chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A solicited report has been received from consumer via Patient Assistance Program concerning a Female patient, enrolled in Non-interventional/Post-marketing study. The patient's concurrent disease included allergy to cipro, allergy to iodines and allergy to sulfa drugs. Concomitant medications included rosuvastatin calcium for hyperlipidemia. Patient had been received nasal FLUMIST (intranasal) and oral Lisinopril, on an unknown date. The patient had documented allergy to flu vaccine and documented allergy to lisinopril and also diagnosed with hyperlipidemia. Action taken with Lisinopril was unknown. The outcome of the event of documented allergy to flu virus vaccine, documented allergy to lisinopril and hyperlipidemia was unknown. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event documented allergy to flu virus vaccine to be related to FLUMIST. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event documented allergy to lisinopril to be related to Lisinopril. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event hyperlipidemia to be not related to FLUMIST and Lisinopril.
the patient had been on of immunosuppressive dose of acyclovir for his herpes zoster in infection.   He then went to the local pharmacy to have a shingles vaccine on June 6th or 7th of 2022  1 week later on 06/15/2022 the patient went to the Pharmacy and got the 3rd COVID vaccination which was his booster  he then ended up in our emergency room with less than 2000 platelet counts.
felt like she was actually dying, and she has been close to dying; Severe nausea and vomiting/severe nausea unable to eat without vomiting for 24 hours; Severe nausea and vomiting; unable to eat without vomiting for 24 hours; fatigue; Severe and uncontrollable diarrhea; got really severely dehydrated; moderate fevers; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Lot Number: ER8731) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On 17Apr2021, the patient experienced severe nausea and vomiting- vomited every 5 to 10 minutes for 12 hours, severe nausea unable to eat without vomiting for 24 hours, fatigue so severe. She had Severe and uncontrollable diarrhea- more than 12 times in 12 hours- almost constant. She felt like she was actually dying, and she has been close to dying. She got really severely dehydrated. She also had moderate fevers. It's been days and she have not recovered. All of the events experience occurred on 17Apr2021. The patient did not received any treatment for all of the events. The patient was not pregnant. The patient does not have COVID prior vaccination and the patient has not been tested for COVID post vaccination. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
10 days after I received my 2nd dose I experienced Vertigo while reclining at the chiroprators office.  He noted rapid eye movement indicating vertigo,  I went to my Physician an hour later and he observed the same eye movements and said it was vertigo.  He mentioned that it might be related to the 2nd shot.  It is now 7 months later and I still experience a very mild vertigo when I lie down...not sitting up...  I just thought it should be noted somewhere in case more people are experiencing this.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 06-JAN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K008252, expiration date: 24-OCT-2015), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to VAQTA. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS # 1501USA004957, MARRS # 1501USA004958, MARRS # 1501USA004959 and 1501USA004960). Additional information has been requested.
GBS, onset approx. 10/30/01; currently hospitalized. Ongoing. Per doc 211932, 60 Day follow Up, GBS with rediagnosis of CIDP, also states that patient walks bu still has neuropathies and residuals. The annual follow up states, "Developed CIOP, medically on disability. Last known symptom muscular weakeness although ambulatory."
This case was reported by a pharmacist and described the occurrence of stiff neck in a 63-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Novartis; unknown; unknown given on 3 September 2012; varicella virus vaccine (non-gsk); Merck; unknown; unknown given on 3 September 2012. Concurrent medications included NEXIUM, Allopurinol, Amiodarone, COUMADIN, Digoxin, Diovan HCT, Furosemide, KLOR-CON, Levothyroxine and Zolpidem. On 3 September 2012 at 12:15 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 4 September 2012, 1 day after vaccination with BOOSTRIX, the subject experienced stiff neck, neck pain and the pharmacist thought the subject was experiencing an arthus-type reaction. The pharmacist explained that she was not sure of the seriousness of the reaction since the subject had not seen a physician yet. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. Follow up received from pharmacist on 31 October 2012. The pharmacist noted that she spoke with the subject and that the event was not an arthus-type reaction but "was just muscle soreness/stiffness" of neck that "resolved on its on with NSAID therapy in 24 hours." On 5 September 2012, 24 hours after stiff neck muscles and muscle pain in neck began, the pharmacist noted that stiff neck muscles and muscle pain in neck symptoms had resolved. The pharmacist did not consider this event to be serious.
Patient called on 10/11/21 to report a rash on her arm that started several days following Moderna vaccination. Rash appears as 2 circular inflamed spots: 1 right around injection site and 1 down the arm a few inches away. The patient reported that it is itchy but has had no problems with breathing, rash anywhere else, or closing of the throat.
nausea, full body aches (every muscle and joint, along spine, hips, wrists, fingers, shoulder blades, legs), painful injection site, fever (100F), malaise.
Post vax, the pt developed local swelling at the injection site, fever of 101-102, very cranky, and urticarial lesions generalized after 24 hours. Treated with Tylenol, cold compresses, and Benadryl.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: unable to lift arm over head
Pt recvd vax 1DEC92 & exp strong burning upon inject; 10 mins following vax exp lightheadedness & felt dizzy as if would pass out; 1/2 hr later was more seriously dizzy & had to sit down because afraid of falling;
Within 24 hours fever,  Achy, chills, intense headache, nauseous, vomiting, neck and spine hurting, fatigued 24 hours-90 hours (presently) - fatigue, neck and spine soreness, headache, overall malaise
I felt kind of like daze and light headed 10-15 min after the vaccine. The remainder of the evening felt fatigue also felt pain at the injection site on left arm . On12/16 left arm was still hurting  and wasn't able to participate physical activities couldn't go to the gym.
16 year old got the first dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine) in a 16-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine) outcome was unknown.            no concomitant or treatment medications were provided. patient wanted to get the second dose of the vaccine.   Reporter did not allow further contact
AFTER RECEIVING THE VARICELLA IN THE UPPER LEFT ARM, THE NEXT DAY I BEGAN HAVING A RASH ON THE LEFT SIDE OF MY SHOULDER AND BACK. A COUPLE OF WEEKS LATER THE PAIN AND ITCHING WAS SO BAD I SAW MY PCP. I WAS THEN DIAGNOSED WITH SHINGLES. I MISSED A MONTH OF WORK, APPROX. CAN'T REMEMBER THE YEAR, 2008-2010. TWICE AFTER HAVING THE FLU VAC WITHIN 20 MINUTES I BECAME PALE, DIAPHORETIC, TACHYCARDIC, HYPOTENSIVE, WEAK, BODY ACHES AND PAIN, VERTIGO AND SEVERE NAUSEA/DIARRHEA. LATER FEVER. I NOTIFIED MY SIPERVISOR WHO SENT ME HOME. I MISSED APPROX 2-4 WEEKS OF WORK. (CONT.)
resembling a cold sore in the right side corner of my mouth; sore arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient, self-reporting). A patient of unspecified age and gender received BNT162B2 (BNT162B2, PFIZER-BIOTECH, COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 as dose number unknown, single for COVID-19 immunization. Medical history included Vitamin B deficiency from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that patient received the Pfizer vaccine on Wednesday, 31Mar2021. initial physical reaction was a sore arm, subsequently had an additional reaction two days later that patient thought patient might pass along. On the evening of the next day, patient started developing something resembling a cold sore in the right side corner of patients mouth. This was something have had before, indicating a Vitamin B deficiency. As of today, Saturday 03Apr2021, patient have added supplements to remedy this. Therapeutic measures were taken as a result of events. The outcome for the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Given Moderna injection  0811 lightheadedness, tightness left side of throat and scratchiness at 0822 dizziness at 0823 assisted to stretcher, at 0823 Benadryl 50mg po at 0824  Hospital emergency team called  Sent to ED for follow up pulse 110  BP 158/104  resp 22 Discharged from ED 1006  still complaining of palpitations  went home for the day family will be with her
Medical Hypodermic Needle-Pro Syringe and Needle 22G 1 1/2in  Needle came off of syringe in the patients arm.  We were able to pull needle out of her arm, successfully, with out incidence.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. Per guidance from the Department of Health, Centers for Disease Control and Prevention, and Pfizer have determined that the dose of vaccine that you received is valid.
Had symptoms of a cold; At night he slept in stages; Vertigo; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Had symptoms of a cold), SLEEP DISORDER (At night he slept in stages), VERTIGO (Vertigo) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (Had symptoms of a cold), SLEEP DISORDER (At night he slept in stages), VERTIGO (Vertigo) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (Had symptoms of a cold), SLEEP DISORDER (At night he slept in stages), VERTIGO (Vertigo) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: abnormal (High) 98.3 -high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported. Patient's all events had been resolved but still feeled there was something wrong but not vertigo anymore. Patient did not feel normal and was unable to explain. Overall patient feeled a lot batter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant follow-up Outcome of the events updated in follow up report.
did not go back to get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not go back to get the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not go back to get the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not go back to get the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
I had slight headache and was very tired. My face was also drooping. About day later I got Bell's Palsy. I went to the ER. They are the ones who dx me with Bell's Palsy. I had a CT scan to make sure I was not having a stroke. I also developed a bacterial roseate.
Patient presented with 4 inch diameter red, hard all around, raised area that she said was starting to become itchy she also said the area was warm to the touch told patient to take BENADRYL and ice the area.
within 15 minutes after receiving first dose of Pfizer-BioNTech vaccine patient began to complain of chest pain and shortness of breath. Pt was taken to Primary Care Clinic.  1345- Initial VS 1348- Epipen right upper thigh; EMS activated   1350- Benadryl right deltoid, pt states sx's much improved.  "My throat feels open now" 1352-IV initiated.  Repeat VS: P: 130,  SpO2 100%, 143/86 1355- EMS arrived/report given by Dr./pt transported to ED
inj site red hot & swollen approx 3 inches diameter afeb;no aches or chills-instructed to cont to monitor if sx cont contact MD;
Local title: Physician assistant ER note. Date of note: OCT 16, 2010 at 19:03 chief complaint: rash. Present Illness: This is a 63yo, male, came to ER with: receiving PNEUMOVAX 2 days ago, developed redness in the area, some soreness, little pruritus. Some chills the night of the immunization, none since. Allergies: lamotrigine, DEPAKOTE, fluvastatin, BAYCOL, lovastatin, atorvastatin, trazodone. Review of system: Cardiovascular: None, no chest pain. Pulmonary: None, no SOB.  Neurological: No H/O arthritis. Physical exam: Temp: 98 F [36.7 C], (10/16/2010 18:53). BP: 160/102 (10/16/2010 18:53), Resp: 16 (10/16/2010 18:53), Pulse: 97 (10/16/2010 18:53), Pain 2 (10/16/2010 18:53). General: ambulatory, awake, alert, Skin: lateral right bicep, there is confluent erythema, slightly raised, NT, no scale. Warm to palpation. Assessment: 1) local drug rash. Plan: 1) cool compresses, 2) BENADRYL 25 mg tid, 3) if fever, chills, sweats, return to ER.
BLURRED VISION; HEADACHE; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced blurred vision. On 04-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and headache on 05-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Early menstruation cycle  February 25 start period  March 23 start period  Received COVID vaccine on April 6th and then on April 8th my period started. I?ve never had my period start this early in the 34 years of me living.  I ended up staying home from work because the period was heavier and with more painful cramping. Took Ibuprofen
Possible diagnosed with peripheral T cell lymphoma March 2004. Information received from medical records states chills, sweating, rash, lymphadenoedema. msv Per follow up report-Patient surgery procedures-Bone Marrow transplant with residual morbidity. Possibly/probably in remission.
18 hours after second Pfizer vaccine for Covid-19 I awoke with fever, chills and body aches. Symptoms resolved after about 36 hours. The first 12 hours being the most severe. Temperature went as high as 102 F. Localized swelling and redness at injection site gradually increased over the following days. One week out and all symptoms (besides arm) have resolved.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 29-NOV-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Nausea, vomiting and abdominal pain for 7 days following vaccine booster administration.  Cyclic vomiting and auto-immune symptoms continuing still 6+ months after administration.  Similar AE's after 2nd dose but more time limited
My lymph node under my left armpit is swollen and very painful, I also have a headache and slight fatigue.
She fainted about 5 minutes after getting the vaccine, I used an ammonia inhalant and she regained consciousness, she ended up feeling fine afterward.
Patient presented with HA, malaise, N/V/D and tested positive for covid. She was dx with viral sepsis due to covid. The patient was given  vanc/zosyn, decadron for sore throat, robutussin-DM, tylenol, zofran prn.
Received dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA570A, expiry date 30th June 2022) for prophylaxis.   On 12th August 2022, the patient received Menveo. On 12th August 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The pharmacist reported that the patient received Menveo that had expired on 30th June 2022.  The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. HCP (Health care professional) requested follow up but only provided address. Additional Supportive Information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Had typical response, sore arm, chills, fever, aches general not feeling well for many days.  Around May 7, woke up very dizzy when getting out of bed, laying down at night room would spin like a tornado for 30 seconds. head in a fog, light headed during day off and on.  Ears felt pressure, thought maybe ear or sinus infection. After a week did telecon phone call with doctor office on 5/14/21 and finally office visit on 5/17/21.  no real results given vertigo exercises.  It is now 7/13/21 and I still have the problem. some days worse than others.  On 7/2/21 I actually fell and now have a broken arm.
THIS SHOT WAS GIVEN HIGH INTO MY RIGHT SHOULD BLADE. MY ARM STARTED TO THROB ABOUT 3 HOURS LATER. I HAVE SHOOTING PAIN THROUGHOUT MY RIGHT ARM ESPECIALLY AT NIGHT. ON A SCALE OF 1-10, THE PAIN IS A 20! I CAN BARELY MOVE MY ARM IN CERTAIN DIRECTIONS. PAINFUL TO SHOWER, DRESS, AND TYPE. MY JOB REQUIRES A LOT OF TYPING. I PUT A SALONPAS ON DURING THE DAY AND TAKE ADVIL. AT NIGHT I USE A HEATING PAD LYING ON MY SIDE WITH MY ARM ON A PILLOW. IF I DON'T MOVE I MIGHT SLEEP. I REALLY HAVEN'T SLEPT CORRECTLY IN 3 WEEKS. MY DOCTOR SAID TO ALERT THE PHARMACY REGARDING THE INJURY WHICH I DID DO. I JUST KEEP DOING THE HEATING PAD TREATMENT AND HOPE THE PAIN GOES AWAY AS THE DAMAGE IS ALREADY DONE!
I had a terrible headache and fever from 6:00am on 4/8 until 4:00am on 4/9.  101.4 with Tylenol and Advil alternating every 2 hours.  Severe body aches, severe fatigue. It was incredible how terrible I felt.  At 4:00am on 4/9 I miraculously felt fine! With the 1st injection I had a severe headache for 3 days.  I do not get headaches any more since I made lifestyle changes. (I used to get migraines) I have been an RN for over 40 yrs.  I am glad I got the vaccine but BOY was the second one tough!
pulmonary embolism in right left lower , middle lobe and left lobe and inflammation of left lobe
This spontaneous report as received from a Licensed Practical Nurse refers to a 3 month old female patient with no drug allergies. The patient's medical history included heart murmur. On 06-MAR-2013 the patient was vaccinated with the first dose of ROTATEQ (lot # reported as 0382AE, EXP 20-OCT-2013).There was no concomitant medication. On 13-MAR-2013, patient developed intussusception. The reporter reported the patient was lethargic, vomited one time and had decreased oral intake on 13-MAR-2013 and was hospitalized on 14-MAR-2013 in the Medical Center. The patient sought medical attention. The outcome of patient developed intussusception was reported as recovering/resolving. Additional information has been requested.
Patient reported experiencing fever, night sweats and nausea. Patient called out from work next day due to symptoms.
Starting approximately three days after the first injection, my left shoulder started hurting. The shot was administered in my left upper arm intramuscularly. It is now a month later and my left shoulder still hurts when I move it and when I touch it.
Edema severe noted shoulder to mid-upper arm, left arm only. Declines pain. Redness noted and warm to touch.
Large Red, warm, elevated and hard area on the right deltoid. Benadryl given at 8 AM on Friday October 22, 2010. Area remained warm, elevated and hard for 2-3 days. No other signs or symptoms noted. Benadryl seemed to control the swelling and firmness of the area.
A report has been received from a Health Professional concerning an 11 year old, male patient. No information regarding the medical history and concomitant drugs were provided. The patient received FLUMIST quadrivalent (intranasal) on 13-Oct-2014. The reporter reported that they inadvertently administered FLUMIST quadrivalent then a Flu shot to a child then one of the physician's in the practice relumed and said that patient not had any adverse events. The outcome of the event of administered FLUMIST quadrivalent then a Flu shot to a child was unknown. The report was considered to be non-serious by reporter.