chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in her head but not a headache; shooting pain on top of head; feels slightly under the weather; itching at injection area; swollen at injection area; large dark red area by injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in her head but not a headache; shooting pain on top of head), ILLNESS (feels slightly under the weather), VACCINATION SITE PRURITUS (itching at injection area), VACCINATION SITE SWELLING (swollen at injection area) and VACCINATION SITE ERYTHEMA (large dark red area by injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (pain in her head but not a headache; shooting pain on top of head), ILLNESS (feels slightly under the weather), VACCINATION SITE PRURITUS (itching at injection area), VACCINATION SITE SWELLING (swollen at injection area) and VACCINATION SITE ERYTHEMA (large dark red area by injection site). On 09-Mar-2021, PAIN (pain in her head but not a headache; shooting pain on top of head) had resolved. At the time of the report, ILLNESS (feels slightly under the weather), VACCINATION SITE PRURITUS (itching at injection area), VACCINATION SITE SWELLING (swollen at injection area) and VACCINATION SITE ERYTHEMA (large dark red area by injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs reported.  No treatment reported.
WITHIN 4 HOURS A FEELING OF NAUSEA.  WITHIN 5:30 HOURS ACUTE FLU SYMPTOMS INCLUDING FULL BODY CHILLS, AND SHAKES,  SWEATS, ACUTE NAUSEA WITH FEELING OF VOMITING, ACUTE ONSET OF DIARRHEA, ACUTE DIZZINESS TO THE POINT THAT I COULDN'T STAND UP AND THE ROOM WAS SPINNING.  I PASSED OUT IN MY BATHROOM RESULTING IN A FRACTURED RIGHT ANKLE AND A SPLIT ON THE BACK OF MY HEAD WHICH DID NOT REQUIRE A STITCH. I CALLED MY NEIGHBOR AND SHE CALLED 911.  I WAS ADMITTED INTO THE ER AT HOSPITAL AND WAS KEPT OVERNIGHT.
Bumps around her waist and in-between her fingers; This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was not recovered/not resolved.   It was unknown if the reporter considered the papular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the Shingrix, the patient returned to the pharmacy reporting bumps around her waist and in-between her fingers. The reporter did not consent to follow up.
Headache, constant nausea, redness and swelling to area, body aches/chills/fatigue disrupted sleep. Moderate reaction. Advised to manage symptoms with Ibuprofen and call back if fever/joint swelling/warmth occurs.
Symptoms started at nighttime the same day I received the vaccine.  Extreme nausea with vomiting, low grade fever, chills/ night sweats, myalgias, migraine headache. Not relieved by ibuprofen or acetaminophen.
Information has been received from a physician concerning a pt who was vaccinated PO with a dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). concomitant vaccinations included standard routine immunizations. The physician reported that the pt subsequently developed a high fever. The physician also reported that the pt was admitted to the hospital for possible sepsis for an unknown length of time. The physician indicated that the pt did not have sepsis and the child recovered while hospitalized. Additional information has been requested.
Case number PHEH2012US018685 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with the follow-up received on 16 Oct 2012: This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the right arm on 04 Sep 2012 at 15:00 pm. Concomitantly, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B085BA) intramuscularly on 04 Sep 2012. The MENVEO vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error (incorrect storage of drug). Follow-up received on 16 Oct 2012: Updated patient height and weight, vaccine route of vaccination, site of vaccination, time of vaccination and concomitant vaccine.
Itching scalp on 6/7/14, hives on 6/8/14 knees, elbows and behind ears. Chest tightness on 6/7/14 and used albuterol inhaler and took OTC BENADRYL.
Presented to ER with c/o SOB, + Covid 19 2 weeks prior to admission. Admitted for acute on chronic respiratory failure secondary to Covid-19.  Patients course was complicated by development of progressive hypoxemia which required high-flow nasal cannula, transferred to ICU, intubated. Required vasopressors, developed ARDS, required blood transfusions for GI bleed. Had a Code Blue arrest on 2/18/22, CPR 11 minutes, brother wished to transition to comfort care.
On August 23 2006 at around 10:30 am my son was mistakenly given the MMR shot he was looked at by a nurse and then allowed to leave the facility. Upon arriving home he was groggy and tired he did not eat for me and at 6pm the same night spots appeared on his stomach and face he was also running a fever of 103.6 so I proceeded to emergency room he was looked at by the doctor and discharged he has had diarrhea for the last two days also. He has yet to babble at me and has cried uncontrollably since and I cannot find any info on what to do the doctors say it is a waiting game so I will watch for more signs and hope for the best. You dont have this listed so he also had IPV2 shot administered on this date.
He was sick and had allergies. He had a cough, runny nose, and also a low grade temperature in the 100s. We took him to urgent care. We was informed that he got exposed to someone with COVID, but he tested negative for it. Then we took him to another urgent care because he got exposed again to COVID. He still was testing negative though. He had a low grade fever again. He took Zithromax for 5 days. They also gave him a nebulizer treatment and a saline nasal irrigation. He is better now, but he still has occasional coughing.
Recipient reports itching to arms and neck approximately 25 minutes after receiving first dose of Moderna Covid-19 Vaccine.  50mg Benedryl IM administered to Right arm.  Recipient held for observation following benedryl administration.
8 days after shot there is itching, redness, swelling, firmness at injection site. Redness extends about 3 inches.
I was showering, felt like throwing up, then found myself sitting in the tub with the shower running. I believe I passed out. I did not my head or hurt myself.
Was administered a Tdap vaccine at approx 5:15pm. About 7pm that night I noticed the injection site had a big cluster of small blisters and the area warm. Within an hour had some water blisters appear under arms and other parts of arm and some on inner leg and few on face. Persisted for several days.
Sterile Diluent was expired at the time of administration. Lot# T018894, Exp# 03/02/2023 Merck Vaccines was contacted. Revaccination not recommended.
Shoulder pain, she is unable to sleep on the side where her shot was administered, and cannot lift with that arm.
This spontaneous report as received from a consumer, as part of a marketing research (reference number# MRK239) conducted by Observant LLC refers to her child who was a 15 year old female patient. The patient was vaccinated with GARDASIL (Lot#, dose/frequency, route unspecified) in 2006, then the patient experienced muscle pain at dose on an unknown date. Subsequently patient recovered with sequelae from muscle pain at dose. It was reported that event did not re-appear after the next dose. The reporter felt that muscle pain at dose was non-serious and it was related to the therapy with GARDASIL. Patient's sister experienced unspecified adverse event post vaccine of GARDASIL (MARRS# 1209USA011061). Additional information has been requested.
Local reaction right deltoid red/swollen and hot 3 1/2 x 2 1/4mm Benadryl, Motrin and ice.
Three days after getting the vaccine she started feeling pressure in the base of her skull and upper neck which then leads to a headache. She said she never had this before and did not think it was any kind of muscle related accident. She said she thinks it might be her lymph nodes being inflamed and causing pressure but she said she is not sure and she can't specifically feel her lymph nodes . She has these bothering symptoms 3/4 of the days since it started. She takes ibuprofen or Tylenol and says it helps and it goes away but is just concerned that is lasting so long.
Itching at site starting on 2/20/2021. Red rash below injection site seen on 2/22/2013 , uneven measuring about 2? by 2?. Pink dot where needle went in.
Maybe 30 minutes after vaccine, patient complained of a itchy throat. Then itchy inside his chest. He then coughed and said his lungs felt tight. He had developed a rash beginning hives on his chest as well. He was given epinephrine and 50mg prednisone in ER. Medical records state anaphylaxis. msv
Patient reported URI symptoms 2 weeks prior to admission. UTI symptoms had completely resolved prior to his moderna vaccination. Patient developed chest pain 2 days after vaccination and presented to the ED shortly thereafter. Cardiology was consulted, and he was started on ibuprofen and colchicine. His chest pain resolved by the following hospital day. He was observed for one subsequent day and discharged.
Less than 24 hours after shot:  extreme  fatigue    Next day:  swelling in Lymph Nodes front of right arm pit    Then day after that: swelling in Lymph Nodes along collar bone, right side, still swelling in Lymph Nodes at arm pit    Following day:  swelling in Lymph Nodes along collar bone , left side, still had swelling in Lymph Nodes in arm pit and right collar bone area     Contact with Dr. first day of Lymph Node swelling.  Covered all questions and answers involving location and appearance of swelling.  Advised to keep close watch and take Tylenol for discomfort if needed.   Report any changes to Doctor
Caller states that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose.; Caller states that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2022 (Lot number: FE3594, Expiration Date: Nov2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose-1, Lot: FE3594), administration date: 10Feb2022, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant), EXPIRED PRODUCT ADMINISTERED (medically significant) all with onset 03Mar2022 and all described as "Caller states that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose.".  Clinical information: Reporter stated that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose. Reporter stated that vaccines were pulled back, but the pharmacist wasn't there and they forgot to mention it to him. 7 people, later clarified to 6, got those vaccines yesterday Reporter queried the level and they said she had 90 days, but the vaccines expired on Nov21, so the end of Feb2022 was the expiration Reporter states the seriousness is Medically Significant because the vaccines are not effective as they should be.; Sender's Comments: Based on information provided and temporal association, causal relationship between the reported events and the suspect BNT162B2 cannot be excluded.
Chills, body aches and severe right arm pain on day of injection. On day 2, developed rash near injection site and lymph node enlargement that made it uncomfortable to wear a shirt and unable to work. Saw PCP after 4 days who advised observation and symptomatic Tx. On 1/27/21 reports improvement and returning to work on 1/28/21.
The patient was given Pfizer Bivalent Booster vaccine 1 day past beyond use date on 12/02/2022.  The patient was not able to be reachable and we are not able to gather any information on any symptoms, sings, time course, etc.
nausea; vomiting; soreness/ sore arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 18th September 2019, the patient experienced nausea and vomiting. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received Shingrix in her left arm. The patient had a sore arm at the injection site. The soreness had mostly resolved on 18th September 2019 but she was experiencing nausea and vomiting which was unresolved. The patient consented to follow up. There was a discrepancy in the reported outcomes of the events tenderness nausea and vomiting. In XML, outcome was mentioned as recovering/resolving and in case narrative, it was reported as not recovered. However outcome of these events is captured as per narrative.
Pt came on 06/08/2018 saying has rash below the site of vaccine and had low grade fever, fatigue and pain in the arm after vaccination, and now it hurts her arm with sharp pain on and off. Pt had in past ZOSTAVAX and had shingles previously. She was advised to see MD walkin clinic as MD office closed and it was late Friday. Pt was suppose to report back with MD evalation, but did not left message for pt Saturday. So waiting for response.
Tenderness, soreness, in left shoulder. Chills and fever day after shot was given. Redness on skin surface about six inches long, 3 inches wide.
15 x 15 cm circular, raised, red, hot area on (L) thigh. ? cellulitis (L) leg.
Insomnia 03/12/21 12:00am-7:00am fatigue, headache 03/12/21 7:00am-3:00pm
Large are of redness to the right deltoid, muscle aches in right arm patient unable to lift arm above his right shoulder. Patient states " I just do not feel right". Patient seen by family physician and was given ATARAX and SEPTRA (PC) on 6 APR 2009. Still being treated. Patient received waiver not to receive any future anthrax vaccinations.
Right chest pain at the time shot, chest cramps, difficulty sleeping, difficulty taking deep breath?s.  Similar symptoms when given shot to the left arm
Syncope and collapse after receiving vaccinations listed below. Patient was lightheaded as he stood up. Rested on floor after woken with ammonia salts for about 15 minutes. Appeared WNL after rest. Mom commented patient had nothing to eat all day and doesn't sleep well at night. Played basketball in 90 degree weather. Followed up with parents on 7/29/15 patient is okay.
5 days after receiving the vaccine-woke up, felt faint and had difficulty breathing, tightening of the chest-went to ER.
Rash post vaccines stable w/o anaphylaxis or other sxs. No suggestive of HSP. Persisting rash on legs L/buttock and right face. New fatigue.
pt recv vax 24APR95 & 25APR95 devel fever of 104;fever lasted for 4 days;no further details were provided;
Rash on my right shoulder/ rash on my right chest/ rash on my right upper back; Arm was sore at the injection site; A headache; Burning sensation in my stomach (squeezing it & shooting flaming arrows out of my stomach); Tired; No appetite; Fever of 101.8°F; Cramps in my left calf; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.8°F), MUSCLE SPASMS (Cramps in my left calf), VACCINATION SITE PAIN (Arm was sore at the injection site), HEADACHE (A headache) and BURNING SENSATION (Burning sensation in my stomach (squeezing it & shooting flaming arrows out of my stomach)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Fever of 101.8°F) and MUSCLE SPASMS (Cramps in my left calf). On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site), HEADACHE (A headache), BURNING SENSATION (Burning sensation in my stomach (squeezing it & shooting flaming arrows out of my stomach)), FATIGUE (Tired) and DECREASED APPETITE (No appetite). On 23-Jan-2021, the patient experienced RASH (Rash on my right shoulder/ rash on my right chest/ rash on my right upper back). At the time of the report, PYREXIA (Fever of 101.8°F), MUSCLE SPASMS (Cramps in my left calf), VACCINATION SITE PAIN (Arm was sore at the injection site), HEADACHE (A headache), BURNING SENSATION (Burning sensation in my stomach (squeezing it & shooting flaming arrows out of my stomach)), FATIGUE (Tired), DECREASED APPETITE (No appetite) and RASH (Rash on my right shoulder/ rash on my right chest/ rash on my right upper back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 101.8 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
nurse from dr office called to inform us that patient reported redness on the side of the face that turned to swelling on the same side she got the vaccine and then started to experience heat on the back of her scalp so they told her to go to the er
The employee reported difficulty breathing.  She  transferred to the Emergency Department for elevated heart rate and possible syncopal episode.  Symptoms self resolve with no medications required.
Information has been relieved from a physician concerning a 10 year old male patient (also reported as 11 year old) who on 16-AUG-2000 was vaccinated with his first dose of MMR II and on 04-MAR-2003 was vaccinated with his second dose of MMR II. On 04-JAN-2010, the patient experienced mumps. The patient was diagnosed on 05-JAN-2010 other signs and symptoms were R parotitis. The patient was exposed to others with mumps. Diagnostic laboratory test performed on 05-JAN-2010 included IgM: 0.49, IgG: 4.76 and serum amylase: 137. Additional information has been requested.
Pt recvd 3 doses of Hep B vax & 3rd dose given 9SEP91 & on 28SEP91 pt devel hoarseness; On 1OCT91 devel fever, chills, cough, myalgia, & malaise; Pt dx bronchitis; tx meds; 2wks later to MD c/o earache;
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient was intramuscularly vaccinated with 0.5 ml expired dose of GARDASIL (lot # 666598/0786, exp date 18-OCT-2012) on 22-OCT-2012 for patient's third dose. No adverse effects reported. Additional information is not expected.
Pfizer 4/2/21, 4/26/21, 10/6/21. Positive on 1/10/22
She was in pain because she had a sciatica issue; feels like her tongue is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (feels like her tongue is swollen) and SCIATICA (She was in pain because she had a sciatica issue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN, LOSARTAN, OMEPRAZOLE, MONTELUKAST and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced SWOLLEN TONGUE (feels like her tongue is swollen). On 01-Mar-2021, the patient experienced SCIATICA (She was in pain because she had a sciatica issue). At the time of the report, SWOLLEN TONGUE (feels like her tongue is swollen) and SCIATICA (She was in pain because she had a sciatica issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.  No treatment details were reported.
SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and normally had to take anti-histamines in the spring. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included levocetirizine. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and fatigue. This report was non-serious.
Chill on day 2 and woke up day 3 with facial,lip and tongue swelling. I went to  hospital and was diagnosed with angioedema.
This spontaneous report as received from a registered nurse, refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored 0.5 ml doses of GARDASIL 9 (route of administration was not reported) with the following lot numbers: lot # L013429 with expiration date on 21-JUL-2017; lot # L043214 with expiration date on 30-AUG-2017; lot # M007764 with expiration date on 30-JAN-2018; lot # M009378 with expiration date on 23-APR-2018; lot # L024993 with expiration date on 17-OCT-2017. The vaccines were stored at the temperature of 0.3 degrees Celsius for 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 1SEP94 & taken to ER on 3SEP94 when mom noted pt body stiffen; thrust head back lasted few seconds; NO jerking movement; had noisy breathing then relaxed;