chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness and Tingling at injection site and then it began to spread down the arm stopping at the wrist and then up into the shoulder. Patient came into office for evaluation on 08/26/2015, Doctor evaluated the patient and treatment was observation and consultation with a neurologist.
arm soreness; mild influenza like symptoms; less arm stiffness; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: arm soreness), influenza-like symptoms (Verbatim: mild influenza like symptoms) and limbs stiffness (Verbatim: less arm stiffness). The outcome of the pain in arm, influenza-like symptoms and limbs stiffness were not reported.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms and limbs stiffness to be related to Arexvy.     It was unknown if the company considered the pain in arm, influenza-like symptoms and limbs stiffness to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-OCT-2023 The HCP (health care professional) stated, the patients have been doing well on Arexvy.  They were mainly experienced arm soreness and mild influenza like symptoms.  Her patients in general have less arm stiffness than Influenza vaccines. The follow-up could not be possible as no contact details were available.
Pt developed a localized reaction. Entire left deltoid area was red, swollen, and warm to touch. Pt denies pain and tenderness.
liver failure; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FAILURE (liver failure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC FAILURE (liver failure) (seriousness criterion medically significant). At the time of the report, HEPATIC FAILURE (liver failure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient was a healthy young women who went into liver failure after her second Moderna dose.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious (medically significant) AESI  of Hepatic failure that occurred in the context of mRNA-1273 vaccination(second dose). Latency cannot be assessed since vaccination date was not disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to the previous dose was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious (medically significant) AESI  of Hepatic failure that occurred in the context of mRNA-1273 vaccination(second dose). Latency cannot be assessed since vaccination date was not disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to the previous dose was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
L lateral thigh 2 cm area of redness and slight tenderness @ sight of Kinrix; just a bit inferior at sight of the Proquad 1 cm local reaction. The Proquad reaction is just erythema and nontender. MD instructed to observe no treatment given.
I received the 2nd dose of Moderna on 4/26/21. My arm is in extreme pain. I can't lift my left arm. I can't drive or dress myself. Pain level is 9/10 with Advil and Tylenol. I need help with daily activities. The nurse who injected me pulled and pushed the needle in an and out and left it in my arm for longer than a usual shot. I'm really in bad pain.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015 the patient was vaccinated with improperly stored RECOMBIAVX HB injection (lot # J004700, exp 26-NOV-2015, strength, dose and route unspecified). The reporter did not state if the administered RECOMBIVAX HB was the first dose in the series. No concomitant medication was reported. No adverse symptoms reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. This is one of several reprots received from the same reporter. Additional information has been requested.
This child had erythema, induration, swelling, and elevated warmth, of entire right thigh for 1-2 days following DTaP, Hib, and Hep B.
6.5 X 7.5 cm round raised area, mildly tender, no fever.
focal sz 8 days p/vax;CSF clear;MRI  findings & course c/w acute disseminated encephalomyelitis;
Seven or so hours after injection on Saturday, I developed a rash that quickly became hives on my lower back, which spread to my inner thighs.  Took Benadryl OTC tablets, and used Benadryl topical gel on affected areas.  Overnight, the rash spread to my outer thighs.  By about 9am the next day, (Sunday) developed a headache which became more severe as the day wore on, a fever (102), and, body aches.  Talked with my primary care manager on Sunday afternoon who advised me to continued with my benadryl treatment, but to go to the ER if I developed any breathing problems.  This all persisted in varying stages of severity through Tuesday, when I started having breathing issues, and went to the ER, where I was given steroids and a breathing treatment, chest xray, blood tests, etc.  Was also given a prescription for five days of prednizone, and, released.
Patient is a 89 y.o. female with a history of a TAVR that presented to the emergency room few hours after having a 40 min episode of chest pain.  The patient states she was just eating and suddenly started having sharp pain on the left side of her chest.  There was a little bit of associated shortness of breath, but not much.  She states it was sharp in nature and seem to stay about the same for about 40 min.  She states that she does seem to get chest pain sometimes when she vacuums, but usually if she sits down it immediately goes away.  She reports that she saw PAC about a week ago and was thought to be a little bit fluid overloaded.  She was started on a little bit of oral Lasix and was supposed to come see provider later in the week.  She states she has diuresed very aggressively the last few days and is feeling quite a bit less short of breath.  In the ER, her EKG did not show anything acute.  Troponin was normal.  BNP was mildly elevated, but her imaging did not show any signs of acute congestive heart failure.  Her D-dimer was elevated.  However, she was not having any pain while she was in the emergency room.  Her pulse was normal and her oxygen saturations were in the high 90s.
Mother described normal nursing baby with normal bowel movements.  After 2 months vaccines was constipated for 2 days and continued to 4 month shots.  Appointments with 3 different doctors all advising BM's would return to normal but still dealing with constipation. Use apple/prune juice for constipation.
Subsequent to receiving her first dose of Engerix B, the pt experienced itching at the injection site. As of 08/29/2000, the outcome of the event is resolved.
Vaccination Failure; Nasal Swab: Positive; This is a spontaneous report received from a contactable consumer(patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Lot Number: EL3247) at age of 34-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (Lot Number: EP6955) at age of 34-year-old, both as single dose for covid-19 immunisation. Medical history included Penicillin hypersensitivity.  No covid prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced vaccination failure on 26Aug2021.  No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 26Aug2021.  The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
The patient had no reaction to the first dose.  She started to feel achy all over and have discomfort in her arm the evening after the vaccine. She noticed the glands in her neck were swollen and her throat was hurting. She said she felt anxious so she used her inhaler even though she was not short of breath. When I saw her the next day she was still achy but had not taken any pain relievers. She had naproxen and was planning to take it. She was still not short of breath.
Lip tingling, Throat tightening. Started 2 minutes after administration of vaccine. Saturations and  blood pressures remained stable.  Given 1x Benadryl with slow resolution.
Information has been received from a consumer concerning her 4 year old daughter who at 15 months of age was vaccinated with the first 0.5 mL dose of ATTENUVAX (Lot number was not provided). Subsequently, the patient experienced allergic reaction to ATTENUVAX. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Light fever, diarrhea, body aches, back pain, chest pain, headache, chills, vivid dreams,  Lasted for 48 hours
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a second dose of RECOMBIVAX HB (lot #, dose and route not reported). The physician reported that the patient was found to be HBsAg positive 1-2 weeks after the second dose of RECOMBIVAX HB was administered. The patient sought medical attention at the office. At the time of the report the outcome of the patient was unknown. No further information is available.
She was on hormone replacement therapy since 2019 for menopausal symptoms, received a Covid vaccination mRNA 15 January and 2 February 2021  She also has a history of prior traveling frequently and had been more sedentary related to the pandemic as she was not teaching water aerobics as she normally had been prior to the pandemic  On 24 March 2021 due to some right lower extremity pain an ultrasound showed DVT proximal right deep femoral vein, and proximal right posterior tibial vein in the calf, the saphenous vein at right mid calf as well and the lesser saphenous vein had thrombosis proximal to mid, 3.4 cm from the popliteal vein with a left ankle cord and pain associated with superficial venous thrombophlebitis, Xarelto was instituted at that time, but stopped after a couple months with near resolution of symptoms   A follow-up right lower extremity ultrasound 23 April 2021 showed resolution of DVT in the femoral vein with chronic occlusion in the superficial thrombosis of the greater saphenous vein  Labs in June 2021 showed hemoglobin A1c 5.4, CBC normal, M spike 0.09 IgM kappa, JAK2 negative, protein C and protein S and Antithrombin normal, factor V Leiden negative, beta-2 glycoprotein antibodies negative, hexagonal lupus anticoagulant 11 (upper limit of normal but normal), DRVVT negative, TPO antibody negative, centromere antibodies were tested and low-level positive at 1.4 with normal less than 1, TSH was 0.09 and free T3 was elevated and PNH flow cytometry showed rare PNH clone of the RBC and granulocytes, recommend repeat in 6 to 12 months, ANA has been negative, HIV has been negative, TSH was 0.65 with titration of Synthroid as needed, normal CRP and ESR and negative RF and negative CCP antibodies of, and uric acid normal, August 2021 kappa lambda ratio normal, IgM 466, IgG slightly low at 701
PT DEVELOPED WHEEZING, SOB AND FELT HER THROAT CLOSING. SHE TOOK BENADRYL AND ALL SX RESOLVED BY NEXT MORNING
From initial information received on 08/20/03 from a health care professional regarding ad adverse event occurring in the USA, it was reported that a 61 year old female pt received TD ADS ADULT, Lot # U0841AA, administered IM in the right deltoid on 08/08/03.  Six days later, the pt developed cellulitis at the injection site. The pt's recovery status is unknown.
feverish, fatique, lymph node above left clavicle, muscle soreness of entire left shoulder and arm .  Instructed to use ibuprofen, heat and rest arm.  She will follow up daily for the next 3 days.
I began noticing a sudden hair loss in October, 2021.  I continue to experience hair loss. My thyroid TSH was sufficient upon onset, and continues to remain sufficient.
Missed menstrual cycle after 1st dose of Pfizer vaccine. 1st day of previous menstrual cycle was 8/10/2021, received 1st dose of Pfizer on 8/24/2021 and was supposed to get menstrual cycle on 9/7/2021 and completely missed.
Fever, 10cm in diameter red area around injection site. 10 cm in diameter, T about 102.9.
Information has been received from a physician concerning an 8 week old male with no known drug allergies and a history of circumcision and family history of cancer (maternal grandfather) who on 30-APR-2008 was vaccinated with the first dose of RECOMBIVAX HB vaccine and on 29-MAY-2008 was vaccinated IM with the second 0.5 ml dose in the left thigh of RECOMBIVAX HB vaccine. There was no concomitant medications. On 30-JUN-2008, the patient was at a well baby visit and the parents expressed concerns about the baby spitting up after each feeding and not seeming satisfied after feeding. It was reported that the parents tried to increase amount of formula but spits up more and have tried adding cereal to the bottle with little improvement. Informed to delay solids until 4 to 6 months. Feeding issues were reviewed with the patient's parents, not specified. Physical exam revealed no abnormalities. Parents reported no problems with previous immunizations.  On 30-JUN-2008, at the 2 month visit the patient received the following vaccines a dose of DTaP 0.5 ml IM in the left thigh, a dose of ACTHIB 0.5 ml IM in the left thigh, a dose of PREVNAR 0.5 ml IM in the right thigh, a dose of poliovirus vaccine inactivated (unspecified) 0.5 ml SQ in the right thigh and a dose of ROTATEQ (MSD) PO (dose not reported). The patient was to follow-up with the physician in two months. No further information is available.
Pt reported that she had nausea, dizziness, body ache, subjective fever, fatigue, HA alomost immediately after her 2nd Moderna vaccine on 1/6. Symptoms have persisted over the weekend and pt reported to have been bedridden. Advil helped.
This 41 year old reported receipt of YF vaccine on Wed 3/11/2015. He was fine until Sat 3/14/2015 when he leaned over in car and felt nauseated, woozy-dizzy and onset of diffuse generalized headache as if "car sick". Later that day he developed a fever 100.3F (did check) with onset of watery brown diarrhea 2-3 times that day and vomited once about 6pm. He went to bed feeling achy with diffuse sweating. He awoke Sunday with generalized malaise, myalgia and arthralgia, headache easing and was able to take MOTRIN. He was able to hold down liquids and some bread sticks. This morning he reported to work feeling better but still achy, tired and not sure what he can/cannot eat. He researched online YF side effects and noted he was to report any n/v/d.
Patient was supposed to receive 0.3 ml of adult pfizer vaccine, instead received 0.3 ml of undiluted pediatric pfizer vaccine.
Initial report received from HCP on 27 Dec 2009. The patient was vaccinated with FLUVIRIN, (batch no: unknown) on an unknown date. The patient experienced stiffness that started behind the right ear that radiated to the right side of the neck approximately 30mins post vaccination and lasted about 24hrs. The outcome of the event was not reported.
headache; Immediate injection location pain; left chest pain/Continuous left chest pain; Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-Year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9262 and Expiration Date unknown) via Intramuscular on 03Feb2021 09:45 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included Hypertension. The concomitant medications was reported as Lisinopril. There is no other vaccine in four weeks. Immediate injection location pain and left chest pain on 03Feb2021 10:00. Continuous left chest pain and headache for about 12 hours on day one. Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist. The outcome of events was recovering without treatment was given.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Migratory arthritis cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Itchy rash on both left and right forearms. Started about 24 hours after injection.  Self treated with Benadryl & OTC  1% Cortisone cream Notified family doctor by phone and he advised it was common reaction and not to worry. VA doctor advised to avoid second shot until cleared by allergist & is arranging for consult.
I had administered the vaccine, pt tolerated well, pt given discharge instructions and instructed to wait for 15 minutes at the observation area.   As I was waiting for the next patients to arrive, another technician notified me that she had a reaction of vomiting.  When asked patient stated after the injection she felt burning from the site to the nape of her neck and while waiting at the observation area she had nausea and went to one of our stations to vomit in the trash.  Patient was escorted to our treatment room  for vitals and was given a cold pack for the back of her neck.  Our Allergist provider was called to assess patient.  When I had arrived to the treatment room to observe her, patient stated this was the first time she had this type of reaction.  The provider ordered for her to stay and be observed for 1 hour with 15 minute intervals of vitals.  The patient had no other reactions and had no pain, vitals were within normal limits.
pt recv vax @ work place a/2:15;did not report any s/s of feeling ill either before or p/inj;lt for break 330PM & had MI during break;
lt arm swollen, red, 6.5x 6mm erythema w/mild induration;
DIZZY; FALLS; SHAKING; NEUROLOGICAL DISORDER; DIFFICULTY IN WALKING; LEGS STIFFENING; LOWER BACK PAIN WORSE; BACK OF LEG AND BACK OF ARM PAIN; FEVER RUNNING CONSTANTLY; BODY ACHES/PAIN ALL OVER BODY; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included failed neck and back surgery, and car accident, and concurrent conditions included hashimoto's disease, high cholesterol, high blood pressure, type 2 diabetes, glaucoma, arthritis in back, herniated disc, bulging disc, upper back scoliosis, severe hearing loss, irritable bowel syndrome, sulfa and sulfate drugs allergy, upper/lower back pain, and neck pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone for neck pain, and upper/lower back pain. On 16-MAR-2021, the subject experienced body aches/pain all over body. On 16-MAR-2021, the subject experienced legs stiffening. On 16-MAR-2021, the subject experienced lower back pain worse. On 16-MAR-2021, the subject experienced back of leg and back of arm pain. On 16-MAR-2021, the subject experienced fever running constantly. On 17-MAR-2021, the subject experienced difficulty in walking. On an unspecified date, the subject experienced dizzy, falls, shaking, and neurological disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty in walking, back of leg and back of arm pain, legs stiffening, and lower back pain worse, and the outcome of body aches/pain all over body, fever running constantly, dizzy, falls, neurological disorder and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from non-other health professional. This case involves four months old patient (gender not reported) who was vaccinated with 0.25ml FLUZONE QUADRIVALENT (batch number, expiration date, dose, route and site of administration was not reported) on 09-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether the patient had any 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 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. List of documents held by sender: none.
TOOK FIRST DOSE WITH FOOD; This spontaneous case report (PVX2019-2430) was received from a consumer on 24-Sep-2019. It described a 50-year-old male consumer who "took first dose with food" (PT: Product administration error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif with food on 23-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took first dose with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose with food" was considered as not applicable.