chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy,crawly, nerve tingling sensation under the skin on her face and areas she had previously had shingles; itchy / under the skin on her face and areas she had previously had shingles; crawly, nerve tingling sensation under the skin on her face and areas she had previously had shingles; metallic taste; injections were slightly painful; This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for eosinophilic granulomatosis with polyangiitis.   The patient's past medical history included shingles. Concomitant products included prednisone.   On 22nd June 2021, the patient received Shingrix. On 25th June 2021, the patient started Nucala (subcutaneous) 300 mg cyclically (300 mg daily). On 25th June 2021, not applicable after receiving Shingrix and less than a day after starting Nucala, the patient experienced pain. On an unknown date, the patient experienced tingling sensation, itchy skin, crawling sensation of skin and taste metallic. Nucala was continued with no change. On an unknown date, the outcome of the tingling sensation, itchy skin and crawling sensation of skin were unknown and the outcome of the taste metallic was not recovered/not resolved and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the tingling sensation, itchy skin, crawling sensation of skin and taste metallic to be related to Shingrix and Nucala. It was unknown if the reporter considered the pain to be related to Nucala.  Additional details were reported as follows: The case was reported by patient herself. The patient received one dose of Nucala, she took 3 injections for a total of 300mg, dosing in both thighs and her stomach.  The patient noted that the injections were slightly painful and noted she might try to leave it out longer before injecting with her next dose. She added she left it out for 30 minutes. The patient also noted that since receiving the product she has experienced a metallic taste that lingers still.  She also noted that she had a history of shingles and 2 to 3 days prior to the first dose of Nucala, she received Shingrix. The patient stated that she experienced an itchy, crawly, nerve tingling sensation under the skin on her face and areas she had previously had shingles. She was unsure what might have caused these issues, but also noted she takes other medications and was taking 50mg of prednisone also that the pharmacist mentioned might decrease the effects of Shingrix.  The patient was encouraged to discuss these with her physician and offered to review the safety statement. She told her physician did, but only after she had received the first dose and found out she did not have an Epi-Pen.   The patient was prescribed an Epi-Pen. The reporter consented to follow up.
Patient was admitted to inpatient level of care on 10-1 with complaints of abdominal  pain. Patient noted to have tested positive for covid on 10-1. Patient had surgery on 10-1 with exploratory lap, reduction of intussusception, reseciton of J and J anastomosis with reanastomosis x2. Patient noted to have a history of a TBI.
Got dose one on 3/6 and saw Dr. on 3/8 re: reactions. She thought swollen lymph nodes were causing the pain in my thighs which began the night of 3/6. I also mentioned I'd started getting "a cold" which she said could be a reaction. Leg pain subsided by 3/10, but the "cold" worsened that week into a full blown deep cough, fatigue, runny nose, but no fever. Sometime around 3/11-3/14 I noticed I was dealing with tinnitus in my left ear (my "good" ear, not the one with Meniere's) and suspected it was from the vaccine, as I'd not had this before. Cold subsided by 3/26 but tinnitus got worse, with both a high pitch and a bass, pulsating sound. The tinnitus keeps me awake at night.
I woke up with a headache and slight cough and the cough got worse throughout the course of the day. I went and got tested. Doctor prescribed the antiviral drug and prednisone. For two days the coughing was bad, like a really bad upper respiratory cold. Today is the first day I'm not coughing at all and I feel pretty good today.
ELEVATED BUN NOTICED 4/90. REPORTER AND PT FEEL EVENT MAY BE RELATED TO CAPOZIDE.
Patient had a fever of 103 and generalized seizure lasting less than 15 minutes, unknown exact time.
neckache, fever h/a, body aches, enlarged lymph glands x 4 days;
WITHIN 3 HOURS OF RECEIVING THE FIRST DOSE OF PFIZER COVID VACCINE MY BODY WAS COVERED WITH HIVES AND RASHES. IT HAS BEEN 4 DAYS AND THE HIVES AND RASHES HAVE STARTED TO FADE BUT ARE NOT GONE.
pt received Pfizer for first dose on 10/12/21, then in error received Moderna 0.25ml on 10/29/21
P/1st Engerix-B vax, vaccinee developed hives & swollen lips; events resolved.
Tangerine size swollen, warm to touch, hard area on right arm where DTaP #5 was administered.
some swelling, redness, soreness, red @ site of Td; no other complaints; advised cool compress & APAP;
large raised knot at injection site approx 3 inches in diameter.  Area is red, hot and painful
After her first dose, patient reported today that she still has a scab after her first COVID injection that she received on 2/21/21. Her injection site scabbed and has not fully healed. She did state that she has scratched it multiple times and noticed it was bleeding so this could be perpetuating the issue. She has not felt any itching, warmth, or pain at the site. She has tried applying antibiotic ointment and has been covering the scab to prevent further skin deterioration. The injection site area has not grown in redness and did not appear to be infected. Patient stated that she tends to take longer to heal and just wanted to let us know.
Swelling at injection site - roughly golf ball size, lasted about 12 hours; Slight chills roughly 4 hours post injection - lasted about 8 hours.; This is a spontaneous report from a contactable healthcare professional (patient). A 77-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EK9231), via an unspecified route of administration at left arm on 24Dec2020 10:00 at a single dose for COVID-19 immunisation. The patient received COVID-19 vaccine in a hospital facility. Medical history included known allergies to penicillin and bee/wasp stings. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included thyroid (ARMOUR THYROID), rabeprazole, vitamin d3, and acetaminophen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 14:00, the patient experienced swelling at injection site - roughly golf ball size, lasted about 12 hours. The patient also experienced slight chills roughly 4 hours post injection and lasted about 8 hours. The patient did not receive treatment for the adverse events. The outcome of the event vaccination site swelling was recovered on 25Dec2020 02:00, while for chills was recovered on 24Dec2020 22:00.
Missed her 2nd dose and its been 3months she had her 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
It was more than two months after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It was more than two months after first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 47B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It was more than two months after first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It was more than two months after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
patient had rash over chest and arms 4 hours after vaccine, took allegra and rash subsided
Presented to emergency department on 4/17/2021 with complaint of chest pain.  During work up she was found to be COVD-19 positive.  Currently receiving supportive care for management of headache, nausea, and vomiting possibly due to infection. Not requiring supplemental oxygen or antiviral treatment at this time. Patient is currently admitted at time of writing.
Patient presented to our clinic for a laceration.  Provider ordered patient to get a TDAP.  Patient was accidentally given a Kinrix instead of a Boostrix.  No adverse reactions noted.
Carpal tunnel syndrome; Therapeutic procedure; Eyeglasses wearer; Gum disorder; Vaccination site pain; Joint pain; 2nd dose: 03May2021; Booster: 27Oct2021; FACILITATED COLLECT  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-163-4171254-00 (Agency).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till Nov2021 for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of Admin: Subcutaneous), administration date: 12Apr2021, when the patient was 64 years old, for COVID-19 Vaccination, reaction(s): "Carpal tunnel syndrome", "Therapeutic procedure", "Eyeglasses wearer", "Gum disorder", "Vaccination site pain", "Joint pain"; Bnt162b2 (Dose 2, Route of Admin: Subcutaneous), administration date: 03May2021, when the patient was 64 years old, for COVID-19 Vaccination, reaction(s): "Carpal tunnel syndrome", "Therapeutic procedure", "Eyeglasses wearer", "Gum disorder", "Vaccination site pain", "Joint pain". The following information was reported: CARPAL TUNNEL SYNDROME (medically significant), outcome "recovered", described as "Carpal tunnel syndrome"; THERAPEUTIC PROCEDURE (medically significant), outcome "recovered", described as "Therapeutic procedure"; CORRECTIVE LENS USER (medically significant), outcome "not recovered", described as "Eyeglasses wearer"; GINGIVAL DISORDER (medically significant), outcome "recovering", described as "Gum disorder"; VACCINATION SITE PAIN (medically significant), outcome "recovered", described as "Vaccination site pain"; ARTHRALGIA (medically significant), outcome "recovered", described as "Joint pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "2nd dose: 03May2021; Booster: 27Oct2021".  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. The reporter's assessment of the causal relationship of reported adverse event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 Carpal tunnel syndrome , Therapeutic procedure , Corrective lens user , Gingival disorder , Vaccination site pain , Arthralgia , Inappropriate schedule of product administration and the suspect drug BNT162B2 cannot be excluded.
parental report 2-3 days p/vax 4 episodes of arching back, extremities stiffened, face red, h breath, less than 10-15sec, no sz activity;child returned nl activity;similar episodes reported for about 2wk;no fever, emesis, diarrhea, or rash;
patient experienced severe pain in the shoulder due to possibility of nerve was hurt by the needle during immunization. patient reporting pain referring back to shoulder blade and she said she is unable to lift her arm above shoulder level
pt given vax 14APR95 & returned on 19APR95 w/rt deltoid swollen & rashy measuring 11cm x 11cm; pt then given DPh & return tomorrow if not better; will call in AM tomorrow;
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 20-JAN-2023 Reporter's comments: The pharmacist had reported that, an expired dose of Twinrix which was expired on  01 January 2023 was administered at the time of reporting.  The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Twinrix vaccine, which had led to expired vaccine used.
(L) upper arm w/redness, swelling, no fluctuance, Nl to touch. No lymphangitis or fever. Pt taken to ER.
Injection site red rash; Injection site red rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date unknown) for prophylaxis.   On 25th April 2019, the patient received Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The reporter did not have the expiration date of Shingrix. The patient developed a red, round rash at the injection site.
1st dose on December-2020 have not received the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   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 case was reported by patient herself. The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix and they had not received the second dose, which led to incomplete course of vaccination.  The reporter stated that they will be getting the second dose as soon as possible. Gave medical disclaimer. Referred to health care professional.  The reporter did not consent to follow-up.
Client received an influenza vaccination on 10/21/03. On 11/8/03 he developed an upper respiratoy tract infection. His URTI resolved without treatment. He then developed shooting pains from his lower back down both posterior thighs on 11/14/03. Upon waking on 11/15/03 he experienced numbness and tingling in both of his hands and feet. He experienced progressive symmetric numbness for the next 24 hours, prompting his admission to a Hospital and then his transfer to another hospital. His symptoms continued to progress throughout 11/16/03, requiring his being placed on a mechanical ventilator. Nurse follow up on 05/18/04 states: weakness, leg pain, gait unsteady, arms weak, speech slurred, eyes droopy, difficulty swallowing. Medical records state weakness, ataxia, cough. Other correspondance states apnea.
Rash on face, red, raised -cheeks, forehead, chin area-ongoing; Rash on face, red, raised -cheeks, forehead, chin area-ongoing; Soreness and swelling of left arm; Soreness and swelling of left arm; This is a spontaneous report from a contactable consumer. A 71-years-old female patient (not Pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in left arm on 03Feb2021 at 11:45 as 1ST dose, single for covid-19 immunization. Medical history included blood cholesterol increased, drug hypersensitivity, known_allergies of penicillin. Concomitant medication(s) within 2 weeks of vaccination included rosuvastatin, glucosamine & chondroitin; COQ10; fis. Facility where the most recent COVID-19 vaccine was administered included School or  Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Feb2021, the patient experienced rash on face, red, raised -cheeks, forehead, chin area-ongoing, soreness and swelling of left arm. The events assessed as non-serious. The treatment of antihistamine, aloe vera cream received for the events. The outcome of the events soreness and swelling of left arm was recovered where the events rash on face, red, raised -cheeks, forehead, chin area was not recovered.
Case number PHEH2013US014814 is an initial spontaneous report received from a nurse on 10 Jul 2013. This report refers to a 20-year-old female patient. Her medical history and concomitant medication were not reported. She received only Men CYW-135 liquid component of MENVEO (batch number: A11082) intramuscularly on 05 Jul 2013, without being reconstituted with Men A. No adverse event was reported following medication error.
Developed pain and redness at inj site the AM after. Swelling and redness extended length of left upper arm and tenderness in armpit and numbness and tingling in hand. Developed baseball size hard area at inj site. Rx with Benadryl only. Resolved in 8-10 days.
The pt developed red, hot and hard area (8"x6") at injection site. Treated with Keflex on 04/23/2002. The pt was in ER on 04/26/2002 with seizure due to temp of 105 deg. F. but chest x-ray showed bilateral medial basilar areas of atelectasis and infiltrate and minor bronchiolitis. Follow-up on 04/29/2002, the pt's still has firm area under skin, no redness, he or swelling.
pt recvd vax; exp fever, myalgia & localized pain persisting for more than 1 wk p/ vax;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Copd" (unspecified if ongoing); "obesity" (unspecified if ongoing); "TIA" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: COVID 19 Treatment from 07Jan2023 to 12Jan2023. Patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy, burning hives and rashes on left arm, armpit, upper chest and neck
Within one hour: Arm pain at site of injection which then radiated along nerve to tip of fingers. Muscle ache .joint pain and left arm weakness including shoulder. Patchy numbness. These symptoms spread to left leg between hour one and  two post injection. Brain fog. Mentle fatigue, and sleepiness followed along with mild headache.  Increased temperature with chills began after two hours. 4hours after limb pain,weakness and patchy numbness spread to right side. All symptoms continue 31 hours post vaccination and was unable to work the 26 and 27 of April
Feeling dizzy and light headed 30 mins after injection. One hour later felt  nausea and dizzy. BP 177/73, and 156/70-72 w/ repeat. Symptoms improved with Tums.
The patient received her first dose of COVID 19 vaccine at her living facility on 2/1/21 and did not remember this. She received the vaccine at our office on 2/9/21 which was only 8 days after the first one.  Pt did not have any SE but the vaccine's were not given the recommended 21 days apart.
Patient was given the vaccine and waited the recommended time (15 minutes) after the administration of the vaccine and did not report any reaction at that time. Approximately six hours after the injection, she suddenly noticed she was having trouble breathing, could not catch her breath, and a call was made to 911. She was transported via ambulance to the hospital, where she remained for a week.
Patient arrived to the healthcare facility with complaint of left upper quadrant abdominal pain on and off for approx 2 weeks. Noticed it began shortly after receiving the COVID vaccination. On April 15th, patient stated they had an increase in the left upper quadrant abdominal pain and new shortness of breath. Upon admission to ED patient had CT angio chest with contrast completed, results showed b/l pulmonary embolism with distention of the main pulmonary artery.