chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received my 2nd shot at 8:20 a. Around 6:30 pm I started feeling really bad. In my 71 years I have never felt so cold, and the shivers kept coming in waves. I was very feverish and so very cold at the same time. Could not get warm no matter how many blankets I had. Every fiber of my being ached. Felt somewhat nauseous but did not throw up. The next day I was no longer cold, by even my eyelids still hurt and I had no energy at all. Even though it took 36 -48 hours to fully recoup, I would still get the vaccine.
Began with intermittent head and ear aches,  chills and sweats, and body aches  beginning 12hours after injection.  By 24 hours,  symptoms were primarily head and ear aches with reduced body aches.  At 36 hours symptom s only minor head and ear aches.  Completely gone by 48hours.
7-24-07 Immediately following vaccine administration, became pale - juice given - very pale - lying down for 10 minutes then OK. AM 7-25-07 Mother called stated her son is weak, not eating, no fever - recommend physician visit. 7-27-07 Spoke with mother, he's feeling better - physician stated he was dehydrated and to drink Gatorade and eat small amounts of food.
Myalgia, 101 degree temperature, severe chills.  Symptoms lasted 24 hours or less
After two weeks vaccine the top of the shoulder got pain and the wrist left hand very weakness up to now.
Within 4 weeks of receiving the 2nd booster, I started having dizziness & nausea.  It started out being periodic symptoms & now it is constant and debilitating.  I have gone to an ENT, had a CT scan on my head, tried PT & nothing is helping.  Other people in my area have experienced similar symptoms which seem to have no clear cause & same timing.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 22Sep2021 as dose 2, single (Lot number: EN6204), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 02Mar2022 at 02:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. Patient received no other medication in 2 weeks.
Headaches Extreme fatigue  Swollen arm Arm is very hot to the touch and sore Arm is hard at injection site Arm is very itchy at injection site Loss of appetite
Received Covid (Pfizer) #1 shot - had been told by pulmonologist she was okay to receive the shot - prior to coming to office to receive vaccine, patient pre-medicated with 100mg Benadryl and 40mg or prednisone - developed cough and shortness of breath - vital signs remained normal - given 0.3mg of epi via epi pen - developed a sensation of difficulty swallowing, was transported via wheel chair to Hospital.
- Moderna Covid-19 Vaccine  - Sore arm which included shooting pain.  - Upset stomach that was extremely intense 6 days - Headache was intense for 2 days - After going to bed (day of shot), was awaken by pain in the throat. The feeling that my throat was narrowing or closing. It became uncomfortable to swallow. Subsided. Next morning complete loss of voice. Contacted my doctors office and also a trauma nurse at a care center for two opinions on what to do. Loss of voice lasted for 4 days. - Experienced another event of throat narrowing and pain 2 nights later.  Additional information for Item 18:  - Approximately 7 days after shot, experienced itching and red rash at and near  injection site. Itching still itching still exists 15 days after the injection. - Fibromyalgia flare still exists 15 days after the shot. This was the first vaccination since being a baby.
Patient was still sick; Had a bad reaction to the booster; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient was still sick) and VACCINATION COMPLICATION (Had a bad reaction to the booster) in a 62-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient was still sick) and VACCINATION COMPLICATION (Had a bad reaction to the booster). At the time of the report, ILLNESS (Patient was still sick) had not resolved and VACCINATION COMPLICATION (Had a bad reaction to the booster) outcome was unknown.            No concomitant and treatment medications were reported. Patient had a bad reaction to the booster it had been 19 days and was still sick.   This case was linked to MOD-2021-435816, MOD-2021-435845 (Patient Link).
Moderna Bivalent Booster was given to patient but was only given half the dose not full dose.
Erythema, induration 18cm X 18cm on right arm. Treated with Keflex 500 Tid #15 and ice.
Information has been received from an office manager (Bachelor of Science) from a physician's office concerning a 56 year old male patient with hypertension, high cholesterol, metabolic syndrome, vitamin d deficiency and impaired fasting glucose who on 25-JUL-2011 was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 mL, subcutaneous (lot # 670613/0657AA). It was reported that the patient died on 26-JUL-2011 after receiving the ZOSTAVAX (Merck). The office manager stated that on 25-JUL-2011, the patient received ZOSTAVAX (Merck) and flew out of town and was found dead in a department store on 26-JUL-2011. The reporter indicated that on 10-APR-2012, the patient's wife went to the physician's office and showed them the death certificate. The cause of death was unknown. The reporter considered the event to be disabling and immediately life-threatening. A lot check has been initiated. Additional information has been requested.
Headache, Myalgia, FATIGUE, CHILLS, WEAKNESS, NECK ACHE Narrative:  Other Relevant History:
Began menstruating a little over five hours after vaccination. This is NOT PT's normal menstrual cycle which normally starts like clockwork a week from now. Aside from other expected side effects like fatigue, nausea, and body aches, pt is resting and doing well.
shudders and chills; Information has been received from a consumer (patient's father) and refers to a 6 month old male patient. The patient had no medical history, concurrent conditions, drug reactions or allergies reported. Concomitant medication included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid.  On an unknown date (reported as a couple of months ago), the patient received Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (route of administration reported as shot; dose, lot #, expiration date were not mentioned) for prophylaxis.      Since that time he had been getting shudders and chills. No treatment was given for the event. The patient had spoken with pediatric nurse practitioner. At the time of reporting, the patient had not recovered from the event.  Causality assessment was not provided.
Headache; fever 100.6; chills; body aches; sore throat; weakness; tired; pain at site; redness at site; itching at site/arm.
There was no adverse event at all reported. Vaccine was administered to an 11 year old minor who was not eligible ye to receive the vaccine under pharmacy protocol/standing order guidelines. Wrong birthday was provided by the parents intentionally to get the vaccine sooner than his actual age of 11. Wrong birth year of 2009 was given instead of his actual birth year of 2010. Month and date wad give correctly.  Pfizer vaccine is currently approved for 12 years and older.
Swelling L side of face in area of parotid. Dx: parotitis. Rx: KEFLEX 250/5 1 tsp TID x 7days.
Upper shoulder tenderness, appearing days after injection site tenderness fading away, told by coworkers early sign of possible SIRVA.
About 23 hours after my injection,  I started noticing fever blisters/cold sores on my upper lip.  I cannot ever remember having  any fever blisters/cold sores in my life.  Sunday morning I began using  Campho Phenique  approximately hourly as treatment.  So far I have not seen any improvement,.  I will  continue this treatment today and contact my PCP if I do not have success.
Case number PHEH2015US019671, is a combined initial and follow-up spontaneous report from a nurse received on 01 OCT 2015 and on 02 OCT 2015. The report refers to a 33-year-old patient of unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with expired FLUVIRIN 2014/2015 (batch number: 1413801), expiry date: JUN 2015) at a dose of 0.5 ml intramuscularly on 30 SEP 2015. No adverse event was reported. No further information was provided.
Patient experienced flushing, feeling hot, flutter in heartbeat, lightheaded, dark vision, erythema.
A few days after the vaccine I started to experience some intermittent pain deep into the right buttock region when walking, that I had never experienced before. I had to go in for an MRI for a previous sports injury on my right hip and at the time they found bone marrow edema indicative of unilateral sacroiliitis in the area that became sore after the vaccination. My primary care retired and I am still in the process of getting follow up testing.
Soldier rcv'd his 1st Anthrax Vax. on 2/26/99. Shortly after he developed focal paresthesias, ataxia and findings c/w cervical myelopathy. DX: ADEM vs MS.  Follow up report states since the report was filed, the patient has continued to be followed.  His disease has progressed and he has been given diagnosis of multiple scleorsis-most likely preceeding the single dose of anthrax vaccine and unrelated to it. Per follow-up: 7/27/00 1230 - Call to pt - missing info. on VAER form - Diagnosed with MS. Pt will send copy of medical records 6 hrs.
Patient called to report tiredness, fever, shivering, nausea, upset stomach, vomiting and diarrhea
redness & swelling most of upper arm-began evening of vax & area extending daily 6SEp, 7SEP, 8SEP, 9SEP;by 8SEP axillary lymph nodes swelled;began cipro 9SEP AM;severe resp distress onset 9SEP pM;adm to hosp 9SEP97;
Hand/arm numbness; Hand/arm numbness; burning; Body inflammatory response.; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Workplace clinic via an unspecified route in right arm on 21Dec2020, at 39 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension and asthma, both from an unknown date. The patient didn't receive any other vaccine in the 4 weeks prior vaccination. Concomitant medication included lisinopril taken for an unspecified indication, since an unknown date. The patient was not diagnosed with COVID-19 prior vaccination. On 19Jan2021 the patient experienced hand/arm numbness and burning and body inflammatory response. The events resulted in Doctor or other healthcare professional office/clinic visit and Disability or permanent damage. It's unknown if the patient received any treatment. It was reported that on 10Sep2021 the patient underwent SARS-CoV-2 test via nasal swab, which turned to be negative. At the time of the report the events had not resolved yet.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events Hypoaesthesia, Burning sensation, Inflammation and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was given two doses of the vaccine at the same time. One of the doses given was MMRV which is not supposed to be given under age 4. Mother advised to monitor for fever. It is unknown yet if she had any problems.
3RD DOSE GIVEN TOO EARLY   1ST DOSE - 7/12/2022 2ND DOSE - 09/20/2022 3RD DOSE - 10/14/2022
This spontaneous report as received from a physician refers to a 3 months and 29 days old male patient. On 21-MAY-2013 the patient was inadvertently vaccinated with a dose of ROTATEQ (dose, route and lot # unknown). No adverse effects reported. Additional information has been requested.
swelling of the face; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. This report not related to a study or programme. It was reported that, when she received her first shot, she received a fact sheet from Pfizer. On page 3 of the report, it has risks, allergies, and signs of a severe allergic reaction. It lists 5 things. One of them was swelling of the face and throat. Then when she went down the page it has side effects that have been reported, and it says non-severe, was swelling of the face. She wants to know if it is severe or non-severe. She does have a lot of allergies and she gets swelling of the face fairly often. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Patient was given FLUARIX QUADRILAVENT vaccine on 9/26/16 and noticed on 9/27/16 her right arm felt very itchy. She also noticed small blisters forming near the injection site.
Cough, pressure in the head, almost exploding when coughing, pain of muscles joints and head; congested throat trouble breathing, nasal congestion, phlegm and mucus. Duration of 16 days, HAS REMAINED AN ANNOYING DRY COUGH, WITHOUT SPUTUM ... MILD TIREDNESS.
had redness and swelling in the area where he got the injection; had redness and swelling in the area where he got the injection; bruise; still has that discoloration in the area; This is a spontaneous report from a contactable consumer. This male patient (consumer) reported for himself. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 08Apr2021 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Within 24 hours, the patient had redness and swelling in the area where he got the injection and it still ongoing and now he had a bruise in that area. He still had that discoloration in the area. Still had a bruise 6 weeks later. Doesn't think he should get 2nd injection. Outcome of the event was not recovered. Follow-up attempts are needed; information about lot/batch number requested. Follow-up attempts completed. No further information expected.
Itchy rash with raised bumps, puss like lesion, and purple discoloration  appeared on 2nd toe of both feet and left heel during Covid19 infection in 2/2021.  Treated with over the counter antifungal cream and antibiotic creams and did not respond.  (Covid19 was treated and resolved within 3 weeks without hospitalization).  The rash appeared to be spreading.  Additionally treated with prescription antibiotic/antifungal/steroid cream.  The rash responded  with this treatment by 8/2020, however the discoloration only faded and the rash continues to recur and are slowly responding to the prescription treatment on left heel.
pt recv vax 14APR97 & started itching & swelling rt thigh where hep b vax given;pt recv DPH in clinic w/complete resolution of urticaria;
Vomiting at 10:00PM, 11:00PM, 1:30AM, 2:00AM and 7:30AM.  No other adverse physical symptoms present.
Severe, ongoing pain in left anterior cervical lymph nodes. More than one week of pain - especially sensitive when touched or head is moved to the right.
This spontaneous report as received from a nurse practitioner via filed representative refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient was not a pregnant. On unspecified dates, the patient was vaccinated with complete schedule of doses for GARDASIL 9 at a dose of 0.5 ml. On an unspecified date, the patient was given an additional dose of GARDASIL 9 for an unspecified reason. No adverse effect was reported. Therapy with GARDASIL 9 was continued. The outcome o f the events was not reported. Additional information has been requested.
Vaccine given 7/13/01 on 7/15 pt adm to ED for swelling from knee up since receiving vaccination. Has been fussy. (LLE) hot to touch. treatment: ibuprofen, cool compress.
Delayed symptoms, not at  injection site. After approx 4-5 weeks, rash presenting at first as itchy papules in right elbow crease, erupting into painful red wheals over initial 2 wks. Left arm elbow crease red papules then appeared, itchy; also spreading into wheals; this then developed over forearm area. Skin color of right elbow crease  remains red with slight raised appearance, but right arm area pruritis diminishing. Left elbow crease and now forearm area worsened, eventually with large persistent itchy wheals, including from point of elbow to about 4? from wrist. Pressure or scratching leaves graphic trace wheals. As of Nov. 5 left forearm still marked with several  flatter red wheals, now mildly itchy, approx 2 to 2.5? diameter. Both arms initially had point-of-elbow involvement. Pruritis over forearm and elbow crease seemed to increase at end of day during initial period. Topical cortisone cream seemed to allay pain and itchiness. Neosporin applied to areas with broken skin from scratching; gauze bandaging overnight especially over highly inflamed left forearm. No pus nor red lines occured, mostly saw clear serum-like exudate. This spontaneous urticarial issue is novel to me. Lasting from approx August 17, 2022 to November 5, 2022 (present day) but is now diminishing in intensity.
Janssen COVID-19 Vaccine EUA  Moderate headache. Sleep and and headache relief medicine (acetaminophen and caffeine). Headache gone approximately 48 hours after vaccination.  Aches in legs. No treatment.  Aches gone approximately 48 hours after vaccination.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree (also reported as Celsius degree). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree (also reported as Celsius degree). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Within 24 hours local site inflammation, indurated macule 6-8cm. Benadryl q 6-8 for 2-3 days.
Onset 1/30/03 "Lumps" posterior neck, above ear - "top of head hurt" - 2/1/03 Onset rash back, buttocks, anterior chest - little on arms & legs w/low grade fever. 2/2/03 - swelling of joints (wrist, knees, ankles) - "couldn't hardly walk" - Took Ibuprofen 499 mg Q 4-6 x 5 days - developed migraine - took Amerga(?). 2/7/03 - Onset discomfort in hands esp. left middle finger with swelling. Discomfort in ankles, knees - resolved.
Deep lingering ache in muscle - right deltoid, never went away after vaccine given 2 weeks ago.  Can't sleep at night due to pain.  Took Advil. Employee referred to primary care physician for follow up - appointment still pending as of 2/21/12.
Woke up with a swollen stomach and knees. Knees were shown to have early on set arthritis. Stomach became irritated, I developed heartburn and other digestive issues.
Red, minor swollen, warm, sore area from injection site proceeding down arm towards fingers.  About 3 inches wide by 6 inches long.  Only routine soreness of arm, no loss of function.  Minor complaints from patient who has lewy body dementia.  First noticed the day after the shot, got just a little bigger from day after to second day after.
Pt states he had COVID in January and was in the hospital for 2 weeks.  He also stated that a week after receiving the vaccine, he had a mental break.  He was taken to Medical facility.  He spent another 2 weeks in the hospital.