chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Menveo.  Additional details were provided as follows: The reporting medical assistant was patient's mother. The age at vaccination was not reported. The medical assistant mentioned that the patient experienced swelling after having been vaccinated with Menveo. This case linked with US2019AMR150108 and US2019AMR150092, reported by same reporter. The reporter did not agree to follow up.
Blisters on toes; Residual nerve pain; Pain in arm; pain in neck; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date 10th October 2022) for prophylaxis.   On 8th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th May 2021, immediately after receiving Shingrix, the patient experienced pain in arm, neck pain, headache and nerve pain. On an unknown date, the patient experienced blister. On an unknown date, the outcome of the pain in arm, headache and blister were recovered/resolved and the outcome of the neck pain was unknown and the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the pain in arm, neck pain, headache, blister and nerve pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by health care professional from pharmacy on behalf of patient.  The patient reported that within minutes of receiving her first dose of Shingrix, she began to experience pain in her arm and neck, headache and nerve pain. She also developed blisters on her toes (unknown date) which had since resolved. She stated she still experienced the residual nerve pain on and off. The pain in arm, neck and headache had resolved.  The reporter did not consent to follow-up.
The study subject was a 5-year-old male who was seen in the urgent clinic on 21Sep09 for fever, increased sleepiness and leg pain for the last two days. His pain started in the feet progressing to the legs and then to his groin area. He was having difficulty walking. The pain was relieved with Motrin. One day prior to this urgent care visit he developed fever up to 101 F. Review of system was remarkable for new onset of runny nose and cough for the last several days and occasional back pain. Patient was admitted to Hospital on 21Sep2009. PE was remarkable for temperature of 102F and an alert boy in no acute distress. Positive finding were increase warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. Cranial nerves II- XII were intact. X-ray of the hip was normal, sed rate was 18 and CRP was elevated at 10.5. CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A & B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus and enteroviruses. CSF fluid was negative by PCR for enteroviruses. CSF fluid: no WBC, no RBC, glucose 63 mg/dl and protein 16.8 mg/dl. CSF culture was sterile for organisms. MRI of brain and cervical, thoracic and lumbar spine with and without contract did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. CK was elevated at 1094 U/ml. Nerve conduction study performed on 24September demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. Patient received IVIG on 24September and 25September. Patient was discharged home on 27September2009. Final diagnosis: Guillain-Barré Syndrome. Discharge medication: Lyrica (pregabalin) 1/2 capsule (25mg/capsule) twice a day for pain as needed 12/0209 Urgent Care, ED and Hospital Records received for DOS 9/21/09-09/27/09. Pt admitted with ascending paralysis, pain in legs x2 days, fever, bilat LE weakness, blunted ankle and knee reflexes, headache, sleepiness. Received IVIG x2.  Pediatric neurology consult obtained. Continued to improve and dc home. DC DX: Guillain-Barre syndrome.
As per client's mother, he started complaining that his left arm was in pain from the moment he received the shots, and that he could not move it because it was sore. Denies any swelling, or rash at the vaccine site. Mom applied ice packs and gave tylenot for pain, but now after 3 weeks the child still complaints of pain to the left arm.
missed the appointment on 19Jun2021 for the 2nd dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the appointment on 19Jun2021 for the 2nd dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the appointment on 19Jun2021 for the 2nd dose of the Moderna vaccine). On 19-Jun-2021, PRODUCT DOSE OMISSION ISSUE (missed the appointment on 19Jun2021 for the 2nd dose of the Moderna vaccine) had resolved.            No concomitant medications information was reported. No treatment medications were provided.
mom states pt recvd MMR/DTP/HIB/OPV 28OCT92 & exp rash & fever; MD put pt on rx-pt is still fussy but getting better 9NOV92; also had swollen neck glands;
Fever, chills, cough, lethargic, body aches, nausea
Aching, nausea, dizziness evening after vaccine administered (afternoon) following morning, atypical chest pain, blood pressure increased, dizziness. Treated at emergency room.
Patient had previous vaccine 4/5/21 J&J. He wanted Pfizer just in case J&J needed Booster
I am experiencing muscle pain in both of my legs; Having hard time walking/ I can barely walk; Muscle hurt in my legs and felt like hurting; I guess muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Lot number: EN6199) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "knee replacement", start date: 05Jan2021, stop date: 05Jan2021, notes: Verbatim: Left Knee replacement. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Anatomical location: left arm, Lot number: unknown), administration date: 11Feb2021, for Covid-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "I am experiencing muscle pain in both of my legs"; GAIT DISTURBANCE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Having hard time walking/ I can barely walk"; PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Muscle hurt in my legs and felt like hurting; I guess muscle aches". The events "i am experiencing muscle pain in both of my legs", "having hard time walking/ i can barely walk" and "muscle hurt in my legs and felt like hurting; i guess muscle aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, gait disturbance, pain in extremity.  Additional information: Patient had 2nd Pfizer shot, Covid shot about 10 days ago and was experiencing all of the sudden muscle pain in both of legs. Patient wants to know if this was the side effect of the drug or something else. Patient received the second shot on the 4Mar2021 and until 15th March and had hard time getting out of bed, had hard time walking, muscle hurt in legs and felt like hurting, was not sure was that a reaction from the shot or something les. Patient went to doctor on Monday and got blood test. Concomitant medication (knee replacement), patient stated, "No medication, take Motrin once in a while, take Motrin for the pain and "swell" (not clarified). It's 200 mg and it's not all the time, it's a "liquid gel" (not clarified), patient don't take it every day, one "tablet" (not clarified) a day."  No follow-up attempts are possible. No further information is expected.
the patient gets very sick every year after receiving her flu vaccine; Initial information regarding this unsolicited valid non-serious case via the agency (reference number: 00311644) was received from a consumer and transmitted to Sanofi 12-Oct-2020.  This case involved a female patient of unknown age who experienced gets very sick every year after receiving her INFLUENZA VACCINE (flu vaccine) (Illness).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient became very sick every year after receiving her flu vaccine (illness), unknown latency following the administration of INFLUENZA VACCINE.  Final diagnosis was the patient gets very sick every year after receiving her flu vaccine.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
fluzone given 24OCT95 tightness in chest & cough 27OCT progressed to diarrhea on 30OCT95; gradually resolved;APAP PRN
02-07-09 (L) arm 8X8 in redden- warm to touch - (R) arm 2X1 in redden - warmth to touch c/o pain. BENADRYL 2 tsp BID - Cool compresses
This spontaneous report as received from a registered nurse, refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# reported as L005559, expiry date 15-APR-2017)(dose and route were not reported). No adverse effects were reported. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Large local reaction x 2 days - fever 101.3 same day after receiving injection - could not lift arm above head. Arm was sore, red & tender to touch. Advised by physician to use ALLEGRA & ALAVERT. Use topical steroid & NSAIDS.
It was found towards the end of the day that patient was vaccinated at 11 years old, which is not yet an approved age group for the COVID-19 Pfizer Vaccine. I called mother the next day to inform her of the administration error that occurred and mother, who is also a nurse, said that she was fully aware and was okay that her child was getting it at an age that has not yet been approved.
Information has been received from a registered nurse concerning a 30 year old female teacher who on 10/20/00 was vaccinated with a dose of Hepatitis B vaccine recombinant at 12:00 PM. It was noted that there were no illnesses at the time of the vaccination. One day post-vaccination, the patient developed "a 2" diameter injection site rash and a 1/8" nodule under the injection site, with itching". Unspecified medical attention was sought. Follow up info from a registered nurse indicated that on 10/21/00 at 13:00, the patient also experienced swelling, itching, and redness approximately 4 inches in diameter around the injection site. It was also noted that the number of prior doses equals 1. As of 10/24/00, the patient recovered from her experiences.
Rash & UrticariaPruritus Narrative:  I had mild rash and pruritus this tome that again started about around a week to 10 days after my shot. It is located in my armpits, ankle and lower abdomen/inguinal region. I believe it is mild at least in part because I've been on the other two meds this time of montelukast and loratidine. At this time, I plan to continue COVID boosters unless advised otherwise.
Vaccination given on afternoon of 10/12/16 - next morning had fainting spell, felt lethargic all day. Next morning had rash/hives over large part of body and itching. Took BENADRYL and PEPCID rash subsided, itching still active on 10/18/16. Itching subsided on 10/20/16.
The first two I woke up in the middle of the night sick.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (The first two I woke up in the middle of the night sick.) 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 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 ILLNESS (The first two I woke up in the middle of the night sick.). At the time of the report, ILLNESS (The first two I woke up in the middle of the night sick.) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2022-449887, MOD-2022-449915 (Patient Link).
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored M-M-R II (lot # N023024, expiration date: 23-AUG-2019, dose and route of administration were not provided) for prophylaxis. Administered vaccine experienced multiple temperature excursion between 47 to 77 degrees Fahrenheit (55.5 degrees Fahrenheit) for 1 hour and 20 minutes. There was previous temperature excursion between 47 to 77 degrees Fahrenheit (51.9 degrees Fahrenheit) for 4 hours and 24 minutes. Digital data logger was involved. No adverse effects were reported.
Patient called to report she had a hard lump the size of a quarter at injection site that was red and tender. It appeared shortly after the injection and has been there ever since. MD office had prescribed her steroids which helped for a little while but the pain persisted. She said she has limited mobility in that arm (ex: it hurts to put on a seat belt) and has gone to a few physical therapy sessions which did not help.
Patient's wife states starting Monday 11/28/22 patient has been very weak, falling down, cannot stand up or stay standing, mobility issues.
Redness and swelling near injection site.  Treated with cool compress and elevation of arm.
PT REPORTS SWELLING AND REDNESS OF LEFT ARM ON AND AROUND SITE OF INJECTION. ON THE NEXT DAY SWELLING AND REDNESS INCREASED TO 5.5 INCHES IN LENGTH AND 3.5 INCHES WIDE. PT ALSO REPORTS PAIN AND TENDERNESS.
This spontaneous report as received from a register nurse concerning to a patient of unknown age and gender. The patient's historical conditions, concurrent condition s, drug reactions/ allergies and concomitant medications were not provided. On 27-AUG-2018,  the patient was vaccinated with PROQUAD rHA (recombinant human albumin), subcutaneous lot # R007679 and expiration date 11-SEP-2018 (dose and anatomical location were not reported) as prophylaxis. The nurse reported that the patient may have received less than the full dose of PROQUAD. No adverse effect were reported. The reporter referred to intends to revaccinate the patient after an appropriate time period.
High fever, chills, shortness of breath, headache/migraine, nausea, vomiting
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ ORAL, (lot # K022993, expiration date 26-JUL-2016) and (lot # L004466, expiration date 02-AUG-2016) (L006184, expiration date 13-DEC-2015), orally, doses were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
It started around August, I've had intestinal issues such as nausea, diarrhea, frequent needs to go to the bathroom. I initially went to the doctor about a month after the symptoms and they did a bunch of tests, but nothing came up. I've had a bunch of tests since then such as an endoscopy, colonoscopy, and other tests but they haven't found anything. The symptoms have remained the same, the nausea and diarrhea is daily, I go to the bathroom about 10 times a day. There is no vomiting just the constant nausea.
Information has been received from a licensed nurse practitioner concerning a 19 weeks old male patient without any pertinent medical history, drug reactions or allergies, who on 03-SEP-2009 and on 02-NOV-2009 was vaccinated with the first and second dose of ROTATEQ respectively (oral route, lot # 664291/0769Y).  Concomitant therapy included PENTACEL and PREVNAR.  On approximately 05-NOV-2009, "3-4 days after receiving the second dose of ROTATEQ", the patient developed a rash on the trunk and possibly on the groin.  No lab diagnostic studies performed.  The patient sought medical attention in the physician's office.  At the time of the report the patient's outcome was unknown.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number 664291/0769Y in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  Follow-up information has been received from a registered nurse via medical records concerning the 5 month old white male with eczema.  It was reported that on 03-SEP-2009 the patient received a first dose of ROTATEQ (lot # 664398/0573Y) and concomitantly received a first dose of PENTACEL into his left thigh (lot # C3436AB) and a first dose of PREVNAR into his left thigh (lot # D81705).  On 02-NOV-2009, the patient received a second dose of ROTATEQ (lot # 664291/0769Y) orally, and a second dose of PENTACEL (lot # C3482A) IM into his left thigh and a second of PREVNAR (lot # D90888) IM into his right thigh.  There was no illness at time of vaccination.  It was reported by the registered nurse that the patient was seen on 05-NOV-2009 with complaints of rash.  It was reported that the patient had a history of eczema but different from rash presented on 05-NOV-2009.  The patient used NUCORT as needed and AQUAPHOR twice a day.  On 06-NOV-2009, the rash had spread to patient cheeks and by 12-NOV-2009 the rash had almost gone. On 17-NOV-2009, the patient presented for follow-up and overall history and findings, suggested that the patient's viral infection was resolved.  The registered nurse reported that the patient's rash was not due to the vaccination.  No further information is available.
The pt received MMR on 12/10/01 (SC) and on 12/18/01, the pt reported to office with a maculopapular, non-vesicular rash to entire trunk, extremities, face and scalp areas. On 12/18/01, the pt apparently was feverish at home. In the office on 12/18/01, the pt exhibited malaise and irritability. Mother reports the pt is "feeling better today".
One minute after the shot my left are began to itch, my tongue started to swell, and it was difficult to swallow.  Within two minutes my blood pressure shot up, I was very dizzy & somewhat disoriented, and was having trouble breathing and had to take off my mask.
mild itchy rash on various body parts which was relieved after taking a 10 mg  Antihistamine tablet
I have slight soreness at the injection site and some fatigue, both of which I expected.  However, I am also experiencing significant "brain fog".  It is difficult to do my normal activities and I lose track of what I am doing.  It feels like I have a cloud inside my brain.  I have not gone to the doctor, but felt this should be noted.
Information has been received from a physician concerning a 16 year old patient who on 02-AUG-2001 was vaccinated with a SC dose of Varivax (lot # "18897"). On 27-JUN-2006 the patient developed shingles. Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Woke up 4/5/21 with neck pain. Then nerve pain moved to bottom of neck down to shoulder and to scapula. Pain will radiate down to elbow. Then loss of use of arm began. Unable to lift shoulder into shoulder flexion.
4/29/08-vaccine 5/1/08-fatigue, oral ulcers 5/2 above plus swelling in neck, trouble swallowing and bronchospasm.  5/2/08 seen in ER, rx IV SOLUMEDROL + po prednisone x8 days.  5/3/08 no bronchospasm but had 'leg pain' (no clear dx) that lasted 4-5 days.
Patient reports she passed out, this morning, the morning after the vaccination .  She said she was going to the kitchen and found herself on the floor.   She states feels "achy all over, and has broken out in a cold sweat"
Patient got the Pfizer vaccine dose 1 on 9/21/21. On 10/1/21, she started having shortness of breath. As time went on her oxygen sats dropped in the 70s . This lasted for several days. As days went by, patient experienced increased shortness of breath, confusion, disorientation, increased sleepiness, inability to stay awake, tremors in upper extremities and memory impairment. On 10/8/21, while at work. It was noticed by patients co-workers, that she couldnt stay awake, that her speech was somewhat slurred. She was sent home. On 10/9/21, Patient went to local urgent care, informed them of her symptoms and that she had received her first dose of Pfizer on 9/21/21. Urgent care diagnosed patient with bronchitis and sent her home on antibiotics.
The patient's husband called and reported that her arm and shoulder was just a little sore on the first day but it became increasingly stiff and painful over the next 2 days. Ice did not offer any relief  but heat and acetaminophen offered slight relief from the pain and discomfort. The patient was unable to sleep due to the pain and stiffness. I advised her to contact pcp immediately for follow up.
CLIENT RECEIVED MODERNA FIRST DOSE ON 4/13/2021. SECOND DOSE PFIZER ON 08/28/2021.
Any previous pain increased by 10 fold. Has pain in his joint and back, lasted for 4 to 5 days. Was lethargic for 4 to 5 days.