chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female (age not reported) who was vaccinated with a first dose of Gardasil (lot number unknown) IM. On an unspecified medical dates, the patient developed diffuse rashes and continued to get them. Medical attention was sought. The family physician treated the patient with steroids and was planning to give a work-up of blood test. The physician advised the patient to discontinue therapy with Gardasil. At the time of reporting the patient was recovering. No further information was provided. Follow-up information was received from the physician. the physician reported that the patient had diffuse urticaria and angioedema 12 to 20 minutes after injection. On an unspecified date the patient was given steroids and recovered from urticaria and angioedema. The physician considered urticaria and angioedema to be other medical event (OME) Additional information is not expected. This is one of two reports.
Information has been received from a registered nurse concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #655291/0985F). The patient developed an injection site reaction which included swelling, pain and redness. No other information was provided. Additional information has been requested.
Janssen COVID-19 VAccine EUA Fever, chills, body aches, fatigue, headache, sinus congestion
patient came for the Moderna COVID Vaccine today.  5-7 minutes post vaccine while in the waiting area patient became pale and diaphoretic, myself along with Dr.  attended to this patient who did become unresponsive for a few seconds.  She recovered quickly with no intervention and no meds.  She was never SOB and had no focal neuro deficits.  She did state that she had a remote history of passing out but it was a long time ago.  Patient was observed for another 30 minutes and recovered without any deficits.  Husband was called and he came to pick her up.
65-year-old male with past medical history of AFib on Eliquis, asthma, hypertension, diabetes type 2 and diastolic CHF presents to medical center with complaints of weakness.  Patient's reports he has had intermittent weakness and swelling in his lower extremities for approximately 1 week.  Also admits to chills, mild shortness of breath, 1 episode of nonbloody diarrhea.  Due to weakness patient has had 1 fall yesterday denies any head trauma loss of consciousness.  Patient does not require any assistance with ambulation.  Takes Eliquis for chronic atrial fibrillation, last dose was day prior to admission.  Otherwise stated above denies any fever, cough, nausea, abdominal pain.  Reports friend's daughter recently tested positive for COVID but has not been in close contact with the daughter however has been in close contact with his friend.  Received 2 doses of Pfizer vaccine in June has not received Brewster.  Chronic history of asthma on Symbicort, denies any tobacco use, does not require supplemental oxygen at home. Of note patient was flushed and tremulous on exam did admit to feeling cold.  Denies any history of essential tremors, Parkinson's disease, alcohol abuse.  Reports he only drinks 1 6 pack per week.  ED course: VS:  SpO2 90% on room air, improved to 94% on 2 L nasal cannula  Labs:  BUN/creatinine 30/1.6, glucose 324, AST/ALT 45/40, troponin chin 540.3, ABG 7.44//27//58//18.6 Imaging:  EKG:  Atrial fibrillation with heart rate 97, CXR:  Increase interstitial opacities with patchy infiltrates Received 2 L NS in the ER PMHx:   DISCHARGED 01/20/2022:  DISCHARGE SUMMARY NOT PREPARED AT THIS TIME.
Pt recvd vax devel a neuromuscular & an immunologic vax associated complication;
her tongue was swollen; swollen lymph glands; Initial information regarding an unsolicited valid non-serious case was received from consumer via Medical Information (Reference number- 00746458) and transmitted to Sanofi on 30-Aug-2021.  This case involves a 60-year-old female patient who experienced her tongue was swollen (swollen tongue) and swollen lymph glands (lymphadenopathy) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious her tongue was swollen (swollen tongue) and swollen lymph glands (lymphadenopathy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
chills; fever; headache; muscle ache; fatigue; nausea; racing heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 09:30 (Lot number: ff8839) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: el3248, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 47 years old, for covid 19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en6203, Location of injection: Arm Right), administration date: 04Mar2021, when the patient was 47 years old, for covid 19 immunization. The following information was reported: CHILLS (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "muscle ache"; FATIGUE (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "nausea"; PALPITATIONS (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "racing heart". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, headache, myalgia, fatigue, nausea, palpitations.  Additional Information: On the 3rd dose (yesterday)  had chills fever headache, muscle ache, fatigue, nausea and a racing heart. Started at the end of the day and got worse overnight. Still bad this morning. Not tested covid post vaccination. other vaccine in four weeks.   Follow-up attempts are completed. No further information is expected.
REDNESS/SWELLING THE MORNING AFTER THE VACCINE. PAIN AT SITE AND LATER TO ARM AND SHOULDER AND BREAST. ADMITTED INTO E.R. AND PLACED ON BACTRIM AND LEVAQUIN D/C HOME. RETURNED TO E.R. NEXT DAY DUE TO INCREASE IN PAIN AND RASH NOW DOUBLED IN SIZE. ADMITTED IN HOUSE X 2 DAYS, PLACED ON VACOMYCIN AND CONTINUED ON BACTRIM. D/C HOME ON 10-01-07. CONTINUE ON LEVAQUIN AND BACTRIM. 11/29/07-records received for DOS 9/29-10/1/07-DC DX: Cellulitis. Cellulitis left arm, redness, erythema and swelling around the vaccine areas. Unable to move shoulder or elbow. Rash.
VAGAL SYNCOPE WITH DROP OF THE BLOOD PRESSURE (BP READING 49/30), LOSS OF CONSCIOUSNESS FOR LESS THAN 10 SECONDS. TINGLINESS IN THE FINGERS. PALOR.  FEELING WARM THEN COLD. CLAMY. SWEAT.  RESOLVED IN NEXT 30MINUTES WITH LEGS ELEVATED .
3/14/13 - patient feverish, started with small dermatitis on upper right arm. Came into clinic 3/15/13 and seen by NP. Discharged with dermatitis diagnosis. 3/20/13 patient returns to clinic still complaining of fever and worsening rash and tingling down right arm. Upon exam, Nurse Practitioner diagnoses Zoster due to very apparent Zoster lesions on upper right arm.
This spontaneous report as received from a physician via company representative refers to a 48 year old female patient. Pertinent medical history and drug reactions/allergies were not reported. On 12-OCT-2012, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (Lot# was reported as H013847 and expiration date April /2014) (dose and route were not reported) and influenza virus vaccine (manufacturer unknown) (dose, lot number, expiration date and route were not reported), in separate arms. Concomitant therapy was not reported. The patient called in to the physician, office on 15-OCT-2012 stating that she "had been itchy all over her body for 2 days (13-OCT-2012) and felt like her throat was closing". The physician, instructed the patient to go to an unspecified Emergency Room. The field representative reported that the patient was admitted to an unspecified hospital on 15-OCT-2012. "While in the hospital they reported" the injection site where the pneumococcal vaccine (manufacturer unknown) was administered was red, swollen and hot to the touch. Lab diagnostics studies were not reported. The patient was discharged from the hospital on 17-OCT-2012. The field representative reported that the patient "had since recovered". Additional information has been requested.
GBS; acute weakness all over extrimities/ Weakness generalised; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   Concurrent medical conditions included hypertension and gastroesophageal reflux disease.   On 8th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th January 2021, 40 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and weakness generalized. The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and weakness generalized were unknown.   It was unknown if the reporter considered the guillain barre syndrome and weakness generalized to be related to Shingrix.  The initial information was received on 27 May 2021 via medical record ( case is medically confirmed).The patient received his first shingrix vaccine on 30 October 2020 and his second dose on 08 December 2020.The current condition included hypertension, GERD. On 17 January 2021 he had generalized weakness in all extremities. The physician suspected to be GBS and give IVIG treatments, was admitted 2 months for treatment.
couldnt move - open eyes  headaches fuzzy brain feeling servere joint pain stomach/bathroom system issues throat hurt soar very very soar - no relief eyes strained
Patient noticed very large, raised lump at the injection site on 3/5 in the morning. Estimates lump is 5 inches across, raised 1-2 inches. Lump is itchy when touched. No rash present, and otherwise no discomfort. Patient got some relief from hydrocortisone and diphenhydramine topical products. At time of report (3/6 in the morning), lump has persisted, but has not worsened in any way. Advised patient to follow up with urgent care/ED this weekend should lump worsen in any way.
patient's mother called and said patient developed chills and headache within 2 hours of getting vaccine. called to check on later that  night and was told temp had gone up to 103 and patient had vomited once. temp had gone down to 100 with medication
Flu like symptoms; Fever of 102.3; This is a spontaneous report from a contactable consumer(patient). A 36-year-old male received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3246), via an unspecified route of administration at Arm Right on 12Jan2021 17:00 at the 36 years old at single dose for COVID-19 immunization.  The medical history included High cholesterol. The concomitant medications were Hydroxychloroquine and azithromycin( ZITHROMAX Z-PACK). The Historical Vaccine was first dose BNT162B2 (Lot number=EL1284)on 22Dec2020 17:00  at 36 years old at Left arm for COVID-19 immunization and experienced Covid test result Positive on 30-DEC-2020. The patient previously took Codeine and experienced Allergy. On 13Jan2021 16:00 the patient experienced Flu like symptoms and fever of 102.3 Fahrenheit at 23 hours after the second dose. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovering.
Pt vaccinated with DTP 2 hrs later, mother reports shaking of body.  Brought to urgent care clinic, doctor felt it was a a seizure post DTP and gave phenobarbital.  When MD saw him next day was still febrile but no more seizures, improving.
Aching, weakness, tired, unable to do regular activities.  Spent most of the day in bed.
Pt accidently received two injections because the first injection did not have any medicine in it. No air was injected into the pt muscle either because the injection was a Moderna 0.25ml booster injection. Pt received the correct medication with the 2nd injection. The rph apologized and reassured the pt that she will be ok and to call the pharmacy if there's any questions. the pt wanted the rph to print out his license and write a statement regarding the events of what happened and sign and date it
VESICULAR RASH/ CALAMINE LOTION BENADRYL P.O.
sore arms and legs chest and back; sore arms and legs chest and back; sore arms and legs chest and back; upper inside of mouth going numb; fever up to 100.4; sore arms and legs chest and back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb) and PYREXIA (fever up to 100.4) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb), PYREXIA (fever up to 100.4) and VACCINATION SITE PAIN (sore arms and legs chest and back). At the time of the report, BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb), PYREXIA (fever up to 100.4) and VACCINATION SITE PAIN (sore arms and legs chest and back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 100.4 (High) high.         Concomitant medication include  blood pressure medication. No treatment medication was reported.
allergic reaction to both shingrix and moderna; This case was reported by a other health professional via interactive digital media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MRNA 1273 VACCINE (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)) for prophylaxis.   On an unknown date, the patient received Shingrix and MODERNA (MRNA RIBONUCLEIC ACID VACCINE). On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter need to tell the patient why the patient had allergic reaction to both Shingrix and moderna vaccine.
Received Tdap on 5/3/10.  On 5/5/10 site began to get red (size of baseball) and knot under injection site size of a quarter.  Pain when touching site.
Throat tightening , difficulty swallowing, sore throat, hoarseness,  ringing in ears, dizziness
Event #1: Immediate pain, which I thought was normal at first, got worse over the weeks. Still experiencing intermittent extreme arm and shoulder pain and weakness. Event #2: Within the next weeks after the flu shot, I began to have breathing difficulties, similar to asthma. I have never had asthma before. Both times, it has taken six or more months of treatment by another doctor for breathing to return to normal.
rash-flat-red sl raised-covering;upper extremities-trunk-neck;(not face) c/o severe itchiness;duration longer than 1 wk;mom reports to MD 24NOV97;
Person had a seizure-like episode requiring intervention from others to help her lie down. Fiance had sublingual Clonazepam available which was administered. EMTs called, arrived and evaluated. VS stable and pt up and walking, declined transport to hospital with EMT. Left for home with fiancé.
Approximately 30 minutes post-injection, patient experienced rash on her face/neck similar to first MMR dose. It was less severe, and breathing was not affected. Resolved with a 25 mg dose of Benadryl. Patient experienced pain and redness at the injection site for a few days post-injection. She also complained of peripheral neuropathy ("weird tingles like when my funny bone gets hit") up and down both arms and in both hands for a few days. Forty-eight hours post-injection, patient developed a visible facial tic in her lips. It lessened in severity over a few weeks. Tic and tingling in arms and hands is now intermittent but still unresolved 60+ days post-injection at time of this reporting.
One of two pts recvd DTP/OPV & exp inject site rxn which was red, swollen, hard & warm to the touch; no ATB were prescribed; no office visit;
About a week after vaccination, my left arm, which had the vacine, started throbbing up and down. I was wondering if I was having a heart attack. It lasted a few days.  A week or so later, that arm started hurting from back of shoulder down to my hand and my fingers are  numb/tingling. It feels like my muscles are in pain in that left arm. It has not disappated.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Patient details and suspect drug details updated.
"Hands started itching at 22:00". :By morning I was covered over with rashes, red blotches, and whelps from scratching" - per employee.
Severe swelling, extreme redness (eg. very ripe strawberry). Very extreme headache. Fever, dizziness, vomiting. Was seen at a local medical facility. I was seen there 3 times, given 3 shots (one each day) plus a prescription of CEPHALEXIN, 500 mg. The condition was determined to be cellulitis.
reported dizziness, tightness in throat, tingling in both legs. Given 25mg of liquid Benadryl: 1326. Reported resolution of s/s at 1351
Patient states that after receiving the vaccine he experienced muscle and joint aches across entire body.  He self-treated with over-the-counter tylenol, ibuprofen, and physical therapy.  He never received relief after doing self-therapy and visited his doctor for treatment who informed him that he may have to endure symptoms for over a year.
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 9th December 2017, the patient received SHINGRIX (intramuscular) .5 ml. On 17th December 2017, 8 days after receiving SHINGRIX, the patient experienced itchy rash, erythematous rash and pimples. On an unknown date, the outcome of the itchy rash, erythematous rash and pimples were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, erythematous rash and pimples to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their employees received the SHINGRIX vaccine. The patient broke out in a rash. Rash was all over torso and was bothersome but not life-threatening. Rash was described as being itchy, red and pimply.
Parent: Mom, describes that day after vaccines rec'd pt. developed large red raised area on left thigh. This went away then today, 8-17 parent observed rash in area where vaccines given on left thigh. Denies nausea, vomiting or fever.
This spontaneous report as received from a medical assistant refers to a 23-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9, in the left deltoid, lot # N017833, expiration date 16-NOV-2019 (dose and route of administration were not reported) for prophylaxis. On an unknown date, the vaccine had been incorrectly stored at temperature of 32 Fahrenheit degrees up to 35 Fahrenheit degrees (0 Celsius degrees to 1 Celsius degrees) for a total time of approximately 11 hours. The temperature excursion had not occurred as a result of a reading from a Digital Data logger. No adverse effects were reported. There was no prescription drug treatment for the experience required. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA012500: US-009507513-1803USA012502: US-009507513-1802USA003340.
Information has been received from a consumer concerning her best friend's son, a approximately 13 months old male who in approximately 2003 was vaccinated with MMR II as well as other unspecified vaccines at 12 months old. There were no medical history, drug reactions and allergies. About a month after receiving MMR II, the patient started to spin, was not speaking, and was staring. He then had a full evaluation done by a neurologist who diagnosed him with autism at 18 months old. The patient had not had the booster of MMR II because he had a unspecified titer test done which showed he still had MMR II in his system. At the time of reporting, the patient has shown very little improvement and was still not talking. Upon internal review, autism was determined to be an other important medical event. No further information is available.