chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes below her ears; her head hurt; a real red abrasive looking rash on her head; a scab that is healing right on her waterline; painful; broke out in a rash and it got real bad, it was miserable and horrible; her ears still hurt; eyes swelled close; a red rash that turned to lesions and there was pus in it.; This spontaneous case was reported by a physician and describes the occurrence of EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), RASH ERYTHEMATOUS (a real red abrasive looking rash on her head) and SCAB (a scab that is healing right on her waterline) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), SCAB (a scab that is healing right on her waterline), PAIN (painful) and RASH (broke out in a rash and it got real bad, it was miserable and horrible). On 18-Apr-2021, the patient experienced RASH ERYTHEMATOUS (a real red abrasive looking rash on her head) and HEADACHE (her head hurt). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes below her ears). The patient was treated with HYDROXYZINE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), RASH ERYTHEMATOUS (a real red abrasive looking rash on her head), SCAB (a scab that is healing right on her waterline), PAIN (painful), RASH (broke out in a rash and it got real bad, it was miserable and horrible), LYMPHADENOPATHY (swollen lymph nodes below her ears) and HEADACHE (her head hurt) outcome was unknown.        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.   No concomitant medication were reported.  Treatment medication also include pain pill, and fresh eye solution.   This case was linked to US-MODERNATX, INC.-MOD-2021-089663 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089663:
The pt experienced a "funny taste" in mouth, tingling and numbness in hands. Pt was given Benadryl and after 5 minutes the numbness was better and no tingling. Vitals improved 30 minutes after onset. Pt states had not eaten today. Coke offered to pt and she improved.
immed p/vax red, warm, macular rash lt arm, shoulder, rt shoulder lasted 1/2hr;
Vaccine was given past the 10 week thaw date. 10 week thaw date was 4/21/23, vaccine given 5/5/23
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 at 12:00 as dose 2, single (Lot number: EM9810) at the age of 82 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (05Jun2022) Positive, notes: five days after completing Paxlovid, positive rapid home test on day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks. COVID 19 Treatment with Pfizer Paxlovid from 26May2022 to 31May2022. Full rebound of symptoms on day 10 from positive test, five days after completing Paxlovid, positive rapid home test on day 10 on 05Jun2022 at 12:00.
Information has been received from a nurse practitioner (N.P.) concerning a 24 year old female with no pertinent medical history and no drug reactions or allergies who on 19-APR-2011 was vaccinated with a dose of GARDASIL (lot # 667194/1271Z, exp: 11-DEC-2012). There was no concomitant medication. The reporter stated that on 19-APR-2011 the patient had experienced flu like joint and body aches and/or pain since the injection. No treatment was given for this adverse event. Pap smear was performed with no result provided. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Follow up information has been received from the nurse practitioner (N.P.) concerning a 24 year old female with no pre-existing allergies, birth defects and medical conditions who on 19-APR-2011 at 8:45 AM was vaccinated with the first dose of GARDASIL (lot # 667194/1271Z) into left upper arm. The patient was not sick at the time of injection. On 24-APR-2011 the patient had flu like body aches, diarrhea, vomiting-became dehydrated. The patient was hospitalized for 5 days. The patient needed fluids. The patient had colonoscopy performed which showed nothing found. On around 20-MAY-2011 the patient recovered. Additional information is not expected.
PATIENT WAS ASKED IF HERE FOR COVID SHOT SAID YES . HE FILLED OUT PAPER WORK AND SIGNED . GIVEN VSAFE AND PFIZER INFO. AFTER GETTING VAC  TOLD US HE HAD THAT SHOT ALREADY AND WANTED A SHINGLES SHOT.
On day of vax and day after, pt had progressive symptoms of Anticholinergic overdose with dry mouth, elevated heart rate, significant confusion, agitation and hallucinations.  Resolved spontaneously, no know ingestion.
Exhaustion began 12 hours after vaccination and progressed  to lightheadedness, muffled hearing and the inability to stand without feeling faint.  Chills, fever of 100-101 began at 18 hours after vaccine.  At 26 hours post vaccine fever has reduced to 99 and ability to stand without feeling faint has increased
pt recv vax 1/18/97 & 1/25/97 pt exp a fever of 105.8, swollen glands in neck & groin, pain in the legs & arms & a rash on chest;
Left leg with large area of redness, warmth and swelling upper thigh to knee with 2 puctate wounds where IPV and DTaP were given. Symptoms noticed 8/14/03 2nd day after immunizations were given. Tx with Augmentin and Atarax for 10 days.
This spontaneous report was received from a nurse and refers to a 14-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-DEC-2018, the patient was inadvertently vaccinated with MMR II, (recombinant Human albumin (rHA)), lot# M049212, expiration date 16-12-2018, (dose and route of administration were not reported) for prophylaxis, which was expired. No adverse effects were reported.
First couple of hours hands feet face flushed red, itchy all over. Over next 24 hours developed pain, cramping, tingling and weakness in my arms hands lower legs and feet. At 48 hours still had tingling and cramping in hands and feet, weakness improved. As of today I'm still having tingling and now have decreased sensation in my feet and cramping in my muscles. I feel overall improved in areas, I'm assuming this will go away with time.
patient received two 0.25mL Fluzone Quadrivalent doses on 13Nov2019 due to inadequate supply of Fluzone Quad 0.5 ml, no AE; Initial information received on 23-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 12 years old male patient who received 0.5 ml vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U6653BD and expiry date: 30-Jun-2020) via intramuscular route in the left arm, on 13-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong technique in drug usage process. It was reported that 12 year old patient received two 0.25mL Fluzone Quadrivalent doses on 13Nov2019 due to inadequate supply of Fluzone Quad 0.5mL.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Within 2 hrs---Blinding headache, confusion. At 12 hrs---Blinding headache, extreme confusion, fatigue. At 24 hrs---chills alternating with sweating, Blinding headache, extreme confusion, fatigue, bone aches-wrist and ankle. Left work early because of symptoms, unable to perform any activities other than complete bedrest. Blinding headache not relieved by 800mg ibu. Difficultly falling asleep. Woke up in 4 hrs when 800mg ibu wore off and need another dose. At 36 hrs---headache present (but improved from previous), extreme fatigue. ***Experienced similar with first dose (7/2018) but onset of symptoms was swifter with 2nd dose. 1st dose fatigue did not resolve for 21 days.
Swollen erythematous R thigh 24 hrs after vaccinations. Treated with Benadryl, Motrin, and ice. Worsened over 48 hrs then began to improve.
Rash developed on bilateral antecubital fossa. Red, raised papules. Scabbing over. More developed; One on the back, one on the R axilla, left knee, R forearm.
Verbal report of painful blistering to both inner arms, chest, (L) buttocks, patient to be evaluated by PCP office today.
Arm soreness; stuffy nose/congestion; tired; knee pain; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on the left arm on 29Dec2020 12:30 at single dose for covid-19 immunisation. Medical history included tree fruit allergy. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (ADVIL). The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient experienced arm soreness, stuffy nose/congestion, tired and knee pain on 29Dec2020 17:30. The patient did not receive treatment for the reported events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: pending on 29Dec2020. Outcome of events was recovering.  Information on the lot/batch number has been requested.
Pt was diagnosed with bronchitis 2 weeks ago.  States that her cough is improving, but she has increased weakness.  There is evidence of right lower lobe pneumonia.
Child fainted immediately upon walking from immunization room (immediately after receiving shots). Small duration (5-10 seconds) seizure observed. Pt awakened quickly cried and irritable when aroused fully T97.6-98 via ear probe thermometer.
After vaccine pt felt dizzy. Drank water and sat an additional 15 minutes and felt better
Subcutaneous vaccine injection site developed in to large, hot, itching rash about the size of an adult hand. Patient took pictures and went to local emergency room for reaction on 04/21/2022. Emergency room physician prescribed unknown steroid cream for patient to apply. Rash resolved within 7 days.
stroke-like symptoms, nonverbal within 18-24 hours after booster injected.. Patient had a stroke the  day following the  first vaccine in January.  Patient had waited 3 months after testing covid  positive to receive the first vaccine
Itching Rash that keeps growing in a circle pattern.  I received the vaccine 11 days ago and rash keeps growing.
Narrative:  Patient called to report he is having side effects of 2nd COVID vaccine . Patient reports he initially had a fever, and chills which have resolved. Patient states but he is now extremely fatigued, nauseated, and loss of appetite.
Next day red ring around site R arm-10/29/03 red area increased swelling, hot, pain shoulder into neck. MD-Keflex ordered.
Very tired, a little nauseous, sore arm at injection place.  During night feet cold but upper body hot.
I 'm trying to get someone to update my VAMS account. I did get my second Pfizer Covid-19 Vaccine shot on 2/9/2021 about 6:30 pm at vaccine location. Vaccine Lot EN6201 EXP.6/21 Please let me know you received this information and can correct it. Felt sluggish the next day only. Thanks.
achey neck; soreness in the upper body; fatigue; brain fog; Type 2 Diabetic/issues maintaining blood glucose levels/flared up again/BG levels were erratic; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single ad received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus and covid-19 from an unknown date. The patient's concomitant medications were not reported. On 07Jul2021, type 2 diabetic/issues maintaining blood glucose levels/flared up again/bg levels were erratic, achey neck, soreness in the upper body, fatigue and brain fog. The patient was a long distance cyclist so he got his fair share of exercise. He eat moderately good and was a Type 2 Diabetic. After his COVID infection in February it took months for my blood sugar to stabilize. He could eat perfect and exercise and would wake up with bizarre fasting Blood Glucose levels. This settled down and then flared up again after he had the first dose of the Pfizer vaccine. For 3 weeks my BG levels were erratic and then every so often they would be erratic or he would have to be so much more religious to get the levels down to manageable levels. After his second vaccine he had the same exact symptoms. BG levels were all over the place. In addition, both times he got the vaccine and it brought on the same exact COVID symptoms with the achey neck, soreness in the upper body and fatigue as well as brain fog. After meeting with His endocrinologist a couple of weeks ago he said that the majority of patients have found that they were not able to control their BG levels for 1-3 weeks after getting vaccinated. The patient underwent lab tests and procedures which included blood glucose: unknown (For 3 weeks, erratic and then every so often they would be erratic, blood glucose: unknown (After his second vaccine he had the same exact symptoms. BG levels were all over the place ), blood glucose: unknown (wake up with bizarre fasting Blood Glucose levels). The outcome of events were unknown.  No follow-up attempts are possible. No further information is expected.
Patient was hospitalized due to COVID-19 from May 19, 2021 to May 22, 2021. Patient was then placed on hospice on 6/5/2021 and expired on 6/7/2021.
Booster administered less than 6 months after completion of primary series. Dose #1 6/8/21 and dose #2 7/28/21.
Hospitalized with COVID 19 pneumonia, fever ,cough, dyspnea, generalized weakness, and recurrent falls and NSTEMI
Injection site discoloration; injection site became swollen with a reddish purple circle around; injection site became swollen with a reddish purple circle around; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingrix .5 ml. In July 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site discoloration, injection site swelling, injection site erythema and fever. On an unknown date, the outcome of the injection site discoloration, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site discoloration, injection site swelling, injection site erythema and fever to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: The case was self reported by the patient. The patient received first dose of Shingrix vaccine 2 weeks ago. The patient experienced a fever and injection site reaction. The patient stated that the injection site became swollen with a reddish purple circle around the site. The patient stated that the fever had recovered and the redness at the injection site was improving, but still it was there. The caller disconnected prior to getting further information about the event and vaccine itself. The reporter did not consented to follow up.
Rec'd GARDASIL #1 on 11-30-12. Mother states c/o nausea Friday night. Child awakened Saturday am & went to shower. Mom heard her collapse, patient came out of shower, vomited, became dizzy again. C/o of feeling "stiff" symptoms lasted about 1 hr & then were gone. Mom states she doesn't want her to have any more GARDASIL.
pt recv vax & waited 4 months p/2nd dose of vax to become pregnant & lab eval revealed no immunity to varicella;
Breakthrough case admission after 2 vaccines ; Pfizer 4/10/21 Lot# Ew0162;  Pfizer 5/1/21 lot# Ew0172
After 1 series of Hep B vaccine (4/20/07, 12/21/2007 and 02/15/2008) post-vaccine HBsab was negative (titer on 3/10/09). Follow-up Information 23-MAR-2009: I am requesting that this VAERS record be either deleted or corrected to reflect the following information: This record was initiated because the submitter understood that a VAERS Report was to be filed when a client received the 3-dose adult series of Hepatitis B vaccine and then was found (by immunity titer) to be a "non-responder", but the client in fact did not have a titer drawn at all. The VAERS report states in Question #7 that the client had a post-vaccine Hep. B Surface ANtibody (titer) drawn on 3/10/09 when in fact it was a Hep B Surface Antigen which, of course, does not check for antibodies in response to vaccine. Therefore, this VAERS report was completed in error.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unspecified date in 2014 (a year ago), the patient received her first dose of GARDASIL (lot #, expiration date, dose and route were not reported) and on 24-JUN-2015, she received a second dose of GARDASIL (lot#, expiration date, dose and route were not reported). No adverse effect reported. Additional information has been requested.
sore shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of arthralgia (1st dose received on an unknown date refer case US2022AMR089793).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder soreness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR089793   Additional Information: GSK Receipt Date: 05-JUN-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine and only reaction the patient experienced was a sore shoulder for a couple of days. The patient reported that they said if you drink plenty of water throughout the day when you get it you did not have as many reactions really recommend getting it. Additional supportive information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR089793:same report, other dose
I've been feeling unusual/new joint and nerve pain in toes, first on right side and then also on the left, and tingling in extremities as well as joint/pain in hands. The vaccine also caused unusual cramping and changing the timing of my menstrual cycle.
Pt recvd 1st MMR vax on 18FEB92 & on 2MAR92 pt devel cold sx consisting primarily of runny nose & a cough; 6 days later pt devel rash all over body; @ time of the report pt had t100.8; no further detials were provided;
PATIENT WAS ACCIDENTALLY ADMINISTERED HIGH DOSE FLUZONE WHEN THEY WERE 63. CONTACTED PATIENT AND LEFT VOICEMAIL BUT HAS NOT RETURNED OUR CALLS.
From faxed info received at manufacturer on 1/13/03 from (WAES97121476), it was reported: "A Comparative Study of the Safety, Tolerability, and Immunogenicity of Comvax Given Concomitantly Versus Nonconcomitantly With a Primary Series of DTaP and IPV." Information has been received concerning an 11 week old male who entered a study, title as stated above. On 9/26/97, the pt was vaccinated with the first dose of Tripedia, IM and the first dose of IPOL, SC. On 10/9/97 the pt was hospitalized and underwent a right inguinal hernia repair from which he subsequently recovered. The pt did not receive haemophilus B congugate vaccine+hep B vaccine recombinant, prior to the events. The pt was withdrawn from the study on 12/1/97 for reasons not yet determined. The reporting physician felt that this experience was not related to study therapy. No further info is available. Reported on 02/27/2003: "The manufacturer for Tripedia, which is an Aventis Pasteur product, was listed as Merck, Sharp & Dohme.  Further clarification is needed.  From email correspondence received at Aventis Pasteur Inc. on 02/10/2003, it was decided that this case should have not been submitted to the FDA because it is part of a study and would have been submitted under an IND.  Case is closed.
Seizure (afebrile) x 2 next day. Taken to ER via EMS. Fully recovered at ER. Neurologist recommended KEPPRA.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was acute on chronic systolic heart failure.
Developed painful, erythematous lump at vaccination site 7 days after administration. Possible delayed-type hypersensitivity reaction.
Patient had appointment for Covid-19 vaccination.  He filled in the form that he has not have any covid vaccine before and we also verbally asked if he has ever has any other Covid vaccine.  We proceed the the Pfizer vaccine 1st dose as patient request.   At the end of the day, we processed the vaccine through billing insurance.  We get a denial for Medicare part B information.   We called several times to patient but he had not respond.  We checked the immunization website and  it showed he already had 2 Pfizer Covid 19 on Jan/25/2021 and 02/18/2021.
spontaneous prolapsed uterus requiring total hysterectomy; no history of abnormal pap smears, no history of prolapsed uterus; no history of any female related issues
Patient reports she formed  a "ping pong" sized lump at the injection site, she denies redness/drainage
Localized reaction to the left deltoid, arm swollen, warm to touch, some cellulitis. Treated at clinic with Augmentin 400/5ml 1 tsp bid x 10d.