chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports in left arm around the injection site a 4" diameter red spot, warm to the touch and swollen. In addition she has felt fevered/sweats, headache and nausea. She complains of "not feeling herself".    Patient called doctors office who instructed her to take ibuprofen and benadyl. If fever reoccurred or persisted then to go to urgent care with it being a Friday
Since July 10,2021, I started with a strong cough, by early morning I had a headache, I took medicine for the migraine, but it didn't work.  I got strong body pain, the next day I had a fever for 3 hours, never lost smell or taste, but my taste and smell changed, everything tasted horrible.  I continued like this, tired, fatigue, the next day I felt like asthma, fatigue and cough.  Almost 40 days I had strong fatigue.  Since the second day I didn't eat anything, just a little coffee, for fear of the headache, I lost weight approximately 30 pounds.  From one ear I do not hear well, and my vision has gotten blurry.
Pt recvd 2 doses of Engerix-B; pt exp no problems p/1st inject but 2 wks p/2nd inject devel itchy rash on arms; rash faded on arms but then devel all over abdoment & was extremely itchy;
5/06 Onset with  edema, calf pain rt lower leg . 5/07  INR 2.0,  5/09 medical exam w/ ultrasound (result of 5 cm clot in peroneal vein), INR that day 2.7.  Warfarin/ INR  has been in good control for years after DVT/ PE event in 2005.  Decision was to stop Warfarin and begin Apixaban and a hematology consult.  Symptom are gradually resolving.
About 2 week after the shot I began to get a rash on both arms and legs. The rash was very red and bumpy. It would last a week, go away for about 3 weeks and then return. This went on from April to about August.  I would also feel a tightening in my heart. It felt as if someone was squeezing it; this happened about twice a month from May to July. My menstrual cycle has changed drastically. A month and a half now goes by between each cycle. I know that it is the vaccine because I have been on my current birth control for two years now.
Pt moved during injection, partial dose lost/not injected. Pt vaccinated again per doctor's instructions (md on site)
Pt vaccinated with DTP began wheezing within 3-8minutes & a rash developed, type unknown, child may have been wheezing before immunization but definitely more pronounced afterwards. Required Epinephrine & ER visit.
This prospective pregnancy case was reported by a pharmacist and described the occurrence of low blood sugar in a neonate male subject whose mother was vaccinated with BOOSTRIX (GlaxoSmithKline). On 29 January 2014, the 29-year-old subject's mother received an unspecified dose of BOOSTRIX (transplacentary, administration site unknown). The subject's mother last menstrual period was on 3 June 2013 and estimated date of delivery was on 6 March 2014. The neonate was exposed to the vaccine during the third trimester. At 39 weeks gestation, the neonate was delivered by normal vaginal and weighed 7 lb. At an unspecified time after birth, the neonate experienced low blood sugar. Therefore, he was hospitalised for 3 days. At the time of reporting, the outcome of the events was unspecified. Please see report A1059531A for details regarding the mother case.
Per mom-immediate fever, child could not be touched or moved, fever of 102 for 5 days with constant screaming, personality change and child could not handle being touched, changed or held.
1st Covid vaccine 12/19/20 Pfizer EH9899 @ 0930 2nd Covid vaccine 1/9/2021 Pfizer EL3246 @ 0930 2/26 Covid symptoms 3/2 tested positive for Covid,  lost taste/smell, had covid tongue with ulcers in mouth - seeking medical attention
Lots of pain on legs and hands, burning sensation on them, pressure when breathing in chest on left side, sore throat on and off
Information has been received from a physician concerning an 18 year old female who was vaccinated IM, first dose, with Gardasil vaccine (yeast). Subsequently the patient experienced itching both arms after receiving the vaccine. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 07-SEP-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered severe visual impairment and vision loss. As a direct and proximate result the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Acute severe visual impairment and vision loss were considered disabling. Upon internal review, acute severe visual impairment and vision loss was determined to be medically significant. Additional information has been requested.
Patient still reports sharp pain next to site of injection when he is moving it after 3 months of injections
Information has been received from a Pharmacist concerning a 77-year-old male who on 05-OCT-2007 was vaccinated subcutaneous with a 0.65 mL dose of zoster vaccine live (Oka/Merck). On 24-OCT-2007, the patient developed pimples on his neck, and secondary infections. The patient was treated with Valtrex for the latter event. Pharmacist stated the patient informed her that a physician diagnosed him with shingles "per he latter event". At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a Pharm D. concerning a 70-year-old female (previously reported as 77-year-old male) with no pertinent medical history of allergies who on 05-OCT-2007 (also reported as "10-10-08") was vaccinated subcutaneous in the right arm with her first 0.65 ml dose of ZOSTAVAX (Merck) (lot # 658208/0886U). There were no illness at the time of vaccination. Concomitant therapy included clonazepam, gabapentin, tramadol HCL and TAZORAC 1% cream. It was also reported the patient broke out in painful lesions, saw a dermatologist and was diagnosed with shingles. The patient was treated with VALTREX 1 gm on 01-NOV-2007 for the latter event.
I received sore throat; fever; upper respiratory for about 4 days and I took Tylenol and I felt better.
marked maculopapular rash over extremities w/some involvement of  face, neck, trunk & le ;pt initially w/temp & 4-8 small lesions some w/vesicles;also tx w/ATB for ROM then rash progressed;
SWEATING; CHEST PAIN; SEVERE STOMACH PAIN; LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAR-2021, the subject experienced chest pain. On 29-MAR-2021, the subject experienced severe stomach pain. On 29-MAR-2021, the subject experienced leg pain. On an unspecified date, the subject experienced sweating. Treatment medications (dates unspecified) included: pantoprazole sodium sesquihydrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe stomach pain, and the outcome of chest pain, leg pain and sweating was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Patient went to Emergency Department on 9/14/11 with abdominal pain, body aches and fever.  Fever in E.D. was 100.2, Pulse 97, Resp. 18, B/P 130/85.  Patient reported swelling of left arm.  E.D. report indicates hot and tender area of left deltoid area at site of immunization. No adenopathy of neck.
Generalized pruritic rash. Pt was given BENADRYL 25 mg 0.5 ml IM.
Vaccinated 1.19.10 then developed itchy hives on bilateral upper extremities and chest, which resolved with BENADRYL per the patient.
Affect family administered at 07/08/2019. The patient reports within 1 minute of vaccine she had pain. Vaccine was given in the upper outer arm. States that she had progressive swelling and redness that stretched from her inner biceps area halfway up the arm up to past her shoulder near her neck. She states that the pain was severe and was not relieved with aspirin 325 mg, a hot shower or almost constant ice to the area. Rest did not help. She states that she was unable to lift the upper arm due to the pain. This continued until 07/13/2019 when she was able to move her arm. Over the last 48 hours the swelling and redness has subsided substantially. She is now able to lift her arm at the shoulder.
11/28/2022 - I was running a fever of 101.0, body aches, fatigue, stomach ache. Took a home COVID-19 test and was positive. Symptoms lasted about 4-5 weeks after onset of symptoms.
Began with very watery diarrhea followed by vomiting. Intermittent vomiting and diarrhea persisted for at least one week.
My menstrual cycle is now irregular though I?ve been very regular. My last 3 cycles have been very late or not at all. I am not pregnant.   I also had the typical cold like symptoms for the first few days following my second dose- low fever, nausea, chills, fatigue and, of course, a sore arm.
Started breaking out in hives underarm and then to leg and back.  She said there was a lot of itching. She went to see ER. doctor on 8/13/2016.  Doctor prescribed prednisone and Benadryl.
Per patient's daughter after she received her vaccine she had a raised red area on her left deltoid. As time progressed the redness and spread from the deltoid to her antecubital. Upon this nurse's assessment the area from the patient's left deltoid down to the antecubital site was red and very warm to the touch. Patient's daughter stated that her mother had no pain and has not had fever since the vaccine, just the rash.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 30 month old female patient who experienced softball sized nodule on the upper thigh. At 30 months of age, the patient received a dose on 17 Sep 2010. Patient received PREVNAR therapy on 17 Sep 2010. On 19 Sep 2010, the patient experienced softball sized nodule on the upper thigh and was taken to emergency room. Patient was discharged on the same day. As of 20 Sep 2010, the outcome was unknown.
patient was only given a diluent of ActHib vaccine, no symptoms noted other than soreness to both lower extremities due to having four vaccinations that day per mother
Started with increased fussiness, lack of sleep, and crying on date of vaccination. By morning of 1/1/2013, infant had small hive like bumps extending from abdomen and core to upper legs, arms, neck, face, and behind ears. Symptoms have continued and have also included increased reflux with decreased appetite. All symptoms including rash/hives have not subsided as of 1/4/2013.
Vaccine expired on 11/1/21. administered 11/5/21. Reported no side effects after vaccine
Pt recvd Engerix-B, 3rd dose given APR90; pt's titers were tested following exposure to a pt w/Hep & it was determined that pt did not seroconvert;
Patient is a healthcare worker who needed Tdap booster - reported today that she had lump & redness at injection site. Palpable 3 cm x 4 cm lump - red - tender to touch. Never had reaction with other vaccines.
After minutes of observation, pt was driving home, at about 35 minutes after vaccine was administered pt felt thickening of tongue, feeling tightness in throat, lips feeling thick, stopped at a pharmacy bought OTC allergy medicine Zyrtec , took it & went home. Also took Benadryl when she go home
Administered expired vaccine to 6 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 6 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 6 patients). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 6 patients) had resolved.        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.   Reporter stated that they had a Moderna vial expired on that day at 6 AM but they have it administered to 6 patients until 11 AM. The vaccine was removed from the freezer at 20-Oct-2021 at 6 AM, and was out for more than 24 hours. Lot no: 050C21A and expiration date: 06-Nov-2021.  No concomitant medications or treatment details were reported.
Muscle injection site swelling and pain that started approx. 8 hours after Fatigue (patient states she is 4 days away from starting her period and feels this may be contributing to fatigue) Scratchy throat
One day post flu vax, experienced temps 100.0 - 100.3 F nightly, extreme fatigue, muscular aching w/ burning sensation.  Has continued thru today.
5 minutes after receiving his vaccination, he reported feeling lightheaded. He was taken to a private section of the arena and monitored
Shingles; Dose received: 3; Dose received: 3; This is a spontaneous report from a non-contactable consumer (reporting for herself).  A 58-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in the right arm on 28Sep2021 at 14:00 (Batch/Lot Number: FE3592) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (INFLUENZA) taken for immunisation from 27Sep2021 to 27Sep2021 in the left arm; venlafaxine hcl (VENLAFAXINE HCL) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took demerol and amoxicillin and experienced drug allergy. Historical vaccination included first dose of BNT162B2 administered on 05Mar2021 at 15:30 in the right arm, Lot number: EN6205 for covid 19 immunization, and second dose of BNT162B2 administered on 26Mar2021 at 15:30 in the right arm, Lot number: ER8732 for covid-19 immunization. The patient did not have Covid prior to vaccination. The patient did not take a covid test post vaccination. The patient experienced shingles on 28Sep2021 at 17:00. The event of shingles resulted in emergency room/department or urgent care visit. The patient was given Valacyclovir HCL 1 Gram as treatment for shingles. The outcome of event shingles was recovering and for the at risk events was unknown.   No follow-up attempts are possible. No further information is expected.
Hives. Within 20 minutes of receiving vaccines at 4 month well child visit developed hives.
Soreness around the injection site for approximately 30 hours.; This is a spontaneous report from a non-contactable consumer. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN5318), via an unspecified route of administration in right arm on 26Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness around the injection site for approximately 30 hours on 26Jan2021 10:15 with outcome of recovered. There was no treatment for the event.  No follow-up attempts are possible. No further information is expected.
Initial report received on 17 June 2013 and follow up information received on 21 June 2013 from an investigator participating in a study. A 15-month-old female subject had febrile seizure on 17 June 2013 i.e. 06 days after receiving second intramuscular dose of the study vaccine MENACTRA in the right thigh on 11 June 2013 (Batch number U4331AA). The subject received first intramuscular dose of the study vaccine MENACTRA in the right thigh on 05 December 2012 (Batch number U4331AA). The subject had current herpangina infection and past  history of febrile seizure. The subject was concomitantly on MOTRIN 160 mg/5ml per OS for fever from 17 June 2013. The subject was very tired day prior to SAE became fussy at about 12:30. Her parents took temperature at about 01:30 which was 101.0 F tympanic. She had fever on 17 June 2013. Her parents gave her MOTRIN. At 02:00, the subject had seizure that lasted about 4 minutes. Her parent rechecked temperature, which was 103.5 F tympanic. Parent gave her MOTRIN at 05:00 and 08:30. The subject had another seizure at 09:45 that lasted 5 minutes and temperature at that time was 102.7 F tympanic. She was seen at provider's office at 11:00, with a fever of 102.7 F documented. Lab investigations were not performed. The subject received corrective treatment with TYLENOL every 4 hours for 24 hours and ADVIL every 6 hours and push fluids. The event of febrile seizure was resolved on 17 June 2013. The outcome of the associated symptom of fever was not reported. The event of febrile seizure was considered important medical event "as per protocol seizure". The event of febrile seizure was not related to the study vaccine or to the trial procedures. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: None. Follow up information received on 11 July 2013. The associated symptom of fever resolved on 18 June 2013. This case is linked with AER# 2013-04026 (SAE# Febrile seizure from 12 March 2013 to 13 March 2013). Follow up information received on 27 August 2013: The subject was concomitantly on MOTRIN till 19 June 2013. She also received TYLENOL from 17 June 2013 to 19 June 2013, per OS, dosage: unknown, for fever. The associated symptom of fever resolved on 17 June 2013 and not on 18 June 2013 as reported earlier.
THIS IS NOT AN ADVERSE EFFECT , WE USED THE MODERNA ONE DAY AFTER THE BEYOND USE  DATE  , THE LOT NUMBER DID NOT EXPIRE , WE HAVE CALLED MODERNA, PATIENT HAVE NOT REPORTED ANY ADVERSE EFFETS
Redness at injection site. Itchy and painful injection site. Extremely sore muscles throughout the body. Lethargy.
patient reports the first few days she experienced numbness ad tingling (2/12-2/15) to bladder and bilateral feet, around 2/18 her entire neck began to feel inflamed and she is still experiencing this, the neck inflammation is causing pain at a level 4 on the pain scale. Had visited the chiropractor with minimal reduction in symptoms. Has had some abdominal pain that is still present, began around 2 weeks post vaccine, this pain varies in location and is described as short lived shooting pains.
Rash, itchiness, redness, swelling at injection site a week after injection.
Erythema multiform minor of hands and feet; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed erythema multiform minor of hands and feet.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, approximately 7 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient developed erythema multiform minor of hands and feet mostly. On 19 Jan 2021, the patient had a telehealth visit with an allergist, who confirmed the diagnosis. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, erythema multiform minor of hands and feet was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication is not provided. The patient experienced an unexpected and medically significant event of Erythema multiforme. The event occurred approximately seven days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Treatment details were not provided. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
06/29/09  Pt came in today c/o redness on left deltoid had fever X 2d.  Used alcohol on area.  Redness & swelling warmed to touch 6" X 4 1/2"
1-2 days p/vax high fever & sore throat, also several bouts of diarrhea;
I would like to reports some symptoms I had; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (I would like to reports some symptoms I had) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (I would like to reports some symptoms I had). At the time of the report, ADVERSE DRUG REACTION (I would like to reports some symptoms I had) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Diffuse pain and rash 09/12/2015 to 09/14/2015.  Pain resolved and itching began 09/14/2015 PM.  Itching severity gradually worsened. Hydroxyzine po administered by wife 09/14/2015 and 09/15/2015 at bedtime improved itching.
Within a minute of administration, patient became diaphoretic, pale, vomited. Chair reclined. After vomiting, she immediately felt better. She was given water and monitored for 30 minutes. Upon assessment, it appeared as though patient was having a significant amount of anxiety at the time of injection, possibly causing aforementioned events.