chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the day of the this 2nd dose, I did feel a slight tingle on the left side of my face.  However, on Sunday September 19, 2021 at around 5 pm, my right head was in excruciating pain, and I fell to the floor because the left side of my body wouldn't function.  My left arm hurt from the top, all the way through my forearm, and up my middle finger. I went to the the ER the following day and they diagnosed me with  hemiplegic migraines. (I am 32 and have NEVER had migraines) The Friday of that same week I began vomitting, and was still in excruciating pain in my arm and my head.  I went to the ER again and was told it was a migraine.  My right vision has lowered from 20/20, and today is still blurry.  My IPO in my eyes was a 19 on the right side and 18 on the left.  I have treied numerous medicine for the headaches, nausea and vomitting, and arm pain.  I had bowel incontinence 3 times, and was told that my body is now full of inflammation and an autoimmune disorder was triggered.  I have gained 40 lbs since my second vaccine, am swollen, constantly battling headaches, and having multiple doctors appointments to resolve the issues.  I also did not have a period until November 27th,  since my second vaccine.  My life has been completely altered since this second vaccine in a negative way.
Following day there was a rash below the injection site. There was swelling and "fever" at the site and around the site.  The arm was sore (which was expected). The area continues to have a knot and occasional fever & soreness. Currently (15 days after injection) the knot is not present. Asper crème was applied and use of the arm was continued. No other treatment was given. I did heavy yard work on the day of and days after the injection. There were muscle aches that could have been due to the yard work or the vaccine but they have subsided. There were 7 days of fatigue.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 16-NOV-2015 the patient was vaccinated with VAQTA (lot # L002717, expiration date 02-JUN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-089564, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089653, MOD21-089655, MOD21-089658, MOD21-089660 (E2B Linked Report).; Sender's Comments:  MOD21-089564:same reporter MOD21-089636:same reporter MOD21-089642:same reporter MOD21-089644:same reporter MOD21-089646:same reporter MOD21-089653:same reporter MOD21-089655:same reporter MOD21-089658:same reporter MOD21-089660:same reporter
Immediately after VARIVAX vaccine pt c/o throat pressure. Resolved within seconds of giving BENADRYL PO.
Patient developed a papular rash all around the injection site. Rash took several days to go away.
13 days p/DT/OPV/MMR t100-5 mins p/pt recvd APAP; pt had sz & stopped breathing; MD feels there may be epileptic tendencies; Had had sz as infant;
Redness and swelling 6cm X 8 cm at injection site, erythema, warm to touch, low grade fever, itchy. Pt provided Tylenol, loratadine.
Had initial reaction in arm, felt tired and achy.  Reason reporting now is shots increased my nerve sensitivity, and peaked 1 month later.  I now have Trigeminal nerve sensitivity and lower back nerve pains.  It is getting better (5 months since last shot), and hopefully will disappear.  I have heard of other legitimate cases.
started getting an itchy arm at the injection site and now is itchy a little swollen and red
Fever, chills and exhaustion at 0847 for 2 hrs until taking adult dose tylenol, then stomach pain at approximately 1712 lasting about 2 hrs.
patient stated he felt lightheaded dizzy, became diaphoretic and pale, stated he was nervous about needles and has always been. pt was sitting on chair, 1025-02 sat on RA=99% HR 46 complained of tunnel vision still pale diaphoretic. he transferred himself to a wheelchair and a nurse took him outside across the street to the emergency room. as they got outside he started feeling better, so she did not take him to the ER, but to outpatient treatment department and put him in trendelenburg position on stretcher vital signs as follows 1030-117/65 hr=66 02 ra=98%, 1040-122/68 61, 97% RA, color back to normal.  1046-laying flat on stretcher, 116/77 59, 100% RA, 1052-135/77 56 98% RA, 1057-sitting up on side of stretcher-states he feels normal 147/92 60 99% RA
This spontaneous report as received from a 69 year old female patient with morphine allergy. The patient was vaccinated with a dose of ZOSTAVAX (1 time vaccine, dose and lot # unknown), subcutaneous to prevent shingles, 4 years ago, in approximately May 2009. Concomitant therapies included AMBIEN and FOSAMAX. The patient stated she had been diagnosed with shingles on 22-APR-2013. She stated it first broke out under her right breast, and spread in a 6-8 inch band from her front right side (sternum), to her middle right back side. The patient sought unspecified medical attention and was treated with acyclovir. No lab tests were performed. The outcome of shingles was unknown. Additional information has been requested.
Five days after receiving the shot the patient experienced neck and shoulder pain and is still experiencing that today as of 04/29/2019.
Received Pfizer vaccines on  3/31/21, 4/21/21, 11/21/21; tested positive for COVID by PCR on 5/17/22; admitted to hospital on 5/18/22 d/t fever, N/V, cough, dyspnea, dizziness. Underlying congenital heart disease w/ tricuspid atresia and a-fib on Warfarin.
On 1/8/01, pt received vaccines and developed erythema of extremities and subsequently, desquamation of extremities, distally. Had similar reaction with last set of IZ's. DTAP was the only vaccine in common.
patient developed coughing, shortness of breath, lip swelling, hoarse voice, and tightness in throat.  She became diaphoretic and pale.  Symptoms worsened and progressed to anaphylaxis without shock.  EpiPen was given and placed immediately on oxygen.  EMS/911 called. Patient was given nebulized albuterol and placed on exam table. Normal saline drip via IV given. Patient stated allergy to Benadryl so not given. Within 5 minutes color improved, diaphoresis resolved, and hoarseness/shortness of breath resolved. Lips swelling improved. Patient transported in guarded condition by ambulance by to Clinic.
This spontaneous report as received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ oral, (strength, dose and lot # were not reported). No adverse effects were reported. On 17-DEC-2014 a telephone call was placed to the medical assistant who stated that she was unfamiliar with the reported incident of incorrect product storage. The reporter transferred the call to another person who was also unfamiliar with the event. This is one of several reports received form the same reporter. Additional information has been requested.
In December of 2022 my doctors and I noticed that my BUN and Creatine level numbers were starting to get low. In January of 2023 the numbers really started to slide. My doctors ran a kidney biopsy, colonoscopy, the results came back with ACNA vasculitis, acute renal failure.
small amount of pain at injection site; This is a spontaneous report from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced small amount of pain at injection site on an unspecified date. Caller reports small amount of pain at injection site. The outcome for events unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Given third dose of omicron bivalent booster. No reaction for 15 minutes.
patient was given a vaccine from a bottle that was 31 days in the refrigerator.  Moderna was notified and they replied statign there should be no problem vaccine should be active But Pt may get another if they choose to., Pt was notified of this event.
Also bad nightmares after each vaccine; swollen lymph node under left collar 2 days after now on day 4 andlarger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 12:00 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single and administered in arm left, administration date 01Feb2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High BP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; TIROSINT. The following information was reported: NIGHTMARE (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Also bad nightmares after each vaccine"; LYMPHADENOPATHY (non-serious) with onset 16Nov2021, outcome "not recovered", described as "swollen lymph node under left collar 2 days after now on day 4 andlarger". Therapeutic measures were not taken as a result of nightmare, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101616389 same patient/drug, different AE and dose.
Immediate induration without erythema or pain with needle retraction after vaccine given.  Area marked with sharpe.  Approximately the size of a nickel.    A picture of the reaction site was taken with patient phone.  He was encouraged to continue to document his reaction with more photos and report the reaction to vsafe patient was instructed to consult with his PCP if needed.  He was instructed to seek immediate medical attention at urgent care or the emergency department if needed.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 30 year old female patient with no pertinent medical history who on 04-NOV-2008 was vaccinated subcutaneously with the first 0.5 ml dose of GARDASIL (lot number 0947X). On 09-JAN-2009 the patient was vaccinated subcutaneously with the second 0.5 ml dose of GARDASIL (lot number 1423X). Concomitant therapy included prenatal vitamins. Subsequently the patient was pregnant. The last menstrual period (LMP) was approximately 14-FEB-2009. The estimated delivery date (EDD) was 21-NOV-2009. Unspecified medical attention was sought. A urine test was performed to confirm the pregnancy. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from the physician concerning the 30 year old female with a history of 1 pregnancy and 1 live birth and no birth defect or infant complications in previous pregnancy who was vaccinated with 2 doses of GARDASIL as previously reported. Concomitant therapy included prenatal vitamins. On an unspecified date, the patient experienced bronchitis and on 03-NOV-2009 was treated with KEFLEX 500mg daily for 10 days. There was no complication during pregnancy, labor. On 17-NOV-2009, the patient delivered a normal, healthy female baby weighing 8 pounds 12 ounces at 39th week. The baby's length was 20, Apgar score was normal. No further information is available.
Facial tingling - pins and needles, feeling of heaviness in arms and legs. Evolved to pins and needles in arms, legs and chest and tightness - no swelling. Inability to move eyebrows when asked by EMT to smile and raise eyebrows.
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #8 of 32, a 11 year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. An 11 year old male on an unspecified date was vaccinated with his first dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of optic neuritis and retinitis. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327, 1004USA02328, 1004USA02329, 1004USA02330, 1004USA02331, 1004USA02332, WAES # 1004USA02334 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Developed a lump Rt upper arm.  It has continued to grow, is red, warm to touch with an mild induration about 4-5 cm in diameter - Advised to use ice.
Patient states that she is having a shooting nerve type pain in her right leg and right arm. She said it started a few days after receiving the vaccine.
Slight difficulty breathing.  Was trying to sleep (I work night shift).  Kept thinking to myself, "okay now breath",  I was a little scared to fall asleep, but I did.  Developed chills and headache around 2:30 pm.  General mild body aches.  Chills continued until 5 am, also had low grade fever (with antipyretics on board).  Felt like I was back to my normal self at 5 am on 10/28/09.   Then on 10/29/09 I developed diarrhea which continues through to this date.  On 10/30/09  had several hours of nausea, weakness & fatigue.  On 11/1/09 noticed tightness & occasional heaviness in chest with raw sensation when breath in.  Also developed mild cough 11/1/09, which continues.  Took Tylenol & Motrin evening of 10/27 & morning of 10/28/09.  Rested entire day of 10/30/09 with emesis basin nearby.  Have used my Albuterol inhaler at least daily since 11/1/09.
Erythema at the injection site . 3inches by 3 inches Noted on day 9 post vaccine
given QUADRACEL instead of PENTACEL on his 15th month with no reported adverse event; Initial information received on 18-Mar-2022 regarding an unsolicited valid non-serious case received from call center.  This case involves a 30 months old male patient who was given quadracel instead of pentacel on his 15th month with no reported adverse event while receiving vaccine Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) Vaccine (dose, formulation, lot number and expiry date: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was given quadracel instead of pentacel on his 15th month with no reported adverse event (wrong product administered) (unknown latency) following the administration of Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) Vaccine.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever, vomiting, diarrhea, rash, irrability, loss of appetite, visual issues, agitated, sleep disorder, tingling, anxiety, toxic diapers, bowel issues, abdominal pain.
I received the vaccine injection at around 12:30pm on 02/06/2022. By around 9pm that same day, I began feeling a mild headache so I took some Tylenol pills. By 12pm, my symptoms had turned into chills and severe muscle aches, followed by feeling feverish and hot, even slightly dizzy and nauseous at points. This continued throughout the night and into the next day. My symptoms lessened slightly around 12pm on 02/07/2022, but the muscle aches and headache continued strongly. It's currently 12:24AM on 02/08/2022 and I still have a headache, muscle aches, and feel hot.
5:30 PM: soar in my arm and neck on left side 9:00 PM: Vertigo, dizziness, fast heartbeat, vomiting, soar neck and arm. These symptoms lasted hours.  3/6/2021: Fatigue, headache and still soar.
Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored of RECOMBIVAX HB (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness on right leg from knee to upper thigh, noted area on thigh with fever in leg.
Gave Pneumo vaccine in Left deltoid muscle IM. Deltoid are aswollen and warm to touch, no blistering or broken skin.  Client stated "it feels like I have been burned, like it ahas a blister".  Client advised to take antiinflammatory as needed.  If swellling and fever continueu, see PMD or ER.
I had a slight headache on the top of my head, on and off chills, no fever, ache shoulder joints, ache hips, ache knees and thighs for about 11 hours.  I was able to move around and I ate my normal breakfast, lunch and supper,
Pt. developed a low grade fever day 7 post-vaccine. This has continued for 4 days now with fever averaging 103. The highest 105.7. He was seen at the ER on Day 9 post-vaccine. Day 8 post-vaccine, pt. developed a heavy rash not contained to the trunk of the body, but widespread. We are continuing to monitor and provide supportive care, per doctor.
Pt recvd 2-1cc injects of Recombivax 29NOV90 & 29DEC90; 31MAY91 recvd Engerix-B; pt "did not develop immunity";
Fever of 103; just had joint pain and inflammation in those areas; just had joint pain and inflammation in those areas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever of 103"; ARTHRALGIA (non-serious), INFLAMMATION (non-serious), outcome "unknown" and all described as "just had joint pain and inflammation in those areas". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller speaks of someone who had a fever of 103 that resolved after 1 to 2 days. She just had joint pain and inflammation in those areas and concerned of what the second dose may do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Scratched arm where vaccine administered during night while asleep. In morning felt pain and more itching. Next day had redness and small blisters over area about the size of a quarter.