chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylaxis; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 4460704#1849-2117958061.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "endometrial cancer" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "fatigue" (unspecified if ongoing); "heart problem" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID; CYCLOBENZAPRINE HCL; METHOTREXATE SODIUM; ARAVA; DULOXETINE HCL; LISINOPRIL. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". Clinical information: Patient's past medical history included: multiple sites, encounter for observation for other suspected diseases.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
pt had chills, skin was white, she felt cold. later had fever and sweats and could not get out of bed
Pt devel fever 102, diarrhea, vomiting, severe abd cramps 24 hrs p/vax-lasted 2 days;
generalized weakness; no appetite; headache; soreness of back muscles; fever; Achey arm; congestion; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: generalized weakness), appetite absent (Verbatim: no appetite), headache (Verbatim: headache), muscular back pain (Verbatim: soreness of back muscles), fever (Verbatim: fever), pain in arm (Verbatim: Achey arm) and respiratory tract congestion (Verbatim: congestion). The outcome of the weakness, appetite absent, headache, muscular back pain, fever, pain in arm and respiratory tract congestion were resolved (duration 4 days).   It was unknown if the reporter considered the weakness, appetite absent, headache, muscular back pain, fever, pain in arm and respiratory tract congestion to be related to Shingrix.     It was unknown if the company considered the weakness, appetite absent, headache, muscular back pain, fever, pain in arm and respiratory tract congestion to be related to Shingrix.   Additional Information: GSK Receipt date: 25-JUL-2023 The reporter stated after administration of Shingrix his wife (patient) experienced the same symptoms (achy arm, fever, soreness of back muscles, headache, low appetite, generalized weakness and congestion) which he had. The symptoms lasted for a shorter amount of time and were less severe. The reporter did not consent to follow up. This case is linked with US2023101959 and US2023105218 different patient, same reporter.; Sender's Comments:  US-GSK-US2023101959:Same reporter,Male patient US-GSK-US2023105218:Different patient, same reporter
Diabetes Mellitus, chronic pain, weight loss, gastro intestinal symptoms, arthralgias.
Erythematous itchy maculo-papular rash that appeared 10 days after vaccine on trunk and spread up to neck and down to thighs. I am a physician and am treating myself with cetirizine, prednisone 40 mg daily, and topical steroids.
Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; Vaccine administered to underage recipients; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to underage recipients), POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to underage recipients), POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly. The temperature excursion details provided were as follows: The storage condition at the time of the excursion was Refrigerated and the lot number was unknown. The maximum or minimum temperatures reached, as applicable (specify temp is in C or F) was unknown. The Excursion duration was Unknown (12-Jan-2021- 22-Apr-2022) and the date when the vials moved from freezer to refrigerator was unknown.  No treatment information was provided.
Fever 102 degrees,  tremors,  muscle weakness began about 2 hours after the vaccine.  Bed bound for 3 days after the vaccine due to weakness and shaking.
24-36 hrs after receiving the Hep B immunization by Engerix B, she exp cervical lympadenopathy. Afebrile Axillary lympadenitis. Bld draw for CBC with diff.
Severe arthralgia and myalgia, persistent low grade fever all symptoms x 5 days.
Large, red hard itchy swollen spot at injection site. Small raised bumps: appeared on 8th day late afternoon was very itchy. Put antibiotic cream on it was all I had cream had painkilling agent that seemed to lessen itching. Did not go to doctor
t 103-104 X days, responded to APAP & sponge baths; swelling & beet red at inject site to elbow;swelling lasted 2 days, erythema 4 days
Painful injection site started after on hour.    Body aches began  at 9:00 PM and persisted through 11/28.      Temperature 100 degrees F.   Lack of appetite. Dizziness and Headache. occurred at 8:00 AM on 11/28.  Took 200 mg ibuprofen at 12:00.  Began to feel some relief at 1:30.
PATIENT REPORTED FEELINGS OF EXTREME WEAKNESS, STOMACH PAIN, SEVERE MUSCLE PAIN, A SORE ARM WITH RASH, AND REDNESS AND SWELLING AT INJECTION SITE LAST GREATER THAN 4 DAYS.
Very itchy during the night.  Got worse each day (hives appeared).  1/21 seen at doc. office.  Steroid shot.  Referred me to Allergist on 1/22. Taking steroid pack, Zyrtec, Zantec and Benadryl. Docs don't think caused by Vac.  I do.
Numbness of hands, feet, distal extremities LUE 1st, then all 4. As of 10/24 all but LUE recovered. Grip weak LUE.  11/4/08 Reviewed ER medical records of 10/12/08. FINAL DX: extremity numbness of unknown etiology Records reveal patient experienced inability to feel legs/arms.  Walked into ER.      11/4/08 Reviewed PCP medical records of 10/15-10/24/2008. FINAL DX: transient numbness of extremities, improving.  High suspicion of reaction to flumist. Records reveal patient experienced numbness & had been seen in ER.  Feeling better but still numb in distal extremities, fall while running in school, dropping things, anorexic for a few days, 8# weight loss, diarrhea that had resolved.  Exam revealed slight decreased grip strength on left, decreased sensation from knees down & from elbows down,  areflexia in UE's.  RTC 10/24 improved but with left arm numbness persisting, difficulty writing, occasional HA, palpitations, SOB.
was administered an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 21-FEB-2023, the patient received Havrix. On 21-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: was administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-MAR-2023 HCP reporting via webform. The reporter reported that patient was administered Havrix.  No additional adverse event information was available.  The reporter reported that patient was administered Havrix, which led to expired vaccine used. The case had been linked to US2023035908, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023035908:same reporter
2 hours after immunization developed major headache, with fatigue and diarrhea. Treatment with Motrin 800 mg po and sleep. 9/18/07: Headache, fatigue & diarrhea continues. Stayed home from work to rest and recover. 9/19/07 Diarrhea resolved. Returned to work with decreasing headache and fatigue. Noted light headedness with bending over. Recovered as of 9/21/07.
Presented on 3/7 with increasing orthopnea and chest heaviness. Had been admitted in mid february with volume overload and COVID +. Diuresed with improvement and discharged to home.  CXR showed multifoacal pneumonia. Started on antibiotics and cardiology consutled and patient diuresed. Positive DVT nad heparin started. Developed tarry stolls and heparin stopped and IVC fileter placed on 3/13.Started on Bumes drip but poor symtpomatic improveme\ttn. Renal function worsening and seen for possible AshSplit catheter placement for dialysis. Developed hypotension that required rapid response and discontinuation of diuresis.  Dialysis plans aborted and transferred to ICU for hypotension management. Family requested DNR.
This spontaneous report as received from a doctor's nurse via a company representative refers to a non-pregnant female patient of unknown age. On an unknown date the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported). It was reported that the patient experienced injection site reactions after getting ZOSTAVAX. The patient's adverse event started within 24 hours of the injection. Her reaction was "warm, red and hard" and was the size of an egg. The adverse event lasted 10-12 days. The patient sought for unspecified medical attention. As a treatment, she was advised to alternate between warm and cold compresses. No rash was involved with the patient. On an unspecified date the patient was recovered. This is one of several reports received from the same source. Additional information is not expected.
Patient describes hives, burning in skin like a Niacin feeling and also reports fever. A little nauseated
Oval raised, red, itchy spot at site of injection about 2 inches wide and 3 inches long beginning 8 days after injection.  Three days later it tripled in size.  Two days after that it was the entire upper arm.  Cleared up 8 days after it started.
Shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (Shoulder soreness). At the time of the report, ARTHRALGIA (Shoulder soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-062329, MOD-2021-062340 (E2B Linked Report).; Sender's Comments:  MOD-2021-062329: MOD-2021-062340:
had it like 3 or 4 days rapid heart beat; rapid heart beat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485; Expiration Date: 31Oct2021) via an unspecified route of administration, administered in arm right on 06Aug2021 17:00 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On 06Aug2021 the patient experienced had it like 3 or 4 days rapid heart beat; rapid heart beat. Concern: Reporter stated, I wanted to be found out that, I have been reporting. I've been reporting everyday about my side effects (further not clarified) but is the rapid heart beat suppose to be one of the side effect. I want them to document, report it, rapid heart beat, I had my 1st shot. Well, I had it like 3 or 4 days rapid heart beat. When probed for date of administration, reporter stated, 06Aug2021, I have started heart rate. When probed for expiration date, reporter stated, 31Oct2021, 30th. Anatomical location: Reporter stated, On my right arm, my right upper arm. Medications and Medical conditions: Reporter stated, No. Time of the vaccine: Reporter stated, About 5 o' clock in the afternoon, 5pm at withheld. Route of administration: Reporter stated, No When probed if received any other vaccine: Reporter stated, No, haven't had any vaccine. The patient underwent lab tests and procedures which included heart rate: rapid on 06Aug2021.Patient did not receive treatment for the adverse event. Outcome of the event was resolved on an unspecified date in Aug2021.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
On November 27 2022 I noticed my skin was itchy on my lower leg. I put Neosporin and a ban aid and changed it out daily, on Sunday December 4 2022 I removed the ban aid to take a shower and although I thought it would be healing it looked much worse. It had redness, discharge and little holes in my skin so I went to Urgent Care. I was prescribed an antibiotic and a topical cream.
12 hours later after receiving the vaccine I could feel pain and a tingling feeling moving from the injection site up my arm to my neck and then to my right cheek. It was uncomfortable and it lasted for about 3 days. I had to take medicine once and then it went away. I got the next dose on February 26, 2021 (Lot #: EN6202). I got it in my left arm, and I didn't have any problems with it. In mid June 2021, I started having bad episodes of cheek pain, congestion, and teeth pain. I went to about 3 different doctors. They all thought it was a sinus infection. I took some antibiotics, but that didn't help. I went back to my dentist in June 2021, and I told them there was something wrong with the right side of my face and teeth area. They decided to do a root canal. On October 14, 2021, I went to have the root canal. When the dentist went half way through it, they saw a cracked tooth. They said they wouldn't be able to do the root canal because my tooth would need to removed. On October 22, 2021, I had to get my tooth pulled. Then on October 29, 2021, I had to go back to the doctor because of the pain I was in. They gave me steroids that did help. My cheek and gums are still numb. I saw an ENT doctor on February 21, 2022 because the numbness on my face had spread from the center of my right cheek to the bottom of my eye and upper gum area. I have nasal congestion. My doctor told me that if I notice paralysis in my face then I need to come back in. The numbness is only on the right side.
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.   Covid antibody testing completed.
Increase in neurologic symptoms including: tremors, frequent PVCs, tachycardia on standing, orthostatic intolerance, excessive sweating w/o exertion, headaches, hoarseness of voice, poor concentration. The symptoms became moderately severe several weeks after vaccination and gradually diminish over the following 3-4 months. Both Moderna doses were received as recommended. Similar symptoms and pattern has occurred following previous influenza-like illness and influenza vaccination. A neurological evaluation took place approximately 2 weeks after the 1st Moderna Covid-19 vaccination dose. Laboratory testing is consistent with a hyperadrenergic condition.
Utilizing cooler to keep punctured vial refrigerated/he vial then be placed back in a cooler with ice packs; Expired Moderna doses (greater than 12 hours post puncture) were administered to 6 Patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (greater than 12 hours post puncture) were administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated/he vial then be placed back in a cooler with ice packs) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 8:55 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 8:55 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (greater than 12 hours post puncture) were administered to 6 Patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated/he vial then be placed back in a cooler with ice packs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (greater than 12 hours post puncture) were administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated/he vial then be placed back in a cooler with ice packs) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/vials: 6 doses/1 vial.  On 15-Apr-2022, the vial was initially stored in the refrigerator. The vial was first punctured on 19-Apr-2022 at 1 PM central time. HCP reported after the vial was punctured, the vial would then be placed back in a cooler with ice packs and a data temperature logger monitoring the temperature inside the cooler. HCP reported no temperature excursion occurred inside the cooler according to the data logger. HCP stated she could probably send data logger data. HCP stated they made home visits to administer the vaccine to individuals. Once a dose was drawn up, the vial was immediately placed back in the cooler. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 5 minutes.  No treatment information was reported.
Armpit pain; Lymph node swelling in left arm pit; Extremely Chills and shivering; Flu like symptoms; Fever; This is a spontaneous report from a contactable consumer, the patient. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6200), via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 32-years-old), as a second single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not had any allergies to medications, food and  other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications (Unknown) within 2 weeks of vaccination. On 13Mar2021 at 06:00, the patient experienced flu like symptoms, arm pit pain, lymph node swelling in left arm pit, fever, extreme chills and shivering. Therapeutic measures were taken for the events with Advil and iced lymph node. At the time of report, the clinical outcome of the events flu like symptoms, arm pit pain, lymph node swelling in left arm pit, fever, extreme chills and shivering was recovering. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected
Pt had onset of diarrhea on 9/22/01, PM and has continued until clinic visit in the AM of 9/24/01. She vomited X 1 in the AM of 9/24/01 without fever or other symptoms.
Allergy to tetanus toxoid; Initial unsolicited report received from physician (rheumatology) on 23-May-2018. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had allergy to tetanus toxoid. Lab data and corrective treatment were not reported. The outcome of events was not reported.  List of documents held by sender: none.
About an hour after receiving the vaccine my left leg and left arm were numb. The numbness continued for at least an hour before I fell asleep for the day and the numbness on my left side was gone. Only the expected arm soreness around the shot remained.
5-10 min after IM (L) eye started swell after rubbing eye and developed a cough. Eye swelling increased and cough continue with a soft wheeze. Treatment: albuterol aerosol, PO steroid.
The night patient received the vaccine she developed body aches, chills and loss of appetite. No treatment was received.
Toes and feet tingling and hurting . Glucose was over 300 . Still feeling dizzy. Feet sometimes goes numb . Ankles swelling and painful.
Guillain Barre syndrome - ascending paralysis - feet to mouth. See ER hosp. admission notes attached.
Medical history and concomitant medications were not reported. The patient received FluMist vaccine on 19-Nov-2007. On 23-Nov-2007, four days after receiving FluMist vaccine, the patient developed glomerunephritis. No additional information was reported. The event of glomerulonephritis subsequently resolved on an unreported date. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The sponsor considered the glomerulonephritis an important medical event. The reporting source of this case is spontaneous, thus the reporter's comment is not applicable.
Information has been received from a nurse and the patient's mother concerning a 24 year old female with migraine & depression, no known drug allergies (NKDA) and a history of seizure due to an overdose of WELLBUTRIN which was only one incident couple years ago. Concomitant therapy included LOESTRIN 1/20 and WELLBUTRIN. On 29-JUN-2009 the patient was vaccinated with the first dose of GARDASIL (LOT #658556/1060U). On 30-JUL-2009 she had a seizure. The outcome of the patient was recovered. She sought medical attention and was taken to ER but was not admitted. Upon internal review, seizure was determined to be an other important medical event. No further information is available.
Covid arm with rash and feeling sick with fever 5 days after first shot. Received second shot and had covid arm and feeling ill again within 12- hours
w/in minutes of vax pt felt unwell;devel nausea, fatigue, chills, dizziness & felt faint;lt arm @ inj site very painful;