chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed scheduled dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed scheduled dose) 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 24-Feb-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 PRODUCT DOSE OMISSION ISSUE (Missed scheduled dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed scheduled dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-JUL-2021 , Containing No new Information
No additional AE; HCP calling to report an AE regarding PNEUMOVAX 23. HCP reported that a patient was administered an expired dose of the PNEUMOVAX 23 vaccine. HCP provided limited pertinent information and had no further clarifications. Permission was provided to con; Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-OCT-2023, the patient was vaccinated with and expire dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W021636, expiration date: 01-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The reporter provided limited pertinent information and had no further clarifications.
After 10 minutes, clammy hands which lasted for 10-15 minutes.  After 4-5 hours, sore arm on injection site. Soreness persisted and relieved for 3 days.  After 5 days, louder than previously experience in right ear along with pressure inside of right ear. Persisted for a few hours, hard to sleep. Then relieved.  After 5 days, scratchy throat, even swallowing caused gag reflex. Persisted for a few hours, hard to sleep. Then relieved.  After 6 days, right arm lymph node swollen to a little over a half centimeter. Saw doctor and got blood test for white blood cell count. Has not relieved yet. Please contact me at a later date to understand how long it lasted.
The wrong vaccine administered. Pt is 4 months old and was given the Kinrix that is in the age group for kindergarten vaccines. No adverse reaction to vaccine noted.
This spontaneous report was received from a physician via a field representative and refers to a 15 year old male patient. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/ allergies. The patient concurrent condition included myalgic encephalitis. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient was diagnosed with "myalgic encephalitis (encephalitis), and felt more sick." It was unknown if the patient sought medical attention, if received treatment for the event or if laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered. The causal relationship between the events and therapy with GARDASIL 9 was not reported. Upon internal review the event encephalitis was considered to be medically significant.
TD Vaccine was administered on 8-12-05. Reported local reaction on 8-15-05 of swelling, redness, Tenderness and hot to touch. States had slight elevated temp yesterday of 99.2 oral. Noted a large area of redness to Left Deltoid. Area firm and warm to touch.
Myopericarditis with chest pain onset 3 days after vaccine dose #2. 1 day after dose #2, patient experienced fevers and chills.
Pt received three vaccines, TDAP, VARIVAX & MENACTRA. ADACEL given in upper (L) arm (deltoid). No immediate reaction seen 1 day later started with redness & swelling 2inch from injection. Diameter of redness swelling 3inches is getting better still soreness.
Could not breath; Throat shut down; Tingling in legs; Could not swallow; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Could not breath), THROAT TIGHTNESS (Throat shut down), PARAESTHESIA (Tingling in legs) and DYSPHAGIA (Could not swallow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was reported.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DYSPNOEA (Could not breath), THROAT TIGHTNESS (Throat shut down), PARAESTHESIA (Tingling in legs) and DYSPHAGIA (Could not swallow). On 20-Mar-2021, DYSPNOEA (Could not breath), THROAT TIGHTNESS (Throat shut down), PARAESTHESIA (Tingling in legs) and DYSPHAGIA (Could not swallow) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment product information was provided.   Reporter did not allow further contact
On 4/28/00 she had a temperature of 103.9 and poor apetite. Tylenol given. 4/29/00 Her temperature was 99-100 and poor appetite. Tylenol given.  On 4/30/00 she broke out in a patchy red rash on her face and a raised pimple-like rash on her arms, legs and trunk as well as a temp of 99-100. Tylenol and Benadryl given. When she woke up on 5/1/00 the rash was gone, fever gone and appetite had returned.
ITP treated with Win. 9/29/09.  Hospital records received DOS 4/8/09 to 4/9/09. Assessment: Idiopathic Thrombocytopenic Purpura. Child presents with 'rash' on stomach. cough. Petechia and bruising diffusely spread on body. Crying.  ICD-9 Codes: 287.31 Immune Thrombocytic Purpura, 782.7 Spontaneous Ecchymosis.
Pt admitted with acute portal vein thrombosis and pancytopenia about 5 weeks after vaccination, did not have known pre-existing liver disease but did have ETOH chronic use and likely prior unrecognized liver disease
pt recvd 1 dose of Engerix-B & more than 6 hrs later devel severe itching which was generalized from head to toe; tx DPH; lasted 2 days;
There was no adverse reaction.  This 3rd dose was administered 2 weeks too soon .  It was intended that she receive the flu shot this day, but she received the covid vaccine in error instead.
ascending paralysis, resp failure requiring intubation, IVIG x5 days followed by plasmapheresis x5 days.  patient remains intubed and in ICU 10/22/09 Hosp. records received for dates 10/1/09 to 10/18/09. Current DX: GBS. Pt. presented to ER on 10/1/09 with c/o numbness in all extremities, pain, weakness in legs, back pain, numbness in mouth. Pt. was in ER 1 day prior and sent home, sx. Increased pt. returned to ER. Pt c/o flu like sx 10 days prior. pt received gardasil vax 8/17/09. Assessment: WNL except, absent knee reflexes, hypoflex of lower extremities. (+)intramuscular fluid around spine at the occipital cervical junction. DX at time of assessment: GBS vs. idiopathic polyneuropathy vs. MS. Pt. admitted to medical unit, sx. deteriorated transferred to ICU. Further assessments: absent deep tendon reflexes of upper and lower extremities, c/o pain throughout entire spine. MRI of spine (+)arachnoid cyst. 10/5/09 pt. intubated,  tx IVIG with no response. Plasmapheresis. DX: GBS, respiratory failure, hemothorax. 10/15 tracheotomy placed.
(1) Hives, (2) SOB, (3) Throat swelling, (4) Stiffness of upper & lower extremities. Oxygen SAT decreased 94% on RA. Rx: 6 lit oxygen, EKG, SOLUMEDROL 125 mg I/M BENADRYL 50g I/M
loss of appetite, nausea, head ache, muscle pain, tingling in hands.  I could not get out of bed for one full day.  I felt like I did when I had chemo.  I was able to resume my life the next day but was still very tired.  Injection site is very very soar.
A report was received from a health care professional on 27 October 2003 concerning a 57 year old female vaccinee who experienced fever, myalgia, a sore throat and shortness of breath on 24 October 2003 and swollen glands, headache, fever and hallucinations one day later, and elevated blood pressure and a temperature of 100 degrees Fahrenheit three days later after receiving Fluvirin vaccine on 24 October 2003. On 24 October 2003 in the evening, the vaccinee developed fever, myalgia, a sore throat and shortness of breath. On 25 October 2003 the vaccinee experienced hallucinations and continued to have muscle aches, swollen glands, headache and fever for which the vaccinee did not seek medical care. On 27 October 2003, the vaccinee attended her doctor's office with a temperature of 100 degrees Fahrenheit, and continuing headache, myalgia and had an elevated blood pressure of 160/90 mmHg. the outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1: 05 December 2003. Follow-up information received from a health care professional on 05 December 2003 indicated that the vaccinee received Pneumovax on the same day the Fluvirin was administered. The adverse events occurred 10 hours after administration of Fluvirin and Pneumovax on the same day and experienced no adverse events. The vaccinee recovered on 27 October 2003 following treatment with methylprednisone dose pack. The reporter has assessed the relationship of the Fluvirin to the fever, myalgia, sore throat, swollen glands, headache, hallucinations, elevated blood pressure and nausea as probable. Follow-up pending.
The patient received the flu shot on 3/22/21, developed a high fever of 104F in the evening and continued to have high fever of 104F through 3/24/21. On 3/24/21, the patient developed complex febrile seizure. No other signs of infection. Unremarkable CBC and BMP.  Negative Respiratory Viral Panel.
Within 48 hours I woke up with a slightly raised  rash on the left side of my neck. Through out the day a smaller patch appeared on the right side. Today, 72 hours later the rash is lighter but still present and slightly itchy. No other symptoms accompanied this rash.  I have taken two doses of benadryl.
Patient felt of having a vertigo a few minutes after the vaccination.  Patient was asked to relax in the chair and was offered drinking water.  After the vertigo symptoms went away,  patient went home.  She called back around 30 minutes later and mentioned having "chest pressure / tightness".  Patient was asked to go the Emergency Room.  Patient did not response to our follow-up phone calls.
Swelling, redness, tenderness, & heat at the site. Fever chills.
I had the extreme fatigue right after the vaccine. It kept me down for a couple of days. It got better, but I am still extremely fatigue. I had some more blood work done from my nephrologist, and my hemoglobin was really low. It was below normal, like 9. My nephrologist put me on another medication, Calcitriol .25 mcg, one in the evening, Monday thru Friday. They lowered my vitamin D 1000 iu to one in the morning instead of 2 in the morning, M- F. As a result of the blood work and low hemoglobin I had to see hematologist. I received an injection, Aranesp. I had blood work done for the kidney transplant list.
I had a possible reaction on my Left arm and chest. My Right arm received the injection. I never have any sticks in my left arm since I have  developed Lymphedema post breast cancer mastectomies and treatment in  April 2006. When I arose  my effected arm was red in color, with a rash on top of that. It was hot to the touch and swollen and stiff.  My husband took me to the emergency room of the hospital named in Item 21 and later that day I was admitted to the hospital. They diagnosed it as a severe infection, resulting in cellulitis and started me on round the clock IV antibiotics.
Extreme neuropathic pain in my legs, from my knees down to my feet, on and off.  It was horrible after the first vaccine sand I?ve never encountered this kind of pain in my legs before until after the vaccine.  Now, constant cramping in my right calf muscle that is so horrible when I first get up in the morning. It started at the end of May 2022, and has not let up, but increased in intensity each day that passes.
pt recv vax 6OCT98 & 7 days later exp chills & aching;
Patient was seen in UC on 11/27/21 for suspected shingles. He received the Covid booster on 11/20 and developed the rash 1-2 days later. No symptoms of respiratory distress or throat closing. He was prescribed Valtrex for suspected shingles but his rash worsened and spread. He was seen again in UC on 11/29/21 and received Solu-Medrol. A course of prednisone was prescribed as well as cephalexin to cover for cellulitis. Uncertain if his rash may be related to the booster or not.
case had shortness of breath along with low blood pressure and low blood oxygen level. went to hospital, tested and admitted the same day
Child's mother, reports a rash that started with a low grade fever (100.4) on 5-16-08. The rash worsened on 5-17-08. It covered her chest, back, trunk and face. Her cheeks were very red with white, raised areas noted. The rash on chest and trunk and back was red and "splotchy," not raised. Her right arm, where she received the DTaP and VAR, was swollen and very red; also itched. She saw her doctor on 5-16-08 for another health issue; the Dr told mom to "watch the rash." I talked to mom on 5/19/08 - she says the rash is getting better; no fever. follow up 1/15/10 - 6/2/08 update - after i reported this, the child's rash worsened.  parent took the child to the dr - she was diagnosed with Fifth's Disease.  the dr felt the  rash was due to illiness, not vaccine.
Developed sniffles starting about 1/18/22; tested negative on 3 home tests for COVID-19 from about 1/18/22 through 1/21/22; over the week of 1/24/22-1/28/22, developed persistent cough. Went to urgent care Saturday, 1/29/22. X-ray suggested bronchitis. Treated with antibiotic for 10 days but symptoms persisted for about another month.
9MAY97 530PM pt appeared to have a sz & body went limp, eyes rolled back, arms moved in a uncorrdinated manner for approx 30-45seconds;10MAY97 pt face was blue when picked up went limp & pale;remained pale for about 5min;
This spontaneous report as received from a nurse refers to a 36 year old female patient. On 01-OCT-2014 the patient was vaccinated with GARDASIL, (lot # unspecified) 0.5 ml, intramuscular in right deltoid. The patient had never been sexually active, but would like to received GARDASIL because she was going to get married. No adverse effects reported. Nurse states due to Health Insurance Portability and Accountability Act of 1996 (HIPPA), she did not want this AE report to go to Merck's vendors, but to a health agency like the FDA was okay. Nurse stated the patient gave her consent to report this to Merck. Additional information is not expected as there was no consent to contact physician.
Information has been received from a female consumer reporting on herself for VARIVAX (Merck) a pregnancy registry product who in August 2011, was vaccinated with a dose of VARIVAX (Merck) (lot number, route and dose not reported). Consumer reported that she was administered VARIVAX (Merck) in August 2011 and now she was 14 weeks pregnant. The consumer provided the name of the nurse practitioner, but did not state whether contact could be made with the nurse practitioner regarding the adverse event before consumer disconnected. The consumer did not want to give any additional information for the adverse event. The patient sought medical attention by contacting the nurse practitioner. Follow up information was received from a healthcare worker indicating that the 35 year old female patient on an unknown date was referred to a high risk perinatal center for reason unknown. It was reported that the pregnancy outcome of the patient was a spontaneous abortion. The reporter stated they did not know the exact date of the abortion but estimated it was between the date of her first OB intake on 18-OCT-2011 and a follow up call made by the Center to the patient on 18-NOV-2011 (between gestational weeks 14-18) when spontaneous abortion was reported. The patient's OB intake information stated there was no previous miscarriages. It was reaffirmed the patient's last menstrual period (LMP) was 12-JUL-2011. The dose series of VARIVAX (Merck) and the patient's status was unknown. Upon internal review spontaneous abortion was considered to be medically significant. Additional information is not expected.
2 days p/vax pt devel a red tender area @ the site of inject; MD dx this as an infect & treated pt w/ATB;
Severe injection site reaction: left arm diameter size of a baseball, patient reports tender to touch, and warm to touch, itching, red and irritated. In last 24 H visually it looks like a red, large bump. Patient denied systemic effects and counseled to put ice pack and oral BENADRYL if necessary.
This case is linked to cases US-SA-2021SA422716(CLUSTER).  This case involves a Nine months old male patient who was administered a dose of  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 15-Dec-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number:  UJ709AB and expiry date; 30-Jun-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  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 holder's compliance with the requirements set out in the 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.
Day following vaccination reported elevated temperate, loss of appetite and significant headache; headache treated with over the counter pain reliever; other symptoms resolved without intervention.
Sore area by nose after 2nd dose; Painful swelling by nose after 2nd dose; Excruciating headache between eyes after 2nd dose; Small scab by nose after 2nd dose; Very acidy nasal drip after 2nd dose; Skin raised with blister like bumps by nose after 2nd dose; Body aches after 2nd dose; Chills after 2nd dose; Fatigue after 2nd dose; Muscle aches after 2nd dose; Headache after 2nd dose; Lymph nodes achy after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Body aches after 2nd dose) and PAIN (Sore area by nose after 2nd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer female (Breast cancer right  side 10 years ago).   On 01-Apr-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 02-Apr-2021, the patient experienced PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose). On 04-Apr-2021, the patient experienced SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose) and HEADACHE (Excruciating headache between eyes after 2nd dose). At the time of the report, SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose), HEADACHE (Excruciating headache between eyes after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose) outcome was unknown and PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose) and HEADACHE (Headache after 2nd dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 f (High) 101 F.         Concomitant medication history not reported by reporter. Treatment information was unknown.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1800 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
patient presented to clinic on 10/25/2019 c/o shortness of breath since having vaccine. Patient seen by Dr and diagnosed with Acute Bronchitis and give nebulizer & inhaler and advised to return if SOB continues. VS-98.60, 68- 20- 138/62. Stabe at time of departure. Patient did not return to clinic
Red, welt like patches that  cover my  entire body including face and ears, trunk, and all four extremities.  Rash even present on the palms of my hands and soles of my feet.  The rash is  very itchy and warm to touch.
patient reported headache, tingling, generalized hives, difficulty breathing, swelling in face. headache and tingling started on october 5th and other symptoms started the day after
Moderna COVID-19 Vaccine EUA  No initial reaction besides small (<5mm diameter) bruise, after three days formed a hard red welt still present at time of filing report (12/31/20 1135am) >60mm diameter.
Child developed generalized Maculopapular rash, low grade fever and has irritable.
I got my second Covid Moderna vaccine on April 8th 2021. I am prediabetic with fairly good control .  I tested my glucose the evening of the 2nd vaccine and my glucose was very low at 66.  I haven't seen lows or very high glucose readings in the past.  I also had a reading the next day that was higher than my normal reading.  The higher reading was 132.  In the ensuing months my glucose readings changed to  higher than normal readings and hypoglycemic, lower, readings,( 1-2 times a month for the low readings). My highest glucose reading is now 265, so far, and my lowest reading has been down to 56.  I don't feel when its low until it gets really low and hard to recover with glucose tablets and the gel when it?s really low.  I am now on Acarbose medicine to balance my glucose. Please add this side effect to your list of reactions to the Covid vaccine. (I did get a fever of 101  after 2nd vaccine)