chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given 0.5 ml instead of 0.3 ml, patient had sore arm & headache night of immunization but assumed it was normal
Patient developed rash 6 days post vaccination. Onset was sudden. Rash was spotted and red, spots were not raised or have any abnormality to note. Area of coverage for rash included the backside of both arms and legs and across lower back. There was no apparent local reaction at site of injection. Patient reported no other distress (pain, itch) associated with rash other than it being unsightly and mildly uncomfortable. Patient had already contacted a relative health care professional who instructed them it could be due to allergy and to take BENADRYL to see if that helped it clear up and as the pharmacist patient reported to I concurred. Patient has been using BENADRYL and Calamine lotion with no resolution for approximately 4 days. Rash as of 8/13 during follow up call to patient had not remarkably improved, but patient stated it was not getting any worse. Patient noted at this time they are very active and usually upon rest it seemed the rash was less uncomfortable. They plan to follow up with primary care provider within the next week if it does not resolve. As an additional note patient did want it reported she was not sure if this could be related to her adverse reaction as she feels it does predispose her to other adverse reactions to medications.
pt presents to ED with c/o fever and diarrhea; COVID test positive in ED; ABX given; inhalers; admitted; COVID PNA; hypoxic respiratory failure; transferred to ICU; O2 supplementation; encephalopathy; vasopressors for shock; acute renal failure - hemodialysis; pt's condition continued to worsened; transitioned to comfort care and pt passed away in the hospital
feeling as if had not slept for 4 weeks, extremely tired; arm is extremely sore; feels like crap as if had flu; diarrhea; fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF); A spontaneous report was received from a other health care professional (reporting on self), concerning a 41-year-old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling as if had not slept for 4 weeks, extremely tired, arm is extremely sore, running a fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF at 5 o clock), feels like crap as if had flu and diarrhea.   The patient's medical history included anxiety. Concomitant medications reported included lorazepam and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (LOT number 039K20-2A) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 06 Jan 2021, approximately 0 days prior to the onset of the event, the patient was running a fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF at 5 o clock) and 1 day prior to the onset of the events, feeling as if had not slept for 4 weeks, extremely tired, arm  is extremely sore, feels like crap as if had flu, and diarrhea,  Action taken with mRNA-1273 in response to the events was not reported.  The event, diarrhea, was considered resolved on 07 Jan 2021. The outcomes of the events, feeling as if had not slept for 4 weeks, extremely tired, arm is extremely sore, running a fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF at 5 o clock), and feels like crap as if had flu, were unknown.; Reporter'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.
I started feeling sick in December 2021. I live in a small town and the doctor wasn't available I had to make an appointment at the pharmacy to be tested. I had to wait until January 2022 before I could see a doctor. There was no over the over the counter COVID test in my town. My symptoms was very severe and I thought I was going to die. It was the worst headache I have ever had. I thought I had a Aneurysm in my head it hurt so bad. I had very bad body ache, sore throat, cough and difficult breathing. I also had chills and very fatigued. I was told to take vitamin C & D and iron pills. I work from home and I had to miss about 7 days. The patient didn't have her vaccine card so she didn't know her correct vaccine date or her lot number. I advised her to call VAERS back and update that information when she can. She stated that she will.
RAISED,RED ITCHY AND BLOTCHY SKIN RASHES ON MULTIPLE AREAS INCLUDING ARM, HANDS, THIGH, EAR PIMPLE HIVES PATIENT USED TRIAMCINOLONE ACETONIDE CREAM HE HAD AT HOME AND APPLIED TO THE RASHES WHICH SHOWED SOME IMPROVEMENT
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   It was reported that the reporter had identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received First booster dose on 27-Oct-2021 and  second booster dose on 04-May-2022. Patient did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Pruritis, injection site pruritis. This case was reported by a healthcare professional and described the occurrence of itching in a subject of unspecified age and gender who was vaccinated with influenza vaccine trivalent (FLULAVAL, GSK). On September 15 2009 the subject received unspecified dose of DLULAVAL (unknown). On September 15 2009, almost immediately after vaccination with FLULAVAL, the subject experienced itching. The reporter stated a subject experienced itching from the inside out which began almost immediately after the shot was given. Specific information was not known. The reported stated that the batch of vaccine for lot number AFLLA261AA might be defective which caused the adverse event. The reported did not have specific information and is seeking advice on whether to continue giving injection with this lot. The reported did not have an expiration date. At the time of reporting the outcome of the events were unspecified. The reported stated three additional subjects experienced adverse events. Follow up was received from Sept 15 2009, via Quality assurance (QA). QA stated this is an Adverse Event and it will not be recorded as a complaint.  Follow-up was received on Sept 18 2009, via sales representative, who reported the 50 year old female subject received FluLaval on 14 September 2009. the onset of itchiness (described as skin crawling) at injection site was immediate following injection and lasted the rest of the day. Subject feeling well prior to vaccine, no fever, no other medications, no prior history of adverse events following flu vaccine. Subject was evaluated for rash and was negative. The events resolved on 14 September 2009 and was considered possibly related to FluLaval vaccination.
Developed a rash on my chest that has now spread over my entire body. Though to be pityiraiasis rosea but biopsy said not, though to be drug/photosensitive reaction.
difficult to speak; nose bleed; fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. On 04Jun2021, the patient experienced fever and body aches. On 07Jun2021, she experienced nosebleed and on an unspecified date she experienced difficult to speak. The patient stated she received her second Pfizer covid vaccine on Friday. Over the weekend she had fever and body aches. On 07Jun2021, morning she developed a nose bleed. She wanted to know how to what to do about her nose bleed specifically. She was calling for treatment advice and  agent referred her to her doctor. Agent asked if patient would like to complete a safety report based on the adverse events she has been experiencing. Patient stated if it is quickly, she could not speak more, and she would like to rest. Patient stated the fever has gone and she still has body aches. Patient stated did not had history and investigations, she was all good. Therapeutic measures were taken as a result of fever. The outcome of the event fever was recovered on 06Jun2021. The outcome of the event body aches was not recovered and unknown for nosebleed and difficult to speak.
Spontaneous bloody nose day after vaccine. Not severe in nature but have never experienced a spontaneous bloody nose. Resolved fairly quickly.
I have been breastfeeding almost 6 months now, no issues. Day after my second shot, the whole top of my breast was painfully swollen. I pumped, fed the baby, tried to express the best I could. Used heat pads and ice pads. Went in to get checked out. Dr prescribed me antibiotics in case it was an infection. I did not take. Swelling went down each day. Done by day 4. And back to normal. Possibly clogged ducts/lympnodes
Client received Vaccine at 0843. at 0953 client sitting in observation area and stated felt "dizzy." At 0954  assisted client to walk to lie down supine on the bench. Vitals taken at 0955: BP 170/90, RR 20, bpm 80 (pulse rhythmic and regular with palpitation). Clt stated continues to feel dizzy, with "a little nausea," denies blurry vision, denies vomiting, skin dry and appropriate color. elevated legs at 0958. At 0959 clt reports dizziness and nausea are gone, "feeling better." 0902 Vitals recheck: 170/100, 18 RR, 80 bpm lying down. 0906 PHN's assisted client to sit up. States dizziness returned. Called 9-1-1 at 0909,  administered  50 mg of Benadryl PO to client while sitting up. PHN's assessed clt to lie back down. 0915 vitals recheck: BP 160/90, RR 20, 60 bpm. 0918 EMS on scene and resumed care. Per EMS: 0925 clt signed AMA, vitals stable, c/o continued mild dizziness. Clt not observed falling over and able to sit holding onto walker, states "felt better." Clt's partner will stay with her in hotel room to monitor. PHN's educated f/u with PMD in 24 hours, and s/s when to call 9-1-1. 0930 clt stood up with walker and walked away with steady gait.
Covid Arm: Large swollen knot (half size of golf ball) under skin at injection site. Red lesion at injection site measured 1.5 inches by 1.5 inches. Painful to touch and itchy.   Treatment: Cold compress, Ibprofen for 2 days after injection, Benadryl by mouth 2 days after injection, anti-itch cream topically applied for 2 days after injection.
a little pain; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204 and expiration date not provided), via an unspecified route of administration, on 13Mar2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported patient had not yet been administered second dose over 4 weeks later of the first dose of vaccine. Patient reported he didn't have any adverse effects from the first dose of vaccine other than a little pain the next day, on 14Mar2021, but that had gone away. The outcome of the event was recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing my balance on Sunday, January 3rd, could not do my regular jog my legs were so uncoordinated on Monday, January 4th, and I fell over on my side when I squatted to pick up my cat at the end of the jog, Difficult to climb my front steps. Tuesday  , January 5th, similar leg weakness and lack of coordination, but milder. Less weakness on Wednesday, Jan 6th, when just walking. Thursday, January 7th, did a jog, almost normal, but my left ankle not as responsive as usual. Headache the whole time, and feeling like too much caffeine. I only have one black tea in am. Symptoms seemed most severe in AM.  Headache eased up in evening of 1/7.
At site of injection burse and knot appeared applied ice and took 2 Tylenol. Later on the 30th swelling under left arm same arm shot was given.
Has been bitten by 5 Brown Relcuse Spider since getting the vaccine. Had only been  bitten once by Brown Relcuse Spider in the last 53 years.  Prescribed Cephalexin 500 mg for spider bites.
The shot was at 11:30AM on 4/14/21, I woke up at 2AM on 4/15/21 to feeling like I was burning alive. My body temperature dropped to 95.9 degrees, I was drenched in sweat, vomiting, experiencing diarrhea, and couldn't get up without the feeling of passing out and my stomach felt like a wrench was in there twisting everything. Symptoms lasted around an hour and symptoms turned to just full body aches as of this morning, 4/15/21 at 9AM.
3/15/2021 12:21 H/O tongue denontion to flu shot in past. Similar reaction within 10 minutes. No SOB, no rash. BP 120/80 P-90. gave Benadryl 25mg & water tolerated. 12:37 - BP 106/71 P-82 Pulse ox 100%. felt fine. 3/17 tongue still burns when Benadryl wears off. red itchy bumps L imist. 3/18 P-80's-100: Still itchy.   will start: allegra, Benadryl & Pepcid
Initial report was received from a health care professional on 13 September 2012. A 53-year-old female patient had received FLUZONE INTRADERMAL 0.5 ml IM in the right deltoid (lot number UT4470AA) and within 4 hours experienced periorbital/face swelling, "couldn't swallow-tongue", and pain in chest and throat. The patient had a medical history of C-section (1992), appendectomy (age 7), Lasik (2001), and stereotactic biopsy ("5-06"). The patient had no concomitant medications. No further information was available at the time of the report. The patient outcome was recovered. Documents held by sender: None.
Area of redness with induration at site of injection, fever. Treated with cephalexin for presumed cellulitis.
Severe headache; Severe chills; Shaking; Terrible body aches; This case was reported by a consumer and described the occurrence of headache in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times in life, did not had them for several years).   On 28th December 2022, the patient received Shingles vaccine. On 28th December 2022, less than a day after receiving Shingles vaccine, the patient experienced headache, chills, tremor and general body pain. On 30th December 2022, the outcome of the headache, chills, tremor and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache, chills, tremor and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 4-Jan-2023. Reporter's Comments: The patient self-reported this case. The reporter mentioned this shot was terrible.  The reporter never had to have another one and severe headache, severe chills, shaking and terrible body aches and stated that the symptoms were treated.
Patient developed a very high fever very suddenly and was not acting like herself (not even how she usually acts whenever she is sick with normal illness/fever). She vomitted multiple times and was extremely lethargic sleeping most of the afternoon which she also never does. She also complained about her head hurting. The sickness lasted for almost two days. She was irritable for several days after this.
Patient was sitting in observation area. C/o some numbness to right arm. States she got her vaccine in right arm.  States her left arm was also numb immediately after 1st Covid vaccine and c/o still being numb today.  Advise her to mention it to her PCP. Full range of motion in bilateral arms.  No other complaints
Lethargy; tired; the rash had spread from head to toe; felt really ill; awake for 48hrs, they had not slept; felt really bad; rash on the left forearm that was really itchy; soreness of the arm of the injection; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Lethargy), FATIGUE (tired), INJECTION SITE PAIN (soreness of the arm of the injection), FEELING ABNORMAL (felt really bad) and RASH (the rash had spread from head to toe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product AMLODIPINE for an unknown indication.    No medical history was provided by reporter.  Concomitant products included CANDESARTAN, PANTOPRAZOLE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness of the arm of the injection). On 18-Mar-2021, the patient experienced FEELING ABNORMAL (felt really bad) and RASH (rash on the left forearm that was really itchy). On 19-Mar-2021, the patient experienced ILLNESS (felt really ill) and INSOMNIA (awake for 48hrs, they had not slept). On 20-Mar-2021, the patient experienced RASH (the rash had spread from head to toe). On an unknown date, the patient experienced LETHARGY (Lethargy) and FATIGUE (tired). On 21-Mar-2021, INSOMNIA (awake for 48hrs, they had not slept) had resolved. At the time of the report, INJECTION SITE PAIN (soreness of the arm of the injection), FEELING ABNORMAL (felt really bad), RASH (the rash had spread from head to toe), ILLNESS (felt really ill) and RASH (rash on the left forearm that was really itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-073738 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073738:Patient's case
This spontaneous report was received from a nurse practitioner and from a reporter (role unspecified) from the nurse's healthcare facility and refers to a 15 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-OCT-2016 the patient was vaccinated with an improperly stored dose of VARIVAX injection, 0.5 ml, subcutaneously in right upper arm (lot # M005972, expiration date: 02-FEB-2016) for prophylaxis. The VARIVAX was reported to be stored on unknown dates at 8.6 degrees Fahrenheit (F) for 1 minute, 6.5 F for 1 minute and 47 F for 1 hour and 40 minutes. No previous excursions were involved. The temperature excursion was detected with a data logger. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter has no further information.; Sender's Comments: US-009507513-1610USA014546:
Got injections at 10:45, 30 minutes later started to get itchy, cold main, then noticed red spot and also developed blotchiness on face, upper torso. Called us about 11:30 am - gave benadryl then started to clear. Lasted all about less than 1 hour.
Right thigh redness, patchy over 10 cm area noted today (3/17)
upset stomach; no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: ER8727) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 01Apr2021, outcome "unknown", described as "upset stomach"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "no energy".  Additional information: The reporter asked if Pfizer covid-19 vaccine cause upset stomach and no energy several day after the vaccine is given and how long does it last. NDC number, UPC number and expiry date were reported as unknown. The patient can take second dose on 17Apr.   No follow-up attempts are possible. No further information is expected.
4 min p/the pt was immunized pt collapsed on mom lap; pt remained unconscious for approx 3-4 sec; mom placed the pt on the floor & raised legs; pt then became alert & began to cry; pt was observed for 20 min thereafter was alert & oriented;
Rash, felt very bad and progressively got better after first day, had mild problems breathing, no treatment.