chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a sales representative and described the occurrence of injection site pain in a 44-year-old female subject who was vaccinated with BOOSTRIX vaccine (GlaxoSmithKline). On 20 May 2009 the subject received a dose of BOOSTRIX in an unknown arm. Four days after receiving BOOSTRIX, the subject developed injection site pain in the arm. An unspecified time after vaccination with BOOSTRIX, the subject developed a rash on the whole body. She was seen at the hospital and was prescribed ZITHROMAX and prednisone pack for treatment. The rash was improved at the time of reporting, but the outcome of injection site pain was not known. The physician treating the subject considered the rash probably related to treatment with BOOSTRIX and injection site pain possibly related to vaccination with BOOSTRIX. It was unknown if the subject required an overnight stay at the hospital. Follow-up information was received on 29 June 2009, via physician. The physician reported the events started on 25 May 2009, a the subject also experienced right arm pain and swelling. The events resolved, date not provided. The physician considered the events not related to vaccination with BOOSTRIX.
After FLUZONE HD inj (Monday) pt came in w/ arm red and swelling. Pt is doing fine and will monitor if it gets worse. Pt was instructed to go to ER if it worsens. Pt taking antihistamine.
Dizziness - Denies chest discomfort  Hx of anxiety with needles  Vital Signs: BP 100/68 HR 60 Resp 16 O2sat 94  Skin Signs: Diaphoretic  Circulation: Cap refill <2 sec Respiratory: Breath sound clear bilaterally  Initial Treatment: Full set of vitals. Gave bottled water and snacks while observing x15 min  10:30 AM  Vital Signs: BP 98/72 HR 60 O2sat 95 10:45 AM  Vital Signs: BP 110/72 HR 82 Resp 12 O2sat 94 Follow up Treatment: Moved from triage to observation area under supervision  of MD. Vitals stable. Denies dizziness or chest discomfort. Accompanied  Disposition: Home with father at 11 AM
Onset of fever, redness & swelling at the site the morning of 12/13.  Temp to 101.7.  Swelling up to 6.5x7 on 12/14 but temp is down. Child is otherwise asymptomatic, but does have a recurrent stuffy nose. (Off of antibiotics for 12 days given for otitis media & sinusitis on 11/22/05)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19; (2023) Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid for COVID-19 treatment from 19Jun2023 to 24Jun2023.
This is a spontaneous report from a contactable consumer who reported for himself. This 66-year-old male patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on 16Nov2015. Medical history included blood pressure, cancer, neuropathy. Concomitant medication included gabapentin at 600 mg 1x/day for nerve pain and losartan at 50 mg 1x/day for blood pressure. The patient previously took pneumococcal vaccine. On an unspecified date, the patient experienced the following events: its swollen then it developed to cellulitis, joint pain, become red, fever, some kind of infection at the site/area of infection was getting wider, the area is getting wider it is not as high now but it was about 4 inches in diameter and its very hot to touch, sweating, could not sleep. The outcome for the event could not sleep was unknown and the outcome for all other events was not recovered. Therapeutic measures were taken as a result of its swollen then it developed to cellulitis, joint pain included ibuprofen at 200 mg, two tablets twice a day.
On the evening after the vaccine was given, the patient stated that his right leg started to itch excessively, this was alleviated with cortisone cream. On Wednesday morning, both of his hands began to itch and that's when he called his doctor to report the issue. On Tuesday, March 30, the patient reported swelling on his lower right lip.
Patient was admitted to Hospital on 6/4. Per internal reported event by pharmacist: Patient received the Pfizer vaccine (second shot 3/8)   Test positive for COVID - 6/2/21  Received REGEN-COV on 6/4/21 - was then admitted due to O2 stats. Does this need to be reported as MAB related? Admitted to ICU post infusion   Patient name
Body aches; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 08:45 (Batch/Lot number was not reported) as dose 2, single (Age at vaccination 38-year-old) for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received other medications within 2 weeks of vaccination includes antacid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162B2, solution for injection, unspecified route of administration, administered in Arm Left on 22Jan2021 at 08:45 as single dose for covid-19 immunization. The patient experienced body aches on 12Feb2021 17:30. The patient did not receive treatment for the event. The outcome for the event was not recovered.   Follow-up attempts completed. No further information expected.
Tested for COVID per protocol prior to surgery.  Tested positive thus surgery delayed.  Pt has "head cold" type symptoms.
My left arm, the one in which I had the Shingrix vaccine a week earlier, was aching when I woke up on July 26. I worked out that morning and felt no change. As the day went on, my arm was hurting more and my heart felt like a softball in my chest. A pharmacist gave me baby aspiring about 7:30 PM. When that didn't help, I called my cardiologist and was told to go to ER. I was kept overnight in Hospital which diagnosed tennis elbow. However, on July 29, my left arm had broken out into reddish blisters and holding light objects in my left hand was painful. Orthopedist at first thought I had a pinched nerve in my left armpit or shingles, but now thinks that it's surely shingles.
No adverse reaction after the vaccine on sept of last year. I got COVID-19 and it was Positive; headache, sore throat, cough, body ache, ended with fever the next day, did not feel good. I called the clinic, and they referred to the pharmacy and they gave me Paxlovid. I pick it up and started taking it that night. I finished it after 5 days (the 13th). I felt better at the end of the treatment. I waited 10 days and came back Positive, so I waited another 10 days, and it came negative, 48 hrs I took another test and it negative. I followed procedals.
about 1 week after vaccination, I had a miscarriage.  1 week prior I was 7.5 weeks pregnant with a strong heart beat. Next Drs. visit the fetus had no heart beat.
Erythema,itching  and swelling at injection site, circumference of a medium apple slowly growing  over  time.
Patient states that the vaccine made her have pain inside her left shoulder and she can't move full range of motion.
Felt drunk; This is a spontaneous report from a contactable consumer based on information received by Pfizer from  (manufacturer control number: ). A 44-year-old male patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration, on unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's historical drugs included steroid which caused weight gain. Concomitant medication(s) included etanercept (ENBREL) with Reusable Autoinjector on an unknown date in Oct2020 and ongoing taken for rheumatoid arthritis. The patient previously took steroids and experienced weight increased. On an unknown date in Feb2021, the patient felt drunk for about three hours after receiving "COVID vaccine". The clinical outcome of felt drunk was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 7 hours after second covid vaccine, I felt feverish and aches. It continued getting worse throughout the evening until I finally had to take Tylenol at about 10:30pm. The fever went away by 11:30pm. I woke up next morning around 10am and fever is gone but still feel very achy with achy joints and skin. But better than previous night. Left arm where injection occurred is also very sore.
Patient experience shortness of breath, held her throat, wheezing, and collapsed. Given epi IM in left upper thigh at 5:19pm. Symptoms improved within 1 minute.
Information has been received form a 23 year old female patient, with no known drug reaction/allergies and no pertinent medical history, who in January 2009, was vaccinated with her first dose of GARDASIL. Concomitant therapy included vitamins (unspecified). The consumer reported that she experienced hair loss since 3 weeks ago when she received her first dose of GARDASIL vaccine. At the time of the report, the patient was recovering. The patient spoke to her physician seeking for medical attention. Additional information has been requested.
5minutes after pt received vaccines he complained that his throat hurt and had difficulty breathing. Pt began crying stating "I can't breathe". Pt found to be wheezing. Epinephrine 0.2 ml given along with Albuterol nebulizer treatment. EMS called. Pt's condition improved.
Information has been received from a registered nurse concerning a 14 month old female who was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). The reporter indicated that as a result the patient developed a rash on the face and trunk and a high fever. It was also noted that the patient "developed lymph nodes around the groin area." Unspecified medical attention was sought. The patient subsequently recovered. A product complaint was not involved. Additional information has been requested.
Initial vaccination January 11, 2021 mild injection site soreness.  Second dose vaccine 02/12/2021.  Patient developed myalgias lasting for 1 day.  02/16/2021 patient developed fever chills and body aches.  Temperature upwards of 104. Darkening of the urine.  Symptoms persistent.
Pt developed swelling in neck several days after the vaccine. The swelling is still there today. Pts PCP and oncologist told her to get the second dose.  Soft, doesn't feel like lymph node swelling
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 61-year-old female patient who received SHINGRIX (batch number P539L, expiry date unknown) for prophylaxis. On 25th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left arm. The pharmacist stated that, the patient experienced a rash at the injection site. The rash was about 3 inches in height and no width information. In 2018, the patient had recovered from the rash.
sz 30APR96;became still & rigid, eye rolled back & turned blue for 15-20seconds, lips & jaw clenched tight;followed by 15-20min of listlessness & dec responsiveness;observation 24hr in hosp
COVID-19; A spontaneous report was received from a consumer concerning a 70 years old, male patient who experienced chills, aches/myalgia, headache and felt cold/feeling cold.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038K20A) via unknown route in his right arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, the patient tested positive on COVID-19 test and was diagnosed with COVID-19.  Treatment for the event included none.   Action taken with mRNA-1273 in response to the events was not provided.  The events COVID-19 was resolving.
PATIENT DEVELOPED FEVER OF 101F, BODY ACHES, CHILLS, FATIGUE, MALAISE, AND ARM PAIN WITHIN 8 HOURS OF RECEIVING VACCINE.  SYMPTOMS SUBSIDED WITHIN 48 HOURS, BUT LEFT ARM SWELLING/REDNESS/TENDERNESS/WARMTH OVER INJECTION SITE THAT HAS PERSISTED AND ACCOMPANIED BY MILD PAIN RADIATING TO LEFT HAND.  NO LOSS OF STRENGTH/MOBILITY.  SWOLLEN AREA MEASURES 10.5 X 15CM.
pt awoke the following morning with symptoms consistent with shoulder bursitis/frozen shoulder.  Concern is that the vaccine was administered in an incorrect location
was reconstituted with saline; was reconstituted with saline; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA636A, expiry date 30th September 2022) for prophylaxis.   On 21st October 2021, the patient received Menveo. On 21st October 2021, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.  Additional details provided were as follows: Nurse reports that a patient was administered a dose of Menveo that was reconstituted with saline instead of the supplied CWY diluent which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. The reporter consented to follow up.
After 1 hr. of taking oral typhoid, felt shaky, arms numb and tingling, dizzy and nauseous.
Kidney disorder; Absolute lymphocyte count increased; CLL progression; This is a spontaneous report from a contactable physician. An 85-year-old male patient received the second dose of BNT162B2, intramuscularly on 16Feb2021 at single dose for COVID-19 immunisation, and ibrutinib (IMBRUVICA), orally from an unspecified date to an unspecified date at 420 mg, daily, then from an unspecified date to an unspecified date at 280 mg, daily, and then from 2016 to an unspecified date at 140 mg, daily for chronic lymphocytic leukaemia (CLL). Medical history included minor environmental allergies and chronic lymphocytic leukemia. No drug abuse/illicit drug use, non-smoker, and no alcohol use. Concomitant medications included clonazepam, diphenhydramine hydrochloride (BENADRYL), iodine for supplement, zinc chloride, and quercetin. Patient previously received the first dose of BNT162B2 (COVID-19 Vaccine) on 26Jan2021 for COVID-19 immunisation. The patient experienced CLL progression in Feb2021, kidney disorder (stress on kidney) on an unspecified date, and absolute lymphocyte count increased in Feb2021. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The patient's ibrutinib dose was reduced so that he could take the minimal amount required to reduce stress on his kidney per his physician's instructions. His absolute lymphocyte count stayed stable taking ibrutinib 140 mg daily. His absolute lymphocyte count became elevated after he received his second COVID-19 vaccination. The patient saw his physician on 14May2021. The physician's opinion was that the elevated lymphocyte count was a progression of his disease. The patient asked if it was caused by the COVID-19 vaccine and the physician said it might have but he was unsure. The physician sent in a new prescription for ibrutinib 280 mg daily but the patient had not started taking it yet. The patient underwent lab tests and procedures which included absolute lymphocyte count: 3.5 ul/ml on 10Mar2021, and 5.7 ul/ml on 01May2021. The action taken in response to the events for ibrutinib was unknown. Outcome of event kidney disorder was unknown, and of other events was not resolved.  Causality for ibrutinib: The reporter's causality for the events of progression of CLL, off label dose-280 mg daily, off label dose-140 mg daily, stress on kidney and absolute lymphocyte count became elevated was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events.  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.
Initial report received from a patient on 16 December 2010. A 67-year-old female patient, who has no relevant medical history, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number not reported) on 20 September 2010 at 18:00 pm. Immediately post-vaccination, the patient had bad pain in her arm and could not raise the left arm requiring medical evaluation. The pain subsequently radiated to her shoulder and breast bones. The pain keeps her awake at night. X-rays completed revealed some arthritis, but blood work was normal. Follow-up information was received from a health care professional on 31 January 2011. The lot number of the FLUZONE HIGH-DOSE was U3603AA. The patient had a prior history of shoulder pain or arthritis. She was not seen in the Emergency Room (ER) but saw a doctor. The patient's x-rays showed arthritis and the final diagnosis was arthritis. The outcome was reported as recovered. Documents held by sender: None.
Redness extending down from IM injection to elbow pt describes it as a blotch, no medicines administered mother states began 6/15/04 and is now fading. Instructed to move arm, give ibuprofen as directed, go to ER if worsens and call clinic when called 6/17/04. Pt denies pain/fever, slight inflammation noted by mother.
The patient was administered MMR II, via intramuscular route.; No adverse effects reported.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     On 23-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA recombinant Human albumin (rHA) (M-M-R II) via intramuscular route (strength, dose, frequency, and anatomical location were unknown) with lot # R031679 and expiration date 01-NOV-2020, recostituted with a steril diluent with lot # S002624 and expiration date 05-NOV-2021 for prophylaxis. No adverse effects were reported.
Information has been received from a physician and a medical assistant concerning an 18 year old female who on 08-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil (lot 3654510/0962F) while sitting.  On 08-AUG-2007, a few minutes after vaccination, the patient stood to leave, fainted.  She hit her head on the floor.  She woke up "almost immediately" and she laid down until she felt better (approximately 5-10 minutes).  On 08-AUG-2007, the patient recovered.  Additional information has been requested.
Patient presented to the ED after a fall at home. She was found to have multiple rib fractures. She was admitted for further management and discharged home 1 day later in stable condition with home healthcare.
left thigh muscle pain. Improved with walking. Palpable muscle spasm. Occurred day after vaccine, slightly improved over next 7 days
Fully vaccinated test positive for covid-19; sore throat, muscle aches, sinus pain
1 day after receiving vaccine, patient had muscle hurt and it continued to get worse to the point where patient can no longer lift arm above shoulder.
On day 8 after vaccine, localized swelling , redness, pain and itching  at injection site that is starting to resolve after 2 days
Patients mother noted slight swelling around injection site.  In center it was red, purulent, glossy.  Scabbed over a couple days later, once scabbed fell off; site was still red and purulent. No fevers noted.  Not hot to the touch, kid is not bothered by the injection site.
Case number PHEH2016US001765, is a combine initial spontaneous report received from a consumer (patient and patient's wife) on 20 Jan 2016. This report refers to a 63-year-old male patient. Medical history was not reported. Concomitant medication included irbesartan (manufacturer unknown), citalopram (manufacturer unknown), fenofibrate (manufacturer unknown), ranitidine (manufacturer unknown), allopurinol (manufacturer unknown) and atorvastatin (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 14 Jan 2016. On 14 Jan 2016 later that night, the patient woke up and told his wife that something was wrong, he had hives with no fever/hives and welts all over his torso, according to his wife the welts got bigger to the size of quarters and complained of itching. The patient was treated with O2 BENADRYL tablet. The outcome of the event hives was reported as complete recovery after few hours and for other event it was reported as condition improving (symptoms subsided). The seriousness and causality of the events was not reported.
Headache, facial pain after 1.30 hrs. Itching - 6 hrs lips swelling, headache, abd pain, dizziness, chest heavy - 18 hours. No reaction at injection site.
Approximately a few weeks after my booster shot I experienced the following symptoms: Shortness of breath, Increase of oxygen use. I took the same medication I have mentioned in the previous page and got a nasal spray. It did not help with my condition. I called my doctor about this and she was still trying to figure out if this is because of my COPD.