ILLNESS (Really sick), PYREXIA (fever of 101°F-102°F), CHILLS (Chills) and VOMITING (Vomiting) had resolved. At the time of the report, MYALGIA (Body ache/ pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101°f - 102°f (High) Body temperature 101°F - 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followed up received on 29-jun-2021  that contains event and product information.
Patient presented to ED by EMS on 6/21 due to increased weakness and dry cough, subsequently admitted. Tested positive for COVID-19 via PCR on 6/21. This meets criteria for vaccine breakthrough case review.
Immediately after each injection, I had a metallic taste in my mouth that lasted for 30 minutes.
I have had a Stroke in the past and I had serious side effects from that. Since that time, I have not regained my strength after that time, and I have had problems with my appetite. Since I got my second dose of the vaccine I seemed to be doing Ok. Starting in July the heat has been very bad. Air quality is an issue in my area but recently I felt so weak and shaky that I was unable to do anything. My appetite has been very reduced. I am scheduled for more testing and an MRI showed a growth on my Thyroid. I have been prescribed Thyroid medication and I am seeing an Endocrinologist. I did not have a Thyroid problem before.
Rash on arm around injection site and upper back along with itching all over body Took Benadryl and used topical creams
This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # M032635 with expiration date of 05-MAY-2018, lot # N010105 with expiration date of 15-NOV-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours and 8 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005079: US-009507513-1708USA002718:
1/20/21 developed fever of 105 degrees, after Tylenol and Advil dropped to 104 which continued for 6 days.  Also had nausea and vomiting which led to dehydration, hospitalized on 1/25/21 with Acute Cholecystitis without calculus, Hyperbilirubinemia, UTI, Acute kidney injury secondary to dehydration, Pyelonephritis.  Surgery done for Cholecystectomy. 2 units of blood also administered.
2-3 days mild itchy scattered pruritic macules progressive increased until day of eval on 7/30/09 R arm injection site redness/includes multiple scattered hives both feet / legs arms hands - severely pruritic; tx'd with Prednisone taper/7 days and Triamcinolone.
After receiving first mRNA Covid vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.
The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
feeling sick; dehydrated; Headache for 3 days; Nausea for 2 days; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache for 3 days), NAUSEA (Nausea for 2 days), DIARRHOEA (diarrhea), MALAISE (feeling sick) and DEHYDRATION (dehydrated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048821A and 037821A) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgery on left side due to beast cancer 4 yrs ago.).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DEHYDRATION (dehydrated). On an unknown date, the patient experienced HEADACHE (Headache for 3 days), NAUSEA (Nausea for 2 days), DIARRHOEA (diarrhea) and MALAISE (feeling sick). At the time of the report, HEADACHE (Headache for 3 days) and NAUSEA (Nausea for 2 days) had resolved and DIARRHOEA (diarrhea), MALAISE (feeling sick) and DEHYDRATION (dehydrated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications were Oral medication for breast cancer provided by the reporter . Treatment information were not provided.   This case was linked to MOD-2021-138867 (Patient Link).
I got sick are the years that I got the flu shot; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced "i got sick are the years that i got the flu shot" (illness) when received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "i got sick are the years that i got the flu shot" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "No flu shot for me. Because the only years that I got sick are the years that I got the flu shot and every year that I didn't get the flu shot I didn't get sick at all."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the batch number for this case.
pt c/o itching at inj site, progressed to burning sensation, lightheadedness, numbness of left hand, resolved in approx 1 hour.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 21st February 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose (batch number LT533) received on 4th May 2018, refer linked case US2018128734). On 9th July 2018, the patient received the 2nd dose of SHINGRIX. On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid (the batch number was reported as TN227, which was corrected to ZN22Z as per sales data sheet). This case has been linked with US2018GSK129131, US2018GSK129134 and US2018GSK129168 reported by same reporter.
Injection given too early. 1st dose given 1/25/21. Second Dose given 2/5/21.
pt recvd vax;mom called office stating pt had sz at noc;described it as a "trembling" of whole body,lasted approx 1-1 1/2 mins;mom states 2 prior sz assox w/ fever but never p/ a vax;apap given 9jan95;had sz on 10jan95 at 3:30am;
pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes and trouble swallowing. Pt. was advised to go to UC or ER. Pt. presenting today for Swollen glands (had 1st dose vaccine on Saturday, Monday started having swollen glands in neck
Mother states "eye lids swelling, and severe stomach cramps". Was not seen by physician in office after symptoms occurred.