chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), FLUSHING (Face became flushed and hot), HYPERTENSION (His blood pressure was high), PAIN IN EXTREMITY (soreness in his arm) and BACK PAIN (Slight soreness in his back) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Heart attack and Blood pressure high. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUSHING (Face became flushed and hot), HYPERTENSION (His blood pressure was high), PAIN IN EXTREMITY (soreness in his arm) and BACK PAIN (Slight soreness in his back). At the time of the report, DIZZINESS (dizzy), FLUSHING (Face became flushed and hot), HYPERTENSION (His blood pressure was high), PAIN IN EXTREMITY (soreness in his arm) and BACK PAIN (Slight soreness in his back) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment medications included Tylenol. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-101401 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up information included outcome of the events
About 2 hours after vaccination Mother noticed fever of 102F and administered 7.5ml of Motrin and Pt rested on the couch. after another hour and a half  the fever had not improved and Mom  gave 7.5ml of Tylenol. After the Tylenol mother noticed that the Pt was staring off into space and would not acknowledge his mothers presence. Mother also noted the Pt was shaking as though he was cold and decided to bring him upstairs to bed. Pt was also refusing water and mom tucked him in and watched him and believes that the fever reduced while the pt slept for 2-3 hours. Pt woke up and was  not happy until he was fed ice cream and his reheated dinner. At around 1030 pm pt went back to bed. Pt woke up at around 2AM and was given more 7.5ml Motrin due to another 102F fever and went back to bed. Pt woke up around 6 am and was given Tylenol preemptively and ate breakfast and seems to have recovered.
Patient reports feeling shoulder pain, initially unsure if related to the vaccine. She describes the pain as sharp/stabbing when moving her arm above her head. It increases with movement, no pain at rest reported. She initially visited an urgent care facility where they prescribed a 2 week prednisone burst, during which the pain got better. After the steroid course the pain returned back to baseline.
Case number PHHY2011US52502 is an initial spontaneous report received from a consumer on 13 Jun 2011. This report refers to an adolescent female patient. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 10 Jun 2011. Several hours after vaccination, she developed a headache. The headache became intense during the evening on 11 Jun 2011. Finally, the headache resolved on an undetermined date.
Pt given HPV #2, Hep A 2nd dose, pt. gradually laid down displaying brief syncope episode. PT was assisted down, vitals taken every 10 min. All V/S were within normal limits. Patient was left alone 1 hr after episode. Monitored frequently by dr. Patient was doing well.
Dark, red, warm, swollen area localized over left deltoid area.  Low grade fevers.  Visited ER, urgent care, and pediatrician for follow-up 4 times during week after onset of reaction.
When administering vaccine to patient's left thigh, the patient pulled their arm away and out of parent's grasp and pushed my (administrator) hand away with the vaccine. The vaccine was not fully administered into patient's thigh and the needle was then bent in the process and dropped to the floor. I immediately covered the patients thigh with a child's bandaid that the patient's mother approved prior. I then left the room to find the provider that was seeing the patient's sister to inform her of the incident and ask her to check the patient. The provider then cleared her and they were free to go home.
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.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 22Sep2021 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 28Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: awaiting bilateral mastectomi which, was postponed due to getting Covid; "positive for CHEK2 variant." (unspecified if ongoing), notes: positive for CHEK2 variant; "Known allergies: dairy products" (unspecified if ongoing); "Known allergies: yellow dye, blue dye, red dye" (unspecified if ongoing); "Known allergies: Tegaderm" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical Information:adverse event: I was feeling well again after finishing Paxlovid the morning of 22Jun. On 26Jun I woke up with cough and runny nose and it has only gotten worse. As of 29Jun coughing a lot, but no high temp. report about covid treatment: Yes.If vaccine received: Yes.Other medication in 2weeks: Yes.Anti viral details: Product-COVID 19 Treatment, Brand-Paxlovid Treatment start date- 16Jun2022, Treatment stop date- 21Jun2022, Indication: Treatment of COVID-19.Adverse event start date: 25Jun2022.Ae resulted in: [None of the above].If patient recovered: Not recovered.If treatment ae: No.
Had ER visit on 5/20/11 for hives, big welts with induration on (Lt) thigh & vomiting. Diagnosed with allergic reaction secondary likely to vaccines received on 5/18/11. Treated with BENADRYL & DECADRON.
Hives began at 1:00am on 01-14-2021. Hives on hands, arms, axilla, anterior trunk and upper legs. Hives are warm to touch and pt. complains of moderate itching. Seen by MD on 01-14-2021. Was advised to take Benadryl 25mg every 4 hours as needed for itching.
pt returned to hlth 31 hrs p/vax t101 & hives across trunk & lower extremities; was referred to pvt MD DPH & antipyretics were prescrived which resolved sx;
Patient complained of cough, fever, runny nose, headache, chills, vomiting.
Mother called nurse triage line at 4:28pm 9/8/2014. Patient was experiencing dizziness, weak, rapid heart rate and said she was not feeling good.
woke up a little tired; Achy arm; Diarrhea; Inappropriate schedule of vaccine administered; A spontaneous report was received from a consumer who was also a 74-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced diarrhea, achy arm/vaccination site pain, tired/fatigue and inappropriate schedule of vaccine administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot: L0AM20A) on 28-Jan-2021. On 16-Feb-2021, approximately 6 hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Six hours, after receiving the second dose of the vaccine the patient reported that she had diarrhea, just once. She stated that went to sleep and woke up a little tired the next day and had some diarrhea. The patient reported that she was a little tired and slept for nine and a half hours.  She also stated that she had an achy arm. On 17-Feb-2021, she stated that she was feeling fine at that time.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, diarrhea, achy arm/vaccination site pain, tired/fatigue, was considered unknown . The outcome of the event, inappropriate schedule of vaccine administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 74 Y/O F with nonserious unexpected event of inappropriate schedule of product administration with mRNA-1273 (lot # unknown) and adverse events of NS unexpected diarrhea and NS expected vaccination site pain, fatigue.  Adverse events occurred 6 hours after second dose mRNA-1273, and event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Both feet swollen, right toe hurts, heels hurt. First few days was hard to walk. It is better now but still a little swollen and heels and right toe hurt
reaction he experienced was close to anaphylaxis; This is a spontaneous report received from contactable reporter(s) (Nurse). Other Case identifier(s): 2022NVX-US-000003757.  An 18-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Apr2021, when the patient was 16 years old, for COVID-19 Immunization, reaction(s): "allergic reaction".  The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "reaction he experienced was close to anaphylaxis".  Clinical course: On 06Oct2022, it was reported that a patient started treatment on an unspecified date in Apr2021 with Pfizer BioNTech COVID-19 Vaccine for COVID-19 immunization. It was reported after the 1st dose, the patient had an allergic reaction, and after the 2nd dose, the reaction he experienced was close to anaphylaxis. No further follow-up is anticipated  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ANAPHYLACTIC REACTION and BNT162B2.
About 10 minutes after both vaccines were administered, patient developed rash on both arms in elbow area, a small rash on chest, and several small blotches on neck.  A single dose of oral diphenhydramine 25mg was administered.  After 45 minutes of observation, the patient was released from care.  Rashes were almost completely resolved, and patient said she was only experiencing mild dizziness/drowsiness.
This literature marketed information has been received from a published literature article and refers to 16 patients younger than 65 years old. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Prior or after the protocol implementation on an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, vaccination site were not provided), for prophylaxis, which was not correct as they should had received PREVNAR. This is one of two reports from the same literature (US-009507513-1903USA001313, US-009507513-1902USA002078, US-009507513-1903USA001314 and US-009507513-1903USA001316). ; Sender's Comments: US-009507513-1902USA002078: Original Case : 1902USA002078.
Information was received from licensed practical nurse concerning multiple patients of unknown age or gender. It was reported that on multiple unspecified dates after 20-JUL-2015 temperature excursion, multiple unspecified patients were administered improperly stored PEDVAXHIB (lot # J006416, expiration date 25-FEB-2016) (dosages and routes of administration not provided) or RECOMBIVAX HB (MARRS# 1511USA004146). ROTATEQ, PNEUMOVAX 23, and RECOMBIVAX HB (lot # 004754, expiration date 10-NOV-2016) appeared on a product list because temperature stability information was asked, but no doses were administered to any patients. No additional information available. This is one of two reports from the same reporter. Additional information has been requested.
Acute fever (101.8-102 degrees F), febrile seizure (patient with hx of febrile seizures in the past), then rash developed on trunk, spread to generalized papular presentation. Presumed varicella-like rash. Mild pruritus.
plague build up; blisters; pain.; cold sores all in her mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLAGUE (plague build up) and OROPHARYNGEAL BLISTERING (blisters) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ORAL HERPES (cold sores all in her mouth). On an unknown date, the patient experienced PLAGUE (plague build up) (seriousness criterion medically significant), OROPHARYNGEAL BLISTERING (blisters) (seriousness criterion medically significant) and PAIN (pain.). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency and LIDOCAINE (LIDOCAINE 5% EXTRA) at an unspecified dose and frequency. At the time of the report, PLAGUE (plague build up), ORAL HERPES (cold sores all in her mouth) and PAIN (pain.) outcome was unknown and OROPHARYNGEAL BLISTERING (blisters) had not resolved.            Concomitant medication and treatment information was not provided Action taken for Moderna COVID-19 (mRNA-1273) vaccine not applicable In the source document the reportes refers "plague buils up", this term appears to be a typo error for "plaque build up".  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.   This case was linked.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Left upper arm severely swollen erythematous and warm, able to move arm/shoulder normally and with normal perfusion. This is the most severe localized reaction myself and another pediatrician has seen.
On the night of the 3/9 at 10PM I had  shakes/tremors in both my hands for 24 hours. I was freezing, terrible head aches, and nauseated till , could not get out of bed and was very tired. I could not move till sunday night; 6 days later i started feeling better. I called my pcp on the 16,and the 23 complaining that i had pain in my ccchest anad heart, She said that it was allergies. I called her on the 3/23 again telling her that i still had pain in my chest/heart, She told me that it was allergies and that it was a side affect of the shot.On March 26 a neighbor came over that was a nurse took my pulse and said that i had an irregular heart beat.Called pcps office spoke to Nurse told to come in on3/30. PCP checked my lungs/heart.said nothing wrong. I told her to take an EKG-showed PAC
Patient presented to the ED on 4/27/2021 with aphthous ulcer of tongue. Patient presented to the ED on 5/30/2021 with sepsis and hyperlactatemia. These visits are within 6 weeks of receiving first dose of covid vaccination.
01/06/2022 After about an hour of the vaccine, I felt sick to my stomach. I had to run the restrooms and I had diarrhea. I had a an all over headache and my throat was hurting. I also experienced nausea. By the time I got home I had chills and fever 102.7. I took Advil and that made my diarrhea worst. I had swollen lymph nodes in my neck and armpit. These symptoms were consistent for a straight 5 days. The only thing that subsided prior to the 5 days was the sore throat. In March I ended up with pneumonia I did test for COVID-19 several times and they all came back negative. I still have a cough.
Initial report received from a health care professional on 09 Feb 2010: It was reported that, the patient was vaccinated with H1N1 (batch no: 1009232P), intramuscularly 2 doses inadvertently. Event outcome was not reported on 07 Feb 2010.
09/30/21 sleepy, drunk-like, neck hurts, both arms tingling, arms itchy, lump in throat, foggy, arms numb and tingly, ears clogges 10/1/21 out sick from work, headache, neck hurts, shoulders sore, back hurts, injection site sore, lump in throat, exhaustion, skin burning on arms, headache, injection site sore 10/5 tingly arms and fingers, headache 10/12 continual itching, anxiety, headache, foggy 10/13 arms itching all through the night, cramps in feet 10/14 itching, cramps in feet 10/15 itching, exhuasted, piercing headache 10-17 muscle pain in right hand, neck hurts 10/18 exhausted, right kidney pain 10/19 stiff neck, tight chest, left big toe stiff 10/23 feel awful, whole body hurts, neck and I have not felt myself since I got the vaccine.  Every day since, itchy, foggy, sore muscles, headache, overall exhaustio, weak.  It's been 3 weeks and I continue to feel awful.
It was reported that a 48 year old female received a Fluzone WV '99-'00 vaccination on 10/15/99 and reportedly, on 10/16/99, the pt's lips became swollen, no other side effect. The pt reportedly, recovered from this experience. From additional information received on 11/18/99, corrections of the last name of the reporter, vaccine administrator and an amendment of the adverse reaction time were made.
On first shot, within 1 day I had all the symptons of Covid 19 (severe headache, sore throat, cough, loss of taste and smell, muscle pain, extreme fatigue).  Within 2 hours after the second shot, I became foggy brained.  I was not able to think properly or at times u was not sure where I was and what i was  doing.  I was also very unstable in walking.
MenA reconstituted with another company diluent; MenA reconstituted with another company diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA584A, expiry date 31st August 2022) for prophylaxis.   On 3rd November 2021, the patient received Menveo. On 3rd November 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received menveo reconstituted with another company diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Dizziness; Arm Pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and NAUSEA (Nausea) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The consumer stated she believes it was a combination of the shot and the outside temperature as patient passed out when he went outside and again 3 hours later when he was in the house which prompted a call to emergency services.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-255280, MOD-2021-255280 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Event outcome for all the events were updated from unknown to resolved.
After receiving the first vaccine developed joint pain throughout body after diagnosed by Rheumatologist as having Polymyalgia Rheumatica.
One week after vaccine I experienced an itchy rash on the left arm where the vaccine was administered, the following morning I had mild pain radiating down the arm. Taking Acetaminophen for symptoms.
Pt called in to Nurse and told her that she got shot earlier that day and she woke up from her nap very fussy states gasping for air Respiration were irregular her legs/feet and genital area were swollen
Redness/swelling (L) thigh, noticed by parent this am, at site of injection given 3/1/11. Rx: warm compress/MOTRIN.
Started falling (x4). Rushed to hospital. Slipped into coma. Placed on respirator. Transfer to another medical center 2% chance of survival. Respirator 8 days. Coma 6 days. Six plasmapheresis. Woke up paralyzed. Much physical therapy. Dec 2012 walking with walker. August 2013 by self in walking.
Feeling light headed and very tipsy. I feel like my mind is in a fog. Very difficult to concentrate. Nightmares. Headache.
arm swelling and significant erythema with marked pruritis. Lasted for 3 days, treated with Benadryl and topical cortisone cream
Patient received an 11th dose of ipv vaccine.  Polio vials come in a 10th dose vials with additional vaccine residual.  Per  sanofi pasteur vaccine manufacture and CDC guide lines; only the numbers of doses indicated in the manufactures insert package should be drawn.   After the maximum number of doses have been withdrawn, the vial should be discarded, even if there is residual vaccine or the expiration date has not been reached.  patient parent have been notified and child will be vaccinated, appt scheduled for 07/15/2022. Due to the IPV vaccine incident.  Center has implemented changes to prevent this error form happening again. Created a vaccine puncture log, in which every time we draw a dose from a multidose vaccine vial, we are documenting the dose umber on the log.  We all are aware to only draw the doses indicated by the manufactures package insert, After the maximum number of doses have been withdrawn, the vial will be discarded, even if there is residual vaccine.   The log is attached to each vaccine box.  All the personal who administers vaccines have been trained of these changes.
Headache, Myalgia, Arthralgia, injection site pain Narrative: Patient received first dose of Moderna vaccine on 08/12/2021 at 13:30, reports feeling pain at injection site immediately after administration. Reports by 08/13/2021 afternoon, was experiencing injection site pain and swelling, chills, headache, joint pain, body aches, fatigue, and swollen glands on neck and left underarm. On date of report (08/20/2021), employee states most symptoms have resolved, but continues with axillary swelling/tenderness however is improving. Reports use of Tylenol (no dose/duration) for achiness.