chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On June 5th, I received my 2nd Moderna COVID19 vaccine.  A band-aid was placed over the place where I got the shot. The band-aid was removed approximately 8 hours later when I took a shower.  The next day, I had a band-aid scar and dermatitis. The dermatitis  cleared up after two weeks but the scar has not. It has been almost 1 full month. I have never had this kind of issue happen with any other inoculations.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of Hepatitis B vaccine (Recombinant) (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 11 centigrade degrees (°C) (9 °C to 25 °C) for a time frame of 1 hour and 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA012143: US-009507513-1704USA012141: US-009507513-1704USA003984:
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves a 11 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 11 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. 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. List of documents held by sender- none.
swelling of neck, tongue, ears, face, throat - anaphylactic reaction. Shortness of breath. Generalized pain and swelling of both hands. Dizziness, blurred vision. Face was red. Called 911 taken to hospital and admitted for 24 hrs. Epinephrine given, steroids, heparin. ENT consult, numerous blood test. seen by allergist 2 days after discharge. Tested for everything for 8 hrs (medications, foods and environmental).
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB on 15-JUN-2012 and inquired about receiving a second dose on 03-JAN-2013. No adverse symptoms reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Moderna  Day 2 & 3 - extreme arm pain, headache, body aches Day 4 - headache, nausea, vomiting, diarrhea, abdominal cramps, body aches  Day 5 -7 headache, nausea, abdominal cramps
Red rash with no blisters that started under her left breast Red rash that covered 70% of the body; Itchy rash; it burns; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (Red rash with no blisters that started under her left breast Red rash that covered 70% of the body), RASH PRURITIC (Itchy rash) and RASH (it burns) in a 68-year-old female patient who received mRNA-1273 (batch nos. 046B21A and 030A21A) for COVID-19 vaccine.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash with no blisters that started under her left breast Red rash that covered 70% of the body), RASH PRURITIC (Itchy rash) and RASH (it burns). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash with no blisters that started under her left breast Red rash that covered 70% of the body), RASH PRURITIC (Itchy rash) and RASH (it burns) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Eosinophil count: (High) Eosinophil count 150-170; Lab normal count reported as 50. Patient denies eosinophil disease.     For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl and hydrocortisone cream 2.5% which did not resolve the symptoms. Patient's doctor prescribed prednisone and patient is on second day taking prednisone. Patient reports the rash is fading but the itching and burning are still present. No concomitant medications were reported. Action taken with mRNA-123 is not applicable.
Patient complained of immediate pain at site following injection and has ongoing right arm pain still. It is slightly improved.
Information has been received from a physician concerning a 2-month-old male who was vaccinated PO with a 2.0 mL dose of Rotateq. The physician reported that the patient subsequently developed blood in the stool. Unspecified medical attention was sought. The patient subsequently recovered. Upon internal review, blood in stool was determined to be an other important medical event. Additional information has been requested.
The following morning I started having symptoms like Vertigo. I was dizzy, felt unbalanced, nauseous. Later that night I had a really bad headache. The next day I had Vertigo off and on. Not as bad as the day before.
Arm pain right after first dose, could not do much the first two days, Tylenol did not help at all. First dose triggered severe menstrual cramps two days later. Pain was an 8/9 on a scale of 1-10. Like labor pains. Trouble standing, walking, sitting comfortably. Full dose of Tylenol did not help. Heavy bleeding. Tongue and throat mild numbness at the height of pain. Extremely painful to pass stool and urinate. Worst pain lasted two days. 8 days later mild cramps persist, passing stool still uncomfortable. Day 7 cramps got worse for half a day. bleeding/spotting lasted 7 days (usually 3). Night 7 arm started to hurt again and itch, hives formed injection spot. Next morning (now) arm feels hot, itchy, sore and irritated.  Still cramping in lower abdomen today.
Pt states that he was sore after the first dose of the vaccine and lost mobility in his arms (not able to lift above his hands above his shoulder level). Pt states that after his second dose, the arm mobility returned, but did not subside as it did with the first dose and he has been working with a physical therapist. The patient reports that he is regaining functionality of his arms, but is not 100% recovered.
he felt that his arm hurt a little worse than the first dose; achy; slight headache; tired; felt generally sick; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation and the patient felt that his arm hurt. About 24 hours after receiving his second dose of the Pfizer COVID-19 vaccine (on an unspecified date), the patient felt that his arm hurt a little worse than the first dose, he was achy with a slight headache, tired, and felt generally sick. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient administered varicella vaccine, few days later presented with fever, then rash all over. Diagnosed: Likely varicella -> advised to use supportive care.
Developed hard lump to injection site on 03/24 that has persisted. 03/30 area became warm to touch and more swelling. 03/31 improved-no erythema, streaking, or fluctuance. 03/28 she developed swelling of the lips and itchy throat-resolved with Benadryl. 03/30 had itching of the lips-resolved with Benadryl. 03/31 with mild swelling of the lips. No other new exposures-food, environment, medication, topical products.
Arm was heavy; She was in pain; Unable to move her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was heavy), PAIN (She was in pain) and MOBILITY DECREASED (Unable to move her arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced LIMB DISCOMFORT (Arm was heavy), PAIN (She was in pain) and MOBILITY DECREASED (Unable to move her arm). At the time of the report, LIMB DISCOMFORT (Arm was heavy), PAIN (She was in pain) and MOBILITY DECREASED (Unable to move her arm) outcome was unknown.        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
The data provided included nausea but I don't think that qualifies for my experience. I had dry heaves from 2:30AM till 8:00AM. I am right now still somewhat nauseated at 9:13AM same day but at least I'm not retching unable to even  keep a sip of water from causing violent retching.  I only weigh 118lbs and wonder if the doses are just too strong for that body mass. My doctor told me beforehand to stay hydrated before the shot so I drank lots of water/liquids the days prior to the shot and thought I would be generally OK.  I have had no problems with my yearly influenza vaccine or any other vaccine but I would think twice about doing this vaccine again.
This spontaneous report was received from medical assistant (M.A) concerning a patient of unknown age and gender. On 04-FEB-2015 the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intermuscular), and the dose administered underwent an unsupported temperature excursion. No adverse experience reported and no concomitant therapies were reported. Also it was reported that the therapy with GARDASIL was continued. Additional information has been requested.
-RIGHT ARM SORENESS:  lasting ~2/3 days; Ibuprofen taken ~7 hours after administration -RIGORS: lasting ~1hr, 7 hours post-injection (400mg ibuprofen taken beforehand) -NAUSEA: lasting ~1hr, 7 hours post-injection -FEVER: 100.4; lasting 1 day occurring ~7 hours post-injection
Tx: MEDROL dose pack. Sharp pain on left arm where injection was gven along w/numbness down to hand and difficult grip at times.
Information has been received from the licensed practical nurse concerning 6 patients of unknown age and gender. The patients' concurrent conditions and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot# K002919, expiry date 26-FEB-2016; dose and route of administration were not reported). Additional information is not expected as all the scheduled correspondence has been obtained. This is one of several reports from the same reporter.
Pain, swelling, and redness at site. Pain and redness migrated down arm over 5-6 days.  Headaches  Body aches Fever and chills Joint aches and pain Lack of appetite  Lethargy and fatigue
Patient exhibited flu like symptoms the next day then 2 days after vaccine (November 7) she developed a head to toe rash.  Somewhat itchy with the scalp being severely itchy.  By Tuesday morning November 9 the rash had mostly subsided after patient took benadryl and an oatmeal bath
pink rash both under her breast; This is a spontaneous report form a contactable consumer (patient). A female patient (age: 83; unit: unknown) received the first dose of BNT162B2 (Pfizer BioNtech Covid-19 Vaccine), via an unspecified route of administration on 13Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she got her first Pfizer covid vaccine dose last Saturday, 13Feb2021. She had a pink rash both under her breast on Feb2021. She was asking if this is normal and what she should do. The outcome of the event was unknown.  Information about lot/batch number has been requested.
1/8/21 fatigue, chills, cough, congestion, diarrhea. 1/8/21 Dx'd with Acute viral syndrome
At a routine checkup at my eye doctor's, on 10/25/21, he found that I had a stroke at the back of my left eye.  I then went to a retinal specialist and my GP to try and identify the cause.  Still waiting on results of more detailed lab work which hopefully provide some answers.
A.M had a few red areas, when coming after playing in afternoon had round red eraser size areas that itched mainly on back and stomach with a few on face and arms.
A few minutes after my daughter received her first Hepatitis B shot she lost her eyesight and hearing. She also became physically ill. Still in the parking lot, the Dr's office said to elevate legs above heart level and consume sugar. It took 3 days for her to feel better and for paleness and severe fatigue to subside.
8-22-08 received. Two weeks after receiving HPV #2 and MENACTRA (9-8-08), symptoms consisted of loss of sensation in feet, loss of balance due to no feeling in feet; walks only with assistance.  12/19/2008 MR received for DOS 9/16-19/2008 with D/C DX:  Acute labyrinthitis.  Headache.  Dizziness.  Difficulty walking. Pt presented with 1 week hx of difficulty walking, dizziness, frontal h/a after transfer from local facility.  Pt reports leg weakness, falling to the left, tinitis and occ double vision.  PE (+) for 4/5 motor strength in legs, slow unsteady gait and unable to walk with eyes closed.  Pt had some improvement on amitriptyline and d/c.
Pt states he has since visited the Dr. with heart palpations' and mummers'. Dr. stated she was going to later on to prescribe medications but no current change.  Very agitated and mood swings.
The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022; The pharmacy gave Moderna COVID-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported.  The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna COVID-19 vaccine instead of 24-Feb-2022. The Moderna COVID-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022. The vial did not undergo any temperature excursions. The reporter did not know which dose the patient was received. The reporter did not have any other adverse events or side effects to report for the patient.  No treatment information was provided by the reporter.
Headaches, vertigo, confusion, disorientation, dizziness, nausea, sore throat. I had these symptoms for about 3 days after 2 weeks from the first shot (received on 3/14/21). These same symptoms restarted the day after the second shot (received on 4/4/21), and are still ongoing.
patient was given shingrix instead of varicella vaccine; This non-serious case was reported by a physician and described the occurrence of wrong vaccine administered in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: patient was given shingrix instead of varicella vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date 29 Jun 2023. The patient was given shingrix instead of varicella vaccine. The patient had not had shingrix vaccine. In reviewing the patient's medical history the provider asked if the patient had ever had chicken pox and the patient said he didn't know. HCP decided to get titers (even though did not necessarily have it. In the meantime the patient went to the pharmacy and while at the pharmacy got vaccinated with Shingrix. Titer levels came back low or negative and provider instructed the patient to get varicella vaccination instead of Shingrix, and patient told HCP that he had already gotten Shingrix. In speaking with the HCP he felt like this patient was varicella naive and should have gotten varicella vaccination instead of Shingrix. Although this patient was not immunocompromised, so it could have been assumed that the patient had previous exposure to varicella since they are 55 yrs of age, and were not immunocompromised.  The patient was given shingrix instead of varicella vaccine which led to wrong vaccine administered.
pt reported itchy tongue- evaluated by paarmedic- given oral liquid benadryl- monitored by paramedic-  paramedic determined patient to be able to return to work, pt would contact his PCP.  patient would be around co-workers for rest of day and worked very near a hospital.
Hives on both arms, face, and neck, dizziness since the vaccine, shallow breathing started after the hives, itchyness. went to urgent care was put on Xylan and pred for 5 days and told not to do the third vaccine
Patient experienced itching on her head and back 15 minutes after vaccination. Onsite EMS was called vitals BP 193/77  HR 91. No difficulty breathing or swallowing patient had anaphylactic R&N to Idoine she stated the itching she is experiencing is minimal. Symproms were subsiding patient relaesed to home.
Pt recv vax on 12/11/98; on 12/12/98 pt exp stiffness, jerking, gagging &shaking for 20 -25 sec
NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included no illicit drug usage or drug abuse.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and headache. This report was non-serious.
Pt received vaccine on 11/5/10 at 345, then was in ER 11/6/10 at 5AM with fever, large local reaction on (R) deltoid & vomiting. Pt was dehydrated. Fever for 11/6/10 - 11/8/10.
Seven children ages 3 - 9 years old who were exposed to other children who were vaccinated with varicella virus vaccine live and who had not experienced a post vax rash experienced herpes zoster. Subsequently the pts experienced herpes zoster. The pts did not have known exposure to chickenpox nor had they received varicella virus vaccine live. The physician believed the occurrences of herpes zoster had occurred within 30 days of the vaccinee's vaccination. No further information is available.
Mild injection site pain; Mild tiredness; Minor aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01, single), for COVID-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03May2021, outcome "unknown", described as "Mild injection site pain"; FATIGUE (non-serious) with onset 03May2021, outcome "unknown", described as "Mild tiredness"; PAIN (non-serious) with onset 03May2021, outcome "unknown", described as "Minor aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial and follow-up information has been received from a nurse practitioner concerning a 17 year old female with attention deficit disorder who on 20-MAR-2008 was vaccinated "in the arm" (exact time not specified) with Gardasil (659180/1758U). Concomitant therapy included ADDERALL TABLETS and hormonal contraceptives (unspecified). On 20-MAR-2008, at an unspecified time, the patient experienced nausea, tingling in legs, faintness and decreased blood pressure (measurement not provided) and at 2:30 she was being transported to the emergency room, where the patient was hydrated and monitored. At the time of the report it was not known if the patient had recovered from these events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  The patient was not admitted to the hospital. The patient recovered and and was able to attend school the next day. Additional information has been requested.
MMR, Varicella, INFANRIX Dtap administered on 07/03/12 child had shortness of breath, and cough was seen in ER 07/06/12, Dx reaction to MMR.
MENTAL CONFUSION, DIFFICULTY WALKING, IRRITABLE, WEAKNESS, MEMORY LOSS