chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the patient's wife refers to her 60 years old husband with a medical history included esophageal cancer no drug reactions or allergies. On 01-JUL-2015, the patient was vaccinated with one dose of ZOSTAVAX, (dose, route, lot number and expiration date were not reported). The patient's concomitant therapies included FLOMAX and REMERON. On 09-JUL-2015, the patient developed shingles after received ZOSTAVAX. The reporter stated that the shingles developed on his abdomen area and have already begun to blister over. The patient sought medical attention by office visit and was treated with unspecified antiviral medication. No laboratory diagnostic tests were performed. At the time of the report the patient was recovering from herpes zoster. Additional information is not expected because the physician cannot be contacted.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
I developed a rash on my upper left arm near where I received the vaccine.  It was about  3 inches long and 2 inches wide. Initially it was red, warm to the touch and itchy. Sometimes it hurt.  It has since gotten much lighter, sometimes it itches and it is barely warm. Once in awhile I feel  very mild pain where the rash is.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 89 with afib, CAD, DM, HTN, HLD. Patient not receiving much care and there is not a lot of documentation on his chart. Details surrounding his death are unknown based on chart review.
Redness, swelling 9 cm x 5 cm within 10 minutes of administration.  16 mL Benadryl Elixir given.  (1mg 1kg 1 dose).  No breathing difficulty.  Within 30 minutes post Benadryl redness decreased to 6 1/2 x 4 1/2 cm.
Information has been received from a physician's assistant concerning a 15 year old female who on 14-APR-2009 was vaccinated with second dose of GARDASIL (dose and route not reported, lot number 658563/1063U). The physician's assistant reported that after receiving the second dose, on the same day (14-APR-2009), the patient experienced congestion, hives and a rash on her face. The physician's assistant reported that the next day (15-APR-2009), "everything was cleared up and the patient was fine". The patient sought medical attention by calling the physician. Additional information has been requested.
a 68 year-old male who presented to the Emergency Department with complaints of difficulty breathing and shortness of breath associated with oxygen saturation levels of 86% as measured with his home pulse oximeter. He reports that his wife is COVID-19 positive and he too resulted positive 3 days previously with use of a home COVID-19 test kit. In addition to breathing problems he endorses recent onset of lethargy and fatigue, cough, and chills. He has a complex medical history notable for receipt of a liver transplant in 2019, asthma, type 2 diabetes, osteoarthritis, obstructive sleep apnea night, hypothyroidism, and hypertension. This patient received a COVID-19 bivalent vaccine booster on the day of symptom onset. He was admitted to hospital for acute hypoxemic respiratory failure. He is currently in isolation on supplemental oxygen. He is being treated with dexamethasone 6 mg daily for an anticipated duration of 10 days, remdesivir 200 mg IV once followed by remdesivir 100 mg IV daily for 4 days, antitussive and as-needed analgesic medication, as well as his usual immunosuppressant and other maintenance medicines.
Initial report received from a health care professional on 04/11/2006. A 33 year old female patient with a significant history of allergies developed swelling of her left upper arm, swelling of her face, left cheek and jaw, numbness and vomiting nine hours after receiving the intramuscular injection of Adacel, lot number C2454AA (expiry date 06/28/2008) in the left deltoid on 04/10/2006. The patient received in concomitant the intramuscular injection of Hepatitis B vaccination (lot number D040F). Site of administration not reported. Per reporter the patient had no illness at the time of vaccination. She was seen by a physician and treated with Motrin. At the time of this report the patient had not recovered.
pt received COVID vaccine on 8/26/21; presented to ED on 9/11/21 with SOB; diagnosed positive for COVID; placed on 100% BiPAP and eventually required intubation, proning and paralytics; developed a tension pneumothorax and bacterial pneumonia, septic shock; condition worsened; pt placed on comfort measures and she expired in the hospital
This spontaneous report as received from a certified medical assistant, refers to a 12 month old male patient. He had no pertinent medical history, drug reactions or allergies and his concurrent conditions were not reported. On 29-APR-2016, the patient was vaccinated with VARIVAX, subcutaneously, in the leg (which had a lot # reported as L046885 and an expiration date of 23-NOV-2017; however, dose and dosage number were not reported). On the same day, immediately after the vaccination, the patient developed redness and swelling at the injection site. Therefore, he was administered BENADRYL and treated with an ice pack. One and a half hours later, the events resolved. Subsequently, on 09-MAY-2106, when the patient returned for follow up, the redness and swelling at the injection site had returned along with the formation of a hard lump at the same site. No laboratory diagnostic studies were performed and no product quality complaint was involved. At the time of reporting, the patient had not recovered from the redness, swelling and the hard lump formed at the injection site. Moreover, the reporter did not provide any causal relationship between the events and the vaccination with VARIVAX. Additional information has been requested.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: patient called and said she ended up with an infection at injection site and is on antibiotics
8 - 10 hours post vax, pt developed night sweats and fever for two nights. Additionally pt experiences ached and numbness of the right shoulder muscle only which were continuous over several weeks.  These symptoms lessened to occur only in the evening and as of 11/15/1999 they occur only if the arm is used quite often. Pt denied weakness in the right arm or hand and denied numbness anywhere else.
Information has been received from a consumer concerning her 17 year old daughter who in 2007 (also reported as "around 2007") was vaccinated with a "full series" of GARDASIL (lot #, dose and route not reported). There was no concomitant medication. In early 2009 the patient was having "shoulder pain and a snapping scapula". The patient sought medical attention by office visit. The mother reported that an electromyogram was performed by a neurologist indicated possible amyotrophic lateral sclerosis (ALS) or Muscular Dystrophy. At the time of the report, the patient had not recovered. Upon internal view, possible amyotrophic lateral sclerosis was determined to be an other important medical event. No further information is available.
Provider d/c note:  "41 yo female who presented for nausea and vomiting that was bloody today. She was diagnosed with Covid 8 days ago. She complains of fatigue and nausea during these recent days. Since she wasn't able to keep things down, she has not been taking her medications including insulin.  (HPI per Dr)   Hospital Course: No notes on file patient is a 41yr old female with a history of HTN, DM, Asthma, Depression, Hyperthyroidism who presented with HONK, intractable N and V, oropharyngeal thrush. Today she is seen sitting in chair, says pain in throat is horrible.   Intractable N/V/ hematemesis - resolved.   Oropharyngeal thrush  Dysphagia/Odynophagia secondary to Esophagitis, Gastritis and Duodenitis - on diflucan. EGD done 8/24/22 revealed esophagitis, gastritis, duodenitis but no candida like plaques appreciated. Patient is tolerating soft diet.  Biopsy revealed Inactive mild chronic gastritis and Acute ulcerative esophagitis. GI recommends PPI BID x 6 wks. Continue PPI q12hrs x 6 weeks followed by once daily dosing, continue fluconazole to complete a two weeks course of treatment, f/up pathology, f/up in GI office to discuss repeat EGD to evaluate for healing of esophagitis. GI signed off. "
2 weeks after the vaccine, she developed a sensation of pain in her thyroid gland, mild hoarseness, and then within a week she was having chest pains, heart palpitations, and hot flashes.    She initially presented to me on 6/15/22 and was reporting  severe fatigue x 2 months, hard to even get up.    Overwhelming sense of exhaustion.    Also she had arm soreness for a couple days at injection site starting the day after the vaccine.    Her baseline fatigue since age 41 after birth of her son is 4-5/10 but after vaccine had increased to 8-9/10.    Never has felt this fatigued in the past.     Labs on 6/15/22 revealed she was hyperthyroid with TSH <0.01 and free T4 1.72 (RR 0.7 to 1.8).   Thyroid stimulating antibodies were elevated.     Baseline TSH August 2021 was 0.65.    Thyroid function studies were also normal in 2017 and 2015.    Methimazole was started for Graves hyperthyroidism and on follow-up 8/1/22 her TSH had improved to 0.02 and her symptoms had largely improved except for ongoing thyroid tenderness.   Endocrinology consultation pending for Graves Disease which I believe onset was most likely triggered by the Pfizer-BioNTech COVID-19 vaccine given temporal onset and also other case reports in the literature of new onset Graves or exacerbations of existing Graves with COVID-19 mRNA vaccines.
After taking the shingles vaccine I suffered a 50% hearing loss in my right ear. My ENT prescribed # shots of steroids in my ear as well as oral medicine [steroids] I also have been involved with HBOT therapy at my own expense
skin reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced SKIN REACTION (skin reaction). At the time of the report, SKIN REACTION (skin reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided
During my second dose, I had a reaction after ~ 1-2 mins after getting the shot. I had HBP (for the first time) and tachycardia, I felt like my body is going to experience an episode of syncope but I was able to ask for help prior.   On my third dose, did not had immediate reaction but have been developing a lot of unknown causes of itching hence hives-like rash.
Starting about 12 hours post injection, teeth chattering chills lasting 3 hours and Dull headache lasting about 18 hours. Sore arm at injection site for about 2 days. No fever. Took 1 Aleve when chills started.
Sore throat; Nauseous; Red arm; Red mark that is about two inches in all the way around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nauseous), INJECTION SITE ERYTHEMA (Red arm) and INJECTION SITE RASH (Red mark that is about two inches in all the way around the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K208 and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nauseous), INJECTION SITE ERYTHEMA (Red arm) and INJECTION SITE RASH (Red mark that is about two inches in all the way around the injection site). On 07-Feb-2021, NAUSEA (Nauseous) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), INJECTION SITE ERYTHEMA (Red arm) and INJECTION SITE RASH (Red mark that is about two inches in all the way around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Fatigue (ongoing), nausea (1 hour), hives (5 hours)
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 78-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 77, in right arm, on Feb 3, 2021; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6201), in right arm, in 2021, single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing). The patient's concomitant medications not reported. The patient had pain in extremity (her arm was just a little sore with the first 2 doses), onset 2021, with outcome of unknown. Additional information:  Her arm was just a little sore with the first 2 doses. She had difficulty reading the handwriting on the vaccination card. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Seizure-like activity roughly 1 to 2 minutes after vaccination, lasted roughly 30 seconds
Soreness on 2nd day, itching started on 4th day and redness started on 5th day as a quarter size and has spread to size of my palm
Initial report received from a health care professional on 20 January 2012. This case involves 1 of a cluster of 4 patients who had received FLUZONE INTRADERMAL (lot number UT4163AA) and experienced reactions. Information regarding the other 3 patients is captured in case numbers 2011-10556 (serious case), 2012-00783 and 00784 (both non-serious cases). A 51 year-old male patient had received a right arm dose of FLUZONE INTRADERMAL (lot number UT4163AA) on 27 October 2011 at 5:00 pm and the following day experienced extensive swelling of the vaccinated limb. It was not reported whether the patient required any medical evaluation or treatment. The patient recovered on an unspecified date. Documents held by sender: None.
intermittent chest pain (stabbing pain); The severity of pain was described as high as 7 out of 10; Pain is not exercise induced (seems random); The pain is around fourth rib and lasts for 15 minutes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 23-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Batch/lot unknown=Unknown), administration date: Nov2021, when the patient was 23 years old, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "intermittent chest pain (stabbing pain); The severity of pain was described as high as 7 out of 10; Pain is not exercise induced (seems random); The pain is around fourth rib and lasts for 15 minutes". The events "intermittent chest pain (stabbing pain); the severity of pain was described as high as 7 out of 10; pain is not exercise induced (seems random); the pain is around fourth rib and lasts for 15 minutes" required physician office visit. It was unknown if therapeutic measures were taken as a result of chest pain. Additional information: The patient had not been exercising. Patient reported had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Urticaria however startup 4.5 days after s/b with urticaria multiforme and edema of joints.
Narrative: HEADACHE UPON AWAKENING SINCE SHOT BUT DISSIPATES WITHIN A FEW HOURS WITHOUT MEDICATION,INTERMITTENT ALL WEEK Symptoms: Headache Treatment
Erythema, warm to touch, mild edema, full ROM, mildly pruritic (19 1/2 cm length x 14 cm circ. gone by 1/12
Elevated temperature; uncontrolled  muscle twitching in upper body. Involuntary shaking.
This case was reported by a nurse and described the occurrence of accidental overdose in a 12-year-old male patient who received FLULAVAL (batch number 9A3ZM, expiry date 30th June 2015). Co-suspect products included FLUMIST (batch number CJ2129, expiry date 5th January 2015). In 2014, the patient received FLULAVAL (unknown) and FLUMIST (unknown) at an unknown dose and frequency. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information received on 17 November 2014: The patient was inadvertently administered 2 Flu vaccines in the same visit.
Splenomegaly; bloating/felt like pressure; night sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of NIGHT SWEATS (night sweats), SPLENOMEGALY (Splenomegaly) and ABDOMINAL DISTENSION (bloating/felt like pressure) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced NIGHT SWEATS (night sweats). In May 2021, the patient experienced ABDOMINAL DISTENSION (bloating/felt like pressure). In June 2021, the patient experienced SPLENOMEGALY (Splenomegaly). At the time of the report, NIGHT SWEATS (night sweats), SPLENOMEGALY (Splenomegaly) and ABDOMINAL DISTENSION (bloating/felt like pressure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that the same night that she received the second vaccine shot, she experienced profuse night sweats. The patient reported that in early May 2021, she began to experience pressure and bloating. She said that In June 2021, she had an ultrasound that diagnosed splenomegaly.  No information regarding concomitant medication was provided.  No information regarding treatment was provided.
Patient received his first shot of the Pfizer COVID 19 vaccine on 8/8/21. Patient is a 16 year old male who currently does not take any medications or have any medication allergies. Patient saw his pediatrician for an annual physical on Friday 8/6/21 and received a meningitis vaccine on that date (unsure on which brand). Per patient's mother, they had discussed receiving a COVID-19 vaccine at that visit. Discussed that per the CDC, COVID-19 vaccines and other vaccines may be administered the same day, as well as within 14 days of each other. About 2 minutes after receiving the vaccine, he reported feeling dizzy and was sweating. Patient sat down and this helped with his dizziness. Patient drank a bottle of water. Patient did not report any shortness of breath, itchiness, trouble breathing, hives, or other signs of anaphylaxis. This pharmacist took patient's blood pressure approximately 5 minutes later and his blood pressure was ~100/60 and heart rate 51. Patient and his mother waited in the pharmacy for an additional 20 minutes. His dizziness had subsided, and he was no longer sweating. This pharmacist took his blood pressure prior to patient and his mother leaving. At this time, his blood pressure was 110/60 and heart rate 56. Patient was able to walk around with no dizziness concerns. Discussed this adverse reaction with patient and mother, and encouraged them to seek care if any additional issues arise. Stated that I would report this adverse event to VAERS and contact patient's pediatrician Dr on Monday 8/9/21. Both patient and mother confirmed understanding.
Fever (101.4), body/joint aches, headache, chills, weakness/fatigue, sore stiff arm (injection site) took Tylenol every 4 hours better in 48 hours
Oral mucosa felt particularly sensitive to a beverage I was drinking. The sensation was similar to that of when tongue scalded. The symptoms progressed over the next few days with my teeth being very sensitive, my lips severely chapped, a circular patch of dermatitis appeared on my right cheek and my oral mucosa and tongue developed a severe burning sensation and became excessively dry.  I could not drink anything acidic, carbonated or very hot. I could not eat spicy foods or anything that was very dry or salty. I was tested for Sjogren's when my RA was diagnosed and the test was negative. I have never had any symptoms of Sjogren's before the development of this. I did not take my DMARDs for two weeks before getting the vaccine and for two weeks after as recommended to achieve maximum benefit. The burning sensation has dissipated but the other symptoms continue and are significantly diminishing my quality of life.
Vax given 4/2/03 - PT reported punctate papules on abdomen on 4/4/03.
On 8/30/2022 in the evening, I was not feeling well. I was sneezing, I had congestion. I was coughing. I had congestion in my chest and in my nose. I felt cold. I did not have a fever. I was extremely tired. I just felt very cold. I took a COVID-19 home test and tested positive on 8/31/2022. I called my doctor on 8/31/2022 and she prescribed PAXLOVID for the 5 days and I took it for the 5 days. I had a negative COVID-19 test on 9/10/2022 and my symptoms resolved.
pt showed signs of Bells palsy 2 days post vax subsequently has full blown Bells palsy;
Rash 24 hours after administration with Urticaria (diffuse) and localized vasculitic changes (mild) - right lower leg.
Misadministration of 1st dose of Rota virus vaccine (ROTATEQ) at 6 mnths of age. No reported adverse yet.
I did not have an adverse reaction to the vaccine. I was diagnosed prostate cancer in 11/2021. I had prostate surgery on 01/2023. As of today, I am not receiving any treatment and I am feeling good.
Patient developed a rash Saturday evening. The rash is not localized to the site of injection. It is all over his body. Patient stated that he went to see his doctor today 08/21/17 and the physician felt that the rash was due to an allergy to the vaccine.