chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injitching; hard arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (injitching) and VACCINATION SITE INDURATION (hard arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (injitching) and VACCINATION SITE INDURATION (hard arm). At the time of the report, PRURITUS (injitching) and VACCINATION SITE INDURATION (hard arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not provided. Treatment medications was not provided.
developed a little lump after receiving the Pfizer covid vaccine; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient developed a little lump after receiving the COVID vaccine on an unspecified date. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
About 8 days after the vaccine I developed swelling, hives, itchiness and a big red circle that was warm to the touch. It is at the vaccine site and the injection site has a red mark as well.
allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Red swollen hot itchy arm that goes to almost the bend in my arm. I have fibromyalgia but do not take medication for it. I have had much more fibromyalgia pain and spent 2-3 days in Bed . That seems better today except for the covid arm.
Redness just below the injection site, warm to touch and mild diffuse pain. No fever reported.
I'm having severe dizziness.  I had to crawl to the bathroom and my husband had to lift me up onto the toilet.  I also had diarrhea for a day.   I'm still dizzy and need a walker to get around in my house.
Client arrived on 5/27/21 to the Health Center to get his second dose of Pfizer. Client reports that after her first dose on 5/6/21 of Pfizer lot #EW0179 she experienced itchy throat on only the left side, runny nostril on the left side and watery left eye 5 hours after receiving dose.  Client reports she was vaccinated on the left arm. Client reports it resolved on its own after 4 days.  Client approved lead PHN to administer 2nd dose with a 30 minute wait and no reaction occurred.
Pfizer vial has 6 doses, 7th dose used for patient, however there was exactly 0.3 mL left in vial to use for patient dose - patient with no symptoms or adverse effects. Reporting to vaers d/t 7th dose usage.
Exposed to 2 girls in school with recent chickenpox.  Now 1-2 days with progressive scattered erythematous maculopapular rash with one small vesicle on back.  Pruritic, no fever.  Return to school when lesions are crusted.
Sudden asthma exacerbation with stridor. EMS transported to hospital, where admitted from 11/11-11/13
Irregular heart beat. Chest pain. 10/10/2021-10/25/2021
Constant need to urinate at night after the first shot. Second shot is causing pelvic pain.
Patient presented to pharmacy to receive the adult bivalent COVID19 moderna booster. The pharmacist who was preparing the vaccine drew up the pediatric monovalent COVID19 Moderna vaccine for 6-11 years, which was administered to the patient. The pharmacy manager discovered the error on 12/05/22 upon returning to pharmacy from weekend off. The patient was contacted to discuss the incident; the patient stated that she had a sore arm that persisted through the weekend from time of vaccine administration on 12/03/22.   The patient's primary care physician was contacted to discuss the incident. After reviewing the CDC guidelines and after discussion with the pharmacy manager, the patient's doctor instructed the patient to wait 2 months after receiving the incorrect monovalent Moderna vaccine and then receive the correct adult bivalent Moderna formulation at that time.
Pt had a vaccine shot (Moderna) on 04-22-21 and ever since then she has been having like weird side effects for instance her hands from her elbows to her finger tips she is experiencing a lot of pain on both hands and both areas are cold. Pt has no fever. as above, 1st dose of moderna 4/22/21, 3 d later both hands started to swell and they are falling asleep, numb and tingling in both hands and pain in both hands, from elbow to fingers in both arms all fingers are involved, fingers are cold in both fingers and forearms are colder as well than rest of the arm fingers are cold, taking hydrocodone 10 mg /325 mg four times daily but pain is still high. injection was to left arm
Acute soreness in right upper arm; could not sleep on right side. Soreness has diminished but continues to hurt when arm is raised or is in certain positions.
Pt complains of frequent headaches and inability to concentrate. "Just feels like there is something wrong with him". Pt was referred to an ophthalmologist. Pt experienced anisocoria, (left pupil larger than right) and pain behind right eye. Pt, initially had left pupil dilated more than right with blurred vision. Has had headaches with vomiting and treated with Motrin. Several trips back to ER dx'd with migraines and treated with Elavil. Elavil was stopped and then started on Prozac. Seems a lot better now. Has a lot of stress with school and work.
C/O NUMBNESS TO LEGS "THEY FELT ASLEEP" A SHARP PAIN TO LEFT SHOULDER TO RIGHT SHOULDER-SHARP PAIN TO THROAT-11/12/09-STATES RASH TO LEGS- CHILLS WHEN TO DOCTOR DX WITH URINARY TRACT INFECTION.
rash; onset of rash on 06Jul2021 that has worsened; This is a spontaneous report from a contactable consumer or other non-HCP (patient).   A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Right on 18Jun2021 (around 13:30-14:00, around 15:00) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient's medical history included ongoing arthritis, ongoing prior to any doses of Pfizer-BioNTech Covid-19 Vaccine, ongoing diabetes, ongoing cholesterol, bronchitis, sinus infection, rash, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities and obesity (start date was unknown, and unknown if ongoing). She thinks they said she has Bronchitis, but it's not really bad; she has an inhaler, but she never has to use it. She thinks she has had maybe a sinus infection or something like that. She has history of having had a rash that comes up on her hand and sometimes on legs but went to dermatologist gave her some cream that cleared it up. The patient had no family medical history relevant to adverse event. The patient's concomitant medications included simvastatin taken for cholesterol started years ago, enalapril taken for diabetes mellitus started years ago. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. The patient previously took flu shot, she just always gets the flu shot every year and never had any reaction with those. The patient took vaccine to help prevent the Covid, where she wouldn't be so sick if she got it. The patient received the first dose of the Pfizer Covid 19 vaccine on 18Jun2021. On 06Jul2021, Tuesday, developed a rash. She asked could it be related to the first dose. She initially reported having had no reaction to the first dose of the Pfizer-BioNTech Covid-19 Vaccine shot but later reported having onset of rash on 06Jul2021 that has worsened. She asked for further information on side effects, rash, and if she should go to her doctor about this. The rash started out small on 06Jul2021, now rash has worsened and keeps spreading. She does not know what the rash was, but it was irritating, going all across her back and all up under her breast. She does not know if rash was from the first dose of Pfizer-BioNTech Covid-19 Vaccine and just didn't show up until later. The adverse event not required emergency room and physician office visit. No relevant tests were done. Last Friday (09Jul2021), the patient received the second dose (of bnt162b2). The patient has been administered both doses of the Pfizer-BioNTech Covid-19 Vaccine. The outcome of the event was not recovered.  Follow up information has been requested.
all she wanted to do was sleep; arm was sore; tired; her arm turned bright pink all around the wound which lasted about a week; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (all she wanted to do was sleep), PAIN IN EXTREMITY (arm was sore), FATIGUE (tired) and VACCINATION SITE RASH (her arm turned bright pink all around the wound which lasted about a week) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SOMNOLENCE (all she wanted to do was sleep), PAIN IN EXTREMITY (arm was sore), FATIGUE (tired) and VACCINATION SITE RASH (her arm turned bright pink all around the wound which lasted about a week). At the time of the report, SOMNOLENCE (all she wanted to do was sleep), PAIN IN EXTREMITY (arm was sore), FATIGUE (tired) and VACCINATION SITE RASH (her arm turned bright pink all around the wound which lasted about a week) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
Patient received shots at 10 AM on 12/23/04. At 6 PM Mom noted patient had fever of 104 with hallucinations and jerky movements. Had been given Tylenol at 10 AM & ibuprofen in afternoon. Baby was taken to the ER at 11:30 PM because of fever. Given Tylenol suppository for fever of 102. Mother reports baby recovered by next PM. Still whinny but no fever.
Localized induration and redness right deltoid, generalized maculopapular rash, low grade fever. Benadryl, Tylenol, ice.
pt devel sl soreness @ inj site;16MAY97 lump, about the size of a lemon was felt under the skin;soreness cont;19MAy97 until 28MAY97 rash began around inj site silver dollar size;28MAY97 fine macular pinpoint rash;swollen nerve;
Patient received Pfizer vaccine on 01/29/21 and 2/19/21. COVID positive 1/14/22. Presented to ED on 1/16/22. COVID-19 pneumonia Very nominal hypoxia as oxygen placed in ER.  Will put him on a Decadron and remdesivir. ER provider has discussed with family and they are okay with normal treatment for COVID as mentioned above. He is hemodynamically stable , afebrile , not in respiratory distress , saturating over 90% on room air. He was sent from nursing home.He has PMH of HTN , Tobacco use , marijuana use , cocaine use, CKD 3, Depression , HTN , BPH, Bipolar 1 disorder . He was diagnosed with COVID 19 01/14/22 and was sent in for failure to thrive symptoms - not eating and drinking , had fever 101. CXR was unremarkable. No significant leukocytosis. Patient was initiated on decadron , doxycycline. Clinically , no signs of pneumonia or dyspnea. Will discharge back to nursing home. No indication for antibiotics or steroids at this time. Blood and sputum cultures negative. Discharged on 1/18/22.
I have a rash on my arm where I received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old patient received bnt162b2 (BNT162B2), administration date 04Sep2021 (Lot number: 301308A) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot: FC3180), administration date: 11Aug2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I have a rash on my arm where I received the vaccine".  No follow-up attempts are possible. No further information is expected.
sl fever 24OCT95 began 7PM;hives all over body began 25OCT95 6PM;these hives lasted for approx 24hrs;pt exp soreness in roof of mouth
After 1st dose- numbness, pins and needles in my hands and feet lasted on and off the day, emailed my doctor to check in about this before getting 2nd dose.  They said this was a know reaction and I should get 2nd dose. After 2nd dose- swollen left side of my face, hot, numb feeling.  went to ER.  was given Steroid and Benadryl.  The next morning the swelling went to my neck.  And lasted as 3" lump for 5+ weeks.   Now has come back as lump when began a small cold- went to the dotcor as this lump lasted 2 weeks- getting ultrasound on neck lump next week.
woke up sore, arm stiffened, 8 pm on 12/02 excruciating throbbing headache, left side of body went numb, chest pain, memory loss, couldnt move arm on 12/03, lymph nodes underarm swollen into size of softball
On the morning of Wednesday, January 6th, I woke up with a red splotch on the arm that I received the vaccination on. The splotch was located about 5 inches away from the injection site. It was raised and itchy.  I didn't take anything in hopes that it would dissipate on it's own. On the morning of Thursday, January 7th, I woke up with a splotchy circle directly around the injection site. It was also raised and itchy. I went to work that day and one of the RN's looked at it, they stated that it could be an allergic reaction to the shot and suggested I take Benadryl to see if it would dissipate. I took some last night (Thursday, January 7th) and woke up this morning to find the splotches a little faded. They aren't as raised however they are still itchy. I will continue to take Benadryl for the next few days to see if it completely dissipates.
Nausea, cough, diarrhea, joint pain, muscle pain ,throat irritation.  Lasting 5 days  Still not totally resolved   Utilized Tylenol (OTC) around clock every 3.5 hours.
Patient  age 72  Admit 1/1/2023  COVID positive 12/30/2022  Date of death 1/2/2023  Immunizations Janssen x1
Arm started hurting one hour after dose. Patient experienced delayed cutaneous hypersensitivity reaction (COVID ARM). She spiked a fever of 101 24 hours after receiving. Redness, swelling, tender, heavy arm. RPH recommended pt get Cortisone OTC and oral antihistamine.
Patient is a 75-year-old male significant past medical history for COPD, lung cancer, presented to the emergency room today with chief complaint of increased shortness of breath.
48hr p/vax pt came down w/shingles;pt suspects there might be some connection but of course it's only a theory;it's a fairly light case;took med;
#c/o Tdap reaction: She states she had Tdap 2 days ago and since then, she has been having very bad pain at deltoid area all the way to her left fingers, mostly 3rd and 4th finger. She denies fever/chill/rash/tongue or lip swelling. States pain was really bad sometimes that she could make a fist. She denies numbness/weakness/swelling of LUE States she took OTC Tylenol 500mg before coming in today. She does not want any stronger meds.
Pt received covid vaccine BUD.  Vaccine expired 7/7/22, vaccine given on 7/9/22
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 78-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. On 27th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, 1 day after receiving SHINGRIX, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced injection site redness and itchiness. The redness was the size of a half gallon of milk and a softball. The symptoms might have begun the day after injection, but it was not certain. It was stated that, the symptoms had not improved. No inflammation was noted by the reporter. The reported gave consent to follow up.
Patient presented with a redness and rash at the injection site and above/around the shoulder.   Injection site went numb and shooting pain fired from the elbow, down to the fingers.  Diphenhydramine (50mg) was provided and patient was observed every 5 minutes for 15 minutes.  Numbness turned to burning sensation, then all symptoms cleared out between 5-10 minutes.  All symptoms were gone by 15 minutes other than arm soreness from injection.
My vision has "dulled".  My eye jelly has detached from the retina.  My arm is sore and painful at the point of injection
4/1-Patient currently has a 100.5 fever, headache, tiredness, fatiguenes, body aches, nausea. Patient took 2 tylenol at 2pm on 4/1/21. Advised to continue taking the tylenol or ibuprofen. Patient hasn't seen PCP but contacted urgent care to see what can be done.  4/3-Placed follow up call on 4/3/2021 at 10:45am: Patient advised she is feeling much better today aside from being a little bit tired. Her fever broke friday morning on 4/1/2021, and she reported she had taken a total of 5 tablets of tylenol. She did not seek any medical attention, but reported she had contacted an urgent care facility the day her symptoms started (3/31/2021) since she felt nervous regarding the adverse effects. She was advised by urgent care facility that if she needed to go in she could, but patient reported she did not need to go. Patient also reported that on 3/31/2021 when her symptoms occurred she also had chills and shakiness that same night.
MODERNA monovalent 2nd booster dose  given to the patient on Wednesday, 8/31/2022.
Warm flushing feeling within about 10-15 seconds of injection, as well as metallic taste in mouth. Repeated on an off for the next hour. Taken to ED of hospital. Noted right arm mild rash distal to injection site and on chest, mild to moderate nausea.. IV Bendadryl 50mg given, IV Solumedrol 125mg, IV Pepcid, IV Zofran. Discharged home with PO prednisone x 4 days. PO Pepcid and Benadryl PRN
Found a red, slightly raised rash around the injection site 9 days after getting the vaccine. The rash is about 1.5-2 inches diameter.
The patient had become dizzy and had to lay down on the floor.  We helped him up into a bench which he sat there for 15 minutes.
This spontaneous report as received from a pharmacist refers to an 8 day old patient with unknown gender. Relevant medical history and concomitant medication were not provided. ON 04-JUN-2013 the patient was vaccinated with RECOMBIVAX HB dose 1, 5 Microgram, intramuscular. Lot number was not provided. On 09-JUN-2013, 6 days after onset of therapy, the patient was vaccinated with RECOMBIVAX HB dose 2, 5 Microgram, intramuscular. Lot number was not provided. No adverse events were known. The reporter considered an 8 day old infant received a 2nd dose of RECOMBIVAX HB 5 mcg on 06/09/2013 to be not related to RECOMBIVAX HB. Additional information has been requested.
First dose about 18 months ago and has not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 18 months before reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient stated that she had not yet received the second dose till the time of reporting, which led to incomplete course of vaccination. The patient planned to receive the second dose soon, she had nothing else to report.
Information has been received from a physician referring to a female patient of unknown age. Medical history and concurrent condition of the patient were not reported. On an unknown date the patient was vaccinated with her first dose of GARDASIL (lot#, expiry date, dose, frequency and route not reported). Then the patient administered her second dose of GARDASIL three weeks after the first dose on an unknown date. No adverse effect was reported. Additional information has been requested.
Screamed x 3 days after vaccines - not consolable. Also had local reaction at Prevnar site. Red hot thigh.
Started as quarter size raised red and itchy lump at injection site, got bigger and took up most of upper part of upper arm. remained red, hot and swollen for 2-3 days. I took an antihistimine and put hydrocortisone on it on the first day I noticed it.
Patient complained of numbness and tingling bilateral lower extremities, dry mouth, lethargic, headache, shortness of breath, numbness of lower lips, light headed. patient presented with clammy skin, slurred speech, dry mouth, tachycardia, n/v x2.
Acute saddle pulmonary embolus with acute cor pulmonale diagnosed 4/14/2021. Treated with anticoagulation, now on Eliquis for 6 months.