chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a big lump at injection site; warm too touch; sore; itchy; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump 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 injection site lump (Verbatim: I have a big lump at injection site), skin warm (Verbatim: warm too touch), pain (Verbatim: sore), pruritus (Verbatim: itchy) and tiredness (Verbatim: tiredness). The outcome of the injection site lump, skin warm, pain, pruritus and tiredness were not reported.   It was unknown if the reporter considered the injection site lump, skin warm, pain, pruritus and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site lump, skin warm, pain, pruritus and tiredness to be related to Arexvy.   Additional Information: GSK receipt date: 16-Oct-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient had received Arexvy and had big lump at injection site, warm too touch, sore, itchy and tiredness. The follow-up could not be possible as no contact details were available.
Patient came in 11 days after immunization and said her arm was "so sore she couldn't lift it" and it started swelling and burning immediately after immunization. She went to her PCP who said it was warm and swollen. We did not witness the swelling and warmness as it was now gone. Patient still complains of severe soreness at this time. PCP told patient to take ibuprofen and use ice.
I started to develop a muscle twitch in my right eyelid that stayed for about 3 weeks. It started to get better, but it still comes back moments in the day and spreads to other parts of my face. The doctor suggested to do hot compressions and to check back in a few weeks to see if it's still happening. No testing has been done yet currently.
Individual was one of the vaccinator and wanted her 2nd dose. She is giving out Pfizer vaccine in her room, unfortunately, she needs the moderna vaccine second dose. She asked me to give her dose now as there was no one in her line. I administered the Pfizer 0.3ml to her and after giving her, she told me that she needed moderna, however she did not tell me and I should have looked at her chart first. She knew she was moderna but did not verbalized this until later.
Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse.; Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse.; SIRVA; Hurts to move arm and wears out; Hurts to move arm and wears out; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 13:00 (Lot number: EN6199) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 17May2021 13:00, outcome "not recovered" and all described as "Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse."; SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious) with onset 17May2021 13:00, outcome "not recovered", described as "SIRVA"; LIMB DISCOMFORT (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 17May2021 13:00, outcome "not recovered" and all described as "Hurts to move arm and wears out". Therapeutic measures were not taken as a result of vaccination site pain, condition aggravated, shoulder injury related to vaccine administration, limb discomfort, pain in extremity.  Additional information: Relevant medical history and concurrent conditions were none. Relevant past drug history was none. Known allergies were None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were None. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Reported Event: Pain at injection site for starting 2 days after injection until now (2 1/2 months) and is not getting better and maybe worse. I am guessing SIRVA. Hurts to move arm and wears out. Will be scheduling visit with primary doctor to see about prognosis and therapy soon. AE resulted in None of the above. The reporter assessed the case as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.   Follow-up attempts are completed. No further information is expected.
pt recv vax 26APR99 & infant's rt thigh was sl red, w/a lump 2-3" big;area does not appear tender or sensitive;no fever, no irritability;mom encouraged to give pt warm bath, warm compress or covered cold compress to site;
5 days of muscle pain and headache Raised blood pressure measured by chance on day 5 after vaccine
erythema, ecchymosis, pain & edema @ injectt site are reported in pt who recvd flu vax sx occurred 12 hrs p/vax & resolved w/in 48 hrs;
Patient presented on 09/11/2021 after going to urgent care with a red, warm, swollen 2 inch circular size injections site.  She stated that her armpit was swollen and tender on the same arm and she had excessive sweating.  She was also nauseated and had body aches and a fever of 101 to 102.  It did appear that maybe her Pfizer dose was injected subcutaneously as it was a bit low on the deltoid muscle and pt is probably considered obese.  Pt did go to urgent care and prescriber did prescribe Cephalexin 500mg three times a day for 7 days.  I spoke with prescriber and he was a bit concerned she might have cellulitis.
11/3/06 Soreness right arm, chills, shakes, knot (right) arm started out golf-ball sized - baseball sized to softball size; felt hard. Unable to move arm. Saturday/Sunday, called mom, knot in arm smaller. Still feel hard. Able to move arm. Monday, no treatment.
This spontaneous report was received from a health professional and refers to a 40 year old female patient. No medical history or concurrent conditions were reported. On 01-JUL-2015 at 03:39 PM, the patient was vaccinated with her first dose of VAQTA, 1 DF in the right deltoid (right arm). No concomitant medication reported. On 01-JUL-2015 at 6 PM, 2 hrs 21 min after onset of therapy the patient developed swelling, pain in her right shoulder with tenderness in the right axilla, the patient also had a fever with a body temperature between 102.8 - 101 (units unknown) and vomiting. On an unknown date, the patient undergone an evaluation which showed increase in WBC. The outcome of the events were unknown. The reporter did not assess the causality of the events with VAQTA. Additional information has been requested.
local react around site 1 wk p/recvd immun-warm to touch-red itchy & hard 2 1/2" radius around site;
Moderna bivalent 10 mcg dose given instead of bivalent 25 mcg dose
IVC thrombus w/wedge-shaped R-sided pulmonary infarct, suspect PE. Pt initially on Lovenox 100mg subQ bid., started on Apixaban 10mg PO bid for 5 days followed by Apixaban 5mg PO bid for 5 days. Pt continued to demonstrate need for supplemental O2 w/O2Sat 86% on room air at rest, d/c from hospital with home O2.
Pt recvd OPV/DT in rt buttock which became swollen, hard, red & warm to touch (size 3" in diameter) w/in 24 to 48 hrs p/immun; tx w/ATB; however, sx not dx as cellulitis;
Initial unsolicited report was received from a physician on 26 January 2015. A female patient had received on an unspecified date a dose of ADACEL (lot number U4955AA) and an unspecified amount of time later, experienced pain at the sight of injection. The patient had a MRI of the area which showed a large area of marrow edema in the posterior lateral humeral head with possible subcortical cystic change with adjacent deep right deltoid and teres minor muscular edema. According to the reporter, "clinical correlation is recommended as to the etiology of soft tissue and marrow edema." Outcome was not reported. Documents held by sender: none.
Pt recv vax on 6/1/95; on 2/3/99 pt exp varicella
pt recvd vax;1st dose pt exp severe pain in upper arm; tricep found very warm to the touch; MD dx w/ rotator cuff syndrome; pt treated w/ injections of steroids & xylocaine;
Mother reported event this morning. Left upper arm hot, red, swollen. Size of a tennis ball and itchy. Referred pt to Dr.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 21-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Grandma returned w/child @ 1205PM red, swollen eyes, tearing; no rash, dyspnea or wheezing-DPH given; observed x 30 mins; seen again 31MAR93; no swelling or redness of eyes;
Redness, induration, swelling at short distance from injection site and 4 days later.
developed a large lump in the right armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Aug2022 at 13:00 as dose number unknown (booster), single (Lot number: FO7139) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: AXILLARY MASS (non-serious) with onset 29Aug2022 at 14:30, outcome "not recovered", described as "developed a large lump in the right armpit". Therapeutic measures were not taken as a result of axillary mass.  Additional information: The patient reported that she had developed a large lump in the right armpit. The patient first noticed it after her first booster. After the second booster, noticed it has gotten larger.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300087850 Same patient, different drug and different event.;
Headache, injection site pain, skin felt in fire, memory loss, balance loss, hearing loss, changes to body smell, change to sense of smell, weakness, fatigue, body aches
Very sore arm  Tightness  in high chest, near collarbone only on right side Felt like I needed to cough but couldn?t. No true shortness of breath.
Patient woke up with chest pain and frequent cough. Completed a virtual visit and was advised to go to the Emergency Room due to the chest pain symptom. ER work up included X-ray and CT and patient was diagnosed with blood clot. Planned to have follow up with provider.
Large red area next to where the injection was given. This is the second follow up booster shot, per pt she did not have a reaction to the first shot. Per pt it feels like a bruise. Painful when touched.
Received vaccination at 3:30 pm.  At app. 7:00 pm, noticed phlemmy throat, wheezing and coughing.  At app. 2:00 am, had extreme chills and fever of at least 102, headache, body aches, head congestion, plugged left ear, mattery eyes, swollen eyelids, weakness, and was pale and gray.
patient had trouble breathing epi administered , still having difficulty, administered another epi, EMS called patient alert and answering EMS questions when transported
Injection site: red, painful, swelling, itching, warm to the touch. Itch started around the 7-10 minute mark after injection. Pretty intense for about 20 minutes, then subsided to almost nothing for several hours, then increased, but was bearable. Redness started almost immediately. Redness spread to about 3 inches in diameter from shot site. (Still present as of 10/29 evening). Still present on 10/29 evening: redness, itch, warm to the touch.  Started taking Claritin (antihistamine) on Tuesday morning. Ran a low fever all day Tuesday, but fever increased and so did fatigue. Went to bed early (8 p.m.) and fever broke around 2 a.m. Wednesday morning.  Fatigue continued through Wednesday and Thursday. Fatigue mostly gone by 10/29 morning.
Bruise at site of injection. Swelling and soreness next day.  Bruise has expanded to about 3 inches across and is still present almost one week later.
This was the patient's second dose. After administration of the dose, patient was instructed to wait for 15 minutes before leaving pharmacy area. Just before the 15 minutes were up, staff found the patient face down on the floor. He was found conscious but had an open wound that led to bleeding/blood pooling on the ground.
Pt. states he received the Hep A vaccine for post exposure during mass clinic at the County health unit on 02/13/2019. Received the vaccine around 1 pm and then noticed his legs were itching several hours later, the next morning he was itching more and noticed small red raised area similar to poison oak rash, on his arms legs and chest. States he has never had a reaction to a vaccine but was told in 2007 that he could be allergic to latex after he developed numerous mouth ulcers after hip surgery.
This spontaneous report was received from a nurse refers to a patient of unknown age. the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was intramuscularly vaccinated with improperly stored GARDASIL 9 (lot # L038503 and expiry date 18-DEC-2017) following a temperature excursion of 35F for 21 minutes. No adverse event reported. Additional information has been requested.
Softball sized area of redness centered at vaccination site and pt complains of pruritis starting 2/11/12 and continuing today (2/13/12).  Pt has been icing intermittently.
Infant flinched; Some of the vaccine leaked from the syringe, resulting in the infant receiving less than the full dose; HCP called to report that during administration of MMR II, an infant flinched and some of the vaccine leaked from the syringe; This spontaneous report has been received from a pharmacy student, concerning a 16-month-old patient (reported as "infant" [conflicting information]) of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) injection, dose frequency: 0.5 ml, administered as prophylaxis (lot number W029539 was verified to be valid, expiration date not reported but upon internal validation was established as 15-SEP-2024) (route of administration and anatomical location were not provided). However, during the administration of the vaccine, the patient flinched (Tremor) (It was mentioned that "no adverse effects were reported" [conflicting information]) and some of the vaccine leaked from the syringe (Product administration error), resulting in the patient receiving less than the full dose (Underdose). The reporter asked about the validity of the dose being less than indicated in the prescribing info, and had questions about revaccination.  The outcome of the event of flinching and its causal relationship with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) was not provided.
pt recvd vax 1PM temp @ 8PM was 105.6 MD consulted APAP double dose ordered through out noc; temp on thrusday was 103 & gradually dec over next 24 hrs;
Patient presented to the emergency department with complaints of catching his chest tube in his wheelchair resulting in removal of the chest tube. He was also hypoxic on presentation. He remains hospitalized at this time.
Headache for 18 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at 10:15 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included hypertension from an unknown date. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did receive other vaccines within 4 weeks prior to vaccination (unspecified). On 28Dec2020 at 11:30, the patient experienced headache for 18 hours. Therapeutic measures were not given for the events. The clinical outcome of the event headache was recovered on an unknown date in Dec2020.    Information about batch/lot number has been requested.
warm; Injection site reaction; itchy; tender and Painful; redness; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE WARMTH (warm), INJECTION SITE REACTION (Injection site reaction), INJECTION SITE PRURITUS (itchy), INJECTION SITE PAIN (tender and Painful) and INJECTION SITE ERYTHEMA (redness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced INJECTION SITE WARMTH (warm), INJECTION SITE REACTION (Injection site reaction), INJECTION SITE PRURITUS (itchy), INJECTION SITE PAIN (tender and Painful) and INJECTION SITE ERYTHEMA (redness). At the time of the report, INJECTION SITE WARMTH (warm), INJECTION SITE REACTION (Injection site reaction), INJECTION SITE PRURITUS (itchy), INJECTION SITE PAIN (tender and Painful) and INJECTION SITE ERYTHEMA (redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient went to see her physician, who gave her a topical steroid and oral Benadryl. Their symptoms resolved within 72-96 hours of vaccination.
1. Severe pain/muscle locking approximately five days after vaccine administered at left shoulder and left elbow, tingling in left hand           2. Prolonged pain at left shoulder, left elbow, and left shoulder blade, occasional tingling in left hand
This incident occurred on 1/20/2022 at 12:30pm at a local Medical Center .  At the HCF, an 11 year and 9 month old male patient received the 12+ dose of Pfizer.  This was his 1st COVID vaccine.  Due to the nature of the drive-in clinic, we have our vaccinators check each screening form to assure that the proper vaccine is given.  We also screen and turn away kids 11 and under once patients meet the data team at the first checkpoint.  This patient however, somehow received paperwork and entered the clinic.  Our vaccinator did not notice the age 11 that was written on the screening form and proceeded to vaccinate him.  The patient responded normally to the injection, waited 15 minutes for observation and left the clinic.  The issue was later brought to the site manager?s attention by a data entry personnel during checkout.    This is a 17-year-old and 3 months male, accompanied by his mother. Client has history of epilepsy, according to the mother, and takes Keppra 2000mg PO daily.  He apparently had a recent episode and dosage increased from 1500mg to 2000mg.  There are no other meds taken and no known drug allergies.  He had a bit of common cold 2 weeks ago and felt healthy today after receiving his first dose of the vaccine.  Apparently, mother chose Moderna for him over Pfizer.  However, mother was unaware of the age qualification.  M.A. injected the vaccine Moderna 0.5mL IM to the client?s left arm and was observed for 15 minutes in the treatment room.  Client did not manifest any symptoms and was discharged home.  Upon learning about the incident, mother informed and was given instructions to go to the nearest ED or call 911 if developed any untoward symptoms such as shortness of breath, rashes, swelling, high fever.
Erythema, warmth, induration, 4 x 6 cm distal to injection site.
Pt laid down (his preference) for 15 min after immunizations then sat briefly and ehn stood at front desk while Mom made appointment. He started feeling weak so Mom made him sit and then we were notified. Had him lay on floor. BP 82/50. Able to take fluids. Provider came to check on him. BP 104/60. Sat up, able to eat some snacks, then able to stand without dizziness. Left with Mom after few more minutes.
Patient presents with apparent rash across upper arm, sx appeared on day of vaccination. SOB reported.
Information has been received from a physician concerning a 6 year old male who on 29-AUG-2000 was vaccinated with a 0.5ml SC dose of Varivax. On 23-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Moderately sore arm, rash / redness size I?d softball at site of shot; body aches; nausea.
2nd dose received 2/26/21  Noted a round red circular outbreak around injection site that evening that resolved by morning.  2-27-21 experienced tiredness, chills and low grade temperature elevation that resolved by 2-28-21 am. 3-1-21 7 PM noticed a red raised itchy rash with some of the lesions being circular distal to right elbow.  Applied Cortaid to area and then took Benadryl 25 mgs at 7:45 pm when new eruptions noted on left wrist and hand.  Took an additional Benadryl 25 mg dose 2 hours later as more rash on legs and abdomen.  Last dose of Benadryl 25 mgs 4 hours later and rash resolved by morning.  Skin felt itchy at times for next day or so but no further rash noted. Feeling ok since.  I have photos of rash.
localized rxn to inj site, 6-8cm, swelling, low grade fever, resolved w/o rx;
I had numbness in my lower legs. I went to the doctor about it.  They did a MRI and blood work.
Pt. received ZOSTAVAX injection on Friday 8/3 in right abdomen and noticed a red rash on his lower right abdomen that was growing in size from Saturday 8/4 until it was reported on 8/6. He was given diphenhydramine and ranitidine x5 days.