chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe shoulder pain that started quickly, thought it was a dislocated shoulder.  Pain intensified to a 9/10 and could not move arm.  No noticeable swelling or redness at shot site.  Next day still severe pain, rash that changed frequently over entire body from neck down.  Could not move arm.  Could not contact doctor for help, left message, office closed.  Did not call emergency line but should have.  Day 3 pain 7/10, rash continued to change, opposite hand showed some swelling.  Still not noticeable swelling or redness at the shot site (left arm).  Finally able to see doctor 4:30 PM on 6/4/2015.  Prescribed Methylprednisolone 4 mg dospack 21's which I started taking at 6:00 PM.  Almost immediate relief of pain and rash that continued to improve over time.  By 6/6/2015 almost all pain and rash gone.  Continued taking Methylprednisolone as prescribed.  6/8/15 - today still some pain in upper left arm.  Feels like a pulled muscle.  Concerned about the continuing side effects. I missed a week of work due to the pain, rash, and inability to move my left arm.
From initial information received on 4/10/04 from the patient's mother, regarding an adverse event occurring in the USA, it was reported that a 10 year old female patient started her 5-dose post exposure series with RIG, and IMOVAX RABIES on 12/31/03. The lot number, route and site information for these products were not provided. The next day, the patient experienced a fever of 101 degrees F. In mid January, the patient experienced vomiting, diarrhea, headache, stomach pains, and an intermittent sore throat. Antibiotics were prescribed on and off six times. The patient had multiple wounds from head to toe and bruises that are still present. Her right arm is numb at the wound sit from an attack from an unspecified animal that occurred on 12/22/03. The signs and symptoms still persist. It was not reported if the suspect animal had been captured and/or tested. It was not reported if the patient continued with the vaccination series. It was reported the patient reportedly did not recover from this event.
Dissiness, chills, nauseas, left and right left pain. Left arm pain at injeciton site.
Pt staying in facility; Pt had a positive COVID test on 10/24/21; received monoclonal antibodies; still has increasing SOB; on supplemental O2 and BiPAP, but pt pulls BiPAP off frequently; decrease in appetite; weak; pt in severe respiratory distress, family refused hospitalized; comfort care with pain management; pt died in the facility; death certificate and med records sent per VAERS request
Breakthrough case admission after 2 vaccines  Moderna 3/1/22 Lot# 083J21A;  Moderna 3/30/22 Lot# 083J21A
feeling of swelling in the hands and feet; itching all over; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (feeling of swelling in the hands and feet) and PRURITUS (itching all over) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PERIPHERAL SWELLING (feeling of swelling in the hands and feet) and PRURITUS (itching all over). On 20-Mar-2021, PERIPHERAL SWELLING (feeling of swelling in the hands and feet) and PRURITUS (itching all over) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non significant follow-up received
Elevated blood pressure by 20-30 points; This is a spontaneous report from a contactable consumer (reported for herself).   A 74-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN 6205/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 09:00 (at the age of 74-years-old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included hypertension, blood cholesterol increased, drug hypersensitivity (Penicillin allergy) and mycotic allergy. Concomitant medication(s) included norvasc (AMLODIPINE BESILATE), timolol maleate (TIMOLOL MALEATE) and latanoprost (LATANOPROST). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took bactrin and experienced drug hypersensitivity, statins and experienced drug hypersensitivity. On 04Mar2021 at 07:00, the patient experienced elevated blood pressure by 20-30 points. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 04Mar2021 (elevated blood pressure by 20-30 points). At the time of reporting, the outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Eczema red spots on chin just below the lips. Spots varied in size from 1/4 of inch in diameter to an inch in diameter. These spots would come and go for months. The red spots eventually went away. But it turned into a rough patching on the cheeks and arms. Eczema was diagnosed later on the arms by a dermatologist. The eczema still is active.
Swollen arm at injection site, lump at injection site. Chills, fever during night after administration. Didn't improve until Mon 10/28 - swelling started to return to arm 10/29.
Patient received flu shot at 10:30 AM. At 11:30 AM, reported generalized itching; taken to ER. Treated with Benadryl and Prednisone orally. Released from ER at 3 PM.
Patient reported on 4/23/18 swelling in entire arm down into forearm. She was advised to seek medical attention from a physician as soon as possible.
Headache, Arthralgia, NauseaVomiting, malaise Narrative:
Vaccine or covid arm red rash. Began 8th day after vaccine. Rash warm to the touch and itchy. Still have ad of today April 11.
Information has been received from a registered nurse concerning a patient with a history of pulmonary disease who was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 0650649/0790P). The registered nurse reported that the patient developed redness, swelling and heat in the injection site arm after vaccination, during the past 3 months. The patient received oral antibiotics. At the time of the report, it was unknown if the patient recovered. The registered nurse felt that redness, swelling and heat in the patients injection site arm was considered to be disabling. It was also reported that two other patients had similar experienced and were treated with oral antibiotics WAES0606USA04360 and WAES0510USA07487. It was also reported that another patient had similar experiences and was treated with intravenous IV antibiotics WAES0510USA08765). The registered nurse reported that three patients recovered and one patient did not recover. Additional information has been requested.
Four month old male who had received DTaP #1, HIB #1, IPV #1, HBV #1. HBV #2 and PCV #1. In office received DTaP #2, HIB #2, IPV #2 and less than 60 seconds later developed urticaria on head and neck. No respiratory distress. Observed for 20 minutes with almost complete resolution of symptoms.
It started at night with a sore throat and a runny nose. Then the next morning it worse so I did a COVID-19 test and it was positive. I had headaches and fatigue. I slept a lot. I took Mucinex and ibuprofen, and Tylenol depending on how long it had been. The headache didn't really go away. Within like 5 days everything cleared up.
started the evening of vax w/whelps & redness & swelling on rt eye lid; next day had whelps on legs & trunk; 2 days later is having whelps which are partially elevated; swelling & tingling of lower lip;
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 028L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details not provided.
Pt vaccinated with INFLUENZA developed fever, myalgias, fatigue, pain in the rt arm which later migrated to lt arm. Paresthesias developed in rt hand & rt arm weakness. Symptoms have gradually improved has mild pain.
11 DAYS AFTER VACCINE DEVELOPED PALPITATIONS AND SEVERE GASTRITIS TAHT PERSISTED DESPITE MEDICAL THERAPY
Swelling in left arm and left leg; This case was reported by a other health professional via call center representative and described the occurrence of peripheral swelling in a 52-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2014-2015 season) (batch number DL352, expiry date 30th June 2015) for prophylaxis.   In December 2014, the patient received Fluarix 2014-2015 season (intramuscular). In December 2014, 12 hrs after receiving Fluarix 2014-2015 season, the patient experienced peripheral swelling. On an unknown date, the outcome of the peripheral swelling was recovered/resolved.   It was unknown if the reporter considered the peripheral swelling to be related to Fluarix 2014-2015 season.  Additional details were provided as follows: The patient received Fluarix 2014-2015 season in left arm and had Swelling in left arm and left leg. The reporter stated the Swelling was gone in twenty-four hours. The reporter did not consent to follow up.
Information has been received from a consumer concerning her 4 month old son with an unremarkable medical history who on 08-OCT-2007 was vaccinated with a first dose of COMVAX (Lot #657379/0376U). Concomitant suspect vaccination on the same day included ROTATEQ (MSD). Other concomitant vaccination on the same day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (-) tetanus toxoid, poliovirus vaccine inactivated (VERO) (IPOL) and (PREVNAR) (CRM197). On approximately 15-OCT-2007, one week later, the patient experienced a low grade fever. On approximately 29-OCT-2007, three weeks later, the patient experienced blood in his stool. Subsequently, the patient completely recovered. On 10-DEC-2007, the patient was vaccinated with a second dose of COMVAX without incident. Additional information is not expected.
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant Human albumin (rHA) (M-M-R II) vaccines experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.   On 19-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, dose number and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event was reported.   This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Developed fever and lump near site of injection that is painful and radiates to lower arm of left arm from PNEUMOVAX 23 vaccine. Adverse reaction occurred 4 hours after injection. Informed patient to contact PCP for guidance and if symptoms worsen to seek medical care. In the meantime to use aspirin or ibuprofen for the fever, pain and swelling and alternate use of tylenol for the pain and fever.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 17-OCT-2012 10:25, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
patient didn't feel good after his vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (patient didn't feel good after his vaccination) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (patient didn't feel good after his vaccination). At the time of the report, MALAISE (patient didn't feel good after his vaccination) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (Unknown) was unknown.   No concomitant medication was reported.  Reporter stated that the patient did not feel good after his vaccinations either.  No treatment information was provided.   Reporter did not allow further contact
Patient felt aching/soreness when she went home. She called the nurse and the nurse advised her to use hot/cold compress around the area. The next morning the injection area started to get red and spread to upper arm area but still localized at the injection site. On 6/3 around 11:30am, she called me and I advised her to stop using the compress and monitor for any fever and if the area gets hot or tender to touch. Otherwise at that time, the redness didn't bother her at all and no symptoms at the time she called me. On 6/3 around 12:45pm, she called and reported to have a slight fever at 99 degree Fahrenheit. I advised her to go to clinic, urgent care or emergency room to have it check.
Rash; some fatigue; some chills; covid arm (right arm) after second dose; Itchy Rash after 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm (right arm) after second dose), RASH PRURITIC (Itchy Rash after 2 days), RASH (Rash), FATIGUE (some fatigue) and CHILLS (some chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 012L20A and 062E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO), METFORMIN, METOPROLOL SUCCINATE and LEVOTHYROXINE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (covid arm (right arm) after second dose) and RASH PRURITIC (Itchy Rash after 2 days). On an unknown date, the patient experienced RASH (Rash), FATIGUE (some fatigue) and CHILLS (some chills). In March 2021, VACCINATION COMPLICATION (covid arm (right arm) after second dose) had resolved. At the time of the report, RASH PRURITIC (Itchy Rash after 2 days), FATIGUE (some fatigue) and CHILLS (some chills) outcome was unknown and RASH (Rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.   This case was linked to MOD-2021-377027 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Additional events, Concomitant medication were updated.
running fever; tiredness, and fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced running fever, tiredness, and fatigue after taking the vaccine on 19Jan2021. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
This spontaneous report was received from a pharmacist regarding a 53-year-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies were not reported. On 07-FEB-2017, the patient was vaccinated with a dose of PROQUAD lot number reported as M034691, expiration date: 24-JAN-2018 (strength, dose, frequency, route of administration, and anatomical location were not reported) for prophylaxis. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
In the nights immediately following the MMR vaccine patient woke inconsolable, not settling for hours. He also had a 102.1 fever, which I mentioned to Dr. when she did a follow-up call one or two days after his vaccine (do not know the exact date). Dr. said that it could in no way be related to the vaccine. Patient continued to wake up inconsolable for the next few nights at which point we brought him back to the pediatrician and saw Dr. who diagnosed him with an ear infection and prescribed amoxicillin. We gave him the antibiotic as dosed until Friday morning (1/16/15) when his lips turned blue. I immediately took him to the pediatrician and he was staring off and not responding when I called his name and his lips were in and out of a blue the whole way to the office.  When we arrived at the pediatricians office his lips went back and forth in color (his oxygen saturation was normal around 95-98 -cannot remember exactly, when checked), was given a breathing treatment and responded to it but then his lips turned blue again at which point the pediatrician we saw (do not remember her name) advised we go the Hospital. On the way to hospital his lips were in and out of color and he was staring off. Upon arrival, his oxygen saturation was once again checked and it was 83%. He was put on oxygen and given Prednisone and Albuterol. An x-ray was taken and the Dr. said his lungs looked good but sounded "like someone who had a bad chest cold". The Respiratory Specialist put something down his nose to get the mucus out (didn't get much of anything out). Blood was drawn. Patient seemed fine after all treatments and interventions aside from being tired and scared. He slept normally until 4 am when he woke crying again. Went back to sleep for a bit and then woke for the day. Took his morning nap as usual (still in the hospital). Meds were administered throughout this time. At around 11:30 AM he cried inconsolably for an hour (at around 45 min) the nurse on duty gave him Tylenol...he continued to cry and have violent fits and arch his back and when he calmed he'd stare off. We were discharged at 3 PM with no solid answer as to what caused the blue lips other than he has asthma. We left the hospital and over the 3 nights and days after being discharged (1/17-1/1) he cried and stared off and on ALL day and woke inconsolable. We took him in on 1/19 and Dr said his ear infections had not improved at which point he was given an injectable antibiotic. We refused further doses of antibiotics.
The 1st vaccine my daughter had a  sore arm (a few days)  very tired (a few days) and very nauseous. she was nauseous until her 2nd vaccine.  about 12 hours after her 2nd vaccine she had a fever off & on for 3 days threw up off & on for 3 days had a headache off and on 4 days. extremely tired for 3 days, stomach ache and nauseous for almost 2 wks.
pt states devel fever w/ h/a 1 hr p/vax given; pt took APAP & started feeling better about 3 hrs later;
a minor cut from the syringe; a minor cut from the syringe; the finger flange was broken and the glass from the finger flange had broken off into one additional piece; This spontaneous report has been received from a nurse, reporting on herself, a 51-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medicatons provided.  On 20-JUL-2023, another healthcare professional (HCP) handed the reporter the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringe (lot #X004289, expiration date: 10-DEC-2024) and the reporter got a minor cut from the syringe (Skin laceration; Injury associated with device). The finger flange was broken and the glass from the finger flange had broken off into one additional piece (Syringe issue). The reporter stated that the cut was small and the only treatment needed was a band aid. She did not seek medical attention. On the same date (20-JUL-2023), the patient recovered from the event. The reporter stated that she did not have the product for return as the syringe was already disposed of. Moreover, no photos were available to be sent, they did not take any photos prior to discarding syringe. No additional details were available at this time.  The causal relationship between Skin laceration and the suspect vaccine was not provided.
Pharmacist gave vaccine, spoke with patient for a few minutes and the patient stood up . He reached for a chair and fell backwards, fainting. A second or two went by an patient sat straight up and drank a glass of water and left after 30min-1hr.