chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 76 year old male consumer reporting on himself who in December 2009, two years ago, was vaccinated subcutaneous with a dose of ZOSTAVAX (Merck) (lot #, dose and site of administration not reported). Concomitant therapy included gabapentin and "perkatin". On 20-DEC-2010, the patient underwent heart bypass. On 01-NOV-2011, the patient contracted shingles on face and eye on right side of face. He had pain still in facial/eye area. Treatment for the adverse event was given (unspecified). The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from shingles on face and eye on right side of face and pain in facial/ eye area. The outcome of heart bypass was unknown. Upon internal review, heart bypass was determined to be an other important medical event. Additional information has been requested.
Initial extreme fatigue 1 day following the vaccine, which resolved after overnight rest Five (5) days after vaccine, extreme fatigue and chills, and several hours later a temperature of 103.5, as well as some muscle soreness Night sweats first night; next morning temperature returned to normal. Fatigue continued with some daytime sweating for 2-3 days. Saw primary care doctor 5 days after symptom onset; mostly cleared up, normal temperature Patient suspected a flare-up of mononucleosis / Epstein Barr as cause.
Numbness right side of throat, right side of tongue, right side of face and right side of neck.  Symptoms still present at the time of release
This spontaneous report was received from a pharmacist and refers to a 76 year old patient of unknown gender. On 21-May-2014 the patient was vaccinated by the pharmacist with ZOSTAVAX (lot # J001698, expiry date: 08-MAY-2014, 0.65 ml once, subcutaneously). No adverse events were reported. Additional information has been requested.
large red areas of rash rt. side with pain, burning, tingling. Started on Lt side at 6:00pm 10/17/09. To physician on 10/18/09, diagnosed with bilateral shingles due to H1N1 Vaccine. Given Samvir 500mg 1 q 8 hours.
Patchy Maculopapular rash starting in bilateral upper extremities, then radiating to trunk. No itch,.
left arm which is where I received both of the shot started hurting on the site of the vaccination; sore arm and like a kind of heavy that cannot be lifted; sore arm and like a kind of heavy that cannot be lifted; sore arm and like a kind of heavy that cannot be lifted; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient left arm which is where patient received both of the shot started hurting on the site of the vaccination, sore arm and like a kind of heavy that cannot be lifted on an unspecified date. Reporter queried I didn't know who to call. So, I got my two vaccine already, I am fully vaccinated. The second shot I received it in May 4th so it's been over a month and half and today all of sudden on my left arm which is where I received both of the shot started hurting on the site of the vaccination and I feel the same thing when I felt when I got vaccinated what's like the sore arm and like a kind of heavy that cannot be lifted and I don't know if that is normal. I have been googling it and I know there's people that have had sore arm for weeks but I had sore arm for one night and then now it came back and I don't want to have later. So I don't know if this is normal or I should be concerned or got to the hospital. The outcome of the events were unknown.  Information about lot/batch number has been requested.
3-4 minutes after immunizations, child had rash on face and legs.  Legs were solid red and hot to touch.  Gave 3mL of Childrens Benadryl per MD, child waited and was fine.
Racing heart and shortness of breath the night after receiving booster shot. Heart rate was between 190 and 200 at its worst. Sharp pains in back and neck. Later, fever of 101.8 degrees. Primary care doctor sent me to urgent care when I called Thursday afternoon. At 9pm Thursday my heart rate was at 120 but went down to 100 while I was at urgent care, so I was sent home. Doctor told me to see a cardiologist.
Information has been received from a wife concerning her husband who was vaccinated while having a cold and fever of 102 F. She stated, At this time the fever is over 102 F.
Fever up to 102 degrees Fahrenheit, swollen gums, malaise, fatigue, loss of appetite.
Fatigue on 4/1/21 that became very noticeable around 2:45 pm. General muscle soreness/aches on 4/1/21 and a bit on 4/2/21. Left shoulder sore and uncomfortable to move through full range of movement from 4/1/21 afternoon until afternoon of 4/3/21. Soreness did noticeable die down as time passed.  Discomfort/muscle tightness starting around 3:00 pm 4/6/21 in the left axillary region. No swelling/redness/rash visible on surface. Discomfort most noticeable when stretching arm forwards/backwards or squeezing upper arm against side. Squeezing arm to side results in a feeling similar to if someone were trying to hold a marble in their armpit.   4/8/21 woke up still with arm pit discomfort and a return of the discomfort in the out shoulder muscle where the vaccine was administered.
I just starting having some this weird pain and discomfort in my heart; I just starting having some this weird pain and discomfort in my heart; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration on 04Jun2021 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient got the first dose of vaccine (Unspecified) on 04Jun2021 and shortly after that started having the information in the hard. Patient just started having some this weird pain and discomfort in heart in Jun2021 and presumed that is the information that started to come out and no one really mentioned it before. Patient would have never got it here now and heard they also recommended that we do not get the second dose if we are getting hard information after the first dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Got the chicken pox shot and then recieved mild case of chicken pox from the shot 1 month later
Case number PHEH2016US028941, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 62 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into left deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Have shingles now/Suspected vaccination failure; Have shingles now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot and had shingles now but no pain. The patient reported that had to pay years ago for the shot well worth it due to the fact that the patient had shingles now no pain. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
7 year old was given Quadracel, no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 years old male patient who was vaccinated with 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number C5763AA and expiration date:26-Aug-2022) via intramuscular route in the left deltoid for prophylactic vaccination on 08-Sep-2020 (PT:product administered to patient of inappropriate age).  Medical history was not reported.  No concomitant medication as given to patient.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency)..  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
About one hour after my first Covid vaccine shot, my throat began swelling up. I had the chills, and was very, very tired. I didn't have trouble breathing, the swelling did not get real bad - it was more of an annoyance. If it had gotten worse, I would have gone to Emergency. It didn't. Obviously, it's an allergy, I'm concerned about the second dose.
Hives on face, neck, chest, and around injection sight. Slight swelling and itching of eyes and tongue. Whole body itching.
Redness and swelling, blisters, rt thigh area, blisters formed first, very sore to touch no fever noted.
No adverse event; The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 18C22A) for COVID-19 prophylaxis. The patient did not have information about previous COVID-19 vaccination doses.     On 25-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was stated that no other adverse reactions were reported. No treatment information was provided.
C/O redness, swelling, skin hot with possible fever, 98.8 at visit, tenderness streaking after SQ inj MENACTRA.
pt recv vax 11JUL97 & chickenpox varicella 3wk p/vax pt less than 20 varicella lesions on hands face & body afeb;
Extreme swelling and pain left shoulder next day. Applied ice took Advil, after several days call Dr. Nurse said is normal continue with ice and Tylenol. After 2 weeks my shoulder began to have extreme throbbing, pain swelling and loss of motion in left arm. It continued to travel down arm and left leg and into center of back and neck. I called my Dr. Went in for evaluaton. Dr decided the shots H1N1 and pnuemonia possibly from needle hit nerve and caused extreme bursa injury. Wanted to prescribe pain meds and phys therapy. I decided no pain med instead using ice and Tylenol and started Phys Therapy that same week. Still now after 3 mo, I am suffering from extreme pain. I now have a Tens Unit to help manage pain and continuing with Phys therapy which is helping slowly. I wake up wit throbbing pain many times at night almost like a bad toothache in my arm and shoulder and neck on left side.
Day 2 of vaccination - redness. Day 3 of vaccination - severe itching, warmness at sight of vaccination. Day 6 of vaccination - no itching but still red.
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 11-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated that she had pressure in her head and it felt like someone was constantly holding her head. She also complained of dizziness and weakness and a small area of redness at injection site. In a later statement she states she had a headache as well.
pt recv vax OCT96 pt devel full blown chickenpox that consisted of greater than 50 lesions;
limited AE is being submitted; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (limited AE is being submitted) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (limited AE is being submitted). At the time of the report, IMMUNISATION REACTION (limited AE is being submitted) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.   Reporter did not allow further contact
Initial and follow up information has been received from a registered nurse concerning a 23 year old, white, female, RN with no known drug allergy and no medical history who in approximately, October 1982, was vaccinated with MMR. In approximately June 1993, the patient was revaccinated with MMR. In June 1993, it was reported that the patient had negative serum immunoglobulin G test (IGG) for mumps and rubeola. It was reported that on 10/18/00, the patient had a positive MMR titer. The reporter stated that on 2/16/05, the patient had a negative mumps and measles titer. It was reported that labs were negative on 2/16/05. On 2/16/05, varicella titer was also negative. The patient had stated that she has had positive titers in the past. It was reported that labs were negative on 5/31/05. The patient sought unspecified medical attention. At the time of the report it was unknown if the patient recovered. Additional information has been requested.
asymptomatic- tested positive on binax rapid antigen test- test performed as follow up to known exposure
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 66-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 16-NOV-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Patient developed redness and swelling on and around site of injection on right arm. Area measured aproximately 4 inches in width and length.
flu vax given at 5PM pt started having shaking chills & sweats @ 11PM; vomited 13x & had diarrhea; lost 6 pounds fluid; gave vax to 9 other pts from same vial w/no react;
Blood pressure shot way up 180/110; big pressure and headache, anxiety due to illness; have headaches virtually every day since the vaccination.
arm is pink; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is pink) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is pink). At the time of the report, VACCINATION SITE ERYTHEMA (arm is pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment drugs were provided.
Pentacel not reconstituted resulting in patient only receiving DTaP/IPV component of vaccine and no Hib.
Pt vaccinated with Pneumovax 23 developed swelling of his arm w/water blisters & severe localized pain.
Vaccination at 1:30pm with Lightheadedness, jaw tightness and dizziness at 1:45pm. HR 73, Pulse Ox 99%, B/P 120/80, T 97.7. Benadryl 25mg po given with water. Pt also given sandwich as she had not eaten since breakfast. Pt reported not sleeping well d/t being a caregiver. Pt unable to drive d/t symptoms and requested eval in ER. Transported to ER at 2:15pm.
Lips tingling and L arm tingling/numbness 10-15 min after 1st dose on same size injection was administered. Symptoms lasted for 8 hours post-vaccination and resolved w/out medical treatment.
Information has been received from a physician concerning a 7 month old patient who was vaccinated with the first dose of ROTATEQ (lot # not provided) when patient was 2 months old, and received the second dose of ROTATEQ (lot # not provided) at 7 months of age.  The patient is not experiencing any known symptoms.  Additional information has been requested.
Got my shot and got shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got his/her shot and got shingles but was gone in a few weeks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.