chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in legs and stomach) and GASTRITIS (Swelling in legs and stomach) in a patient of an unknown age and gender 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 PERIPHERAL SWELLING (Swelling in legs and stomach) and GASTRITIS (Swelling in legs and stomach). At the time of the report, PERIPHERAL SWELLING (Swelling in legs and stomach) and GASTRITIS (Swelling in legs and stomach) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Facility consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Patient c/o dizziness. VS taken with elevated BP. No other symptoms reported. Observed for 45 min until BP drop to a decent reading. Sent patient home with son. Son return 15 min later and stated that mother dizziness return but now have SOB. Went to car with VS machine and anaphylactic kit. Patient c/o dizziness, SOB, tingling sensation of hands, itchy throat, and visibly shaking. VS taken with elevated BP again and HR 110-120. Administered Epi pen and called ambulance.
patient mistakenly received an injection of quadracel instead of pentacel with no adverse event;Initial information regarding an unsolicited valid non-serious case was received from the physician via Medical Information (Reference number- 00712491) and transmitted to Sanofi on 05-Aug-2021.  This case involves a one-year-old male patient who mistakenly received an injection of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event (Wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 02-Aug-2021, "the patient received a 0.5 ml (dose 4) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number: C5763AA; expiry date: 26-Aug-2022) via intramuscular route in the left upper thigh for prophylactic vaccination instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported)."  It was case of actual medication error due to wrong vaccine administered (latency: same day).  It was reported, "Doctor stated that a patient mistakenly received an injection of QUADRACEL on 02AUG2021 instead of PENTACEL. Doctor asked if QUADRACEL and PENTACEL contained the same amount of DTAP-IPV antigens and if so, whether she could just administer ACTHIB to the patient instead of administering PENTACEL."  At the time of reporting, no adverse events were 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.
This patient had a rash and itching on his neck and trunk. The patient took Benadryl for 3 days.
Last vaccination was in December of 2021. June 6th he developed a continuous cough and sore throat for about two days then developed runny and stuffy nose. I attributed it to his seasonal allergies. Days two and three developed low grade fever, never higher than 101 but never lower than 99.1. I took him to ER at Hospital on June 9th and was given two albuterol for his breathing and gave him an xray and oxygen. Also gave him two doses of amoxicillin once they found out it was bilateral pneumonia and also gave him a steroid- about 4 mL dexamethasone. They released him the same day and he vomited the entire night. Fever broke the next day, June 10th. Since then he has continued albuterol treatments twice a day and amoxicillin twice a day. Still coughing but less, and no fever.
PENTACEL was administered on 7/21/17 nodule developed at injection site-nodule. Still present months later. Ultra sound ordered. Nodule on side of leg, approximately 6 months ago patient received PENTACEL vaccination to the side of the leg it was given by experienced nurse after that mom noted a nodule 1st evaluated approximately month or 2 afterwards very subcutaneous now appears to be more tabs to the skin this is a little bit more than what I would expect from vaccine reaction under had reported to the VAERS.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot#, dose, route and frequency were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Did not loose consciousness but patient reported he felt like he would if he stood up; A severe pressure in his head; He felt a loss of equilibrium; Patients grandma did walk with him and he was able to walk of the store about hour after receiving with her assistance.; This is a spontaneous report from a contactable pharmacist .   A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as dose 1, single for COVID-19 Immunization. Patient medical history and concomitant medications not reported. Caller is a pharmacist calling on behalf of a patient experiencing an adverse event after receiving the first dose of the Pfizer Covid 19 vaccine. The patient received his first dose of the vaccine at 1:20/1:30pm. Within ten minutes, the patient said he experienced a severe pressure in his head; patient did not loose consciousness but patient reported he felt like he would if he stood up on unspecified date. He felt a loss of equilibrium. Caller reports the patient did not experience any blood pressure changes. Patients grandma did walk with him and he was able to walk of the store about hour after receiving with her assistance. EMTs determined consumer was okay without a hospital trip. Family was okay with that decision. Caller asking if this specific symptom has been reported before (severe pressure in head with loss of equilibrium). The Outcome of all the events were unknow.  Information about lot/batch number has been requested.
Chills, UNCONTROLABLE SHAKING, fingers and toes were white and blue, sinus congestion, sore neck, headache, cough, chest discomfort, sore throat, fever 101.7 and weakness.
Began to have paresthesia. Left face in  trigeminal 2 distribution, as well as lower extremity paresthesia from soles of feet to below knees bilaterally. Has been present from the evening after inoculation. Not worse but not resolving.
I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pain on the left side of my breast and armpit area.  I felt my lymph nodes and they are swollen as well.  I stopped wearing a bra because it was painful.
Rotator cuff type injury associated with movement of shoulder, especially reaching (ie. To turn on a faucet). Also trouble lifting arm and other range of motion issues. No issues at elbow or wrist, including putting weight on elbow that affects shoulder. It's all about shoulder movement. Started at 5 pm Friday and worsened dramatically over the next 6 hours. First moment was reaching for a remote and the sudden pain resulting in the arm dropping from the reaching position and lost ability to hold item in hand. Over time more motions hurt including motions like shifting while sitting upright that involve tensing the shoulder.  Overnight pain has not worsened but also no relief.
Pt. states that after receiving the 1st dose of Moderna 09/21/2021. started experiencing symptoms 09/25/2021 of burning in the chest and mouth, loss of taste, and abdominal cramps. Lasting 10/18/2021 with lingering burning in the night time. Received 2nd dose of Moderna 10/20/2021 and experiencing similar symptoms, will follow-up with Primary if continues.
Generalized intermittent hives 4 days after receiving DTaP 2, IPV  2, PCV7 2, HIB 2, Flu Vaccine 1.
Patient told the school nurse the following day that she had swelling in the face, puffy eyes, a heavy chest, and trouble breathing.  She took Benadryl and used her inhaler 3 times which seemed to relieve some of the symptoms.
I received the vaccine in my right arm and sometime in the week following a small rash developed on that arm on the radial side of the elbow crease.  The rash has grown to be about the size of a quarter, itches and oozes after itching.  Ha persisted to present which is more than 3 weeks post vaccine.  I believe the reaction was a re-activation of prior inflammatory reactions.
Flu shot given 10/30/14. Since then he is having clear nasal drainage if he moves from laying down or reclining position to a more upright position.
Pt in clinic on 4/10/06 for 12 mo immunizations. Reported to nurse that child had a febrile seizure the day after shots on 11/14/05. Child was being prophylactically treated with Motrin/Tylenol for shots. Family reports child did not have a fever when he started screaming and shaking after eating while at grandmother's house. Child taken to ER. T 102.9 (R) upon arrival. Child had recent Zithromax treatment for ear. Finished 2 days prior to immunizations. ER dx: "High Fever"-pt was referred to pediatrician.
88 Y/O female resident of ALF was transferred to ER due to increasing confusion and weakness. She was previously diagnosed with COVID unclear when. According to reports from ER she answers some questions but refuse to follow directions. Refused treatment. CXR showed no evidence of pneumonia. Room air O2 Sat > 93 % Troponin 31, EKG WNL CBC, CMP, UA WNL Baseline mental status per ALF is independent and oriented to environment. Pt vaccinated with Moderna 1/22/21, 2/22/21
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
Post vax, pt began to experience slight, intermittent ringing in both ears; intermittent periods of hearing loss (alternates between ears), reduced ability to concentrate, memory problems, visual disturbances (characterized by blurred vision and scintillation's). Pt also experiencing fatigue and joint pains (shoulders, arms,  and neck). Symptoms have improved, but currently are not completely resolved. Pt had 5th shot and symptoms worsened.
Information has been received from a consumer concerning her 19 month old son no pertinent medical history and with milk allergy and possibly egg whites uncooked allergy, who in the past received a dose of DTaP with no adverse symptoms noted. On 15-APR-2010 was vaccinated with a dose of VARIVAX (Merck) in his left arm (dose, lot number and route not reported). Concomitant vaccine included DTaP (manufacturer unknown) on the same day (15-APR-2010) in his right arm. On 22-APR-2010 the patient experienced a large, red swollen area on his left arm, fever and diarrhea. Over the next day or two the area on his arm became larger with a swirl like "hurricane like" pattern to it. On 26-APR-2010, the patient was seen by a physician. The area of his arm looked like it was "pus filled". The patient was treated with an unnamed antibiotic and "it completely stripped his digestive system" with diarrhea and loose stools. Stool cultures 3 times were negative, no parasites found, the patient remained without formed stools which were continuing to 26-JUL-2010 and he still had a red mark on his left arm. He would see his pediatrician on 27-JUL-2010 and possibly an allergist. Follow-up information has been received from a physician concerning a male patient with allergies to cats, dogs and amoxicillin who on 15-APR-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot n. 666486/1647Y), subcutaneously in his left arm. Concomitant therapy included a fourth dose of INFANRIX (lot n. C3380AA), IM in the right arm. Reporter stated that mother called from out of state on 16-APR-2010. Patient had rash on left arm, warm to touch. It was recommended to see a local doctor. Patient was seen at the reporting physician's office on 10-MAY-2010 and the patient was healing from a skin lesion on left arm. This date, the patient recovered from rash on left arm and warm to touch. Additional information is not expected.
Injection in left deltoid was too high. Left arm/shoulder pain began within hours of administration.  Pain was excruciating the night of vaccine administration causing very limited range of motion to arm and complete inability to sleep. Pain has lessened but continues to remain present. Range of motion continues to be limited. Pain and night continues to inhibit sleep. At time of administration, pt was 4 weeks pregnant with a rough estimated date of delivery as 10/3/2021
Patient reported painful arm and swollen hands, difficulty with movement, chills, fever, aches.  Patient did not report to the physician.
received dose one of Shingrix in 2019 /is past due for dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date in 2019).   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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The patient was past due for dose two now. The reporter did not provide exact date of dose one.  The reporter did not had the lot number or expiration date to provide. The reporter consent to follow up.
This spontaneous reprot was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The certified medical assistant reported that on unspecified dates, unspecified number of patients received improperly stored doses of PROQUAD (Merck) (lot#, strength, dose #, dose and route of administration were not reported). There was not concomitant medication reported. No adverse effects were reported and there was not a product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.
Employee reported onset of pain  to left deltoid starting on 6/4/19 and nausea starting on 6/5/19 Instructed to take Tylenol, Ibuprofen and Ice.
Rash appeared on my neck, chin and face two days after the shot and began to increase and spread.  I went to the Dr on the third day of the rash and Predisone 10 MG and Valacyclovir HCL 1 Gram were prescribed. The rash lessened quickly and then started to decrease and disappear in a few days.  I have been taking the medication for 5 days and the rash is almost gone.
Phone call from client to report adverse reaction post vaccine given on 7/12/2010 early afternoon. She was given H1N1 LAIM and PNEUMOVAX 23 LASC. The symptoms were from the PNUEMOVAX 23 site. She did not notice any reaction on the day of the shots, but woke up the next day 7/11/10 with body aches, fatigued and with an elevated temperature. Site of injection was small at that time but continued to get larger. On 7/15/10 she decided to see her oncologist who wanted her to have the shots prior to starting chemotherapy for Chronic Lymphocytic Lymphoma. Her temp then was 100.3 and she felt it was higher earlier in the week, but she doesn't have a thermometer. She measured the reaction site today at 4 inches across the arm and 5 inches down from the site. She is feeling better today, aches and fatigue are gone, and she doesn't feel she has an elevated temp.
Initial literature report received on 06 Sep 2010: This patient had history of end-stage lung disease secondary to alpha1-anti-trypsin deficiency and chronic obstructive pulmonary disease. After suitable organs became available, he was admitted for potential bilateral lung transplantation and was found to have ongoing shortness of breath associated with new-onset malaise, myalgia and other non-specific symptoms for 48 hours. The onset of these symptoms occurred shortly after he was given H1N1 (manufacturer unknown, influenza H1N1 vaccine, batch number not reported). His partial pressure of carbon dioxide (PCO2) was 72 mm Hg, partial pressure of oxygen (PO2) was 77 mm Hg and oxygen saturation (SaO2) was 94% on 10 liters of oxygen via nasal cannula. Prior to transplantation, he was transferred to the cardiovascular intensive care unit where his shortness of breath improved utilizing a BiPAP device, without the need for intubation and mechanical ventilation. Chest X-ray showed chronic emphysematous changes with mild increase in bronchovascular markings. The recent worsening in symptoms was attributed to a combination of severe underlying lung disease and a reaction to the vaccine. The decision was made to proceed with a transplant. However, as a precaution, nasopharyngeal swabs were obtained and empiric anti-viral therapy with TAMIFLU 150 mg twice a day was started immediately pre-operatively. He underwent bilateral lung transplantation on the day of admission. In the immediate post-operative period his nasopharyngeal swab came back positive for novel pandemic influenza H1N1 virus with the use of a real-time reverse transcript-polymerase chain reaction (RT-PCR) assay. The transplant procedure was well tolerated by the patient and he was extubated on the first today post-operatively. Postoperatively, two consecutive bronchoalveolar lavage samples from the transplanted lungs were positive for H1N1 virus. He received induction immunosuppression with anti-thymocyte globulin for the first 5 days along with mycophenolate mofetil and steroids. Tacrolimus was started on day 3 with the dose adjusted to maintain levels of around 10 ug/L to 15ug/L. Marked improvement in his condition was noticed and he was transferred to the ward. He developed some delirium postoperatively, mostly secondary to high tacrolimus levels, which resolved spontaneously. TAMIFLU was continued for a period of 14 days, and then replaced by inhaled RELENZA for another week. His chest X-ray post-operatively was satisfactory. He was discharged home in a good condition 3 weeks after bilateral lung transplantation and has remained well to date.
Patient came to clinic complaining of a sore arm, up into neck and shoulder after receiving TD injection on 7/29/14. The arm was slightly swollen and warm. Patient referred to PCP.
Moderate arm soreness with onset about 4 hours after vaccination and lasting until 30 hours post vaccination. Moderate headache the 2 mornings following vaccination. Used 500mg x 1 each morning with good affect.
Pt recvd vax 2JUL92 & on 4JUL92 exp pain in the side of neck & ipsilateral shoulder & upper arm, & a tingling sensation; sensation of discomfort;
NAUSEA; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune, prediabetic, cholesterol, tricuspid valve leek, and severe osteoporosis, and other pre-existing medical conditions included patient is allergic to simvastatin and aspirin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right arm. Concomitant medications included pravastatin for cholesterol, and furosemide for tricuspid valve leak.  On 15-MAR-2021, the subject experienced flu like symptoms. On an unspecified date, the subject experienced nausea, and headache. Laboratory data (dates unspecified) included: Laboratory test normal (NR: not provided) NEGATIVE (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, and flu like symptoms. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J002777, expiration date 07-JUN-2014) injection, subcutaneous. On an unknown date the patient experienced injection site reaction after receiving ZOSTAVAX, that was described to be like a "big welt or target" that itched but was not reported to have been a rash. The outcome of injection site and injection site itching was unknown. The causality was unknown. This is one of several reports from the same source (MARRS 1308USA010306, 1308USA006743 and 1308USA010308). Additional information has been requested.
GETTING KICKED IN THE CHEST BY A MULE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced getting kicked in the chest by a mule. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of getting kicked in the chest by a mule was not reported. This report was non-serious.