chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted within 5 min after administration. He dropped his head, did not fall off chair he was in. 911 was called. He then had a few seizure like movements of his head for about 10 seconds, and then woke up. He admitted this happens to him occasionally. He refused 911 treatment, the ems team conferred with him by phone. His wife returned from shopping and they left.
Information has been received from a certified medical assistant concerning a patient, who on 12-SEP-2007 and 14-JAN-2008, was vaccinated with the first and second dose of COMVAX (dose, route and lot number not reported). Concomitant therapy included a dose of Hep B (manufacturer unspecified) administered on 12-JUL-2007. It was reported that the patient received COMVAX off schedule. The patient experienced no adverse events. Additional information has been requested.
erythema multiforme beginning same day Hep vax given pos mucous membrane involvement;
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the first 0.5 ml dose of Gardasil. Subsequently, the patient fainted and experienced seizures. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, seizures was considered to be an other important medical event. Additional information has been requested.
pt recvd vax & exp burning & swelling @ inject site which required tx w/ice; w/in several hrs of vax sx subsided; The nurse then switched to a diffrent lot# of vax & the sx did not recur; No further details were provided;
Redness and swelling at injection site, mild fever of 99, fatigue, nausea, diarrhea, chills, body aches and sore joints.
mild disease / cold-like symptoms; 5 of our employees tested positive with breakthrough infections; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (5 of our employees tested positive with breakthrough infections) and NASOPHARYNGITIS (mild disease / cold-like symptoms) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced COVID-19 (5 of our employees tested positive with breakthrough infections). On an unknown date, the patient experienced NASOPHARYNGITIS (mild disease / cold-like symptoms). At the time of the report, COVID-19 (5 of our employees tested positive with breakthrough infections) and NASOPHARYNGITIS (mild disease / cold-like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. no treatment details were reported.   This case was linked to MOD-2021-270723, MOD-2021-270620 (Patient Link).
p/vax a repeat prostate specific antigen level was 8; biopsy neg for prostate cancer
what is in this COVID vaccine that's making the Xeljanz not work for me anymore; This is a spontaneous report from contactable consumer. This 72-year-old female contactable consumer (patient) reported for self that received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date (at 72-year-old), as dose number unknown, single for COVID-19 immunization and tofacitinib citrate (xeljanz) at an unknown dose for unknown indication. The patient's medical history and concomitant medications were not reported. On an unknown date the patient complained that COVID vaccine made the Xeljanz not work for patient anymore It was mentioned that patient was on Xeljanz, she called in saying that she recently got her COVID shot and now the Xeljanz was not working. Consumer stated that she had been taking Xeljanz for few years and everything was going fine, she had no problem after she took the COVID shot, the Xeljanz has stopped working, She had been in so much pain to the point where you can barely walk sometimes, she had arthritis (Intent: Indication). She wondered if what was in this COVID vaccine that's making the Xeljanz not work for her anymore, since they were made by the same company. Consumer was provided with the number of Pfizer Medical Information Department. The event outcome was unknown.  PSCC Communication: PC Filed.   QR comment: CEP ID was not available over the call, hence CEP name was captured as Xelsource. Is there a Product Complaint: Yes Description of Product Complaint: Call was transferred from Xelsource by withheld. Transferring agent stated, "I do have a patient on the backline who have couple of question regarding the Pfizer. She is on Xeljanz, she called in saying that she recently got her COVID shot and now the Xeljanz is not working, she just had a couple of questions, I do have her on the back line." Consumer stated, "I have been taking Xeljanz for few years and everything was going fine, no problem after I took the COVID shot, the Xeljanz has stopped working, I have been in so much pain to the point where you can barely walk sometimes, I have arthritis (Intent: Indication). I was wondering what is in this COVID vaccine that's making the Xeljanz not work for me anymore, since they are made by the same company." Limited information was available over the call.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
CHILLS, FEVER, UPSET STOMACH, HEADACHE, MUSCLE AND JOINT ACHES, CONSTANT TIREDNESS, NO ENERGY, NO APPETITE, THIRSTY.  I HAD ALL OF THESE REACTIONS AFTER THE FIRST INJECTION ALSO. FIRST INJECTION WAS ON MARCH 3RD AND REACTION STARTED AROUND NOON ON THE 4TH
Dose of COVID 19 vaccine given 4 days after expiration. Incorrectly calculated expiration date.
This spontaneous report was received from a medical assistant refers to two unspecified patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On multiple unspecified dates, patients were vaccinated with improperly stored (temperature: -8.3 degree Celsius for 11 hours, because of data logger), PROQUAD (Merck), lot # L050908, expiry date 14-JUN-2017, (dose and frequency not reported). There was no previous temperature excursion reported. No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. No further information was provided.
Injection site swollen and painful, red, soft ball size. Advised to use cold compress and take BENADRYL.
On 9/28/06, pt presented to pediatric clinic with 4 day history of ascending weakness in bilateral lower limbs.  She was hospitalized on this day.  She also had associated pain to ankle, knee, and shoulder joints.  Deep tendon reflexes in lower extremities were absent at this time. DC DX: Guillain-Barre Syndrome. Presented with a 4 day history of ascending weakness in bilateral lower limbs. introductory symptoms began with weakness and tingling in the toes progressed to feet and legs. Associated pain in ankle , knee and shoulder joints reported as 7 out of 10 on pain scale with movement.  Neurologoic: 3/5 strength in both lower extremities, DTR absent in lower extremities. Tenderness to palpation of muscles medial to shoulders over scapulae and midline of lower back. 5/5 upper extremity strength bilaterally and downgoing plantars bilaterally. Intact light touch. On admission patient had increased protein (65)in CSF without elevated WBC. Neurology gave a diagnosis of distal ascending symmetric peripheral polyneuropathy, likely acute inflammatory demyelinating polyneuropathy (AIDP/GBS). Treated with IVIG for 5 days. Began to gain strength in both lower extremities and DTR.  DC home. In the hospital, she had a lumbar puncture and she received IVIG 0.4 mg/kg/day for 5 days.  She began to gain some strength back in lower extremities and deep tendon reflexes.  Discharged home in stable condition on 10/03/06, however, still c/o weakness and unable to stand for prolonged periods of time.
About 2 days after the vaccine, I notice a rash on my left arm.  It was deep pink, spotty and sensitive  to the touch.  It was 5 inches in length. I put ice on it.   I called my doctor and was prescribed an antibiotic (I can not remember the name).  I only took 2 pills because I consulted with other healthcare professional who suggested an antibiotic would not help.  The rash did started to go away.  It took several days for it to resolve.
On 02/15, we had a snow event. I was shoveling a path of snow and when I came back in the house, I noticed that my ears were ringing a lot. I noticed that I could not hear out of my right ear. I thought it was just stopped up, but nothing worked to clear it. I went to a walk-in clinic, and they set up an appointment with my PCP. My PCP set up an appointment for me to see an ENT. Doctor performed a hearing test and started me immediately on steroids. Beyond that, I had an MRI on my right ear, which they were unable to find any problems. I did that for several weeks. Right after my hearing loss, within the next week, I had a kidney stone, which I've never experienced in my life. After that I was sick for about 4-5 weeks. I had about 4-5 COVID-19 tests which were negative each time. I had a fever, headache that would not go away and loss of appetite. I could eat, but I didn't feel like eating. I was feeling a lot of anxiety, which I also do not have.  I did start physical therapy for my equilibrium loss.
Patient experienced extreme fatigue/lethargy, severe headache, painful and swollen arms, extreme erythema in left arm, and shivering. Patient stated that she had no energy to get out of bed and could not lift her arms. These events occurred the evening after the vaccinations were administering.
Initial report received from a healthcare professional on 03 September 2013. A 28-year-old female patient had received intramuscular first dose of ADACEL (Lot number C4432AB, anatomical site of vaccination was not reported) on 03 September 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 12 February 2013 and the expected date of delivery is 12 November 2013. The patient's health during pregnancy and risk factors (e.g. : alcohol, tobacco or recreational drugs) were not reported. Treatment for infertility was not reported. The patient did not experience any adverse event ill the time of this report. List of documents held by sender: None.
Diffuse headache, tremulousness, fatigue, skin hyperalgesia, nausea.
Urticarial rash within 6 H of administration of PREVENAR Lt  - MMR, VARIVAX, HAV
pain at the site of injection for 2 weeks. could not lift arm for several days. redness for a prolonged time
I was diagnosed with type 1 diabetes in 1997. I have never had any complications. On Thursday, 4/15/21, I had a seizure in bed and was taken to the emergency room. While the cause is unknown at this time, and I doubt it is related to the vaccine, I thought I should report it.
5/8/07 Sleeping and woke up with chills and c/o neck pain and aches-> Motrin 600 mg. 5/9/07 c/o nausea, stomachache, earaches T 102.4 deg at 3:00 pm Ears ok one red canal only per school nurse-ES Tylenol given and slept 3-4-07 pale and c/o weak and not feeling well. School nurse checked -> adeq strength/BP 102/60 P72 no numbness/tingling All s/s resolved in pm.
Nurse NP answers call 05DEC11 re 46 y/o patient with a large local reaction in her left upper arm about 48 hours after receipt of AVA #8 (03DEC11). NP speaks directly with patient, who confirms receipt of AVA #8 in LUE on SAT 03DEC11 around noon (around 48-50 hours ago). Patient denies receiving any other vaccines on the same day, but patient also received Typhoid IM (?) arm on 03DEC11. Patient did not receive any other vaccines w/in 30 day window prior this date. "The person who gave it to me didn't know what he was doing and gave it in in my triceps at the back of my left arm in the fatty tissue." The injection was very painful and it began to swell up that evening. My husband marked the redness last night and now the redness is a couple inches beyond his mark & extends down to just above my left elbow and is increasing in size. I took (1) 800 tab of ibuprofen and a BENADRYL last night for the itching. My left shoulder hurts a bit too. Patient denies prior h/o large local reactions (LLRs) with AVA's #1-7. "AVA's 1-7 were always sore like after a tetanus shot, but NEVER like this." Patient denies systemic malaise, fever, HA or chest pain. Patient denies paresthesias, numbness, weakness in LUE. Patient asked to email NP digital photos for review and further recommendations. PMH: Fibroid tumors uterus & anemia secondary to menorrhagia; partial hysterectomy (ovaries left in place) OCT 2010; no chronic or autoimmune dz. SOCIAL HX: Never smoked; very occasional ETOH; NO ILLICIT DRUG USE. MEDS: ZOLOFT. ALLERGIES: PCN, Sulfa, Latex (contact). FH: M (deceased 1976) Breast CA; MGM DM2; Sister (47 L) Sarcoidosis.
patient had not eaten all morning and was dehydrated ( we were told this after the fact)  .  patient received vaccine and was fine upon immediately receiving vaccine.  patient stood up and headed out the door of vaccination room in good spirits.  Once patient got outside of the door to waiting area , patient began to feel dizzy and sat down in the chair.  Patient began to sweat and show signs of impaired vision (spots) and discomfort.  Pharmacist immediately ran to get the patient soda and a bag of chips to get patient's blood sugar up.  patient immediately began to perk up.  patient later stated he had not ate all day leading us to assume low blood sugar and abrupt movement was the cause of his dizziness.
Abdominal pain; This is a spontaneous report from a non-contactable physician. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for covid-19 immunization, flu vaccine and shingles vaccine. On 26Jan2021, the patient experienced abdominal pain. AE severity was "6-7 out of 10". The outcome of the event was recovered on 28Jan2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
vaccine expired on 8/31/2022; vaccine administered on 9/6/2022 no known adverse reaction
5mo p/vax#3, pt exp dizziness, h/a & feeling very tired;some sx began w/a sore throat, raspy voice & now has no voice at all;also exp labored breathing, stomach burning, sporadic muscle pain, blurred vision & coughing;more tests are planned
Patient vaccinated at 12:37pm. While in observation, patient became warm at 12:40pm and fell off chair and onto the floor. Patient reported feeling cloudy and not remembering falling to floor. No injuries were sustained. Cool compresses applied to neck and forehead. Patient able to stand and was assisted to table to lie down if needed. Patient  vitals within normal limits. Patient reported not eating prior to vaccination  and also having a great fear of needles. Patient given lunch and reported improvement at 1:13pm. Patient released at 1:37pm. Vitals remained normal throughout observation.
body ache, tremors, never pain,  sleep deprivation, cold sweats, and general discomfort
Nexk to my head feel really hot, nauseous, dizziness, high blood pressure, shaking feel Hot and cold
Fatigued the same day she received vaccine. The next day she, developed low grade fever, chills, nausea, headache, left arm swelling and tenderness. This has persisted for over 5 days. Arm swelling and tenderness are improving.
feel two days not so good; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain burning (6 months terrible).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingles vaccine and felt not so good for 2 days. The reporter reported but better than getting shingles again. The follow-up would not possible as no contact details were available.
Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and tingling/numbness/discomfort in left arm within 5 minutes after injection in left arm. (She was negative for lip or oral mucosa swelling, voice change, SOB, rash, visible flushing, urticaria) Her vitals remained stable and initial sx resolved spontaneously within 15-120 minutes apart from  swelling (without erythema or induration) and tenderness on left medial anticube, which was treated with ice. Patient had normal ROM, strength of left arm. Patient was observed or 50 minutes and cleared by NP and MD to leave with instructions to FU with ED if return of symptoms.  Arm swelling was resolving when called the next day.
About 16 hours after I received the 2nd dose of the vaccine, I had chills, body aches, a headache and  mild fever.  Throughout the day, the symptoms worsened.  My temperature went up to 102.6 and did not drop below 101 until around 2:00am the next morning.  My fever fluctuated between 99.0 and 101 until mid-afternoon and then stayed around 98.8.  I did not spike a fever after that.  The body aches and chills subsided when the fever did.  I had a headache for 3 days total after the vaccine.   My arm was swollen, red and hot to the touch  where I received the injection.  My arm hurt but not as badly as the first dose.  4 days after the injection, my arm is still swollen, a little  sore and hot to the touch.  The redness is almost gone.  I was exhausted for 3 days. I took Tylenol every 4-6 hours for 3 days.  It helped a little bit.  An ice pack helped my arm.
Prior to vaccination, the patient stated that she was nervous, but seemed relieved and okay directly following the vaccination.  Following vaccination, patient became restless during the 15 minute post-vaccination window about 2-5 minutes after receiving the vaccine.  She initially presented with uncontrollable shaking/bouncing legs, palpitation, sweating, and shortness of breath (though this was very brief.   Patient remained coherent and oriented to time/person/place.   The shaking and palpitations subsided after a couple minutes and resumed towards the end of the 15 minute waiting period, accompanied by nausea.  25 minutes post-vaccination she appeared to have stabilized, and we assisted the patient to her room nearby at her request to allow her to lie down while being monitored.  After returning to her room, she very quickly ran to her sink due to her nausea, then after a minute of attempting to vomit, she collapsed and appeared to have briefly lost consciousness.  EMS was called and the patient was rolled onto her side to prevent choking in the event of emesis.  Patient remained responsive, but was weak and clammy with a weak pulse and breathing.  After the firefighters came, a search of the apartment found the previously listed medications.  Additionally, the patient experienced a seizure-like episode lasting 15 seconds in duration.  Once the EMT came, they assessed her and monitored her in the ambulance; they reported that her condition appeared stable, her vitals were strong, and transported her to Hospital for observation/testing.
Myopericarditis, chest pain, pericardial effusion, pleural effusion
Tachycardia and palpitations within 5 minutes of administration.  Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present.   50 mg  oral Benadryl taken an hour after vaccination.
Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 204. No concomitant medications were reported. It was reported that the vial had not undergone any temperature excursions. No adverse reactions were reported. No treatment medications were reported.
Pain of injection site, fatigue, headache for about 36 hours, after all systems but injection site gone.  After 48 hours injection site was not painful.  Mild signs as expected.
Patient C/O tingling in lips, throat and fingers. She was given Allegra and taken to ER
I developed a shortness of breath and a dry cough.  I previously had Covid and the feeling is the same.  I also suffered the common effects listed (fever, chills, etc).
Pt diagnosed with Varicella today. Given fever precautions and told to return for any problems. Temp 101.3 at office. MD describes papulo-vesicular lesions on abdomen and back.
Chills in evening, chills overnight, headache and feeling of nausea early next morning, 11/13/20, and throughout the day.  Took Tylenol and Pepcid-AC to counteract symptoms.  Temperature of 100.2 at 10AM,  rose to 101.4 at 12:30PM.    Fever, finally, broke at 2:30pm after taking Advil.  Chills throughout 2nd night, 12/13/20, and I sweat through PJ's and bedding.  Took more Advil and Pepcid-AC on Saturday, 11/14/2020 and began to return to feeling normal in afternoon, although minor headache and sensitive stomach remained.  Much better as of 11/15/2020.
A report has been received from a Pharmacist concerning a 60 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced ADMINISTERED FLUMIST QUADRIVALENT TO A HEALTHY 60 YEAR OLD PATIENT which started on 14-Oct-2013. The outcome of the event of ADMINISTERED FLUMIST QUADRIVALENT TO A HEALTHY 60 YEAR OLD PATIENT is unknown. The report was considered to be non-serious by the reporter.