chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines excursion, administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 38-year-old male patient who received HAB (Twinrix adult) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th May 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: Vaccine coordinator reported the vaccine excursion that was previous reported to be discarded, was administered to the patient. The reporter did not consent to follow-up. Additional supportive information: The vaccine excursion that was previous reported to be discarded, was administered to the patient, which led to incorrect storage of drug. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022078361:Same reporter US-GLAXOSMITHKLINE-US2022078360:Same reporter
Pt vaccinated with HIB titer developed meningitis & uveitis within 12 hours. Infection resolved w/Antibiotic therapy.
Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported. On 19-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Pt received  initial J and J vaccine on 3/9/21 and the booster on 11/19/2021, and still experienced a breakthrough infection. He started having symptoms  on 11/21/2021 and was diagnosed with covid pneumonia on 11/29/2021. Initially he thought it was a reaction from the booster as he was having chills, fatigue, and achiness, but as the days passed he started having fevers. Highest was 103.  His pulse ox was also slowly dropping every day, until I took him to the ER and he was diagnosed with covid pneumonia after a CXR.
Less than 24 hours after injection I had all over body aches, fever, fatigue and headache.  This continued until after 48 hours following the injection.  I was still running a fever just over 100. On this date, I noticed diminished to absent sense of taste.  I have no sinus congestion or drainage or allergies.  I can still smell.  I have not taken any medication since the injection accept Tylenol.   I have no covid symptoms or difficulty breathing.  Over all I do feel better than the past 4 days.  Fever is gone and stamina is coming back, just noticed today I am not able to taste and do not have any other explanation for his.  I called the place I received my vaccine and they had not heard of this side affect.  I would like to know if this is a known side affect and if my taste will return.
Pt presents to office w/patches of vesicles x 1 day. Dx: Shingles. Tx: Acyclovir 200mg 5x/day x 7 days.
Received Smallpox vaccine on 12/07/2001. On 12/14/2001, Read 12/14/2001 positive  lymphadenopathy. Returned 12/18/2001, increase in size of pustules, extreme axillary tenderness, red straking from site to ant. axillary area. Levaquin 500mg 1 po qd #5
In January 2000 the pt's daugter was vaccinated with Varivax and measles vax. On 2/3/00, the pt became sick with a high fever. In the latter part of the week she began to feel better, but she broke out with a few lesions on her face and arm.
4 small lung nodules; fever for a day; felt tired/tiredness persisted; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PULMONARY MASS (4 small lung nodules), PYREXIA (fever for a day) and FATIGUE (felt tired/tiredness persisted) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Vaccine (Took flu vaccine sometime in Oct or Nov2021). Past adverse reactions to the above products included No adverse reaction with Flu Vaccine. Concurrent medical conditions included Chronic arthritis, Hypertension and High cholesterol. Concomitant products included ATENOLOL, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired/tiredness persisted). In May 2021, the patient experienced PULMONARY MASS (4 small lung nodules). In March 2021, PYREXIA (fever for a day) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown and PULMONARY MASS (4 small lung nodules) and FATIGUE (felt tired/tiredness persisted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: 4 small lung nodules possible problem in the aorta and they found 4 small lung nodules.. On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Immunology test: 495 level at the last test was 495.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that she did not have a medical history of Covid-19 infection.  The patient stated that she was asymptomatic (pulmonary-wise) and was not having any kind of respiratory illness for the past 5 years. For this reason, she was referred to a pulmonologist by her internist and she would have a CT Scan every 5 months. The patient's son was a radiologist and she was afraid that the nodules might migrate to other organs. The patient was not saying that the nodules was from the vaccine but they just want to know if there had been reports of indeterminate lung nodules such as from people who had received the Moderna vaccine. Patient mentioned that she read an article that some patient who had gotten the Pfizer vaccine had interstitial lung disease hence, she was wondering if Moderna had something similar. Patient stated not to get the booster dose because of the lung nodule.  Patient height was reported as  5' 2 2/1"-3".  No treatment information was reported.   This case was linked to MOD-2022-517797, MOD-2022-517950 (Patient Link).
first dose / around 08/2018  / had some injection site pain./ arm pain; was not well for maybe less than a day; first dose / around 08/2018 / later / got the second dose / does not remember when / (02/2021) she felt she was getting shingles; Nerve pain; (02/2021) she felt she was getting shingles; left trochanter bundle pain / increased during the night/ nerve pain; Could not sleep; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox, shingles (in May 2018) and nerve pain (right trochanteric occurred in May 2018).   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2021, more than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain femoral, insomnia and nerve pain. On an unknown date, the patient experienced injection site pain and unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and nerve pain were unknown and the outcome of the shingles, injection site pain, unwell, pain femoral and insomnia were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site pain, unwell, pain femoral, insomnia and nerve pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient who was a retired physical therapist. Around August 2018, the patient received the first dose of Shingrix vaccine in her left arm and she had some injection site pain (refer linked case US2021060549). Then later the patient received the second dose of the Shingrix vaccine, she does not remember when, in her left arm and had some injection site pain and she stated she was not well for maybe less than a day.  About a month back (February 2021) she felt she was getting shingles, but she did not have a rash, but had left trochanter bundle pain, which increased during the night and thus could not sleep. This lasted for about 5 nights. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. The patient does not saw a Health care professional (HCP). The reporter did not have Shingrix lot no. The reporter did not want to provide pharmacy information. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021060549:Same reporter
pt recvd vax & approx 9 hrs following vax pt devel sweating & did not feel well; pts husband suggested ER but pt did not; pt died @ home;
initial sx-laryngitis followed by cough for 2wk then low back pain/stiffness, significant pain in low back traveling from side to side;unable to get up on own d/t pain & sore muscles (typically very active);cont w/muscle pain
Please note I have submitted this report 3 times to your system and been told every time no report was received or exists.  Unacceptable.  Adverse events as reported through your app, daily:  High temp Massive swelling of arm Pain  Shortness of breath Dangerously high BP AND HR Exhaustion Inability to sleep Arthritic activation in every joint in my body, no prior history before Moderna vaccinations
C/O large area swelling, redness and pain with itching. BENADRYL used for discomfort. Pt could not tolerate ice.
Headache, NauseaVomiting, fatigue, soreness at injection site Narrative: Per nursing report: "took first Moderna vaccine yesterday [5/5]. C/o extreme soreness to left arm at site of injection last night with c/o nausea, headache and fatigue this morning [/]."
The patient received Moderna as a first dose on 13SEP2021. The patient was then accidentally given Pfizer as a second dose on 16OCT2021. The patient did not have any immediate adverse reactions.
A non-serious spontaneous report of "inadvertently gave H1N1 to a patient with asthma" was received from a nurse practitioner concerning a 41-year-old female. Medical history included asthma. Concomitant medications included budesonide and formoterol. On 03-Nov-2009, the nurse practitioner inadvertently administered H1N1, intranasal to the patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Information has been received from a nurse concerning a 10 year old female who on 10-JUL-2007 at approximately 13:00 was vaccinated SC in the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot#657099/0453U). Forty eight hours after receiving the vaccination the patient developed an "outbreak of zoster" which started on her neck and moved toward her armpit. The nurse also reported "some site reaction after receiving the shot." Concomitant vaccination at the same time included a booster dose IM of Adacel (Lot# C2690AA). Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Follow up information from the nurse, indicated that on 12-JUL-2007 the patient developed shingles in C-5 dermatome pattern on the left. Additional information has been requested.
2 days after the vaccination, we noticed a shingles outbreak on my ribs on the left side of my back. I went to the PA and was prescribed medication valacyclovir and the outbreak lasted about a week. It was about the size of a 50-cent piece. Small shingles outbreak.
Transverse Myelitis with weakness/paralysis in right leg and hips. Required emergency hospitalization which included Solumedrol IV and Plasma Exchange.
"Heavy Breathing/Paralysis, Hives, Blurry Vision, Chest Pain, vomiting.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 16-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medications was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exo date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Day 7 after vaccination Temp.99.2. Swollen/tender lymph nodes, muscle pain, loss of appetite noted. Skin Findings included: redness,swelling,itching,pain, and streaks on left arm. Area checked by ICP @ hospital. Then referred to CHN office. Then referred to Dr.  @ Medical office. Opsite had been used to cover site while @ work. This was switched to Tegaderm. Patient was observed for three days by Dr. Symptoms resolved. No antibiotics given.
Patient received immunization Wednesday. Thursday morning shot area was pink. Friday arm was red and itching. Saturday arm was red , warm and hurting. ( site white in middle and red all around). Doctor prescribed Cephalexin 500mg  1 capsules twice a day for 7 days.
Low back pain; Injection site bruising; Pain in arm; Pain in hip; Early morning stiffness; This spontaneous case was reported by a physician and describes the occurrence of BACK PAIN (Low back pain), INJECTION SITE BRUISING (Injection site bruising), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Pain in hip) and MUSCULOSKELETAL STIFFNESS (Early morning stiffness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 22-Jul-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced BACK PAIN (Low back pain), INJECTION SITE BRUISING (Injection site bruising), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Pain in hip) and MUSCULOSKELETAL STIFFNESS (Early morning stiffness). At the time of the report, BACK PAIN (Low back pain) and MUSCULOSKELETAL STIFFNESS (Early morning stiffness) had resolved and INJECTION SITE BRUISING (Injection site bruising), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (Pain in hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported , No treatment medication was reported .   This case was linked to MOD-2021-164432 (Patient Link).   Reporter did not allow further contact
Visible blood  in urine for 48 plus hrs. Still have blood in urine as of now.
5 mins after receiving dose pt fainted. 911 was called.  slowly brought pt to the floor. attempted to arouse pt, was unresponsive for 10-15 seconds. pt was feeling much better by the time ems arrived in approximately 15 mins. vitals were stable. pt agreed with ems personnel he needed no additional treatment.
This serious initial spontaneous case, was received from other health care professional on 10-Nov-2017, concerning a male patient of an unspecified age. The subject's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with Influenza vaccine (dose, batch number, manufacturer, trade name, route of administration and anatomical location: not reported). It was reported that, the patient experienced hearing loss after taking a flu shot. At the time of this report, the outcome of the event was not reported. Case Comment: A male patient had hearing loss after receiving flu vaccine. Company assesses the event causality as unassessable due to unavailability of information regarding vaccination, temporal latency, severity of the event, reversibility of the event and clinical status of the patient at the time of vaccination. The company assessed the event as serious (medically significant).
This is a spontaneous report obtained from a contactable nurse. A patient of unspecified age and gender received on unknown date PREVNAR 13 at single dose. Relevant medical history and concomitant medication were not reported. The patient developed fat necrosis at the injection site. Event outcome was unknown.
I doubt this is related, but I received a phone call that I should report this.  I came down with shingles.  Started with pain on my back, then the rash developed.  The rash dried within a couple of weeks, but the pain symptoms lasted for 4 weeks at a severe level and I still have discomfort in that area.
Entire deltoid area is red, warm and hard. Affected site measures 60mm x 55mm in size. Child complains of pain to the touch. Parent first noticed the symptoms on the morning of 8/9/12. Approximately 44 hours post vaccination.
Hives and swelling of front, side and back of neck, severe itching, rash across shoulder and collar bone.  Saw doctor 2/11 and received steroids for 5 days.  Swelling and itching reduced then flared back up.  Returned to the doctor.
13 year old patient incorrectly received Pfizer 5-11 year old formulation on 11/20/2021 for his first dose. Guardian was counseled and patient received Pfizer 12+ formulation for his second dose on 12/11/2021.
LOCAL TITLE: EMERGENCY                                           STANDARD TITLE: EMERGENCY MEDICINE NOTE                          DATE OF NOTE: JAN 13, 2022@16:32:30  ENTRY DATE: JAN 13, 2022@16:32:33                                       URGENCY:                            STATUS: COMPLETED                          *** EMERGENCY Has ADDENDA ***  ER Triage Note   Patient is a 52 year old FEMALE presents to Emergency   Department on 01/13/22 16:28.       Tetanus status: Last TD (ADULT): Jan 08, 2018    Chief Complaint: Visit CC: hypoxia covid+ 84%RA ambulating .  Patient is a 52 year old FEMALE who is being admitted to the Hospital. This patient meets inpatient  level of care because  covid-19 day 8 of symptoms, hypoxia  Patient is a 52 year old FEMALE currently  on was Unit admitted on JAN 13,2022 18:08.The patient is being discharged 17-Jan-2022.
Pt states that she started to have itching ears, eyes, and throat that started on 11/3/2014. Patient received 0.3mg of epinephrine intramuscularly, 20mg of Pepcid orally, 25mg of Bendaryl intramuscularly, 60mg of prednisone orally.
Since getting the first dose, I have gotten two small, round sores, a little smaller than the size of a dime. They happened separately, about 2 weeks apart. The first was on top of my right foot, the second on my right abdomen.  They begin as a bruise, then the skin flakes away and a scabbed wound is present. It is painless. It is also gross and disturbing. Please advise.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patient of unknown age. The nurse reported that the patients might have received PROQUAD (Merck) (lot#H015787, exp 24-FEB-2014) that was exposed to 45F for 3 weeks (504 hours). The temperature excursion had been determined to be unsupported by in-house stability data. There were no adverse symptoms reported. Additional information has been requested.
Patient developed a rash on upper arm of the arm that was injected.  Dr said it resembled a slight case of shingles.  No major problems reported.
Injection in left arm on Tuesday 1:20 pm. Chills/low fever started at 11:30 pm. At 2:30 am the next morning, awake with nausea and vomiting only lasting 30 minutes. Fever ranging from 100-102.5, joint pain, and nausea until the next morning (Thursday) at 5:30 am. Intermittent chills/ low grade fever throughout the day on Thursday.  Fatigue lasting through next couple of days. Left arm of injection side is red, painful and itchy. If indicative of first vaccine shot, will last at least 2 weeks like last time.
Patient developed hives/rash on chest and arms immediately after receiving vaccine, administered 50 mg Benadryl po, took vitals twice fifteen minutes apart and was then driven home by her husband. Vital signs remained stable throughout episode.
painful swelling lt upper arm since this AM or ? yesterday; 3x5 cm mildly indurated erythema lt arm distal to including inject site; single 5mm ax node; t98.8 APAP given;