chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red circle at injection site; like a 3rd degree burn; looked like a flesh-eating disease, affected area looked like pastrami; when the blisters oozed out, it burned her skin; 3 quarter size blisters appeared at the injection site on left arm; injection site bothered her a little bit; A spontaneous report was received from a consumer, a 60-year old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced like a 3rd degree burn/ burns third degree, 3 quarter size blisters appeared at the injection site on left arm/ injection site blisters, looked like a flesh-eating disease, affected area looked like pastrami/ skin disorder, when the blisters oozed out, it burned her skin/ skin burning sensation, injection site bothered her a little bit/ injection site discomfort, and red circle at injection site/ injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The night of vaccination, the injection site bothered the patient a little bit. On 17 Feb 2021, 3 quarter size blisters appeared at the injection site on the left arm. On 18 Feb 2021, when the blisters oozed out, it burned the patient's skin. The patient stated it looked like a flesh-eating disease, like a third degree burn. On 19 Feb 2021, the patient saw her doctor. On 01 Mar 2021, the patient stated the affected area was healing, but it looked like pastrami- she had a red circle at the affected area.Treatment for the events included ice pack, silver sulfadiazine cream 1% and triamcinolone acetonide cream 0.5%.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Incorrect dosage of mRNA COVID-19 vaccine product was inadvertently administered. Patient received Moderna 100 ?g 0.5 ml age not indicated
2 days after 1st dose developed severe sharp pain in right ankle radiating to toes, worse when cold or sitting, now has progressed to one spot in ankle with swelling  pain radiates up back of calf,  pain relieved with heat, walking, and massage as well as OTC PAIN  meds.  have not had one day without pain   got worse after second dose of vaccine. pcp treats with gabepentine with no relief.    in july developed sinus infection had 4 root canals done and 5 rounds of antibiotics.  ENT doctor did ct found only in left sinus and feels it is fungal infection  on round 6 of antibiotics now.  may require surgery  constant drainage since july  will see ENT doctor again in february.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 27-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up Information was received on 28-APR-2021and added the stop date of the event and patient declined further follow-up
Pt reports feeling lightheaded. Denies LOC. Pt Placed in Trendelenburg Position. Pt Reports Relief Of Symptoms After Arrival. Pt offered & Accepted Water/Declined Snack. Orthostatic VS Obtained. No S/S Of Distress Noted. Pt Refused Wheelchair, Ambulated To Exit With staff Escort. VS Are As Follows:  1350: BP 108/78, HR 73, RR 12, O2 Sat 100% On RA 1402: BP 104/72, HR 67, RR 14, )2 Sat 100% On RA 1407 (Lying): BP 110/79, HR 68, RR 12, O2 Sat 100% On RA 1412 (Standing): BP 112/78, HR &0, RR 12, O2 Sat 99% On RA
Oxygen saturation dropped from 96% to 90% within 2 hours after administration O2 saturation returning to 97% then 10 hours after injection O2 saturation to 90% for 3 hours.
Diarrhea over48 hours. 24 hours of blood in stool leading to ER visit.  Significant abdominal cramping and urgency. Day 8 post vaccination and symptoms resolved although gut is not back to ?normal?
Patient alleges that he wanted to get four vaccines in the pharmacy consultation room. After the third dose (Engerix-B) he passed out for about 10 seconds. I held the patient so that he would not fall off his chair. I gave him some water after he regained his consciousness. I asked if he wanted me to call 911 and he declined. He sat in the vaccination room for 10 minutes and after that got a fourth vaccine at his consent. I called him on 09/24/2018 to check up on him and he stated that he didn't have any problems after that.
Macular and papular itchy red rash on arm in which vaccine was given. Started below elbow 3 days after vaccine and now present with wrist to shoulder (6 days later).
had shot,still got shingles/suspected vaccination failure; shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot,still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shot, but still got shingles, thank god he/she gotten the shot because they were still quit painful. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Chief Complaint   pt presents with c/o SOB d/t covid + dx.  History of Present Illness     Patient is a 68yo man with a PMHx Lupus (on MTX & hydroxychloroquine), HTN, HLD, DM type 2, depression/anxiety, who presented to the ED for worsening cough, dyspnea, and hypoxia at home with O2 saturations in the 80s. Pt reports that he's been sick since last Monday 7/26, where he had a long day of working outdoors on the farm, and by the end was very fatigued, sweaty, and developed a cough. Originally he and his wife thought it was just dehydration, but by Tuesday 7/27 pt's cough was worse and he was feeling more short of breath and was feeling feverish. Tuesday he was seen, where his CXR reportedly showed bilateral upper lobe opacities per the wife, and at that time he was prescribed ivermectin, which he took for 3 days. Since then, pt has progressively gotten worse with more dyspnea, cough, and fatigue. He also endorses diarrhea multiple times per day with liquid stools, abdominal cramping, reduced appetite, poor po intake, reduced UOP, dark colored urine, a few episodes of vomiting, and decreased ability to smell and taste (not total loss). Pt states that he and his wife are both vaccinated with Moderna, and got their second vaccination in April.
Abdominal pain, pain on the injection site,  trouble breathing on small occasions,  body pain
About six days after I received the Shingrix injection, I awoke to discover what appeared to be a group of insect bites clustered in a circle about 1 inch in diameter on the upper interior portion of my right buttock  (bad place!). I couldn't think of any way I could have received insect bites in that location during the night. They were slightly raised welts that itched and were tender to the touch.  For several days I applied diphenhydramine cream, which helped with the itching. The "insect bites" appeared to be getting better.  However,  on 8/17/19, about 5 days  after they first appeared,  the lesions took on a more rash-like appearance, with multiple small blisters and general  redness in the area. I was out of the country at the time, so I sent photos of the affected area to my personal physician at home. He said  it looked like a shingles outbreak and advised me to see a doctor promptly. I  was examined by a doctor on 8/20/19,  who agreed that this appeared to be a herpes zoster outbreak. Over the next several days the pustules  gradually dried up and faded away. They did not itch or hurt further after the first few days.  I have never had shingles before. I did received a Zostavax injection in October 2013, with no adverse effects.  It would appear to be an incredible coincidence if this minor shingles outbreak just happened to  occur within a few days after I received my first Shingrix injection. Hence, I am reporting this as a possible adverse event associated with the Shingrix  injection, although I realize that that  vaccine uses a killed virus and should not trigger a shingles reaction.
Muscle aches, fuzzy headed, headache,  chills and lots of pain in my knee replacement done 9/21/2020. That knee pain abated after a few hours.
Patient presented w/ swollen rash at injection site. Pt. instructed to apply cold compresses and take BENADRYL. Pt. complained of mild discomfort. Pt. also instructed to contact MD.
not asverse event; HCP calling in to report a temperature excursion for PEDVAX HIB. PEDVAX HIB was administered after temperature excursion on 03/28/2023. Consent to contact was provided. No additional AEs. No PQCs.          ?    Names of vaccines involved (including; This spontaneous report was received from a nurse referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 28-MAR-2023, the patient was vaccinated with inappropriate storage haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, one time dose, lot #W021183, expiration date: 22-FEB-2025, administered intramuscularly (strength and anatomical site injection were not provided) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 50.9 Degree Fahrenheit for a time frame of 1 hours. No prior excursion was reported. No adverse event was reported.
Tinnitus. Very loud humming in ears, Started exactly two weeks after second doze of vaccine. First I experienced vertigo right after the vaccine then it transitioned into a strong headache and then it turned into loud humming .
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. No information about medical history concurrent conditions and concomitant medications were reported. On 07-MAY-2014 the patient was vaccinated with an improperly stored ZOSTAVAX dose 0.65 ml, route subcutaneous. The reporter also stated that the ZOSTAVAX reached a high temperature of 19F for a total of 14 hours over multiple excursions. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1405USA005084 via same reporter link. Additional information has been requested.
Paresthesia and burning sensation followed by fasciculations in thighs and forearms; This is a literature report.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), 5 hrs after the suspect product(s) administration, outcome "unknown", described as "Paresthesia and burning sensation followed by fasciculations in thighs and forearms". The patient underwent the following laboratory tests and procedures: Biopsy skin: Low small fiber density in distal leg; Blood immunoglobulin M: Unknown Results; Heart rate: Unknown Results; Immunohistochemistry: Unknown Results; anti-C1q: Unknown Results; Unknown Results; Unknown Results; Unknown Results; Not done; Normal; Normal; Negative, notes: Rheumatologic w/u; 4; Normal; Normal; Unknown Results; Unknown Results; Magnetic resonance imaging: Not done; Neurological examination: Normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/drug and different event and patient.
Bruising, joint pains in  right ankle, knees and wrist.  Swollen lymph nodes under left arm pit and swelling on right ankle.  Previously had swollen lymph nodes on right arm arm that went down.
Tired since about 10:00 AM, lethargic, pain at injection site, muscle aches, brain fog, slight headache.
Could not sleep; Scared; "turned bright red, like a lobster" after she showered/Redness; tired; nausea but could not throw up; aches; fever/the second night I was showering and had a fever; chills/the second night I was showering and had a fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), FEAR (Scared), ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness), FATIGUE (tired) and NAUSEA (nausea but could not throw up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 032120A and 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2018, High cholesterol since 2019, Latex allergy (Had latex rubber bands in mouth for braces. Mouth swelled up. Drooled.) since 2009 and Drug allergy (Had a paper cut on eye. Given sulfa drug as antibiotic. Eye swelled. Weeped. Turned red.) since 1982. Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN for High cholesterol.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEAR (Scared), ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness), FATIGUE (tired), NAUSEA (nausea but could not throw up), MYALGIA (aches), PYREXIA (fever/the second night I was showering and had a fever) and CHILLS (chills/the second night I was showering and had a fever). On 22-Feb-2021, the patient experienced INSOMNIA (Could not sleep). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 26-Feb-2021, INSOMNIA (Could not sleep) had resolved. At the time of the report, FEAR (Scared) and ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness) had resolved and FATIGUE (tired), NAUSEA (nausea but could not throw up), MYALGIA (aches), PYREXIA (fever/the second night I was showering and had a fever) and CHILLS (chills/the second night I was showering and had a fever) outcome was unknown.            This case was linked to MOD-2021-371729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow up received. Patient demographic details added, medical history added and additional events added.
About an hour and a half to two hours after receiving tehe shot I noticed that the right side of my face started to feel ti gly/numb. I went to the urgent care and was giving benadryl and monitored. After receiving the benadryl I started to feel the right side of my face again. As if this morning 3/28/2021 I feel completely fine. I only have soreness in my left arm where the injection was.
Trouble sleeping; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping) and PAIN IN EXTREMITY (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Trouble sleeping) and PAIN IN EXTREMITY (Sore arm). At the time of the report, INSOMNIA (Trouble sleeping) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient experienced trouble sleeping for first night and sore arm post moderna shot. Event took place after use of product.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a 67-year-old female with no pertinent medical history or allergies who in May 2007, was vaccinated with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included acyclovir 800 mg 5 times a day for 10 days. On 03-NOV-2007 the patient reported having "pain and blisters on stomach, waist, and right side of back". On 08-NOV-2007 the patient reported she was diagnosed with shingles. No diagnostic labs were reported. At the time of reporting the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Nausea, vomiting, called EMS due to dizzines.  Had low B/P on arrival of EMS.  Admitted to ICU and placed on epinephrine gtt. Given Benadryl and solu cortef.  Pt now with bradycardia 30-40's with b/p 170/80.
Flu and 2nd shot. I wasn't feeling well after the 1st dose, 2nd dose was increased fatigue, breathing got worse. Influenza P-free Quadrivalent vaccination on same day on 2nd dose. The next day, all my muscles and joint and feet hurts and painful to walk, headache and extreme fatigue and cough. Progressively worst the next day. I slept all weekend and didn't work. Breathing got worst. Had fever on weekends 100.3 after Tylenol. Tuesday called out sick and went to doctor. I was not improving. Tests shows nothing wrong. BP was high.
Friday I started getting abdominal pain and it was worse at night and I couldn't sleep - felt like I wanted to vomit - but no vomiting. Saturday night I did vomit. I had to stay upright because of nausea. Monday, the symptoms were less. Slight abdominal pain was still there. It would come at one spot and it was very severe pain. Monday by 8:00 it was less. Next morning it was a little more severe. And then the next three days I had nausea on and off and it was tapering off. On Tuesday morning, I talked to the Dr. - Telehealth call - he told me it was most likely it was from vaccine and to take the next vaccine also. By the next following Thursday, suddenly the nausea was all gone. (So the symptoms lasted a week.)  Doctor told me not to take any medication. I had no reaction to second vaccine.
Fever began approx 3 hours after shot was administered. Fever gradually increased despite regular doses of tylenol, according to directions. Fever reached 103.9 and would not come down, even after ibuprofen. 2nd day a 102 fever in the morning and 101 throughout the rest of the day with regular tylenol doses. 3rd day feverish symptoms with low grade (99.0) fever. 4th day normal.
Starting in the morning on Saturday 09/10/2022, I had a headache, low grade fever, fatigue and a sore arm. The next day, the headache was worse and the fatigue was very pronounced and the arm was more sore. I developed COVID-19 arm this day. On Monday 09/12/2022, I woke up feeling better, but I quickly became short of breathe, had cold sweats, diarrhea, nausea and light headedness making me feel like I was going to pass out. So,  I called the emergency number. I went to the hospital who ran an EKG, did a full blood chemistry panel, urine test, chest X-ray and CT scan. Everything came back looking okay. They were unsure what caused it but thought it was a syncopal reaction. I am still tired to this day and feel quite weak, and I still have the COVID-19 arm.
This spontaneous report was received from the registered nurse regarding a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 22-AUG-2018, the patient was vaccinated with improperly stored VARIVAX ((product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter.; Sender's Comments: US-009507513-1807USA011693:
The EMT gave a dose of the Moderna vaccine to an individual who is 16. The age restriction is 18 and older.
PATIENT BEGAN TO COMPLAIN ABOUT CHEST TIGHTNESS AND MIGRAINE AT 1310. THEN AT 1315 110/80 bp, 99% SPO2, 83 HR.  PATIENT REPORTS USUALLY TAKING BENEDRYL FOR MIGRAINES AT HOME.  1316, 25 ML BENEDRYL ADMINISTERED PO BY RN AND APPLIED COLD COMPRESS.  1330 PATIENT REPORTS CHEST TIGHTNESS IMPRIOVING AND STILL HAS MIGRAINE.  PATIENT LEFT INDEPENDANTLY 1345.