chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 58 year old male patient. When he took dapsone his "02 levels drop".  On 07-NOV-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004080, expiration date 22-AUG-2014) injections, 0.5 ml once, subcutaneous in the arm for "recommended vaccination". Concomitant therapies included Symbicort, losartan potassium (manufacturer unknown), Omeprazole, Simvastatin (manufacturer unknown and Lorazepam. There was no pertinent medical history. On 07-NOV-2013 the patient developed a fever, fatigue and the injections site was red, painful to the touch and swollen after receiving PNEUMOVAX23. The reaction was "almost leading to cellulitis in the arm". Lab diagnostic studies were not performed. The patient was being seen by the physician on 08-NOV-2013. No treatment was given for the events. The patient was not recovered from the events at the time of reporting.
pt recvd flu vax on 1NOV93; reports approx 2 days p/inject noticed a skin rash on arms, hands; itching occassionally; also reported a couple episodes of a quick gasp for breath;
Employee states he began having diarrhea 2 hours after the immunization which lasted for 1 day. Condition resolved after 1 day, no other symptoms reported.
tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Monovalent was given to patient instead of the bivalent booster. No other issues noted at this time.
Showed almost immediate signs of fever over 101 and very lethargic.  Tylenol took while to help the symptoms.
Patient reported he had never received a dose of COVID-19 vaccine before. He is incarcerated at the Abuse Center. Inadvertently, the Moderna COVID- 19 Vaccine EUA was adminsitered. When being entered into the computer, it was discovered he had received a previous dose of the Janssen COVID019 Vaccine EUA.
Cough, fatigue, fever  aspirin 81 mg chewable tablet Take 1 tablet by mouth daily.     ? calcium carbonate-vitamin D3 (CALCIUM 500 + D) 500 mg(1,250mg) -400 unit tablet Take 1 tablet by mouth daily.     ? cod liver oil capsule Take 1 capsule by mouth daily.     ? fish oil-dha-epa 1,200-144-216 mg capsule Take 1 capsule by mouth daily.     ? flaxseed oil 1,000 mg capsule 1,200 mg.     ? latanoprost (XALATAN) 0.005 % ophthalmic solution       ? red yeast rice 600 mg capsule Take 1 capsule by mouth daily.
Hives began shortly after vaccine.  Benadryl taken by Patient.  Severe fatigue began that night with a headache.  Next day 101 fever that continued until May 4th going up to 102.4 for several days.  Headache lasted one week.  Diarrhea lasted 10 days, intense body aches and pain for over a week.  Pt had COVID in Dec 2020 and stated the vaccine response was worse than the COVID-19 infection.
Vaccine Administered at Ralph's pharmacy 702 on 3/6/06. Pt reported to the pharmacy and arthralgic pain in around the thumb area on the left side. The report to the pharmacy was made on 4/10/06.
5 x 6 cm area of erythema, slight heat on left deltoid. Not indurated, slightly tender.
Rash on entire torso, arms, and fingers, especially dominant under both arms. This occurred about 40 hours after vaccine. The rash lasted for at least 48 hours and was itchy. The itchiness lasted an additional 24 hours after the rash dissipated. I took Benadryl.
This spontaneous report was received from a nurse and refers to her son, a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In August 2017, the patient was vaccinated with his third dose of GARDASIL 9 injection (dose, route of administration, lot # and expiration date were not reported). The vaccine was exposed to unspecified temperatures that were too cold. The nurse received a letter from an unspecified local health department which stated that the patient needed to be revaccinated with GARDASIL 9. No adverse symptoms were reported.
This spontaneous report as received from a certified nurse practitioner refers to a 16 year old non-pregnant female patient. The patient's pertinent medical history included anxiety, depression, obsessive-compulsive disorder and irritable bowel syndrome. The patient had no medication allergies. On 11-AUG-2016, the patient was vaccinated with GARDASIL 9 injection, subcutaneously, 0.5 ml (dose, lot #, expiry date and anatomical location were not reported). Concomitant therapies included ABILIFY, clonazepam, LAMICTAL and ZOLOFT. On 12-AUG-2016, after receiving GARDASIL 9, the patient presented with rash and sought medical attention. No lab diagnostic studies were performed. The patient received treatment for the adverse event (details were not specified). Product quality complaint (PQC) was not involved. The outcome of the event was reported as not recovered. The reporter did not provide the causality assessment between the event and GARDASIL 9. Additional information has been requested.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 not reported, batch number: not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient received the Janssen covid-19 vaccine and had no antibodies/negative antibody test (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative (No antibodies). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210900383. ; Sender's Comments: V0:20210900277-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
On 11/6 the patient began itching on his right upper arm, upon examination there was a small red spot near the vaccination site, the next morning the patient presented to the pharmacy around 10:30 am and displayed a red spot approximately 6 inches in diameter.  Recommended benadryl for the next two days and monitoring.  Told the patient to call back with any further worsening or questions.
Large red, raised hive at injection site.  Hive is itchy and tender; otherwise I feel fine.
ZOSTAVAX vaccine administered 4/8. Patient came in 4/19 to tell us she had a rxn to the vaccine (large area swollen, red, hot and itching.
The decedent received his Johnson and Johnson COVID 19 vaccine on 11/14/2021.  After receiving the vaccine, the decedent started to experience difficulty breathing, chest pain, hot and cold flashes, fevers and lethargy.  The decedent did not receive any treatment prior to death.
Pt presented in office 2 days post infection with redness, pain and swelling at injection site (left upper arm/ deltoid). Area also pruritic.
This patient was give afluria which is only to be given to 18 and older.  no Reaction to vaccine.  I-92579218 and I-92318744
Big red itchy rash at site of injection. Showed up one week after vaccine was given.
Patient started to get a migraine approx. 3.5 hours after receiving the flu vaccine on 10/28/2020. Today(10/29/20) at 2:00pm, when she called to report her migraine, the migraine has only subsided a little.
Immediately elevated blood pressure 191/115 /69and raised to 202//103/70
12 hours after injection, experienced normal side effects (e.g., muscle aches, chills, headache, fatigue)  Within 1 week of receiving the vaccine, I began to experience blurriness in my left eye.  After conferring with my primary care facility, it was recommended that I see an ophthalmologist. Confirmed that I had a Branch Retinal Vein Occlusion (BRVO) and recommended I meet with a retinal specialist.  Dr. confirmed the BRVO was caused by a blood clot and commenced treatment via eye injection.  I then met with my primary physician to discuss the situation.  He recommend further tests to determine whether I had other clotting.  In addition to blood work, he order MRIs of my brain, head and neck region and also recommended that I meet with a thrombosis specialist.  I met with a Dr. who ordered additional blood work for additional testing.  All tests performed to determine if I had additional clotting have come back negative.
left ventricle was swollen; Her BUN, Kidney Cholesterol were elevated.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), when the patient was 70 years old, for Covid-19 immunization; Bnt162b2 (Second dose), when the patient was 70 years old, for Covid-19 immunization. The following information was reported: LEFT VENTRICULAR HYPERTROPHY (non-serious), outcome "unknown", described as "left ventricle was swollen"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "Her BUN, Kidney Cholesterol were elevated.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller got her Pfizer Covid booster shot weeks ago and took a xray last week. It showed that her left ventricle was swollen. Her BUN, Kidney Cholesterol were elevated. Added that, a year ago everything was fine and she has no heart condition. Asking if Pfizer has reports that it would be permanent. Response included Spoke as per document attached Myocarditis and Pericarditis. The observed risk was higher among males under 40 years of age than among females and older males. The observed risk was highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. Patient was asking where could she find more information regarding what she experiencing. Response included Referred caller to CDC.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist via representative refers to an 80 year old female patient. On 06-OCT-2014 the patient was vaccinated with her sixth dose of PNEUMOVAX23 (route, dose and lot # not reported). The dates that the other 5 doses of PNEUMOVAX23 were unspecified. No adverse effect reported. Additional information has been requested.
About one week after getting the Shingles vaccine, I had an outbreak of chicken pox. Two large pustules opened and several smaller ones which I still have at this date (4/3). No longer itching.
SkinRash Narrative: Employee developed a possible Delayed reaction to vaccine of rash;hives on elbows, knees, shoulders, and knees on 2/3/21. They seem to be shrinking and not as 3D per employee. Advised to follow up with PCP if gets worse or develops trouble breathing.
A red, sensative, hard rash  at the site of injection at about 3 inches in diameter. Does not itch.
Information has been received from a mother concerning her 14 year old daughter who on 11-JUL-2007 was vaccinated with a first dose of Gardasil. On 11-JUL-2007 the patient fainted. On 04-SEP-2007 the patient was vaccinated with a second dose of Gardasil. On approximately 04-SEP-2007, the patient experienced a seizure. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Upon internal review seizure was considered an other important medical event. Additional information has been requested.
Subsequent to receiving vax, the pt presented to clinic with varicella type rash and temperature of 100.4.
None - PENTACEL was accidently drawn up and administered to Pt instead of Hib. DTap was administered on the same day
Patient reported that 3 days after her first dose of Pfizer COVID-19 vaccine she experienced severe chest pain. She went to the ER and was worked up, exam normal. ER doctor told her that it could be related to vaccine but still recommended she get the second dose, saying that they could not guarantee this event would not happen again.
Full body rash from neck down. Legs had ?measles like appearance? and arms and hands were very red. Very itchy.  Already had a groin rash from yeast, being treated but that got worse.  Caused 2 trips to ER and dermatologist visit.  Treated with  topical and oral steroids, antihistamines. Much improved but still some rash remaining.
very mild case of Shingles; slight rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patients wife. The patient experienced a very mild case of Shingles and slight rash but no pain after receiving 1st dose of Shingrix. The reporter asked when it was safe for him to get second vaccine.
Child legs red slightly swollen and warm to touch. Instructed to use Benadryl cream and Benadryl liquid around the clock for 24 hrs. Repeat if worsens.
Lab confirmed covid; Lab confirmed covid; This is a spontaneous report from a contactable other health care professional. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ocrelizumab (OCREVUS). On an unspecified date, the patient experienced lab confirmed COVID. Caller stated, I can add that one of these patient's was a male, around 50, and obese. Quoted by HCP was OK- two ms patient now>1 month post second vaccine (both Pfizer) with lab confirmed covid. Both with medically significant illness, neither required hospitalization (one went to ER for shortness of breath and lowO2). On an unspecified date, the patient underwent lab tests and procedures which included COVID-19: lab confirmed COVID. The outcome of the event was unknown.  No further information was reported. Information about batch/Lot number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid 19 . The case will be reassessed once new information is available
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a male patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unkonwn. Additional information received: HAVRIX that was at 17 F was administered. No other information available. This case is one of the 2 cases reported by the same reporter for the same vaccine.
temperature excursion/vaccine were still valid to use; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of intercepted product storage error in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient did not receive Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced intercepted product storage error (Verbatim: temperature excursion/vaccine were still valid to use). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 The reporter stated that he/she did not know how to say it, like a temperature excursion and what happened was his/her data logger quit reading but they noted it very next morning and it stop reading it at 4 o'clock pm the day prior.  It did not show any excursions or anything but, we just need to make sure that our vaccine were still valid to use. The first one was Havrix or the Hepatitis A. It was followed by option 3 with the timing 8am to7pm on Monday to Friday.  The reporter was informed about the role of Pfizer drug safety and when probed to proceed with question reporter hung up the call abruptly.  The further probing could not be done as reporter hung up the call abruptly.  Thus, product details expiry date and purchase details were unknown. Hence, limited information was available over the call. The temperature excursion had occurred to Havrix and asked vaccine were still valid to use, which led to intercepted product storage error.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was not vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 subjects experienced not responding to therapy (please see case numbers A0962819 and A0962821-22A for the other 3 subjects).
Flu-like symptoms: shaking chills, 103.5F fever, extreme fatigue and dizziness (negative flu test);  left arm induration, redness and serve tenderness. For to ongoing cancer treatments, I was admitted to the hospital and was given high dose antibiotics ( including vancomycin) and  3L fluid boluses for dehydration.
EE received COVID Booster on 2-17-22 around 1600pm. EE went home after shift. At 4am she awoke to chills, sweats, migraine, and body aches. EE missed work on 2-18-2022.  EE received a Pfizer lot# FJ6369 in her Left arm.EE taking OTC medication Tylenol to relieve her migraine.
Fever 101.3, body aches, headache, diarrhea, sweating
causing distruction and death; This is a spontaneous report from a Pfizer-sponsored program Database Support from a non-contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced sleep at night that is causing destruction and death that Pfizer is causing.The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: causing distruction and death
Swollen, erythematous rt deltoid area, fever >102, malaise, prostration, generalized myalgias, ?confusion;
10/8 - achey, chills, fever. 10/9 - rash on right side of face 10/10 - under eye swelling and dark red
Initial report received from healthcare professional on 18 November 2014. A 3 patient (age and gender was not reported), whose medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (Batch number UT4993BA, expiry date 6 May 2015, site of vaccination and dose number was not reported) on an unspecified date. On an unspecified date, the patient had experienced 3 inch to 5 inch round, hard, red warm area around injection site. Lab investigations and corrective treatment were not reported. The patient required emergency room or doctor visit. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were reported as unknown. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
patient presented to emergency department on 11/29/21 with left lower extremity pain and redness patient tested positive for covid-19 on 11/26/21 patient was admitted for further management of sepsis patient expired on 12/6/21 due to severe sepsis
Swelling in left leg and painful injection site with excessive fatigure and swollen lymph nodes
Swollen arm 18x30 cm elbow to shoulder as marked and measured by Dr at Walk in Clinic. Red, Hot, and Painful. Moved down to elbow. Was prescribed antibiotic (cephalexin)  and probiotic (OTC) for 7 days. Rash and redness lasted for11 days.
Red, itchy, swollen (L) arm from deltoid to mid forearm (crossing elbow joint). Resolved after 2 days.
Presented to clinic appointment with dizziness, suspected to be vestibular neuritis.  Dr. requested filing VAERS report. Abnormal head impulse test suggests a peripheral lesion. Suspect vestibular neurities, possibly related to recent influenze vaccination.