chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 09-Dec-2021,Lot 064H21A Moderna Covid-19 vaccine was removed from the freezer and was assigned a beyond use date of 08-Jan-2022. Concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD- 2022-451522, MOD-2022-451532 (Patient Link).
Note: not sure which Pfizer vax option to pick nor the lot numbers, etc. so please contact PCP for that. Patient too second required dose of Covid vax on 2-9-2023 and felt fine until 2-13-2023 when she went uncincuois for 10 to 15 minutes per ambulance and witnesses that called on her phone to alert us. When arriving at the hospital solid blood clots every time they tried to take blood even with ultrasound IV. Heart testing was also bad. Before this date there have been zero health concerns re: Patient NOR immediate family of blood clotting, thick blood or heart issues. They admitted her and gave her an injection to thin the blood and checked the heart more. They had to single stick every time, because they never co
LOSS OF ENERGY; TIRED; HEADACHE; DIFFICULTY SLEEPING; PAIN IN THE ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mango allergy, and shellfish allergy. The patient experienced drug allergy when treated with cefaclor, and erythromycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine.  On 10-APR-2021, the subject experienced difficulty sleeping. On 10-APR-2021, the subject experienced pain in the arm. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced loss of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on 11-APR-2021, and was recovering from pain in the arm, loss of energy, tired, and headache. This report was non-serious.
Patient reported tingling sensation in face/head that started 2 hours after vaccination.  It was resolved by 5 hours after vaccination.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient's arm became sore for a couple of days after receiving the SHINGRIX vaccine. She did not remember in which arm she received the vaccine. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information. For tolerance after 2nd dose refer case US2018206746.
6  hours after the shot I spiked a fever to 103.6. It stayed elevated for 12 an additional 8 hours.  My normal temp is 97.6.  24 hours later it is at 99.5.  I have had a crushing headache for  17 hours.
administered an ActHIB vaccine subcutaneously instead of Intramuscular; Initial information received on 22-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UI988AA, expiry date- 03-Oct-2020 via subcutaneous route instead of intramuscular in the left thigh On 19-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation via subcutaneous route; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was a case of actual medication error due to inappropriate route of vaccination.  It was unknown whether the patient had any adverse event.  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 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.  Documents held by sender: none.
Add severe chest pains for 1 1/2 half to 2 minutes. Severe headaches for 2 days following.
Pt recvd vax w/3.1cc of Hep B on 25JUL91; dosage was given by body weight; On 28JUL91 pt devel raised red welts & itching back & buttocks; pt later recovered;
Staff LVN administering MMR-V and VZV incorrectly verified vaccines resulting in child receiving two administration doses on VZV. Child's parent(mother) was contacted by provider in clinic and informed of the vaccine error and informed of signs and symptoms of vaccines reactions and contact information. Follow to patient and parents was also provided 24 hours after vaccine administration and additionally will continue for 48 hours for follow nurse calls .
This spontaneous report as received from a nurse refers to an 8 months and 30 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This spontaneous report as received from Register Nurse refers to unspecified number of patients of unknown age and gender. On an unkonwn date, the patients were vaccinated with GARDASIL (dose, strength, frequency and lot number were not reported), which since 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Measle-like rash all over legs and arms appeared 2 days following injection. Rash lasted 8 days and continued to leave darkened spots for over 2 additional weeks.
Pt reported left sided facial drooping, left HA, and left neck pain that began the morning of 4/27/21 when reporting to the emergency department on 4/28/21 at approximately 1800. Pt left the emergency department after being given IV insulin for elevated blood sugars. Pt followed up in the Urgent at a Health Center approximately May 1 who told him to follow up. Pt was seen on 5/7/21 still experiencing left sided facial drooping, left HA, left eye pain, and left neck pain. Pt was followed up on 5/10/21 with same symptoms.
Immediately following vaccine administration, patient stood and felt dizzy and clinic staff notified immunizer. Immunizer sat with patient and pharmacist was notified of patient feeling unwell. Patient was partially conscious and sitting in chair, leaning against another immunizer. Pharmacist stepped away to acquire ammonia inhalant from emergency kit. Patient was then moved to the ground and was fully unconscious. Pharmacist used ammonia inhalant. Patient then awoke and was able to sit up after 5 minutes. Gave patient water, orange juice, and pretzels and directly observed patient for 15 additional minutes. Patient's family member then remained with patient until patient was feeling well enough to stand up.
Patient received a Prevnar 20 and Spikevax vaccine, one in each arm on 10/23/2023. She states that about 24 hours later she felt numbness spreading from her fingertips up to her wrists, The numbness 'went as fast as it came'. She also stated that she has local redness around the vaccination site that she knows is normal. When asked if it happened beforem, she said no and is certain that this is due to the vaccinations.
First Day Headache Dizziness Severe fatigue  Nausea  Vomiting  Sweats Cough Hearing impaired in left ear (2 weeks now) Some loss of appetite  Dry mouth
developed a gulf ball size lymph node enlargement to the left underarm on Friday (same day of administration), low grade fever, body aches and chills. 2 days later developed sub clavicular lymph node enlargement that is painful to touch. Having chest pressure from the swelling in both underarm and chest lymph node
Myocarditis  - abnormal EKG and elevated troponin- treated with ASA and toradol for pain
The pharmacist told employee that he experienced redness and inflammation after receiving PNEUMOVAX injection on unspecified date.; The pharmacist told employee that he experienced redness and inflammation after receiving PNEUMOVAX injection on unspecified date.; This spontaneous report was received from a male pharmacist of unknown age via a company representative referring to himself. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, lot # and expiration date were) for prophylaxis. On an unspecified date, the patient experienced redness and inflammation after receiving pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The patient took some ibuprofen and recovered after few days. It was unknown if the patient sought medical attention or performed any lab diagnostics/studies. The causality between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy arm), macular rash (couple of spots on ankles of either foot the same texture as arm rash) and rash in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026C21A and 047B21A) for COVID-19 immunization. Concurrent medical conditions included seasonal allergy. On May 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 29, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 30, 2021, patient experienced pruritus (itchy arm), macular rash (couple of spots on ankles of either foot the same texture as arm rash) and rash. The patient treated with loratadine for rash; 1 dosage form. At the time of the report, pruritus (itchy arm), macular rash (couple of spots on ankles of either foot the same texture as arm rash) and rash outcome: unknown. Concomitant product use not provided.
blisters all around her lips; felt really lousy; chills; really high fever (about 102.5°F); This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters all around her lips, inside and out), FEELING ABNORMAL (felt really lousy), CHILLS (chills) and PYREXIA (really high fever (about 102.5°F)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 an unknown date, the patient experienced BLISTER (blisters all around her lips, inside and out), FEELING ABNORMAL (felt really lousy), CHILLS (chills) and PYREXIA (really high fever (about 102.5°F)). At the time of the report, BLISTER (blisters all around her lips, inside and out), FEELING ABNORMAL (felt really lousy), CHILLS (chills) and PYREXIA (really high fever (about 102.5°F)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication information not provided.  Treatment information not provided.
Information has been received from a physician via a company representative concerning a patient (encounter key# 150534) of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 17-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 degrees Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)'. No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Day 1 after injection:  fever of 101.0, chills, site pain and swelling,  muscle pain radiating from injection site., headache and diarrhea.  Day 2 after injection:  same symptoms except the fever was only 100.8.
PATIENT DESCRIBES SWELLING  (SIZE OF HALF AN EGG) AND REDNESS AT INJECTION SITE, REDNESS TRAVELED DOWN ARM A LITTLE. REPORTS "TWO PUS FILLED SMALL NODULES" WHICH SOUND LIKE LITTLE BUMPS, MAYBE A RASH. REPORTS STINGING AND ITCHING BUT UNSURE IF THAT STARTED BEFORE OR AFTER SHE PUT SOME CORTISONE CREAM ON HER ARM
Left side of face felt numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left side of face felt numb) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HYPOAESTHESIA (Left side of face felt numb). At the time of the report, HYPOAESTHESIA (Left side of face felt numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
injection arm started to swell real bad; hand swelled really bad; injection arm turned red; injection arm was bruising; blood pressure was really high; bleeding under her skin (getting larger everyday); right hand completely with blood under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high). In April 2021, the patient experienced HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin), PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) high blood pressure.         The patient did not go to hospital, instead went to her primary care doctor who said that bleeding under her skin and it is getting larger everyday; there is a complete band around her right forearm about 4-5 inches wide and 20 inches long. The patient saw the paramedics, her PCP, as well as the nurse at the site, as well as her surgeon who recommended she should go back to PCP to get some bloodwork done to check if she is bleeding elsewhere.  No treatment information was provided.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of hemorrhage subcutaneous, and nonserious unexpected contusion, erythema, peripheral swelling, hypertension. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient said two weeks and one day after his first dose, he experienced a red, round, itchy ring about 4-5 inches in diameter around injection site. He said it appeared and disappeared w/in about two minutes.
I have sincehad random purpura bruises covering my legs and arms. These bruises are occuring without any injury. Each morning I wake up to 1-2 new bruises. Older bruises are healing but very slowly.
Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA216254 (same reporter). This case involves a five years old male patient who was vaccinated with fourth dose of IPOL (Batch number: N1K921M, expiration date: 14-Nov-2019, dose was not reported) via intramuscular route in left arm on 01-AUG-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as vaccines were stored out of temperature range. The discovered that Ipol that was stored outside of range was given to the patient. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
This spontaneous report was received from a physician and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX and PROQUAD for prophylaxis (strength, dose, route of administration, frequency, lot number and expiration date were unknown). It was reported that the vaccines had a temperature excursion of 15°F to 46°F (17°F) for 20 minutes and 15°F to 46°F (30.6°F) for 40 minutes. There were no previous temperature excursions. Data logger was involved.
Infant was given pediatric Hepatitis A vaccine instead of the pediatric Hepatitis B vaccine.
Patient with syncopal episode after receiving pediatric influenza vaccine in the left arm using Lot #79ED9. Helped patient from falling, placed patient on the floor with feet elevated. Patient was responsive after being placed on the floor with head elevated.
Local reaction/red/swollen area where shot given x 1 wk. pain under axillary area. Given Benadryl. Got rash al over body on 10/5/02 for 2 d red/bumpy.
This spontaneous report was received from a licensed practical nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-MAY-2017, the patient was inadvertently vaccinated with an improperly stored single dose of M-M-R II with lot # M017348 and expiration date on 06-APR-2018 (strength and anatomical location was not reported) reconstituted with a sterile diluent (manufacturer unknown); administered subcutaneously for prophylaxis. The storage temperature was reported as 66 degrees Fahrenheit (°F) (66°F) for a time frame of 36 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
Initially pain at injection site causing stiffness and trouble lifting the arm. By 8 hours, all joints (lower back especially) stiff and achy. 24 hours later, chills, headaches, joints aching and the left arm unable to move without intense pain through shoulder, back, and across the chest. By 48 hours, fever and headaches grew. Fever broke overnight and by the third morning felt just dull headache but the pain the arm was significantly diminished and full range of motion was returned.
4 month old daughter was given 4 month vaccinations, including the oral ROTATEQ on Wed 1/4. On the morning of Fri 1/6 she developed a fever and rash that lasted for over a week. Her pediatrician could not determine cause of illness. Other symptoms began to show-diarrhea, vomiting, lethargy, red eyes, swollen cracked lips, red swollen soles of feet. Fever, rash and other symptoms lasted for 13 days. Finally on 1/20 her doctor diagnosed her with Kawasakis disease and she was admitted to the hospital on the same day. She was given an IVIG and high doses of aspirin to treat the illness. We believe there is a correlation between receiving the ROTATEQ and her development of fever and rash and ultimately Kawasaki disease. She was healthy on the day of receiving her vaccinations and became ill less than 48 hours after receiving the oral vaccination. She also received vaccinations for PENTACEL and pneumococcal conjugate, ped. 7 valent.