chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at injection site/swelling at injection site that immigrated down arm below elbow. After patient returned to pharmacy the pharmacist recommended the patient seek medical treatment. Urgent care referred her to the emergency room and the ER dr told her the fluid from the swelling would be reabsorbed by her body.
arm is sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 20th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and less than a day, arm was sore at the injection site. The reporter did not consent to follow up.
This is in follow-up to report(s) previously submitted on 12/12/2009. Information has been received from a nurse concerning a 17 year old female patient, with no pertinent medical history and no drug allergies/drug reactions, who on 01-NOV-2008 (previously reported as 07-NOV-2008) was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot # 661764/0650X). Concomitant therapy included Hepatitis A vaccine (inactivated) (manufacturer unknown) and Hepatitis B vaccine (recombinant) (manufacturer unknown).  The nurse reported that the patient felt dizzy and fell 10 minutes after receiving GADASIL vaccine.  It was noted that her blood pressure was low. These events were originally reported with onset dates of 7-NOV-2008. There were no laboratory diagnostics studies performed.  It was reported that she felt normal 20 to 30 minutes after the fall. The patient was recovered on 07-NOV-2008.  The patient was seen by the nurse. Follow up information was received from other health professional: Approximately 10 minutes after injection given on 01-NOV-2008, the child vomited and passed out. The patient's blood pressure dropped to 70/50. The patient was given juice and the blood pressure improved to 90/60. After 10 minutes, patient improved. On an unspecified date, the patient recovered (previously reported as 07-NOV-2008). Additional information is not expected.
Nausea, food not tolerated, chills, sweating, no energy, headache still after 3 days
I have developed a lingering bitter taste  in my mouth that has not gone away.  Certain foods and their smells are bitter smelling & tasting.  Specifically coffee, which I drink regularly since high school    I have had COVID-19 twice, once in March 2020 (before the shut down), and in Jan 2021. The 2nd time I had Covid, I lost my sense of smell and taste for about 2-3 weeks.
LOTS OF BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lots of body aches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and lots of body aches was not reported. This report was non-serious.
Rotavirus Diarrhea, admitted overnight at hospital for dehydration and hyperthermia, Cousin did have diarrhea.  2/12/07 Received medical records from hospital which reveal patient experienced multiple episodes of nonbloody vomiting & diarrhea since 12/25 w/decreased oral intake.  He had lost 2 lbs.  On exam, patient was tachycardic & very tired appearing w/sunken eyes & dry mucous membranes. Tx w/IV hydration w/improvement & admitted overnight for continued hydration & monitoring.   FINAL DX: hypernatremic dehydration likely due to viral gastroenteritis.
Felt like was going to pass out, disorientated, lightheadedness, move bowel several times, bled . Symptoms progressive getting worse. Symptoms have now lasted several months. Diagnose with Colitis. Put of pregnozone, meslimine, zipatatory,
I recently reported that patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine. I am re-reporting as we have recently realized that patient has history of CLL and hypogammaglobulinemia which may have affected the efficacy of the vaccine.
Pt recvd 1st dose of Engerix-B 30APR91 or 01MAY91, following 1st dose pt exp severe h/a; following 2nd dose 28 or 29MAY91 or 03JUN91 or 04JUN91 exp blinding h/a & felt awful; malaise, chills, rash on x 5 days & sore throat, flu-like sx;
head ache for two weeks one and off fever for three days fatigue for two weeks severe pain in chest for three weeks. Hurt to run or breath.
Saturday- felt fine for a Couple of hours after vaccine. Felt fatigued around 4 PM, laid down, lost ability to move arm, extreme pain in neck.  Sunday- more of the same throughout the day. At night when I took a shower the pain moved over the course of a few minutes in the shower from my arm to my lower back. Arm was fine, Lower back pain bad enough that I was limping.  Monday- woke up & pain was evenly dispersed between lower back and head. Slight soreness in arm and neck. Took extra strength ibuprofen because I had to work. Totally fine for the rest of the day time. At night my arm and neck started to become very sore again. After I ate dinner I developed a very intense fever, chills/ shakes, my arm felt like it had a heartbeat and my heart was racing. Laid in bed all night. Felt scared and disturbed that this was happening days after the vaccine. Considered going to the hospital but I couldn?t move. Slept for 10 hours.  Tuesday (today)- feeling almost all better aside from slight pain in neck.
Hypotension; This is a spontaneous report from a contactable consumer (mother) or other non hcp. A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hypotension on an unspecified date (12 minutes after the injection). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 5-10 minutes after vaccine was given syncope occurred. I experienced light headedness, extreme diaphoresis, ringing in the both ears, & became pale immediately prior to losing consciousness for about 60 seconds. When I regained consciousness, I still was experiencing diaphoresis, ears ringing,  and I was confused; this lasted about 30 minutes before subsiding.
short of breath, dry cough, runny nose, dry throat, sore arm where injection was, swollen arm, slight dizziness.
After person vaccinated, had syncopal episode and hit ground.  Head was not protected.  Person regained conciousness.Fire personnel working site and provided immediate intervention. EMS on seen in 5 minutes. When LOC improved, was sat upright, but when sat fully upright had repeated syncopal episode. LOC when EMS arrived. transported to ED.
Tumor; puffiness in the nail under the cuticle of her left thumbnail; Tumor, arterial venous hemangioma under her thumbnail; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM (Tumor), SWELLING (puffiness in the nail under the cuticle of her left thumbnail) and HAEMANGIOMA (Tumor, arterial venous hemangioma under her thumbnail) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Hemangioma (arterial venous hemangioma under the thumb nail). Concomitant products included LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST SODIUM (SINGULAIR), WOMEN'S DAILY, SERTRALINE, MILK THISTLE [SILYBUM MARIANUM], TEMAZEPAM, NALTREXONE, MAGNESIUM and ROSA CANINA (ROSE HIPS) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM (Tumor), SWELLING (puffiness in the nail under the cuticle of her left thumbnail) and HAEMANGIOMA (Tumor, arterial venous hemangioma under her thumbnail). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, NEOPLASM (Tumor), SWELLING (puffiness in the nail under the cuticle of her left thumbnail) and HAEMANGIOMA (Tumor, arterial venous hemangioma under her thumbnail) outcome was unknown.            In Concomitant medications critical plus d3 was also reported. Patient has underwent a surgery for arterial venous hemangioma  under her thumb nail but the patient thinks it was growing again. After surgery she took Excedrin for the pain.
Patient reported, dizziness, body weakness and stomach pain which resolved on 2/4/2021.
I had swelling and redness at the injection site & it was hot to the touch and it itched.
I woke up with a severe headache, upset stomach and throat irritation.  The symptoms lasted for 11 hours and worsened after eating.
Prolonged pain in arm that he received influenza vaccine in, but only with certain movements (range of motion is not affected).
Fever 102.2, severe headache, lethargy, nasal congestion, chills, R sided neck pain, bilateral eye pain
I had arm pain worse than normal vaccine headache within 15 minutes of shot. The next day I felt super tired and run down and I had joint pain . I felt like that for five days. I went to the clinic for the headache and sinus pain . I received  an antihistamine.
This spontaneous report as received from a registered nurse refers to a 1 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with VAQTA strength 25/0.5 (units not provided) (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
From initial information received from a health care professional on 19/Jun/2003 regarding an adverse event occurring in the USA, it was reported that a 22-month-old female patient received her second dose of ACTHIB, lot number UA825AA/W0828-2, administered intra-muscular in the right thigh on 16/May/2003. Later that same day the patient developed swelling, tenderness, redness and bruising at the site of injection. The patient's recovery status is currently unknown.
This spontaneous report as received from a 75 year old male patient with diabetes and no allergies. On 16-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot # unknown). Concomitant therapies included metformin, pravastatin sodium, carvedilol and glyburide. On 17-APR-2013, the patient experienced an incidence of 10 to 14 "splotches" under his left arm measuring approximately "quarter sized". The patient stated that these "splotches" were not painful or itching. The patient did not seek any medical attention or receive any treatment. No lab test was performed. The outcome was reported as not recovered. The patient would contact his physician. ZOSTAVAX was not discontinued. The causality between the event and ZOSTAVAX was unknown. Additional information has been requested.
2/4/03 Around 11:45 started having back, leg and neck pain, also headach.  2/5/03 Fever 102.  Severe Back & leg pain.  2/6/03 Had to go to ER for pain relief.  2/8/03 Stomach cramp till 2/9/03.
Redness on site of injection, RA circle size 1 1/2" inch. No pain but stiffness. BENADRYL cream was given.
Inadvertent administration of a double dose of DTAP vaccine in our office. The patient received DTAP on X-XX-11 and again on X-XX-11 (4 days after). Vaccines received in the state and the state-wide vaccine report and the patient's chart was not reviewed accurately on X-XX-11, therefore a double dose was received on X-XX-11 (4 days after the first dose). DTAP 8-26-11, lot # U3497CA, dose 0.5 mL. left thigh DTAP 8-30-11, lot # U3497CA, dose 0.5 mL, right thigh.
nausea, diarrhea, muscle pain in legs and lower spine, fever, lethargic, abdominal pain, I felt like my digestive system wasn't working as I had constipation and pain and I never have that, chest pain on right side, headache, i slept for 3 days off and on, muscle pain and digestive issued lasted for several days, sneezing
I received a tetnus shot and have had several side effects: drousyeness, hot flashes, sleep disturbances, and possible headaches (started yesterday) since receiving the shot.
1st dose in Jul2022, not received another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 1st July 2022, batch number:X239D, expiry date:7th August 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in Jul2022, not received another dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAR-2023 The reporter reported that Twinrix series for patient who missed 2nd dose and had returned for 3rd dose of Twinrix.  The patient had not received another dose of Twinrix at time of call.  The exact date of vaccine was unknown at time of call. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Chills,  sore arm with a bruise, leg spasms, drop in blood sugar throughout the day, lots of appetite
I developed a red line on my lower lip and blisters also discoloration on my lip surrounding the blistered area.
SEIZURE; HIT HIS HEAD ON THE CONCRETE; This spontaneous report received from a consumer concerned a 55-year-old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the patient was sitting with his wife after receiving the JANSSEN COVID-19 vaccine, when he had started to slump over. Patient experienced seizing (passed out and slipped out of his chair and started). It was reported that the patient hit his head on the concrete.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure (pass out and slumped over) and hit his head on the concrete was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210414732 and 20210414751.; Sender's Comments: V0 20210415021-Covid-19 vaccine ad26.cov2.s-Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
While performing my normal exercise routine the morning after receiving my vaccine, 7 minutes into the workout I suddenly felt faint and nauseous. I stopped exercising and sat down for several minutes until the feeling of nausea and lighheadedness/ feeling that I was going to pass out subsided. I was extremely pale and felt cold as well. As the situation had resolved itself, I did not report it to my physician. I have never experienced such a thing while exercising before, so I concluded that it could be connected to the vaccine.
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 with my mother. I tested positive for COVID-19 on 11/24/2022.
Client seen by nurse practitioner at clinic 2-11-04 - client stated that shortly after she received both injections her arms became red and swollen. Continues to complain of tenderness to touch and pain on movement especially lifting over head- minimal swelling. Afebrile.
Sudden onset up upper shoulder pain/shock around to chest and up bil sides of neck 12/4, following additional testing--resulted in aortic dissection and surgery on 12/13/2021,
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (route and lot # were unspecified). The physician reported that in approximately 2010 ("about 1 year ago") the patient was hospitalized for neuro cardio "gen" syncope after vaccination with PNEUMOVAX 23. The patient was passing out. The reporter felt that the patient's condition would exist regardless of vaccination with PNEUMOVAX 23. Additional information is not expected.
Patient passed out after receiving shot. Fell on floor and bumped head. Called 911, patient taken to hospital.
Left arm (site of injection), red and swollen.  No fever or pain. Area not measured.
Information has been received through the pregnancy registry from a woman concerning a 23-year-old female with diabetes mellitus, and with an allergy to birth control pills who on 27-MAY-1999 was vaccinated with the first dose of VARIVAX. There was no concomitant medication. On 12-JUL-1999 the patient was tested and was found to be pregnant. Follow-up was received from a physician. LMP was 29-MAY-1999. The second dose of VARIVAX was not administered. Expected date of delivery is 04-MAR-2000. Follow-up information indicated that on 05-AUG-1999 the patient electively terminated the pregnancy. The product of conception was not examined. Upon internal review, elective termination was considered to be an other important medical event. Upon internal review, it was noted that the source country was incorrectly entered into WAES #99070782. Therefore, WAES #1003USA02904 was created with the correct source country to replace WAES #99070782 which is being deleted from our files for V210. No further information is available. Upon internal review, it was noted that the source country was incorrectly entered into WAES #99070782. Therefore, WAES # 1003USA02904 was created with the correct source country to replace WAES #99070782 which is being deleted from our files for V210. WAES#99070782 was previously submitted to the FDA on 24-AUG-1999.
Had very unusually heavy menstrual period after the 1st dose. Bleeding through 1 Ultra Tampon every hour.  Passing clots half the size of my palm. Soaking through pads and through clothing overnight. Then this month I had very heavy Bleeding for 1 day on 12/6  between my period. I had blood clots as well. Just one lone day.... never had this happen to me ever in my life.
My symptoms lasted for 48 hours. Chills, Fever, Headache, Flu like symptoms
Began as a persistent cold sore in my mouth. Over the next couple days I grew very fatigued, had a fever and developed over 20 cold sores all on the left of my mouth. It became so painful that I was unable to consume anything other than liquids for multiple days. I went to my doctor who thought it could be hand foot and mouth disease or potentially shingles. I was given a prescription mouth wash to help with the pain and after about a week my mouth cleared up. Since then, however, I have had an issue with cold sores and painful red patches appearing in my mouth at least once a week. I have since went back to my doctor to raise the issue and was told to continue using the mouthwash as needed.
Three days after the third dose of the vaccine I started to have digestive issues. I had a strong local reaction around the area of the shot. It was hot, red and swollen for a week. I have now been experiencing Diarrhea for almost eight weeks. I was dehydrated and I have a lot of abdominal pain. The pain was on the sides of my ribs and abdomen. I saw my doctor and I was prescribed antibiotics and later an antiviral. None of those helped. I went to the ER and they prescribed Omeprazole and some other medication that would coat my stomach and might help. Those measures have helped the pain and reduced the issues for now. I had not had any problems with the first two doses.
Needle punctured the skin. When the vaccine was being administered the needle hub and plunger came apart. Not sure how much of the vaccine was actually administered into the site.
Patient received 2nd Pfzier COVID vaccine on 6/2/21. On 6/21/21 while exerting  himself at sports practice, he developed chest pain and shortness of breath that resolved with rest. He had no recurrence of chest pain or shortness of breath but presented to ER for evaluation.
Information has been received via an internet blog from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL. In the middle of the patient's series she "had a bout of Bell's palsy that paralyzed the right side of her face". Two months later, patient was diagnosed with Grave's disease. The doctor says an immune reaction to something he can't determine is most likely responsible. Upon internal review, a bout of Bell's palsy and Grave's disease were considered to be other important medical events. No further information is available.
1.  Mild injection site soreness lasting about 51 hours. It did not impair my functioning, from 4 hours to 51 hours after dose..2.   2.  Small (2-3 cm by 8-10 cm) skin erythema near injection site, onset about 4 hours after, ending about 48 hours  after dose. Neither side effect required treatment. Spontaneous resolution od both adverse events.