chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10cmx5cm red raised patch just distal to IM immunization site (Dtap and MMR) onset AM 12/15/05. Afebrile in clinic and at home. No complaints from child (normal activity, eat sleep) Mother gave Tylenol after immun on 12/13/05.
Soreness radiating to clavicle and down towards elbow, now cellulitis-like redness above elbow (size about 2-3 inch diameter). Patient received vaccination on Saturday evening. Patient said symptoms started next day on Sunday. Patient came in to report on Monday evening. Patient said that since the start of the symptoms, the redness has reduced and also travelled downwards towards the elbow. Patient facetimed with relative who is a medical doctor (?) and relative said that it looks like cellulitis. Upon asking patient further, patient said she is taking amoxicillin to treat it.
On 12/9 the mother reported redness around the injection site on the right arm. Upon inspection, the are had a baseball size area of redness around the injection site. The area was mildly discolored, a dusky color behind the redness). The area was very firm and the skin in that area had an altered texture. At 36 hours there seems to be no improvement. Ice packs and Tylenol were recommended. There is not sign of infection, pain, or issues with ROM.
Information has been received from a registered nurse concerning a female who on 30-OCT-2007 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (Lot # "0099U") and concomitantly was vaccinated with influenza virus vaccine (unspecified). It was reported that the patient experienced soreness of the arm, not the injection site, and a fever within hours of receiving the vaccines. The fever had gone to 102 Fahrenheit. She had seen her doctor each day since then. It was reported that the patient also sought medical attention by phone. It was unknown if the patient had received pneumococcal 23v polysaccharide vaccine in the past. The registered nurse reported that two other patients experienced adverse reactions after receiving pneumococcal 23v polysaccharide vaccine (WAES # 0711USA02460 and WAES # 0711USA02461). The patient was vaccinated with a total of 45 persons. They all worked together and were vaccinated during a vaccine clinic at their company. A total of 45 persons received the influenza virus vaccine (unspecified) and 12 persons received the pneumococcal 23v polysaccharide vaccine. There have been no other adverse symptoms reported. In follow-up the registered nurse stated that the problem that the patient had did not have anything to do with the vaccine. She stated that it was coincidence that the two events occurred in the "shot" time frame. Additional information is not expected.
broke out in fine, non papular rash; t99.1 (A); TC to MD DPH ordered; see MD if temp >/-104 @ ER;
This spontaneous report as received from a Licensed Vocational Nurse (office manager) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-AUG-2018, the patient was vaccinated with improperly stored Oka-Merck PROQUAD (lot # R011803, Expiry date: 21-OCT-2019) 1 DF for prophylaxis. Concomitant therapies included MERCK STERILE DILUENT. It was reported that the vaccine experienced a temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (5.5 degrees Fahrenheit) for 13 minutes and 30 seconds (incorrect product storage). There was previous temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (8.6 degrees Fahrenheit) for 24 minutes. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
difficulty breathing and slight light headiness.  Took two puffs of inhaler.  breathing a little better, light headiness still on going.
Information has been received from a physician concerning a female patient who on 31-MAY-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 657005/0314U). On 31-MAY-2007, the patient experienced a fever of 102 deg F along with dizziness and nausea. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
High dose flu vaccine given, patient denies symptoms of flu after vaccine administration when contacted by phone on 11/4/2020.
Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite tingling" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.
No additional adverse effects reported; improperly stored GARDASIL 9 was administered to a unspecified patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.    On 21-FEB-2020 the patient was vaccinated with improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R020948, expiration date was reported as 04-APR-2021, but upon internal validation established as 04-MAY-2021; dose, frequency and route were not reported) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature of 33.4 Fahrenheit (F). Time frame was 933 hours. No previous temperature excursion. The digital data logger was involved. No additional adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R020948; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
The next day or two noticed a red raised rash which looked like a "bug bite" on abdomen then noticed spread to lower back & upper thighs.  C/O itchiness- no other symptoms.  Did not take Benadryl.  7/7/06 Pt's better - never took Benadryl.
death of unknown cause; Swelling on Right side of the neck and under chin; Warmth on right side of neck and under chin; Redness on right side of neck and under chin; A spontaneous report was received from a healthcare professional concerning an 89-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of redness, warmth and swelling on right side of neck and under chin, and death of unknown cause.  The patient's medical history included Alzheimer's and chronic obstructive pulmonary disease (COPD). No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced the events of redness, warmth and swelling on right side of neck and under chin. There was no indication that the patient was transferred out to hospital, which was unlikely because she was under hospice care.  On 01 Jan 2021, the patient died due to an unknown cause of death.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 01 Jan 2020. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 89-year-old, female subject with a medical history of Alzheimer's and chronic obstructive pulmonary disease (COPD) who experienced redness, warmth and swelling on R side of neck and under chin and expired from an unknown cause. The events of redness, warmth and swelling on R side of neck and under chin occurred 2 days after administration of the first and only dose of the mRNA-1273 vaccine and patient expired 4 days after mRNA-1273 vaccine administration.  Lot # of the vaccine was not provided.  De-challenge and re-challenge are not applicable.  The events of redness, warmth and swelling on R side of neck and under chin are temporarily associated with the administration of the mRNA-1273 and thus, a causal relationship cannot be excluded. Due to limited information, the fatal outcome was considered unrelated to mRNA-1273 administration pending additional information.  Fatal outcome is confounded by the patient's underlying condition and advanced age.; Reported Cause(s) of Death: Unknown cause of death
Initial report was received on 23 July 2010 from a healthcare professional. A 13 month old female patient received a third dose of "ACTHIB" (lot number C3479AA was reported, but it is a PENTACEL lot number) in December 2009. The patient had received the first dose of "ACTHIB" (lot number C3428AA) on 06 August 2009 and the second dose of "ACTHIB" on 01 October 2009(lot number C3428AA). The patient experienced a fever on 10 July 2010 and was admitted to the hospital on 15 July 2010 with a diagnosis of H B influenza meningitis. No pre-existing medical conditions and no concomitant medications were reported. Haemophilus influenzae type b, biotype 1 was identified as the organism in the patient's lab sample. At the time of this report, the child was doing well and continues to improve. Documents held by sender: None.
Mouth sores starting within 24 hrs of receiving vaccine.  Still going on 5 days later.
From initial information received on 09/03/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 month old male patient received Fluzone SV '2003-'2004 USP pediatric dose vaccination and a Tripedia vaccination on 08/31/04. The lot numbers, route and site of administration are unknown. Reportedly the next day the patient developed a fever and was lethargic. The patient's recovery status is currently unknown.
one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who experienced one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) Powder and solvent for solution for injection unknown strength, dose, frequency, expiration date and lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event (expired product administered) (unknown latency) following the administration of HIB (PRP/T) vaccine.  Action taken with Haemophilus type b (hib) vaccine (act-hib) was not applicable.  It was not reported if the patient received a corrective treatment for the event (one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse 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.
Pt came to my office (urgent care-type setting) 4/6/21 for possible adverse event following COVID vaccine. No active symptoms at time of exam. She wanted guidance regarding whether she should receive her second COVID vaccine scheduled in 2 days. She reports she received her 1st Moderna COVID-19 vaccine on 3/11/21. about 2 hours later felt like right side of face was  puffy/droopy but was not visibly droopy. She did not report this symptom to any healthcare provider or VAERS at the time and did not seek any treatment. Symptoms went away 2 weeks later. This past week felt it again but went away. Last week left eye felt like it was moving and caused transient visual disturbance. Did not have a headache at that time. Shut eye and went back to normal. Sees a neurologist for migraines but states symptoms were not similar to her migraines Cannot see her neurologist until June. Never had Bell's Palsy in past. No known tick bites, rash or recent viral illness. Denies difficulty closing or opening her eye, mouth asymmetry or slurred speech. Symptoms described may be Bell's Palsy. no treatment initiated since Greater than 3 week since onset and symptoms resolved currently
12-13-12 shot given. Woke up 12-14-12 with swollen, red, warm localized reaction. By afternoon progressed to baseball sized area - red, swollen, warm. 12-17-12 arm is much better "almost gone".
Persistent headache for days, lightheadedness, blurred vision, heavy, almost vertigo-like. Fog
Pt noticed there was a 4" circle at injection site 48 hrs after received the vaccine, it was hard, itchy and warm to touch. The rash spread pass elbow 96 hrs after the injection. Pt went to the doctor on 4/15/09. Dr. did not think it was a reaction to vaccine, but thought it was a reaction to the vehicle, pt was given LIDEX Rx, ATIVAN and BACTRIM DS
face was red, left arm becoming red; they became foggy; tired; a mild fever with a temperature of 102.5; working heard to breath; Left arm hot to touch; Flulike symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), INFLUENZA LIKE ILLNESS (Flulike symptoms), ERYTHEMA (face was red, left arm becoming red) and FEELING ABNORMAL (they became foggy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flulike symptoms). On 28-Apr-2021, the patient experienced DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), ERYTHEMA (face was red, left arm becoming red), FEELING ABNORMAL (they became foggy), FATIGUE (tired) and PYREXIA (a mild fever with a temperature of 102.5). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), INFLUENZA LIKE ILLNESS (Flulike symptoms), ERYTHEMA (face was red, left arm becoming red), FEELING ABNORMAL (they became foggy), FATIGUE (tired) and PYREXIA (a mild fever with a temperature of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 102.5 (High) 102.5 F. On 28-Apr-2021, Heart rate: high (High) more than 100 beats per minute. On 28-Apr-2021, Respiratory rate: high (High) Respiratory rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Recvd MMR/DTP/HIB/OPV on 5JUN91; Fever & rash developed 9 days later; Temp low grade for 3 days reached 104; Resolved w/APAP; Rash began on trunk & extremities;
Severe abdominal pain, green mucousy stools preceded by blood in stools for weeks after given Rotavirus vaccine.
Patient experienced Afib with tachycardia for 3 nights in a row starting on 8/28.  Resolved with Metoprolol and flecainide regimen On 9/7 patient had another episode of sustained Afib that did not resolve with meds.  Went to ER had had to be cardioverted by electric shock.  Patient feels after almost 9 years of no Afib issues, to have this right after the Covid shot is a cause of concern.
PATIENT HAD INCREASED BREATHING, DIZZYNESS, TIGHTNESS IN THROUT, AND TINGLING ADMINISTERED EPI-PEN TO PATIENT AND CALLED 911. PATIENT WAS TAKEN TO THE ER.
Pt reported to pharmacist after 15 days, arm was sore to wrist, with severe pain, also some pain in left side.
On Wed 9/15 I had normal COVID side effects (sore arm and feverish) but in addition I had a large amount of blood in my urine (urine was raspberry red).  This continued through Thursday and into Friday morning.  I called the clinic on Friday morning and was directed to the Express clinic.  At the clinic, I provided a urine sample and the results were that all of my parameters (with the exception of blood in the urine which was large) were normal and there were no signs of infection.  The doctor recommended that I go to the ER for a CT scan which I did that evening.  The CT scan was negative for kidney stones and they could not see any abnormalities.  Therefore, they referred me to a Urologist on on 9/23/21 at 10 am.  Another urine sample was collected and still contained blood although not to the extreme of the previous week.  Cellular abnormalities were not detected.  The urologist recommended a urology cytoscopy which has been scheduled for 10/27 where they will check my bladder, urethra, etc.  I have seen 2 doctors and been to the ER as a result of this event.  I did not receive any other vaccines on 9/14.
Patient came to the drive through flu clinic and presented her medicare card. it was assumed that she was 65+, however she was 1 week shy of 65 years old. patient has not reported any adverse side effects.
The pt developed cellulitis of left arm at vax site. Symptoms started approximately 1 week after vax. The problem was reported approximately 9 days post vax. Was sent to the ER and received Ancef followed by oral Keflex.
6AM 10/28/05, MOM NOTICED RED, HOT, TENDER, HARD AREA, 2" IN DIAMETER. FUSSY, IRRITABLE.
06/12/2012 - Patient c/o soreness and sharp pain to right arm upper sq area.  Patient woke up this morning (06/22/2012) with 3 inch diameter swollen area to right upper sq area of arm.
on 5/14 developed severe bilateral pulmonary embolism with severe right ventricular hypertension and heart failure. Progressed to cardiac arrest requiring mechanical circulatory support (ECMO) in PICU. Managed in the Cardiac ICU
The pt experienced a rash on the back, chest, diaper area that started on 9/26. The pt was taken back to the MD and the MD feels it is a reaction to the vax. Was advised to keep the child out of daycare for one week.
Rash on chest, abdomen, neck, back - 1st noted on 12/19/11. Saw N/P on 12/19/11. N/P wasn't sure rash was vaccine related.
Pt felt anxious with throat itching after vaccine. Pt was observed in her car and given IM Benadryl. Pt felt better and was able to leave with friend
Mom noted both extremities shaking & very pale; Cont for 20-30min; paramedics had to give valium; Seen in ER; intubation for resp fail; cont on phenobarb;
Injection site reaction lasting greater than 2 days.  Red rash around injection site along with hard painful bump extending 1" in diameter.
Blood clot in left leg. Currently on blood thinners to address it. I have no history of blood clots before this,
Within 36 hours of receiving the vaccine, a few pink/red spots (1/4-3/8 inch) appeared on my lower legs/feet. They were not itchy. Within a week, I had many flat spots covering my legs and one on top of my right foot had formed a 2-inch diameter, 1/4 inch thick, hard and sore lump under the skin (unlike any of the other spots). A scab formed there too. I also noticed my right foot was puffy and sore on top. It took a very long time for the lump and scab on my foot heal. Months later I still have dark scars on my feet. Most of the sports start pink, go purple, then to fade with yellow like a bruise. Initially I thought I had flea bites, and I hoped the condition would go away on its own, but it did not. (Continued.)
Ever since I received my J&J vaccine in March of 2021 I have experienced very irregular periods. This is not something I have experienced in the past. My periods have always been regular. In college, I had my periods frequently, every 21 or so days. From age 22 to 30 I was on birth control so that affected my cycles. I went off my birth control in October 2020 and I immediately went back to regular menstruation between every 28-35ish days. After my vaccine on March 8th, I had another period on March 25th, then May 1, July 22, and October 7th. So 4 periods since I got the vaccine in March 2021. I received a Moderna booster shot on October 26th and haven't had a period since. The reason I think it might be related to the vaccine is because nothing else in my life changed as far as weight, stress, eating habits, exercise, illness, etc.
lightheadness, sweating, dizziness, neck pain, stiffness, vertigo;
More severe lightheadedness, 112/70 HR 50. Blackout, seizure < 30 sec. Diag: faint from needle shot.
Patient developed swelling, erythema, itching, and warmth on left arm a few hours after receiving the above vaccinations. Over the course of the next day, the arm became more swollen and spread around the side of her arm. She took ibuprofen and diphenhydramine to relieve the discomfort. Symptoms continued to worsen, and medical care sought at local ER. She was prescribed the following medications: -Cephalexin 500 mg every 12 hours for 7 days -Hydroxyzine 25 mg every 8 hours for 5 days -Prednisone 20 mg once daily for 5 days. Left arm showed improvement after initiation of above therapy.  Meanwhile, patient started to develop small red dots on her left wrist and later on anterior thighs, lower legs, and bilateral upper arms. Continued cephalexin but held prednisone and hydroxyzine. Subsequently diagnosed with idiopathic thrombocytopenic purpura (ITP). Concern that vaccines precipitated/caused ITP in this patient.
Adverse reaction on hands; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction on hands) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction on hands). At the time of the report, VACCINATION COMPLICATION (Adverse reaction on hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Mom stated riding in car pt eyes rolled back in head, threw up x 1, didnt act right, looked yellow; Taken to ER; MD stated immun rxn;