chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with allergic contact dermatitis hives to >50% of his body, noted to bilateral arms, bilateral upper and lower legs, torso, back and neck that occurred 3 hours after immunization. Patient presents to Clinic today (10/11/23) after receiving vaccine at the pharmacy yesterday.(10/10/23).  Patient presents today with hives covering almost entire body after receiving his COVID-19 Pfizer booster vaccine yesterday at 2:30. He noticed a patch of hives break out on his arm 3 hours after his vaccine and since then, the hives have spread to his torso, chest, bilateral arms, bilateral upper and lower legs and his back, as well as posterior neck. He states an allergic reaction like this has never happened before. Denies shortness of breath, difficulty breathing or throat swelling/ pain. Endorses itchiness. Has taken several doses of Benedryl with no relief. Denies fever, body aches, chills.
Sciatic nerve pain along the right lower back, hip, and leg. Unable to work, lift leg or pick up my young children without severe pain and weakness. Symptoms started 10/20 and continue to worsen. Saw PCP 10/23 and started prednisone 10/23.
Left arm sore to the point she has trouble moving it. Needs pain med every 6 hours to help. Lasting >3 day
Pain in right arm, fever of 102.4, numbness in left arm and tingling in pinky and ring finger, headache, heart palptations.
A day or two after the vaccine, I awakened frequently throughout the night having to urinate. This went on for a couple of weeks. Around Oct 11 or 12 I started having an urgent need to urinate frequently throughout the day. On October 14, I went to the doctors office and saw a nurse. She took a urine specimen and referred me to physical therapy for pelvic floor therapy.  The urges have not stopped, but the daytime urgency has gotten better. I don't know what dose number in series means, but this is my 3rd booster after having the initial 2 doses.
This spontaneous report was received from a physician and refers to a newborn patient of unknown gender. There was no information about the patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 02-DEC-2017, the patient was vaccinated with a dose of RECOMBIVAX HB (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis after receiving a dose of RECOMBIVAX HB on 01-DEC-2017. No adverse effects were reported.
Information has been received from a registered nurse concerning a patient, who on 22-OCT-2012 was vaccinated with an expired dose of ROTATEQ, 2 ml, orally, lot # 669529/0548AA (expired 20-SEP-2012). No adverse effect was reported. Additional information has been requested.
pt was found in his home by police, unresponsive with two bottles of empty medication beside him on the floor; nasotracheally intubated for respiratory failure; hypotensive; brought to ED; found to be positive for COVID; admitted; cardiovascular condition worsened requiring 3 vasopressors; Acute kidney failure; family decided to make pt a comfort care only; pt expired in the hospital
herpes zoster; neurological eye disorder; vision problems; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) vaccine (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live(ZOSTAVAX) vaccine, the patient suffered herpes zoster, neurological eye disorder and vision problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), this patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her/his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, patient suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality between the events and suspect vaccine was related.   The events of herpes zoster, neurological eye disorder and vision problems were considered to be disabled by the lawyer.
Rash on his trunk; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on his trunk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on his trunk). At the time of the report, RASH (Rash on his trunk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
bulges spondylosis; retinal revascularization; eye pressure: increased 24; feels like ovaries pain; loss of central L eye vision; diminished colors. loss of central L eye vision.; stroke; diminished colors. loss of central L eye vision. Couldn't drive as usual; severe back pain; leg heavyness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0183), intramuscular, administered in left deltoid on 11Jun2021 10:31 (at the age of 50-years-old) as dose 2, single for COVD-19 immunization. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN) taken for back, leg pain and limping from 25May2021 and ongoing. The patient previously received FLUARIX vaccine (Batch/Lot number: 59HN3), intramuscular, administered in right deltoid on 04Jan2021 for an unspecified indication; and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in left deltoid on 21May2021 11:52 (Lot number: EW0183) as dose 1, single for COVID-19 immunization and on 21May2021 experienced left eye central vision loss treated with Avastin eye injections, back pain/hip/knee pain, blurred vision thought needed new glasses, limping right leg. On 12Jun2021, the patient felt like she had ovaries pain. In Jun2021, the patient experienced diminished colors, loss of central left eye vision, couldn't drive as usual, severe back pain, leg heaviness, and she ended up in the ER after having a stroke. The patient had CT, X-rays, MRIs and saw Neurology, Ophthalmology. The patient was referred to "Ortho Phys med- Pain" had eye injection and will need more on a monthly basis. The event ovaries pain was reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 28Jun2021 which included CT scan head brain lumbar: normal, there was no mass and no stroke; and hip and knees x-rays were normal. Rheumatoid lab tests in Jul2021 was normal. On 27Aug2021, fluorescent angioscopy: left sub retinal revascularization and eye pressure: increased 24, comments: normal was 10-14. On 12Sep2021, MRI spine: bulges spondylosis, sub centimeter CSF cyst, comments: face and degeneration disc bulge, foramen narrowing. The patient did not report to physician yet and was more worried about vision and on and off limping, and constant back pain, will seek this week. The patient received treatment for the vision loss with Avastin 1.25 mg eye injection, intravitreal from 27Aug2021 and ongoing. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
COVID19 positive test; COVID19 positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "thyroid nodules" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Jan2016, stop date: 07Jun2022; BENAZEPRIL, start date: Jan2016, stop date: 07Jun2022. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant) with onset 07Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 07Jun2022, outcome "recovering" and all described as "COVID19 positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive, notes: Initial COVID19 positive test (antigen, confirmed by NAAT test) on 07Jun2022, also mild symptoms; (12Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (13Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (14Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (15Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (16Jun2022) Positive, notes: tested positive again with antigen test morning of 16Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
dolor de las cervicales / neck pain; dolor intenso de cabeza / intense headache; fiebre /fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (dolor de las cervicales / neck pain), PYREXIA (fiebre /fever) and HEADACHE (dolor intenso de cabeza / intense headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 036A211A) for COVID-19 vaccination.     The patient's past medical history included Varicose veins, Vascular disorder NOS and Operation NOS.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fiebre /fever). On 12-Apr-2021, the patient experienced NECK PAIN (dolor de las cervicales / neck pain) and HEADACHE (dolor intenso de cabeza / intense headache). On 12-Apr-2021, PYREXIA (fiebre /fever) had resolved. At the time of the report, NECK PAIN (dolor de las cervicales / neck pain) and HEADACHE (dolor intenso de cabeza / intense headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided Action taken with mRNA-1273 in response to the events were Not Applicable
Red at the right arm in the part of injection (back) swollen from up to the upper arm. CLARITIN to decrease at time. Itch/no pain. Hydrocortisone to decrease itch. Patient given steroid to decrease itch.
Have fever blisters from the Moderna Booster; Muscle spasms in back; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Have fever blisters from the Moderna Booster) and MUSCLE SPASMS (Muscle spasms in back) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for an unknown indication.    Concurrent medical conditions included Malignant neoplasm of female breast, unspecified.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PALBOCICLIB (IBRANCE) (Oral) 100 milligram. In April 2021, the patient experienced MUSCLE SPASMS (Muscle spasms in back). On an unknown date, the patient experienced ORAL HERPES (Have fever blisters from the Moderna Booster). The patient was treated with DIAZEPAM (VALIUM) in April 2021 for Muscle spasm, at an unspecified dose and frequency and NALOXONE HYDROCHLORIDE (NARCAN) in April 2021 at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Have fever blisters from the Moderna Booster) and MUSCLE SPASMS (Muscle spasms in back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 2.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that Ibrance started  over a year ago, pharmacy first shipped ibrance to patient on 11/04/2021. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
chronic anxiety disorder; she was scared to death; woke up in the middle of the night with a powerful and debilitating anxiety attack; woke up in the middle of the night with a powerful and debilitating anxiety attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY disorder (non-serious), outcome "unknown", described as "chronic anxiety disorder"; NERVOUSNESS (non-serious), outcome "unknown", described as "she was scared to death"; MIDDLE INSOMNIA (non-serious), ANXIETY (non-serious), outcome "unknown" and all described as "woke up in the middle of the night with a powerful and debilitating anxiety attack".  Additional information : Patient states she was super sensitive to medications, and they had a hard time treating her anxiety. The patient states that se not had anxiety before the vaccine.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101779797 same reporter, different patient/AE
PATIENT CAME WITH SWOLLEN ARM (RIGHT ARM) AND COMPLAINED OF NECK/HEAD /ARM PAIN, COULDN'T SLEEP AT NIGHT , HAD FEVER, WENT TO PATIENT FIRST ON 11/19, GOT ANTIBIOTICS FOR 10 DAYS (NOT SURE).
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an improperly stored 0.5 ml dose of M-M-R II (lot # 671255/1002AA expiration date 28-JUN-2013) SQ on 29-JAN-2013. The nurse reported that the vaccine exposed to 49F for 18 hours. No adverse effects were reported. Additional information has been requested.
Crohn's disease Flare up; Arm Hot; Sore Arm; Neck Ache; booster; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4216571-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but Manufacturer Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "unknown", described as "booster"; CROHN'S DISEASE (medically significant), outcome "recovered", described as "Crohn's disease Flare up"; FEELING HOT (non-serious), outcome "recovered", described as "Arm Hot"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore Arm"; NECK PAIN (non-serious), outcome "recovered", described as "Neck Ache". The action taken for adalimumab was unknown.  The reporter's causality for the events of arm hot, Crohn's disease flare up, sore arm and neck ache with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of with Crohn's disease aggravated was not reported, for the events pain in arm, neck pain and arm hot with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Crohn's disease aggravated, Immunization, pain in arm, neck pain and arm hot 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
Patient developed shortness of breath over 24 hours after receiving 1st dose which lasted throughout the night into the next day. The shortness of breath was on and off along with a deep burning upper back pain, headache & bilateral knee pain.
Hives face & trunk (day p/) cleared up fairly quickly w/some DPH;
Patient received vaccine on 5-8-07. 5-09-07 normal slight of sore arm muscle. 5/10/07 gland in Left armpit and left neck swelled and became painful. Glands continue to be swollen and painful-armpit>neck. Patient reports very painful to lift left arm above head. No fever. Advised to see primary provider, today.
Tingling in mouth and lips started 2nd morning after 2nd shot. By end of 2nd day mouth was burning (both tongue and roof of mouth) and taste had dulled. Begin to notice mild inflammation and thickening of saliva. Morning of 4th day, welt formed in mouth after eating breakfast.   Some bleeding in the gums on 5th day evening. As of 6th day morning (4/19/21) I still have altered sensation in mouth, altered taste, tingling in lips but not as much burning and no other welts have presented. Other reactions were listed as common: headache (2 days), chills (1 day), swollen lymph glands (4 days).
This spontaneous report was received from a nurse practitioner via a company representative referring to a 68 year old male patient. The patient's concurrent conditions and medical history were not provided. The patient's drug reactions and allergies were not reported. Approximately in 2015, reported as "about a year and a half ago", the patient was vaccinated with ZOSTAVAX (dose scheduled, route of administration, lot # and expiration date were not provided). There were not concomitant medications reported. On 17-OCT-2016, the patient went to see a health care professional for "ear pains and no rash" and was given an unspecified treatment for this. On 19-OCT-2016, the patient visited the physician office, "for a vesicular rash on the left side of the head by the ear and lots of pain". The nurse practitioner diagnosed this rash as shingles. The patient was given a high dose of unspecified pain medication for treatment. At the time of this report, the outcome of shingles was reported as not recovered. The outcome of ear pains was not reported. The causality between the events and ZOSTAVAX was not provided. Additional information has been requested.
devel swollen gland several hr p/vax;next morning devel sore throat was exudation & erosions;seen by MD 2 days p/vax;throat cult negative; tx w/med;also devel worsening joint pain, rash on hand which desquamated;
Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 16Feb2021 10:00 AM (age at vaccination was 40 years old, vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 26Jan2021 11:15 AM (vaccine location: Right arm) at single dose for COVID-19 immunisation. The patient's medical history included environmental allergies. The concomitant medications were reported none.Patient experienced chills, body aches lasting a while, joint pain everywhere and headache, all starting 14 hours and 30 mins after second dose on 17Feb2021.The outcome of events was recovering without treatment given.  Information on the batch/Lot number has been requested.
Large redness, itching & induration @ left thigh surrounding site of immunization within about 24 hrs. of vaccines - treated with BENADRYL
Moderate, cramping (abdominal), headache and nausea. Joint pain for 4 days with most noticed in hands. Extreme fatigue for 4 days.
In June of 2022 I noticed. The symptoms seem to manifest right when I wake up, vertigo. In the past when I've had vertigo, I was shown how to do the "Epley" maneuver. This year when I do this it does not make the vertigo any better. I will have to lay down and rest. The last episode I had the maneuver didn't work and I threw up. It lasted two days. Now when I turn my head, I just get dizzy and does not go away for several minutes. My doctor prescribed meclizine. I was told that the crystals in my ear are in a different plane and are trying to situate themselves. This happens every few weeks and has become progressively worse and the Epley maneuver is not working well. Sometimes I have to use the furniture to get around and I no longer drive. My visit with the doctor was a telehealth visit and no tests were given.
Patient was screened for COVID-29 vaccine and since no contra indications was given vaccine around 1:10 pm. Around 1:30 pm patient told facility staff she was feeling numbness, tingling, short of breath, weakness, dizziness and felt like fainting. The patient appeared shaky, and clammy. Blood pressure taken at 1:35 pm was 172/100 mmHg, then repeated 168/101 mmhg, then 164/106 mmHg. Facility staff called EMS and they arrived and assessed patient. BP reading 160/100 mmHg, HR 120 bpm, and O2 SAT was 100%. Patient was taken to ER at 1:55 pm. Patient was alert and answering questions.
Site of injection became sore to touch, red, itchy, and with bumps at almost-exactly 7 days post-injection. Approximate size of affected area: 4mm wide by 8mm long