chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Went for flu for heel pain, otherwise healthy. Woke up next morning with 102 temp. Took ibuprofen, by that night, temp 103. Arm very painful. Talked to Dr's office and they said to take ibuprofen or go to ER if fever persists. Still has hot flashes, but feeling better.
This spontaneous report as received from a health care professional refer to multiple unspecified patients of unknown demographics. Since 03-DEC-2015 unknown number of patients were vaccinated with improperly stored PROQUAD (Merck) (dosing regimen unspecified) (dosing regimen and lot # unspecified). No concomitant medications reported. No adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the Dept and did not recommend repeating this dose in question. No ill effect post administration was reported.
Adverse local reaction with localized redness and swelling/induration 2.5 x 2.5 inches.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-NOV-2011, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-APR-2013,  the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir  and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
he presents to the emergency room by private auto complaining of upper respiratory type symptoms with a cough over the last 3 weeks.  She believes her symptoms are getting worse and yesterday she developed some reproducible right-sided chest pain which is worse with coughing and deep inspiration.  The pain seems to radiate to her right back.  She also complains of some increased shortness of breath.  She did speak with her primary care physician who requested she go to the emergency room for further evaluation.  She had a Covid test obtained yesterday and is still awaiting the results.  She has been vaccinated for Covid.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Additional Details: PATIENT DESCRIBED PAIN AND BODAY ACHE THE NIGHT OF INJECTION. ONE WEEK LATER, SHE DEVELOPED A FEVER AND PAIN AT INJECTION SITE WITH RED SWELLING THE SIZE OF A TENNIS BALL. ON JUNE 6TH, SHE DECIDED TO GO TO URGENT CARE TO GET MEDICAL ASSESSMENT.
Update on my recent visit about a very strange hive like rash.  I saw my Dr first who thought it was a contact dermatitis and then the dermatologist (also thought contact dermatitis) who gave me   Triamcinolone Acetonide Ointment USP .1% which saw me thru the worst. It was hive like rash on my elbows, wrists, back, upper buttocks and left side chest. Extremely (!!!) itchy and red.  The ointment helped the itch tremendously and was getting better but after the second vaccine got a new outbreak allacross my torso. Continued with the ointment and it all went away within a few days after second shot. It kind of peeled off like sunburn (especially the elbows). Looked online and saw that a few other moderna test subjects had same - especially the strange red and hive-like itchy rash on elbows.  It was pretty unpleasant and strange but small price to pay to be safe.
She was vaccinated on 2/2/21 and started feeling bad on 2/4/21. She was treated by her doctor, improved somewhat, got worse, then went to the hospital on 2/16/21. She died on 2/20/21.
Swelling, redness, pain over most of upper left arm. Onset morning after shot. Lasted 3 days total.
Shaky hands, chills, dizzy, trouble standing and walking. Some fever, shot arm swollen (couldn't raise). Stomach upset (close to throwing up). Unable to drive. Unable to prepare meals. Took 1 full week to recover.
arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: I have allergies that require me to carry an epi pen and I had no allergic reaction at all. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021319544 same reporter, different patient
Hives on her skin; swollen, red area at the injection site; swollen at the injection site; red area at the injection site; Initial information received on 08-Oct-2019 and additional information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA281538 and 2019SA281612 same reporter.  This case involves a 5 years old female patient who experienced hives on her skin (urticaria) and swollen, red area at the injection site (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered.  On 02-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Frequency = 6th) lot UJ223AA, Expiration Date: 30-Jun-2020 via intramuscular route in the left thigh.  On an unknown date, the patient developed a non-serious hives on her skin (urticaria),  swollen, red area at the injection site (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  (Other relevant tests included no lab data.)  Final diagnosis was swollen, red area at the injection site and hives on her skin.   The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and used Ice.  The outcome of the event was Unknown.  Documents held by sender: none.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/29/21 and 3/02/21. Covid + 1/15/22. Admitted to ED on 1/15/22 with acute hypoxic respiratory failure secondary to COVID PNA c/b acute exacerbation of COPD .  D-dimer was within normal limits at 218, and CXR did not show an acute infiltrate but did show a large hiatal hernia. During admission O2 requirements progressively increased requiring high O2 and remained dyspneic. Treated with remdesivir and steroids. Transitioned to comfort care/DNAR.  Patient expired 2/01/22.
Headache, Rash, chills, malaise Narrative: Per pt. report: "just started today with malaise sore arm and chills within 24 hours. rash associated with 1 shot noted five days after. Rash resolved within three days afterward"
Friday evening 1/8 - Saturday evening 1/9 Mild raised rash on upper inside lip. Saturday 1/9 Rash on chest above breast extending to shoulders. Very red raised on left side. Mild on right side and center. Put hydro  cortisone otc cream on it. Sunday  1/10 Rash very faint. No treatment Today. Mouth better.
Approximately 45 minutes after vaccine administration, coughing began.  Also had fatigue, headache and some chills.  Noted to be flushing, dizzy, and have an increased heart rate,   Referred to Urgent Care for evaluation.  Diagnosed as Adverse Event to Vaccine Administration
4PM (1 hr p/vax) pt red in face x/around eyes;mom gave Tempra @ 4PM d/t assumed fever (temp not taken);7PM hives began to devel all over body in blotchy character @ 9PM mom called MD who advised DPH;pt said to have sore legs & won't walk
Brain fog; Digestive issues; Huge knot on his left arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the first vaccine dose.   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the left arm on 03May2021 at 10:00am (Batch/Lot Number: EW0176, at age 41-years-old at vaccination) as a single dose for COVID-19 immunisation at a pharmacy/drug store. Medical history and concomitant medications were not reported. The patient had no prior vaccinations (within 4 weeks) of the BNT162B2 vaccine. On 03May2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date in May2021 (after the first vaccination), the patient experienced a huge knot on his left arm and it has remained the same. It was hard as a rock. The patent has been having a lot of side effects since the vaccine and one is brain fog which began around 18May2021 at the latest after the first dose of the vaccine and was ongoing and continues to get worse. He has an appointment with a neuropsychologist to undergo testing to see what was going on. He has a lot of digestive issues and was undergoing tests. The digestive issues also began around the same time as the brain fog and was ongoing and worst. Treatment for event digestive issues included taking Linzess 150mg once per day by mouth since 24Sep2021. The outcome of events huge knot on his left arm, brain fog and digestive issues was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 Same patient/reporter; different dose/AE
Initial unsolicited report was received from a pharmacist on 25 February 2015. A male patient (date of birth not reported) with a history of a slight reaction after dose 1 of YF-VAX and multiple allergies except no egg allergy, had received on an unspecified date dose two of YF-VAX (Sanofi Pasteur lot number, route and site of administration not reported) and an unspecified amount of time later, experienced a "severe reaction", was hospitalized for one week and "nearly died". According to the reporter, she did not remember the patient name or other information since it was received so long ago (reported as six years). The patient has additional events captured in cases 2015SA026087 and 2015SA026088. Documents held by sender: none.
1054 - Received vaccination. Asked to wait until 1109 for observation. 1103 - Pt ran to bathroom to vomit. Emerged to appear diaphoretic, distressed, and states that he "feels off".  Pt reports that he had COVID infection approx. 1 month prior to this date.  1105 - Placed in a reclining chair. Given apple juice. HR 75 bpm and regular. Monitored by on-site provider. 1110 - Pt states that he is "feeling better already" and appears improved. He wants to leave since his "time is up". Advised that it is best to stay for another 15 or so minutes to ensure he's recovered from probable vasovagal episode. Pt. declines. Advised to discuss this event with his PCP prior to 2nd dose and, if 2nd dose is advised, to ensure the staff are aware of this hx prior to vaccination. Pt. left site.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had no pertinent medical history, concomitant medication and drug reactions/ allergies. On unknown dates, the patient was vaccinated with VARIVAX and M-M-R II (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. On unknown dates, the patient had low titers for VARIVAX and M-M-R II (antibody test negative). No adverse effects were reported. The patient did not sought medical attention and no treatment was given for the event. The outcome of antibody test negative was reported as not recovered. Causality assessment for antibody test negative was not provided.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 25-JUL-2013 (lot # H021608, exp: 13-AUG-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
Red circular skin reaction at injection site, soreness at injection site 8 days following dose 1 of Moderna vaccine
26AUG93 felt hot to touch; mom gave APAP; 27AUG93 330 t103 R mom sponged; 27AUG93 430 t101 R; pt taken to hos; & devel a fine red rash all over body;
she slept quite a bit; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL9264) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and clopidogrel (strength: 75mg) via an unspecified route of administration on an unspecified at 75mg for an unspecified indication. Patient medical history and concomitant medications were not reported. She got the first dose of the Pfizer COVID shot on Monday. She is doing fine. She reads on the fact sheet about things that should be mentioned to the vaccine provider and she cannot remember if she told the provider she is on Clopidogrel 75mg, a blood thinner. She is asking if this is ok since she is scheduled to get her second dose in three weeks. She slept quite a bit on 08Feb2021. After she came home from getting the vaccine, she slept the whole day and the next day she was fine. States it might have not been from the vaccine since she stayed up late the night before. Outcome of event was recovered on 08Feb2021.
CIRCULATION PROBLEMS; CANNOT WALK LIKE BEFORE BECAUSE OF PAIN; PAIN; PROBLEMS IN LEGS; HEADACHE; QUALITY OF LIFE HAS GONE DOWN DRASTICALLY; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-OCT-2021, the patient experienced quality of life has gone down drastically. On an unspecified date, the patient experienced circulation problems, cannot walk like before because of pain, pain, problems in legs, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot walk like before because of pain, pain, and quality of life has gone down drastically, and the outcome of headache, circulation problems and problems in legs was not reported. This report was non-serious.
Information has been received from a pharmacist concerning an 18 month old female with no medical history or allergies who on 20-MAR-2008 was vaccinated IM with two doses of VAQTA.  There was no concomitant medication.  It was reported that the patient received the two doses at her 18 month old wellness check.  Her appearance was noted to be more pale than usual.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received which indicated that on 21-MAR-2008 at 09:00 AM, the patient had diarrhea and very foul stools. It was reported that the patient was given TYLENOL one hour prior to the patient's wellness check on 20-MAR-2008. The patient recovered on 09-APR-2008. No further information is expected. requested.
This spontaneous report was received from a registered nurse refers to a 70 year old female patient with osteopenia, hypertension and desipramine allergy. The patient's medical history included fatty liver and glaucoma. On 02-MAR-2010, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported). Concomitant therapies included lisinopril, milk thistle and WELCHOL. On 26-JAN-2013, the patient experienced shingles which manifested as one blistered area and as nerve pain radiating around and towards the back of the patient. Treatment included VALTREX and NEURONTIN. No laboratory diagnostic tests were performed. Patient sought medical attention (unspecified). The outcome of shingles was reported as recovering. The causality of shingles for ZOSTAVAX was unknown. Additional information is not expected.
Extreme Fatigue Dizziness Leg Swelling Pain in the Leg Hives Facial Swelling Headache
Starting at 9pm day of shot, fever of 100.6 to 99.8 for four days accompanied by chills.  Fever finally subsided the Sunday evening after shot but came back Monday evening to 99.8.  Also experienced inflamed joints, intestines and bladder.  Bodily functions felt like I was eliminating broken glass.  Severe abdominal crapping occurred as well. Small water blisters that were itchy and burning emerged randomly on all parts of my body.  These were not clusters or a swath of redness.  Injection site still raised and hot 5 days afterwards, but not showing signs of infection or pus. Have not sought medical care because worst of it is over (I hope).
Pt did not experience any adverse events. Reporting this as a medication error. Pharmacy did not see previous doses given at clinic site, so patient received an extra dose of both vaccines listed. Last bivalent pfizer given 10/18/2022 GH9702 Previous shingrix given at site 06/22/2021 JH25S
Pt recvd 3 doses of Engerix-B & 21APR92 titer test indicated low titer; 28ARp92 recvd booster dose;
Itchiness at injection site; Red bump (1/4inch in size) at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Red bump (1/4inch in size) at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Red bump (1/4inch in size) at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Red bump (1/4inch in size) at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt states became ill w/in 24 hrs of vax; next morning had fever 102 & rash all over & swollen glands in neck; had muscle pain since then has had intermittent fever w/rash; muscle burning & fatigue which began 1 month p/vax;
pt recv vax 27JAN99 135PM & got up walked out of the lab & was standing in the hall by the doorway for about 5min;alout hit heard & mom said pt fainted;saw MD told to observe;
P/receiving Influenza vax, pt devel severe erythema, induration, edema, & itching @ inject site; rxn area was 10-20 cm in size;
This case was reported by a nurse and described a 14 year old female pt who tested positive for hep B surface antigen after receiving hep B vaccine for prophylaxis. On 7/5/00 the pt received the 3rd dose of hep B vaccine. In August 2003, a test for hep B surface antigen was "positive." On 9/11/03, the nurse reported that "the initial test was a false positive. Upon retesting pt for a whole hepatitis series, all tests were negative except for surface antigen."
no additional AE was reported by patient; patient received a dose of GARDASIL at age 6; This spontaneous report was received from a registered nurse and refers to a 6-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-JAN-2015, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vial, 0.5 ml, lot # K008931, expiry date 04-MAR-2017 (route and anatomical location of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). The reporter stated that no additional adverse event was reported by the patient (no adverse event).
A report has been received from a physician concerning a 12 year old, female subject, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started on 13-Oct-2015. The patient experienced back pain which started on 13-Oct-2015. The outcome of the event of back pain is unknown. The report was considered to be non-serious.
Sore arm; Chills; Fever; Joint pain; Fatigue; Headache; Canker sores in mouth; Left knee swollen; Difficultly walking; Sores on genitals; Hives/welts on legs; ulcer in mouth; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products.. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included ethinylestradiol; norgestimate (TRINESSA LO) from an unknown date for birth control. On 14Apr2021 at 14:00, the patient experienced sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent SARS-COV-2 test (Nasal Swab) and the result was Negative. Therapeutic measures were taken as a result of the event joint swelling which included treatment with oral steroids. The clinical outcome of the events sore arm, chills, fever, joint pain, fatigue, headache, canker sores in mouth, left knee swollen, difficultly walking, sores on genitals, hives/welts on legs, ulcer in mouth were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.