chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received shot at 3pm - woke up at 6am next morning with a temperature of 103.1 - very shaky and nauseous.  Slept most of day.  Administered 200 mlg Ibuprofen at 6am and 2pm. Awoke at 6am next day with a temp of 100.  Stayed home from school lethargic but awake.
Kinrix was administered subcutaneously instead of intramuscularly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 5-year-old patient who received DTPa-IPV (Kinrix) (batch number C6002BA) for prophylaxis.   On 17-AUG-2023, the patient received Kinrix (subcutaneous). On 17-AUG-2023, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Kinrix was administered subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was 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: 17-AUG-2023 The reporter stated that Kinrix was administered subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. Lot number provided did not identify as a GSK vaccine. The reporter did not have initials or gender at the time of call. The reporter consented to follow up via postal.
Woke up at 5:30am on Feb. 22, 2021 with my arm itching only at the site of the shot on my left arm. Very red and had heat in it. Experienced head ache with sharp pains in various locations inside my head the day before. As of 1:10pm on the same day, the redness is still there and is warm to touch. No swelling appears to be at the site.   I did not have any side effects of the shot at any other time other than tasting a sweet taste in the back of my throat 2 minutes  after being given the shot. It went away by the time I was released from vaccine location.
Parent described patient developing a tennis ball-sized area of swelling with a line of redness surrounding it around the DTaP injection site on the left upper arm as well as fever up to 101 F the day after receiving the injection. No other symptoms were reported. Patient was given Ibuprofen and Tylenol by her parent. Patient was seen in office 3 days after immunization. At that time, there was a macular erythematous rash on the L upper arm in a circular shape. No raised area was noted on exam.
Information has been received from a physician concerning a 19 year old female who on approximately 08-OCT-2007, "also reported as sometime last week", was vaccinated with he first dose of Gardasil vaccine. On approximately 08-OCT-2007, "also reported as sometime last week", this patient fainted for about 2 to 3 minutes. The physician reported that "they kept and eye on the patient and waited for her to come back and in time she did." Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Muscle disorder; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "So, I have gotten the first shot already. I am supposed to get the second one in 2 weeks but today I looked at the doctor and I was diagnosed with a muscle disorder that I have, which now require me to take Prednisone every day. I do not know what the LOT number is, I do not have it." Therapeutic measures were taken in response to event with prednisone. At the time of this report, outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
All over uneasy/unwell feeling w/in 2 hours of vaccine. Temp 101.4 degrees. 1 1/2" red, warm, spot at area of injection itchy very bad. Tingling, numbness down arm of injection.
Sore arm at the injection site and a slight temperature from the 9th to the 12th and On March 19th I developed the Covid arm original spot was 3cm X 5cm it was raised, red, itchy and hot to the touch. On the 20th through the 31st of March that left arm spread from injection site all the way down passed my elbow, and it had definite raised border. It was hot and itchy. I ran low grade fever and I stayed in bed, I was very fatigued and had a problem with loose bowels. On March 25th I drove to the Publix pharmacist and had them look at he recommended l going to my primary care doctor. They marked it and watched it to see if it grew. Then on April 3rd I woke up with severe vertigo while lying down in bed. I took some Antivert, I had fullness with a low frequency droning and also a high frequency tinnitus.  Chills nauseated and I continued to have loose bowels. I had some Ophthalmic migraines. I also had hyper acoustics, noises seamed loud and were painful, I was losing hearing in my left ear. On the 14th of April I went clinic and I saw Dr., He did an injection of steroids through my ear. I went back on April 22 and received a 2nd injection into my left ear. I continued to have Ophthalmic migraines and a temp daily, still loose bowels and fatigued. It would decrease for a week and then symptoms would return. On May 3 I went back for a third injection. On May 17th I went back for hearing test improved and I still had a whole in eardrum from injection. On August 18th the hearing test my hearing is back to normal prior to vaccine. I was on Acyclovir 800 mg 3 times a day from the beginning of symptoms and now I'm tapering off of the Acyclovir.
The patient started to feel light headed and her face became pale and slowly collapsed about 5 minutes after vaccination. She was seated on a chair and I was by her side, so she did not hit anywhere on her body. Her body was laid flat on the floor and her legs elevated and she started to be able to answer questions. Her BP was 90/48 at the time of syncope and was seen by a doctor. She was monitored on a reclining chair and her BP rose up to 102/54 after 15 minutes of being monitored. She stated that she has never had syncope but admitted that she was scared of needles and has never had more than 3 shots at the same time, and she did not eat anything in the morning so she was already a little light headed when she came to the clinic. She was monitored for additional 15 more minutes on a chair with her husband and she stated that she felt much better.
CANCER SORE TIP OF TONGUE, WITH SWELLING , REDDNESS AND PAIN. CANKER SORE UNDER UPPER LIPRIGHT SIDE, NOT AS SEVERE
Patient presented to ED after falling in bathroom at home.  Daughter states that patient has been having a stuffy nose and a fever of 101 yesterday. Of note, patient's husband has been diagnosed with COVID about 2 days ago and is on oral medications.  Patient was found to be COVID positive in the ED.
This was my second shot, I had no adverse reactions to the first. For 8 days after my second shot, I had a continuous headache stemming from the base of my skull. I had read this as a possible side effect so I was not concerned. On the 9th day, I woke up without a headache and thought my symptoms were over. However on that day, my sense of taste started changing. I started putting a lot more salt on things. In the following 3 days, it's progressed that anything sweet has a rancid taste. Bitter and salty items taste just fine but even plain water now tastes foul and it seems to be getting worse each day. I've never experienced this before so I am assuming it's the vaccine. At a guess, this isn't a big deal. I wouldn't be concerned except it started a week after vaccination instead of immediately. I thought it best to at least document it by informing someone.
Hard, red swollen in deltoid area and 5 inches wide band. Spoke with another that afternoon same day of flue shot. Used Benadryl PO and ice. Was clearly looking better by bedtime and gone next morning.
temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 009C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Marked swelling at site of injection with bright red rash extending about 7 inches in diameter from injection site. Area was very itchy and tender. Induration was present at site.
last night had aches, body aches, sniffles, then had swelling near both eyes.   Of note patient with history of cosmetic filler for b/l eyes - last ~01/2021
This spontaneous report as received from a registered nurse refers to a 24 years old female patient with no drug reactions/allergies and no pertinent medical history, who on 11-DEC-2012, was vaccinated with the third dose of GARDASIL 0.5 ml intramuscularly in her right arm (lot # 672721/0101AE, Exp: 10-OCT-2012). No other co-suspects were reported. No concomitant , medications were reported. The next day, on 12-DEC-2012, the patient started to have severe pain in her right arm, which she described as muscle pain. There was no sign of swelling or redness at the injection site. The patient called the physician's office. They recommended acetaminophen (dosage and manufacturer unspecified) and she reported no pain relief. It was also reported that no treatment was given for the AE. The patient reported no pain relief since that day. The patient reported previous doses of GARDASIL 0.5ml intramuscularly (lot numbers not reported): the first on 13-JUN-2012, and the second on 09-JUL-2012, which she did not experienced any adverse reaction. No diagnostic laboratory studies were performed. The patient sought medical attention via office visit. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Partial seizure - new onset 1 week after varicella vaccine. 11/9/2009 hospital records for 9/5-9/10/2009. Patient with c/o's numbness and weakness rt arm and leg, confusion and headache. Neuro and rheumatology consults. Tx: IVF and pain meds. DC DX: Focal neurological deficit most likely related to complex migraine.
Patient developed spontaneous ecchymosis around the right eye. There is no other medical explanation of her spontaneous eye bruising identified
1-2 weeks after MMR and VARIVAX imm. Developed spots on face and irritability for 1 week; No BM changes. 2 wks later present with palpable purpura on legs, arms and mild on face. -No irritability and aching well.
1 day- chills, sweats,nausea and joint pain. 2 day- nausea, chills, joint pain, fatigue.  3 day- joint pain, "covid arm" appeared, fatigue.  4 day (today)- "covid arm", joint pain, fatigue.
Client fainted post second dose Moderna vaccine. States he has a history of passing out with needles.  Alert, Oriented, and answering questions appropriately.
Local reaction at injection site, lt arm, 5x9CM; abscess 2x2 CM - no culture taken; BP 156/90. Treated w/warm compresses & Cephalexin x 10 days.
Experienced generalized mid weakness 20 minutes after receiving the vaccine. BP 112/51, HR 71 O2 sat 97%
Associate developed symptoms of congestion, runny nose, and a sore throat. Received the vaccine in December 31rst 2020. I tested positive for covid on January the 6th. My symptoms lasted approximately 10 days, but they were very mild. I got my second shot on January 25th and did not have other reactions.
Patient's right deltoid has local swelling approximately the size of a golf ball. There is also some redness at the injection site.
Deep venous thrombosis involving the common femoral vein and  central portions of both superficial and deep femoral veins. Thrombus is also present within the saphenous vein.  symptoms- leg swelling and pain since 5/2/21
little achy; slept all day; Anxious; trigger finder which was better was all bent when I woke up; Tired; Headache; very depressed; very weepy/crying; really sad feeling; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (very depressed), CRYING (very weepy/crying), PAIN (little achy), SOMNOLENCE (slept all day) and ANXIETY (Anxious) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027821A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Spice allergy (chili) and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid disorder NOS.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced DEPRESSED MOOD (very depressed), CRYING (very weepy/crying) and MALAISE (really sad feeling). On an unknown date, the patient experienced PAIN (little achy), SOMNOLENCE (slept all day), ANXIETY (Anxious), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), FATIGUE (Tired) and HEADACHE (Headache). The patient was treated with DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for Adverse event, at a dose of 50 milligram once a day; LORAZEPAM for Adverse event, at a dose of .5 milligram twice a day; VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Adverse event, at an unspecified dose and frequency and DESVENLAFAXINE at a dose of 50 mg. At the time of the report, DEPRESSED MOOD (very depressed), CRYING (very weepy/crying) and ANXIETY (Anxious) had not resolved, PAIN (little achy), SOMNOLENCE (slept all day), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), FATIGUE (Tired) and HEADACHE (Headache) had resolved and MALAISE (really sad feeling) was resolving.            She went to neurologist and had EEG  and was seeking for therapy and transcranial magnetic stimulation and breathwork  to try to under control.   This case was linked to MOD-2021-375416, MOD-2021-380319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received added patient's demographics, concomitant and treatment medications were added and new events were added.
44 year old  male, while in post-vacc recovery area, c/o diaphoresis, feeling anxious, wiping sweat from brow and forehead.   Initial vitals: 144/80, 60, 20.  Encouraged to do breathing exercises to assist with relaxation.   Remained seated, upright. Second set of vitals at 0850: 11/60, 60. Reassessment of client- clam, no s/s of distress.   Final set of vitals at 0905: 110/78, 60.  Discharged from clinic at 0906, unassisted.
16 hrs post vaccine, severe chills, then dizzy when standing, dry heaves and diarrhea. BP remains normal 126/78, Pulse 70, EKG normal sinus, oxygen saturation 96-110% Extremely tired for another 12 hours
Flu like symptoms that led to passing out for approximately two minutes. After coming to my arms cramped and then my hands became contracted like lobster claws. I could move my arms and had some sensation in my fingers, but it mostly felt like pins and needles and I couldn't move my hands. It took 20 minutes of actively prying my hands against things to flatten them out. Anytime I tried to lift or use my hands they tried to claw up again. That lasted for six hours. I had muscle pain in my hands and arms that was severe for two days and is still mild over a week later now.
After injection pt had blood run down arm & small knot. Pt only bled for shot time and stopped with compression of cotton ball. Used alcohol pad to wipe blood from pt lower arm. Pt was afraid I hit an artery & said he had a HA (before vaccination) and heavy legs. Pt waited 15 min w/no other sx. Called pt at approximately 7:30 said he was fine.
Dizzy; Disoriented; Tired; Sad; Headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ep6955, Expiry date: Unknown), via an unspecified route of administration in left arm on 22Mar2021 13:45 as single dose for COVID-19 immunization. The patient had penicillin allergy. The patient reported yes for concomitant medications (other medications the patient received within 2 weeks of vaccination). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 12:00 PM, the patient experienced dizzy, disoriented, tired, sad and headache. Treatment was not received for any event. Patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Seriousness of events was considered as non-serious. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
On 01/23/20, 63 yo M presented to clinic for scheduled appointment. During this visit, pt was ordered and administered the second-in-series Varicella-Zoster vaccine IM (Shingrix). Per immunization record, 0.5 mL was injected in left deltoid at 0839 (Lot #EE924). Pt was discharged in stable condition. At ~2348, pt called nurse triage line and reported fever, body aches and shivering. Pt did not own a thermometer, so temperature was unknown. Pt was advised to go to ED. Per documentation, pt was transported to ED on early morning of 01/24. Per ED MD documentation, pt had "..no hives, no shortness of breath, no swelling, vitals and labs are reassuring." Vitals documented at 0115 included T: 37.9 °C (100.2°F). The only intervention documented included acetaminophen 650 mg PO at 0152. No other interventions were documented. Pt was discharged with instructions to follow up with PCP.
High fever; Dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (High fever) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (High fever) and DIZZINESS (Dizziness). At the time of the report, PYREXIA (High fever) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Left axillary lymphadenopathy at 5-8 days Nausea, Stomach pain, and diarrhea at 7 days post vaccine, lingering mild abdominal discomfort at 8-10+ days.  No sick contacts or unusual foods.  Tested negative for COVID on weekly testing.
Mild fever and a rash, the symptoms right at the day after and it last for 3-4 days; Mild fever and a rash, the symptoms right at the day after and it last for 3-4 days; Unusual symptom that she was like a little bit out of it and she was sleep talking; Unusual symptom that she was like a little bit out of it and she was sleep talking; She gave it (Trumenba) with Menactra and a Flu shot; Trumenba indicated that you can't co-administer with the other 2 shot; This is a spontaneous report from a non-contactable nurse received via  Sales Representative. This nurse reported for a 16-year-old female patient (reporter's daughter) that she received meningococcal group b rlp2086 (TRUMENBA), meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and an unspecified product (flu shot), all via an unspecified route of administration on an unspecified date at single dose for immunization. Concomitant medications and past drug/medical history were not reported. The reporter's daughter had a side effect for meningococcal group b rlp2086. Symptoms were mild fever and a rash, the symptoms right at the day after and it last for 3-4 days. Reporter was mentioning an unusual symptom that patient was like a little bit out of it and she was sleep talking and that's another sign now and reporter also did co-administer, she was a nurse, so she gave it to her daughter at the doctor's office. She gave it with MCV-4 (clarified as Menactra) and a flu shot. She just co-administered the 3 vaccine together and meningococcal group b rlp2086 was indicated that it couldn't be co-administered with the other 2 shot. The patient's outcome of fever and rash was recovered, and the rest of events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Patient c/o feeling warm and itching, VSS at 136/89, 02 97% with mask, HR 88. Flushing noted to chest and patient scratching UE bilateral. Dr. notified and gave orders for 8omg/ml x 1 dose and send patient to ED if symptoms do not resolve. Patient monitored 1 on 1 for 60 minutes, hives on chest resolving, scratching stopped. Patient had no SOB, no difficulty breathing, no sweating, N/V noted. VSS, family member, with patient and will go to nearest ED or call 911 if symptoms worsen. NP evaluated the patient prior to D/C.
Fatigue, nausea, joint ache, headache  Starting 30 minutes after shot All symptoms  still in effect  12 hours later
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a Dermatologist for a persistent vesicular rash which was diagnosed as chronic herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Extreme vertigo second day with vomiting, extreme dizziness 3rd without vomiting.
Patient had seizure 5 min after receiving shot.  Lasted 2-3 minutes, given versed IM and started to improve.  Monitored through post ictal phase - blood glucose was 186, BP 176/90.  Was able to walk after about 20 minutes but taken by ambulance to hospital for further monitoring.