chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of swelling, right arm sore and itching.  Slight swelling warmth to touch noted.  Right deltoid (per LPN).  Advised to use cool compress for swelling, Benadryl for itch and Tylenol for pain.  Return to clinic if no better in 2 days.
Information has been received from a physician concerning a female who was vaccinated with Varivax. On 29-NOV-2006, the physician reported that "recently", the patient developed breakthrough chicken pox after receiving one dose of Varivax. The time frame between vaccination and break through was unspecified. Unspecified medical attention was sought. The breakthrough was recent and the physician reported that the child is recovering and that the lesions were crusted over. Additional information has been requested.
bad vertigo, especially when getting out of bed in the morning today (10/29/2021).  I noticed it slightly in the morning yesterday, but it went away.  Today it was much worse.  And it is continuing, though not as bad as it was when I got out of bed.  I almost fell.
Patient.  Developed disseminated areas of shingles.   Developed 12 days after vaccine. And presented to my office on 8/28 with vesicular aphthous ulcers in entire mouth painful and difficulty eating. Treatment of valacyclovir 1000 x 7days and f/u scheduled.
12MAR91, pt recvd DTP/HIB mom came in 23JUL91 & reported that pt eyes were swollen shut next morning 13MAR91 & pt very quite & just laid around all day; Mom denied fever or rash;
Lupus sores in mouth; Sore at injection site; Acute and chronic inflammation in intestinal lining and gut; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (MARKETING PROGRAME NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4231447-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since 20Aug2019 (Batch/Lot number: unknown) at weekly (unk, weekly) and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at weekly for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "recovered", described as "Lupus sores in mouth"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Sore at injection site"; GASTROINTESTINAL INFLAMMATION (non-serious), outcome "not recovered", described as "Acute and chronic inflammation in intestinal lining and gut". The action taken for adalimumab was dosage increased. The physician switched patient to weekly dosage due to acute and chronic inflammation in the intestinal lining. She was diagnosed with acute and chronic inflammation in her gut. She had also lupus sores in mouth. She thought that this had to do with her lupus. Her rheumatologist had suggested to bump up her dosing to weekly to help. She recently went to see her gastroenterologists as of 11Jan2022.  The reporter assessed the causality as no reasonable possibility between Adalimumab and Lupus erythematosus (Systemic lupus erythematosus), Vaccination site pain and Gastrointestinal inflammation. The reporter did not assessed the causality between bnt162b2 and Lupus erythematosus (Systemic lupus erythematosus), Vaccination site pain and Gastrointestinal inflammation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Was vaccinated in the evening of 11/14/05 and had minor discomfort at injection site. The next morning the deltoid muscle was sore. Arm has gotten progressively sore to the point today she is able to lift her arm to nipple height. Has pain radiating down to fingers and up to left side of neck. States she was unable to enjoy her vacation because pain was severe. 11/24/05 was first time she reported symptoms. I have taken her off duty today and have prescribed OT.
Patient received multiple Typhoid vaccine outside recommended spacing period due to error in cross-communication between systems.  Times of doses: 1st- 06 May 21; 2nd- 05 Aug 21, 3rd- 04 Nov 21.  No adverse reactions reported by patient.
Evening of the shot -achiness, chills, fever, could not sleep - just tossed and turned all night, nauseous. Lasted about 12 hours.  Next day, very tired, slept off and on all day and night - 24 hours  Two days after the shot, I still felt tired, but much better. Three days after, I was just fine.
Left arm turned red, became very sore to the point it was difficult to move. Patient got the chills and could not stop shaking. A warm bath did not make him feel better so they went to ER.
Severe Nausea for the last four days non stop to the point of crying and waking up in the night having to sleep with heating pad just to subside the nausea,
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates from January 2017 to 08-MAR-2017, the patients were vaccinated with improperly stored doses of GARDASIL lot # M014929, expiration date 27-MAY-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of >46 but < 77 degrees Fahrenheit for 4 hours. Data logger was involved. Previous temperature excursion of  >46 but < 77 degrees Fahrenheit for 2 hours was reported. Additional information has been requested.
Information has been received from a physician concerning a 21 year old female with no pertinent medical history and no drug reactions/allergies, who on 11-JAN-2008 was vaccinated with the first dose of GARDASIL and on 11-Jul-2008 was vaccinated with the third dose of GARDASIL (Lot # 659968/0847X).  There was no concomitant medication.  The patient went into a seizure episode a minute after administration at the physician's office, and became unconscious for about 30 seconds.  Patient was extremely nervous about receiving shots.  Subsequently, the patient recovered before leaving the office.  Upon internal review, seizure episode was considered to be an other important medical event.  Additional information has been requested.
Immunizations were administered at Health Dept. aprox. 4:00pm. At Aprox. 4:30pm Mother reports child begin to complain of left side of face itching and red spots appeared around her left eye and jawline.  At aprox 8:30pm child begin to complain of face burning and very painful and red. Mother gave child 1 25mg Benadryl tablet and took to ER.  child was triaged at Medical Center at aprox 20:51. No SOB, Normal heart rate andy rhythm noted on ER report. Tx'd with Zofran 8mg IV, SoluMedrol 125MG IV. Pt was discharged 23:33
first dose 3 years ago/never received his second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of shingrix 3 years ago from the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter informed that, the patient received first dose of Shingrix and never received his second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Pt received shot at 5pm on 12/21/2018, around 10pm her faced started swelling. She took a Benadryl 25mg. The next morning, 12/22/2018, her glands in her necks were  swollen, she took another Benadryl 25mg. Her symptoms got better during the day, but took one more Benadryl 25mg when she went to bed. Today, 12/23/2018, all the symptoms are gone.
Raised rash; HEADACHE; PAIN; FATIGUE; CHILLS; FEVERISH; The rash is present around the knees and ankles and the back of the arms; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shellfish allergy (had shrimp allergy).   On 3rd June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced raised rash, headache, pain, fatigue, chills, fever and rash. On an unknown date, the outcome of the raised rash, headache, pain, fatigue, chills, fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the raised rash, headache, pain, fatigue, chills, fever and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing the common side effects in addition to a rash described as raised rash like she gets from her shrimp allergy.   The rash was present around the knees and ankles and the back of the arms. The reporter did not consent to follow up.
Extreme fatigue (2.5 weeks, would sleep 9-16 hours per day) Insomnia (2 weeks, difficulty sleeping when lying down to sleep at night until 2-3:30 AM) Painful injection site (5 days) Bruising at injection site (3 weeks)
Blood clot right leg calf .  Blood Thinners compression sock.  Still has blood clot
Red patchy rash on right arm, swollen area from site on injection down to elbow, pain in right arm.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2014, the patient was treated at a clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
pt recv vax & exp local pain & swelling in the deltoid area @ the inj site; pt recovered; MD noted that pt was vax w/2nd dose of vax 1mo later w/no rxn;
One hour post vax, pt developed angioedema, lower lip swelling, and wheezing. He was treated with Epinephrine, Benadryl and Prednisone.
This spontaneous report as received from a healthcare student refers to a 12 year old male patient. Patient's pertinent medical history and drug reactions/allergies were reported as none. On an unknown date in November 2012, the patient was vaccinated with GARDASIL, intramuscularly to prevent HPV. Concomitant medication was reported as none. On an unknown date in 2012, three weeks after onset of therapy, the patient experienced follicular mucinosis. Laboratory diagnostics performed included punch biopsy with amino histo-chemical test for which the result was not provided. The patient sought medical attention and on an unknown date, the patient started treatment with TAZORAC and dexamethasone (manufacturer unknown). The patient recovered from follicular mucinosis on an unspecified date in 2013 (reported as eight months later). The causality between follicular mucinosis and the suspect product was not reported. Additional information has been requested.
This spontaneous report sa received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that in June 2010, the patient received the first dose of GARDASIL, intramuscular (lot number and expiration date were not provided) and in August 2011, the patient received the second dose of GARDASIL, intramuscular (lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug interaction NOS" (unspecified if ongoing), notes: Other medical history: No, Known allergies: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral drug PAXLOVID was taken from 26AUG2022  for the treatment of COVID-19. I got rebound COVID on day 6, 04Sep2022 and still can't get a negative test I have a viral load still on 09Sep2022 of 24  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough case admission after two vaccines Moderna 1/31/21 Lot# 010M20A;  Moderna 2/28/21 Lot# 004M20A
Patient reported feeling burning sensation along rib cage approximately 5 days after vaccination. Patient stated it was sensitive to touch or to lay on, but laying on other said or leaving side along gave relief. Burning sensation escalated for about 5 days, but began to improve on 6th day
Beginning on the evening of the vaccination and lasting all the next day (October 20) I had strong muscle aches,  headache, eyes felt weird, fatigue, weakness. I kept feeling cold, but didn't have a fever. Of course my arm was sore, but I had been warned about that and iced it right away. So the soreness wasn't too intense, though I didn't want to use my arm for anything heavy. These symptoms were severe enough that I had to cancel my plans for the day.  Today, October 21, the symptoms are much much less. I'm back to walking, exercising, etc.
crazy cramps in her legs and they hurt. It comes and goes more in the left leg than the right leg; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EL9267, Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 10Feb2021, between 10:30 to 11:30 (at the age of 72-years-old), as dose 1, single for COVID-19 immunisation. Medical history included HIV (reported as It is undetectable. She was diagnosed in 1995 or 1996). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other vaccines was administered with COVID-19 vaccine. The patient experienced crazy cramps in her legs and they hurt. it comes and goes more in the left leg than the right leg on 11Feb2021. It was reported that it was in the muscle and in the back of the thighs. Patient was inquiring on how to stop this. Her next dose was scheduled on 03Mar2021. Event did not result to either physician office or emergency room visit. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Flu; Initial information received on 26-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, every time the patient got the flu shot, he/she got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
Achy muscles, hot and clammy skin, sweating and light headedness for a few days following the vaccine.
No adverse effects; She believes a drop or two came out of the syringe and full dose was not received; She believes a drop or two came out of the syringe and full dose was not received; This spontaneous report was received from a patient of unknown age and gender, reporting on theirself. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 29-JUL-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 PFU for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported).   On 29-JUL-2019, during the zoster vaccine live (ZOSTAVAX) administration, the patient stated that she believed that a drop or two came out of the syringe (product leakage) and full dose was not received (incorrect dose administered). No adverse effects were reported.   At the time of reporting, the outcome of product leakage was unknown.   The causal relationship between the vaccination with zoster vaccine live (ZOSTAVAX) and product leakage was not provided by the reporter.
tested strongly positive for Covid; tested strongly positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 70 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "discectomy" (unspecified if ongoing); "fusion of a neck vertebrae" (unspecified if ongoing); "herniating disc" (unspecified if ongoing); "severe shoulder pain symptoms" (unspecified if ongoing); "Arm pain symptoms" (unspecified if ongoing); "upper back pain symptoms" (unspecified if ongoing); "newhand surgery to correct the injury" (unspecified if ongoing); "a tendon transplant" (unspecified if ongoing); "Mild arthritis, hands/wrist (Mainly on the right)" (ongoing); "hereditary condition diagnosed a few years ago" (unspecified if ongoing); "Left shoulder pain/Persistent shoulder pain" (ongoing); "Loss of range of motion" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, in Nov2021 as dose number unknown, single; CELEBREX taken for arthritis (ongoing). Vaccination history included: I've had flu shots before this. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested strongly positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test (normal high range 13.0): (unspecified date) 600.0 AU/mL, notes: Reference: Neg less than 13.0; SARS-CoV-2 antibody test: (unspecified date) Positive; SARS-CoV-2 test: (2021) Strongly positive; (unspecified date) Unknown results.In mid-Jul (unknown year), patient developed headcold symptoms and tested strongly positive for Covid. Patient's case was also very mild, no fever or sore throat, just sinus issues. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200101818 same patient, different vaccine dose/event;
This spontaneous report as received from a 40 year old female patient regarding herself. The patient's concurrent conditions included asthma. It was reported that the patient had received BOOSTRIX, BEXSERO and RECOMBIVAX HB in the past. It was reported that the patient had no drug reactions or allergies. On 14-MAR-2016 at 7 or 7:30 in the morning the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, once intramuscularly. The patient stated that on the day she was given PNEUMOVAX 23 they attempted to do a blood draw from her left arm before giving her the vaccine but they could not do it, so they took the blood from her other arm. The patient was not taking any medications concomitantly. On 14-MAR-2016, within 2 hours of getting the vaccination patient developed a lot of pain and swelling, the swelling went about 7 inches down her arm and it went around the entire circumference of her and the entire area of the swelling was a light red color. On 14-MAR-2016 the patient was also unable to lift her arm more than a couple inches from a sitting position. The pain was severe and it hurt to have clothing touch it. It was reported that the pain reached its peal at around 10:00 on the day the patient received the PNEUMOVAX 23. The patient also stated that it took about 36 hours before she was able to lift her arm more than couple from a seated position. On approximately 15-MAR-2016 (also reported as yesterday) the patient was able to left her arm to shoulder height and an approximately 16-MAR-2016 (reported as today) she has full motion. On an unknown date approximately in March 2016 after receiving PNEUMOVAX 23 the patient experienced pain in her left side and in the left side of her neck, but didn't specify the status of those pains or when they began. The patient did not undergo any lab diagnostics studies. There was no treatment given for the events. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of injection site pain, hypokinesia, erythema, peripheral swelling, swelling and injection site swelling was reported as recovering. The outcome of the event pain in her left side and in the left side of her neck was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. There was no product quality complaint reported. Additional information has been requested.