chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty breathing; Swelling of face and throat; Swelling of face and throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), SWELLING FACE (Swelling of face and throat) and PHARYNGEAL SWELLING (Swelling of face and throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027821A or 027821B and 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), SWELLING FACE (Swelling of face and throat) and PHARYNGEAL SWELLING (Swelling of face and throat). At the time of the report, DYSPNOEA (Difficulty breathing), SWELLING FACE (Swelling of face and throat) and PHARYNGEAL SWELLING (Swelling of face and throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Heart rate: fast (High) fast heartbeat.         Concomitant products included Blood Pressure medicines. No treatment information was provided.
This spontaneous report as received from a caller who said that GARDASIL (start date, dose, route and lot # not reported) had been administered to an unspecified patient/patients. No side effects were mentioned. This is one of several reports received from the same source. It was linked to MARRS# 1401USA002803. Additional information is not expected.
Pediatric dose of Pfizer administered to 12 year old patient.  Vaccine administration error.
It was reported that an 18 month old female received vaccines on 10/20/99. On 10/21/99, the pt's "left upper arm (was) red, hot (and) swollen". The pt has recovered. Correspondence was returned on 11/22/99 as, "Reviewed, no additional info." From mailed follow-up correspondence received on 07/23/01, it was reported that the patient recovered from this experience. No further available regarding this patient or this case. This case is closed.
Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no known allergies who in February 2007, was vaccinated with Gardasil. In May 2007, she received the second dose and on 29-JAN-2008, she received the third dose. There was no concomitant medication. There were no adverse events following the first and second doses. On 29-JAN-2008, four hours after the third dose, the patient experienced numbness in her legs, severe headaches, Dizziness, nausea, fever, muscle weakness and her body would not stop shaking. The patient sought medical attention and has been in and out of the hospital since 29-JAN-2008. The reporter was unsure of the exact amount of time she was hospitalized. As of 04-FEB-2008, the patient had not recovered. Additional information has been requested.   03/13/2008 MR received for DOS 1/31-2/5/2008 with D/C DX: Anxiety NOS with hysterical gait disorder. Pt presented for admission with 2 day hx of shaking episodes which began within hours of HPV vax #3 on 1/29/08. Also c/o photophobia, nausea, and dizziness. Pt has episodic multi-amplitude shivering/shaking type movements of the upper and lower extremities, trunk, and head somewhat decreased when distracted on PE.  Neuro and psych consults. Neuro exam (+) for psychogenic wide-based gait with pseudotremor and ataxia. D/C for outpt f/u.
elevate heart rate (120-125). facial swelling, 30 minutes post injection - lasting approximately 12 hours.  Hives, itching, approximately 45 minutes post injection lasting 24 hours. Rash 30 minutes post injection lasting 3 days. Swollen lips approximately 45 minutes post injection lasting approximately 12 hours., Breathing problems approximately 45 minutes post injection lasting 12 hours. Abdominal cramping with nausea and diarrhea 2 hours post injection lasting approximately 2 days.  Physician instructed patient to take Benadryl and ibuprofen approximately 45 minutes after injection and continue until resolved.  Patient used inhaler to assist with breathing issues.
Swelling, redness to left leg. Give Benadryl and Motrin PRN. RTC if s/s worsen.
Low grade fever, chills, headache, night sweats, dry cough, muscle aches. 7 days constant symptoms so far. Was expecting 72 hours of symptoms, but it appears the symptoms will be continuing for much longer than 72 hours. Will go to an urgent care clinic, or emergency room if this continues. Primary care physician not available until another week.
Initial literature report received on 31 Jan 2011: This article described about adverse events associated with pandemic influenza vaccines and comparison of the results of a follow-up study with those coming from spontaneous reporting. This patient had medical history of chronic obstructive pulmonary disease (COPD), diabetes and peripheral ischemia. Concomitant medication included triflusal and pentoxifylline. He was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number unknown) on an unspecified date. He experienced acute pulmonary oedema, COPD exacerbation, acute respiratory failure and hypertensive crisis and hence it was reported that Influenza A vaccine was contraindicated in this patient. Outcome of the event was not reported. Two years later, he was vaccinated with S-OIV FOCETRIA (batch number unknown) on an unspecified date and experienced similar reaction (see case PHHY2011ES07993).
Raditaing pain towards neck and arm; swelling which is size of golf ball on injection site; Raditaing pain towards neck and arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Raditaing pain towards neck and arm), VACCINATION SITE SWELLING (swelling which is size of golf ball on injection site) and NECK PAIN (Raditaing pain towards neck and arm) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Raditaing pain towards neck and arm) and NECK PAIN (Raditaing pain towards neck and arm). 29-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling which is size of golf ball on injection site). At the time of the report, PAIN IN EXTREMITY (Raditaing pain towards neck and arm), VACCINATION SITE SWELLING (swelling which is size of golf ball on injection site) and NECK PAIN (Raditaing pain towards neck and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a nurse practitioner refers to a 37 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SQ in the left arm with 0.5 ml MMR II (Lot number 1768AA, exp. date 10-NOV-2013) on 14-AUG-2012 at 07:45 a.m. No other co-suspects were reported. There were no concomitant medications. On 14-AUG-2012 (also reported as 24-AUG-2012) by 09:00 a.m., the patient was experiencing pain in her left arm, tingling, itchiness, nausea and her vision started going bad and hurting. The patient was admitted to the emergency room (ER) at unspecified hospital but no diagnosis or treatment was given besides BENADRYL. Magnetic resonance imaging (MRI) and computed tomography (CT) were performed (results not provided). At the time of the report, the patient had not recovered. The patient continued to have pain and partial loss of vision in her eye. The relatedness for pain in her left arm, tingling, itchiness, nausea, vision started going bad and hurting and partial loss of vision in her eye was unknown for MMR II. Pain in her left arm, tingling, itchiness, nausea, vision started going bad and hurting and partial loss of vision in her eye was considered to be disabling by the reporter. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), administered in arm, on Mar 20, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), on Feb 28, 2021, for COVID-19 immunisation. The patient had vaccination site pain (it's really hurting and she feels so bad in her arm where she got the vaccine) and felt abnormal, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Covid-19 test positive; Lowgrade fever; Cough got worse; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 test positive), COUGH (Cough got worse) and PYREXIA (Lowgrade fever) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COUGH (Cough got worse). On 12-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 test positive) and PYREXIA (Lowgrade fever). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 test positive), COUGH (Cough got worse) and PYREXIA (Lowgrade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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 Treatment information was reported; Sender's Comments: Based on the information provided, a causal association between the event of Covid-19 and the administration of mRNA-1273 vaccine is assessed as unlikely related.  Based n available information. the event pre-existed vaccine administration and the other events of cough and fever are symptoms of the disease.  Hence also assessed as unlikely related.
Arms horribly sore, 8:30 PM high fever, 10:30 PM shakes, 2:30 AM kidneys hurting, back hurting, headache throughout event 8:30 Am starting to decrease in symptoms.
Constant clearing of throat. Coughing with severe pain in the esophagus from the bottom of my neck down the middle of my chest, so bad you did not want to cough. Hoarseness. Heart Rate over 100. Lasted 3 hrs at least, then I went to bed at 8:30 I was so tired.  I called the Dr to report this--Never received a return call---finally went to bed.
Intussusception; 15 days after receiving vaccinations. Presented to local ER with vomiting and irritability.
On date of injection left deltoid sensitive. By Friday arm was very red: Hot and swollen from site to elbow. This lasted till 8/11/08 client was on vacation - Did not seek medical attention: Iced area and was given Tylenol and Benadryl by parent.
Information has been received from a physician, concerning a 50 year old female patient. The patient had no medical history, drug allergies, previously drug reactions, concurrent conditions or concomitant medication reported. On 25-SEP-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 intramuscularly lot # N005096, (strength, dose, anatomical location and expiration date were unknown) for prophylaxis, at the physician's office. Since that day, the patient experienced raised, red, and warm to touch at vaccination site; then, on 27-SEP-2017, she returned to the physician's office to show him and physician reported that "the site looks like cellulitis"; therefore, as treatment for the cellulitis, it was prescribed doxycycline (manufacturer unknown) 100mg twice daily for 10 days, and PERCOCET 5mg/325mg for vaccination site cellulitis pain (subsequently the patient could sleep). The physician stated that the patient had scheduled appointments in 2 days and 4 days for follow-up. At the time of the report, no laboratory diagnostics or studies were performed, the patient was not recovered from the vaccination site cellulitis and the causal relationship between the vaccination site cellulitis and the PNEUMOVAX23 was not assessed.
I got the 2nd dose on 06/06/2021 and then for a couple days after my heart was pounding and I was just tired. I felt tightening in my chest, intermittent pain in upper back. Periodically this would come in waves. My hands felt like pins and needles kind of flushed over my body. It was mainly hands and feet but I would feel it in my face and sometimes arms and legs. I did go to the ER about a week after 2nd dose (around 06/13/2021). They told me it could've been anxiety and stress. They did an EKG, blood work, and x-ray and didn't find anything abnormal. I did f/u with PCP and I just went last week and explained symptoms there as well and they're looking into my issues. They told me today I had a high white blood cell count and that my liver has elevated enzymes. They want me to come in the middle of July to do more fasting blood work. No fever, no malaise, but I did feel tired and fatigued and nauseous. I had bad brain fog and my body felt like it wasn't mine. It was like someone took my brain and put inside someone else's body. 1 week after 2nd dose I had bad sinus pressure behind eyes like my eyes were going to burst out of skull.
pediatric dose instead of the adult dose; pediatric dose instead of the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a male patient who received HBV (Engerix B pediatric) (batch number LN992, expiry date 13th December 2022) for prophylaxis.   On 3rd May 2022, the patient received Engerix B pediatric. On 3rd May 2022, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient was administered a pediatric dose of the Engerix-B vaccine inadvertently instead of the adult dose. The reporter consented to follow up. Additional supportive information: The patient was administered a pediatric dose of the Engerix-B vaccine inadvertently instead of the adult dose, which led to adult use of a child product and underdose.
Client received Moderna vaccine, 6-10 minutes later, he stated he has light headed, hot, and was sweating. Clinical staff began assessing his vitals and applied cold presses around his neck and forehead. Client was kept until his wife  picked him up. He was walking on his own and feeling better around 3 p.m.
I thought I was going to die; high fever; couldn't get out of bed for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of anxiety in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine with an associated reaction of no adverse event (got covid-19 shots plus two boosters) and Shingles vaccine with an associated reaction of no adverse event (never had a reaction to 1st shingles shot). Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced anxiety (Verbatim: I thought I was going to die), fever (Verbatim: high fever) and bedridden (Verbatim: couldn't get out of bed for 3 days). The outcome of the anxiety was not reported and the outcome of the fever and bedridden were recovered/resolved (duration 3 days).   It was unknown if the reporter considered the anxiety, fever and bedridden to be related to Shingles vaccine.   It was unknown if the company considered the anxiety, fever and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient got both shingle shots.  The reporter stated that never had a reaction to any shot he/she had ever gotten a couple of. The reporter stated that the second shingle shot and he/she thought he/she was going to die man.  The reporter further stated that a high fever and he/she could not even get out of bed last year for 3 days. The reporter further stated that his/her guessed was better than having shingles.  Then he/she went to the internet and that tried to find out why and any internet he/she said most people had bad reaction to the second shingles shot and he/she was going to tell you what he/she did not want shingles but it was the worst 3 days of his/her life. The follow up would not possible as no contact details were available.
consumer reports receiving her first dose of the Pfizer covid-19 vaccine on 22Mar2021 and then getting covid-19 disease later.; consumer reports receiving her first dose of the Pfizer covid-19 vaccine on 22Mar2021 and then getting covid-19 disease later.; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 22Mar2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer covid-19 vaccine on 22Mar2021 and then getting covid-19 disease later in 2021. The patient experienced some covid-19 symptoms in 2021 (not specified what symptoms) and reported being recovered from them. The patient was scheduled to receive her second injection of the Pfizer covid-19 vaccine on 01Apr2021. The outcome of events was recovered on unknown date in 2021.  Information on the lot/batch number has been requested.
ear ringing, muffled hearing in right ear, severe frontal headache, crushing pressure in head and severe neck pain with stiffness and decreased range of motion
Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date.  Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Having itching red swallowed arm cant stop itching to the point i want to take my skin off.. took so many antihistamines,  rash medication nothing is calming it down... my both arms are having fever it's red and sever discomfort.... it's been over a week I still have the same symptoms
(+) occult stool 24 hrs post immz 8/11/15. (-) occult stool 72 hrs post immz 8/13/15. (-)  visual stools with blood 48 hr post immz 8/12/15.
Vaccines given 06/02/2003; local cellulitis developed 06/03/2003 right thigh.
DIARRHEA; VOMITING; FEVER FOR ONE DAY; NAUSEA; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry:, and 2022) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced fever for one day. On 10-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever for one day, diarrhea, vomiting, and nausea. This report was non-serious.
Information has been received from a school nurse concerning a male patient who in 1999 was vaccinated with on 0.5 ml dose SC of varicella virus vaccine live. On 14-Oct-2003 the patient broke out in chicken pox. No labs or diagnostic studies were performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Nausea 12 hours after vaccination for duration of 3 hrs, mild headache becoming more severe 12 hours after vaccination until 21 hrs after vaccination.  Advil decreased headache for it to become mild. No fever.
Suspected vaccination failure; got the shot and then got shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew the patient, who got the shot and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
low grade fever early AM 21AUG96;on 22AUG96 large, hard swollen lymph node on rt thigh groin area;2 palpable lymph nodes on lt thigh groin area;pt acts sick;