chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination on 10/21/2015 and immediate pain with fever following. 10/25/15 called with complaints of fussy, temp and drowsiness. 10/26/15 experienced atypical febrile seizure. 10/27/17 still fever, with another atypical febrile seizure, received final dx of pneumonia.
4-19-10 12:10pm. PC from clients mother. States that on Sat 4-17-10 patient was c/o very sore left upper arm. She stated there was a red "rash" in the injection area but later became "red and swollen" left arm also states he c/o chills during the night. Ibuprofen has been given but arm cont. with redness, swollen and pain. Referred to PMD. States she  will phone his office today for appointment or advice. Mom states she will phone health department with follow-up information. This Tdap was given at a school clinic by health department. P.C. to mother she states Pt is doing much better. The swelling in his arm has subsided except for a spot the size of a quarter around the injection area. He is still taking IBUPROFEN. Mom did not call the Dr. but states she will call the Dr. today to let him know. Denies fever, chills, itching or trouble breathing.
This spontaneous report as received from a Licensed Practical Nurse. On 02-MAY-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Pt noticed increased weakness in legs after receiving COVID vaccine.  Had been walking steadily.   Now unsteady with walking, feeling like legs will buckle. Pt referred for home PT.
Patient broke out in a rash after ROTOVIRUS immunization given within 24 hours.  Also had a temperature of 101.  Mother gave TYLENOL rash was on whole except face.  Patient also received PENTACEL, and PREVNAR
within 10 seconds after received both vaccines pt experienced syncopal episode which included bladder incontinence, loc of 5-10S. After pt was oriented x 3. Transferred to local ER. CT scan of head nl and pt dx'ed with vasovagal rxn.
had a little fever last night; felt a little yucky yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 13Jan2022 (Batch/Lot number: unknown) as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "he has autoimmune disease" (unspecified if ongoing); "her husband and her got sick with COVID", start date: Jul2021 (unspecified if ongoing), notes: got sick with COVID, she says treatment for the COVID-19 was offered to her husband; "had brain fog for two months" (unspecified if ongoing); "they were sick for three weeks" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "had a little fever last night"; NAUSEA (non-serious) with onset 13Jan2022, outcome "unknown", described as "felt a little yucky yesterday". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She said she and her husband got sick within a couple hours of each other, and when they went to get tested, he tested positive and she was negative. She said the only thing they figured out was that she must have been a couple hours behind him and did not have enough when she tested positive. She said they were running fevers and had aches. She clarifies they did the COVID test in August, the COVID test done in the nose, whatever that is. She said treatment for the COVID-19 was offered to her husband, the infusion, because he has autoimmune disease. She says because she tested negative and didn't feel like going back to be tested again the next day, she didn't get offered any treatment, she said her husband didn't take the test, clarified to infusion, because he would have to go to the hospital for that and he didn't want to expose anyone or go anywhere. She said they recovered from COVID, and she was back to normal until Monday when she took the booster dose. Caller declines to complete a report for her husband, she said his side effects were different for him and she wouldn't want to give something wrong. She said her husband got his booster yesterday and felt a little yucky yesterday and had a little fever last night, and then was good to go today, he was a withheld.  The lot number for bnt162b2 was not provided and will be requested during follow up.
He reports arm soreness/soreness in arm; This is a spontaneous report received from a contactable Consumer from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 16:00 (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: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "unknown", described as "He reports arm soreness/soreness in arm".  Additional information: Consumer calling about the Pfizer COVID-19 vaccine who says he took it on March 3rd and has several questions about it. He says he was worried over something and may be paranoid but he didn't feel anything when he got the shot, which he was looking the other way because he was afraid of needles. He stated he did not feel anything when the needle went in and he was questioning whether he received the vaccine or not. He wants someone to tell him that he will be ok. He says he has soreness in his arm today so they did put the needle in, but he has no sickness they said he may feel in first two days, and now it is Friday he is wondering did they inject him and thinks he should have looked. He says he may be just stressed about it, he would like to know when they poked him with the needle and he is sore next day, is it because the needle was injected in his arm or because the medication is in there? Pfizer COVID-19 vaccine NDC/LOT/EXP: Unknown. Caller says he doesn't have his vaccine card, he remembers on the back it said second dose March 24th in three weeks. He says his other question was they had his last scheduled, how does this work, it doesn't show what time just the date of 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, fatigue, nausea, muscle pain, weakness. Severe injection site soreness..
I had fatigue and headache and new to expect that so that was fine and pasted but now that its been a week later my arm is itching again and an red and a little swollen. The skin is tender to touch and just keep itching.
Mother called MD. 3/1/03 Chicken pox looking lesions on back, chest. Increased congestion. 3/3/03 Per grandmother more lesions.
Patient experienced severe chills and body aches from 2am - 6am the next morning after receiving the vaccine the day prior.  Patient believed he had a fever.  Patient took Ibuprofen and found symptom relief.  Symptoms lasted from 2am - 6am.
4/29/21 1400 - LUE site warmth, firm, itching, and redness. Temperature 98.3 F, blood pressure 127/90, heart rate 90 bpm. No treatment plan, ongoing monitoring.
shot given lt deltoid, neg blood return; felt pain, & dizziness; also h/a, blurring vision, vomiting; pale, tremulous; BP 120/80, HR 80;
experienced hives all over her body; experienced pain for a total of 48 hours with no relief; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "experienced hives all over her body"; PAIN (non-serious), outcome "recovered", described as "experienced pain for a total of 48 hours with no relief". Additional information: Patient experienced hives all over her body 48 hours post vaccination with Prevnar. Patient also experienced pain for a total of 48 hours with no relief.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
After 16 hours very tender at site of injection followed by shoulder pain when the left arm is lifted and left-side neck pain (not sharp, but an ache) when the head is turned to the left. Less so, but still achy when head is turned to the right..
Info has been received from an RN concerning a school student who was vaccinated with a dose of varicella virus vaccine live. The nurse reported that her student developed break through varicella after vaccination. It was noted that all of the children in school except one had been vaccinated  (80 per grade from K through to 8th). The case was reported to be mild and the child did not return to school until all the pox had crusted. The child did not have the normal stages of chickenpox and the pox healed quickly. Additional info has been requested.
Myalgia, Fever, fatigue low grade fever Narrative:  Other Relevant History:
Patient had a hive type skin reaction that covered her upper chest and neck area. It consisted of Nickle sized red flat areas and was pruritic 20 minutes after vaccine administration. B/P was 172/102, P 79, O2 sat 98%.  Patient given 25mg liquid Benadryl orally. Patient had no other symptoms.  Ten minutes after administration of Benadryl B/P 172/98, P 86, O2 99 %. Patients hives subsiding and fading. Patient continued to have no other symptoms.  Twenty minutes after Benadryl administered patients hives were no longer visible. Patient educated on when to seek treatment at ER/UC. Patient sent home.
Treatment of COVID-19; Treatment of COVID-19; Moderna Vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: KPCM13), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 19Feb2021 as dose 2, single (Lot number: 024M20A), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing); "Known allergies: sulfa based drugs" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2016; VITAFUSION VITAMIN D3, start date: Jan2021; FERRASORB [ASCORBIC ACID;FERROUS BISGLYCINATE;LEVOMEFOLIC ACID;MECOBALAMIN;PYRIDOXAL PHOSPHATE], start date: Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Apr2022, outcome "unknown", described as "Moderna Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID).; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Extreme headache beginning 10 hours after vaccination. Increased blood pressure due to pain and pressure behind eyes. Sinus pressure and pain. Headache lasted 6 hours until treated with 600 mg ibuprofen. 10/10 pain. 102 degree fever. Arm completely immobilized and unable to lift above waist beginning 6 hours after vaccine until approx 24 hours post vaccine.
Her Lymph node the right side of her neck (under jaw, near right ear) became incredibly swollen and painful. She had difficulty swallowing and turning her head. OTC ibuprofen did not help. She saw her doctor and was prescribed doxycycline, cephalexin, tizanidine, and indomethacin. The swelling and pain eventually decreased.
Patient collapsed when being helped out of her son's car. EMS promptly on scene. Patient in PEA and was transported to Hospital, where she died. Was reported to be in usual health before event.
At 2PM PT recd MMR; immed became dizzy & was assisted to supine position in hallway (did not fall); was able to converse w/nurses throughout; able to ambulate out w/mom p/15 min;
Received the wrong vaccine, needed a dose 2 Pfizer, instead given Janssen
Itchy throat, tongue and cough. Generalized itching. Benadryl 50mg and solumedrol administered. Pt. kept for >1hr for observation. Released to home in no distress. Pt. instructed to go to ER is becomes symptomatic.
Inconsolable crying/screaming began 330PM; Lasted until 8PM, when fell asleep; ate/drank very little; generalized shaking; both thighs red, swollen; mom thinks Pt. had fever, but temp not checked.
had his first SHINGRIX vaccine about 3 years ago, has not received dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received his first Shingrix vaccine about 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-JUL-2022 Reporter's comment: The patient reported that he did not receive dose 2 yet. The reporter provided education as per the content and was referred to an Healthcare Professional (HCP). The Medical information (MI) number was also provided. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
VACCINE EXP. TO TEMP OUTSIDE OF REC STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
9 days after the injection, her arm at the injection site is swollen and warm over around a 4"x4" area, encompassing much of her upper arm.  It has been this way for 1.5 days.
Woke up at 7am day after vaccine injection. Right eye was burning and felt like it had a film on it. Tried eye drops but did not relieve burning.  Early afternoon when I left home and drove to run errands noticed both my eyes were blurry and right eye felt swollen. No appearance of swelling however. Was advised by primary care dr. To go to urgent care to have it checked. Was given prescription for prednisolone acetate drops. Also had flu shot the same day in left arm.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-COT-2015 02:26, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.0 (6hours 38 mins) and 0.5 (2 hours 20 mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient given varicella vaccine in left thigh. Within 10 minutes areas of swelling approximately 5-6 cm in size with a large weal in the center of it. Ice was applied, BENADRYL.
Pt had itchy throat, tightness & respiratory distress post vaccination.  Given Epinephrine 0.3mg. 911 was called and pt taken to ED
Initial unsolicited report received from non-health care professional on 02 Aug 2016. This case involves a female patient (age was not reported) who was exposed to the vial of Pentacel (batch number: C5139AA and expiry date-14 May 2017) on 18 Jun 2016. Product complaint was filed as CO2016-00360 PC 329911. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 18 Jun 2016, same day, patient had finger laceration when she pulled out a vial of Pentacel that had been broken in the box. Lab data and corrective treatment were not reported. There were no issues/complications reported. On unspecified date the laceration healed. List of documents held by sender: none.
Mildly sore injection sites in both arms lasting 2 days Muscle aches,  fatigue and Fever to 100.5   Began 16 hrs after injections.     Took Tylenol and slept a lot.  Normal in 24 hrs.
Patient had immunization at outside Pharmacy, his second dose shingrix, and subsequently 2 days later he went into his first ever episode of Atrial Fibrillation w/ RVR
I began to feel unwell on 02/09/2022 with cough and cold like symptoms. I was diagnosis on 02/12/2022. I have been told by doctor that I may be experiencing long haul COVID, since I have a slight cough and Phlegm that will not go away and a shortness of breath.
Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever. This has happened several times in two days. Comes and goes.
Swollen, errthymic, painful and warm to touch upper Left arm where injection was given plus flushed face and chest with hives to face.
Pt. developed a fever  about 8 hours after his vaccinations. At 3am, 12/05/2020 pt. started shivering and then had a seizure.
Inadvertantly given Pfizer bivalent as 1st dose primary series. Will return in 21 days for 2nd dose of Pfizer monovalent.
Mother called to report hives approximately 2 hours after Hepatitis B #1 given at Health Department. Seen by MD. Hives on neck, underarms, back and stomach. Treatment: Benadryl by MD. He signed a medical contraindication for no further Hepatitis B shots.
Gradual onset of pain, redness, swelling of (L) upper arm approximately 4 hours after IM deltoid injection. Skin warm to touch. Proximal distal - 8" - circumference 7".
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (dose 2), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 09Oct2023 to 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine bnt162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Injection arm soreness worsening throughout the day. Fatigue worsening throughout the day. Headaches. Body soreness & tiredness. I almost feel like I am in a bit of a fog too.
Tetanus (Td) vaccine was administered by Nurse on Duty in left buttock on 04-09-02.  Within hours, pain was experienced in groin area and continued to worsen, with reddening and swelling (from crotch area to hip).  Streaking appreared around point of injection; Patient returned to offices on 04-12-02.  Doctor treated infection with Cephalexin 500mg caps Generic Keflex.
MMRV and Varicella were given at the 12 month WCC today.
Pt passed out/fainted, fell over out of chair and hit head on chair next to him, got patient to another chair and gave ice pack for head, gave pt water and some candy, patient was pail and clammy after fainting for about 10 minutes before getting color back and feeling better, patient stayed for another 15 minutes and was ok. We did advise if he has any concussion symptoms he would need to report to the ER, pt stated he had not eaten all day either.
Pt recvd 2 doses of Engerix-B 17SEP91, 15OCT91 2nd dose was uneventful; p/1st dose pt exp severe malaise, pain & stiffness in shoulders, legs, neck & hips; As of 24OCT91 pt still has joint pain;
pt recv vax DEC96 & pt appeared jaundiced;FEB97 pt exp a skin color change;MAR97 pt devel cold agglutinin autoimmune hemolytic anemia & was hosp;pt placed on pred on JUN97;lab eval including eval for hep B;
Hospital Employee came in to receive both seasonal & H1N1 vaccine.  Administered bilateral arms & nurse applied bandaid to 2nd injection site & Stated "i don't feel good, hot & tight in my chest".  Reddened / flushed face/ no visible breathing difficulty.  Benadryl 50mg IM administerd to Right Gluteal & transported to ER for follow-up with MD.  Symptoms has subsided prior to transport.
Temp 102-103 x 3-4 hrs, joint pain, muscle aches, chills, rapid heart rate, nausea/vomiting/diarrhea s/s lasted 3-4 hrs.
Mother and child were checking out when patient became light headed. She was assisted to a prone position by staff, where Vital signs were taken. Patient's Color was pale and skin was clammy. After lying in prone position for approximately 10 minutes, she was able to sit up and stand on her own with no issues. Dr. came out to the lobby and talked to patient when she was feeling better. Child walked out of the clinic  with mother.