chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen red rash at injection site 4? across appearing 48 hours after shot; severe leg and arm cramps and headache 18 hours after shot that lasted 24 hours; headache persisting 48 hours
Client states she broke out in hives. Developed into fever, nausea and weakness. Stated home from work the next day 03/08. Went to Dr. later and was told that she probably had a reation to the injection.
just trying to walk or go to the bathroom was difficult; muscle aches; arthralgia (in fingers and knees); high feverof 102°F; blinding headache; Arm was swollen and hurting; go to the bathroom was difficult and felt miserable; Serious chills; very week and tired; didnt feel like eating; Glands are still swollen / Had swollen glands behind the earlobes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable) and CHILLS (Serious chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), ARTHRALGIA (arthralgia (in fingers and knees)), PYREXIA (high feverof 102°F), HEADACHE (blinding headache) and VACCINATION SITE SWELLING (Arm was swollen and hurting). In April 2021, the patient experienced LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes). On an unknown date, the patient experienced GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 04-Apr-2021, ARTHRALGIA (arthralgia (in fingers and knees)) and HEADACHE (blinding headache) had resolved. At the time of the report, ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), MYALGIA (muscle aches), PYREXIA (high feverof 102°F), VACCINATION SITE SWELLING (Arm was swollen and hurting) and LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes) had resolved.            Concomitant product information was not provided.  It was also reported that patient feels fine now and has no additional things going on.   This case was linked to MOD-2021-239045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received captured reporter details, patient demographics, product details, treatment and events.
This spontaneous report was received from an office manager referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored doses of PROQUAD lot # M037011, expiration date 21-FEB-2018 for prophylaxis (strength, dose and route were not provided). No adverse effects were reported. It was confirmed by a data logger that the temperature excursion was 9 to 25 Celsius degrees for 6 hours and 56 minutes. No previous temperature excursions were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Patient with history of COVID vaccination admitted to hospital with COVID detected PCR test. Patient expired on 9/18/2023. Providers discharge summary, "Patient admitted with DKA, likely due to COVID 19, after progressive symptoms for the 10-11 days prior to admission. He reported decreased appetite and PO intake, his high anion gap acidosis was likely combined due to DKA and starvation ketosis. Initially patient started on insulin drip, and when he improved to the point of being able to eat he was given a diet. Subcu insulin started and subsequently his insulin drip was discontinued.   Patient also with acute hypoxic respiratory failure requiring nonrebreather mask and up to 8 L O2. This was able to be weaned down on hospital day one. Patient was treated with antibiotics for possible coinfection with bacterial pneumonia, given his comorbidities and high mortality risk.    This morning I saw the patient and he stated he was feeling well, his breathing was stable and he was requiring only his home 2L O2. His labs were reviewed, and the anion gap had increased again, with noted acidosis with a bicarb of 10. Insulin drip was ordered to restart, and we held his morning subcu insulin.    While waiting for the insulin drip, patient went to the bathroom. When he returned to bed he was noted to be pale and breathing rapidly; nursing notified the team and we came to bedside to evaluate him. He was restarted on nonrebreather mask with no improvement in his symptoms. On my evaluation I heard wheezes in all lung fields but I did appreciate breath sounds. We ordered a stat XR which was done and personally reviewed by myself. Compared to prior it appeared slightly more congested with no obvious effusion, no pneumothorax noted.    RT trialed an albuterol MDI, but due to his rapid breathing he likely had limited benefit. Nebulizer ordered. We also had ordered an ultrasound guided IV line, due to difficulty placing Ivs. ABG also taken, and results reviewed by myself.    Patient noted to have tachycardia to 150s, EKG obtained and I noted sinus rhythm without ST changes. I did order a troponin as the telemetry was occasionally noting Vtach.   Patient suddenly became unresponsive, and nurse called code blue. Less than a minute after unresponsiveness I initiated chest compressions. ICU team arrived shortly after and took over running the code. I spoke with his wife who noted he has signed documents to be full code unless he was without brain function. ICU team continued high quality CPR until it was deemed futile. I spoke with his wife again, offering my condolences, and notified care management to help make arrangements."
Discomfort; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) and PAIN (Pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DISCOMFORT (Discomfort) and PAIN (Pain). At the time of the report, DISCOMFORT (Discomfort) and PAIN (Pain) had not resolved.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623056, MOD-2022-623061.
Erythema and tenderness to left arm less than 24 hours after injection (5.5x4").
Twenty minutes after injection, pt complained of severe iching and redness of entire arm that she received injection in. No respiratory symptoms and no urticaria. Pt received Benadryl and Decadron per MD and symptoms resolved.
First Shot om 3/22/2021. For various reasons I delayed and had second shot today; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Shot om 3/22/2021. For various reasons I delayed and had second shot today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Shot om 3/22/2021. For various reasons I delayed and had second shot today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Shot om 3/22/2021. For various reasons I delayed and had second shot today) had resolved.            Concomitant medications were not provided. Treatment information was not reported.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 16-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011661:
Posturing, seizure-like activity. I was unable to breath during each event, unable to ambulate as normal, difficulty with speech. I was in the EMERGENCY ROOM for 9 hours.  Given medication, head CT, labs drawn, and IV. Have to continue to monitor myself for further adverse reactions.
FEVER; This spontaneous report received from a health care professional concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Received MMR/Varivax on 7/8/05. Rash began on 7/19/05 evolving quickly with papular over entire trunk and extremities.
Patient received an adult dose of Pfizer instead of the pediatric dose.   Managers, Pediatric Doc, Peds Covid physician (Dr. Notified) Had patient stay a full hour to be monitored.  Mom is a nurse and she called her peds doc. Had pharmacist also speak with mom.  Reassured mom and told her that we would keep her even longer than normal.  The patient was playful and not exhibiting any adverse reactions.
04/05/23 presents to ED for "fever, cough, SOB and fatigue". PMHx of "hypertension, diabetes, pulmonary hypertension, CHF"
First day: I swelled up like the Pillsbury Dough Boy.  I had high blood pressure, (which I normally do not have), migraine like headaches for three days and now I have a rash all over my face and arms.  The rash is very itchy and annoying.
Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown). Concomitant therapy included bupropion HCl (WELLBUTRIN) and ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot# unknown) injection. The patient developed injection site redness, a knot under the skin was hot to the touch. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested.
This is a spontaneous report from a contactable nurse and vaccine coordinator. A 56-year-old female patient received PREVNAR 13 (Lot # P007262 Exp. Date 25Nov2015), subcutaneous at 0.5 ml, single on 09Dec2014. Medical history included breast cancer from Dec2011, chronic obstructive pulmonary disease from Oct2003 and ongoing, Crohn's disease from Feb2008 and ongoing. Concomitant medication included albuterol neb 0.083% as needed, Albuterol inhaler 108 8.5ml 1-2 puffs every 2 hours as needed, anastrozole 1mg 1 tab daily, Calcium + Vit D twice a day 500-400mg, FLOVENT 12g 2 puffs 2 times a day. The patient received the PREVNAR 13 vaccine on 09Dec2014 subcutaneously instead of intramuscularly in the right arm and was diagnosed with cellulitis of the right arm on 12Dec2014. The patient was not hospitalized and was treated with an unspecified antibiotic. The outcome of the events was unknown.
itchy face, arm, and neck, chills, low grade fever, chest pain, joint pain
Case number PHEH2016US030182 is a spontaneous report initially received from consumer on 15 Nov 2016. This report refers to 76 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618501) at a dose of 0.5 ml intramuscular on 24 Oct 2016. On 01 Nov 2016, the patient left knee started hurting for the two days and the pain went away. On 03 Nov 2016, the patient left knee hurting was recovered. On 14 Nov 2016 the patient's right knee started hurting. The patient took ibuprofen and her condition was improving. It was reported that, the doctor did not prescribed the vaccine, they did not have any on hand yet. The patient still appearing joint pain in other part of body might be due to old age. The outcome of the events left knee hurting was completely recovered on 03 Nov 2016 and right knee hurting was improving. The seriousness of the events was reported as serious disability. The causality of the events was not reported. Follow up report received from consumer on 13 Dec 2016: Updated reporters comment and event verbatim.
redness at the injection site; swelling and redness at the injection site; pulse rate went as high at 120; erratic heart rate; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2020, the patient received the 1st dose of Shingrix. On 19th November 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, high pulse rate, heart rate irregular and headache. On an unknown date, the outcome of the injection site erythema, injection site swelling and headache were recovered/resolved and the outcome of the high pulse rate was unknown and the outcome of the heart rate irregular was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, high pulse rate, heart rate irregular and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in right arm and the next day she observed swelling and redness at the injection site, and headache which all resolved. But also had erratic heart rate which had not resolved and was seen at the emergency room and multiple tests were done and was under observation for 7 hours and the doctor would not find the cause of the erratic heart rate.  The blood pressure was normal at 110/75 and currently due to the erratic heart rate her pulse rate went as high at 120.  The reporter was scheduled to see a cardiologist for further examination. The reporter consented to follow up and emergency room visit required.
Pt received MMR on 9-10-14. 1 wk later she noticed red halo around site. She used OTC BENADRYL EOD x 1 wk and noticed color and itch improved. Still sore when pressed. Objective: minimal light erythema, warm to touch, looks like 3 puncture wounds ? insect bites all on pt's (R) arm.
18 yo male had Menveo and Tdap yesterday; last night began experiencing localized pain at injection site, subjective fever, chills, tightness in chest, N/V and dizziness. Continues to have symptoms today, including tachycardia and headache
Post vax, the pt was hospitalized with compromised immune system, dehydration, and massive headache.
Erythema site reaction. Slipped and fell in the middle of the night and doesn't remember it happening.
Within 24 hours of the 1st vaccine, I experienced extreme back pain and could barely stand up. When laying down I had extreme pain when moving from side to side. The pain then traveled to my left side and into my chest. I had chest pain at various times through the day and night. After two weeks I made an appointment with cardiologist to discuss blood pressure and chest pain. He ordered  cardio stress test and echocardiogram. I passed the stress test. The echocardiogram showed a small amount of fluid around my heart and slight regurgitation of my mitral valve. I discussed by concern about the COVID vaccine with my cardiologist. He said I may have experienced inflammation from the vaccine but could not confirm. It is July and I still experience slight chest pain from time to time., which I believe is from the pericarditis, which is a result of the COVID vaccine.
Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.
Patient started vomiting and feeling light headed at some point during the 15 minute observation period following immunization. Patient received vaccine at approximately 9:15am and started vomiting. Pharmacists came to observation room and at 9:38 patient's blood pressure was 138/96 HR-74, at 9:43 132/87 HR-66. At this point vomiting had resolved and patient was sipping water. She remained under observation for approximately 15 additional minutes with no additional symptoms. Patient reporting feeling better at that time.
Pt. received MENVEO #2 and MEN B #1 on 5/3/16 - on 5/4/16 Mom called complaint of pt. has rash on body - next day - pt. received shot at 4 pm. - at 6 pm. - pt. took shower because itchy - then rash next day. Seen on 5/4/16 pt. given steroid and hydroxyzine.
Report 2001023796-1 described probably cellulitis in a 19 month old male who received Infanrix. The  vaccinee's allergies, medical history, and concomitant medications were not specified. There was no illness at the time of vaccination. On 06/04/2001, the vaccinee received a 0.5cc IM right deltoid dose of Infanrix. It was not known how many previous doses of Infanrix he had received. on 06/05/2001, he experienced "proably cellulitis" with a right deltoid 10 x 9cm area of erythema and induration surrounding the injection site. The induration was the size of a 50 cent piece. The area was hot to touch and had irregular borders. The "probable cellulitis" was treated with Augmentin 300mg twice daily for ten days. The reporter indicated that the adverse events could possibly be associated with erroneous administration. As of 10/04/2001, the outcome of the "probable cellulitis" was unknown.
Constant headache x 2.5 weeks.  Pain level 4/10. Stabbing like to left side of the head. Typical pain medications for headaches did not improve the issue. The pain was constant, sleep did not cause the pain to go away. Each day, I woke up with the same headache. Had appt on 9/20/21 for the annual work exam. The issue was brought up during check-in with the nurse but not discussed or documented during the visit with the doctor.
Information has been received from a emergency medical technician concerning a 19 year old patient who was vaccinated with MMR II and had negative titers to measles. This is one of several reports from the same source.  Additional information has been requested.
Pt reported local redness, warmth, swelling in arm, chills, low grade fever starting the following day.  she states that she is feeling better today.  Pt advised to see/call PCP.