chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure and mild asthma" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache that lasted 2 hours;  site of injection is sore but only to the touch( 2 days so far);  diarrhea lasted for only one day
Next morning 1/23 woke up with acute vertigo, dry heaves and chills.  Next day only dizziness when raising or lowering head.
On 01 Dec 2006, 57 days after receiving FluMist therapy, a 16-year old female patient with non-Hodgkin's lymphoma experienced a spontaneous abortion. The patient was a participant in the study and received study vaccine as either FluMist or placebo vaccine on 05 Oct 2006. The patient was administered FluMist as annual flu vaccine 10 Nov 2006 by her primary oncology attending physician. On 10 Nov 2006, the results of a routine urine pregnancy test were weakly positive. A repeated pregnancy test in the blood conducted on 13 Nov 2006 showed a positive result. The patient was estimated to be in the first trimester and the last menstrual period was not known. The patient's methotrexate therapy was stopped on 10 Nov 2006 and 6-mercaptopurine therapy was stopped on 13 Nov 2006, due to the pregnancy. On 01 Dec 2006, the patient experienced vaginal bleeding lasting for two to three days. A urine pregnancy test was negative on 01 Dec 2006. On 09 Dec 2006, the patient was seen in a local clinic where an ultrasound indicated that the patient had experienced a spontaneous abortion around 01 Dec 2006. The chemotherapy treatment with methotrexate and 6-mercaptopurine was resumed on 11 Dec 2006. The reporter assessed the event of spontaneous abortion as not related to FluMist therapy, but rather to the patient's methotrexate and 6-mercaptopurine therapy. (OMIC)
Around 8 hours after the shot, I developed a line of blisters about an inch long. It is very itchy. The blisters are still there and fluid inside and still very itchy.
Patient had bruising down the vaccinated arm about 6 hours after vaccination.  36 hours after vaccination he had bruising down the other arm.
Pt called to report that he started to have chest pains and flutters during rest approximately 8 days after 2nd dose of Moderna vaccine given in pharmacy.  Pt then was admitted to the hospital for 3 days following with unknown diagnosis but was told that his "blood was thick" and that his troponin level was elevated and he was not getting proper perfusion to the bottom of the heart muscle.  Pt states that he was told it was not a heart attack as there was no blockages they could find and they also ruled out pulmonary embolism.
Reported to OH today complained of pain, redness, warmth to left deltoid and, complained of itching on 1/6/08. States that morning noticed  symptoms, redness, warmth at injection site 2 3/4 " below site has area of redness Temp 97.9.
3/20/21: Sudden fatigue, body aches, malaise, sweating lasting throughout the day.  3/21/21 previous day's symptoms improved with some lingering fatigue but increasing manic symptoms, including perseveration, inability to focus, paranoia, manic anxiety, inability to make decisions, racing thoughts lasting throughout the day but clearing by the morning of 3/22/21.  SYMPTOMS VERY SIMILAR TO ADVERSE REACTION TO CANNABIS
On 04/02/2021 that night it began with headache, chills, fatigue, on 04/03/2021 body aches, nausea and upset stomach, stuffy nose, sore throat.-those symptoms latest till about the 5th. Headache and fatigue lasted for a couple weeks. I went to the ER on 04/06/2021-only stayed for 6 hours. On 04/09/2021 I woke up and could not hear out of my left ear, that latest for 6/8 hours. I went to an ENT on 04/12 and hearing was normal.
Information has been received from a physician concerning an 18 year old male who on 12-JUN-1992 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported).  On 7-JUN-1996, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported).  On 11-NOV-2009 the patient experienced mumps.  Lab results for 11-NOV-2009: IgM was negative, IgG was 3.3 and Serum Amylase was 221.  The patient was afebrile.  The outcome for mumps was not reported.  Follow up information has been received concerning an 18 year old male patient who on 12-JUN-1992 and 07-JUN-1996 was vaccinated with the first and second doses of MMR II (route, site, dose and lot number not reported).  On 16-NOV-2009, the patient experienced mumps (thought the date diagnosed was reported as 17-NOV-2009). The patient was afebrile and had L parotitis.  On 17-NOV-2009 a first blood work was performed with negative result and on an unspecified date an IgG and a serum amylase test were performed and the results were 5.88 and 97, respectively.  The outcome for mumps was not reported.  This is one of several reports from the same source.  No further information is available.
lot number FL8095 was initially opened but not diluted with 0.9% sodium chloride.    0.2 mL of pure Pfizer pediatrics  orange top (instead of diluted Pfizer pediatrics orange) was drawn and administered to patient at 1035.  Chain of command, patient's PCP and medication error coordinator were notified.   Patient's Shanda, was  contacted at 1450.  She reported patient was doing fine and had no complaints at that time.  RN explained the error to patient's mother, mother advised to closely  observe patient, and agreed to take patient to ER with any adverse symptoms.
Starting a week or so after receiving the vaccine, I developed severe diarrhea that persisted. I called the clinic on 04/01/2022 and they advised me to go to the ER. So, I went and they referred me to a gastroenterologist. The gastroenterologist did a colonoscopy and found Microscopic Lymphocytic Colitis. They started me on a course of steroids (budesonide) and I am still on it currently. I will be having an upper GI tract endoscopy. The nurse said sometimes this is caused by viruses and sometimes bacteria, but unsure in this case.
Redness and swelling at injection site day after injection (in left arm) and lasting 3 days. Starting on 4/22/2016: Fever of 103.4. Next morning rash started on face and spread to belly. Neutrophil count dropped to 1. WBC decreased.
This spontaneous report as received from a patient's mother refers to a 7 year old female patient. The patient's medical history included light symptoms of flu after receiving an unspecified influenza virus vaccine four years ago, it was reported as a mild case and the patient recovered quickly. On 05-FEB-2015, the patient was vaccinated with (Oka/Merck) VARIVAX, (route, anatomical location, dose number, lot # and expiration date were not reported) 0.5 ml to prevent chicken pox.On 08-FEB-2015, three days after vaccination, the patient developed chicken pox like rash all over her body. The patient was complaining that it was very itchy. On 08-FEB-2015, the spots were really red and bumpy. On 09-FEB-2015, the spots seemed to be smaller, flat and blended, and the patient seemed to be getting better. The reporter considered it as a mild case and the patient did not have a fever. There was no treatment given for the adverse event. There were none lab diagnostic studies performed. The patient did not seek medical attention. The outcome of the event was reported as recovering/resolving. The relatedness between the event and the vaccination with (Oka/Merck) VARIVAX was not provided. Additional information has been requested.
101.1 degrees fever; arm was sore/arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2020, the patient received the 2nd dose of Shingrix. On 19th May 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 20th May 2020, the patient experienced fever. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were reported as follows: On 19th May 2020, the patient received 2nd dose of Shingrix. On 19th May 2020 afternoon, the patient experienced arm at the site of short had been sore and at night the patient experienced arm pain. On 20th May 2020, 1 day after receiving the vaccination the patient experienced fever 101.1 degree F and 101.4 degree F.
patient received booster Pfizer and is under 18 years of age- Sheis almost 17 years old.  patient had no adverse reaction. Observed for 30 minutes as she does have other medication allergy.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289666, 2018SA289702 and 2018SA289688 (same reporter). This case involves twelve-year-old male patient who was vaccinated with a dose of IPOL (lot N1K931M via unknown route in unknown administration site) on 18-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that nine doses were indeed given out of an opened multi dose vial of IPOL after the temperature excursion which reached 32.76 F for 19 hours 44 minutes. It was not known whether patient had any adverse event. 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 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. List of documents held by sender: none.
Expired Hiberix administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a infant patient who received Hib (Hiberix) (expiry date 23-MAR-2023) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired Hiberix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-APR-2023 The patient received one dose of expired vaccine Hiberix, which was 3rd dose of the series. Patient received a dose of Hiberix, which was expired on 23rd April 2023, which led to expired vaccine used. The reporter did not agree to follow up from GlaxoSmithKline.
On 5/23/2023, I felt a little run-down. I developed nasal congestion and the beginning of a sore throat. On 5/24/2023, each of the symptoms got worse. On that day, I took TYLENOL, which helped. That evening, I developed a fever. The TYLENOL helped reduce it, but as soon as the TYLENOL wore off after about six hours, the temperature would spike again. On 5/25/2023, I took a home antigen test in the morning and got a positive result. I began resting, and my fatigue, nasal congestion, chest congestion, cough, and sneezing got worse. I also ran a fever of about 101. I continued to take TYLENOL that day, and it continued to help my symptoms. I also lost my senses of taste and smell. I emailed my doctor for guidance, and he advised me to continue taking TYLENOL and resting. He also told me to hold off on taking PAXLOVID. On 5/26/2023, the symptoms continued, though the chest congestion got worse. On 5/27/2023, I had profound fatigue. I took a nap in the early afternoon, and within about an hour, I woke up with a wet cough. It produced a lot of phlegm. I had some trouble breathing, so I immediately sent another email to my doctor. My doctor then advised me to start the PAXLOVID regimen immediately. I was on PAXLOVID for five days afterwards. Within the first 24 hours of beginning the PAXLOVID, my symptoms began to improve. I still had all the symptoms, but they were now less intense. My main issue was then the fatigue, because it continued in its intensity. Within 12 hours of starting the PAXLOVID, I had profound side effects that included persistent diarrhea, headache, and loss of appetite. The side effects continued for the next four days that I took the medication. On about 6/1/2023, I took another home antigen test and got a negative result. At this point, my symptoms were similar to those of a mild cold and included nasal congestion, minor sore throat, and continuing loss of appetite. I continued to isolate and rest during this time. I felt better, but I still had profound fatigue. On 6/4/2023, I took another home antigen test and got a positive result; I had a rebound. On the evening of 6/5/2023, I took another test and got a negative result. I took a test this morning, and the result was still negative. At the time of this writing, I continue to experience fatigue and diminished smell and taste, but I feel better than I did earlier during my illness.
The decedent's condition didn't get better. 2 days after the vaccine, he was dead.
Left arm very swollen/red/tender to touch. Knot spreading to armpit area. Describes as very painful.
1-2 minutes after injection, patent went limp, fell to floor and had a 5-15 second seizure and then awoke quite tired.
Night sweats; Bad sweating; Bad itching in hand; Severe Chills; Fever; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VACCINATION SITE PRURITUS (Bad itching in hand), CHILLS (Severe Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VACCINATION SITE PRURITUS (Bad itching in hand), CHILLS (Severe Chills), PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 08-Apr-2021, HYPERHIDROSIS (Bad sweating) was resolving. At the time of the report, NIGHT SWEATS (Night sweats), CHILLS (Severe Chills), PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache) was resolving and VACCINATION SITE PRURITUS (Bad itching in hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-071399 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071399:Husband case
Chills and muscle aches that lasted for 5 or 6 hours. I bundled up, rested, and drank lots of fluids.
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 12-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning her 72 year old female mother with tachycardia and no drug reactions or allergies who on 07-JUL-2010 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (Lot# 664668/0153Z). Concomitant therapy included TAMBOCOR. On 12-JUL-2010 the patient began to have muscle pain in the legs, groin and back. On 13-JUL-2010 the patient broke out in a rash in the legs, groin and back. The patient had swelling, itchiness, warmth, redness, inflammation and blistering in legs, groin and back. The rash on the back looked "like a large patch". The affected area in the groin and on the legs looked "like little blisters". At the time of the report, the patient was not recovered. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The patient's muscle pain, rash, swelling, itchiness, warmth, redness, inflammation and blistering in legs, groin and back were considered to be disabling by the consumer. Additional information has been requested.
Patient called three days after getting Prevnar 13 vaccination to report skin rash (small bumps) on her arms, chest, and abdomen.
Red spot on first R. knee, then L. knee, then R. anterior thigh.  These developed into cellulitis.  Initial pustule was scraped off by patient.
Child w/large area of erythema over (L) deltoid consistent w/local reaction to immunization (DTaP). IPV site -  not red.
Client reports redness at LRL. Vital signs initiated, WNL. Benadryl 25 mg IM administered. Redness resolved.
On May 2, I experienced some dizziness around 5 pm. Today May 3rd again at 5 pm, experiencing light headed and dizzy
vaccination site red; vaccination site swollen; vaccination site hot; vaccination site itchy; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that:  A 76-year-old female patient received dose bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: E19264 but it could be EL9264, and expiration date were not reported) via a unspecified route of administration in left arm, on 05Feb2021 at 14:30PM (at the age of 76-year-old) as single dose for COVID-19 immunization. The patient was not administered an additional vaccine on same date of the Pfizer vaccine. The concomitant medications included a Proto-nix used for Barrett's oesophagus, Celexa used for Anxiety, Rosuvastatin used for Blood cholesterol increased, and baby Aspirin for a while.  On 14Feb2021 at 9PM the patient had a huge reaction at the injection site where it was red, swollen, hot, and itchy. The reaction is in the left arm and that is where she received the injection. It is still hot and swollen and red. She has no fever. On 16Feb2021 for the first time she took a little Tylenol. She is due in 10 days for the next dose. The outcome of event is not recovered.  Follow-up (16Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 76-year-old consumer reported a significant information regarding suspect drug and events.
This spontaneous report as received from a consumer refers to a female patient of unknown age.    On 20-JUL-2017 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous in the left arm for prophylaxis. In July 2017 the patient experienced injection site swelling, injection site pruritus and musculoskeletal stiffness. The outcome of musculoskeletal stiffness, injection site pruritus and injection site swelling was reported as recovering/resolving. The causality assessment was not provided. Additional information has been requested.
HYPOXIA 11/14/2022 & 11/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
2 wks following DTP/OPV vax, child developed hives which have persisted on & off for 2 mon.  Dermatologist suggested that hives might be due to vax since no other cause was found.
Vomiting, temperature of 100.3, headache, body aches, chills, diarrhea. Started at 4:30am 12/1/21 with vomiting, and headache. Vomiting stopped at 5:30am still had stomach pain. After the vomiting stopped body aches, chils, temperature, diarrhea and headache continued until Thursday 12/2/21. As of 12/3/21 still complaining of headache and lethargy.
Heavy chest; Hypotension; Trouble breathing; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of chest heaviness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced chest heaviness, raised rash, hypotension and difficulty breathing. The patient was treated with epinephrine (Epi Pen). On an unknown date, the outcome of the chest heaviness, raised rash, hypotension and difficulty breathing were recovered/resolved.   The reporter considered the chest heaviness, raised rash, hypotension and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received the shingrix shot about 2 years ago and was advised not to take the second shot (underdose) due to adverse reactions. The patient stated that minutes after receiving the vaccine, she experienced a heavy chest, hypotension, raised rash (which lasted for 24 hrs), and trouble breathing.  She eventually took an epi-pen and began to feel better.  All her symptoms had resolved at the time of reporting.  The patient did not consent to follow-up and no health care professional was provided.
Patient is experiencing a red, raised circular rash, about 2 inches in diameter around the site of administration on the shoulder. She was informed this is an expected reaction in a small percentage of shot recipients per the package insert. She was advised to ice the area twice to three times daily and continue w/ her regimen of an antihistamine. She has not reported any pain, tenderness or soreness at the area. Finally, she was advised to reach out to pharmacy and/or PCP if not significantly dimished or resolved w/i 72 hours.
No adverse events have been reported by the patient, family nor the doctor. it has been about 2 weeks since three vaccines have been administered. (2 Pfizer and one moderna).
Redness to left arm at sight of injection. Pt complained of pain to arm. Dyspnea and rash- per ER notes.