chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness; inflamed knees; had inflammation and swelling in the knees; This is a spontaneous report from a contactable consumer or other non hcp.  A 64 years old female patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) as dose 1, single via an unspecified route of administration on 27Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021 the patient experienced arm soreness, inflamed knees, had inflammation and swelling in the knees that has last for 10-11 days. She went to her doctor and was told it was not a common side effect and prescribed an inflammation medication. She went to Pharmacy where she got the vaccine and the pharmacist said they were not aware of this side effect and to call Pfizer. Patient stated that still has it and it's not gone all the way, not all of it and it's getting much better from the beginning, but she still had it. She went to the doctor and showed it to them and they know and she was prescribed a medicine for the inflammation. Because this was a reaction and read it was common when reading the paperwork, she wants to know if this happens often and should she get the second dose, since she was to get it soon. The patient asked will this happen again. No further details provided.  The outcome of events arm soreness were unknown, inflamed knees and swelling in the knees that has last for 10-11 days was recovering.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of GARDASIL (Lot # not reported) in October 2012 "two months ago". No other co-suspects were reported. No concomitant medications were reported. The physician reported that in 2012 the patient had experienced continual paralysis in the arm that received the injection. The outcome of continual paralysis in the arm that received the injection was unknown. The relatedness of continual paralysis in the arm that received the injection was unknown for GARDASIL. Upon internal review continual paralysis in the arm was considered medically significant. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of feels-sluggish in a 22-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included allergic to raspberries, allergy to neomycin and allergy to pine oil. On 25 April 2014 the subject received 1st dose of HAVRIX (unknown route). In April 2014, less than one week after vaccination with HAVRIX, the subject complained of feeling sluggish. The subject came back to the clinic and wondered if the event could be related to neomycin. At the time of reporting the outcome of the event was unspecified. The nurse refused to provide additional information. Follow up information received on 3 June 2014 from the nurse: On 25 April 2014 the subject received 1st dose of HAVRIX (intramuscular, unknown deltoid). On 25 April 2014, less than one day after vaccination with HAVRIX, the subject experienced feels-sluggish. The subject also experienced slight injection site sensitivity. On 29 April 2014, the event was resolved. The subject declined appointment to allergist. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. The subject was advised to not receive the second dose of vaccine since he was allergic to component of vaccine. This case was reported to a regulatory agency.
Fatigue joint pain all extremities ,and neck and back beginning 3rd day after vaccine and still persistent (1/26).No fever
Severe pain to left arm, aches and pains to joints, headaches and nausea.  During the night had chills.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; PROBLEM WITH URINATING; This spontaneous report received from a patient concerned a 51 year old male. 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: 1808978, and expiry: unknown) dose was not reported, 1 total, administered on 05-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient was tested positive for COVID-19 PCR test (confirmed covid-19 infection and confirmed clinical vaccination failure). In JUL-2021, before test the patient was experiencing body pain, soreness of the body, pounding headache that went all the way to his back, fatigue and problem with urinating. Patient went to physician office. He recovered after 2 weeks being off from work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection and problem with urinating in AUG-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210837367-JANSSEN COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure- This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Narrative:  Timing ERROR only, 2nd dose given 75 days after 1st
Patient reported injection site reaction of redness, swelling, slight burning, and soreness for about 1 week.
Symptoms of an enlarged spleen; Blood in stool that lasted 3 days; General tiredness; A spontaneous report was received from a dentist, a 63 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced general tiredness, blood in stool that lasted 3 days, and symptoms of an enlarged spleen.  The patient's medical history, as provided by the reporter, included high blood pressure. No relevant concomitant medications were reported.   On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 026L20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.   On 04 Jan 2021, the patient had general tiredness.  On 16 Jan 2021, the patient experienced blood in his stool.   On 17 Jan 2021, the patient had symptoms of an enlarged spleen. He stated that he had intense pain on the side of the spleen. Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, blood in stool that lasted 3 days, was considered resolved on 19 Jan 2021. The outcome of the event, symptoms of an enlarged spleen, was considered resolved on 19 Jan 2021. The outcome of the event, general tiredness, was considered unknown.; Reporter's Comments: This case concerns a 63-years-old male patient, who experienced a medically significant unexpected event of blood in his stool, and non-serious unexpected event of Symptoms of an enlarged spleen along with expected non-serious event of General tiredness. General tiredness occurred on the same date after the first dose of mRNA-1273, lot # 026L20A. The event of blood in his stool occurred approximately 12 days after first dose of mRNA-1273, lot # 026L20A. The event of Symptoms of an enlarged spleen occurred approximately 13 days after first dose of mRNA-1273, lot # 026L20A. Treatment for the events included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
mastitis - 10 day abx course.  symptoms began 4 hours after vaccine R. breast pain and headache. 12 hours later breast redness, high fever, fatigue, body aches, chills followed.
The patient came in for a Dtap vaccine. I gave a Tdap unintentionally. The patient  had no symptoms and tolerated injection well. I spoke with two doctors at our office who researched the vaccines and stated to me that the patient would not need another dose of dtap and should have no adverse reaction to the vaccine. the patients mother was notified.
Chills for 1 hour at 11pm, 12 hours after shot.  Ear pain in left ear 27 hours after shot
Soreness under the arm on the day of vaccination.  The next day broke out in red patches/blotches about an area of 3 inches in diameter.  Weather was hot.  Blotches were gone by the time she called public health office on 8/6/2010.  No treatment.
Lips swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LIP SWELLING (Lips swelling). At the time of the report, LIP SWELLING (Lips swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Patient got Moderna vaccine on Sunday, 07 Mar 2021 and woke up with lips swelling on 09 Mar 2021 morning.  No treatment information was provided.
deep muscle pain in left hip with nerve pain 1 week after 2nd shot, calves were extremely tight after walking 2 days after 2nd vaccine, low back went out 2 days after 2nd shot, rash on lower shin of left leg onto foot 12 days after 2nd shot of vaccine.
pt was given expired vaccine. vaccine expired on 7/7/22. this was pt first dose.  no adverse event occurred.  attempting to re-vaccinate patient.
Shot given 6/6/14 - HAVRIX expired 5/30/14 called manufacturer to determine if ok to give another dose. 1st dose invalid ok to give another dose as soon as possible. Called patient and emailed to let know he needs a new immunization.
Moderna COVID-19 Vaccine EUA  Chills: began two days after injection. Lasted one evening.   Fatigue: Began to set in the hour of injection.  Resolved next day. Returned two days later with fever.  Spiked temp to 100 then dropped to normal within. A couple hours. Left feeling fatigued the next day as of the time of filing this report. Heavy cough for about an hour the evening temp spiked. Congestion and sneezing Increased beyond normal from time of temp spike. Still current as of time report filed. Fogginess occurred soon after injection. Still occurring when this report was filed.
Rash appears on neck and few days after shot, cream then visit to dermatologist when rash spreads to chest and eventually down to legs - no itching - two doses Prednisone cream - 6 biopsies (nothing conclusive) (not allergic to egg or chicken).  Small brown spot around area where shot administered. 1/26/2010 Death  8/18/2008 MR received from dermatology consult dated 12/18/07 and 01/02/2008 with DX:  Contact dermatitis, possible drug eruption/allergy.  Pt presented with rash which began 2 days s/p flu shot.  PE (+) for erythematous annular and confluent patches on thighs, waistband and chest.  Erythematous cribiform patches of edematous papules on nape of neck. 31x3mm band of light brown macule on R upper arm at flu shit injection site. Rashes improve with steroids. ROS also (+) for SOB, night sweats, foot swelling, constipation and diarrhea. F/U 1/2/08 with rash slowing resolving.  8/25/2008 MR received for several OVs beginning 12/27/07 with DX:  Contact Dermatitis.  Erythema Multiforme.  Allergic urticaria.  Unspecified adverse effect of unspecified drug.
Pt vaccinated with DTP/OPV developed high fever of 105.4, vomiting 1x. Seen in Hosp.  Chest X-ray, WBC treated w/tylenol & released.
On Sunday, Oct. 17th while on a trip I developed 24 hrs of diarrhea with bright red blood which resolved.  Two days later developed left sided rib pain extending to mid back which progressed to right side within a day.  Had difficulty lifting my arms, getting up from a chair, bed or car.  Pain increased with movement.  Saw my family physician upon my return home on Oct. 28th.  Lab work was done and results confirmed a diagnosis of PMR (Polymyalgia Rheumatica).  I'm now on Prednisone and will be seen again in one week for followup.
minor allergic reaction; hands started swelling a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: Unknown) at the age of 27 years 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: VACCINATION SITE REACTION (non-serious) with onset 26Mar2021, outcome "unknown", described as "minor allergic reaction"; PERIPHERAL SWELLING (non-serious) with onset 26Mar2021, outcome "recovered" (27Mar2021), described as "hands started swelling a lot". Therapeutic measures were taken as a result of vaccination site reaction, peripheral swelling.  Additional information: The patient took pfizer Covid vaccine because of general wellness. Had a minor allergic reaction five hours after. Caller report a history of getting hives as a reaction randomly throughout caller's life. Most recently caller had a reaction after receiving the typhoid vaccine, like 5 years ago. Hands started swelling a lot: Began 5 hours after receiving first dose Pfizer Covid Vaccine. By the next day the swelling was completely gone. Caller confirms it was gone entirely, without lasting effects. Zyrtec was received as treatment and caller's hand swelling had gone away. Reports Zyrtec alleviates that, no covid prior to vaccination, no investigation assessment. Event Caller reports the Typhoid Vaccine reaction was 5 years ago. Reports it was the oral Typhoid vaccine you take for five days in a row. Caller's body didn't like getting Typhoid every day for three days.   Follow-up attempts completed. No further information expected.
Immediate onset of severe tinnitus in both ears that lasted all day for several days.  After two full days the symptoms waned, but then on third day symptoms returned with addition of people's voices having a garbled sound like that of a computer voice modulator at high registers.  Also have added sensation of pressure on the inner ear of both ears similar to being deep under water.  Also, had sensation of ears being 'wet'.  It waned after one day and then came back.  Have experienced continued fluctuating  levels of tinnitus, with ear pressure and distortion of loud sounds and higher pitched tones.
Information has been received from a physician's assistant concerning a 29 year old female who on 14-APR-2008 was vaccinated in the left arm with her first dose of GARDASIL (Lot # not provided). Concomitant therapy included ORTHO TRI-CYCLEN LO. The patient experienced a left ear ache and pain at the left scalp. On or around 20-APR-2008, the patient developed numbness and/or tingling of the left arm. The pain on the ear and scalp did resolve, but the arm sensation still persisted. The patient was treated with VALTREX (time unspecified by reporter) by the primary physician because he suspected that it was shingles, but later ruled that out. The patient sought unspecified medical attention by seeing her primary physician. No other details were provided. Additional information has been requested.
Varicella Information has been received from a physician concerning a patient who was vaccinated with varicella virus vaccine live (Oka/Merck). In September 2005, the patient developed breakthrough, which was described as a mild case with less than 30 lesions. The lesions were reported as maculopapular in nature. The adverse event improved and the patient is recovering. No further information was available regarding the adverse event. There was no product quality complaint.
Individual received vaccine on 12/17/20 at 0815.  Began with feeling faint and "spinning" at approx. 11:00 am, reported resolution of symptoms at approx. 11:11 am on 12/17/20.
right knee replacement began to ache and feel as if it was swollen; right knee replacement began to ache and feel as if it was swollen; soft tissue is inflamed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "knee replacement surgery" (unspecified if ongoing), notes: had no issues with replacement for 5 years after surgery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 2022, outcome "recovering" and all described as "right knee replacement began to ache and feel as if it was swollen"; SOFT TISSUE INFLAMMATION (non-serious) with onset 2022, outcome "recovering", described as "soft tissue is inflamed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had gotten only Pfizer Covid shots and 1 booster. 2 weeks after getting the booster, the right knee replacement began to ache and felt as if it was swollen, still 3 months later minimal change in what the patient felt. X-rays showed nothing wrong with replaced knee, just that soft tissue was inflamed. Ice and stretching was recommended. The patient had no issues with replacement for 5 years after surgery.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt c/ discomfort in throat, chest, and stomach. Pt decribes discomfort as "tightness." Pt stated pain level was 5 out of 10. Pt stated, "this feels like anxiety." Vitals were WNLs.
facial urticaria-mild fever & irritability 3hrs p/vax;rx DPH-APAP
Moderate headache and minor/medium body aches (flu like).  A bit painful to urinate.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-JUN-2016, the patient was vaccinated with a dose of improperly stored VAQTA "10Pk 50U/1ml SD Llok w Caps Adult" with lot number L031196 and expiration date of 05-FEB-2017 (dose, route of administration and anatomical location were unknown), which was stored at the highest recorded temperature of 47 (8.333333333 Celsius degrees) for 24 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
About 8 days after vaccine I developed a rash on the left side of my body that started as tiny bumps but has gotten bigger. Its red, painful, itchy, and bleeds.
Pt described having heart palpitations, starting about 4 hours after vaccine the same evening of administration. Pt complained that even had palpitations continuing for 4 days after, also complained of shortness of breath when laying down and feeling winded quickly. Pt said he spoke with his primary care provider; PCP is referring pt to see a cardiologist. Pt said that no longer having palpitations but still having shortness of breath and easily winded; pt inquired if pharmacy could give him a faster referral to get him in for cardiology referral; told him pharmacy does not have that kind of authorization and to continue to follow up with his PCP if still have additional symptoms. Advised pt to hold on getting a 2nd Pfizer vaccine until have approval from either his PCP or the cardiologist.
4 days after vaccination patient developed increased prominence and tenderness of varicose veins in both legs with significant hardness of the veins
Information has been received from a medical assistant reporting that a patient (age and gender unknown) was in the office to receive Dose 2 of GARDASIL (lot # and route of administration not reported) which will be late. Dose 1 was administered sometime in April 2012. No symptoms reported. No other details. Additional information has been requested.
10/29/2002  10:00am. Apprx. 15-20 minutes after receiving HBV # 2 client started having swelling under both eye. No difficulties breathing. Gave 0.6ml Benadryl. Im in left deltoid . Difference monitored for 1 hour  20 minutes.
Pt to ED via EMS 5/27 with dyspnea, pt was found on the ground in the Tripod position. Pt COVID+ 5/27, pt is on BiPAP, transitioned to 3L oxygen via nasal cannula without complaints of dyspnea and no respiratory distress noted. 5/28 pt remains on 3L via nasal cannula with no signs of respiratory distress noted. 5/29 pt alert and oriented x3-4, gets confused at times, pt up independent, no SOB at this time, pt on 2 liters nasal cannula. 6/1 Pt A+ox4 c c/o tolerable back pain. 6/2 pt AOx4, on 2L NC, pain level 8/10 for back pain Tylenol #3 given as ordered. Pt discharged 6/2.
Got the COVID vaccine(1st dose) on 01/12/2021. Had Benadryl with it due to previous allergic reactions. Later that night, I had nauseous. Slept for 10-12 hours. Woke up fine, had no issues or symptoms. Later on as the day progressed, around noon-1pm, I noticed I had started to get a headache and some dizziness. Daily headaches and vertigo are normal for me, currently seeing a neurologist for this, but I realized that this was getting worse from the daily headaches and vertigo that affects me. Took 2 Excedrin extra strength migraine relief to no relief.
11:30pm 8-11-2009 vomited, upset stomach, dizzy, tired, cough. Thought would get better continues to have symptoms.
10/8, 5:00 pm: sweating, took shower, went to sleep 9:00 pm: sweating, temperature 100 degree f, took Tylenol, got very itchy 10/9, 1:00 am: took Benadryl for itching, did not help 1:00 pm: temperature 99.8, body aches, hands and feet with pins and needles sensation. 2:00 pm: took shower and notice hives on arms, chest, hands and feet, took Benadryl and Tylenol 10:00 pm: pins and needles sensation in hands and feet worsened, reddened finger tips and soles of feet 10/10: temperature 99.3, hives faded but still itchy, still have pins and needles sensation in hands and feet
4 days post vax, the pt developed unilateral parotitis. It was noted that to the physician's and pt's knowledge there has been no exposure to wild-type mumps.
Client felt dizzy for a few minutes and had elevated blood pressure the highest at 172/110.
Swelling of thigh (looked like entire quadriceps muscle was swollen) and red rash distal and medial to injection site, about 2.5 inches long and 2 inches wide.  Tenderness to the touch.
Arthralgia, Diarrhea, NauseaVomiting, sore arm Narrative:
Lip, tongue swelling, face edema (+/- hives), starting 3 hrs after vaccination of Pediarix, Hib and Prevnar. Lasted around x3days.
High fever 105 on 12-18, 19 2 days later red papular rash on trunk went away 2 days came back more extensive measles rash some congestion and irritability.
admitted to hospital earlier in the week for COVID pneumonia, was dc'd to home and returning back to ED via EMS; hypoxia (O2 sats 70-80s on RA); placed on BiPAP; developed PE; AKI; RF secondary to COVID pneumonia; on dexamethasone, antibiotics and steroids; condition worsened eventually requiring intubation with mechanical ventilation; pt's condition deteriorated and she passed away in the hospital