chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning his daughter, a 23 year old female with no drug reactions or allergies with acne who on 31-AUG-2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (Lot # 653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified) and doxycycline. On 30-OCT-2006, the patient was vaccinated, intramuscularly with the second 0.5 ml dose of Gardasil. On approximately 31-OCT-2006, "two months after the first dose", the patient experienced arthralgia, with progressive pain in her knees, and wrists, and left wrist swelling. On 26-FEB-2007, the patient was vaccinated, intramuscularly with the third 0.5 ml dose of Gardasil. The patient sought unspecified medical attention. Laboratory evaluation revealed elevated sedimentation rate (sed rate), elevated C-reactive protein, negative rheumatoid factor, and antinuclear antibodies (ANA) pending. The physician reported that he believed the pain was causing the patient significant disability as she could not participate in former activities. The patient was treated with ADVIL. At the time of the report, the patient had not recovered. The physician considered the patient's arthralgia with progressive pain in her knees and wrists and left wrist swelling to be disabling. Additional information has been requested.
Patient admitted to hospital for 48 hours on 2/25/03 and discharged with minor heart attacks. Patient had several other risk factors (smoker, family history).
Pt c/o high fever of 102.4F the next morning following immunization, with flu-like symptoms including chills/fever, total body achiness, and nausea.
Vomiting lasting 18 hours, diarrhea lasting 36 hours, unable to keep down liquids or food, fatigue, large swelling in left armpit, body aches
Glands below the right ear swelling with infection. Thought it was a tooth problem. Went to a dentist. After his xray, he said the infection was not from a tooth. He prescribed Amoxicilin . This is the 3rd day.  glands are still swollen. Ice packs are helping.  An unexplained infection!
there was an excrusion from freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided by the reporter.
This is the booster shot. Immediately after the shot, having a lot of pain which became sensitive to the touch.  Having soreness and sensitivity, no swelling discoloration just tenderness. Unable to raise arm up. Prescribed Predisone  4 mg and therapy.
Since receiving flu vax, has had episodes of "breaking into a sweat followed by severe h/a & cold chills; when episode starts "feel like passing out";
PATIENT STATUS POST MODERNA VACCINE RCVD 1425. SITTING IN NURSE STATION, PATIENT HAS SOB, DIAPHORESIS, CHILLS. 1508 PATIENT IS TRANSFERRED TO EXAM ROOM FOR EVAL. BP 100/60. SHE REPORTS A TIGHTENING IN THROAT. EPIPEN 0.3MG ADMIN IM AT 1515. VITAL SIGNS 118/78. HR 109. 02 SAT 97% ON 2L 02. 1522- PATIENT CONTINUES TO REPORT A SORE THROAT BUT NO DIFFICULTY BREATHING. 1535 PT IS TRANSFERRED BY EMS TO HOSPITAL
LEFT ARM, REDNESS AROUND VACCINATED AREA. NO REPORTED ITCHING, ONLY "DULL PAIN" (PAIN SCALE RATING 4 OUT OF 10). NO FAINTING. ADMINISTERED 50MG ORAL DOSE DIPHENHYDRAMINE. HER SPOUSE RECEIVED SAME VACCINATION, SAME VACCINE LOT# ON SAME DAY. NO REPORTED REACTION.
Red, bumpy, itchy rash on left deltoid muscle area. Rash still present on 10/31/2000. Saw MD, given antihistamines and cortisone cream.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that on 07-APR-2015, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J003528; expiration date 25-MAR-2015) (dose and route not provided). No adverse effects were noted. Additional information is not expected because the reporter did not provide consent to follow up.
began to feel numbness in the forehead and lip; began to feel numbness in the forehead and lip; nervousness; This is a spontaneous report received from a contactable consumer (patient's daughter). A female patient of an unspecified age (reported as 65, year not provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of COVID vaccine on 25Jan2021. They waited 15 minutes for some adverse event, and nothing happened. On 25Jan2021, on their way back home, the patient began to feel numbness in the forehead and lip. The reporter wanted to know if this was reported or was it just nervousness. The outcome of the events was unknown. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
12/06/06 AM redness and swelling noted at injection sites. Gave Tylenol and used, swelling, redness and hardness spread up to his shoulder on 12-7-06. To his physician, mother said he was given steroids by his Dr.
Unable to eat; food tastes bad; has been having weird episodes that he is unsure if it is anxiety or hypertension; has been having weird episodes that he is unsure if it is anxiety or hypertension; thoughts have been cloudy; has been feeling like total crap; This is a spontaneous report from a contactable consumer or other non-health care professional ( patient). A 56-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration (at the age of 56-years), administered in arm left on 24Feb2021 at 14:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, the patient experienced has been feeling like total crap. On 25Feb2021, experienced thoughts have been cloudy, has been having weird episodes that he is unsure if it is anxiety or hypertension. On 26Feb2021, experienced unable to eat, food tastes bad. Patient received the Covid-19 vaccine a couple of days an ago. and it was not doing too good. He received the vaccine at the hospital . He is having some bad side effects. He wants to make sure nothing is wrong with him. He has just moved to the area and does not have a doctor. For most of his life he does not even take aspirin. He was in pretty decent shape. For the past two days he has been feeling like total crap. His thoughts have been cloudy. He has not been able to eat. Food tastes bad. He has been having weird episodes that he is unsure if he is anxious or has hypertension. He is in perfect health. What does he do? This is crazy. Is there something that will make this go away? The events has been feeling like total crap, thoughts have been cloudy and has been having weird episodes that he is unsure if it is anxiety or hypertension was reported as worsened. The patient was taking Covid-19 vaccine for Covid protection. The adverse event did not required any emergency room and physician office. The vaccination facility type was hospital. The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
this is one of three consecutive pt to devel a fever of 103 deg F and a rash following receipt of Tetramune w/ this lot.
pt recv vax 18DEC97 & exp chills, n/v & was seen & treated in ER;
SKIN FLAKING LIKE DANDRUFF; KNEE PAIN; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 65 year old male. 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) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced slight headache. On 01-APR-2021, the subject experienced skin flaking. On 01-APR-2021, the subject experienced knee pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin flaking on 02-APR-2021, and slight headache on MAR-2021, and had not recovered from knee pain. This report was non-serious.
This spontaneous report was received from a medical assistant referring to a child patient of unknown age and gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-DEC-2018, the patient was vaccinated with VARIVAX (lot # R017637, expiration date 20-JUN-2010) and sterile diluent (lot # and expiration date unknown by the reporter). The unspecified child "moved during administration" and an unspecified amount of VARIVAX "squirted" into the eye of the medical assistant while she was administering the dose (underdose). No adverse effects reported, and no additional information was provided. This is one of 2 reports from the same reporter (information captured in MARRS case #1812USA003303). Sender's Comments: US-009507513-1812USA003303.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA252194, 2018SA252198 and 2018SA252204, same reporter. This case involves patient (age and gender not provided) who was given expired vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) Lot number, dose, route and site of administration not provided on an unknown date. It was an actual medication error due to expired vaccine used. It was reported that patient was given expired vaccine Pentacel on 05 Jul 2018, which got expired on 30 Jun 2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
On 12-17-15 patient returned to pharmacy to show a noticeable "hardness" at immunization site (no inflammation). She complains of severe pain when using arm above chest high with weakness and tingling of 3rd, 4th and 5th digits. Denies any other trauma to arm.
Low grade fever 12/17/2003 gone 12/18/203, rash started 12/18/2003 in AM on trunk and thighs, small papules
0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg given orally. 0842 Cheeks feeling better arms, still flushed NO SOB,NO CP NO NAUSEA 854am Reports no worsening symptoms 910 Feeling better released to go home.
This is a spontaneous report from a contactable consumer (office manager) received via a sales representative. This officer manager reported similar events for two patients. This is second of two reports. A 12-years-old male patient of an unspecified ethnicity received TRUMENBA (lot # M13066, exp date 30SEP2016), via an unspecified route of administration on the left arm on 25JAN2015 at 0.5 ml single. The patient medical history was not reported. There were no concomitant medications. The patient experienced fever, body ache, rash, red swollen arm, nausea and vomiting all on an unspecified date with outcome of recovered. IT was unknown if the patient had received any treatment.
Evening of 11/4/2016 mother noted about a 5cm size redness/itching around the injectin site. On Saturday 11/5/16 the redness became tense to the touch and had increased to 10cm by 12cm in size with the center being purplish in color. Child brought the the emergency room. Vital signs stable, no fever. Provider gave rx for Keflex. On Saturday night the redness had spread to groin area. By Sunday morning redness reduced in color and size. Monday 11/07/2016 redness just pink.
after the first shot on day 2 i broke out in whelps all over my body and had to leave work, i had a few stomach issues but nothing to be alarmed about. after the 2nd shot id say a month and a half after i broke out all over my body again at work and my throat started to close up and had to be taken by ambulance to the hospital. i continued to break out all over with the whelps for over a week and still have photos of this event. then i started having severe diarrhea that hasn't stopped. I've had a colonoscopy and taken numborus antibiotics to try and stop it but it hasn't. I was told by the dermatologist and the GI dr that alot of people that has had the shot are complaining about the same issues so i decided to finally report whats going on
some tremor; was in bed for for 7 to 10 days; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (some tremor), BEDRIDDEN (was in bed for for 7 to 10 days) and MYALGIA (muscle soreness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (some tremor), BEDRIDDEN (was in bed for for 7 to 10 days) and MYALGIA (muscle soreness). At the time of the report, TREMOR (some tremor), BEDRIDDEN (was in bed for for 7 to 10 days) and MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.   This case was linked to MOD-2021-290104 (Patient Link).
Shot given at 3:47- approximately 3-5 minutes later started to experience blurred vision, rapid heart rate, difficulty breathing, and dizziness.   Blood pressure was taken and was low 86/52.  Pulse rate was 110.  Became increasingly dizzy, stabbing chest pain, and lethargic.  Was transferred to an ambulance with great assistance, because when I stood up I became so dizzy I couldn't stand.  In the ambulance the chest pain/ stabbing became unbearable.  I was started on IV fluids, and also had an EKG done, and was put on oxygen.  While en route to the hospital I had a horrible feeling of nausea and dry heaving.    Upon arriving at the hospital  I was worked up for cardiac issues and everything came back normal.  I was also given benadryl.  Nothing helped the dizziness or nausea and I still felt short of breath when I was discharged.  I was able to get some interrupted sleep.  This morning I am still feeling very dizzy and light headed.  I'm extremely cold and have the worst headache I have ever had.  I feel foggy and I am having trouble concentrating.  I have been drinking a lot of fluids and also been taking tylenol.
Heavy period lasting more than 7 days. Went on birth control, no help. Skip placebo week, no help. Now anemic and have fainted several times.
Discharge Provider: PRIVATE MD Primary Care Provider: PRIVATE DO Admission Date: 11/15/2022 Discharge Date: Nov 25, 2022 COVID positive date 11/15/2022 PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01] COVID-19 [U07.1] Altered mental status [R41.82]   HOSPITAL COURSE: 72-year-old woman with past medical history significant for motor vehicle accident with subsequent TBI and right above knee amputation 2010, expressive aphasia, management, hypertension, hyperlipidemia, depression presented to the emergency department due to concern for altered mental status and worsening fatigue.  She was found to have COVID-19 infection and admitted for further management of encephalopathy and generalized weakness.  Throughout this hospitalization patient was nonverbal however was awake but not oriented to any of the questions and did not follow any commands.  Prior to this presentation patient at baseline was able to express 1-2 words per family and was able to follow commands however family has noticed that progressively patient's mental status started declining to the point where patient has remained nonverbal and not being able to even eat which has affected her nutrition.  From COVID standpoint patient was started on Decadron at the time of admission however since she did not require any oxygen this was discontinued and she remained stable.  Initial thoughts were patient's encephalopathy was thought to be secondary to COVID-19 however since there was no improvement in her mental status neurology was involved who performed MRI brain which was negative for any acute abnormalities.  Patient was placed on CorPak for nutrition.  GI was consulted as patient was having acute on chronic vomiting prior to the Corpak placement.  Gastroenterology did not recommend any interventions as her symptoms were most likely secondary to COVID-19.  After extensive conversation with DPOA and another daughter the family requested to go with hospice as patient's prognosis was poor.  Neurology also discussed with patient's family that even if we perform lumbar puncture or further studies patient's prognosis is overall very poor in the setting of not being able to eat and no response to any stimuli and nonverbal status.  Hospice was immediately involved and patient's family to the patient in stable condition home with hospice.  Corpak was removed prior to discharge.
Administration error, injected 0.5 ml instead of 0.25 ml for the booster dose
Polymyalgia Rheumatica started in January after being sick with Covid for two weeks (even after (3) shots).   Sore muscles and ligaments in legs, hips, arms, shoulders, wrists and fingers
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Headache-Mild, Additional Details: Patient called day after recieving vaccine that has been experiencing headache, swelling at site, and trouble breahting since tha vaccine.  We recommended for her to go to ER immediately  for the trouble breathing.  Tylenol for headache, and benadryl for swelling. We told her to let the ER doctor know about all of these reactions
PATIENT CALLED TODAY 09/06/2017 AT 12.30PM AND STATES THAT SHE WAS SUFFERED PAIN AT RIGHT BICEPS,RIGHT NECK AND RIGHT EAR PAIN. PATIENT ALSO STATES THAT HER HEARING BECAME VERY SENSITIVE. PATIET WAS TREATING THEM WITH VINEGAR AND SOAKING THE AREA WITH SOAP WATER.
"I received the Covid vaccine at about 11am on Tuesday 10/17/23  and by 2pm i was starting to get nauseated. I finished the day and went home. on the way home i was experiencing rapid heartbeats. I felt like i was going to collapse. I was unable to take public transportation so I called an Uber to take me home. Throughout the night I experienced muscle aches and muscle (all over my body) contractions, cold and hot flashes. I thought I was going to have a heart attack. Today (10/20/23)  I'm still feeling weakness."
he was stressed; no appetite; not feeling well; vaccine reacted with acid reflux and his throat swelled and it was hard to get solid foods down; tired and is out of it; soreness at injection site in right arm; sweats; Chills; temperature 100.7 degrees; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: ER8730, Expiration Date: 31Jul2021), dose 1 via intramuscularly administered in right arm on 24Mar2021 at 16:45 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Medical history included Appendicectomy: Years ago, his appendix blew up and had to be removed, ongoing Acid reflux (esophageal). Family history included leukemia (mother) and diabetes (grandmother). Concomitant medication included ongoing omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) from 22Mar2021 as 20.6 mg, daily (for 14 days) for Acid reflux (esophageal). The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Consumer stated that, the vaccine reacted with his acid reflux and his throat swelled and was hard to get sold foods down. He went to urgent care and was put on anti-inflammatories. He was tired and out of it. He has soreness at injection site in his right arm. He had sweats. He first stated for over 24 hours after getting the vaccine. Clarified that the sweats started around 5 hours later and lasted until 3:00 AM. It lasted for a solid 5 hours. His pillow was soaking wet. He was totally fine and started sweating. They come and go but have improved. He had chills. He first said he didn't have a fever, but his temperature was 100.7 degrees. He has no appetite and was not feeling well. He was tired immediately after getting the vaccine. He was laying down with his eyes closed during the call. He doesn't feel like he was hit by a truck. He checked his temperature frequently. He was hungry but he was afraid to eat. He was still not feeling well but it improved after seeking treatment. The pain at the injection site feels deep on the bone, not on the surface. Patient went to the Urgent Care. He had an EKG, lungs were tested. Everything was good. His oxygen level was 100%. His vital signs were good. His heart rate as good. It was up but it could have been because he was stressed. The patient underwent lab tests and procedures which included temperature was 100.7 degrees on 24Mar2021, Covid 19 test was negative on 26Mar2021; EKG was good, heart rate was good, lungs test was good, oxygen was 100 %, vital signs was good, all on an unknown date. Therapeutic measures were taken as a result of vaccine reacted with acid reflux and his throat swelled and it was hard to get solid foods down, not feeling well and included treatment with children's Ibuprofen, Benadryl and Mylanta. Outcome of the event no appetite and throat swelling was not recovered, for temperature 100.7 degrees was recovered on an unspecified date of 2021, for stressed was unknown and other events was recovering.  No follow-up attempts are possible. No further information is expected.
ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
c/o pain @ inj site w/notable swelling from upper arm to elbow-onset approx 4hr p/vax;saw MD stated severe localized rxn;