chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site; Mildly tender injection site; slight swelling at injection site; This is a spontaneous report from a contactable nurse. A 64-year-old non-pregnant female patient received bnt162b2 (BNT162B2 also reported as COVID-19 vaccine; lot number: EL 3246; expiration date: unknown), via an unspecified route of administration left arm on 02Jan2021 15:45 at a single dose for covid-19 vaccination. Medical history included HTN (hypertension) and controlled PAT (paroxysmal atrial tachycardia). Concomitant medication included unspecified medication. The patient previously took cephalexin [reported as Cephlexin]. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/facility. It was reported that the patient had mildly tender injection site, slight swelling and redness at injection site on 02Jan2021 08:00 PM. The reporter did not consider the event serious. The patient was not tested for COVID-19 since the vaccination. The patient did not received treatment for the adverse event. The outcome of the events was not recovered.
Worsening episodes bloody stools, colic, reflux, to many foods. Currently exclusively breast fed - mom eats only lamb & buckwheat as baby's symptoms increase. No fevers.
Patient received the Pfizer Covid vaccine for his 3rd dose. After giving the vaccine, it was realized that he received the Moderna vaccine for his first two doses. Discussed this with patient and he commented that he didn't want to have to wait to receive Moderna for his 3rd dose. Also, he had called the pharmacy the previous day to schedule his Covid vaccine today and he told the pharmacy technician at that time that he had received Pfizer for his first two vaccines.
C/O chest tightness, coughing, wheezing in obvious distress. Taken to ER. Given Epi 0.2mg SQ and SOLUMEDROL 250mg IV, BENADRYL 50mg and Albuterol nebulizer treatment.
21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 11-Apr-2022, MOD-2022-536025 considered invalid as no individual patient information reported. Concomitant medications were not reported. No other side effects were reported by the reporter. Treatment information was not reported.  It was reported that the analysis of the vials associated with storage excursion was complete. The vaccine administered on April 5, 2022, April 6, 2022 and April 7, 2022 from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   This case was linked to MOD-2022-538271, MOD-2022-538141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Significant Follow up was received. Patient Identifiers, Date of birth, dosage information was updated. On 11-Apr-2022: Non significant follow up: Analysis added
ADVERSE EVENTS: Spouse was unable to get out of bed   Legs were very weak (had to be helped up and even then very unsteady) Level of mental fog (limited recollection of events leading to her physical state at the time) TREATMENT: Visited primary physician the day after vaccine Spouse had a low grade fever and a blood panel was taken (results were inconclusive as to cause
Patient admitted 8/24/21 for nausea, diarrhea, and shortness of breath.  History of non-Hodgkin's lymphoma and chemotherapy given 8/9.  Resulted positive for COVID on 8/24.  Diagnosed with COVID 19, bilateral viral pneumonia and acute hypoxi respiratory failure. Patient received Pfizer vaccination on 3/19/21 and 4/10/2021. Patient is still hospitalized.  Hospital Name City  State
TIA (10 minutes of altered consciousness, encephalopathy) while sitting in a chair 6 hours after first Pfizer covid vaccine. Has a h/o similar TIA. No ongoing symptoms sequelae. Advance his anti platelet therapy to plavix and aspirin.
I got hives approximately 12 days after receiving the Moderna booster. It comes when my skins comes into contact with surfaces, itches, but goes away after 30 min to 1hr. This has been reoccurring from Jan 15th to now.
pt recv vax & devel low grade fever, urticaria,swollen knees & ankles pt could not walk got progressively worse, tx w/meds dx of urticaria made tx w/cortisone;assessment to r/o vasculitis;racing pulse;angioedema,allergic rhinitis;
Given prior to age of 18. Monitored for 15 minutes after injection without any adverse reaction.
9MAY91 itchy hives on arms & lower extremities for 1 day post DTP/OPV vax 7MAY91; denies fever or other s/s; referred to MD who ordered DPH; To ER if rash unresolved &/or worsens;
minor muscle/arm soreness; minor muscle/arm soreness; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 10Feb2021, the patient experienced minor muscle/arm soreness (pain in extremity, myalgia). Additional information included, patient reported that she received her first dose of the Pfizer-BioNTech COVID-19 Vaccine on 09Feb2021. She had minor muscle/arm soreness the day after the first dose. Her second dose is scheduled 3 weeks after first dose on 02Mar2021. She was supposed to have surgery (mastectomy due to breast cancer diagnosis; this diagnosis was prior to receipt of vaccine) this past week but due to weather in her area, it got pushed back to 03Mar2021. Her surgeon has recommended that no vaccination within a week of surgery so she is trying to determine which one to push back, either the second dose or the surgery. She planned to discuss this further with her physician. Consumer asked if there are any allowable deviations for timing of second dose. Is it effective if given later than the 3 weeks. She disconnected so no further contact information or details could be collected. Outcome of the events was unknown.  No Follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
1 month after shot started feeling pain in left side of jaw. Within a couple days felt electrical shocks, could not talk or eat most of the time. Was given HYDROCODONE/ACETAMINOPHEN and PREDNISONE. Pain subsided but it has gradually returned. I am experiencing pain almost everyday now but not as severe. I do have to stop eating sometimes until the pain stops. My doctor says it will take months until pain goes away completely.
PATIENT EXPERIENCES SHORTNESS OF BREATH AND METALLIC TASTE IN THE MOUTH APPROXIMATELY 10 MINUTES POST VACCINATION.  BASED ON OBSERVATIONS, PATIENT'S PUPILS WERE NORMAL.  THE VITALS ARE AS FOLLOWS:  9:39AM- BP 146/102 PULSE 84 9:49AM- BP 143-93 PULSE 79.  PULSE OX=98%.  AT THIS TIME, THE PATIENT COMPLAINED OF WORSENING OF BREATH, "HEAVY BREATHING".  I ADMINISTERED ONE DOSE OF EPINEPHRINE 0.3MG DOSE INTO THE THIGH AND DISPATCHED 911 EMERGENCY SERVICES.  WHEN THE PARAMEDICS ARRIVED, PATIENT WAS STILL ALERT.  FIRST BP READING BY PARAMEDICS WAS HIGH (ASSOCIATED WITH EPI INJECTION).  DURING THE PARAMEDIC ASSESTMENT, PATIENT SOB AND BP RETURNED TO HIS NORMAL CONDITION.  THE PATIENT REFUSED FURTHER TREATMENT.
Information has been received from a physician concerning a 77 year old female who on 05-JUN-2008 was vaccinated with 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (lot #659409/0409X).  Concomitant therapy included BONIVA and "NORPROXIN".  On 20-JAN-2009 the patient experienced shingles after receiving ZOSTER vaccine live (Oka/Merck).  She had minimal pain however had a few skin lesions on "one side and back".  Treatment consisted of VALTREX and DARVOCET.  Subsequently, the patient recovered from shingles on an unspecified date.  No further information was provided The patient sought unspecified medical attention.  Additional information has been requested.
Mother noticed last NOC right thigh to knee swollen + red. 0 hot to touch, but is tender child does walk, but with slight limp. Advised to give Ibuprofen and use cool packs for swelling and pain. If s/s worsen seek medical attention from primary care physician.
Left arm continues to go numb daily at various times for approx. 5-10 mins each time.
about 18hr p/vax pt devel chills, fever (T101), muscle & joint aches, extreme fatigue, h/a lasting for 2 days;
Suspected vaccination failure; shingles on my right leg from above my knee and it runs all the way to my ankle; extremely painful; Extra dose administered; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix, Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles on my right leg from above my knee and it runs all the way to my ankle), pain (Verbatim: extremely painful) and extra dose administered (Verbatim: Extra dose administered).  The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix, Shingrix and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix, Shingrix and Shingles vaccine.   Additional Information: GSK receipt date 18-SEP-2023 This case was reported by the patient via interactive digital media. The patient got the first shingles shot when it first came out . Then took the two Shingrix shots a few years ago.  The patient asked to guess what he/ she was having now(the recent time). The physician said of have a very bad case of shingles on right leg from above my knee and it run all the way to the ankle.  It was extremely painful and the patient was going to be 81 next month. The patient's 85 year old sister, cousin in his 70's , and pastor just got their . The patient received 3 doses of shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 09-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA011187: Original Case: 1809USA010671; US-009507513-1809USA011189: Original Case: 1809USA010671; US-009507513-1809USA011190: Original Case: 1809USA010671; US-009507513-1809USA011186: Original Case: 1809USA010671; US-009507513-1809USA011185: Original Case: 1809USA010671; US-009507513-1809USA011184: Original Case: 1809USA010671; US-009507513-1809USA011188: Original Case: 1809USA010671.
Small nodule approx 10mm on left groin fold, right nodules x2 smaller size felt, crying when lump palpated gently, day after she received immunization, mothers states child crying more then usual, did not want to stand up, mother noted nodule on groin fold on 3/27/06, 3/28/06 see attached progress noted. 3/29/06 M. reports child not crying moves legs better right inguinal lymph nodes 2 x 0.5 cm, left inguinal lymph nodes 2 x 1cm. no increase size, still hard. RTC if worsens to see DR. mom verbalized understanding.
h/o stop breathing 3 days p/vax;while pt was in the car seat pt was noted to be dusky;pinched & rubbed back & started crying;1/2hr later pt on the way to ER did the same thing;adm to hosp uneventful;sleep apnea studies WNL;
Dizziness, loss of hearing, headache, fainting, mild convulsion (erratic arms), pallor, nausea, soreness and itchiness at injection site
Initial report was received on 12 September 2008 from another manufacturer who received the report from the patient's parent.  A female patient was reported to have developed pneumonia on an unspecified amount of time after she had received a polio immunization (manufacturer, lot number, route/site not reported).  The patient experienced a fever (temperature and date of onset not reported) which lasted seven to ten days and had been hospitalized.  No additional information was provided.
Pt broke out in severe rash on face arms and legs 5 hours after immmunization given MMR and Varicella
After the first shot my arm was sore.  After the second one I had about 8-12 hours of chills and nausea.  Now dealing with radiating pain in the arm for forearm- stiffness and also extreme lower back stiffness I did not have before.
leg stiffnes and pain; side effect; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (leg stiffnes and pain) and ADVERSE DRUG REACTION (side effect) 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 MUSCULOSKELETAL STIFFNESS (leg stiffnes and pain) and ADVERSE DRUG REACTION (side effect). At the time of the report, MUSCULOSKELETAL STIFFNESS (leg stiffnes and pain) and ADVERSE DRUG REACTION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Vaccine information was not provided. No treatment information was provided. No concomitant medication was provided.
PURPLE BRUISE LIKE AREA 4 INCHES IN SIZE AROUND WHERE VACCINE GIVEN IN LEFT ARM AND HOT TO TOUCH
S/P vaccine 1/8. Came in to see RN and left thigh to knee + edema. No erythema. Seen again 1/9. Edema decreased with Benadryl. 70% improved by 1/9/04. Told to RTC if not better by 1/10/04.
A nurse reported the occurrence of "excessive" swelling at the injection site in a 4 year old vaccinee of unspecified gender who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received the fifth injection of Infanrix (531A2). Subsequently, the vaccinee developed "excessive" injection site swelling. The reporter stated that this event was probably related to Infanrix administration. As of 3/27/02, the outcome of the event was unknown.
Patient believes that the herpes zoster diagnosis (she never had Shingles vaccine) is directly related to the COVID-19 vaccine.  She was diagnosed at Hospital.
no additional AE; Inappropriate Schedule; Product origin unknown; This spontaneous report was received from a nurse concerning a 14 years old female patient. No information about her current condition, medical history or concomitant therapy was reported.  On 22-AUG-2012, the patient received her first dose of unspecified quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route and lot# were not reported) as prophylaxis (the specific HPV vaccine type was not reported; product origin unknown). The patient was still eligible and requested to complete series.  On 24-SEP-2021, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route and lot# were not reported) as prophylaxis (inappropriate schedule of product administration). The vaccine was purchased with public funds and vaccinated at public health clinic/hospital. There was no temperature excursion. She scheduled for final injection in 2 months. No additional adverse event was reported.
Breakthrough case admission after 4 vaccines Moderna 1/6/21 Lot# 012L20A;  Moderna 3/3/21 Lot# 012L20A;  Moderna 12/22/21 Lot# 060H21A;  Moderna 4/29/22 Lot#048L21A
Information has been received from Pfizer Inc. (manufacturer control # 2016348841) on 20-JUL-2016. Information has been received from a consumer referring to her mother of unknown age on 15-JUL-2016. The patient's medical history and concurrent conditions were not reported. On an unknown date in 2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported). On 12-JUL-2016 (reported as three days ago), the patient experienced diarrhoea. The outcome of diarrhoea and the causality were not reported. Additional information has been requested.
This is an instance of breakthrough COVID-19 after which death occurred. They were vaccinated with the Moderna product on 02/11/2021, 03/10/2021, and 09/04/2021. They were also vaccinated with the Pfizer product on 03/17/2022.  They presented to emergency department on 08/09/2022. Primary complaint was congestion and body aches. Upon further examination, they admitted to having fallen earlier the day and having tested positive for COVID-19 same day. They were found to be hypoxic upon admission to hospital. Lab workups revealed severe kidney problems; they had received a kidney transplant previously. The individual refused to be treated with hemodialysis. Their condition continued to deteriorate and they died on 08/11/2022 in the hospital.
Developed 5 cm x 12 cm area redness and itching of injection site requiring 6 doses BENADRYL 50 mg to control symptoms. Took 2 weeks for redness to resolve.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 22-SEP-2014, the patient was vaccinated with MMR II lot # H017027, 0.5 ml, subcutaneous. No concomitant medication was reported. The nurse is reporting the patient was inadvertently administered MMR II lot # H017027 on 22-SEP-2014 that had expired on 14-SEP-2014. No adverse effects reported. No further information provided. The outcome of administered MMR II that had expired was unknown. No PQC was reported. Additional information is not expected.
PATIENT GOT VACCINE ON 8/5/21 AND CAME ON 8/9/2021 TO PICK UP ANTI BIOTIC AND HAD CONVERSATION THEN FIND OUT ABOUT HER REACTION. SHE HAD SMALL BRUISE ON HER LEFT ARM AT INJECTION SITE, HER AREA OF VACCINATION IS SWALLON, RED AND HOT. SHE STARTED FEVER NEXT DAY, SHE STATED THAT SHE DID TOOK TYLENOL 500MG EVERY 6 HOURS TO HELP, BUT IT WAS ON AND OFF. SHE FELT LIKE ALLERGIC REACTION ALL OVER HER BODY AND HAVING ITCH AT INJECTION SITE AND OTHER AREAS OF  BODY. SHE WENT TO PRIMARY CARE DOCTOR TODAY, AND SHE WAS TOLD TO FINISH BACTRIM DS FOR 10 DAYS, BENDRYL AND TYLENOL UNTIL SYMTOMPS GETS BETTER.
Swelling in the lymph gland under the left arm; extreme tiredness; headache; muscle pain; chills; I was very sick; couldn't keep my eyes open; dizzy; weak; difficulty breathing; I felt like I was having the covid again; Little discomfort in my arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was very sick), OCULAR DISCOMFORT (couldn't keep my eyes open), DIZZINESS (dizzy), ASTHENIA (weak) and DYSPNOEA (difficulty breathing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), PARACETAMOL (TYLENOL), ATORVASTATIN, BUDESONIDE, CLOPIDOGREL, CARVEDILOL (COREG), GABAPENTIN, LOSARTAN, OMEPRAZOLE, PANTOPRAZOLE and POTASSIUM for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced ILLNESS (I was very sick), OCULAR DISCOMFORT (couldn't keep my eyes open), DIZZINESS (dizzy), ASTHENIA (weak), DYSPNOEA (difficulty breathing), MALAISE (I felt like I was having the covid again), VACCINATION SITE DISCOMFORT (Little discomfort in my arm at the site of injection), FATIGUE (extreme tiredness), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills). On an unknown date, the patient experienced LYMPHOEDEMA (Swelling in the lymph gland under the left arm). At the time of the report, ILLNESS (I was very sick), OCULAR DISCOMFORT (couldn't keep my eyes open), DIZZINESS (dizzy), ASTHENIA (weak), DYSPNOEA (difficulty breathing), MALAISE (I felt like I was having the covid again), VACCINATION SITE DISCOMFORT (Little discomfort in my arm at the site of injection), LYMPHOEDEMA (Swelling in the lymph gland under the left arm), FATIGUE (extreme tiredness), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included vitamin twice daily and multiple vitamins.  Second shot scheduled on 27 Mar 2021.  No treatment information was provided.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). Other suspect therapies included on 10-MAR-2014, vaccinated with M-M-R II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.