chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upper arm is swollen; Upper arm is red; Upper arm is warm; Upper arm is itchy; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (the patient had the old shingles vaccine about 9 years ago from reporting without incident).   On 10th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, skin warm and itchy upper limbs. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling arm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and itchy upper limbs to be related to Shingrix.  Additional Information: GSK Receipt Date: 15-OCT-2022 and 17-OCT-2022 Reporter's Comment: The patient self-reported this case. The patient received Shrigrix (shingles vaccine) on Monday. The pharmacist warned him/her that, it might hurt but it did not. Instead, after 5 days his/her upper arm was still very swollen, red, warm and itchy.  The symptoms were not lessening. The reporter wanted to know how long he/she could expect this problem to last and were there any topical treatments that might help. The pharmacist advised to continue with ice packs and add Benadryl, which definitely helped. However, his/her arm was still swollen, itchy and red.
per patient tolerated vaccine 1st dose without any issues, and she will be 18 in April 2021
Headache, fatigue, joint pain, low fever, severe lymph node swelling in left armpit.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 12 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history of atopy: allergy to penicillin. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 1 day after vaccination, the patient experienced anaphylaxis. Her symptoms included generalised urticaria, pruritus, rash, increased heart rate, syncope, blood pressure at 117/72 mmHg and lump in throat. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. The patient was kept as an inpatient overnight. She received treatment with epinephrine, parenteral antihistamine, parenteral H2-blocker, oral steroid, oxygen, antiemetic and lidocaine cream. The patient was referred to allergist. Her skin test and RAST (radioallergosorbent test) results were both negative for latex The patient was prescribed epinephrine autoinjector. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
approximately 3 days after vaccination developed full body hives, no respiratory or GI involvement, no other plausible antecedent known. no h/o type 1 hypersensitivity reactions.
Injection site has become inflamed and was red, and hot to the touch and caused a fever. The redness of the injection site lasted for approximately for 1 week.
clinic is reporting an excessive # of local reacts w/redness, soreness, bumps; no addtl clinical info was available @ the time of this report;
Pt had 2 weeks of vomiting and diarrhea after her 4 month ROTATEQ vaccine. It started with foamy stools the day after the vaccine.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022; Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022. Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion. No treatment information was reported.   This case was linked to MOD-2022-551714 (Patient Link).
SM woke up with redness and swelling at site where he received his anthrax injection. SM also notes that he developed a HA after receiving his anthrax and FLUMIST shot that day. HA resolved the next day. Symptoms: Edema @ injection site 50-120mm, erythema, tenderness, headache, general, flu-like symptoms< 96 hours.
Patient started to feel dizzy.  By 12/31 patient was starting to hurt in upper back.  By 1/2 patient stutter stepped when walking and could no longer walk, pain in back because unbearable.
vial which was expired on 3-Apr-2022 was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial which was expired on 3-Apr-2022 was administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial which was expired on 3-Apr-2022 was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial which was expired on 3-Apr-2022 was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was reported that a vial which had expired on 03-Apr-2022 was administered to total of 24 patients which included 15 males and 9 females, the administrations were mostly for booster shots and no side effects were reported. Treatment information was not provided.
Pt said needle came off first shot and nurse gave him a second shot of same vaccine in same arm because she didn't know how much went in. He was in ER for chemical spill. Says now his legs are heavy and he's weak all over.
Information has been received from a medical assistant concerning herself, a 24 year old female with a history of chickenpox at her 5 years old who on 04-MAY-2009 developed chickenpox lesion on her forearm after giving ZOSTAVAX (Merck) to 50 to 60 patients a week for 3 weeks. The patient had sought unspecified medical attention. At the time of reporting, she didn't recover. The patient thought that she developed chickenpox because she had been giving so many doses in a short period of time. Additional information has been requested.
Vaccination was given at 11am on Friday. By 4pm, the patient's upper left arm was warm, red and swollen. By Friday evening, the patient's temperature was 100.7. Temperature returned to normal by Saturday morning. Upper arm remained red, swollen and very painful to the touch through Sunday. By Monday, the redness, swelling and pain had resolved in the upper arm, but the arm was red and swollen below the elbow.
A week after the vaccination my arm  was red, swollen and itchy.  It increased in size over time and took benedryl and used hydrocorotsone cream to help with the itching.  It disappeared after about 3 days but still itch to date and I still experience some muscle weakness also.
2hr p/vax woke up crying-nl cry but trembling all over w/chills-had 6 stitches removed by PMD right p/vax;when mom picked pt up-stop crying but cont to shake for approx 30min alert later;to ER sx tonsils & ear infect;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, route, lot# and expiration date were not reported) that were exposed to unsupported temperature conditions. No adverse experience had been observed or reported by any of the patients who received these improperly-stored doses. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Rotarix not reconstituted; Diluent given  without  reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.     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: 02-Mar-2023 Reporter's comments: The nurse reported that the administration of Rotarix diluent to a patient without previous reconstitution of the lyophilized powder portion. The reporter mentioned that one of three patients received only the liquid portion, but they were unable to identify this patient. The reporter asked if the patient who received only the diluent had to receive a properly reconstituted dose. Since they did not know which patient received only the diluent portion, the reporter asked about the safety of giving an extra dose to all three patients. The reporter did not provide any information about the patients involved in this case.  Vaccine information (lot number/expiry date) was not shared by the health care professional. The reporter consented to follow up. Additional supportive information: The patient received diluent portion of Rotarix without reconstitution with the lyophilized powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
vision changes/it was swirling; milky-cloudy-like vision. my vision is a little cloudy; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision changes/it was swirling) and VISION BLURRED (milky-cloudy-like vision. my vision is a little cloudy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced VISION BLURRED (milky-cloudy-like vision. my vision is a little cloudy). On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision changes/it was swirling). At the time of the report, VISUAL IMPAIRMENT (vision changes/it was swirling) and VISION BLURRED (milky-cloudy-like vision. my vision is a little cloudy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant information was provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow-up information received on 30-AUG-2021 contains significant information. New events were updated.
Knot; red bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot) and VACCINATION SITE ERYTHEMA (red bump) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Knot) and VACCINATION SITE ERYTHEMA (red bump). At the time of the report, VACCINATION SITE MASS (Knot) and VACCINATION SITE ERYTHEMA (red bump) outcome was unknown.            No treatment information was provided.
Chronic Uticaria 5 weeks after shot.  Hives continue 8 months post vaccine injection. To date no treatment has cured symptoms.
He developed a red rash to both inner thighs and small red dots to abdomen. He denies itching, patient has a PMHX of allergies and carries an EPI-PEN with him. He denies shortness of breath, mouth or throat swelling or any feeling out of the ordinary. Rash and urticaria pruritus. Diphenhydramine 25 mg once.
High injection site left deltoid resulted in  moderately severe left shoulder joint pain, weakness and reduced range of motion causing reduced ADLs for 10+ days
Shortly after being vaccinated patient started to excessively sweat. No other complaints. EMS observed patient and released patient to go home.
No adverse event noted. Meant to give Pentacel and gave PediaRix. Client received 2 doses of Hep B. Notified clients mom and no concerns or reactions noted.
Very 'itchy' Pustules on hands, right forearm and right foot.  Not a significant amount but the areas feel very inflammed but not that much so visibly .  Took antihistamine which helps with the itchy and inflammation.  Not intending to go to the Dr at this point.  Just want the information to be with med professionals. About a week after the first vaccination I developed a couple of 'itchy" bumps on my right elbow.  After a few days resolved but still scabs today.  Received my second vaccination on 4/7/21 and 2 days after I developed a pustule on my left index finger and near my left pinky finger.  Very itchy.  Each day I get a couple more of these pustules on my left hand and right forearm and one on my right foot.  The need to scratch my limbs kept me awake one night.  Took an antihistamine pill which helped.  Don't know when this will resolve but the only thing I can attribute it to is the vaccine.  Just wanted the info submitted if it can be of any help
Dizziness; Lack of sleep; Disassociation; Nausea; Headaches; Aching muscles; Tiredness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included ADHD and Asperger's syndrome.    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 DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea), HEADACHE (Headaches), MYALGIA (Aching muscles) and FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea), HEADACHE (Headaches), MYALGIA (Aching muscles) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medication were not given. It was reported that patient took first moderna vaccine on the 14.
Pt. reports itchy skin, redness around injection site when patient went to physician visit 6 days after injection.  Provider instructed to monitor and seek attention at ER if symptoms worsen.
Muscle pain in left thigh and right calf. Tensed muscles.tingling sensation. Most intense around 13 hours after injection. Difficulty falling asleep due to discomfort. Less painful next morning (today) but still uncomfortable and tingling.
Janssen COVID-19 Vaccine EUA Prickly itchy rash appeared on thighs; discomfort waned after ~ 15 min.  Similar rash appeared on arms, legs, & back after showering same day at ~ 5 pm.  Again, discomfort waned after ~20 min.  Rash appeared on thighs again this morning at ~ 7:30 am.  Again, discomfort waned after ~20 min. I have not yet sought medical attention since symptoms have been intermittent rather than persistent since first appearing.
feeling chills; aches all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 28Oct2022, outcome "unknown", described as "aches all over"; CHILLS (non-serious) with onset 28Oct2022, outcome "unknown", described as "feeling chills".  Additional information: Caller took the Pfizer-BioNTech COVID-19 Vaccine, booster dose, yesterday. Today she woke up feeling chills and aches all over. She wanted to know if the vaccine could give her COVID or these might be just side effects. She described that she did not feel this with other doses.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
stroke; CONFUSED; could not remember name; tired; unable to get up from couch; Drug Reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke), CONFUSIONAL STATE (CONFUSED), MEMORY IMPAIRMENT (could not remember name), FATIGUE (tired), HYPOKINESIA (unable to get up from couch) and ADVERSE DRUG REACTION (Drug Reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products LENVATINIB MESILATE (LENVIMA) for an unknown indication and PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    The patient's past medical history included Endometrial cancer, Uterine cancer, Ovarian cancer, Blood pressure high and Bladder incontinence.   On 19-Mar-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 20 milligram. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PEMBROLIZUMAB (KEYTRUDA) (unknown route) at an unspecified dose. On 15-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization), CONFUSIONAL STATE (CONFUSED) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (could not remember name) (seriousness criterion hospitalization), FATIGUE (tired) (seriousness criterion hospitalization), HYPOKINESIA (unable to get up from couch) (seriousness criterion hospitalization) and ADVERSE DRUG REACTION (Drug Reaction) (seriousness criterion hospitalization). The patient was hospitalized on 15-Apr-2021 due to ADVERSE DRUG REACTION, CEREBROVASCULAR ACCIDENT, CONFUSIONAL STATE, FATIGUE, HYPOKINESIA and MEMORY IMPAIRMENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), CONFUSIONAL STATE (CONFUSED), MEMORY IMPAIRMENT (could not remember name), FATIGUE (tired), HYPOKINESIA (unable to get up from couch) and ADVERSE DRUG REACTION (Drug Reaction) outcome was unknown.            Patient kept on hold of all chemo medications as they were unsure what was the cause and she had her first dose of keytruda yesterday (at the time of reporting) and patient would restart Lenvima at a lower doses soon. No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Body aches; Low grade fever; Chills; Swollen upper lip; This is a spontaneous report from a non-contactable Physician via the Pfizer-sponsored program.  A patient of unspecified age and gender receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The physician reported that 13 hour after vaccination, the patient developed body aches, low grade fever, chills, and swollen upper lip, on an unspecified date. The patient took Tylenol for the body aches, low grade fever, chills, and swollen upper lip. The clinical outcome of body aches, low grade fever, chills, was recovered. The outcome of and swollen upper lip was not revered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Pt was sitting down during 15 minute post vaccination on a chair when she began to slide out of it. Her grandfather called to us and helped her sit upright. She said all of a sudden she felt really lightheaded and nauseous and then she woke up in her grandfather's arms. her face was pale. she stated she had been "nervous" about getting her shot. after drinking some water and eating a piece of candy, patient regained color in her face and was able to walk out of the store normally.