chrisvoncsefalvay/vaers-outcomes huggingface dataset:
circle about 3 inches; vaccination arm was itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (circle about 3 inches), VACCINATION SITE PRURITUS (vaccination arm was itchy) and VACCINATION SITE ERYTHEMA (red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SCAR (circle about 3 inches), VACCINATION SITE PRURITUS (vaccination arm was itchy) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE SCAR (circle about 3 inches), VACCINATION SITE PRURITUS (vaccination arm was itchy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information and concomitant medications were reported.
Information has been received from a female consumer with allergies to penicillin and sulfa and a history of palpitations when young and mitral valve prolapse who on 7/22/02 was vaccinated with a dose of hep A virus vaccine inactivated. Concomitant therapy included Tranxene and Aciphex. On 7/23/02 in the evening, the pt developed heart palpitations that lasted for 45 minutes and diarrhea. Additional info has been received from the physician. The physician reported that he did not know of any reaction as reported by the pt. No additional info is expected.
Information has been received from a physician, via a company representative, concerning a 22 years old male patient. The patient's pertinent medical history and concurrent conditions were not provided. In 2016, reported as "sometime in June or July 2016", the patient was vaccinated with GARDASIL (lot #, expiration date, concentration, dose and therapy route were not indicated). Concomitant therapies were not provided. The physician stated that in 2016, reported as "an unspecified amount of time after the dose of GARDASIL was administered", the patient was complaining of generalized muscle aches, pains and lower extremity weakness. The outcome of generalized muscle aches, pains and lower extremity weakness was unknown. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA008986). Additional information is not expected as no consent for follow up was given.
flublok quadrivalent as it was administered to a 10 year old patient, no adverse event; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old male patient who was vaccinated with a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1963 and expiration date 30-Jun-2020) via an intramuscular route in the left deltoid on 24-Oct-2019.  Medication history not reported and the patient did not received other vaccines.  It was an actual medication error case due to inappropriate age at vaccine administration.  The patient had no adverse event or symptoms.  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.
Case number PHEH2015US015711, is a combined initial and follow-up spontaneous report from a health care professional received on 10 Aug 2015 and 11 Aug 2015, with the follow-up received on 02 Oct 2015. This report refers to a patient of an unknown age and gender. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: X15031) without being reconstituted with MenA lyophilized conjugate component on an unknown date. No adverse event was reported following the administration error. Reporter stated that this report was reported to her by the patient's mother. Reporter was not the one administering the medication, it was done at the provider's office. Reporter does not have any additional information about the patient or about what happened and is not able to assist with additional information. Follow-up received from the health care professional on 02 Oct 2015: Updated reporter comments.
3.7mm long X 4mm erythema at site of injection in left deltoid. No hardness but warmth noted at site.
Sweats, hot flashes, nausea, headache began within 24 hours and continuing ast day 3
Patient was administered a bivalent booster dose when they were actually trying to get a 1st dose primary series Covid shot. Patient reported no adverse events and understood the need to come back and get the 2nd dose in the primary series.
Immunization error occurred at a Bi-monthly vaccine clinic at homeless shelter. Patient  said he was from country and had never  been seen at Health services.  Pt filled out pre vaccination checklist and answered NO to all questions including , "have you had a previous dose of COVID-19 vaccine."  On 05-04-21 pt received a single dose of Johnson and Johnson COVID-19 vaccine in his left arm.  He was monitored for 15 minutes and left without incident.  He was very interested in obtaining COVID-19 vaccine card because he wanted to go to public event.  Clinical supervisor alerted us that he previous dose on 04-01-21.
Had (-) mumps titer, hospital policy is to receive IZ MMR 0.5 cc SQ given 10/23/13, employee with generalized flat exanthematous rash to face, neck, torso, arms 24 hours after receiving vaccine.
This spontaneous report was received from a physician referring to himself a male patient of unknown age. Patient's pertinent medical history, drug reactions and allergies were not reported. On unspecified date in 2015("last year") the patient was vaccinated with ZOSTAVAX 19400 PFU (site of administration, lot #, expiry date and dose were not reported. There was no concomitant medication reported. Subsequently in approximately 2016, reported as "recently" the patient developed a "mild case" of shingles which was an unspecified "light" rash that was located on his left shoulder. It was also reported that "within a couple of days" the light rash "was going away" (recovering). Additional information has been requested.
Swelling, redness and soreness that developed at injection site then moved 8 inches below injection site
Case number PHEH2012US021584 is an initial spontaneous report received from a nurse on 24 Oct 2012 with a follow up information received on 24 Oct 2012. This report refers to an 11-years-old female patient. She was given only Men CYW lyophilized conjugate component of MENVEO (batch number: M11064, expiry date: Dec 2013) intramuscularly on 24 Oct 2012. No adverse event was reported following this administration error (Inappropriate preparation of medication). Follow up information received on 24 Oct 2012: Expiry date of vaccine administered.
Pt reported "difficulty swallowing" and feeling of "tightness in throat" Was taken to Med Obs 1 for further assessment and monitoring.  VS Stable and pt reported symptoms resolving by reporting "better" at 0804 and completely resolved by 0814.   VS WNL and no objective s/s distress noted at any time. Vital Signs: Sitting 0802 BP 147/79  HR 57  RR 16  SpO2 100% RA Standing 0805 BP 147/89  HR 59  RR 16  SpO2 100% RA Sitting (prior to release) 0814 BP 126/82  HR 47  RR 16  SpO2 99% RA
Patient was concealed on Jansen vaccine. Once pt was ready for vaccine, paperwork stated Pfizer but vaccine manager was not aware and gave injection which was Jansen.  Verified dose with sticker on vaccine but not not refer back to the paperwork which stated patient switched to Pfizer.
itchy rash within 3 hours of vaccine spread diffusely no respiratory, GI or mucous membrane involvement, no fever
Redness at injection site size of mandarin orange-did not appear until day 12 after injection. Warm to the touch and slightly raised but not itchy.
Information has been received from a physician concerning a 10 year old patient who on 31-AUG-1999 was vaccinated with Varivax, 0.5 mL single dose, subcutaneous. On 24-MAR-2006 the patient developed a breakthrough case of chickenpox lesions. The patient's outcome was not reported. Additional information is not expected.
pt recvd vax; exp cellulitis; no cultures taken; tx w/ duracef x 7 days;
Information has been received from a registered nurse concerning a 28 year old female with no allergies or medical history who on 4/18/2006 was vaccinated SC with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #649679/0293R). there was no concomitant medication. Later that night or next morning (approximately 4/18/2006), the patient experienced ringing in the ears, fullness of the ears, and hearing loss. The patient called the nurse on 4/28/2006 and reported that her hearing had not improved. She had no drainage and no fever. She was unable to fully do her job because of the decreased hearing. Unspecified medical attention was sought. No diagnostic laboratory test were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Ringing in the ears, fullness of ears, and hearing loss were considered to be mildly disabling by the reporter. Additional information has been requested.
Chest feels like its draining; Shakes that lasted 3-4 hours; Muscle soreness; Tired; Headache; Fever of 103° F; Uncontrollable chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest feels like its draining), TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache), PYREXIA (Fever of 103° F) and CHILLS (Uncontrollable chills). On 15-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest feels like its draining). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, TREMOR (Shakes that lasted 3-4 hours) and CHILLS (Uncontrollable chills) had resolved. At the time of the report, CHEST DISCOMFORT (Chest feels like its draining), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Fever of 103° F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 103° f, (High) 103° F. On 12-Mar-2021, Body temperature: 102° f. (High) 102° F.. On 13-Mar-2021, Body temperature: 101-102° f. (High) 101-102° F.. On 14-Mar-2021, Body temperature: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up was received on 06-MAY-20221. All reported events outcome was updated to recovered/resolved.
In anticipation of side effects from the second dose of the COVID-19 vaccine, I began alternating acetaminophen and ibuprofen.  The expected arm soreness set in after a few hours.  I also noticed that I had developed a headache and  low back pain that I could not associate with anything else.  I felt very stiff and my legs and feet were uncomfortable to the point that I had difficulty finding a good sleeping position.  This morning I had mild waves of nausea but was able to avoid throwing up.  The headache has persisted, as well as general body aches and fatigue.  As the day has progressed, the symptoms have lessened.
Arm swelling, redness, swollen axillary lymph nodes. All presenting on injection arm
After the first shot, the area around the injection site was tender as expected for at least the 3 weeks until my 2nd vaccine.  It's not tender to the touch, but feels more like someone punched me in the arm.  Because of this, I had the 2nd dose injected into my right arm.  Same results in the 2nd arm. Both of my shoulders have felt like this since I received the shots.  I visited the doctor today about it.  She thinks my deltoid may be inflamed and recommended heat, anti-inflammatory, and muscle relaxers at night if needed.  If it's not better in 2 weeks, she would like to get an ultrasound.  She also recommended I report this to your website.
1 1/2 hrs post vax temp soared to 103.5 pt began shuddering, retained conciousness, became cyanotic & mottled, used O2 x 1hr, fully recovered.
PNEUMOVAX VACCINE 11/1/2019 CAUSED SWELLING IN SHOULDER THAT MOVED DOWN THE ARM AND APPROXIMATELY 1/2 OF THE ARM WAS NOTICEABLY SWOLLEN BY 11/02/2019. SHE VISITED THE ER AND THE MD ADVISED ICE AND DIPHENHYDRAMINE. SWELLING STARTED RESOLVING 11/3/2019 AND BY 11/4/2019 HAS MOSTLY RESOLVED BUT LOCALIZED INCREASED DENSITY OF DELTOID AT LOCATION OF THE SHOT IS NOTED. PAIN WAS ELEVATED LATER 11/1/2019 AND PEAKED 11/2/2019 AND HAS NOT FULLY RESOLVED BUT IS MUCH LOWER 11/4/2019 PER PATIENT.
Arm around injection site was swollen for about 2 weeks & since then, I can touch my arm and it kind of hurts at the injection site.  In other words, I can touch my arm and tell exactly where that vaccine was given.  I told some of my medical providers about it, but no one seemed to know much.  I just found out about this reporting system so I?m just now reporting it.
Pt received second Moderna COVID-19 vaccination administered in left arm at her assisted living facility by Pharmacist at 1153 on 2/19/2021. Pt was monitored for vaccine reaction with no known adverse reaction. Approximately  18 hours post-vaccine, she was found deceased in her sleep at 0540 on 2/20/21. Per circumstances/pt history, it is presumed that the patient aspirated while sleeping, perhaps secondary to a seizure. Coroner was notified and declined as coroner's case. VAERS notification being made due to pt death within 24 hours of receiving a vaccine.
Cellulitis around vaccination site. Pt needed antibiotics - responded well. 3/19/08-records received for DOS 5/3-5/4/08-DC DX: Cellulitis left arm. Seen in Ed with C/O rash around injection site, left arm swollen, pain at injection site and reddened induration admitted overnight for IV antibiotics. Temp 102.4.
A few hours after receiving my booster, I started having significant right armpit pain. This was the same arm that I had received the booster. My inner armpit lymph nodes started swelling up a great deal,  and the skin felt very tight and very painful to the touch. My armpit pain and swelling lasted for several weeks, and was quite intense for 3 weeks before very slowly going down. I did not experience this symptom on my first two shots
Heart rate between 130-135 for a whole day after Also had the common headache, body aches and extreme fatigue for more that 24 hours after.
He got his vaccine, felt good, had to wait in the store for about 15 minutes.  Then he left and he had walked there and walked back home, about 15 minutes.  He felt fine as far as he knew.  The next morning his hands felt itchy, almost the inside of his hand, and then spread to the outside.  Then the bottom of his feet were itching, and it spread to the top part.  Then he was breaking out in hives, and got worse and worse and worse.  He was breaking out in hands everywhere he could see.  He was breaking out on his back, inner thighs, legs, feet, and could not stop scratching.  He went to the ER at Community Hospital.  They gave him Triamcinolone and Prednisone.  Yesterday he felt that he was getting better, but this morning he woke up itching again and putting on whatever ointment he had left, he finished off 2 bottles of ointment, and lives alone and cannot reach his back.  The pharmacist did his back and feels that he is going to scratch off his skin.  He feels that it is definitely better, but still there and not nearly as bad as it was.  He is continuing to take the Prednisone.  He will start noticing other areas of hives on his body, and just wants some relief.  He has taken all of his COVID, flu and both shingles shots, and has not had any reaction to any of them before.   This time his shoulder felt like an elephant sat on it, and it hurt even more.
9 days post/vaccination w/temp to 102.6. Persistent temp 11 days post/vaccination w/erythematous papules just beginning, mostly on abdomen, back & GU area (15 lesions). Very suspiscous for beginning of varicella rash.
Adverse event is with the RIGHT arm (the PNEUMOVAX arm). Patient describes an intense soreness and is having trouble lifting his right arm due to the pain. About 2 inches below the injection site, it feels warm to the touch and appears inflamed. The pain radiates to the triceps, rather than just the deltoid muscle. Left arm is unaffected.
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 31-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Information has been received from a female who was vaccinated with the first dose of GARDASIL in the "past 1 week". Subsequently, the patient developed a rash over most of her body in the "past 1 week". At the time of the report the was not recovered. The patient did not seek medical attention. Additional information is not expected.
Following the vaccination, my right eye had the retina partially detach and my kidneys are now in critical condition over the course of 2 months.
Within 24 hrs of administration developed a 10 cm x 6 cm oval pruritic maculopapular dermatitis-like rash around injection site.
patient was administered with 1 ml of Fluzone Quadrivalent instead of 0.5 ml, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 32 years old female patient who received a 1 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT] instead of 0.5 ml dose (lot: UJ223AB and expiry date: 30-Jun-2020) via unknown route in unknown administration site.  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 overdose. Staff member administered 1 ml of Fluzone Quad instead of .5 ml.  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.
No additional AE. No PQC; an adult receiving a pediatric dose of VAQTA; This spontaneous report was received from  a medical assistant and refers to an adult patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reaction or allergies were not reported.  On 17-JAN-2023, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), 0.5ml, lot #U024094 that upon internal review was found valid as vial formulation, expiration date: 10-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided (Product administered to patient of inappropriate age). No additional adverse event was reported.
evening of day vax given mom noticed pt pale next few days became more pale; on 6th days p/vax passed out; seen by MD who noted heart murmur & pt adm to hospital for cardiac eval; dx TEC tx w/blood tranfusion;
Complained of severe headache and fever of 103 on the night of the vaccine that caused her to vomit. She slept upright because movement made it worse. The following days until today she stated that her "head feels very heavy", especially when bending and laying down. Today she states that she had a sharp pain on the right side of her head. She has continued to have fever 101 to 102 nightly since. Yesterday she said that her mouth, (gums) hurt. She said its the entire mouth and worsened today at which time I received a call from her school because it hurt to eat so she didn't want lunch. Her gums do appear swollen now.
Night of SHINGRIX chills, A-Fib (therefore secondary insomnia), low grade fever, Stronger legs following 2 days.
both sides of her arms were itchy; A spontaneous report was received from a consumer, concerning herself a female patient of age 42 years, who had received her first dose on (23-Jan-2021) Moderna's COVID-19 and experienced both arms itchy.  The patient's medical history includes hypertension and asthma, concomitant medication was not provided by reporter.  On 23 Jan 2021 patient received her first dose of two planned doses of mRNA-1273 (lot number:0121204) via unknown route for COVID-19 infection prophylaxis.  On 23 Jan 2021 she experienced her arms were itchy and  indicated that she ate shrimp a week later and experienced the same reaction but has no history but being allergic shrimp.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event both arms itchy was not resolved at time of reporting.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over the body 9 days after vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives all over the body 9 days after vaccination). At the time of the report, URTICARIA (Hives all over the body 9 days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Pt recv vax on 10/24/97;on 10/25/97 pt exp red/hot/painful vax site -rt armx1 wk;tx=Benadryl, Advil; in 1/98 pt exp rt ankle &heel pain, 2/98 shoulder &joint pain cont;dx=inflammation of fascia tendon, possible Perthes Disease or bacteria
covid vaccine breakthrough case  dose 1 Pfizer 4/30/2021  EW0167 dose 2 Pfizer 5/21/21  EW0183  Moderna dose 3 lot number looked incomplete in Immunization Record.  No other info provided.