chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A three year old female pt with no previous medical conditions, developed seizures following treatment with RabAvert. The reporter states that the pt has no history of head trauma and no family history of seizures. The pt was bitten by a grondhog in Oct 01 and given the first dose on 10/22/01. She was given subsequent doses on days 3, 7, 14, and 28. The pt developed seizures in Jan 02 described as foaming at the mouth with tremors. She later had a grand mal seizure in May 02 lasting 20 minutes. The pt was taken to the emergency room after that and diagnosed with febrile seizures. After the first grand mal, she had 4 or 5 seizures. In May 03, the reporter approached the physician to re-examine the pt. On 7/1/03, she was diagnosed with epilepsy. The pt has been treated with Lamictal, Trileptal and Depakote on different regimens. She is currently on Depakote and Trileptal. The reporter also stated that the pt had mental and motor skills of a 3 1/2 year old child, but was thought to be advanced for her age prior to groundhog bite and RabAvert injections. Follow up received 8/12/04: The patient received RabAvert on the following dates, 10/22/01, 10/25/01, 10/29/01, 11/5/01, and 11/19/01. The patient was diagnosed with intractable epilepsy.
She start with a fever then a large 5 inch diameter red, swollen, and hot circle around shot site.  This started two days after shot and still has continued today.  Doctor recommended antihistimine and Benedryl at night.  Also icing if she has discomfort.
Hair was falling and thinning, have bald spots; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair was falling and thinning, have bald spots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21 and 42L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (augmentin caused lips swollen.) and Allergic reaction to antibiotics (Levaquin caused lips swollen). Concomitant products included LOSARTAN, METOPROLOL, BUPROPION, ALENDRONATE SODIUM (ALENDRONATE) and OXYBUTYNIN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair was falling and thinning, have bald spots). At the time of the report, ALOPECIA (Hair was falling and thinning, have bald spots) outcome was unknown.            Treatment medications included antihistamines.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-023307 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated patient demographics, medical history ,concomitant medications Events information is updated.
pt got a 2nd booster (4th dose), two days after administration she got red blotchiness and itchniess on her leg.  She is managing symptoms with zyrtec and topical corticosteroids.  she will follow up with physician if it gets worse.
Patient developed localized swelling and redness in left leg measuring 2" by 2.5".
4/29 & 4/30 injection site warm, painful.  5/1 hives around injection site, itchy.  Rx'd Benadryl, Tylenol or Advil.
approx 5 hrs post vax, experienced intense rush of heat up through my body, headache sweating cold hot. I continue to experience these heat rushes, less intense with r cervical gland swelling. Low grade pyrexia inconsistent with heat experienced. O2 sats and pulse rate within normal levels. profuse perspiration. These symptoms recur with unpredictable periodicity. They continue today and I can find no other description in any world database I can access.
Pt recvd 1st dose of Hep B vax 12APR91 due to needlestick accident; On 20APR91 devel vomiting, diarrhea, & h/a;
Suspected vaccination failure; neuropathy; shingles. Mild case; had blisters; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the neuropathy and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and blister to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got mild singles. Till the time of reporting, the patient still had blisters and neuropathy. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Patient given their next Moderna vaccination a week before they were due next dose.  Prior doses given on 2/21/23 & 3/22/23. Next dose administrated on 5/10/23.
Flu like symptoms, fatigue, 100.1 fever,  took nap for 3.5 hours after lunch because of fatigue, oxygen = 94, All symptoms disappeared on 2/7/2021
Diarrhea; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Patient did not use any treatment medications
The pt's right leg where the vaccine was given turned deep red/purple with scattered hive like areas noted.
Vaccinia lesion on left wrist, radial side.  Noticed red papule 25 Jan, has progressed to white lesion without discharge.  Because he is a healthcare worker, required provider evaluation and removal from patient care. Annual follow up on 03/17/04: "Pt has recovered from adverse events."
pt leg was red & swollen (the rt leg); had a low grade fever & cried inconsolably for 8-9 hrs;
44 yo female pt received her full Pfizer COVID-19 vaccination: first dose 3/27 and second dose 4/17. On 5/11, pt experienced loss of smell, congestion, tiredness. She also had a recent close exposure to someone with the COVID-19 virus. Nasopharyngeal swab obtained and patient tested positive later that day. Advised to quarantine for 10 days.
t103 ax 10 hrs p/vax mom took pt to ER dx fever probably secondary DTP immun; Seen this AM in office w/t37.4 (tympanic) & same dx; pt had emesis x 1;
This case was reported by a healthcare professional and described the occurrence of lichen planus in a 50-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included BOOSTRIX (GlaxoSmithKline) given on 4 May 2011. There were no concurrent medications. On 4 May 2011 at 14:10 the subject received 1st dose of TWINRIX at 1.0 ml in the right arm. Less than one year after vaccination with TWINRIX, the subject experienced lichen planus. The nurse reported that the subject reported that she developed lichen planus after administration of the 1st dose of TWINRIX. No further details were reported. At the time of reporting the outcome of the event was unspecified. Follow up information received 02 May 2012 via consumer. Additional information included concomitant medication of PERCOCET and concurrent medical condition of neck pain. The subject reported receiving the second dose of TWINRIX on 08 June 2011. The subject stated the Lichen planus started at the end of July 2011, described as broke out in raised itchy, red rash on wrist and ankle. The subject indicated that she initially went to her dermatologist's office and was diagnosed with Lichen planus. She then was referred to a blood doctor who did a number of tests which ruled out any other diseases. The subject indicated that she cannot wear shorts, she has rash on arms and hands and won't be able to go on vacation this year. The immunization series was discontinued. Follow-up information was received on 25 May 2012 via healthcare professional who reported the side effect of lichen planus, pruritic raised red rash outcome was unknown. The events were not considered serious.
itchy, scratchy throat, diff breathing, pale w/in min p/vax;pt primary MD notified;p/pt stabilized pt transported to PCP MD;
Headache, Myalgia, Fever, NauseaVomiting, fever; head & body aches with nausea Narrative:
Chronic hay fever symptoms: itchy nose, itchy throat, itchy ears, itchy eyes, stuffy nose, sneezing, runny nose
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated intramuscularly in the deltoid area with a dose of GARDASIL (Lot # and dose not reported). The nurse reported that the patient experienced severe pain n her arm lasting a month. At the time of the report, the outcome of the patient was not reported. Follow up information was received from a Physician Assistant (P.A) via medical records who reported that an 18 year old female student who experienced pain into right deltoid in July 2010. On an unspecified date, an X-ray of right humerus (AP and lateral views) showed no fracture or dislocation (normal radiographic study of the right humerus). The soft tissue appeared normal. There was no radiopaque foreign body. The patient sought unspecified medical attention. It was reported that in August 2010, the patient recovered from the event. No further information is available.
Fever, chills, muscle soreness, cold sweats, headache and nausea. All symptoms apart from headache resolved in 24 hours
Burning at injection, soreness at injection5 to 9 hourafter injection, I feel some shotting pain down arm occasionally. Slight pressure in head but not full on headache within 2 hours of headache.
Some of the vaccine leaked after injection. I called moderna, and their protocol was not to reinject if half of the dose was received. Based on my clinical observation and knowledge the patient received at  least half the dose.
Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events "bleeding from a small gash in her head" and "broke her finger". Outcome of events was recovering.
Pt did not respond to a series of Engerix-B vax; 9APR92 booster series of vax is scheduled to begin;
Discharge Provider:  Primary Care Provider at Discharge:  Admission Date: 7/15/2022 Discharge Date: 7/19/2022  PRESENTING PROBLEM: Generalized weakness [R53.1] Diarrhea, unspecified type [R19.7] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Pt is an 88-year-old male who presented to the ER for evaluation of weakness. The patient has a history of dementia and has had increasing care needs at home. His family had been looking for possible placement at assisted living when his wife got COVID. The patient was also diagnosed with COVID the day prior to admission and he had increasing weakness prompting family to bring patient in as they could no longer care for him. In the ER the patient had labs which were mostly unremarkable, he was not hypoxic and his CXR was negative. He was admitted to the hospitalist team for PT/OT evaluation and possible placement. The patient was evaluated by PT/OT who recommended SAR at discharge. Care management arranged for placement. The patient remained stable on room air, no significant COVID symptoms, only mild cough. He discharged to rehab in stable condition.
theraphy non-responder; Hepatitis B antibody negative; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix, the 2nd dose of Twinrix and the 3rd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, Twinrix and Twinrix, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the outcome of the therapy non-responder and hepatitis b antibody negative were unknown.   It was unknown if the reporter considered the therapy non-responder and hepatitis b antibody negative to be related to Twinrix, Twinrix and Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received all 3 doses of Twinrix about 2.5 years ago. The patient recently had titers done and it shows he was not immune to hepatitis B.      Lab Comments: Lab test performed on an unknown date
Fatigue, stiff & sore muscles, mental cloudiness Extreme opthalmic Photosensitivity causing White Light Blindness after looking at cell phone (iPhone 12 Pro) and TV.  outside naturalight and Indoor lights particularly BLINDING! Began to subside 24 hours after 2nd dose lasting about 4 days.  I am medical professional, Clinical Speciality Pharmacist.
Aprox. 5 mins after vaccine pt had LOC in store. Pt was given water & food. I was notified approx 10 mins after LOC. Pt able to stand & walk but upon moving became nauseous, dizzy, pt very pale. Blood Glucose was checked & was WNL (101) BP was checked WNL (105/58). Recommended pt be taken to ED but refused stayed with patient until pt able to stand & walk with no symptoms. Recommend pt's wife come & pick him up.
10/16 immed local rxn, servere burning pain, tingling digits 4&5 digit. Redness/warmth at site. 10/17 L/sided neck pain, continued redness/pain at site. Local rxn leading to "orange peel" look around inject site w/sloughing of skin. 11/3 sev muscle spasm of neck, unable move neck secondary to pain. Marked weakness of L/arm with decreased sensation. 11/4, numbness, tingling and increased L/sided weakness with numbness to L/jaw. Seen in ER. 11/5 L/sided weakness remains unchanged. Saw a neurologist and dx'd with L/sided weakness, marked. Started RX of Skelaxin. 11/12 saw NP and dx'd with marked L/sided weakness. R/o MS, Guillain-Barre Syndrome, brachial neuritis. 12/21 dx'd with L-sided weakness, brachial plexus neuritis, probable/possible reaction to influenza vaccine. Today; I continue with pain, numbness and weakness in my L/arm; mild pain L/side of neck. Pain increases with use of my arm, ie driving, pushing shopping cart, etc.
Uncontrollable shaking/chills, fever, weakness, sweating, tightness in chest, elevated blood pressure and pulse rate. Two months later and still not fully recovered. Relapses continue, ER visit for potential heart attack proved heart was fine. Still unknown what the problem is. Tests continue.
a patient fainted after receiving a dose of GARDASIL or GARDASIL 9; This spontaneous report was received from a pediatrician, via a company representative, regarding a female patient of unknown age. The patient did not have any concomitant medications, and her pertinent medical history, concurrent conditions and previous drug reactions/allergies were unknown by the reporter.  In approximately 2017 (reported as "about three years ago"), the patient was vaccinated with a dose of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, anatomical site of vaccination, vaccination scheme, lot number, and expiration date were not reported) as prophylaxis.  In approximately 2017, after receiving the vaccination, the patient fainted (syncope). It was unknown by the reporter if any treatment was given or if laboratories or studies were performed due to the adverse event. The patient did not seek medical attention.  The patient recovered from the event on an unspecified date. The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and syncope was not reported.  Upon internal review, the event syncope was determined to be medically significant.
After receiving  my first dose in January and my second dose in Feb. of COVID-19 Vaccine EUA   I developed a rash and itchiness  at the point of inoculation . It began the day after inoculation and lasted about 3 days.
Initial information received from a healthcare professional on 16 Dec 2009: The reporter stated that a 2 year old child received a dose of FLUVIRIN (batch no. 102133P1) on 15 Dec 2009. No adverse reaction had occurred.
light headache, nausea, light dizziness,  these symptoms lasted for a day.
Received Moderna Booster on 10/29/2021 at 5:10 pm.  By 1 am on 10/30, experienced Vertigo symptoms - room spinning and nausea (vomiting).  No appetite.  Vomited twice.  Had to hold the wall in order to walk.
1 of 2 pts who had an inject site reaction (significant inflammatory sterile cellulitis); no cultures taken; no evidence of bacterial infection; both parents were vaxed from the same lot #;
Patient reported severe trembling and uncontrollable "shivering" around 12 hours after receiving the vaccination. She reported flu like symptoms the following day and feeling drained for about 24 hours.
Patient experienced throat tightness about 10 minutes after receiving vaccine, 911 was called and an EMT showed up to asses patient , patient was taken away on a stretcher,  I f/u next day with her and she told me her throat was doing better, she was told to treat with Benadryl which seemed to slowly alleviate the symptom.  She is improving slowly.
Patient was administered vaccine following improper storage (vaccine was left in freezer too long and was considered expired per manufacturer due to lack of stability study data). Patient acknowledged recommendation but will not seek revaccination.
L upper arm & proximal lower arm - mild to moderate swelling with mild erythema; slight warm to touch, mild pain.
Pt called the assistant director and informed her that she was hospitalized after receiving vaccines for congestive heart failure.
Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021) 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 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021). On 06-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021) had resolved.            On 06-Mar-2021, patient had received the Johnson and Johnson COVID19 vaccine. In addition it was stated that the patient chose to get Moderna vaccine. No relevant concomitant and treatment medications were reported.
Arm pain which was expected. Redness/itching ensued accompanied by a red lump.  A hard lump is still felt, itching is still present constantly
I  check resting heart rate every am, Normal low 50?s. High 50?s max with cold or flu shot. Following second shot resting heart rate jumped 20% to mid 60?s and remained there for 4 weeks. During 5th week it graduallly dropped back to normal and has remained low 50?s. I refrained from daily exercise during that period, but otherwise felt  ok.
FELT VERY HOT; CHILLS; NAUSEA; STOMACH CRAMPS; REALLY BAD BACK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced stomach cramps, really bad back pain, and nausea. On 29-APR-2021, the patient experienced felt very hot, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt very hot, stomach cramps, really bad back pain, chills, and nausea on MAY-2021. This report was non-serious. This case, involving the same patient is linked to 20230562092. This case, from the same reporter is linked to 20230567770.
Next morning, woke feeling severe joint pain, dry mouth which progressed to at noon, chills, fever, nausea, headache and severe joint pain.
PATEINT WAS GIVEN DILUTED DOSE FOR PFIZER VACCINE. RPH HAD MIXED OLD USED PFIZER VACCINE LEFT IN TRAY WITH DILUENT. PT WAS INJECTED VERY DILUTED DOSE/ SALINE SLOUTION AT APPOINTMENT. WE FOUND ERROR IN THE LATE AFTERNOON. WE CALLED PATIENT AND SET UP APPOINTMENT FOR 3/21 TO GET RIGHT DOSE.
Information has been received from the physician during a phone call referring to an 18 month oldl male patient. The patient's medical history and drug reactions/allergies were not reported. The patient was vaccinated with doses of ROTATEQ orally (dose and lot# were not reported) respectively in December 2013 (the first dose), in March 2014 (second dose) and in May 2014 (third dose). The patient probably went to the emergency room (ER) on 27-APR-2015 and was administered intravenous fluid (manufacturer and dosage information unavailable) and antiemetic treatment (manufacturer and dosage information unavailable), and was tested positive for rotavirus. On 30-APR-2015, the patient "look great" at the follow up appointment. The final outcome of the event and the causality were not reported. This is one of several reports received from the same reporter. Additional information has been requested.