chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful, pruritic swelling in Right Deltoid region immediately after immunization administered.  Developed nausea, throat irritation and vomited once about 30 minutes later on the way home.  Patient instructed by dialysis RN and attending to go to ER. Given Benadryl PO, Rantitidine PO, Epinephrine IM.  Admitted for observation.
This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Confusion, dizziness, headache, nausea.  These symptoms have persisted and increased in severity from the time of this shot.  Since the shot, I have also experienced heart palpitations, and extreme fatigue.  These symptoms continue to persist daily.
Approximately seven hours after receiving my Moderna vaccination I started feeling extreme pain in my left shoulder.  My shoulder was throbbing I could not lift my hand above my head without extreme pain.  It continued through the night, I delayed going to bed because of the pain after laying down for 15 minutes I got up because I could not do anything without having serious pain.  I went back to bed in a hour later and had the same result and got up and did not go to bed that night.  It did not matter what position I was in, and the throbbing continued and left me extremely uncomfortable.  In the morning I started to research shoulder pain related to vaccinations and I came across SIRVA.   What I read reference SIRVA was exactly what was happening to me I had very limited range of motion in my shoulder and could barely move my arm without extreme pain. Tylenol and Ibuprofen did not help.     I called the nurse help line in the afternoon and it was suggested I go to the ER.  I visited the ER in the afternoon.  The two nurses that saw my arm and where the Band-Aid was place thought that was awful high entry point for a vaccination.  The two nurses and the doctor I spoke to had not heard of SIRVA.  I explained what happened, but long story short is I was given medication one narcotic,  some extra strength ibuprofen and muscle relaxer. I was given a prescription for muscle relaxer and ibuprofen and sent on my way.    I continue to have pain and reduced mobility in my shoulder/arm.
7 cm red swollen area (L) deltoid around the injection site, painful, warm. ORAPRED 5 ml PO BID.
Patient was initially injected with an incorrect dose of 0.3 ml. When the pharmacist noticed her mistake, she got a fresh needle and syringe and inject 0.2 more ml in a second injection.
Information has been received from a physician concerning a 4 month old patient who on approximately 19-FEB-2007 was vaccinated with Rotateq. The patient received the 1st dose of Rotateq and had diarrhea for about 4 days. There was no intervention and it cleared on it's own. The parents did not report it until they came back for the second dose. As of 19-JUN-2007, the patient was recovered. Additional information has been requested.
Patient broke out in hives in sizes ranging from a dime to a half dollar coin on arms, legs, hands, and feet. The patient visited a local urgent care where the cause was not able to be identified. The doctor prescribed the patient 6 doses of Prednisone.
Patient has pain , swollen, itching , thickness on site, redness and heat.  Day after getting vaccine redness has been spread from 3.5 ins to 4.5 ins on the 5th day and still has heat and itching on site.
DULL VISION; EYELID AND UNDEREYE DROOPINESS/PUFFINESS; ACNE-TYPE, PAINFUL RASH ON TEMPLES; DRY, ITCHY SKIN ACROSS FOREHEAD; BODY ACHES; HEADACHE PROGRESSED TO MIGRAINE; TIRED; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 19-MAR-2021 12:20 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced headache progressed to migraine. On 19-MAR-2021, the subject experienced tired. On 21-MAR-2021 18:00, treatment medications included: paracetamol. On 26-MAR-2021, the subject experienced acne-type, painful rash on temples. On 26-MAR-2021, the subject experienced dry, itchy skin across forehead. On 02-APR-2021, the subject experienced eyelid and undereye droopiness/puffiness. On 09-APR-2021, the subject experienced dull vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, headache progressed to migraine, and tired on 22-MAR-2021, was recovering from acne-type, painful rash on temples, and had not recovered from dry, itchy skin across forehead, eyelid and undereye droopiness/puffiness, and dull vision. This report was non-serious.
Pt's Mom called, said pt's left arm noted some swelling around area shot was given, about quarter size, but stated arm was red, top part of arm, bruising at area. Mom was told to give Tylenol, for pain give Benadryl over the counter. Told Mom I would call back to check on pt. Told Mom to bring him in if she was concerned or to her MD. Pain started back 4/11/03. Pt didn't return call.
pronounced ringing in both ears began and cognitive functions impaired within 15 minutes of receiving the vaccine. Within 6 hours  involuntary shivering without a sensation of being cold and extreme and debilitating body pain in all limbs, neck, back and head. Pain caused inability to sleep, work, or participate in routine activities. Pain and shivering was treated after 10 hours of suffering with hydrocodine which resulted in the ability to sleep for two hours. Was drenched in perspiration upon waking up. Pain slowly reduced over the next 8 days. Exhaustion, mild cognitive impairment and ringing in ears continues months later.
soreness at injection site; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 5 and 7 months after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient experienced soreness at injection site and tiredness that lasted for couple days. Did not consent to follow-up. No other details were provided.  Caller reporting adverse event for herself and her husband.  This case is 1 out of 3 cases reported by the same reporter.
Really drowsy and dazed lasting about 5 mins.  Pt. was put back into the RM where Dr. check her and baby was doing better.
date recorded on report states 4/15 after 1st dose given 9am. Reaction began at 10 pm. The reported date of the vaccine is 3/25/21. Client not found in Immunization Registry.  Note on report that month and day for DOB is fictitious. Pt stated they are close to turning 60. Adverse events experienced and are they still occurring now:  1st dose rcvd 4/15/2021 at  9am, ADE occurred at approx 10pm in the evening - pt experienced warmth on the left arm, the skin was rise with welts that was 3-inch in diameter, with dull pain; these symptoms lasted for 2-3 days. About 8 days later, the welts reoccurred but without any pain just rise skin and itchiness for another 2-3 days. ADEs not occuring now.    What happened as a result of the adverse event? Pt reported they applied ice to the left arm area, helped with the itchiness both times the hives/welts occurred.    ***NOTE***  After consulted with Dr. and CDC info site, advised pt that the ADEs he experienced is not a contraindications to getting his second dose since the welts was localized at the injection site area and it was not widespread to other part of his body. Recommend pt to consult his MD if he is still concern about getting his second. Also recommend after rcvding second dose to wait and be observed for 30 minutes instead of the standard 15 minutes, and of course to the discretion of the pharmacist administering the 2nd dose base on observation time.
Mild tenderness present at the left deltoid area measuring 3x2 inches, pain 2/10, T degrees 98. Child taken to ED 2 days after flu vaccine for above sx. Discharged home on meds: Ranitidine 75 mg 1q12 hours. Diphenhydramine 12.5 mg 1 q 8 degrees. Prednisone 10 mg 2 BID.
Edit to Vaccine Excursion Report ID 55197 filled on 12/29/2020 At 845 am on 12/28/ 2020, Moderna, Covid 19 vaccines, arrived at Health Care Center. Vaccines were placed into Immunization Freezer at temperature range of -5.6 F at 830 am. At 845 am freezer temperature noted at 4.3,12.0 10.2 F from 9 am to 930 am. At 945 am temperature was noted at 3.9 F. During the 30-minute temperature rise, vaccine protocol was followed, and a sign was placed on freezer by Lead RN to not use and to not open freezer.  Emergency safety protocol were acted to ensure the viability of all vaccines.   Staff nurse filed a vaccine excursion report on 12/29/2020 with VFC program and incident report.  The case content information, on case number #01832359 per Merck vaccine,? ok to use,? and questioned the nature of the caller?s excursion report.  Moderna vaccine case number MOD20-2372 up to the health officer and provider. Unknown nature of outcome. As this has yet to be determined.
Monday one week after vaccine was administered, red dots all over my legs appeared when I woke up. Did not itch which I found strange bc they looked like flea bites. But I went to the ER and said they were purpura.   Also as of Tuesday  April 13th, I have had throbbing headaches daily lasting on and off all day.   Finally today and last night (April 19 and 20th) I have been dizzy.   I am feeling weird.  I regret taking this vaccine.  If there was a way to undo this I would.
pt recv vax who exp bruising (1.5cm x 2cm) @ the inj site two days p/vax;
Patient contacted pharmacy to let us know she started having pain at the injection site which radiated up to her shoulder as well as pain in lower right quadrant (below the rib cage) which radiated into her back exactly 1 week AFTER administration.  Patient stated she did not have any injection site pain, redness, or swelling immediately following vaccine administration.  The pain in her lower right quadrant did subside after 2 days and the pain at the injection site and her shoulder was subsiding and feeling better as of 4 days post initial reaction.  No other signs or symptoms were reported, no other immunizations were received, and no new medications had been started at this time.  The patient did not report any difficulty or extreme pain with raising her right arm but stated she just had discomfort when doing so.
Site: Pain at Injection Site-Medium, Systemic: Flu vaccine Rx # 1263357 was given same day with covid vaccine-Medium, Systemic: Lymph Node Swelling-Severe, Additional Details: Patient received flu vaccine and covid 19 vaccine on same day and has had mastectomy before. This has caused lymphedema and discomfort for the patient. Patient reported this incidence in November.
Noted arm erythematous, warm area in the Right upper arm 13 1/2x 12cm in size. 2 days after patient got her immunization. No fever.
fever; This is a spontaneous report from contractable consumer from Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiration date were not provided), via an unspecified route of administration, on 07Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive on Covid, 3 weeks before they took their 1st dose of Covid-19 vaccine last 07Apr2021. On unknown date, after taking the vaccine patient had fever. Reporter asked if they still need to take the 2nd dose scheduled on 28Apr2021. The outcome of event was unknown.   Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Arm started to swell several hours after injection. Swelling continued into her upper arm, shoulder, neck, throat. She took Benadryl and Allegra 180 mg and saw her primary care physician the next day. She was given a shot Prednisone taper and Allegra 180mg, which helped but did not completely relieve symptoms. She was put on Prednisone for a longer time and improved slowly over 10 days.
Patient called inquiring about booster dose of Pfizer vaccine and it was determined patient had been given Moderna Dose 1 and Dose 2  was given 21 days after first dose instead of 28 days.
tinnitus; This case was reported by a pharmacist and described the occurrence of tinnitus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as per vaccine indication. The health care professional inquired about Shingrix causing tinnitus. A patient reported tinnitus following administration of a Shingrix dose. The health care professional did not know any more information about the event when it occurred, how long it occurred following Shingrix, did it resolve, patient history of tinnitis or other comorbidities, the Shingrix lot number/expiry date, when the vaccine was administered, etc) other than the patient suspected Shingrix caused the event. The HCP said she would follow up with the patient to get more information about the event.
Fever of 103.4 within 5 hours of booster shot.  Extreme right sided head pain with difficulty walking.  Intermittent loss of vision in right eye that is still present today 10/17/21.  Will see eye Dr Monday.  Still having some gait issues and dizziness.  Fever never under 101 for 48 hours even with 800 motrin q 8 hours alternating with tylenol ESq 4hrs
Very strong post vaccine reaction, severe malaise continuing into third day, HA, sl. Nausea and stomach pain. But worst is inability to lift left arm, severe left arm pain, even joint pain in left wrist. Could barely lift L arm on day 2 after (Sunday) and again unable to lift it day 3 after (Monday).  First dose, I had arm pain, trouble lifting it 1 day, pain for a week and mild soreness for the whole month. Pre-existing joint pains from autoimmune were worse for a week, but this second dose - it only seems to be vaccine side, including left jaw, left eye pain, left collarbone pain near a previously affected injury.
The morning I woke up from having the MMR I felt like I was 150 years old. Stiff, headaches, body aches, confusion and forgetfulness. Since then I have had headaches every day and I have rarely had headaches in my life and I'm still doing strange things like for instance putting crackers in the refrigerator. My confusion seems mostly in the morning. I also lost my vision where I was completely blurry and double vision from approx 6am to 8pm about 2 weeks after the shot. I went to see an Opthalmologist and they said that my eyes were not tracking together and that it may be systematic. So I started with a Neurologist, and he sent me for an MRI of my brain.
Patient received accidental 3rd dose of Hep A vaccine by staff. No current signs or symptoms of reaction noted. Dad with patient. Aware. Dr. aware. Contacting manufacturer. Will follow up with parents.
The pt developed red and hot to touch right leg and cold compresses were applied. On 05/01/2002, the pt awoke with swollen right let to three times the size from groin to torso.  Also had fever of 101 deg F and was seen in ER. Blood tests showed no infection but while there, the pt fell and cut mouth so then the pt was placed on antibiotics. Returned home and the pt remained irritable throughout the weekend. The pt recovered on 05/07/2002.
911 called/Participant experienced tightness and pressure in her chest, not indicated if was related to vaccination/ EMS reported cardiac damage, participant was taken to nearby hospital.
Syncope and paleness within 5 minutes of receiving the vaccines.  Patient had what seemed like 2 short (10-20 second) seizures.
-Significant itching over much of body, started later that evening and resolved after 48 hours. -Patient took Benadryl at home & never went to the doctor.
Two hours after the immunization, the pt. had soreness in the bicep area (frontal to the injection site). The same evening, the patient felt soreness in the entire upper arm. On the next day following injection, the patients arm was red and swollen and hot to the touch (entire upper arm). She called me and I advised her to see her physician. Pt. was able to get into her physician but was only able to see "a resident or fellow" Dr. Dr. felt it was an allergic reaction and pt. was placed on Hydroxyzine 25 mg. at bedtime and Triamcinolone .5% cream to apply twice per day until itching resolved. I was not initially told about C/O itching. Today, 09/28/2018, the pt. claims she only has a very faint pink mark to the bicep area. Otherwise, she feels good. Explained the FLUBLOK vaccine and encouraged her to get another vaccine in the future that is not cell derived.
Fatigue and random body aches that started several hours after the injection on 4/21/2021 have continued to date (5/10/2021). Though the other symptoms such as fever, more severe body aches, and headache subsided around 4/28/2021.
hives on both arms, a little on her neck, and some on neck, waist up; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix (right arm). In AUG-2023, less than 2 months after receiving Shingrix, the patient experienced hives (Verbatim: hives on both arms, a little on her neck, and some on neck, waist up). The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt date: 03-AUG-2023 A Reporter reported about herself she received her 1st dose of Shingrix in her right arm about 2 weeks ago on a Monday in July 2023 (no specific date provided), and reports that she woke up a day or 2 ago (no specific date provided), with hives on both arms, a little on her neck, and some on her back, and only on areas from her waist up. Patient did not have the Lot/Expiry information.  The reporter did not consent to follow-up.
Product Complaint; Flu-like symptoms; Fever; Tenderness at the injection site; Hurt all over; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 59EA2, expiry date 13th September 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, injection site tenderness and generalized aching. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the influenza-like symptoms, fever, injection site tenderness and generalized aching were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, injection site tenderness and generalized aching to be related to Shingrix.  Additional case details were provided as follows: On 28th March 2019, the patient received 1st dose of Shingrix.  Reported batch number DK9L5 pertains to Shingrix adjuvant. After receiving the 1st dose, the patient did not have any adverse events.  The patient received the 2nd dose of the Shingrix in the right arm. On 29th May 2019 during the night, the patient started to have symptoms. The symptoms included flu-like symptoms, fever, and tenderness at the injection site. The patient also stated that they hurt all over.  The reporter indicated that she was seeing an increase in the number of patients reporting adverse events since GlaxoSmithKline had started to increase production of the Shingrix product. She was wondering if she should continue to administer the product. She believed that there might be something going wrong with the process GlaxoSmithKline was utilizing to manufacture the product more rapidly. She reported that, there were three patients reported adverse events including increased pain and having to go to the hospital. The reporter provided information on the most recent patient because she had already reported the other adverse events through her company and would not provide additional details regarding them. The other two were from different batches. This is report 1 of 2.  For the second report of two unknown patients, refer case US2019098282. The reporter hung up the phone and did not provide any additional details.  It was unknown if the reporter had product to return because she would not continue with the call.
Spiked fever a few hours later, raised red itchy and painful rash developed on back and feet and toes. Some Scarring left at rash sites
large amount of cellulitis 3.5 in x 2.5 in on right upper arm
Pt received Pneumovax Vaccine (0.5cc IM) at PCP appt 1/22/04. Pt returned 5 hours after pneumovax injection c/o itching redness around injection  site. Pt  received diphenhydramine and ranitidine( rx earlier today for GERD) and Medrol Dose pack.  Pt was instructed to return the next day for follow up and to go to UC that night if fever, sob, or edema  worsened. Allergy entered into pts chart. No h/o anaphylactic rxns or angioedema.  Pt stated she thinks she had pvx ~7yrs ago without problem. Pt returned the next day.  Left upper arm very red, swollen and tender to touch.  Pt also had a fever of 101.3 F. Pt was sent to UC and tx with diphenhydramine 25 mg po x1, methylprednisolone 125 mg IM x 1, ranitidine 300 mg po x1 and propoxyphene/acetaminophen 100/650 mg po x1 for pain.   Pt was discharged on prednisone po dose taper.  Diphenhydramine was increased  to 50mg Q6h and ranitidine 300mg BID was continued .   Pt was given an arm sling for comfort.  Ice and elevation. Pt felt subjectively better at time of discharge after almost 4hrs of observation. Three opened vaccine vials with same lot number retrieved.