chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is very swollen; big bump on it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is very swollen) and SKIN MASS (big bump on it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PERIPHERAL SWELLING (arm is very swollen) and SKIN MASS (big bump on it). At the time of the report, PERIPHERAL SWELLING (arm is very swollen) and SKIN MASS (big bump on it) had not resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
As soon as the shot was administered in the deltoid muscle within 3 seconds my axillary node was on fire and I couldn't put my arm at rest.  Extremely painful in my armpit.  The injection nurse said that is not normal and gave me a sheet to report to the CDC scan code.  My entire left arm was on fire within a minute.  She had me sit for 30 minutes.  I had no other reaction.  My arm was subsiding a little bit to toleration.  I went home and rested, drank a ton of water.  I went to bed and woke up at 2 am in a cold sweat, I felt like I was freezing and could not stop shaking.  My teeth chattered.  My husband put on many blankets and helped me get warm.  He said I was burning up.  My muscles were so weak and painful, joints hurt and extreme head ache.  I took some Advil and he warmed me up.  My left arm was numb up my left side of my neck and my left cheek.  I took the day off work.  In addition, in the morning I felt like my left leg and foot had minor numbness and prickles.  I could walk but it was colder and prickled on the foot each step.  The next day I was 50% better and made it to work barely.  It took me 3 days to recover from the flu like symptoms.   My left arm continued to feel numb and had bouts of prickles and tingling.  The muscles were hard to use in my left arm and I really didn't use it at all.  Over the course of 2 weeks things have improved.  I still have not recovered feeling in my left pinky and ring finger.  They are weaker still today.  Every morning my left arm is numb for a little while (I don't sleep on my left side) but recovers to about 75% except my pinky and ring finger.  My left neck and cheek have a warming prickle feeling every morning for about a half hour.  They mostly wake up to entirety.  My L foot at the bottom has period/episodic prickles.   Daily my left arm is colder and is weaker than before.  I am a high school teacher so I don't have to use my left arm very much but it is causing pain and negative sensations and is reducing the amount of use of my left arm.
got first dose 2/24/21 and 3/24/21 and he started developing eye rash ~3/19/21, leading to diagnosis of heliotropic rash to dermatomyositis and ILD.
Pt recvd MMR vax on 25NOV90 & following vax devel 1-1/2 to 2 inch depression @ inject site; MD felt that it was a fat necrosis & scarring from the vax; tx w/an unspecified prescription drug; @ time of report pt remained under tx;
Pt. mother stated the area in which the vaccine was given was red, round and raised to the size of an orange. Hot to the touch. Pt. went to family Dr. and received BENADRYL and was told to use warm compresses.
Six days after receiving pfizer-biontech Covid19 first dose, I started have numbness, tingling sensation all over my body more on the left arm/leg. Location of the sensation changes comes and goes through out the day. It started first across my torso then arms, legs. There is no pain only numbness and tingling. Describing the feeling is difficult it is like electric moves around my body. Recently I feel numbness on my legs thigh/ calf areas more on the left leg but still have it on my arms less then the legs again more on the left arm.  I also have short of breath after climbing stairs my heart rate goes up to 130-140 bpm after climbing stairs. Heart rate goes down to 95-85 after 5 minutes rest. I went to urgent care on 8/28/2021, Doctor did EKG which showed  SINUS ARRHYTMIA . Blood was drawn send to lab.
Got the vaccine, still got shingles/ vaccine doesn't work/ Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that, the vaccine does not work. His/Her mom had got the vaccine and still she had got shingle at the time of reporting. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
I had a lot of congestion with a lot of coughing. I had a lot of head and chest congestion which made it hard to breath.
This spontaneous report was received from a physician refers to patient of unknown age and gender. On 05-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # reported as H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The patient did not recover form the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of several reports from the same reporter. Additional information has been requested.
Palpitations starting 10 minutes after injection and elevated pulse up to 101. Pulse went down to 85 after 20 minutes.
pt exp an allergic react following vax w/pneumococcal vax; No further details were provided;
The vaccine was administered at 11:30 am. By 3 pm I started experience neuropathy (heightened skin sensitivity on the right side of my face most pronounced around the orbit of my right eye and the right temple.) My skin was uncomfortable to the touch . No fever. By 6 pm all areas of the right side of my face were overly sensitive to the touch. I went to my pharmacy to report reaction, but it was closed. I call the nurse who was unaware of the adverse reaction I described. She recommended that if the symptoms get worse to see a physician. That evening the symptoms abated a little, but some mild neuropathy began in my right forearm and right thigh. The next morning (Friday), the neuropathy in my right forearm and leg were gone. The neuropathy in the right side of my face was slightly better still. The sensitivity in the underside of my right jaw was gone, but the sensitivity in my temple and the spot between my right eye and temple and in the lower part of the orbit of my right eye were more intense. Today (Saturday) I visited my pharmacy and the pharmacist who administered the injection recommended I report this adverse reaction. The sensitivity (which is still uncomfortable) at my right side temple, lower portion of orbit of right eye and the area between my right eye and ear are still present. If condition persists until Monday, I will schedule an appointment with my primary care physician.
pt recvd vax for prophylaxis;1 hr p/ 2nd dose,exp inject site mass;dx w/ post traumatic myositis upper lt arm;pt remained under MD care from approx 11jan94-1feb94;event resolved
One week after injection, this morning arm at injection site is sore not as bad as following day of injection.  There is a  hard lump just below injection area.  Can I still get Number two injection on February  5?
body aches that affected sleep and day to day activity.  body aches affected the entire body including hands & feet & went into joints.  skin felt like pins & needles. headache that is similar to a headache you would get with the flu.  chills that are similar to chills with the flu. fever as high as 101.5 that went down with tylenol every 4 hours but did not fully go away until 24 hours later. all symptoms began 9 hours after shot & lasted until the following morning.
Severe pain from shoulder all the way down to my hand. Feels like muscle pain. I can't pick up things & cant lift arm over shoulder with out severe pain. Please note I have been told I have a high tolerence for pain. Don't know what to do & don't know how long this will last. People on line who have had same issues after shots say it last for months. I already have limited use on right side due to lymph nodes being removed (breast cancer) now I can't use my left. This pain is actually going up to my neck area on left side.
Injection site red, slight swelling, and painful pain scale 4 out of 10. Patient complained of fever 102 and shaking of arm
redness, extensive swelling  at injection site and "fever" at injection site.  7 days after injection intense itching started
BLOOD CLOT; This spontaneous report received from a consumer via social media through a company representative concerned a middle aged patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total (dose 1) administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from blood clot. It was unspecified if an autopsy was performed. It was reported as, "I personally know someone who was a healthy person middle aged had there life cut short cause of a blood clot caused by this vaccine I'm sorry everyone isn't you". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot was fatal. This report was serious (Death).; Sender's Comments: V0: 20220943772-covid-19 vaccine ad26.cov2.s-Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Information has been received from a 69 year old female with a history of lung cancer, breast cancer, thyroidectomy and a penicillin allergy (rash) who on 13-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included lisinopril (manufacturer unknown), levothyroxine Na, ezetimibe (+) simvastatin (MSD) and various unspecified vitamins. On 13-MAR-2008, after the vaccination, the patient was leaving the physician's office when she became very weak and dizzy and went back into the office. Her blood pressure dropped very low and she was diagnosed with orthostatic hypotension and taken by ambulance to a hospital emergency room. An unspecified blood test was performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. No further information is available.
It felt like I had a really bad cold with a fever, I took a home COVID-19 test that came back positive. I called my doctor to have a telehealth visit with my doctor to discuss my symptoms and positive test. I started taking the medication at 4:00pm on March 9, 2023, by 2:00pm March 10, 2023, I was feeling great. I did not get COVID-19 rebound; I am so happy. My husband who did not take an antiviral took a month to start feeling better.
Approx 2 days after administering both vaccinations the patients arm experienced increased soreness and red swelling at site of injections. Patient went to doctor and was prescribed a steroid dose pack to help with redness and swelling.
Noted redness, swelling & lesions at right thigh injection site. Skin is warm to the touch. Painful. Patient does not have fever.
After receiving the immunization patients right arm, and tongue starting feeling numb.  Gave patient bottle of water and observed for an extra 15 minutes
Vaccine injected too high on arm; in shoulder. Immediate pain. Nearly three years later continuous pain, reduced range of motion, weakness, limited use of arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: Em9809), in left arm and on 03Mar2021 as dose 2, single (Lot number: En6205) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 as dose 3 (booster), single (Lot number: 027h21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient had no known allergies. Other medication in two weeks reported as unknown. Anti-viral details: Product: COVID 19 Treatment. Brand: Pfiser. Treatment start date: 01Jun2022. Treatment stop date: 6Jun2022. Indication: Treatment of COVID-19. Rebound COVID 19. Patient felt fine for a week, now have congestion, scratchy throat cough.  Follow-up attempts are completed. No further information is expected.
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 53-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 21-NOV-2016 to 21-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 21-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Painful injection site, unable to move arm, pain radiating to back bruised and tender to the touch
Severe aches, Temperature over 102 degrees, Nausea. Treated with Aleve and Ibuprofen with no effect until Thursday morning.
pt recvd vax & phoned ofc in pm; very irritable; advised apap; 18oct94 exam; sl swelling of inject site;
patient given Bexsero first and then Vaqta, he stated "I don't feel good" and immediately fainted (patient was sitting in chair), he fell to the floor and bumped the right side of his head. Ammonia salt used to wake patient up, helped him to sit up, provided cold compress to back of his neck and forehead. Water and crackers were given, as patient said he had only eaten breakfast. After 5-10 minutes he stated he was not feeling good again, c/o nausea and dizziness. Call was placed to 911 for EMS transport to Hospital. VS 73/40, 52, 100% spo2, BS 80
Extreme red, hard, swelling of upper arm from elbow to shoulder continuing and including circumference of arm. Very painful, fever 98.9-100.6 2 1/2 days, intense pain, chills, welts on arm, Tues and all night. Advil Benadryl Ice.
Severe pain where the shot was given. Hurt very bad when given the shot. Severe started about 5 hours after the shot was given. Can not lift my arm. Shot was given very high up on the shoulder. Even the Dr.  at urgent care said it probably should not have been given at that spot. Urgent care said I should give it a few more days. Been taken Acetaminopen 500 mg as per Dr. Still in a lot of pain. Please help me.
Mild achiness, nausea and loss of appetite,  fever of 99.4 (my norm is about 97.6), headache, sleeplessness, arm swollen and red. Lasted until about 3 or 4 am.  Then fell asleep.  Woke at 9am and all was gone except the arm.
Pt vaccinated with PROHIBIT mild cold at time of injection. Seen again 11NOV for subjective fever, worsening cold tugging at ears. Dx w/Otitis. Prescribed Augmentin, Codeine & Tylenol. Child found dead 6 hrs later in bed. Normal child
Pt recvd 2-1cc injects of Recombivax 5DEC90 & 17JAN91; 6JUN91 recvd Engerix-B; pt did not develop immunity;
Woke up due to itching and crawling sensation on skin. Developed rash around eyes and on face.
This spontaneous report was received from a other health professional (nurse) refers to a 52 week old patient. Patient's pertinent medical history and drug reactions were not reported. On 05-DEC-2014 the patient was vaccinated with a dose of M-M-R II, intramuscularly in the right leg (reported as right thigh muscle) (lot # J008729, expiry date: 31-JUL-2015). Concomitant medications were not reported. No adverse effects were observed or reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with M-M-R II. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of passed out in a 71-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 5th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th November 2018, 1 days after receiving SHINGRIX, the patient experienced dizziness. In November 2018, the patient experienced passed out (serious criteria GSK medically significant) and injection site pain. On an unknown date, the outcome of the passed out, injection site pain and dizziness were unknown. It was unknown if the reporter considered the passed out, injection site pain and dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The patient received her dose of SHINGRIX, about noon a day before date of reporting. The patient called the office to report that she woke up at about 5am, got out of bed and passed out. The patient also noted local soreness at the site of injection in her deltoid muscle and felt she was too dizzy to drive to the office. The physician directed her to stay home, stay hydrated and rest. The patient consented to be followed up.
Felt realy really sleepy; Not received the 2nd shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Felt realy really sleepy) and PRODUCT DOSE OMISSION ISSUE (Not received the 2nd shot) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage. Concurrent medical conditions included Shwachman-Diamond syndrome and Thyroid disorder NOS. Concomitant products included CHROMIUM, CITRIC ACID MONOHYDRATE, GYMNEMA SYLVESTRE EXTRACT (METABOLITE) for Shwachman-Diamond syndrome, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Felt realy really sleepy) and PRODUCT DOSE OMISSION ISSUE (Not received the 2nd shot). At the time of the report, SOMNOLENCE (Felt realy really sleepy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received the 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Contact information updated
Vaccine administration went well with no immediate side effects.  The day following the vaccine, the patient developed a pea-sized lump at the site of injection that is swollen and painful.  Vaccine was three weeks prior and lump and pain still persist.  Patient advised to seek advice of physician
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-OCT-2013, the patient was inadvertently administered a dose of ZOSTAVAX (lot # 0168AE), subcutaneously that had expired on 06-MAR-2013. No adverse effects were reported. Additional information has been requested.