chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been recieved from a consumer concerning her 8 month old son who on 29-APR-2008 was vaccinated with a dose of MMR II. Suspect vaccination on the same day included a dose of COMAX (OMPC) (MSD), a dose of PEDVAXHIB (OMPC) (manufacturer unknown), and a dose of PNEUMOVAX (MSD). Other concomitant vaccinations on the same day included a dose of PREVENAR, dose of DTaP (unspecified) (+) IPOL. The reporter noted that the vaccines were mixed together in on vial. On approximately 29-APR-2008, the patient experienced a fever and other side effects (not further specified). The reporter stated the patient experienced fever and other side effects (not further specified). The reporter stated her son "always gets fever and other side effects after getting any vaccines." Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Information has been received from a consumer concerning her 15 month old son with level 6 food allergy, gluten allergy and no drug reactions/allergies who on 17-APR-2007 was vaccinated with a 0.5 ml dose of MMR II (Lot# not reported). Concomitant therapy included unspecified medication for the patient's food allergy. On approximately 19-APR-2007, "a couple of days after getting the vaccine", the patient developed a rash. The rash got worse, he started swelling and was taken to the Emergency Room but was not admitted. He later developed eczema and had a fever that lasted 7-8 days. The reporter mentioned that her son "now gets the fever every month or so" and would go "in and out" of the hospital, but was not admitted, except for the time that he was admitted for 3-4 days for an allergic reaction to milk. Between 2007 and 2008 he was at the Emergency Room 12 times for fevers and seizures and unexplained vomiting. On an unknown date the patient had been admitted to the hospital due to fevers and seizures (length of stay unspecified). On 25-JUN-2009, the patient was admitted to the hospital for 3-4 days because of seizures. His last seizure was on 25-MAR-2010 at 5:00 a.m. and his last seizure before this one was in November or December 2009. It was also noted that the patient recently had his adenoids removed to help with the fevers. He still had the rashes and eczema. On an unknown date an EEG (electrocardiogram) for 24 hours was performed with no results provided. At the time of the report, the patient had improved but had not recovered. Additional information has been requested.
Initial report received from a health care professional on 16 March 2011. An unidentified patient (no age, sex or birth date provided) received on 02 March 2011 a left arm subcutaneous injection of ADACEL, sanofi pasteur lot number C3540AA. The patient was given the injection subcutaneous instead of intramuscular. The patient now has a knot the size of a dime at the administration site on the left arm. The reported refused to provide any further information. No contact information provided. The outcome was reported as not recovered. Documents held by sender: None.
Pain in joint involving hand/ Pain in Knuckles; Chills/ First COVID Vaccine caused chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joint involving hand/ Pain in Knuckles), CHILLS (Chills/ First COVID Vaccine caused chills) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported patient's medical history.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CHILLS (Chills/ First COVID Vaccine caused chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (Pain in joint involving hand/ Pain in Knuckles). At the time of the report, ARTHRALGIA (Pain in joint involving hand/ Pain in Knuckles) had not resolved and CHILLS (Chills/ First COVID Vaccine caused chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  It was unknown if patient was enrolled in a COVID-19 Vaccine trail.  No treatment medication reported.  Primary reporter contact for lot number information was unsuccessful.   The reporter causality for co-suspect of Humira for the events Pain in Knuckles, chills and fatigue was not provided.   This case was linked to MOD-2022-624832 (Patient Link).
1 hr p/vax administered had shaking, chills, turned blue extremities & lips, became limp; lasted 15 mins, then taken to ER t102; probable febrile seizure;
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chills-Mild, Systemic: runny nose and eyes-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: onset of adverse effects started about 30 minutes after vaccination
pt recv vax 23JUN98 & the next day pt devel an erythematous lesion @ anterior thigh w/c became indurated;fever & vomiting 2-3x/day;
Localized allergic reaction to varicella vaccine possible early cellulitis with herpes zoster vesicles.
The day after vaccination, patient started breaking out in a rash about 30 hours after vaccination.  Patient had also been outside.  She had no new foods, products, any other identifiable cause of rash.  The rash is itchy, about 1 cm or less red spots with white halo.  The rash was mainly on her arms and legs with sparing of her trunk and head although she had a few spots on her trunk.    I am not at all convinced the rash is due to her shots although mom is.   I did think I needed to report it due to timing.
Redness at injection; Heat At Injection Site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE WARMTH (Heat At Injection Site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE WARMTH (Heat At Injection Site). At the time of the report, INJECTION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE WARMTH (Heat At Injection Site) 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.
family members having COVID right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (family members having COVID right now) in a female patient of an unknown age 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. In November 2021, the patient experienced COVID-19 (family members having COVID right now). At the time of the report, COVID-19 (family members having COVID right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  The reporter reported that, lot of family members had COVID, on 2021 November 7,8,9,10. All patients were vaccinated but reporter don't know the manufacturer of vaccine.  No treatment information was provided by the reporter.  This case concerns a female patient of unknown age with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
15 minutes post shot - headache, 3-4 hrs worse headache. 8 hrs later couldn't breathe, face hurt, hot. Eyes almost swollen closed - took BENADRYL. Threw up due to headache. 24 hrs later better.
large rash, followed by trigeminal neuralgia attack in right jaw area which lasted  for 5 weeks
having rapid heart beat and skipping some; having rapid heart beat and skipping some; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76-year-old female patient received BNT162b2 (COMIRNATY), on 10May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), EXTRASYSTOLES (non-serious) all with onset 11May2022, outcome "unknown" and all described as "having rapid heart beat and skipping some". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his wife got a COVID shot on 10May2022 and she was having some symptoms on the next day, having rapid heartbeat and skipping some.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 3 March 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was on 25 May 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 16 June 2014: Vaccines responsible physician was added as reported source. 15 September 2014 - No further information was provided; patient lost to follow-up. 01 October 2014 - No new information received.
Patient did not have any adverse events regarding vaccine. His vaccine was just given too early - so needed to report it.
MODERNA BOOSTER WAS REQUESTED AND ADMINISTERED TO PT WHO IS 16 YO AT TIME OF VACCINATION. MOTHER REPORTED INJECTION SITE REACTION, TIRENESS, AND LOW GRADE FEVER THE NEXT DAY.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 09-JUN-2015 to 07-JUL-2015, the patients received VAQTA (Lot # L008665 and expiry date of 10-FEB-2017) (unknown strength, route and dose), which was improperly exposed to 10.9C for 494 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports received from the same reporter. Additional information has been requested.
varicella vaccine breakthrough. Had vaccine on 11/16/2004. Seen in office 06/16/05 by MD and DX with Varicella. 20 vesicles on trunk, arms, and face. No fever. Rash broke out 06/16/05 and crusted by 06/21/2005
Patient contracted COVID-19 after initial booster; Patient contracted COVID-19 after initial booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Patient contracted COVID-19 after initial booster".  Clinical course: Patient contracted COVID-19 after receiving the initial booster.  No follow-up attempts are possible. No further information is expected.
Unconsolable - uncontrollable crying/screaming for over 3 hours - started in late evening the day of vaccine. (That had never happened before or since).
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.  This is a spontaneous case concerning a 74-year-old patient of unknown gender with no relevant medical history, who experienced the non serious event of expired product administered. The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 4 days past the expiration date with lot number 047B21A. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old patient of unknown gender with no relevant medical history, who experienced the non serious event of expired product administered. The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 4 days past the expiration date with lot number 047B21A. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
HIVE/SKIN RASH; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: glaucoma, and drug allergy (unspecified drug), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 12:00 for covid-19 prophylaxis. Age at time of vaccination 60 years old. Concomitant medications included dorzolamide hydrochloride for drug used for unknown indication. On 2022, the patient experienced suspected covid-19 infection. On 26-AUG-2022 14:00, the patient experienced hive/skin rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hive/skin rash, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
10 post vax pt devel fever, generalized rash, arthralgia & asthenia;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medications were not provided. On 26-FEB-2014 the patient was vaccinated with PNEUMOVAX 23. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
Saturday morning, woke up with very itchy left shoulder and intense pain. Itchiness & pain lasted all weekend. Put ice pack on Sat. & Sun.
Six to eight weeks after the second vaccine was administered, I experienced an inflammatory response. I've was diagnosed with Psoriasis at age 38, but the disease has been in remission for several years. In May, 2021, I had a flare in psoriasis with new plaques on elbows and lower legs developing. I have experienced mild osteoarthritis in my hands but never in knees. Starting in the Spring, I developed bilateral swelling and stiffness in knees, affecting my ability to walk and move around. Also, experienced swelling in both thumb and wrist joints. This inflammation cycles, appearing at random for a week or more, then disappearing and returning. Not related to any changes in diet or exercise levels.
Pt recvd vax & following the vax pt possibly devel core antibody; No further details were provided
Top of head very sore 4 days; "head band" type headache 5 days; fatigue 5 days; severe full body; uncontrollable chills the first night and morning; severe thirst for 2 days; weakness all over; delirium; shakes and tremors all over, full body; had to remain in bed 4 days; took advil 2 pills for a total of 6 per day.
I had a red and swollen arm after receiving the vaccine. I had a runny nose and mild scratchy throat. I tested positive for COVID-19 on 11/2022. I took over the counter medication to help with my symptoms.
Vaccine 6/22/2004 ActHib and Hep B developed temp 104, no other sx and complete resolution within 24 hours.
Patient reported that her arm hurts red hot and sore at the site of injection. She feels nauseous and dizzy and also reported numbness in the arm.
Blood blisters around the mouth (inside cheeks and tongue).  Tiny bruises in the arms and legs Worsening of previous skin rashes
pt devel a fever of 105 on Wed evening & cont;father took child to ped;pt also had 2 episodes of vomiting & diarrhea;
Red blotchy feet, tenderness.  Patient then admitted into the hospital on 11/28/2009.  Discharged on 12/02/2009 patient states that her private physician attributes hospitalization to H1N1 vaccine.  We are awaiting receipt of patient's medical records.
site of inj red, swollen, warm to touch, baby crying all the time;?temp;tx w/APAP;
3" raised red not area around id injection site. Pt state is recovering 10/12/09
March 15, Monday - Pfizer at Pharmacy late afternoon at 3pm. Gas - approximately one minute after vaccination   March 16, Tuesday - gas and bloat throughout the day, tight stomach before bed    March 17, Wednesday- Gas and burping ..lower back cramp   March 18, Thursday - Gas and burping   All symptoms as of today that are on going.. Will report any further symptoms. I have a doctor appointment scheduled 3/26.
Phone call from parent rec'd - "does not feel right". Increased heart rate and "severe shaking" all over - "teeth" are "knocking together" and unable to control the "shaking". Discussion with parent - to ER.
Got the vaccine, started having dizziness when she got up to leave the facility.  Then through the night had chest tightness.  The area turned red with spots on her chest.  Then her head felt like someone was blowing up a balloon inside of her head (tight feeling).  Then she had a migraine, with a temp of 101.1 that lasted one day.   She then got fatigued that started that night, then started coughing and sneezing.  She then started with nausea, her nose started running.  Then she had severe pain all over her body, and told her that she could feel something going throughout her whole body.  The next day she felt it going throughout the other side.  When she got the vaccine there was nothing there, the next day it was red about the size of two half dollars.  The following day after that half of her arm was red.  It took about 5 days before all of the symptoms completely subsided.   They have now all gone away.  She did not take anything as she is so allergic to medications.
On 12/19/02, I received a call from the school nurse, who stated that child presented to her with itchy, swollen and red right arm deltoid area. No generalized symptoms of fever, breathing problems or hives. The school nurse seemed very concerned about the local reaction and requested that we contact parents and recommend MD evaluation. Family speaks Spanish so our interpreter contacted and conveyed message. I followed up with parent on 12/23/02 and was told that child was taken to ER and told that it was a normal reaction and given Tylenol. Itching resolved. Still some swelling but improving. Followed-up on 1/23/03 and parent states she is completely recovered.
This spontaneous report as received from a pharmacist refers to a 56 year old female patient with penicillin allergy. On 13-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, route and site of administration were not reported). In approximately 2015, the patient experienced bronchitis. On 05-NOV-2015, she was seen in an unspecified urgent care center for bronchitis. The patient was released from the urgent care center and prescribed prednisone for treatment. The outcome of bronchitis was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Patient was sitting chair and became weak and fainted and fell from chair. this cause client to bruise right outer corner of his right eye..  Initial b/p 138/83 Pulse o2-97, and hr. 78. Client do have a tendency of become weal from receiving shot. this was told after incidence happened. Nurse practitioner (Dr.)  assessed client and not that he had an open area in above brow. Noted to have bleeding from incidence. EMS called and offered assistance and ask client if he wanted to go to hospital . Client declined.  reassessment done and noted B/P to 148/77. Client assisted to called, friend took control of any further care.
Mother calls to report that patient had an itchy rash just on the right side (side of injection).  Slight fever.  Eating, drinking, and playing fine.  Dr. has instructed her to use Tylenol/Motrin for fever, Benadryl for the rash, rest and hydration.