chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is red; small blisters; arm a little bit itchy; it is warm to touch; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE VESICLES (small blisters), VACCINATION SITE PRURITUS (arm a little bit itchy) and VACCINATION SITE WARMTH (it is warm to touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE VESICLES (small blisters), VACCINATION SITE PRURITUS (arm a little bit itchy) and VACCINATION SITE WARMTH (it is warm to touch). At the time of the report, VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE VESICLES (small blisters), VACCINATION SITE PRURITUS (arm a little bit itchy) and VACCINATION SITE WARMTH (it is warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Woke up and soon lost my smell and taste.  Headache, left arm was sore, legs were aching and felt weak. Chills but no fever
This spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 22-JUL-2013, the patient was vaccinated with a dose of GARDASIL Lot # H021346, intramuscularly (dose and expiration date were not reported) for prophylaxis. Then, on 11-AUG-2016, outside of the prescribing information, the patient received GARDASIL 9 Lot #L043214 with an expiry date of 30-AUG-2017, intramuscularly (dose not reported) and on 06-DEC-2016, received GARDASIL 9 Lot # M031557 (dose not reported) with an expiry date of 06-APR-2019, intramuscularly (dose not reported) both for prophylaxis, as the second and third dose respectively. No adverse effects were reported. Additional information has been requested.
Generalized macular rash pink in color non itching, not painful. No systemic symptoms.
I began experiencing symptoms on June 10th of cough and body aches. I went to the doctor Monday the 13th and she did a PCR COVID-19 test and it was positive the next day. On Tuesday the 14th I got the monoclonal antibodies infusion. I had symptoms only one day.
Expired vaccination given. event reported/documented. patient's mother notified of event and need for new vaccination.
Myalgias generalized. Red, hot, swollen arm at injection site with aching - decreased within 24 hours. Fever 101, then less 24 hours - resolved completely.
Acute onset of high temp of 101.8 for less than 24 hours. Severe sore throat. Non productive cough. Low grade temp for 4 days 99 to 100. Continued sore throat and cough with congestion. Fatigue and achiness. I went to urgent care on the 18th and was told what I had was viral and told me to take over the county medication. On the 23rd I went to my doctor and she retested me. On the 26/27 I started feeling better. On the 28th I got a canker sore from the viral infection. From there symptoms decreased and I returned back to work.
After getting the first dose of the Pfizer vaccine, I just experienced arm soreness for the first 24 hours, but then I noticed my tinnitus which I had slightly for many years had become louder and constant. Right now I'd say it is a 3/10. My concern is that if I get the second dose that it will become even louder. My second dose was supposed to be today, but unless the tinnitus diminishes I do not want to risk a second shot for a 10-15% efficacy increase for Covid
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included fall (before shingles appeared the patient had a fall). Concurrent medical conditions included cancer. 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. The patient was treated with acyclovir. 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 details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. It was reported that year ago the patient was told that shingles appear when the body had a traumatic experience and before shingles appeared he/she had a fall days before. The patient has had cancer as concurrent condition. The patient took Shingles vaccine because they appeared during treatment for cancer. The patient stated he/she had the vaccine a long time ago. The patient was taking acyclovir 400mg tablet, 1 in morning and 1 at night. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Received vaccine on 12/30/2020 arm continued to be sore. Then on 1/11/2021 woke up to arm no longer sore but very red and a large oval itchy area at injection site. Arm has been red itchy warm to touch for 12 hours now.
Patient received sub-optimal COVID-19 vaccine due to storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The CDC requested that a VAERS form be submitted for this patient.
Patient came in to walk-in clinic with sudden onset of chest pain, nausea and vomiting, diaphoresis. Normal ECG, but troponin was elevated. Recheck of troponin in 3 hours showed that it had tripled. Patient sent to ER for further workup and treatment
pt recvd DTP/OPV/HIB on 17FEB93 @ 230PM; pt started having cough & choking w/several apnic periods @ about 8PM of same day;
10min p/vax c/o funny feeling that started in chest 7 went to my stomach;was clammy, warm, shaky, SOB, BP 140/90;assessed in systemic allergic rxn & Epi given;hosp for cardiac eval;
by mistake a DTAP instead of TDAP ( Infanrix instead of Boostrix); 11YO patient received DTAP instead of TDAP ( Infanrix instead of Boostrix); This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The patient received DTAP instead of TDAP (Infanrix instead of Boostrix).  The reporter consented to follow-up. Additional Supportive Information: The 11 years old patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
sore arm; chilling; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program. A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. The patient had no ill effects after first dose. On an unspecified date, after the second dose of vaccination, the patient experienced sore arm and chilling for 1 day only. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax & had one episode of flu-like FEB95; was sick for about 3 wk & @ that time had a non-specific gastritis & over a period of time forward lost 20 lb; devel back pain in April; c/o some musculoskeletal explanations & saw MD;
Pt reports lg baseball sized red, hard, warm. painful to palpate area at injection site follow eat by  rash - Also rash R side Face
Case number PHEH2014US004026 is an initial spontaneous report received from a physician on 24 FEB 2014. This report refers to an 11 year old patient of unknown gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported), at dose of 0.5 ml intramuscularly on an unknown date. No adverse event was reported following this administration error.    Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration "  was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
When giving the vaccine in the patient's left arm, when I pushed the plunger on the syringe, it looked like the vaccine was dripping out in between the syringe and the needle. I could not determine if the patient received at least half of the dose, so I gave her another 0.5 ml dose in her right arm.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 23rd March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, contusion, muscle pain, fever and fatigue. On 24th March 2019, the patient experienced lymphedema. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the contusion was not recovered/not resolved and the outcome of the muscle pain, fever and fatigue were recovered/resolved and the outcome of the lymphedema was unknown. It was unknown if the reporter considered the injection site pain, contusion, muscle pain, fever, fatigue and lymphedema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX vaccine in left deltoid and had a pretty bad reaction. She had pain at the injection site, bruising, muscle aches, fever, and fatigue, she was really wiped out. These started on 23rd March 2019, and pretty much went away. The fever went away after one dose of TYLENOL, the muscle aches are pretty much gone, the pain at the injection site had gotten less and less. The fatigue was pretty much gone. The bruise was recovered. On 24th March 2019, she developed lymphedema of her arm and by 25th March 2019, the swelling in her armpit was really bad and it was not getting better. The lot number and expiry date was not known.
Pt recvd 3 doses of Engerix-B, 3rd dose given 1NOV90 & it was determined that pt did not convert to protective surface antibody level;
19 days post vacc numbness both legs up to hips. Loss of ability to walk. Diagnosed Guillain Barre syndrome. Having trouble bowel & bladder - due to numbness. Continues to have numbness in both legs to hip. Received IVIG -> able to walk now but having balance issue especially left leg.
made me sicker and worse side effects than shingles; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Mar-2022 Reporter's Comments:  The patient had shingles and stated that he/she had to get the Shingle vaccine anyway. The patient reported that vaccine made him/her sicker and had worse side effects than shingles. The patient still got vaccine as his/her physician had ordered. Additional Supportive Information:  The patient self-reported this report. This case was received from consumer via interactive digital media. The follow-up would not possible, as no contact details were available.
24hrs after - tired and minimal tenderness where shot was administered.  4 days after - woke at 1am with itchy scalp, swollen ears and hives mostly upper body. Called Dr. and sent pictures and was told to take Benadryl. 5th day - woke to swollen eyes, upper lip and full body hives.  Went to ER and was given IV, Benadryl and steroid and continued to take Benadryl and Prednisone for 5 day.  Day 3 of Prednisone, hives had subsided.
Headache, fever, chills, malaise, and fatigue x 3 days then on day 5 had skin reaction on feet.  Treated in medical Center ER for cellulitis with Cephalexin.
Sx 4.5 red tender site in (R) lateral femoral area warm. Cellulitis.
HIVES TO CHEST AND NECK UNKOWN TREATMENT BY TRASNPORTING CREW TRANSPORTED TO BMC SEF
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, dose, strength and route were not reported) which was exposed to a maximum temperature of - 6.2C for a total time of 5.5 hours. No adverse effects were reported. It was unspecified if the patient sought medical attention. Telephone call was placed to the reporting nurse on 17-APR-2015. The nurse was not able to provide additional information at the time of call. Additional information has been requested.
Information has been received through the manufacturer pregnancy registry from a physician concerning a 31 year old female pt with a history of a pituitary adenoma and a previous pregnancy several years ago in which the fetuswas anencephalic, who on 9/11/02 was vacc[[name]]ted with a dose of varicella virus vaccine live. Concomitant vacc[[name]]tion included a dose of MMR vaccine and a dose of tetanus toxoid. It was unknown if the patient experienced a local reaction or varicella or herpes zoster symptoms post vacc[[name]]tion. Subsequently, the pt became pregnant with a LMP date of 9/17/02. On 11/12/02, it was reported that the pt is approximately eight [[name]] pregnant and a "recent scan shows what looks like a blighted ovum, empty sac." Unspecified medical attention was sought. On 11/18/02 a confirmatory ultrasound was done. Subsequently the patient was diagnosed with a blighted ovum that resulted [[name]] spontaneous abortion. The patient had three previous pregnancies include one full term birth, one pre-term birth (at 10 gestational [[name]]; and a miscarriage (at 5 gestational [[name]])). It was noted that the fetus was anencephalic in a previous pregnancy several years ago. Additional information is not expected.
REDNESS AT SITE OF INJECTION; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced redness at site of injection. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 06-APR-2021, and was recovering from redness at site of injection. This report was non-serious. This case, from the same reporter is linked to 20210436344.
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 81-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma and rosacea. Concomitant products included biotin, Vitamin B12, Vitamin C, vitamin d, COSOPT, LUMIGAN, Flax Seed Oil and Glucosamine Chondroitin. On 6th February 2018, the patient received the 1st dose of SHINGRIX  (intramuscular). In February 2018, 1 day 6 hrs after receiving SHINGRIX, the patient experienced localized erythema and skin warm. The patient was treated with KEFLEX. On an unknown date, the outcome of the localized erythema was recovering/resolving and the outcome of the skin warm was recovered/resolved. The reporter considered the localized erythema to be related to SHINGRIX. It was unknown if the reporter considered the skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm at 14:30. On 7th February 2018, about 30 hours after the vaccination, the patient developed a few red splotches 3 inches below the injection site. The next day it had become one large, oval spot, 3 inches long one direction and 3.5 inches long the other direction. The spot was warm to the touch, but did not hurt or itch. The patient did not experienced fever. It resembled the rosacea she has on her face. The patient saw her primary care physician (PCP) and then a dermatologist about the spot, but did not treat it with anything other than a couple of days of KEFLEX to make sure it was not an infection. The warmth was resolved and the redness was fading, though the spot remained the same size. At the time of report, the spot almost blended in with the rest of the arm.
Information has been received from a 71-year-old female with Hodgkin's lymphoma (left upper neck below ear), fibromyalgia, irritable bowel syndrome (IBS) and allergies to Sulfa drugs, codeine and aspirin who on 26-NOV-2007 was vaccinated with a dose of ZOSTAVAX.  The patient noted that she was in remission from the Hodgkin's lymphoma but it had returned prior to receiving ZOSTAVAX.  Illness at the time of vaccination included swollen lymph nodes.  Concomitant therapy included estradiol (CLIMARA), dicyclomine HC1 omeprazole (PRILOSEC), amitriptyline HC1 (ELAVIL), vitamin D (unspecified), calcium (unspecified) and lutein (xanthophyll).  The patient reported that on 26-NOV-2007, she experienced bone pain in hips and thighs 3-4 hours after being vaccinated.  The patient also reported that she experienced a stiff neck, pain on the left and mild pain on the right side.  The patient subsequently called her physician.  No laboratory/diagnostic tests were performed.  The patient indicated that as of 28-NOV-2007 she had no pain and considered herself to be recovering.  No further information is available.
The day after receiving my fourth dose of Moderna, I had a fever, body aches, and pains. I felt like I had the flu. I was also very dizzy. I didn't think much of it and just rested and took it easy. I took some Tylenol the day after. That lasted for 5 or 6 days. I eventually took my blood pressure. The bottom number was in the 40's. I've never had it that low. It was consistently around 100 over 40. I called my doctor, and they weren't concerned because the top number was ok. By around week 2, the aches and pains were gone, but I was still tired and dizzy. I went to see my doctor who was a bit concerned. He referred me to a cardiologist, where they did an echocardiogram. While I was getting that done, I asked if he had seen people with low blood pressure after receiving the booster. My cardiologist did blood work. My cholesterol was high. He recommended a statin, which I did not take. My primary concurred that I shouldn't take that and to continue monitoring. The dizziness lasted around a month or longer. I also started adding electrolytes and my doctor increased my thyroid medication a small amount. After around a month or six weeks, things got back to normal.
Pt stated that injection site was red, painful and hot. She went to MD to check and it was suspected to have adverse or allergic reaction to vaccine. Pt was given antibiotic.
Mother approached the post vaccine monitoring desk to notify staff- about patient's appearance.  Staff immediately accompanied the mom to evaluate patient's status.   Staff observed red and diffused splotches his forehead and what appeared to be petechiae bilateral on forearms and hands.  Mom denied any history of allergies. Mom denied a history of allergies and denied any of the symptoms exhibited to today.  Staff asked patient if he was feeling hot, then identified that patient was non-verbal.  His mom then confirmed that patient was feeling hot. Patient was observed with beads of sweat on his forehead.  Patient's jacket was removed.   LPN took his temperature 98.6.  Staff explained to the mother that staff was likely experiencing an allergic reaction and that the treatment of Benadryl 50 mgs capsules ? standing order written by the Dr.  Mom brought a specialized adaptive cup to assist patient in swallowing the caps.  Patient accepted the medication and swallowed both caps.  Continued with an additional 30-minute monitoring with both mom and patient.  Staff notified the mother to contact her medical provider to update information on the this first vaccination, assess reaction causes(s) and to ask for his or her recommendations on whether patient should pursue a second vaccine.  After the second 30-minute monitoring, staff observed the red splotches on the forehead to have dispersed and less localized.  No diaphorases noted. Staff asked patient how he was feeling, he presented as non-verbal however the mother than stated, ?He is OK.?   The observed possible petechiae were present but faint on both forearms and hands. No evidence of shortness of birth.  He was alert to verbal stimuli. Mom did confirm that patient was answering.
My day began working in the Medical Surgical Unit, once I received the injection I was feeling fine. Five hours past and my eyes became itchy and swollen. Immediately after I started to have an itchy throat while my nose was congested. After conversing with my house supervisor she told me to call Employee Health Nurse. After that they directed me to the ER because my symptoms were worsening. At the ER they took my vitals and then the doctor came to assess me.  She told me that I was having a severe allergic reaction to the vaccination. They started an IV gave me Benadryl, Epinephrine and Pepcid. After, the nurses monitored me for 4 hours until they decided I was well enough to go home. The doctor prescribed me with Epinephrine and Prednisone.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild