chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Treatment included Tylenol   This case was linked to MOD-2021-037334 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI - info to be given over the phone
pain/swelling @ inj site progressed to entire arm & shoulder;saw ENT pp on 6NOV97;motrin-ice PRN;
pt devel large areas of redness & swelling which were hot to the touch on the arm following vax;
Had significant tooth pain about 14 hours after vaccine.  Toothache coincided with sleeplessness, injection site pain and headache. All symptoms but toothache cleared within 2 days, continued taking Advil for tooth pain and salt water rinse.   Already had dental referral to evaluate ongoing sensitivity to hot/cold but sensitivity turned into constant ache.  Have dental  on Thursday, March 11.  May simply be coincidence but today - four days following vaccine - tooth pain is much decreased.
16 nose bleeds since vaccination; allergies were acting up; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (16 nose bleeds since vaccination) and HYPERSENSITIVITY (allergies were acting up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity (Not specified). Concomitant products included LORATADINE for Allergy.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced EPISTAXIS (16 nose bleeds since vaccination) and HYPERSENSITIVITY (allergies were acting up). At the time of the report, EPISTAXIS (16 nose bleeds since vaccination) and HYPERSENSITIVITY (allergies were acting up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that due to unspecified allergies outburst, he was taking Loratadine three times a day instead of once. The patient also noted that after he stopped taking the Loratadine the nose bleeds stopped as well. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-Jun-2021: Event added and concomitant medication was added.
I completed the vaccination forms and signed the waiver and indicated on the forms that I was pregnant as well as verbally telling the nurse I was pregnant.  She administered the FluMist vaccine to me despite my pregnancy.  Then today 01/07/2010 I met with my OB/GYN and they advised me to contact Health Dept. I contacted Health Dept and reported to them. They advised me to fill out a VAERS.
84-year-old male presents from home for chief complaint of feeling weak and fatigued.  He has been feeling short of breath and having coughing for the past 3 days
Pt presented within 12 hours of vaccine with 18x13cm area of erythema upper arm to elbow with edema. No induration. Tender to touch, Pt was treated with Benadryl, Tylenol, compressed.
after about 30 days or so from the date of the shot in my left arm I woke up at 3 in the morning with a terrible aching pain in left arm.  I had no injury so I took a pain killer but it didn't help so I went to ER. They did X-Rays then gave me a shot of Morphine for the pain.  Two days later the same pain occurred in the left arm and I went back to same ER at 5 am and got another shot. That next week went to my primary doctor who recommended an MRI on my left arm. It was clear so they did an MRI on my neck.  Some issues appeared and I was then sent to nerve Doctor who did a nerve test on me. That doctor determined an issue with nerve to my arm.  I have since been doing PT for about 3 weeks with some recovery of use of my arm.  I recently was told about Builain-barre syndrome and now not sure what caused this problem.  No accident and no known injury.  My wife also had the shot at the same time and 4 weeks later she had a blood clot in her corated artery.  Needless to see something isn't right .  Just reporting this for future reference if needed.
left side of his face is acting funny, is moving.; tingles.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left side of his face is acting funny, is moving.) and PARAESTHESIA (tingles.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HYPOAESTHESIA (left side of his face is acting funny, is moving.) and PARAESTHESIA (tingles.). At the time of the report, HYPOAESTHESIA (left side of his face is acting funny, is moving.) and PARAESTHESIA (tingles.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication: Medication for his Back No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Follow Up Received: No New Information was received.
ulcerative colitis flare up; Upset stomach; could not eat; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4467226-00.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 30Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 16Feb2022 (ongoing) (Lot number: 1161756) at citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1)First Dose (1 in 1 Once), Route of Admin: Intramuscular, Therapy Dates/Duration: 1) 09Aug2021 - 09Aug2021), administration date: 09Aug2021, when the patient was 48-year-old, for COVID-19 Immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "Upset stomach"; FEEDING DISORDER (non-serious) with onset 2022, outcome "not recovered", described as "could not eat"; COLITIS ULCERATIVE (medically significant) with onset 2022, outcome "not recovered", described as "ulcerative colitis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ulcerative colitis flare up", "upset stomach" and "could not eat" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. 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.
Had a fever; The injection site became red; The injection site became painful; Got an extra dose (4th) of Pediarix versus just a TDap.; Got an extra dose (4th) of Pediarix versus just a TDap.; This case was reported by a consumer via call center representative and described the occurrence of fever in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received the 4th dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On 11th June 2022, the patient experienced fever, injection site erythema and injection site pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site pain, extra dose administered and wrong vaccine administered were unknown.   It was unknown if the reporter considered the fever, injection site erythema and injection site pain to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Jun-2022 Reporter's Comments: The patient was inadvertently administered a dose of Pediarix in Lt. vastus lateralis instead of Infanrix. The patient had not had any doses of Infanrix and now had four doses of Pediarix. The patient had been seen and was fine according to the reporter. The reporter stated that the day following the vaccine, the patient had a fever and the injection site became red and painful. Fever had resolved, but the patient's leg was still painful and red. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow-up. Additional Supportive Information: The patient was inadvertently administered an extra dose of Pediarix on instead of Infanrix, which led to wrong vaccine administered and extra dose administered.
Pt  had some pain in his right arm and fever after taking the vax.  Next day he woke up, went to the wash room and then had a seizure.  His father gave him a cold compress and provided him with water and extra seizure medicine.  His father called the Neurologist.  He was told to give him some Tylenol for his fever and extra seizure meds if needed and to FU w/ an office appt if he has another seizure.   It had been more than a year since he has had a seizure but had one on 4/14/21 that was 3 days after taking the 1st Covid Vax.
Pt vaccinated with MRVAX developed fever of 100.5, headache, muscle & joint pain, visual disturbances, lost the vision in rt eye. Dx optic neuritis. Also slightly elevated ANA. Subsequently dx as multiple sclerosis.
The Pfizer Covid-19 vaccine was diluted incorrectly. 2.0 mL was used instead of 1.8 mL.  We were notified  by the nurse who administered in 8/16/21. We called Pfizer before calling the patients to see what they recommended. They said they did not recommend giving the dose and that the CDC says that the dose should not be reported.  Our Medical Director called the patient on 9/7/21 and reported the following:  Advised her of the vaccine error around the CoVID shot.  2mL of saline used for diultion vs. 1.8mL.  Explained what that meant in terms of "extra salt water" being given.  Advised it was not a matter for an unknown substance being given.  Patient expressed concern and being upset. "I don't understand how this happened." "You're injecting people with things, how could you do this."  I apologized for the mistake and assured her that we were taking actions to correct our process in the future.   She expressed frustration that she is only finding out about the error now.  I again apologized.    She stated that the error made her not want to get the second dose.  I strongly advised that she get the second dose.  I explained that I've known her for several years and her kids.  I  would want her and the kids to be as protected as possible.  I advised that she does NOT have to receive the second dose here and I could understand if she makes that decision, but I advised strongly that she consider getting it elsewhere.  I also advised that we spoke with Pfizer and based on their recommendations and the CDC, they would not recommend that she needs any extra dosing and to just complete the second dose as previously planned.  Patient again expressed being upset at the error and at the delay in notification.  I again apologized and offered to help her in any way I could or answer any further questions.  She denied any and the conversation ended.
Within 12 hours of receiving the vaccine I had pain radiating from shot site into my left ear.  I then had a stiff neck and pain on the side of my neck.  It traveled to my forehead where shingles broke out.  I was NEVER warned that it could trigger a immune response that could trigger shingles.  That should be included in the information. I spread to my eye and I have not been able to shed my body of the virus and I am on drops and Valtrex still today a year and a half later.
Narrative:  77yo died during MICU inpatient admission. Pt died of septic shock & hypovolemia secondary to C.diff infection & multiorgan failure. Pt had received covid vaccines on 2/19/21 & 4/6/21. Death is not related to covid vaccines.
Patient went to work around around 1:00-1:30 pm feeling weak, left eye drooping, running eyes, right side cheek appearance smile looking strange. As of 10/20/2020 no change in symptoms.
Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited  urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone
PHN gave PNEUMOVAX during Family Planning clinic due to client smoking > 1 pk/day. Given 7/20/11 - vaccine expired 7/3/11. Client informed & supervisor notified. CDC contacted. Recommended repeating dose ASAP. Client notified. Dose repeated 8/18/11 as recommended. That evening client had redness below shoulder area to 2" above elbow. Upper arm ached & was swollen. Client advised to use ibuprofen & apply cool compresses. Client reports symptoms resolved by 8/21/11 with above treatment.
Severe itching progressing rapidly to red welts all over body (hives)by the next day.  Went to Doctor 11/18/2009 4:30 PM. Diagnosed as severe allergic reaction to shot and advised not to take shot in future.  Prescribed Methylprednisolone 4MG and Hydroxyzine HCL 25 MG.
injection site sore; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-year-old female received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration in left arm on 14Jan2021 as 1st single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3248) via an unspecified route of administration in right arm on 04Feb2021 09:15 as 2nd dose single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any prior COVID-19 vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. Patient was 45-years-old and was not pregnant at the time of vaccination. Patient medical history was not reported. The concomitant medications levocabastine hydrochloride (ZYRTEC) at a dose of 10 mg. On 14Jan2021, patient experienced injection site pain in left arm and on 04Feb2021, patient experienced injection site pain in right arm. The patient did not receive any treatment for the adverse events. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning an "around 13 to 14 years old" female who had been vaccinated with the series of GARDASIL (LOT#s not reported, third dose was 0.5 mL). After the series, she had her PAP tests done and came back positive for HPV (type unspecified for now). Unspecified medical attention was sought. It was reported that on an unspecified date the patient recovered. This is the second of three cases received from same source. Additional information has been requested.
Faints - blacks out - low blood pressure. Extreme pain in legs and body. Body jerks no concentration brain fog. Rashes, joint pain Fatigue, constipation weight loss - nausea. Headaches bedridden long periods.  7/20/09 Hospital records received DOS 7/18/08 to 7/13/09. Assessment: Orthostatic hypotension and Fibromyalgia. Syncope and Collapse. Migraine. Aversion to eating. Chronic pain syndrome. Multiple ER visits and hospitalizations. Chronic diarrhea and dizzy spells. Decreased PO intake. Weight loss. Headache, blurry vision. Mental status change. Confusion, inability to eat. Uncontrolled pain. Loss of consciousness. On birth control pills. Constipation. 9/4/09 Received ICD9 codes: 4516; 43239; 4580; 7291; 27651; 78701; 78321; 78052; 3384; 56400; 2871.  7/1/09 Medical records received DOS 6/20/07 to 12/24/07 Assessment: Fatigue, arthralgia, myalgia, easy bruising, lack of concentration. Patient presnts with lower leg pain, aching, sore arms, ankle bruising. Heavy menstrual period. Lack of concentration. Allergies. Painful skin with light touch. Constipation, SOB with excercise. Illness at time of immunization: Tired, not sleeping well. Body aches. Stress at school. Sore throat, Amox.
A week following red, swollen, painful, inflamed arm developed. Three weeks out still painful and itchy but swelling has gotten better. Did not seek treatment, was able to discover this was a possible side effect.
Information has been received from a licensed practical nurse concerning a healthy 7 year old female with no past medical history and no known drug allergies who on 08/04/1995 was vaccinated in the right deltoid with a first dose of varicella vaccine. On 07/02/2001, the pt presented to the physician's office with a fever and a "full-blown" case of chicken pox. It was reported that the pt had at least 150 lesions all over her trunk and extremities. There were no concomitant medications. It was reported that the pt recovered from the experience. No further info is available.
I experienced extreme joint pain, muscle and tendon pain in my hips, back, shoulders and neck for 19 days. Unresponsive to pain medication or anti inflammatory meds. Addendum Dec 1st - continued headaches and fatigue.
COVID Arm.  10 days after vaccine I started itching (mainly on lower legs) 13 days after vaccine my injection site was swollen, warm and itchy.  Itchy bumps then popped up different parts of body.  I called primary care doctor and they scheduled an appt without any input on what was happening to me.   I began taking Benadryl based on suggestion of family member.  The arm started getting better so I cancelled the office visit.  Stopped Benadryl after a week.  Still have itchy spots but wanted to be ready for 2nd dose yesterday.  More itchy spots started last night.   The pharmacist said I was the 3rd person that day that had reported the same issue.
immediate twinge in shot area that then emanated down my whole arm. Excruciating full arm pain later in day and still now 5 days later. feels like nerve damage deep within. Tingly fingers, forearm discomfort. Cannot reach behind me to unhook my bra.
pt recvd DTP/OPV/HIB/HEP B vax pt had fever 103, inc irritability (if just touch pt would cry); taken to ER for eval
This spontaneous report was from a consumer regarding himself, a male patient of unknown age. There was no information provided about the patient's concomitant medication, pertinent medical history and drug reactions/allergies. In approximately 2009 (reported as: "about 8 to 10 years ago"), the patient received a dose of ZOSTAVAX (strength, dose, route, anatomical site, lot number and expiration date not provided) subcutaneously for "shingles" (prophylaxis). On an unspecified date, the patient developed "shingles". There was no treatment given for the adverse event and no lab diagnostics/studies were performed. It was reported that the patient did not seek medical attention. The outcome of herpes zoster was reported as not recovered. There was no causality assessment provided.
ADMINISTRATION ERROR: vaccinator inserted syringe with needle into patient's Right Deltoid, needle became dislodged from syringe, plunger was pushed causing vaccine to spill out of syringe onto patient's arm, very little of the vaccine entered the needle itself. Vaccinator consulted writer (clinical lead at vaccine POD), writer escalated situation to clinical director/administrator for site.  Vaccinator was instructed to document wasted dose and to vaccinate the patient on their opposing arm (left deltoid in this case).  Writer completing VAERS report to document administration error and wasted Moderna vaccine dose.  Patient observed for required duration of time (30 minutes), no adverse events were observed. Lot#: 035C21A Exp: 10/30/2021
The vaccine was administered to the patient at approximately 1135am. A few minutes after the vaccine was administered, the patient started feeling faint, dizzy, and sweaty (patient was sitting in a chair at the time).  He also experienced some tingling in his hands and feet (like they were falling asleep). The patient laid down on his back on floor. The patient said he did not want 911 called. The patient started feeling better after laying down. The patient's blood pressure and heart rate  were checked at 1150am (while still lying down) - blood pressure was 115/68, heart rate was 69. The patient said he had something similar happen once before when getting a Meningococcal vaccine.  When feeling well enough, we had the patient sit up on the ground. The patient sat on the ground for a few minutes to acclimate, and then stood up and sat in a chair. The patient reported he was feeling better and continued resting in the chair. The patient reaffirmed he did not want us to call 911 or a family member to come be with him. The patient left the pharmacy around 1215pm after reporting that he was feeling better.
Pt developed fevers to 102-103 w/in 24 hrs of vaccine. Was given with PNEUMOVAX. Developed rigors as well. Seen in ED 24 s/p vaccines, hypotensive, tachycardic, temp 102. Admitted to ICU, on Abx (Vanco, ZOSYN). Developed cellulitis area around injection sites approximately 36 hrs s/p injections. Also noted to have bradycardia.
Patient states that 2 days after he received the vaccination he was in the ER thinking he was having a stroke. It turned out to be severe vertigo. He has followed up with his PCP and an ENT who believe that it was an adverse reaction to the vaccine
Headache, Fever, CHILLS, NIGHT SWEATS, EXTREME WEAKNESS, FATIGUE Narrative: