chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/27/13 approximately 11:25 AM, pt. came to consultation window and stated he rec'd a Flu shot and has pain in arm and radiates to his hand and has been this way since receipt of Flu shot on 11/9/13. Suggested warm compresses and Ibuprofen and to see MD if does not help or improve.
pt recv vax & lips were purple & wanted to pass out; brought back into clinic; mucus membranes & face pale, eyelids droopy although pt was trying to cry but weak; HR 112, RR34, pupils ERRL;
The patient had facial hives, facial redness and was scratching her face after MMRV. MD was notified and orders to give Benadryl PO. The patient was observed in office for about 45 min The patient remained alert and oriented throughout.
A spontaneous, non-serious event of administration of expired FLUMIST was reported by a nurse concerning a 23-year-old male patient. Medical history and concomitant medications were not reported. On 24-Aug-2009, the subject received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 15-Oct-2009 and 16-Oct-2009: the patient has not experienced any adverse event and was revaccinated for the flu.
101-102 Fever for 48 hrs starting about 8 hrs after shot Swelling in armpit for 4+ days Headache and neck stiffness for 4 days Tinnitus Extreme lethargy In bed for 3 full days after shot. 4th day after shot is today and 1st day I have been out of bed and regaining energy.  Similar reaction after 2nd shot but that one only lasted about 1.5 days. This time with a half dose the reaction lasted twice as long (4 days) and I am still not back to normal but able to function today.
Had swollen red arm on left arm x 2 days, now resolved but (R) upper lid red and swollen. Cellulitis and being TX.
Severe pain at injection site, for 7 days, inability to move arm for 2 days, fever 100.6 for 24 hours, flu-like aches and pains for 3 days
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu, Shingles (Shingles), COVID-19 Vaccine (Past vaccines), Prevnar and HEP B. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, Flu, HEP B, Prevnar and Shingles.    In November 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In August 2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
severe pain & redness the size of a baseball @ the site w/in 24hr of vax;
This spontaneous report was received from a physician referring to a 17 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-JAN-2018, at the age of 17 year-old, the patient was inadvertently vaccinated with PROQUAD lot # N010246, expiration date on 25-SEP-2018, for prophylaxis. No adverse effects were reported.
high fever for 3 or 4 days;parents reported this 2mo later-no tx given;child not seen;
Lymph Nodes under left armpit 3-4 days after injection. Red/Itchy swelling left arm one week after injection.
Aside from the more common side effects, I experienced severe nausea and vomiting.  I vomited every 30 minutes for approximately 8 hours.   I went to the ER and requested IV fluids and meds to stop the vomiting.   This worked wonders.
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, swelling and redness x 3 days Tiredness x 2 days Headache x 2 days Muscle pain x 2 days Chills x 2 days Joint Pain x 2 days Fever up to 104.0 degrees x 2 days Nausea x 2 days Feeling Unwell x 2 days Swollen Lymph node left collarbone x 4 days
nausea & vomiting-aspirated pneumonia adm to hosp; lt arm very swollen, red & sore; dx cellulitis adm 16OCT95
Employee was given the flu shot with a 5/8th in needle. Essentially into subcutaneous tissue. She experienced redness, tenderness and warmth at site. She used icepacks and pain medication (unknown) to ease tenderness.
The patient had previously been diagnosed with COVID-19 in November 2020, but did no require hospitalization and had recovered. He received his first dose of the Pfizer COVID vaccine on 2/25/2021, and on 3/15/2021, collapsed suddenly at home and was unable to be resuscitated. An autopsy was performed at the request of the family, and a massive pulmonary embolus was found in the main pulmonary artery and extending far into the segmental pulmonary arteries of both lungs.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MAGNESIUM, start date: 01May2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Relapse/rebound of COVID-19 symptoms on day 9 of illness,Anti-viral details includes COVID 19 Treatment, Paxlovid, Treatment start date 14Jul2022, Treatment stop date 18Jul2022,Indication included Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she felt like she had covid again; she is scared to get the second dose; horrible headaches; rash; hives; itching; She did not feel well; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history included covid and monoclonal antibodies (I ended up getting a mononucleo (presumably monoclonal antibody) infusion and it saved my life) in Jan2021 and Autoimmune disorder. Concomitant medications were not reported. The patient reported, received first dose of Pfizer's COVID vaccine and didn't feel well after the vaccine. She had horrible headaches and rash or hives and was itching afterwards. She took some Benadryl and was ok. She felt like she had COVID again and had COVID in January. The doctor told her to get the vaccine but terrified of getting the 2nd dose after the symptoms having with the first dose. She has autoimmune issues. She was asking if she gets the second dose, will her side effects be worse? States she is terrified of getting the second dose after the symptoms she had from the first dose. The outcome of reported events was unknown.
Redness around site of injection but no pain. Recommended some benadryl to help with the reaction at site of injection
headache; stomach ache; Initial information received on 03-Dec-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via social via Digital Media.  This case involves adult patient who had headache and stomachache (abdominal pain upper) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) 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.  On 04-Dec-2021, the patient developed a non-serious headache, stomach ache (abdominal pain upper)  (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
Patient reported swelling at injection site that extended to the elbow. By the patient's account, the swelling had significantly decreased by the morning of 9-3-2016.  No other symptoms reported.
Inadvertent/accidental administration of diluent only.   Patient contacted to schedule re-vaccination.
Onset of chills after 20 hours of injection followed by nausea and lightheadedness as day progressed. Symptoms completely gone after twelve hours.
Information has been received regarding a pt who, several hours post vax, experienced a rash and itching. The pt sought unspecified medical attention and took diphenhydramine hcl (Benadryl) to ease the itching. No further information is available.
Generalized tonic-clonic seizures - approx 3 min w/20 minute recovery. - loss of consciousness - lips and jaw blue - whole body convulsions - eyes rolled back - bit sides of tongue - chipped tooth - loss of bladder control. Dates of seizures: 7/08/13 and 3/15/14. Diagnosis: Generalized seizure disorder of unknown origin.
Admitted to hospital for unrelated COVID-19 issue on 1/22/2022, yet tested COVID-19 positive on 1/25/2022 (asymptomatic).
Initial and follow-up information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (lot #655617/1447F). Subsequently, 2 days after vaccination, the patient experienced "RSD reaction" that started in her upper extremities and then moved to her lower extremities. The patient is undergoing a neurology work-up. At the time of the follow-up report, the patient had not recovered. Additional information has been requested. 05/15/07-records received for DOS-1/15/07-seen for repeat chlamydia testing after treatment. C/O episodes of chest tightness without SOB and is worried about pulmonary embolus after reading about this risk on the internet. NuvaRing prescribed. Letter from parent included in notes-per parent. patient had thrid in a series of 3 shots of B12 on 4/16. Developed paresthesia in arm and fingers curled into her palm. Contacted neurologist who referred her to ER, treated with bendaryl and morphine and her arm straightened. Also previously seeing a physical therapist.
Respondent received Moderna and stated they became very ill after receiving the vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Respondent received Moderna and stated they became very ill after receiving the vaccines) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Respondent received Moderna and stated they became very ill after receiving the vaccines). At the time of the report, ILLNESS (Respondent received Moderna and stated they became very ill after receiving the vaccines) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient's race was reported as black/white. Concomitant product use was not provided by the reporter.  Treatment information was not provided.
As soon as I got the vaccine I started with a cough 30 hours later developed a fever chills  headache and it one point to it we?re not too three days muscle aches severely cold and now I have so I said my mouth five days later violent diarrhea five days later still sores
bursitis; A spontaneous report was received from a pharmacist, concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bursitis.     The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced bursitis.    Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, bursitis, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Immediate chills and fever 101 degree out of work for 2 1/2 weeks morning fatigue and fever  both knees/ inflamed could not walk loss of appetite severe insomnia chest pains went to hospital fear of heart attack
Patient was here for a TDAP vaccine and was accidently administered the Pfizer COVID 19 Vaccine
Headache, Myalgia, Sore Throat, Congestion Narrative:
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with no medical history and no drug reactions or allergies who in approximately October 2009, was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Details about the vaccination were unknown because the patient was vaccinated at another health department. Two weeks post vaccination, the patient found out that she was pregnant, with last menstrual period (LMP) of 12-NOV-2009, estimated delivery date (EDD) of 19-AUG-2010. Urine pregnancy test was performed. On an unknown date, the patient experienced generalized edema and was having rapid weight gain. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Patient felt lightheaded immediately after vaccine. Patient bleed a lot straight away. Patient was feeling nervous before vaccine. I have elevated patients legs and instructed her to stay for 30 minutes to ensure systems don't get worse. Patient is fine and coherent and able to talk. Patient was able to walk and had no dizziness no sweating or feeling hot. Patient was getting picked up by partner
Right after vaccine: Slight fever and extreme fatigue. May 8-present:  Severe headache, nausea, motion sickness, lightheadedness, joint pain.
Initial pregnancy report received from a healthcare professional on 28 May 2013. A 35-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular 0.5 ml first dose of ADACEL lot number: U4512AA (Expiry date 09/20/2015) in right deltoid on 28 May 2013. The patient received vaccine during her pregnancy. The patient's last menstrual period date was reported as 17 September 2012 and the expected date of delivery is 09 July 2013. The gestation week was calculated as 34 weeks. The patient did not experienced any adverse event. List of documents held by sender: none.
Information has been received from a physician concerning a 6 year old male patient with no known medical history who on 22Jan98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 11Oct2003 the pt developed a full blown case of varicella. Unspecified medical attention was sought and the pt was seen for a Dr. visit. Subsequently, the pt recovered from full blown case of varicella. Additional information has been requested. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M010486, expiration date 25-MAY-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
One hive on right cheek Watch patient for addition 15 minutes and none noted on chest back or arm.
Reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-month-old male patient who received Hib (Hiberix) (batch number DM5G2, expiry date 15-MAY-2024) for prophylaxis.   On 24-MAR-2023, the patient received Hiberix. On 24-MAR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 The medical assistant reported a dose of Hiberix was reconstituted with sterile water. Adverse event (AE) contained all reported information.  The health care professional (HCP) gave consent for safety team follow up. The patient received Hiberix which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Reactions day the vaccination was give: -fever 105 -vomiting -confusion -screaming and crying for long periods of time -irritable -fast heart beat -difficulty breathing -paleness -blank stare -shaking Treatment: She was taken to the emergency room that night, but was not helped.  Since that day: -fever of 102 to 105 for eight days -stopped eating and drinking -diarrhea for two days -rash -extremely irritable -hasn't slept through the night -screaming bouts -complains of her knees hurting Treatment: A number of doctors appointments, and still seaking treatment.
vaccine which may have been reconstituted with 0.7mL sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6mL Sodium Chloride solution provided by sanofi pasteur no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20 years old male patient who experienced vaccine which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution provided by sanofi pasteur no reported adverse event while receiving vaccine Yellow Fever Vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 07-Mar-2023, the patient received a dose of suspect Yellow Fever Vaccine, solution for injection which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution provided by sanofi pasteu (lot: UJ782AA) via subcutaneous route in unknown administration site for Prophylactic vaccination with no reported adverse event (product preparation error).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax & exp wheezing & abdo cramping; these sx were treated w/DPH;
At 11:00 pm CST on the same day as the injection I felt body aches, muscle pain, headache, and exhaustion.  I woke up at 05:00 am CST on 2-13-2021 with a fever of 100.8, increased pain of body aches, muscles, headache, and chills.  These symptoms lasted all day long. I did take acetaminophen and ibuprofen to aid with the fever and pain.   The majority of symptoms (all but headache) faded the next day (2-14-2021) around 10:30 am CST.  The headache lasted until around 10:00 pm CST 2-14-2021.
When I got the injection, I felt pain from my arm go up into my neck area.  My started hurting more as the hours went on.  In about 5-6hrs I experienced severe neck pain.  The next morning couldn't get up or move.  I went to the ER the next day.  I was in the ER for the 3 days.  Received pain meds.  It took a month for me to fully recover and the pain to die down.  I still get small occasional pangs in my neck and I'm going to the doctor for that soon.
One day after receiving the vaccine patient stated she had a low-grade fever lasting about one day and also felt lethargic for about 2 days. She did not treat her symptoms and recovered after 3 days.
G62.9 PERIPHERAL NEUROPATHY 7/5/2022 BACTEREMIA R09.02 HYPOXEMIA 9/19/2022 BACTEREMIA G62.9 PERIPHERAL NEUROPATHY 7/5/2022 RIGHT INGUINAL HERNIA R09.02 HYPOXEMIA 9/19/2022 RIGHT INGUINAL HERNIA G62.9 PERIPHERAL NEUROPATHY 7/5/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC R09.02 HYPOXEMIA 9/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC G62.9 PERIPHERAL NEUROPATHY 7/5/2022 MRSA BACTEREMIA R09.02 HYPOXEMIA 9/19/2022 MRSA BACTEREMIA G62.9 PERIPHERAL NEUROPATHY 7/5/2022 PRESENCE OF CARDIAC PACEMAKER R09.02 HYPOXEMIA 9/19/2022 PRESENCE OF CARDIAC PACEMAKER
Pt recd vax 22JAN91; 01FEB91 devel dermatitis on hand, postauricular & occipital lymphadenopathy & sl macular rash of upper chest; PE showed sl infected pharynyx; pt had baker's cyst on both knees; 06FEB91 rash & leg discomfort improved;
Redness in bend of the right arm and redness on the outer portion of the under arm also right arm used cortazone didnot help now using a  RX cream betamethasone dipropionate until dermatologist appt. The area is still red and looking like a burn.