chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 41-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Pt was brought to hospital ED ON 8/22-8/29 for COVID, AKI; dc'd to facility where the following day she was lethargic and staff said she had a UTI; sent back to ED on 9/5/22 with AMS, SOB; placed on O2 supplementation, ABX;  9/6/22 transferred to Medical Center with sepsis and AHRF and stayed until 9/24/22; DNR/DNI; dc'd back to facility where she passed away on 10/4/22; was scheduled for follow up appointment.
Received monovalent booster (spikevax) in error instead of bivalent booster.
Numbness  and tingling in all toes 2 hours after shot, numbness in foot a half hour after toes, numbness in face and lips 5 hours after foot numbness.  The next morning at 8:30 am the left arm felt weak and tingly from my shoulder to my finger tips. 11:30 pm headache.
Severe asthma response lasting one month - extremely severe bronchospasms and dry coughing for one month; finally resolved with receipt of a prescription for CIPRO and Prednisone.
Pt recvd 3 doses of Engerix-B vax & 9OCT91 found to be a non-seroconverter;
Immune compromised; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immune compromised) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immune compromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immune compromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CD4 lymphocytes: 234 (abnormal) 234.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No medical history was provided. The reporter reported that his CD4 COUNT was 234 when he received his COVID-19 vaccine on march 9, 2021. Also patient was  immune compromised.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information is not to be expected. The patient stated that at the time of vaccination the CD4 count was 234. Therefore, a causal association of immunocompromization and vaccination appears rather unlikely. Implied causality of a spontaneous report applies, however.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information is not to be expected. The patient stated that at the time of vaccination the CD4 count was 234. Therefore, a causal association of immunocompromization and vaccination appears rather unlikely. Implied causality of a spontaneous report applies, however.
Approximately 100 tiny pink papules grouped around vaccine site on (L) thigh - no pustules, no hives (R) thigh has about 20 of the papules which are pink, 1-3mm, non tender; excoriations present.
This spontaneous report as received from a 61 year old female patient reporting on herself with no drug reactions, allergies or pertinent medical history. Patient with blood pressure. On 29-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) for the prevention of shingles. Concomitant medication included unspecified blood pressure medication. On 30-JUL-2013, the patient experienced a red blotch (the size of a half-dollar0 at the injection site. The area was warm to touch and she also noticed 2 more small spots nearby. The spots were not blistered. No treatment was given for the event. No lab diagnostic studies were performed. The patient did not seek for medical attention. The outcomes of the events were reported as not recovered. Additional information has been requested.
Admission Date: 2/15/2023 Discharge Date: Feb 17, 2023  PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: Patient is an 81-year-old male with past medical history of ventricular tachycardia status post ICD, dilated cardiomyopathy, essential hypertension, hyperlipidemia bipolar disorder who presented with a chief complaint of generalized weakness 1 day prior to admission.  His wife was also sick and was positive for COVID-19 outpatient.  Patient was so fatigued and weak that he had difficulty getting out of his chair, walking or standing.  He admitted to a mild cough without sputum production.  He denied fever or chills.  He also complained of left leg pain that was intermittent.  In the emergency department, he was hemodynamically stable.  His oxygen saturation was normal on room air.  Labs were within normal limits.  Chest x-ray showed patchy infiltrates.  COVID-19 PCR was positive.  Left lower extremity ultrasound was negative for DVT.  Patient worked with PT/OT who recommended home with home care.  The patient was discharged home on 02/17/2023.  He did not qualify for remdesivir or Decadron during his stay secondary to lack of hypoxia.
Aches / Pains; Arms were extremely tired; Knees and ankles got lock; Arms were weak; Felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches / Pains), MUSCLE FATIGUE (Arms were extremely tired), JOINT LOCK (Knees and ankles got lock), MUSCULAR WEAKNESS (Arms were weak) and FATIGUE (Felt extremely tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Ulcerative colitis and Crohn's disease.    Patient had no known allergies. Patient had no relevant medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Aches / Pains), MUSCLE FATIGUE (Arms were extremely tired), JOINT LOCK (Knees and ankles got lock), MUSCULAR WEAKNESS (Arms were weak) and FATIGUE (Felt extremely tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (Aches / Pains) had not resolved, MUSCLE FATIGUE (Arms were extremely tired) outcome was unknown and JOINT LOCK (Knees and ankles got lock), MUSCULAR WEAKNESS (Arms were weak) and FATIGUE (Felt extremely tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  Dosage text was reported as Booster (1 in 1 Once) for Moderna COVID-19 Vaccine  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with HUMIRA(ADALIMUMAB) for the events of Knees and Ankles got lock and Arms were extremely tired and weak was a reasonable possibility, for the events of Arms were extremely tired and weak was not provided, and for the events of were extremely tired and Aches / Pains was no reasonable possibility.
Symptoms: Onset of neuropathy hand tremors and weakness in lower extremities. Onset of pulsatile tinitus Onset cardiac symptoms: left atrial enlargement; tachycardia and bradycardia; heart palpitations; high blood pressure; elevated heart rate;  Onset Right-sighted migraines/headaches Onset Edema (right foot) Onset Difficulty walking (use cane for support) Onset Extreme debilitating fatigue, including dyspnea
9/14-5:30 pm body aches, specifically legs joints and lower back. Tired, temp of 99.3. Took Advil and improved. Injection arm very sore 9/15-2:30 am chills, extreme body aches specifically in leg joints. Headache. Nausea. Temp 99.4. Restless. Took advil and improved but then became extremely over heated. Finally slept again approximately 5:30 am. Injection arm very sore 9/15-headache and mild body aches all day 9/15-5:00 pm body aches in leg joints returned. Headache. Nausea. Temp 99.9. Chills. Took hot shower and Advil and went to bed at approximately 9pm 9/16-6:30am weakness in extremities, arm pain, body aches, headache and mild nausea. Temp 99.2. Tired. Dizzy and lag in eyesight when I turn my head. Slight brain "fog" took Advil
Red, swollen (L) arm with blistering skin feels weak and diffuse arthralgias x 2weeks. Flu and Pneumo shots given in same arm. 10/15/18 Presents today w/ h/o going to the ER On 10/3. Had throbbing in his joints and HA and labs and CXR were normal. He noted Sxs for about a week or two prior to going to the ER. He feels much better now. Wife notes he is red in the face at times. He feels weak at times. He has not taken his temperature. He had his flu and pneumonia shots last of Sept given in the same at (left) at Pharmacy and then his arm he says b/c very swollen and red and had fever in it w/blistering on the skin. Went back in an they were not able to identify what shot caused the issues and told him 'he would live'. Knees, hands and feet have felt stiff in the AM for about 10 min. No lupus or RA in his family. No tick bites, no travel. Notes spider bite in July.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 23-SEP-2014. Demographic details for each patient were provided. This report referred to a 7-month old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 22-JAN-2014 at 3:20 PM, and the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 20-FEB-2014 at 4:00 PM. It was reported that these doses were spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). It was also reported that vaccination repeat was declined. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
pt recvd vax & 28AUG92 had fluu-like sx, then sx went away & returned; now feels fine but has elevation in liver enzymes; reporter pt also had pneumovax @ the same time;
When COVID started, I did have all of the symptoms of the virus, but the tests came back negative. I know that I had some type of virus. Ever since I experienced this, I do stay constantly winded. If I stand up to fast, I will experience a bit a fuzziness. After receiving the vaccine, I found out a couple weeks after receiving my second dose, that I have stage 4 kidney problems. I have never had kidney problems before. My doctor called and told me that he wanted to set up an appointment of blood work and a urinalysis. I was very surprised about the call. I eat very healthy and I don't understand how this happened. The tests were telling him that my kidneys are not filtering like they should. I have another test coming up 7/5/2021. They are going to inject dye into a line to see what reaction occurs and to see if there is a blockage. After the ultrasound they couldn't find anything wrong. I asked if I should change my diet. I don't eat any junk food and I eat a lot of fruit and vegetables. I am just waiting for the follow-up appointment now.
Extreme internal pain like a bear claw starting under my arm left side slowly over 6 weeks moving down over chest into intestines area. Plus stabbing knifes first across my shoulders then across my hips over 6 weeks.
Vaccine diluted with sterile water instead of the recommended normal saline.  No adverse effects reported.
Redness, swelling, warmth and itching. MEDROL DOSE PAK, antibiotics if needed, CLARITIN.
Information has been received from a physician concerning a 4 year old male with asthma who on 10-JUL-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot number 665900/1604Y). Concomitant therapy included BENADRYL, albuterol and QVAR. On 08-MAR-2011 the patient experienced chickenpox; and he sought medical attention via doctor's office visit. At the time of report, patient present status was recovering. Additional information has been requested.
From initial information received on 4/6/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 23 year old male patient received a third dose of TD ADS ADULT, lot number U1347AA, administered IM in the left deltoid on 3/31/05. One day later, on 4/1/05, the patient developed soreness and pain at the injection site. Within 24 hours, he had joint pain in his left knee and experienced bizarre neurological auditory stimuli and short term memory loss. The patient has not recovered from these events. Additional information was obtained during a telephone conversation with the reporting physician on 4/8/05. He described the patient as being sensitive to sound and light. The events of joint pain and memory loss have resolved, but he still has periods where noise and light bother him. The physician reported that he spoke with the patient on 4/7/05 and he was feeling better. (OMIC)
It is became itchy; Mild Nausea; Strange painful stomach ache; Slightly raised rash; Long red rash; Hot to touch rash; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and PRURITUS (It is became itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and NAUSEA (Mild Nausea). On 28-Apr-2021, the patient experienced PRURITUS (It is became itchy). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 400 milligram; LIDOCAINE for Itch, at a dose of 12 %; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Stomach pain, at a dose of 400 milligram. At the time of the report, ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and NAUSEA (Mild Nausea) outcome was unknown and PRURITUS (It is became itchy) had not resolved.            Concomitant product information was not provided by the reporter. Treatment information includes Diphenhydramine.
0500-severe headache.  Took ibuprofen. 0900-severe headache 1000-body aches, chills, sweating, severe headache, fatigue 1130-loose stool, all previous symptoms and low grade temp-99.1
the patient was vaccinated with susuepct vaccine on 23-JUN-2011 and 25-FEB-2016; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2111USA004909), concerning to a 70 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 23-JUN-2011 and 25-FEB-2016, the patient was vaccinated with pneumococcal vaccine (+) polyvalent (23-valent) (manufacturer unknown), respectively, both for prophylaxis (inappropriate schedule of product administration). The dose, strength, route, lot number and expiration date were unknown. The patient did not recall adverse reaction.  This is one of three cases concerning the same patient.; Sender's Comments:  US-009507513- 2111USA004909: US-009507513- 2203USA006291:
Approx 6 hrs after injection mother noticed rash on chest and abdomen. PT seen in clinic approx 24 hrs after injection. Rash flat, red small patches, not simply. Inject site red approx quarter size and adjacent to inject site one nickel size hive.
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patien received Moderna vaccine on 01/19/2022. Patient called in our pharmacy on 01/22/2022 to report adverse events. Patien reported having chills, fever, headache,nausea, vomitting and no appetite since 01/19/2022. Advised patient to call her doctor or go to urgent or emergency room.
During monitoring period post Pfizer COVID-19 vaccine, pt experienced throat constriction, ringing ears, palpations, dizziness & lightheadedness. Vital signs: 194/91-80-98% reporting throat constriction, & palpitations. Given benadryl 25mg IM x 1. Continued to monitor patient expressed throat "is closing but just a little bit" with lightheadedness & dizziness. Epinephrine 0.3mg IM given x 1. Pt reporting more dizziness and lightheadedness and that she is diabetic, coke given, pt does not have her glucometer on hand. EMS called for evaluation. EMS decides not to transport pt after pt states that she does not want to be transported. Patient monitored for 15-20 more minutes and went home with husband.
On approx. March 6th I noticed I was having a ringing in my ears. It has persisted since then, no better no worse.  It does not keep me up at night but it is annoying.  I don't know if it is related to the vaccine shot but I kept thinking that it could be a delayed reaction.  Maybe it started before but at a lower level and took until the 6th for me to notice. This week (week of March 22) I read a news article about someone who committed suicide because he was having severe bouts of tinitis since having had a case of covid.  That made me think that my tinitis could be related to the vaccine.  I tried to red up on tinitis and it seems that there is no treatment for this. Am I correct in that information?
Many itchy skin hives on back, front, neck found in the evening of 06/18 and hives were gone in the morning  06/18
pt recvd vax 28FEB94 & several hrs later, devel fever of 102-103 which persisted several days; 6MAR exp 2 generalized tonic-clonic szs observed by parents; pt taken to ER, fever 101, hospitalized 4 days; MRI scan nl;
Tiny "bumps" covering both arms, both legs below the knee, collarbone area, back, and shoulders. Bumps are extremely itchy. I have unknowingly itched my arms until the bumps begin to bleed. Best described as hundreds of small mosquito bites.
Over 48 hours of extreme pains joint muscle / lymph pain underarm of injection arm . Spiking fevers over 100 for two days
Patient was given the Original Moderna vaccine booster vs the Moderna Bivalent booster on accident. No treatment and no adverse reaction to the additional original moderna booster.
ACHES AND TINGLES. @12:45AM WOKE UP FREEZING WITH A FEVER. WEDNESDAY MORNING WOKE UP WITH A COLD SWEAT. WEDNESDAY NIGHT- SAME SYMPTOMS BUT 10X WORSE. UNCONTROLLABLE SHAKES, FEVER, FREEZING, ENTIRES BODY ACHES. TOOK TYLENOL, NYQUIL AND ADVIL.
I have a lymph node that is right below my left clavicle that is as hard as an uncooked green pea.
Fully vaccinated, not boosted. COVID infection breakthrough, asymptomatic.   Admitted to the hospital with non COVID diagnosis.
Pt complained of vomiting, fever, headache and malaise.  Pt also complained of left upper deltoid swelling, itchiness and redness and pain in axillary lymph nodes.  Pt also experienced hives.
Paralysis/partial immobilization on the right side of the body from April until June. Treated with steroids' until August and finally symptoms improved.  Still experiencing exhaustion etc.
Soreness at injection site, worse as time progressed; limited mobility of injection arm.; Full body aches; Shivers; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2023, the patient received the 2nd dose of Shingrix. On 1st February 2023, immediately after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, general body pain and shivers. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, general body pain and shivers were unknown.   The reporter considered the injection site pain, injected limb mobility decreased, general body pain and shivers to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The patient received Shingrix injection and experienced soreness at the injection site at time of administration. The patient stated that, progressively worsted as time progressed, limited mobility of injection arm. The patient also experienced full body aches and shivers. The reporter stated that the symptoms were definitely related to GlaxoSmithKline product. The reporter agreed to follow up from GlaxoSmithKline.
Upper arm became somewhat sore by later afternoon, became excruciatingly painful by later evening. Did not feel well by bedtime, and a bit fuzzy-headed. Next day, I was fuzzy-headed, body stiff and achy, very tired, upper arm excruciatingly  painful. All symptoms began to clear significantly by evening, and back to normal by the following morning (2/10).
I developed loss of taste 4 days after injection. I got a COVID Ag test on 1/22/2021 which was negative. Symptom persisted. I got another Covid AG test done today 01/30/ 2021, Which was also negative.
Patient complained she felt her heart flutter immediately following vaccination. Patient's vital signs were taken and was assessed by MD at the clinic. Vital signs were within normal limits. Patient felt improved and went home.
Approximately 18 hours after receiving the PNEUMOVAX 23 vaccine the patient's left arm became painful with a "blotty" rash the size of a grape initially. Then it progressed to be the size of 4x4 inches plus slightly under her arm. She took 2 TYLENOL tabs one time and it seems to have helped with the pain. Today is better but still slightly raised. Suggested ice topically to help with pain and swelling and monitor for worsening symptoms.
Began to experience an itching sensation in the throat almost immediately after receiving the vaccination.  She was evaluated, subsequently given 50 mg diphenhydramine IM and improved over the course of an hour and 15 minutes. She was released to husband's care and was to follow up at ER if any worsening and  was recommended to establish with primary care individual.
pt recv vax 1030AM 17DEC97 clinical exam was unremarkable, pt devel T102.6 R 4PM 17DEC97, 99.8 R 830PM but felt hot;had a feb sz 8:30 to 8:40PM lasted ? 3min;taken by rescue squad to ER:temp 102.6 R found to have ROM;