chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump under injection site was bigger, still aches; injection site turned red; injection site warm to touch; injection site swollen; injection site hurts; Swelling arm; fever; chills; Body aches; This case was reported by a consumer and described the occurrence of injection site lump in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chronic pain (have had chronic pain and for which taking Oxycodone). Concomitant products included oxycodone.   On 20th February 2023, the patient received Shingles vaccine. On 21st February 2023, 1 days after receiving Shingles vaccine, the patient experienced fever, chills and general body pain. On 22nd February 2023, the patient experienced injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain and swelling arm. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain and swelling arm were not recovered/not resolved and the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain, swelling arm, fever, chills and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-FEB-2023. Reporter's Comments: The patient got the shot and the following day she had fever and chills and body ached, she noticed at that time the injection site had turned red, was hot to the touch.  By the following day she noticed the lump under the injection site, the following day it was bigger and it still ached, hurted, swollen and red at the injection site typical and prescribed medication were not help or giving relief. She was very concerned of a reaction or complication with the vaccine. On 22nd February 2023, 2 days after receiving Shingles vaccine, the patient experienced injection site induration, injection site erythema, swelling arm, injection site warmth, injection site swelling and injection site pain.
The morning after getting vaccine, patient had high BP 213/159, 92% on room air, shaking, chills, LCTAB with diminishment at bases, emesis. Admitted to hospital for pneumonia.
Poison Ivy like sensation on injection site comes & goes after first shot; Diarrhea after first shot; Burning sensation on injection site comes & goes after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Poison Ivy like sensation on injection site comes & goes after first shot), DIARRHOEA (Diarrhea after first shot) and VACCINATION SITE PAIN (Burning sensation on injection site comes & goes after first shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE REACTION (Poison Ivy like sensation on injection site comes & goes after first shot), DIARRHOEA (Diarrhea after first shot) and VACCINATION SITE PAIN (Burning sensation on injection site comes & goes after first shot). On 30-Dec-2021, VACCINATION SITE REACTION (Poison Ivy like sensation on injection site comes & goes after first shot) and VACCINATION SITE PAIN (Burning sensation on injection site comes & goes after first shot) had resolved. At the time of the report, DIARRHOEA (Diarrhea after first shot) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-435888 (Patient Link).
Patient contacted nurse vaccinator on 11/13/21 to report that he could hardly walk and his knee, hip and neck were very painful. Nurse vaccinator encouraged patient to go to local emergency room and patient refused. Nurse Vaccinator called patient on 11/14/21 to check on him and no answer at patient's home. Nurse vaccinator had  local authorities do a welfare check and it was discovered that patient drove himself to the emergency room the morning of 11/14/21.
1 cm. localized area of redness at site of VARIVIX, 10-11 days after vaccine.
Developed sores in mouth and headache.  Area of injection was red, hot and swollen.
Area of injection site is red in color 2 x 3 inch, and warm. This started 24 hours after injection felt very malaised, the redness and warmth occurred 48 hours post injection. I suggested that the patient begin with some diphenhydramine tonight at bedtime and apply some ice to the injection site.
pt recv vax 27MAY97 & that same day pt exp pain & swelling @ inj site;
The day after administration mom reported nightmares, fever, hot red face, dilated pupil, red eye, warm to touch, body ache, puffy tongue, fever T max 102, headache and crying lasting one day. Mom declined appointment for evaluation, pt not seen.
some of the vaccine leaked from the barrel of the plunger; some of the vaccine leaked from the barrel of the plunger; A spontaneous report was received from a pharmacist concerning a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273). Some of the vaccine leaked from the barrel of the plunger while administration of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. It was reported that some of the vaccine leaked from the barrel of the plunger while administration of the vaccine leading to under dose of the vaccine.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, some of the vaccine leaked from the barrel of the plunger,  was not applicable.; Reporter's Comments: This report refers to a case of syringe leaking issue for mRNA-1273, unknown lot with no associated AEs.
64 year old male with history of prediabetes, hypertension, and HLD who presents with generalized body rash including the mucosa. Received Shingle Vaccine and Amlodipine 5 days ago, since then developed intermittent fever, headache, bodyache, then body rash 3 days ago, and started having lesions in his mouth today. PCP started on prednisone for possible Stevens Johnson Syndrome. However, rash has gotten worse today. Emergency Department MD discussed with dermatology, "I spoke with Dr. of Dermatology he is concerned that this is possibly Steven Johnson's/early TENS.  He is concerned due to the oral lesions.  He recommends patient receive 125 mg of Solu-Medrol and increase his daily dose to 80 mg of prednisone daily. He feels this may be secondary to the amlodipine versus varicella zoster immunization." Prednisone, benadryl, pepcid; inpatient derm consult, rounder to d/w derm in the morning; lidocaine gel; continue IV cyclosporine 1.5mg/kg every 12 hours; continue supportive care; petrolatum or aquaphor ointment to dry lips as needed; magic mouthwash to oral sores.
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions.     On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 27 years 8 months. No concomitant medications were reported.  On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  Patient had no adverse reactions after the administration of vaccine. No treatment medication was reported.
Symptoms 10 min after vaccination 1440, client reports nausea.  Skin flushed, cheeks rosy, perspiration on upper lip, hands shaky and heart rate 100 and irregular.   Client continue to be monitor.  Offer cold water and fan blowing on client.  At 1515  HR 70, slightly irregular and nausea persisted.  1545 HR 70 and client feeling better and tolerated drinking water.  1600 HR 66 client up and about walking in room.  Client denies dizziness.  Instructed to follow up with PCP
Fatigue, muscle aches, brain fog for weeks after 2nd injection.   Symptoms sometimes accompanied with low grade fever
neurological symptoms; This spontaneous case was reported by a nurse and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological symptoms) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurological symptoms). At the time of the report, NEUROLOGICAL SYMPTOM (neurological symptoms) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662850:(same reporter)
Throat tight, tongue feels numb, chest pressure. Evaluated by EMS- Transported to Emergency room/department or urgent care.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt experienced syncopal episode in store, resolved and left after 30 minute stay
11/14 Meningococcal vaccination given. 11/15 hives, gone that evening, BENADRYL had been given. 11/17 noticed erythema, tenderness and warmth. 11/18 pus expressed, seen and placed on KEFLEX.
11/30/2021 had a fever of 102. I gave Ibuprofen at that time, and she didn't have a fever during the day until the night of 12/01 with a fever of 101 and gave ibuprofen. She must have had another during the afternoon 12/02/2021. I don't know if she was treated or not because she was with her grandma. But it resolved by the evening and no fevers after that. 12/03 or 12/04 she developed a runny nose. Sent msg. to her doctor and was told to make an appointment if fever persisted for 3 days, and it did not.
functioning neurological disorder; not able to walk; it was some issue with her knee; This is a spontaneous report from a contactable consumer (reporting for his sister). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 10May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. She didn't have any pre-existing conditions. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Medical history, family medical history relevant to AE or relevant tests. On 11May2021 she was not able to walk, it was some issue with her knee and hospitalized from 11May2021 to 13May2021. The doctors couldn't figure out what was wrong with her so she was sent home. The patient had been to the hospital two times. She was admitted and discharged for not being able to walk and she was admitted on 01Jun2021 for seizure like symptoms and was still in the hospital. The reporter wanted to know what steps he should take to make sure his sister is treated properly. She was diagnosed with functioning neurological disorder and they said it could have been triggered after the vaccine since it happened the day after. She has to have some therapies. She is currently in the hospital and they are monitoring her. She went straight to the emergency room due to seizure like symptoms. The outcome of events was not recovered.  Information on the batch/lot number has been requested.
Recvd vax @ 4pm,by 5pm pt was lethargic.Around 6pm T 101.7pm c/o pain in rt leg & was unable to walk.Pt T was inc,but not taken.730pm fell asleep.8pm tried to wake up pt but could not.If rolled on leg would cry out.1130pm T 103,to ER.
A few days after the vaccine my left arm began to hurt approximately where I received my flu shot several months before. I went into the doctor and told him where it was hurting and he felt it was a shoulder impingement and gave me a shot. That was a week ago and it still hurting so I making this report because of that.
Arm swelled, red rash, itchy, ice 15 mins on 15 mins off 2 days, headache, felt sick tired, took antihistamine 4 to 6 hrs 3 days
This is a 15-year-old female with no previous medical history presenting emergency department with fever, body aches, chills, abdominal pain, multiple episodes of vomiting X 3 days.  Mother states Thursday around 4 PM she received a flu vaccine, Friday morning she woke up experiencing multiple episodes of nausea and vomiting (nonbloody, nonbilious).  Fevers on and off and generalized abdominal pain.  Abdominal pain is described as dull and aching.  Symptoms are viewed as moderate in nature, better with nothing, worse with nothing.  No history of the same
Early a few (5-10) small raised red dots on waist, upper thighs and chest. By evening several more dots on trunk and low grade fever (99-100.5) with general fussiness. Day 2 rash less raised and less red but more generalized all over below neck, low grade fever. By end of day rash all over including face, more fussy, low grade fever.
9/5/13 office visit for attenuated varicella - started breaking out 9-3-13. Not aware of source of exposure.
Seen 4/5/05 for check up and received Pediarix and PCV7, reported by mother T 107 ax with digital thermometer on 4/6/05. Also developed cold symptoms, a viral rash 4/6 fever has ranged 102-103.
I was really fatigued and I was in a work meeting online and I just wanted to put my head down because I was tired and achy. I did work the following day which was Friday and I just went straight to bed because I was so worn out. I slept through Saturday and Sunday but ended up calling my doctor and getting tested for Covid on Saturday. The PCR came back negative but the other test showed I was positive. I really did not have much of a repository response to the vaccine. I did have a few times where I felt a little out of breath but really mostly was fatigued and achy.
Redness/itching generalized. Took Benadryl 25 mg orally. Redness/itching went away. Still has bumps on top half of body.
Initial solicited report received from an investigator in a trial on 02 March 2017. A 23-year-old male subject had medical history of chest pain, Abnormal ECG (electrocardiogram), 3 Dizziness/Fainting Spells The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 29 January 2016. On 08 February 2016, 10 days after vaccination the subject was diagnosed with disease of pericardium, unspecified. The lab data included Troponin I, ECG and Echocardiogram were not available, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 23-year-old male who developed disease of pericardium; unspecified with favorable temporal association post vaccination with ACAM2000. Pericarditis is listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. The company has assessed the event as possibly related to study vaccine.
Client reported receiving COVID vaccine second dose on 04/12/21 at 1:30 pm, adverse reaction began later that day at 3:30 pm.  Client report a rash started on both arms, then felt rash went to her ears, they felt like they were getting bigger as well.  Rash moved to other parts of her body such as face, trunk, and legs.  Rash is itchy, reddish in color, warm to touch, and very painful all over.  Client also report getting the same rash after first COVID vaccine on 03/22, but that rash only lasted 2 days. Client seen by PCP for this recent reaction, prescribed hydroxyzine and a hydrocortisone cream.  Client report no improvement and plan to contact PCP again regarding rash.
Pt recvd vax 5FEB92 & on 10JUN92 donated blood; 22JUN92 lab eval revealed that had elevated SGPT of 82.9; no further details were provided;
cramping; digestive issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 09:00 (Lot number: Ew0179) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELATONIN. Vaccination history included: Bnt162b2 (dose 1, single, lot number Ew0164, Expiry date: unknown, administration time: 08:15 AM, vaccine location: Left arm, Adverse event start date 21Apr2021, Adverse event start time 09:30 PM), administration date: 21Apr2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Felt progressively weaker", "Terrible headache", "Trouble breathing", "Disturbing dreams", "Neck pain", "Shoulder pain", "Intermittent cramps", "Spotting".  The following information was reported: MUSCLE SPASMS (non-serious) with onset May2021, outcome "recovering", described as "cramping"; GASTROINTESTINAL DISORDER (non-serious) with onset May2021, outcome "recovering", described as "digestive issues". The events "cramping" and "digestive issues" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, gastrointestinal disorder.  Additional information: It was reported that the patient did not receive any other vaccine in four weeks. Other medications in two weeks includes multi vitamins, melatonin, Blissfield fe 1/20. The patient did not had COVID prior to vaccination. After the second dose the patient had many of the listed side effects as well as cramping and digestive issues extending at least 3 days after the vaccine. Multivitamin cannot be characterized by the proprietary medicinal product name or by the active substances and, as per EMEA guidelines, has not been coded in the concomitant medication but only captured in the narrative section. Reportedly the patient did not receive the treatment for the adverse event. The patient underwent lab test and procedure on 05May2021 which includes COVID-19 resulted negative.  No follow-up attempts are possible. No further information is expected.
PATIENT FULLY VACCINATED TESTED POSITIVE FOR COVID 9/7/2021 AND HOSPITALIZED 9/7/2021
This spontaneous report as received from a medical assistant, via company representative, refers to a 7 year old male patient. On an unknown date the patient received a dose of VARIVAX (Merck) (dose, route and lot number were not provided). Concomitant medications were not reported. It was believed that the patient had received the recommended 2 doses of VARIVAX (Merck) (dates, dose, route and lot number unspecified). Medical assistant stated that in the fall of 2012 (in September 2012) the patient developed shingles after having VARIVAX (Merck). the patient developed blisters on the upper and lower body, on both sides of the body. The blisters were diagnosed as shingles specifically and not Varicella. Patient was recovered of shingles on an unknown date. The relationship between VARIVAX (Merck) and shingles was not reported. Patient sought unspecified medical attention. It was reported that the patient was possibly treated with acyclovir (unspecified). Additional information has been requested.
2 hrs p/recvd Cholera/Typhoid vax pt devel fever (101-102), generalized achiness, nausea, joint pain, & swelling @ inject site; APAP given;
Fever, flu like symptoms, little blisters. Acyclovir 800mg.
Shortly after my daughter's last vaccine shots in December, she started losing her hair. It began with a round spot and started growing larger. Doctor diagnosed her with Alopecia Areata and prescribed some drops for her bald spot. It is now May and my daughter has very few strands of hair left.