chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen arm; Red arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included CALCIUM CITRATE MALATE;MAGNESIUM CITRATE MALATE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Bone disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMIN & MINERAL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-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 experienced PERIPHERAL SWELLING (Swollen arm) and ERYTHEMA (Red arm). an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown and ERYTHEMA (Red arm) and PRURITUS (Itching) had resolved.            Treatment information was not provided.    This case was linked to MOD-2021-021955 (Patient Link).
Info has been received from a health professional concerning a female pt who was vaccinated with a 0.5 ml dose of varicella virus vaccine live. Subsequently, the pt experienced breakthrough varicella with over 200 lesions. Unspecified medical attention was sought. No product quality complaints were involved. Additional info has been requested.
ptnt initially had swelling of tongue and throat. Epipen was grabbed but symptoms started to subside.  ptnt breathing was erratic but ptnt was frightened. Bp 153/124 at  time of incident.  tingling on fingers and later hands.  Dizziness,flushing.  EMS was called at sign of tongue swelling.  Checked out by EMS and ptnt remained in store by herself.  Remained for 2 hours with multiple symptoms as mentioned above until  partner arrived to pick her up.  Continued to have symptoms over next couple days.
pt exp cranky/fussy; vomiting x1; stomach pain, per dad; not sleeping;
He got his vaccine, after a week and a half he started getting large patches of hives, super itchy areas.  It would be a whole row of welts that would itch, and is still happening.  Would have a long stretch around his belt line, and patches on his legs that would come up on that, and would jump from calf, and sporadic spots and also on torso.  Some nights it would get him out of the bed as it was in in the groin area and the itching would have him get into the bath to sooth the reaction.   He started taking Zyrtec and it does help get rid of most all of that on that day, but if he skips a dose it comes back, but not as severe.   He has notified his doctor and to take an allergy medicine.
No symptoms but abnormal labs: Elevated BNP, positive d-dimer Had to be started on blood thinner Ongoing treatment
immediate mild allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (immediate mild allergic reaction) 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 HYPERSENSITIVITY (immediate mild allergic reaction). At the time of the report, HYPERSENSITIVITY (immediate mild allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Shoulder pain, unable to use the right arm without pain. Pain is also present when sleeping. Range of motion in the right arm is compromised.
ON 3/15/21 patient was found unresponsive by spouse. EMS was called.  Patient was found to have cardiac arrest Was given Epinephrine, Amiodarone and External Ventricular defibrillation Patient passed away on 3/15/21
muscle aches, muscle soreness in all arms and legs from 16-24 hours after vaccine
spot has now grown in size to about 5 inches; spot was about an inch in diameter around the injection site; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT SWELLING (spot was about an inch in diameter around the injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (spot has now grown in size to about 5 inches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Jan-2021, the patient experienced VACCINATION SITE JOINT SWELLING (spot was about an inch in diameter around the injection site) and VACCINATION SITE PAIN (pain at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (spot has now grown in size to about 5 inches). At the time of the report, VACCINATION SITE JOINT SWELLING (spot was about an inch in diameter around the injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (spot has now grown in size to about 5 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Treatment information include Corticosteroid injection and azithromycin.
Hospitalized from 12-5 to 12-8 SOB, Rash, Hives and Blisters
gums feel like jely; jaw pain; right side of face is swolen; allergic reaction; fever; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISCOMFORT (gums feel like jely), PAIN IN JAW (jaw pain), SWELLING FACE (right side of face is swolen), HYPERSENSITIVITY (allergic reaction) and PYREXIA (fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7006320006 and 7006320003) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GINGIVAL DISCOMFORT (gums feel like jely), PAIN IN JAW (jaw pain), SWELLING FACE (right side of face is swolen), HYPERSENSITIVITY (allergic reaction) and PYREXIA (fever). At the time of the report, GINGIVAL DISCOMFORT (gums feel like jely), PAIN IN JAW (jaw pain), SWELLING FACE (right side of face is swolen), HYPERSENSITIVITY (allergic reaction) and PYREXIA (fever) outcome was unknown.            No concomitant medication was reported. Action taken with mRNA-1273 in response to the event was not applicable. Patient went to the dentist for a root canal and doctor gave him Clindamycin 150mg for infection just in case. The patient stated that they were apart of the Phase 3 trial and was offered vaccines when it was unblinded.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Reporter information added.
pt cried till 10PM p/vax;pt devel rapid resp, t100.4 w/APAP;taken to ER:cried constantly 2PM to 10PM;would not eat;swollen rt leg & red;rash noted Saturday;referred to PMD;inc slobbering;irritable;
headache in between head and neck hurt so bad; Lymph nodes in the arm too itching; Severe headache between head and neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (headache in between head and neck hurt so bad), PRURITUS (Lymph nodes in the arm too itching) and HEADACHE (Severe headache between head and neck) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (headache in between head and neck hurt so bad), PRURITUS (Lymph nodes in the arm too itching) and HEADACHE (Severe headache between head and neck). At the time of the report, NECK PAIN (headache in between head and neck hurt so bad), PRURITUS (Lymph nodes in the arm too itching) and HEADACHE (Severe headache between head and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient have been taking (PII)
Lesions red maculopapular rash noted predominantly to chest, abdomen; does not extend on upper thighs, and slightly on upper arms; cheeks-no redness noted, faint light pink maculopapular rash noted to lower neck 15-30 min after vaccines were given.
Patient was give primary Pfizer series immunization instead of Pfizer bivalent. Patient had previously received Janssen on 4/7/2021.
26 Oct. '23 @ 10:33 ~ RSV (Arexvy) ~ Administered Diluent only ~ Left Deltoid IM..  10:35 ~ Moderna (Spikevax) ~ Right Deltoid IM..   10:40 ~ Notified Pharmacist ~ ..  10:41 ~ Notified patient.   10:47 ~ RSV (Arexvy) ~ Administered Reconsituted vaccine ~ Left Deltoid.
Approximately 2 minutes after receiving Tdap, MCV4 and HPV, client was observed with an unsteady gait.  Client hit the side of a hallway wall with right eyebrow, right side of cheek and between nose and lip.  Small abrasion observed to area between nose and lip.  Client reported that she "got hot all of a sudden and could not see".  Nurse was able to catch the client when falling.  Client was eased to the floor.  BP was taken (98/62)and a cool cloth applied to forehead, face and neck.  Client was then assisted to an exam table and lower extremities were elevated.  Client remained in clinic for approx. 20 minutes.  Left with mother in stable condition.  Instructed to go to ER if any signs of nausea, vomiting, headache, blurred vision, etc.  Follow-up phone call to mom approx. 1 hour later.  Mom reported client feels better.
PATIENT RECEIVED MODERNA BOOSTER INJECTION 0.25ML BUT RN NOTED A FEW DROPS LEAKED DOWN PATIENTS ARM AND RN DOES NOT BELIEVE PATIENT RECEIVED THE FULL DOSE. CDC NOTIFIED VIA TELEPHONE AND WAS INSTRUCTED BY CDC FOR RN TO REPEAT DOSE. RN ADMINISTERED 2ND BOOSTER DOSE OF MODERNA 0.25ML TO RIGHT ARM PER CDC INSTRUCTIONS.
Administered Havrix instead of Twinrix; Engerix-B Pediatric dose administered to a 45 year-old; Engerix-BPediatric dose administered to a 45 year-old; 1st dose on 24Jun2018, 2nd on 28Aug2018; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 45-year-old female patient who received HBV (Engerix B pediatric) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included HAV (Havrix adult) for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 6th January 2023, the patient received Engerix B pediatric and Havrix adult. On 28th August 2018, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 28th August 2018, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 6th January 2023, the patient experienced wrong vaccine administered, underdose and adult use of a child product. On an unknown date, the outcome of the drug dose administration interval too long, wrong vaccine administered, underdose and adult use of a child product 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: 9-Jan-2023 Reporter's comment: The reporter was a Medical assistant. At time of reporting, no additional doses had been administered. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received the second dose of Twinirx later than the recommended interval, which led to lengthening of vaccination schedule. Instead of receiving a third dose of Twinrix, the patient was given an adult dose of Havrix, and inadvertently administered a pediatric dose of Engerix-B, which led to wrong vaccine administered, underdose and adult use a child product.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 10:30am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose.
Patient sat down and said he was dizzy a few minutes after vaccination. Patient began to jerk his head repeatedly in a seizure-like motion.
I started to have stiff arm,  headache, and some sore muscles around injection site around 8pm on the 11th. Upon waking maybe around 7:30am on the 12th I had sore and stiff arm,  body aches, headache, and fatigue until about 9pm that evening
Headache, body aches, low grade temperature, chills and swelling in left arm pit.  Body aches, low grade temperature and chills lasted for 48 hours. Headache lasted for 96 hours. Swelling in left arm pit lasted 8 days.
complains of right arm pain and stiffness.  says shot was placed "too high" and plans to file claim.
nodules in lungs. Extreme swelling in left arm & armpit. Neck. Thyroid nodules. Had biopsy. Ct scans on lungs, arms neck. Painful. Numb. Always swollen & numb.
Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Date of Symptom Onset - ?1/11/2022 Symptoms - Body aches, Chills, Low grade fever (99.1F), Headache, Fatigue, 1/12 Numbness and Tingling in arm Home Remedies - Ibuprofen 200 mg, 3 tablets, once on 1/11/2022
09/06/22 presents to ED for "breathing problem". PMHx of "afib on eliquis & metoprolol, hypothyroid, HTN"
"Huge, big, raised circle (size of orange) on arm". Red, warm (99.9 via laser therm.), sl. itchy, sore to touch not with movement.
suspected vaccination failure; shingles/ had it once; it does hurt; nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles, pain and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles shot, and experienced shingles once.  The patient stated that and it did hurt and it could also leave nerve damage long after the shingles were gone. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Pt Started with a red arrow shaped mark on his left upper arm. I thought it was a rash, but it spread down his arm onto his fingers as little blister type sores.  I took him to his doctor and she said it was shingles and said it was most likely caused by the Varicella shot.
Fever of 101 or less for three days.  Rash covering rear of legs, back of arms, and left of face.  Swollen gland in space between neck and jaw.
Severe shakes and chills Cold sweat, nausea, diarrhea  Extreme weakness Headache
On 10/17/03 around 12 noon she began feeling aches. At around 3pm she began feeling feverish and flushed. At 7pm her temperature was 102 orally. The fever, chills, aches, pains and lack of appetite lasted for 48 hours. On 10/18/03 at 7am her temp was 99.8 and at 8pm her temp was 101.5. She had also experienced dizziness, this started on 10/18/03 and lasted through this am 10/21/03. She also noted two hard nodules at the base of her skull; these are still present but have improved. Overall she feels 100% better as of this afternoon 10/21/03. She admits to a history of asthma, but currently not having any symptoms. Also, she is breast-feeding her 10-month-old baby. The Monday (10/13/03) before she got the flu shot her baby had been sick with a three-day viral condition, which included vomiting, fever, and minimal diarrhea.
Left arm is itchy; Arm has red rash; Had a sore arm on site of administration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE RASH (Arm has red rash) and VACCINATION SITE PAIN (Had a sore arm on site of administration) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE RASH (Arm has red rash) and VACCINATION SITE PAIN (Had a sore arm on site of administration). At the time of the report, VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE RASH (Arm has red rash) and VACCINATION SITE PAIN (Had a sore arm on site of administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of GARDASIL, intramuscularly. Subsequently the patient experienced numbness in the area where the vaccine was administered. The patient sought unspecified medical attention. The patient's outcome is unknown. Additional information has been requested.
severe neck pain; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 4-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter asked was severe neck pain a side effect of the injection. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender who on 08-APR-2015 was vaccinated with a dose of ROTATEQ (lot # K011663 (expiration date, dose, route and site of administrations were not reported) that was exposed for 72 hours to temperatures outside of the recommended range. No adverse effects were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
COVID-19; Difficulty breathing; Cough; Wheezing; Feeling very weak; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing) and ASTHENIA (Feeling very weak) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Diagnosis: 1999, Insulin dependent) and Obesity (Most recent BMI, if known: 30-33).   On 13-Mar-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing), ASTHENIA (Feeling very weak), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing), ASTHENIA (Feeling very weak), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (95.5-97.5): unknown (Inconclusive) unknown.   Patient stated that she took pocket mouth mask and an emergency use bag with the help of her husband for breathing difficulty patient stated that due to fear she did not went hospital. Patient had obesity with body mass index30 to 33 No Concomitant medication reported by the reporter Patient experienced COVID-19 March to April   This case was linked to MOD-2021-032045, MOD-2021-032045 (Patient Link).
At 10 minutes post vaccine developed itching. Then became flushed and dizzy, then developed diffuse hives.
Per Patient: Arm became extremely sore the following morning, and remained sore for 3 days. Arm difficult to move the following day, and lasted one day Felt ?off? since receiving the shot, starting to feel normal Friday ? some feeling of nausea at times Right knee started to become sore Thursday morning, and became progressively worse during the day, difficult to walk at times.  Woke up this morning with the knee feeling a little sore.  Did not have this pain pre shot, and didn?t do anything that I am aware of to cause the knee pain