chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Information has been received regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On an unspecified date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a family pharmacy, for the long-term prevention of shingles and/or zoster related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   Subsequently, on an unspecified date, the pt was treated by a healthcare provider at a medical office for shingles. As a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
w/in 15min p/vax pt had persistant episodes of sneezing & coughing-shortly p/devel a wheallike rash over entire body,became dizzy-fainting, vomited x 1;inc resp form 25-36, pulse 108-72;paleness in color;911 called hosp via EMS;
Headache, Myalgia, Malaise, chills tightness in chest Narrative:
This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received on 21Nov2016 the second dose of PREVNAR 13 (lot R19477, expiration date Jan2018, NDC number 0005197102) at 0.5 ml single dose in the left arm intramuscular for immunization. Concomitant medications and medical history were not reported. First dose of pneumococcal 13-val conj vac (dipht crm197 protein) was administered on 15Apr2015. It was reported that the patient experienced fever within 24 hours of receiving the second dose. Outcome was unknown.
Bodyaches, fever chills, headache Symptoms started within 6 hours of injection and lasted till 1700 the next day. Fever as high as 102.3F with chills and headache
Injection site pain-still sore Tiredness Whole body was in pain Injection site swelling  Nausea  Decreased appetite Headache Diarrhea Arm pain Almost fainted when I got injected My hand got swollen I?m still dealing with headaches arm pain site pain.  I have a lump where I got vaccine
Sore arm; Large red rash with blister in the center; Large red rash with blister in the center; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Large red rash with blister in the center) and RASH VESICULAR (Large red rash with blister in the center) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Large red rash with blister in the center) and RASH VESICULAR (Large red rash with blister in the center). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Large red rash with blister in the center) and RASH VESICULAR (Large red rash with blister in the center) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-103611 (Linked Report). This case was linked to MOD-2021-103611 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up information received on 20-Apr-2021 included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103611:
to ER leg complained of generalized aches, headache, weakness, trembling, confusion.  began approximately 1pm. Shaking BP 160/96 = 145/74 T 98.  Medical Records received on 12/07/2004 diaphoresis and hypertensive.
After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better
My husband died May 1st, 3 weeks after his last vaccine April 10 .  He had a saddle pulmonary emboli. He did not have any symptoms that I knew of prior to May 1st. Entering info for research data.
At around 7pm, the symptoms started first with diarrhea. 10-20 minutes later, she started sneezing a lot. She took a Claritin, then took a shower. In the shower, she began feeling itchy everywhere, especially in the face. She developed hives around the body (3-4 small patches on underarm, legs). There was also a hive patch on her left eyelid, which started as a small bump, but worsened while she was in the shower. It grew bigger, taking up half of her eyelid. She came out of the shower 10-15 minutes after she began sneezing. 20 minutes after that, her body hives subsided but the eye hive worsened further. The hive took up her entire left eyelid and the eye was swollen nearly shut. Before going to bed (9:30pm), she took a Benadryl. The eye was still swollen in the morning but less so than the night before. Now, 24 hrs after the symptoms began, the eye hive has almost entirely subsided. She feels less severe symptoms now, like fatigue and scalp tenderness.
SoRe ARm, IbupRofeN DizziNess 6:00 PM HeadAche, Chills 15 MiNutes In AM. No HeAdAche, Had VeRtigo, Trouble Walking Less Vertigo WAlking BetteR
Moderate anaphylactic reaction - according to doctor I consulted afterward.   Throat swelled  - difficulty breathing and swallowing, weak, dizzy, rapid heart beat - started about 16-17 minutes after the vaccination.  Lasted a little over 3 hours.  Profound fatigue the next day.
Developed numbness and tingling to face, forehead and lips about 45 minutes after administration. Everything but nose resolved in 5-10 minutes but nose remained feeling numb - had some sensation but not normal.  2 1/2 hrs later felt like it was continuing to improve, but not normal yet.
Patient has redness and swelling to the left arm at the injection site, she was seen by the provider and informed to apply cold compresses to the area. Antibiotics prescribed.
Patient's color skin change to very pale color and passed out, but regained consciousness.  She had a little light headache and felt ok after a few minutes of resting.  She did not want us to call 911.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 17-MAR-2014, the patient was vaccinated VARIVAX dose 1, lot # H018451, expiry date 09-OCT-2014 (dose, route, vaccination site unknown). On 30-APR-2014, the patient received improperly stored VARIVAX dose 2, from the same lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient stated that she had experienced a random sensation of heat through her body for a moment and then felt a pinch on her neck. Both of those went away but the patient then said that she was having a tingling sensation in her left pinky finger. She said that it was fading but still there. Patient was monitored for 40 minutes and vitals were all within normal limits. Patient said she was fine & didn't want treament. The nurses mentioned Benadryl but she said she had some at home if needed.
8 days p/vax pt got a fever & was fussy;10 days p/vax pt devel red-rash-fine maculopapular;
My main symptoms is brain fog - not feeling disoriented but it is brain fog. The night of vaccine, I had a fever 102 and I had chills and was nauseated and I had diarrhea. That lasted for 24 hours to 36 hours. I also had headache and that lasted 3 or four days. I was also extremely tired and that lasted for three or four days. I had the brain fog for about two weeks. Waited a bit longer for second vaccine (three months) because I had such bad reactions that I didn't want to get again. No treatment.
2 HOURS AFTER INJECTION--LIGHT HEADEDNESS, LOSS OF APPETITE SEVERAL HOURS LATER STOMACH DISCOMFORT, SWEATS, FEVER, CHILLS, EXTREME LETHARGY ARM SORENESS RADIATING DOWN ENTIRE LIMB--INJECTION SITE RAISED, HOT, PAINFUL TO TOUCH--AREA ABOUT 5X3 INCHES INDURATION. 24 HOURS LATER SITE ITCHY
pt recvd vax & w/in 24hrs pt exp lt arm swelling in elbow joint-a lumping aspect & sl soreness;ER MD visit was required to treat event;pt used heat pad to alleviate pain;pt no longer exp soreness, pain or discomfort however sl swelling
Received vaccine 6/14/21. Within one hour, arm started swelling around injection site and become itchy. Patient took oral Benadryl and used cold compress. Itching subsided 6/16/21. Arm is still swollen but has gone down since 6/14/21.
Patient received COVID-19 vaccine on 1/27/21 and had episode requiring ED visit on 1/28/21. He had nausea, chills, SOB, hypoxia on exertion and syncope with collapse. He went to ED and they found no reason for these issues. He has COPD at baseline but his lungs sound fine and he did not have Issues at the ED. ED did not provide any treatment, we provided 4mg Zofran. Vitals are at baseline 1/29/2021 and he reports he feels excellent, no further nausea, chills, lightheaded ness or SOB.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # M020100, expiration date 07-MAR-2019 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of PEDVAXHIB were exposed to temperature excursion of 31.3 degrees Fahrenheit for 87 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009271.
pt recvd vax 15JUL92 & exp significant swelling & cellulitis @ site of inject w/in 24 hours;
I experienced the same symptoms as dose one in a heightened level of severity with symptoms of inflammation all over my body, pain in my wrists, feet, hips, shoulders, fatigue, brain fog, cognitive difficulties, insomnia with night sweats, and heart palpitations, my stomach bloated, chronic cough, shortness of breathe, dizziness with bouts of vertigo, skin rashes, eye pain/blurred vision/watering, anxiety/depression, and any physical or mental exertions inflamed the symptoms. My rheumatologist labeled me my joints as reactive arthritis, and acting in the body exactly like rheumatoid arthritis. Diagnosed with chronic fatigue, obstructive sleep apnea, and my symptoms are all lingering with bouts of flare of up like a roller coaster. 3 weeks ago, I began taking Humira to help with the inflammation and pain, which has seemed to help some. I tried Selzentry maraviroc 300mg for 4 months along with pravastatin 10mg with no success. I am under ongoing care of of specialists.
Visible and significant swelling to lymph nodes in left armpit associated with occasional neurological symptoms (feels like someone poked me with a thumb tack), nerve symptoms resolved with children's Advil.
Swelling at injection site of Bexsero vaccination 3/21;  swelling started today (3/27) at noon (vaccinated on 3/21),  hardness/soreness/itchiness at site  Motrin every 6 hours as needed for pain or discomfort  To help with itching and hives - zyrtec 10mg daily (can use benadryl 25mg in addition as needed)  Hydrocortisone cream 2-3x/day for itchy  Cool compresses
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015, the patient was vaccinated with improperly stored PROQUAD with lot number: L030587, expiry date: 10-FEB-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC). No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I went to bed around 10pm feeling very cold an shivering. I was able to fall asleep, but then I woke up at 2am feeling very thirsty and experiencing intense nausea. I got out of bed to get some water. When I exited the room the nausea intensified so I knelt on the floor to wait until it passed. It didn't really pass so I stood up to try and get back to the bed. After a few steps I blacked out and fell to the floor. I was only unconscious for a few seconds, as confirmed by my wife who heard me fall. When I came to, I was lying face down and still experiencing intense nausea. I was also very hot and sweating, and very thirsty. I laid with my eyes closed an breathing very heavily to suppress the urge to vomit for a minute or two. When the urge to vomit began to subside I took a few sips of water while still lying on the ground. After another minute or two I was able to get up and get back into bed. The extreme nausea subsided after a few more minutes and I was able to drink more water. I went back to sleep after that. I woke up in the morning around 7am. I felt a little "off" for most of the day: slightly weak, a mild headache, with some difficulty focusing. But since then I have felt normal.   I didn't seek medical attention or take any medication. I have experienced Vasovagel Syncope as a child so I expect that I am more susceptible to fainting like in this case.
Immediate pain at injection site. Headache. Muscle soreness in arm. Lump formed in armpit - significant lymph gland swelling in arm of injection. Pain in left breast. Next Period 7 days late. Abnormally long menstrual cycle. Increased heart rate while in bed during the days following the booster.
A physician reported that a 65 year old female inadvertently received an injection of Pnu-Imune two years after prior immunization and subsequently developed a "local reaction". the reporter declined to provided additional information and declined to grant permission for follow-up.
Urticaria - generalized, 5 days after MMR-V, Hep A, PCV-13.
My husband caught COVID, and I ended up with it. I thought it was just allergies at first than I took a test and it came back positive. I am currently still positive. I have the normal symptoms, sneezing, coughing, chills and fever.
Pt reports 24 hours after shot she had pain and weakness so severe in right arm that she went to Urgent Care. They gave her a sling, 800 mg Motrin, a "pain" shot. 48 hours after PPV 23, she went to a different Urgent Care with a temp of 102. Arm was now swollen and "hot". They changed her antibiotic to Cipro. 4 days after injection, 1 week later she has full use of arm, no sling use, slight swelling, redness and heat in right arm.
1/17/16, approx, 4:30 PM: itchy palms, trunk, feet. Then felt very weak; dry mouth stuttering, SOB. Husband could not detect a pulse or BP, even though I was conscious. Paramedics called - my BP was 60/40. Transported to ER. Dx Kw/allergic reaction also had rash. SOLUMEDROL in ER, BENADRYL. Home: prednisone, EPIPEN.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19 which Paxlovid.  Additional information: She received Paxlovid from 05jul2022 till 10Jul2022 and also had rebound of covid infection on day 3 after stopping paxlovid (day 10 overall). New symptoms (cough, congestion, malaise).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within five minutes I could feel my throat tighten, had trouble swallowing, breathing in/out, lips felt tingly, ears felt muffled, heart started to race and felt dizzy. I drank some water, sat down and took two antihistamines that the pharmacist gave me  where I got my vaccination. I sat for about 30 minutes and drove myself home. I was really tired afterwards and didn't go to the doctors. *On April 2nd my arm broke out in a rash at the injection site and my arm was tingly and hand was numb. I went to  Urgent Care to be seen.
I initially had an upper sore arm at injections site the day following the vaccination. It went away and on January 4, 2023 , over 3 months later, I have been having a very upper sore arm at the injection site and my arm hurts to raise it. Also , when I push on the injections site , it is sore. I was just wondering if this is normal? There is no visible signs of bruising or anything like that, just muscle pain in upper arm and the injection site.
MUSCLE PAIN, HEAD ACHE, SHIVERING, LOWGRADE FEVER, SORE ARM.
Sz 5 days after 4 mo immunizations lasted approx 20-30. Pt was also dx'd with BOM & amoxicillin given.
Muscle pain; Fatigue/Tiredness; Some nauseous; Joints pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 08:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hepatic steatosis and high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included telmisartan (MANUFACTURER UNKNOWN), tadalafil (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 00:00, the patient experienced muscle pain, fatigue, some nauseous, joints pain and tiredness, all the symptoms had continued for 14 days after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, fatigue, some nauseous, joints pain and tiredness were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna 1st dose given 3/4/2021 and patient subsequently admitted to the hospital on 4/1/21 with COVID-19
difficulty breathing; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and PYREXIA (high temperature) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing) and PYREXIA (high temperature). At the time of the report, DYSPNOEA (difficulty breathing) and PYREXIA (high temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt was in usual state of health until 6/2/21 and experienced fevers, chills, sore throat, shortness of breath, chest pain, erythematous rash on trunk and limbs, arthralgia inthe ankle. Presented to ED on 6/4-febrile, tachycardic and mildly tachypneic. Pt is still currently admitted in Unit. left axillary adenopathy
Cough, chest pressure, trouble breathing, bruise, stiff arm and neck, light sensitivity, bloodshot eye, headache, weak voice.
Patient received Pfizer COVID vaccine on 3/26/21 and 4/23/21. On 1/10/22, patient admitted to our inpatient facility with NSTEMI type II and COVID-19 pneumonia (status positive upon admission). As of today (1/11/22), patient is still admitted in our med/surg unit.
Pt experienced tingling of arms and legs, dry mouth, numbness of lips a few minutes after vaccine administration
severe lower back pain, pain at the injection site,  heat at the injection site, pain under arm in arm pit
Pt reported swelling of the tongue at night, was seen in office on 10/4/12 for tongue and facial swelling. Loratadine was prescribed.
Pt recv vax on 2/23/99; on 2/24/99 pt exp erythema/ raised areas at vax site-LA; tx=Advil
Flu vaccine administered into left shoulder joint - patient heard "gritty squish" upon injection. Within a few days discomfort set in upon certain left arm movements - such as reaching back, reaching up, twisting/turning arm. Symptoms worsened over time - evaluated by orthopedic (2 different). Surgery date: June 7, 2016.
reporter states that many people @ work place devel hives p/vaccinated w/hep B vax;