chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hands are now red; Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water; Some blisters filled with blood; Putting hand in pocket causes abrasions/cuts; Skin is thin; Soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts), SKIN ATROPHY (Skin is thin) and ERYTHEMA (Hands are now red) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Cephalexin).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site). On 24-Mar-2021, the patient experienced BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts) and SKIN ATROPHY (Skin is thin). On 08-Jun-2021, the patient experienced ERYTHEMA (Hands are now red). The patient was treated with CLOBETASOL at a dose of 1 UNK. On 03-Feb-2021, VACCINATION SITE PAIN (Soreness around injection site) had resolved. At the time of the report, BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts), SKIN ATROPHY (Skin is thin) and ERYTHEMA (Hands are now red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes high blood pressure medication.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Added patient photographic documentation of AE, updated concomitant medications
Became weak, diaphoretic. Sat down. BP 70/40. Gave water and crackers. Repeated BP after 10 minutes = 90/50. Patients states he feels better. Stood up slowly. BP = 90/50.
No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2023, 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 13-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) outcome was unknown and NO ADVERSE EVENT (No adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date).    Concomitant medications were not reported.  It was reported that patient had received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received. Patient name was added.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse events were reported. Follow up information has been received from the registered nurse on 06-NOV-2015. The nurse reported that on unknown dates, the doses of improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017) (dose and route were not reported) were also administered to unspecified number of patients. Follow up information has been received on 30-DEC-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 07-JAN-2016 from the registered nurse. On 27-OCT-2015, the patient of unknown age and gender was vaccinated with a dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported) that was involved in the temperature excursion. The nurse confirmed that no adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Patient tab, product tab, event tab and analysis were updated.
Arm was a little sore after shot, but the next morning pt. wasn't able to walk when he tried to get out of bed.  He fell on the floor and was unable to get up.  His face was very flushed and he broke out in a sweat several times.  We had to have fire dept come and pick him up off the floor.  He was able to get around a little bit with a walker, but spent most of the day in bed and was transported to bathroom by wheelchair.  He was also a bit confused.  He had very little appetite and was unable to eat very much.  At dinner time, he ate a little bit of soup and when he stood up at the table, fell again onto wood floor.  We had to call fire dept to pick him up from floor and EMT's/ambulance to come out and check him over.  VItals were all normal.  He was just a little bit better on the next several days.  We made an appointment for him to see Dr. on 3/3.  Doctor did blood work which came back normal. Pt. is still not back to normal.
Pt sitting on edge of exam table. Gave MCV4 (L) arm then HPV4 (R) arm approximately 30-45 seconds later pt fell to (L) and off table onto floor. Pt awake immediately but didn't know where was BP 100/60 AR 74 MD called to room. Left laying on floor approximately 15 min then sitting position x 15 min. Gave juice and granola bar. Pt c/o headache observed by MD for next 45 minutes.
Cold sores, hives, bumps, rashes, severe itching over arms, legs, chest, and back of neck. Numbness and tingling in cranial nerves. Back of neck hot, pins and needles. Severe head fog, fatigue.
IMMEDIATE major headache     following morning extremely swollen & painful lymph nodes under arms, lasted for several (about 4) days
experienced flu like symptoms; body aches; shivering; fever; The physician prescribed a 3rd dose; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, shivering, fever and off label use. On an unknown date, the outcome of the influenza-like symptoms, general body pain, shivering, fever and off label use were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, shivering and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix about a year before the time of reporting. The patient experienced flu like symptoms consisting of body aches, shivering and fever. The patient had 2nd dose about 3 months after dose 1st dose and there were no events reported with that injection. A physician ordered a 3rd dose of Shingrix. No events were noted with that injection, other than it was outside recommended dosing intervals. The pharmacist became aware that the patient had 3 injections of Shingrix and investigated.  The physician prescribed a 3rd dose of Shingrix, which led to off label used. The reporter consented to follow up.
Received the SHINGRIX vaccine from my PCP and by 8 pm I was so tired and had to go to bed. Throughout the night I had major night sweats and then moments of freezing. At 3:30 am, I got up as I was super thirsty and my head was pounding. I took 1-Extra Strength TYLENOL and went back to bed where I continue to have both freezing and night sweats again. I finally dragged myself out of bed and was soaked. Around 11 am on 9/29/2018, my husband said I was breathing pretty hard and looked bad, felt my head and I was hot. Took my temperature and it was 102 F. I was now having a heaviness on my chest, severe headache and fever. Went to the local hospital where they first ruled out flu and pneumonia is but I remained with temperatures of both 102 and then 103F. HR greater than 120 and B/P greater than my normal 110/70's, stayed above 140/85 for hours. After review of testing they admitted to hospital for overnight to determine what other source could be causing all of the symptoms, fluids given along with TYLENOL and monitored until discharged on 10/1/2018. My first shingle shot back in April 2018 I only had a sore arm but none of the severe side effects this last time.
Began to feel nauseous and feverish, my arm began to hurt, the next day I felt like I had a fever and my arm had begun to turn red and was swollen, the pain in my arm had worsened, took my temperature, it was 100.8, feel slightly better today, January 20th, now the pain in my arm isn't as intense, but my arm looks more swollen and is now itchy and lumpy
Sore joints, fever, swollen glands, dizzy, numbness, tingling, tired all the time, stiff neck. Could not work for 2 weeks. Treated with Biaxin for 16 days.
After first dose, 10 mins, I started getting dizzy and feeling weird. I had to sit down because I almost fell. I felt my heart racing. That lasted for a couple of minutes. After the second dose, I did not feel anything right away but at night I felt like I had a fever and fatigue. The next day they all went away. Then, like a month after I felt something weird in my heart. It felt like some tingling. It was on and off. I waited for a month. Then, I went to get some medical tests done and they came back abnormal. They sent me to the hospital and I was admitted. I was hospitalized for a week. They did troponin test, stress test, radiology, nuclear medicine, echocardiogram, EKG, blood work. The first diagnosis was chest pain. The final diagnosis was Angina Instable. They prescribed me Metoprolol. Sometimes I still feel the tingling but not very often.
I had  joint pain and muscle aches. I had a headache also.  My expected date of delivery is 06/19/2021. I am 16 1/2 weeks today.
Tingling and burning of arms and legs.  suspect acute transverse myelitis.  Symptoms lasted for 1 month.
Information has been received from a certified medical assistant concerning a female former staff member's daughter who on an unknown dates received three doses of GARDASIL. Subsequently, the patient developed headaches after receiving 3 doses of GARDASIL. The patient did not seek medical attention. Additional information has been requested.
Blood pressure of 190 5 mins after injection of second dose. Blood pressure of 220 the following day. Blood pressure over 180 since injection everyday
Muscle spasms, fatigue, and chills lasting a couple of hours. Then sweating.  Managed to sleep through it and felt better by morning.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 10-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 13-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Per office note:  5/12/2021 She had COVID vaccine Mar 19, 2021 and since then has pain in left arm, triceps area. She can lift her arm now but there is some tenderness in the upper arm and occ forearm.
PATIENT DEVELOPED CELLULITIS AT THE SITE REQUIRING ANTIBIOTICS APPROXIMATELY TWO DAYS AFTER INJECTION.
Light fever (~100F) Stiffness of muscles @ injection site (painful to lift arm) All over body aches symptoms disappeared after 48 hrs.
Pt. received vaccines 2/8/04 in the morning, around 1000.  Per Mom's report, he cried from 11:00am - 7:00 pm.  She took the baby to the ER, they listened to his lungs and heart and looked in his ears and throat, and did a SaO2.  All were normal.  She came to the clinic for a followup this am.  He has developed a cough.  He is not as fussy now.  He is a little fussier than normal, has a cough and a runny nose, but no fever.  Physical exam is unremarkable.  Mom was instructed to seek medical attention with fever, difficulty breathing, or excessive crying again.
error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
developed autoimmune inflammatory systemic disease.  It progressed from the time of initial injection.  After much testing, there is a new autoimmune inflammatory condition   painfully affecting all joints.  I am currently taking several anti-inflammatory injectable biologic medication prescribed by the rheumatologist.  I also take several oral anti-inflammatory medications also.  This continues to go on and it has now been two years since the initial Covid vaccine administration.
Admission Date: 5/30/2022 Discharge Date: Jun 1, 2022  HOSPITAL COURSE: patient is a 58 yo male with PMH of diabetes, HLD, gout, HTN who presented to the ED with generalized weakness, nausea and vomiting. He was playing golf on the day of presentation with sudden development of aforementioned symptoms.    In the ED he was noted to be febrile and reported rhinorrhea for 2-3 days prior to presentation. He also reported exposure to COVID at a party about 6 days prior and stated he had been vaccinated against COVID-19 with JJ vaccine but had not received the booster. CXR was obtained which was without acute pulmonary process and patient was initially set to discharge from the ED with written prescription for Paxlovid but due to hypoxia was admitted to the medicine service.   # COVID-19 Patient was treated with oral decadron and was able to wean off oxygen rather quickly and never required more than 2 liters. He remained afebrile without dyspnea and was able to ambulate without hypoxia. He was discharged home in stable condition and discharge instructions provided. He was recommended to self isolate for 10 days from symptom onset and to follow-up with PCP regarding obtaining COVID-19 booster.
Shortness of breath while at rest, heart palpitations/arrhythmia. Shortness of breath started around 4/16 and lasted for 3 days or so. Palpitations are still ongoing.
PNEUMONIA; FLU-LIKE SYMPTOMS/COULDN'T BREATHE; TOO MUCH CARBON DIOXIDE IN BODY; This spontaneous report received from a consumer concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breathing problems, heavy smoker, intubation, and life support. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated on an unspecified date, the patient experienced flu-like symptoms after getting the vaccine, couldn't breathe and ended up with pneumonia, and had too much carbon dioxide in her body required intubation. The patient was kept on life support and was flown to another city and was hospitalized (date unspecified). She was there for about a week or a week and a half . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms/couldn't breathe, pneumonia and too much carbon dioxide in body was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20211115315, 20211115400 and 20211115414.; Sender's Comments: V0: 20211115081-covid-19 vaccine ad26.cov2.s-Pneumonia, flu-like symptoms/couldn't breathe, too much carbon dioxide in body. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pain, redness, swelling, skin hot to touch in injection area, itching, hard knot under skin at injection site.
10/25/06 am school nurse called to take child to Doctor. Rash hives on feet morning of 10/26/06 I reported to school nurse. Evening of 10/26/06 rash spread through body. Got appt 9:00am. 10/27/06 rash appeared to turn to blisters in certain areas of body spreading through out. Treated with Bacitracin zinc ointment. Prescription by Dr. Child did not have high fever. He experienced chills and sweating. Loss of appetite. Sores in mouth and nose, underneath tongue discoloration. Fast heart beat, tiredness. Also treated with Children's Benadryl and appears to have recovered today.  12/14/06 Received medical records which included Lot number.  Reveal patient seen on 10/25 with cold s/s of sore throat, nasal congestion & dry cough for approx 1 day.  Afebrile.  Exam revealed purulent nasal discharge & erythematous pharynx.  Received flu shot.  Developed rash which started on feet following day & spread to extremities.  Exam on 10/27 revealed gen macular erythematous rash with several erythematous, papular & occasionally umbilicated lesions on dorsal & ventral aspect of feet, palms, buttocks belly, chin & mouth.  Patient was out of school until 11/6/06. Final Dx: Hand, foot & mouth disease.
Patient reported itching and rash all over her body that was not relieved with Benadryl. Patient advised to contact MD for irregular vaccine reaction