chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever to 102.7 after immunization s given on 1/9/07. Fever lasted <24 hours. Child also was irritable.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient states 'feeling fine' after injection.
Patient is a 47 year old female with chief complaint of heart palpitations.  Patient stated that she felt heart palpitations approximately 10 minutes after receiving the vaccine.  Patient placed in a seated position and vital signs obtained.  Patient denied any other complaint.  Negative chest pain, SOB, weakness, dizziness and no signs of stroke or allergic reaction. EMS already on scene were notified and assumed patient care.  Patient left AMA with her husband via private vehicle.
Parent reports child had trouble breathing for 10-15 minutes with cyanosis, 2 hrs. post receiving vaccines. Told by phone by PP to go to Emergency. When they arrived child was better, and was discharged without treatment. Parent denies child had a rash, swelling or fever.
Rash on both legs from top of feet about 8 inches up the leg; fatigue; muscle soreness; fever for 1.5 days/ fever (a bit over 101); nausea; achiness; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0176), intramuscular in left arm on 03Jun2021 15:15 (at the age of 12-years-old) as dose 2, single for COVID-19 immunization. Medical history included urticaria pigmentosa from 2010 (started to present in the summer of 2010, when he was 1.5years old. It has nearly completely gone away. No flare ups for few years/getting better over the last 3 years). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0169), intramuscular in left arm on 13May2021 15:00 as dose 1, single for COVID-19 immunization. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any known allergies. The patient experienced rash on both legs from top of feet about 8 inches up the leg on 05Jun2021 10:13, fatigue, muscle soreness, fever for 1.5 days/ fever (a bit over 101), nausea and achiness on 05Jun2021. The patient called physician and mentioned over the phone about rash on both legs from top of feet about 8 inches up the leg. The patient was treated with Benadryl for 2 days. It was reported that rash came 1.5 days after shot and lasted about a day. Outcome of all events was resolved on 06Jun2021.  Comments: Got his vaccine at 03:15 PM on 03Jun2021. The morning of 05Jun2021 around 10 AM, alerted me to the rash on his ankles over about 1.5 days, it got worse later spread to feet and up to knee and then eventually went away. He also had the usual side effect of fever (a bit over 101), achiness, fatigue, and nausea. Withheld is a 12-years-old. The nurse kept in touch with me over the phone and had me give him Benadryl. She was going to home to have him go to the emergency room (ER), until pointed at that he has urticaria pigmentosa.
Information has been received from a physician concerning a 9 year old female who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot#/1182U). On an unspecified date after receiving the vaccine, she developed redness at the injection site. Medical attention sought, and current patient status was not reported. A product quality complaint was not reported. This is one of three reports from the same source. Additional information has been requested.
At 9 pm the night of my second shot I become violently ill.; I vomited all night; eventually just throwing up bile; I also had diarrhea; I had cold sweats and was up every hour; This is a spontaneous report from a contactable consumer (patient).  A 37-year-old non-pregnant female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN6201), dose 2 via an unspecified route of administration, administered in left arm on 21Feb2021 at 12:15 immunization (at the age of 37-year-old) as DOSE 2, SINGLE for COVID-19. The patient medical history was not reported. No known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), lisdexamfetamine mesilate (VYVANSE) and trazodone. The previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN5318), dose 1 via an unspecified route of administration, administered in right arm on 31Jan2021 (at the age of 37-year-old) at 13:30 as dose 1, single for COVID-19 immunization. The patient did not have COVID prior vaccination and not tested for COVID post vaccination. No other vaccine in four weeks. On 21Feb2021 at 21:00, the night of her second shot she become violently ill, vomited all night, eventually just throwing up bile, also had diarrhea and had cold sweats and was up every hour. The patient did not receive any treatment for adverse events except vomited all night. The patient was treated with Zofran at 8 am for vomited all night. On an unspecified date, the patient recovered from vomiting and outcome of all other events was recovering.  Follow-up attempts completed. No further information expected.
Child had immiunizations @ 1045 am, woke up from afternoon nap /c T 39 (R), very pale, mother states hands were purple in color. Fussy & crying, pt was taken to ER, no treatment given
Patient was scheduled for 2nd Moderna vaccine. Given vaccine. I then realized it was given at 3wks instead of the recommended 4 weeks. I did contact Moderna and they stated they only have trial information. During the trail they gave the 2nd dose of Moderna between 21 and 42 days. Referred to PCP. I spoke with two PCP's and they both agreed patient should be covered. Patient was monitored and left in good condition. Patient was called after speaking with Moderna representatives and PCP's on 11/15/21. Patient states no adverse effects. Patient voiced understanding and was offered phone number and case number to Moderna if further questions. Patient did decline.
Dr. ordered ROTARIX, active ingredient not mixed with diluent, diluent only given to patient.
After 12 hours, I experienced a sore arm at the injection site, fatigue, body aches, lose of appetite, and a rash with hives on the trunk of my body from neck to hips that itched.  These symptoms went away after 5 days.  What I didn't notice right away is that the itching didn't completely go away.  During April and May, mostly my arms itched from wrist to elbow and initially I attributed it to dry skin and/or allergy season starting.  By early July, I realized the itching was getting worse, more of my body was itching and normal doses of antihistamines didn't help.  This was not normal behavior for my allergies....I don't usually have itching like this.  I went to the allergist who increased my antihistamine dosage which is keeping the itching at bay.  Since then, I got a cold virus (covid test negative) and the hives on my body came back.  I also had a very strong reaction in September to a wasp sting that required a visit to urgent care.
This is a spontaneous report received from contactable reporter  A 78-year-old female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3249, Expiration Date: May2021) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had kidney removed last year", start date: Oct2021 (unspecified if ongoing); "Sciatica" (unspecified if ongoing), notes: had to lay in bed,had sciatica,one weekend she had to go to ER three times in four days; "back surgery" (unspecified if ongoing), notes: She had back surgery in the past; "mass in her kidney" (unspecified if ongoing), notes: she does have a mass in her kidney and looks very cancerous; "They were able to take the kidney out and since cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Nerve block", notes: heavier dose before could get nerve block Oxycodeine did not take pain away only nerve block did. Vaccination history included: Shingles (Caller and his wife had all vaccines, from shingles to whatever), for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.
COVID-19; COVID-19; Moderna dose number 3/ Pfizer / BioNTech dose number 2/Pfizer / BioNTech dose number 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Lot number: ER8735), in right arm and on 09May2021 as dose 2, single (Lot number: EW0173) at the age of 35 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Aspirin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Moderna dose number 3/ Pfizer / BioNTech dose number 2/Pfizer / BioNTech dose number 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: and after 2 negative tests 48 hours apart; (unspecified date) Negative, notes: and after 2 negative tests 48 hours apart; (02Jun2023) Positive, notes: Covid positive test 2 days after last paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This case was reported by a pharmacist and described the occurrence of tendonitis in a 45-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 27 July 2011 at 15:45 the subject received 1st dose of HAVRIX (.5 ml, unknown, left arm). At an unspecified time after vaccination with HAVRIX, the subject experienced tendonitis. At the time of reporting the tendonitis was unresolved.
Patient developed cellulitis on site of vaccine provider Rxid medication. Child re-evaluated doing better 8/31/08
Severe itch on arm from shoulder to fingertips.  I tried ice, but it did not help.  After 7 days, I was desperate, so I called Dr. who told me to take a Benedryl and use Hydrocortizone cream.  I did that for 8 days and it stopped.
Patient states lips felt itchy and chest tight.  Patient took some diphenhydramine.  After 35 minutes patient felt better and went home. Followed up with phone call almost 2 hours later.  Patient states feels fine now.  States may have been because she did not eat.  Also stated has anxiety when give immunizations and that could be part of the reaction as well.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Initial misuse report received from a healthcare professional on 05 June 2013. An expired dose of Tet Tox Ads were given. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Day 0: Fatigue began in approximately 3 hours, felt sleepy went to sleep early Day 1: Next day, felt a bit tired til about 5pm when fatigue began to set in again. Somewhere between 5-8pm the, began to feel feverish and got a headache, mild body soreness. Required ibuprofen 200mg x1. Overnight had a fever and two episodes of sweating, chills, shaking. Felt hyperalgesia when I would wake up (normal for me with viral illness). Day 2: resolved completely by morning.  Arm soreness: Day 0: not too bad Day 1: peaked around 5pm, limited ROM due to pain, swollen at site. Decreased as other symptoms increased. Day 2: still mildly sore but no need for meds or limit in ROM. Day 3: mild pain persists, no other sx
completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/20/2020.pfizer Lot#EK5730 2nd dose:01/10/21.pfizerLot#EL3248 Diagnosed covid positive: 03/30/21 Exposue:Home Exposure Symptoms:Fatigue, Muscle Aches, Runny Nose,irritation in the throat.
It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; For some reason my tongue and my throat were really dry and irritated but my tongue is sore and my throat was kind of irritated; For some reason my tongue and my throat were really dry; my tongue is sore; tongue really dry and irritated; tongue really dry; Dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number not reported), dose 1 via an unspecified route of administration on 13Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.   On an unspecified date, 12 hours after getting the vaccine the patient experienced kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body. Patient also reported that for some reason tongue and throat were really dry and irritated but tongue is sore and throat was kind of irritated, dry skin and this would not but it was not dry skin, it was something irritating the whole body from inside out. Patient appointment came and went to get the second shot and never got the second shot. Clinical course: It started 12 hours after patient got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body not at the same time, but it might go from nose to ankle, to elbow just one and it varied and the links of tiny twines but at times it is few seconds apart and patient does not know how to describe it. The other thing that patient had that for some reason, patient's tongue and throat were really dry and irritated but tongue was sore and throat was kind of irritated, but the thing about it was, that it lasted for 8 weeks. So, patient appointment came and went to get second shot because it was in a no way going to do that which is still going on. Patient did not know what it was or if it is going to get worse or will go away. So reason to say, patient never got the second shot but although. Patient primary care doctor treated the patient for dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Patient adverse reactions lasted for 8 weeks. Therapeutic measures were taken as a result of, dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Outcome for the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a licensed practical nurse concerning a 15 year old female who on 23-APR-2007 was vaccinated with the first dose of Gardasil in the left deltoid (lot# 654702/0010U). On 23-APR-2007 the patient experienced a rash and swelling from injection site to her elbow. At the time of the report the patient was recovering "on therapy" (not specified). Additional information has been requested. This is in follow-up to reports previously submitted on 5/14/2007. Initial and follow up information has been received from a licensed practial nurse concerning a 15 year old female stundent who on 23-APR-2007 was vaccinated IM with the first dose of GARDASIL (lot# 654702/0011U). Subsequently, immediately after the patient expeiienced rash, "jet red" swelling from injection site to her elbow. The patient was given BENADRYL 25mg tablet with good results. The swelling began to subside before the patient left the office. On 24-APR-2007, the patient recovered from the rash and "jet red" swelling from injection site to her elbow. The licensed practical nurse spoke to the mother and the patient the following day and there was no lasting effects. Additional information not expected.
Pt recvd 1st dose of Hep B vax on 27DEC91 & on 1JAN92 pt devel a fever of 103.5, h/a & myalgia; @ time of report sx persisted; It was also noted that vax vial was broken not determined whether it was a/or p/pt was vaxed;
Left arm pain. This is a 66 yo male, came to ER with: being 1 day s/p PNEUMOVAX in left arm, (flu in right) with some pain and swelling shortly after immunization, and awoke this morning with increased pain, swelling & redness distal to site of vaccination. No itching, no constitutional sx. Allergies: WELLBUTRIN XL. Cardiovascular: None, no chest pain. Pulmonary: None, chronic SOB unchanged. Physical exam: Temp: 98.5 F [36.9C (11/03/2012 09:49) BP: 112/75 (11/03/2012 09:49) Resp: 20 (11/03/2012 09:49) Pulse: 108 (11/03/2012 09:49) Pain: 5 (11/03/2012 09:49) Ambulatory, awake, alert. Left arm dorsal aspect from mid triceps to mid forearm is tender to palpation, +1 non-pitting edema, hot, and erythematous. Distal pulses & sensation intact, active ROM of elbow reduced to 90 degrees of flexion. Assessment: 1) PNEUMOVAX adverse reaction. Plan: 1) ice 2) elevation 3) SOLUMEDROL 125 IM 4) prednisone taper.
With my regular check up with primary care, they did lab work. The blood work showed a drop in hemoglobin down to 9. I still have more tests, but I don't have all the results yet. The hematologist also noted some tear-drop shaped blood cells. They ran the tests for them but haven't gotten the results back yet for that either. The hematologist requested additional tests. The additional tests were for erythropoietin level, reticulocyte count, LDH, and haptoglobin, waiting for results. Tests were done two days ago. The hematologist also said depending on the results, we may also need to do a bone marrow test. My PCP is thinking that some of the symptoms I've been complaining about is the result of the hemoglobin level. Symptoms have been feeling cold a lot lately, out of breath at times without doing anything, and getting dizzy a lot.
Initial and follow-up information has been received from a registered nurse concerning a 11 year old female consumer with a history of asthma. Who on 24-NOV-2007 was vaccinated in the left tricep with a second dose of VARIVAX (Oka/Merck) there was no illness at the time of vaccination. First dose of VARIVAX (Oka/Merck) was on 23-SEP-1997. The patient did not have any adverse events following this vaccination. Subsequently, on 22-FEB-2008 the patient's mom reported that she developed approximately 20 pustules and a low grade fever of 99. It was unspecified if medical attention was sought, but there were no lab studies performed. It was reported that on an unspecified date the patient recovered and is doing fine. Additional information is not expected.
patient got sick as hell; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).   This case involves patient (unknown demographics) who got sick as hell (illness), while patient received INFLUENZA VACCINE [Flu shot].  Medical treatment, concomitant medication and family history were not provided.   Medical history includes a similar reaction (illness) to the INFLUENZA VACCINE in the past.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick as hell (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got shot twice and sick as hell.   Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 68-year-old male patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 22nd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown. It was unknown if the reporter considered the papular rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed little bumps on the leg which appeared after the 2nd dose and might be like chicken pox.
Started out with chills, fatigue, severe headache, muscle/joint pain, arm soreness, nausea, red/hard/hot/swelling from elbow to armpit. Seen by Dr. 7/12, told she has cellulitis and bacterial infection. Prescribed BACTRIM and advised to rest. Told to take Ibuprofen for inflammation and headache. Pt is feeling better, but is still experiencing pain in her arm.
patient received improperly stored vaccine on 23-AUG-2021.; This spontaneous report has been received from a medical assistant, referring to a 1-year-old female patient. The patient's concurrent condition, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 23-AUG-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) dose reported as "1 dose" (strength, vaccination scheme, route and anatomical location of administration were not provided; with lot number T035410 verified as valid, and upon internal review expiration date established as 14-APR-2022) for prophylaxis. The vaccine was exposed to a temperature excursion of minus 3.3 degrees Celsius (?C) during a time frame of 4 hours 52 minutes. No previous temperature excursion was reported. No further information was available.