chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; couldn't catch her breath; She had fluid around her lungs; passed away; healthcare facility; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away), PNEUMONIA (pneumonia), DYSPNOEA (couldn't catch her breath) and PLEURAL EFFUSION (She had fluid around her lungs) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (couldn't catch her breath) (seriousness criterion hospitalization). On 27-Jul-2021, the patient experienced healthcare facility (healthcare facility). On an unknown date, the patient experienced PLEURAL EFFUSION (She had fluid around her lungs) (seriousness criterion medically significant). On 29-Jul-2021, PNEUMONIA (pneumonia), DYSPNOEA (couldn't catch her breath), PLEURAL EFFUSION (She had fluid around her lungs) and healthcare facility (healthcare facility) outcome was unknown. The patient died on 29-Jul-2021. The reported cause of death was Pneumonia, couldn't catch her breath, she had fluid around her lungs, she was on the floor and healthcare facility. It is unknown if an autopsy was performed.            Concomitant products were not provided. Treatment medication were not reported. The patient had pneumonia and couldn't catch her breath. She was on the floor, and then the emergency took her to the hospital on 25 Jul 2021. She had fluid around her lungs. The following day on 27 Jul 2021, the patient was sent to healthcare facility and then she died early morning on 29 Jul 2021.  Company comment: This is a case of death in a 82-year-old female patient who died 7 days after receiving first dose of vaccine. The patient experienced pneumonia, pleural effusion and dyspnoea due to which she was hospitalized but discharged to healthcare facility two days later where she passed away. Very limited information has been provided at this time. Further information will be requested.; Sender's Comments: This is a case of death in a 82-year-old female patient who died 7 days after receiving first dose of vaccine. The patient experienced pneumonia, pleural effusion and dyspnoea due to which she was hospitalized but discharged to healthcare facility two days later where she passed away. Very limited information has been provided at this time. Further information will be requested.; Reported Cause(s) of Death: pneumonia; couldn't catch her breath; She had fluid around her lungs; She was on the floor; healthcare facility
Pt brought in to clinic by mother states swelling at injection site. Thigh assessed and erythema and induration noted greater than 3.5". Site marked with surgical pen. Pt tender to touch. Pt's mother advised to use cold compresses as needed and to take MOTRIN suspension for pain. Pt scheduled for follow-up on 1/22/19.
patient received Quadracel vaccine via subcutaneously instead of intramuscularl/no AE; Initial information was received on 29-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical information under reference number - 00702552).  This case involves child patient of unknown age and gender patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] via subcutaneously instead of intramuscularly (Incorrect route of product administration).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 26-Jul-2021, the patient received first dose (once) 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA and expiry date 26-Aug-2022) via subcutaneous route at the left deltoid for prophylactic vaccination.  It was reported that, "Do they need to receive a second dose for immunity?"  It was case of an actual medication error due to inappropriate route of vaccination (latency was on same day)  At the time of report, no adverse event was reported.  There were no laboratory data/results available.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician and the pt's mother concerning a 19 month old female who had no medical history who on 11Apr2003, at 1000, was vaccinated in the left vastus lateralis with the second dose of varicella virus vaccine live (second dose given due to clinical error in recording first dose given on 20Sep2002). There was no concomitant therapy. On 28Apr2003, the pt presented to the physician's office with diarrhea and vomiting. A diagnosis of gastroenteritis was made. The pt's mother also reported that in April 2003, for over a week, her daughter also developed a fever and a few spots on her skin. As of 02Jun2003, the pt was without complaints. It was also noted that the pt did not have any problems after her first dose. Additional information is not expected.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022 at 12:16 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022 at 12:16 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ethnicity of the patient was reported.  Concomitant medication of the patient was not reported.  Vaccine administration time was mentioned as 12:16:18.  No treatment information was provided by the reporter.
nose bleed, never before had one in lifetime, difficulty breathing even with oxygen tank carried in car, almost got in car accident,  extreme stress - drove to emergency room at hospital, they did nothing. Security kicked me out before I was seen by physician.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a non-hcp. This case involves a two months old female patient who was vaccinated with a dose of FLUBLOK QIV (Lot number: QFAA1831, Exp. Date not reported) via intramuscular route in the right thigh on 15-Oct-2018. Concomitant medications included PENTACEL for Immunisation. Lot number was reported as qfaa1831. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 13-APR-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster.  On or about 22-AUG-2016, the patient was treated by a physician at a clinic for a painful and blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles. The patient continued to outbreak after being treated for this condition, and she has been prescribed a continuous dose of valacyclovir hydrochloride(VALTREX) to curb her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.  Additional information has been requested.
Migraine/ The patient deal with migraines and it progressively made it worse for 4 days after; headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 19Apr2021 at 16:30 (at the age of 22 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included migraine from an unknown date. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 19Apr2021, the patient experienced migraine/headache. It was further reported that the patient deal with migraines and it progressively made it worse for 4 days after. Unspecified medical treatment/shots was received in response to the events. Events resulted to doctor or other healthcare professional office/clinic visit. Since vaccination, the patient has not been tested for COVID-19. The patient did not recover from migraine but was recovering for the event headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/19/2021  8:53 am - got the vaccine 10:00 am - my lips became numb, then the tip of my tongue, tip of my nose, my chin, my forehead, then my cheeks; bp was 172/98 and heart was palpitating; took a Pepcid and benedryl 11:00 am - went to ER to be monitored 4:00 pm - the back of my throat starting tingling and becoming numb; I took Pepcid and benedryl  10:00 pm - took another Pepcid and benedryl   1/20/2021 6:30 am - I took a Pepcid and benedryl.  1:25 pm - headache, my chin, tip of my nose, left cheek, forehead is numb; I took a Pepcid and benedryl 10:15 pm - bottom lip started getting numb  1/21/2021 8:50 am - bottom lip is tingling, tongue is numb, cheeks are tingling; I took a benedryl and Pepcid   1/22/2021 11:00 am - numbness in my cheeks, chin, eyebrows 11:50 am - headache 1:50 pm - numbness in the tip of my nose and moves to cheeks, chin, lips, forehead
numbness in hands & feet, SOB, heart palpitations;conditions have since subsided;pt has numbness in rt hand & foot periodically
Pt has develop intolerance to activity, c/o chronic shortness of breath, heart racing, near syncopal, vision disturbance. Pt has also developed ulcerative colitis with anemia.
Patient reported injection site, red, tender and swollen.  Pt spoke with at Teledoc and reported her symptoms.  He diagnosed thisas a c as a cellulitis and prescribe Doxycycline 100mg X7 days
Pt received vaccine and upon walking to waiting area he fainted. This occurred about 5 minutes after the vaccine. Pt felt fine after about 20 minutes and left with his mom. He was advised to seek medical evaluation since he fainted while walking, mom declined ambulance option.
pt recvd vax;4 hrs later, turned white, eye lids fluttered, limp; episode lasted 5-6 mins; no tx;
Patient developed subcentimeter raised maculopapular lesions on chest, trunk and extremities with fever and irritability post MMR, VZV, Hib, PCV13 injections.
he felt sleepy afterwards; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (he felt sleepy afterwards) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (he felt sleepy afterwards). At the time of the report, SOMNOLENCE (he felt sleepy afterwards) outcome was unknown.            No concomitant medications were reported. The patient received all 3 vaccines from Moderna, and he did great on those vaccines except he felt sleepy afterwards. No treatment medications were reported.   This case was linked to MOD-2023-720962 (Patient Link).
Starting the evening of 1/5/2021,  week after shot, the injection site is red, swollen, itchy and hot
Mother called unit on 11/17/00 and reported child had broken out in a rash all over. Upon questioning mother stated arm was swollen. Advised to bring child to ER.
pt recv 1st dose of vax on 5apr93;same day,devel a local round red rxn "the size of a nickel" at inject site;10may93 recv 2nd dose & devel similar rxn approx 8" in size;recovered;2mar94 lab test revealed HBs antibody neg;
patient presented to emergency department on 11/6/21 with headache and shortness of breath. he does he developed a fever and head congestion the last week of October and received monoclonal antibodies on November 1. he states he aches all over and has had a cough. no pain with breathing patient tested positive for covid-19 on 10/29/21 patient did not require treatment for symptoms associated with covid-19 infection patient was hospitalized for the pneumonia on 11/16/21 and was discharged home on 11/8/21
Early AM 6/16/21: I began noticing petechia on my feet. A bloody sore developed on my lip and my mouth was bleeding a little.  Late afternoon 6/16/21: The petechia moved up my legs and the bleeding in my mouth hadn't stopped. I was incredibly tired.   6/17/21: The bleeding in mouth worsened. I was having to walk around with gauze in my mouth to control the gum bleeding. More big, black, bloody sores developed in my mouth. The petechia was now covering most my body, including inside my ears and mouth.   6/18/21: I was no longer able to eat without sever pain. I was bleeding profusely when I urinated. Petechia had moved into my eyes. I was incredibly fatigued and I had a migraine that was progressively getting worse over the past 3 days. My mother rushed me to the ER at noon. I was admitted to the hospital within 30 minutes of arriving. They began running tests immediately. I lost track of the amount of blood they took to test. I received a CT Scan and MRI to ensure I wasn't bleeding from my brain or had a stroke. By 7:30PM I was in the main hospital. I was given a COVID test at this time. They informed me that my platelet count had dropped to 5,000 and they would be giving me bagged platelets(1 bag)  and IVIG (8 glass bottles).    6/19/21: I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 9,000. That evening I had another dose of 7 glass bottles of IVIG.   6/20/21:I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 125,000.   6/21/21: I was released from the hospital due to my platelet count continuing to go up. It was up to 400,000. I was given a prescription for one more dose of Dexamethasone, Sumatriptan for my migraines and told to continue taking B12.   7/1/21: Had a follow up appointment with the hematologist from the hospital and I was informed my platelet count was okay but that I am now anemic.
HYPOXIA 3/30/2023 HX OF ATRIAL FIBRILLATION HYPOXIA 3/30/2023 ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE WO ANGINA HYPOXIA 3/30/2023 WEAKNESS OF LEFT ARM HYPOXIA 3/30/2023 CLAUDICATION DUE TO PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE
Information has been received from a a registered nurse concerning an 18 year old female patient, who on 01-JUL-2010 was vaccinated with a first dose of GARDASIL (Lot # unknown), and on 01-SEP-2010 was vaccinated with a second dose of GARDASIL (lot # unknown). The nurse reported that on 02-SEP-2010 the patient developed fever 103.5 degrees Fahrenheit, blisters on the tongue and inside the mouth with difficulty swallowing. Therapy with GARDASIL would be discontinued. On 06-SEP-2010 the patient recovered. The patient sought unspecified medical attention. Follow-up information was received from the registered nurse, who reported that the female student with no known allergies was vaccinated with the second dose of GARDASIL (Lot # 666595/070Z), IM, in the left deltoid, on 01-SEP-210 at 16:10. There were no illness at the time of vaccination. The nurse also stated that the vaccin was given in their facility but the patient did not return to report for any care or any side effects. No further information is available.
Since vaccine I feel dizzy and upper abdominal discomfort. Today the dizziness is worst. I am never dizzy.
After dose 1 in March of 2021, the fourth day I woke up in the middle of my sleep cycle and I was jittery with anxiety and my feet were tingling.  I was unable to go back to sleep.  I tried to go back to sleep and lay still but my body would not relax enough to be still.  The next shift at work I got hot I went to the doctor, and all was clear.  I took off work and just had to keep busy due to all the energy and anxiety.  I had the symptoms for four days.
This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950542A, A0950543A, A0950544A and A0950545.
Hands and feet felt like the were on fire, swollen, and cold all at the same time. No fever present. Symptoms lasted 8 hours and since that date of onset, tingling in hands has been reoccurring at nighttime.
Information has been received concerning a 45 year old male with allergens allergy who reported that in 2/1983 he was vaccinated with his 3rd Hep-B vaccine. Previous vaccination occurred in 9/1982. Within a day, post vax, in 2/1983, the pt experienced stomach cramps (which lasted for 2 months and became severe) and over the next 10 years experienced headaches, lost weight, was "in a daze most of the time", had joint pain in 1 of his toes, the joint pain progressed, had trouble with his coordination and had eyesight blurring. At the time of this report, the pt was on 40% disability. The pt was seen by his physician but no dx was made. The pt was not on other medications at the time of the vaccination. The pt reported that he was told that the vaccine was experimental at the time of administration. The pt's stomach cramps, headaches, weight loss, in a daze most of the time, joint pain in 1 of his toes, pain progressing, trouble with coordination and eyesight blurring persisted. These symptoms were considered to be disabling. No further information is available.
TDAP given on 8/18/10. On 8/22/10 arm began to swell & had some pain. On 8/23/10 a knot began to form w/more swelling & very painful. 8/25/10 went to ER. (R) arm was cut and drained by ER doctor. Drain tube placed & covered with gauze. Pt to return to get packing of wound changed at hospital. Given BACTRIM. ER doctor unsure if there was reaction to vaccine or possible infection.
After first vaccine, no reaction other than sore arm. After second vaccine, received May 10 at 10:30 AM. Awakened morning of May 12 with heartburn and low fever (99.9). Heartburn became moderate to severe stomach cramps , headache, body aches, and low flow urination with more cramps. Fever rose, was 101.2 at highest. Cramping was debilitating until around 4PM on 5/14, when they became  mild to moderate, more like gas pains. Fever came down , from then on hovered between normal and around 100. Still low flow urination, and I was drinking a ton of water. My abdomen was very bloated and constantly loudly gurgling , rumbling, etc. Status quo through the weekend, on Monday I went to Urgent Care . Urgent Care performed covid test and urinalysis , guessing I may have  UTI. There was a little blood found in my urine but all tests came back negative. At this point I developed post nasal drip and a constant hacking cough. Status quo through that week , on Friday 5/21 I went to see my regular practioner. She couldnt find anything , referred me to gastroenterologist who I will see next week. Urination is better now, fever seems gone but I am still coughing and experiencing mild gas pain like cramping
Breakthrough case after 2 vaccines Moderna 1/22/22 Lot# 032H21A;  Moderna 2/19/22 Lot#025L21B
Headache behind eyes, Nausea, Chills, Low grade fever, Low back pain  Taken Ibuprofen every 4-6 hours, Hot showers/baths, Heating pad, Drinking hot tea
feverish, cough, congestion, lower energy level, mild headaches, starting 11/28/21
pt recvd vax;fell asleep when got home,slept about 3 hrs (unususal lengthy nap);woke up,did not eat;real quiet & did not move too much,7pm t 102;gave apap;pale & went limp then crying;ems arrived;mom said eyes rolled back;to hosp;having sz
Presents to the ED c/o SOB for three weeks.  Pt states that she was exposed to COVID on 12/25/21 but had a negative COVID test on 12/28/21. The patient was COVID positive 1/15/2022.   From assisted living who presented with shortness of breath.  Tx.  She was placed on 4 L nasal cannula.  Patient on Decadron.
facial redness and swelling, lips swollen,felt nausea  Bendryl 50mg po then 50mg IM