chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Deltoid area of R arm has 2 very small red raised areas at injection site, larger red area about 1" below injection site and "an even larger" approximately 2 1/2 x 4cm/red area on anterior aspect of upper arm-all areas red/warm to touch, arm from elbow to shoulder sore.
EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include Tylenol with symptom improving.
2/12/14 Fever - Ibuprofen/TYLENOL. 8 am awakened with fevers 99s at office mom said it had been 103. Did have low grade fevers 2/11/14 started after shot.
RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for the case. No concomitant medications were reported. On an unspecified date, the subject experienced rash. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
injection site swelling  incresing each day; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a 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 injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced injection site swelling that was increasing each day. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Following the second dose of the vaccination on February 18th, 2021, I felt extreme fatigue, malaise, 101F temperature (with alternating Tylenol 1,000mg and ibuprofen 600mg) the following day as expected. However, the following month I began to experience mood swings, abdominal cramping, low back pain and cramping. This is highly unusual for me (I have been using the Nexplanon implant since 02/2016) and have not had any vaginal bleeding or symptoms relating to my menstrual cycle since the original implant nor the replacement implant in 03/2019. I scheduled an appointment with an OB-GYN to follow up with these concerns. On 03/19/2021 I had a transvaginal ultrasound and noticed prior to the exam I had vaginal bleeding, which I had not experience in 3+ years. I came out of the bathroom into the exam room and stated to the ultrasound technicians, ?I?m bleeding? in disbelief. Following this, I decided to go to a larger facility for continuation of care, thinking there was something very wrong. On 4/16/2021 I had a diagnostic laparoscopy, D&C and hysteroscopy relating to the persisting symptoms relating to my reproductive system. Nothing was found to explain my symptoms, My symptoms have progressively gotten worse since then and are still continuing.
Presented to Urgent Care 01/05/2021 Pt. States swelling started the night prior. Provider describes it as left upper arm finds a patch about the size of a silver dollar which is red, warm, + tender with some indentation in the center. No red streaking up the arm, shoulder
No adverse effects.; Nurse reported lhe patient received a dose ofMMR II (lot number and expiration date unknown by reporter) on 10/24/2009. Nurse reported lhe patient received a dose ofV ARIV AX (lot number and expiration date unknown by reporter) on 11/14/2009.; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies were not reported. Concomitant therapies included sterile diluent (DILUENT MRK).  On 24-OCT-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis and on 14-NOV-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (inappropriate schedule of product administration). Information about strength, dose, frequency, route of administration, lot number and expiration date were not provided for both suspected therapies.  No adverse effects were reported.
This case was reported by a physician and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown date. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information: A 4 month old patient received KINRIX instead of INFANRIX. Doctor did not know the patient's DOB, initials nor vaccine lot number or expiration date.
6 hours after vaccine: extreme chills and nausea x 12hrs. 16hrs after vaccine: headache, diarrhea. Treatment: Rest. Started to feel better 30hrs after vaccine given, all better 48 hours later.
Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 125.4  No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  Patient did not experienced any adverse reaction.  No treatment medication were provided.
Ran a fever, chills, and body aches. Dizzy causing me to fall & exhaustion.
Beginning on 09/01/2015 patient began vomiting and I brought her home early from daycare.  09/02/2015 her fever would not go down even with Tylenol. She was sitting in her highchair.  I was giving her rice baby cereal, she had not eaten in 24 hours.  She turned her body to the right, looked up, clenched hands, legs stiff, toes pointed and her body shivered. Her eyes fluttered.  This lasted approximately 30 seconds.  I text my husband and as soon as he could come home from work, I took her to the E.R. I took her temperature and it was 105.3.  When we got to E.R it was 103.6 Since this febrile seizure patient has had a varicella type rash.  Her pediatrician at this time can not diagnose the cause of rash.  She has been treated for scabies, suspected bed bug bites or allergic reaction (house was inspected and we are not infested by any bugs), eczema and steroid creams, antifungal creams and Benadryl.  Nothing has worked. Rash last from one week, fades, reappears looking different and now we have come full circle back to this varicella type rash.  Some rashes looked like infant yeast, others looked liked hives.  Child seems clumsy, falls more than normal, very irritable, very itchy, reoccuring cough with these rashes, and now after so many weeks she is beginning to breakdown and just whimper and cry.  She is very uncomfortable. She is having trouble sleeping and will wake in the night screaming, but not fully conscious. The doctor ordered more blood work today 11/0/10/2016.  We are suppose to have the results in one week, but I suspect it may take two weeks.
Patient received Pfizer COVID vaccine 0.3 mL IM x1 on 1/4/2021 @0808. Patient had NKDA and was observed for 15 minutes after administration with no adverse reactions observed. Patient returned to work and noticed swelling in left arm around 0900. Patient returned to clinic complaining of left sided arm tingling and feeling hot.  Also edema to ear lobe and arm.  Patient given Benadryl 50 mg po x 1 liquid @0916.  No sign of respiratory distress, blood pressure 134/84, and no other signs of advancing allergic reaction.. Patient discharged to husband @1021.
At the time of injection patient experienced pain at injection site but not enough to notify administering pharmacist on 11/19/2018. Pain persisted and some swelling occurred. Patient visited and urgent care on 01/01/2019 and filled Rx at another pharmacy. Patient notified RPh on 01/03/2019. RPh discussed importance of notifying any adverse effects right away in the future and gave further counseling on the antibiotics and pain medication from the other pharmacy. RPh will follow up with patient in 2-3 days.
Pt. claims after 1 day or so, he was unable to raise his arm. Pt. was seen by several Dr. to help relieve pain and inflammation. After seeing an orthopedic and MRI, pt. was told there was injury to bursa sac and ligaments. Pt. was told injury was possibly from vaccine administration.
6 x 6 area of redness, warm to touch no tenderness, itchy. Patient states symptoms began 1 day after vaccine. Pt was referred to urgent care.
Soreness at injection site 3/10 for 24 hrs. Soreness radiating down to elbow and up to neck and base of skull starting 3 hrs after injection lasting 11 hrs.
Pt awoke today w/facial rash & irritability; recvd MMR on 19MAY93; pt is afebrile-advised follow up contact w/pt's MD;
pain and heaviness in my arm, canker sore, rash on my face  I had a shot 9;50 AM in the morning of Sunday April 18th. I had no symptoms nor pains right after the shot. Later in the evening of that day, I started feeling pain in my left arm and felt that my arm was heavy. I felt like I could barely lift it. Next, I think it was around Wednesday, but I had a canker sore on the floor of my mouth.  I usually take vitamin B supplements in order for me to not have canker sores in my mouth, so I'm guessing it was caused by the vaccine. Since Friday, I've started to having rash on my face. It started from right above my lip and has been spreading to both of my cheeks, eyes, and neck. This is my third time to have rash in my life. For the other two times, I think the reasons were stress, and not vaccination. I'm not allergic to anything.
Severe abdominal pain 3 days following, elevated liver enzymes and bilirubin, continuing for 3 weeks, (so far).
04/01/2022 I had a sore throat was so bad, constant hydration provided no relief. I also had nausea that was so severe I was in a constant state of feeling like I was going to throw up. I had no fever. 04/02/2022 I took 2 at home COVID-19 tests that were positive. I went to an urgent care and tested positive there as well. That same day, I had fatigue and sinus symptoms, headache, congestion and still the sore throat, but the nausea was gone. That lasted through the 6th of April. At some point some coughing started and it lasted past the 6th. I feel good now and am back to my normal fatigue.
Fever. A physician reported via a territory representative that a child received Prevnar and subsequently developed a fever of 104.9F. No further information was available at the date of this report. This is 1 of 2 patients from this facility who developed a fever following receipt of Prevnar.
Fever, body aches and pain in left arm, dizziness, weakness. Lasted about 24 hours so 2 days of work missed.
20 min post vaccination (conducted in workplace setting), patient report feeling of swelling of tongue; in her words "thick feeling tongue."  Also reported L upper chest tenderness and "very tired and no energy."  RN found no SOB, not appearance of swollen tongue or other angioedema, no evidence of urticaria, no respiratory distress including no wheezing. Not evidence of vasovagal response.  After consultation, RN provided 12.5 mg Benadryl IM in opposite arm of vaccination.  Pt remained under observation of RN and after 30 min states she feels better, previous symptoms abated, and again without evidence of anaphylaxis.  Pt was released back to office 45 min after first presenting with symptoms.  Pt stated "I think I was anxious." on departure.
states that one week after she was vaccinated she developed blood clots in your lungs.  Went the ED due to SOB and was admitted x 2 days.  Found to have a DVT in her right leg.  In the hospital she was given lovenox and TPA and started on Xarelto.
07/28/2005 - Same day as injection- arm swollen, red at injection site.  07/29/2005 - Next day - Injection site better - complaint of nausea "dry heaves", cold/hot flashes, weakness.  08/01/2005 - 4 days later at clinic arm swollen at entire bicept/tricept, temperature 97.9 orally - chills / fever, fatigue.  08/03/2005 - Feeling alot better.
9 days after I got my booster shot, I started having hives. Entire body swollen, ended up in the emergency room. They gave me a shot of Cortizone and Prednisone. Other symptoms were dizziness, nausea, eyes itching, skin itching...  At first I thought it was a soap allergic reaction, but after doing some research it turns out a lot of people that got vaccinated have had the same allergic reaction. I have never had an allergic reaction in my life. I still have hives in my body...
tested positive for COVID on 9/12/2021; given monoclonal antibody injections; no cough, no SOB; poor oral intake; pt's condition worsened and he was found deceased in the facility by one of the nurses
ON 7/30/2021, THE PATIENT PRESENTED WITH AN INFLAMED, RAISED RASH ON THE VACCINATED ARM JUST BELOW THE DELTOID MUSCLE.  THE PATIENT SELF-TREATED WITH HYDROCORTISONE CREAM AND REPORTED THE RASH WAS INTERMITTENTLY ITCHY AND SORE.  ON 8/2/21, THE PATIENT REPORTED THAT THE RASH HAD GOTTEN A LITTLE BETTER, BUT RETURNED IN SIMILAR FASHION....RAISED RASH, ITCHY AND SORE.  ALSO, REPORTED THAT SHE EXPERIENCE/D UPSET /STOMACH WITH LOOSE STOOL, HEADACHE, SLIGHT SORE THROAT AND GENERALLY, NOT FEELING WELL.
On December 08th of 2022. I woke up and had considerable swelling in my right leg. The next morning it was still very swollen, and we went to the emergency room around 10:30AM on December 09th. They did an ultrasound of my leg, and they found a blood clot. I was given a shot in the stomach, and I don't know what it was. They prescribed ELIQUIS for me. For the first week I took 2 in the morning and 2 at night. I am currently taking 1 in the morning and 1 in the evening. My leg is still swollen. There was never any pain, but it was always swollen. I was advised to visit my regular doctor within a week. I was not able to see her until December 21, 2022, due to a blizzard. She told me to continue the ELIQUIS and ordered a blood test to see what my clotting factor currently. I have received the results, but I don't know what. I know I have not recovered as my leg is still swollen.
Hair loss, entire strand including the bulb; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss, entire strand including the bulb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 020BZ1A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), FOLIC ACID, ESTROGENS CONJUGATED (PREMARIN), GABAPENTIN (NEURONTIN), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CENTRUM VITAMINTS for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (Hair loss, entire strand including the bulb). At the time of the report, ALOPECIA (Hair loss, entire strand including the bulb) outcome was unknown.            No Treatment medications were reported.
pt recvd vax & t104 @ 530 pt states passed out & woke @ 730 feeling better; next day felt better;
Pt stated had a spreading red area on the arm not at the injection site but at spot where person giving injection held arm.
9 y.o. girl received booster varicella vaccine.  Mother called the next day stating that upper arm was quite swollen surrounding injection site (and red) - about size of an orange.  Also tender.  After 1 day -> arm was back to normal per mother.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient received bnt162b2 (BNT162B2), on 01Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 02Sep2023 to 06Sep2023 were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sensory hearing loss; hearing problem and could barely hear; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (hearing problem and could barely hear) and DEAFNESS NEUROSENSORY (Sensory hearing loss) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced HYPOACUSIS (hearing problem and could barely hear) (seriousness criterion medically significant). On 27-Mar-2021, the patient experienced DEAFNESS NEUROSENSORY (Sensory hearing loss) (seriousness criterion medically significant). At the time of the report, HYPOACUSIS (hearing problem and could barely hear) and DEAFNESS NEUROSENSORY (Sensory hearing loss) outcome was unknown.            Treatment was provided with Prednisone and Valtrex  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
After the third dose I had swelling under my left armpit and that went away about 4-5 days. On 01/03/2021 I had congestion, runny nose, and sore throat. I went to urgent care on 01/04/2022 and they did a Covid test. They did not give me any medications or treatment. I got the results last night and they said I am positive for Covid. Today I started having diarrhea.
pt recv vax & w/in min became pale & slumped over table;pt assisted to floor @ which time began mild sz activity (eyes rolled up in head, tongue, thrust, mild jerking movements) lasting approx 15 sec;exp mild h/a;
Ever since the 2nd shot my monthly period has significantly changed. Previously I only had lower back pain associated with my period. I have not had cramps since I was a teenager. Starting in July I have had heavy cramps. In addition, for the past many years after being off an IUD my period was very regular in length and severity. Starting in July it has been longer and more sporadic between heavy and light in between. I have observed this same adverse reaction for each of my four periods since being fully vaccinated. I didn't think to consult with my Dr regarding the change, but will advise him during my next appt.
Woke up with chills around 6:23 a.m. Difficulty walking due to overall body pain and tenderness to touch. Fatigued.  Experienced nausea. Gradually subsided by 2: 30 p.m with minimal residual pain.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient was prescribed oral steroids for 5 days and given steroid cream to use as needed for rash
3 days after the vaccine, I felt pain in the left leg; I thought I had torn my angle/foot (I have not kicked anything nor made a wrong step, but there was a bit of pain: since I hike a lot in the City and the country, I could have slightly sprayed my ankle without really recalling it), but I have never had such swelling: I could put my finger in the foot from the ankle down and it would leave a 1/3rd of an inch depression in a puffed-up skin/subcutis.  I am a pathologist myself and found it unnecessary to bother anyone with the trouble. So I took aspirin which controlled the swelling somewhat. It took a good 4 weeks for the swelling to fully subside, with a few occasional episodes of worsening. It is all good now.
Pt received the flu shot and her arm became red, itching within minutes. History of asthma, also hives treated with 25 mg Benadryl.
This spontaneous report as received from a physician refers to unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with RECOMBIVAX HB (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Top 1/2 of arm left swollen, red, warm. Received cool compresses, Tylenol/Advil.