chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular) .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The reporter reported that the vaccine was possibly reconstituted with sterile water instead of appropriate diluent. Error was discovered and reported when staff thought an empty box was in refrigerator. The date issue was identified was 8th June 2022 The patient could have received inappropriately reconstituted vaccine. Centers for disease control and prevention/GlaxoSmithKline advised to reimmunize the patient. It was a medication error without harm. The reporter consented to follow-up. Additional supportive information: The patient received the inappropriately reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This is 1 of 5 linked case, reported by same reporter, for different patient.; Sender's Comments:  US-GSK-US2022AMR117819:Same reporter US-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117821:Same reporter US-GSK-US2022AMR117801:Same reporter
Tinnitus has gone from very quiet and manageable to very loud.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 00:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included "BP and Thyroid meds" (blood pressure and thyroid medications). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified BP (blood pressure) and thyroid meds (medications) taken from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11Apr2021 at 00:00, the patient experienced tinnitus which had gone from very quiet and manageable to very loud. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus had gone from very quiet and manageable to very loud was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
We vaccinated the patient with Moderna booster instead of half the dose (0.25 ml) we gave a full dose (0.5ml) we called the patient and let the know, they said they are feeling fine
A report has been received from a female physician via medical representative concerning herself. The age of the patient was unknown. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medication was not provided. The reporter reported that the patient (who was a physician) received FLUMIST in Sep-13 and was diagnosed with the flu in May-14. Patient was down for 12 days. The outcome of the event of diagnosed with influenza was unknown. The reporter assessed the event of diagnosed with influenza to be non-serious.
Patient called today 11/2/17 and informed me that next day after getting vaccine his forehead and eyes were extremely itchy and lasted for almost 23 hours.
Soreness, redness, swelling in left arm at injection site. Fatigue, headache, nausea, diarrhea, muscle pain.
The patient's mother called on 03/16/01, stated the child had a headache and marks on his body. He was seen in the doctors office positive chicken pox approximately 20 total.
When giving the booster a vanishpoint syringe was used and it did not retract. When taking it out of the arm, more than half of the vaccine came out of the syringe. The shot was given with a new syringe, again at the 0.25mL volume.
raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on RIGHT forearm; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 26Mar2021 at 10:15 at single dose for COVID-19 immunization. Medical history included allergic to penicillin, tetracycline, keflex, all sulfa drugs, Diflucan. Concomitant medication was not reported. Patient was not pregnant at time of vaccination. On 18Mar2021, patient tested nasal swab and resulted negative. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021 at 11:00, the patient experienced raised rash on left forearm & upper arm with itching & burning sensation. The patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received treatment with steroids & Benedryl. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the covid booster on Thursday Sept 30th at approx 11 AM. About 10:30 PM that evening, I felt a cascade of heat starting in my scalp and slowly down the body. Red patches appeared all over my body, pinpricks all over, my heart was tachy and pounding. I took 50 mg benadryl PO and the event completely passed in about 30-40 minutes. The next day, Oct 1, there was a similar event at about 11 AM, and again at 10 PM the evening of Oct 1. Treated as before. Total of 3 events in the 48 hours following the vaccine.
Cold; Felt drugged; Tired; Chills; This is a spontaneous report from a contactable consumer (Patient) reporting on herself. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 IMMUNIZATION. Patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced tired, chills.Clinical course of the events includes: On 10Feb2021, the patient states the next day in the afternoon she got a little tired and cold, she laid down for a while, had dinner at 6, had a bowl of chili and got really, really tired, states she was so tired she could not even put her dish on counter, states she felt drugged is the only way she can describe it.The patient states that she got in bed and she got the chills, they lasted for hours, the next day towards the evening got chills again and that lasted about 3 hours and they were gone by 11Feb2021. Patient was in the car and does not have card with her at this time and could not provide much details about product. The outcome for the events was reported to be recovered on 11Feb2021.   Information on batch/lot number has been requested.
Pt vaccinated with Engerix-B developed headache, nausea, tired, weak, stomach pain.
Severe thrombocytopenia; This is a spontaneous report from a contactable Nurse. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient had known allergies: methotrexate. There were no concomitant medications. No other vaccine in four weeks. The patient experienced severe thrombocytopenia on 17Feb2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for severe thrombocytopenia for 2 days. Patient was referred to hematology proactive for severe thrombocytopenia, likely ITP. Platelet (Plts) 5 and then 1. He was sent to the Emergency room (ED) and received plt transfusion w/ minimal effect. He was started on Intravenous Immune Globulin (IVIG) as well as high dose steroids. Plts currently w/i normal range after above treatment. The outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association,  the Company  assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported event Severe thrombocytopenia. 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.
Fever at 1 am. Woke at 3 am with erratic pulse, and fainted upon trying to stand. Woke again at 9am, pulse still erratic, attempted to stand, fainted again.  Patient has no history of fainting from vaccines and was under no stress at time of visit. Patient is a healthcare worker and accustomed to medical settings. This happened greater than 12 hours AFTER the visit. It was not a reaction to being vaccinated but was DUE TO THE EFFECTS OF THE VACCINE.
This spontaneous report as received from a Licensed Practical Nurse refers to a 12 month old patient of unknown gender. On 28-OCT-2014 (also reported as today) the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneous injection, lot number and expiration date were not reported) and PROQUAD (Merck) (0.5 ml, subcutaneous injection, lot number and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Severe headache, tiredness, nausea, weakness, fever of about 103, weakness and paleness, dizziness, and trouble breathing/shortness of breath.
'had her second dose of the covid-19 vaccine on 05Feb2021 and tested positive for covid-19 on 10Feb2021'; 'had her second dose of the covid-19 vaccine on 05Feb2021 and tested positive for covid-19 on 10Feb2021'; This is a spontaneous report from a contactable consumer received from Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received the second dose of BNT162B2 (Covid-19 Vaccine, solution for injection) via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Swap from IBCC - Caller had her second dose of covid-19 vaccine on and tested positive for covid-19 on 10Feb2021, relayed PMI number for future reference, transferred, relayed long hold time, will fax AE/PCOM, Pfizer First Connectd cep id 2191. Outcome of the event was unknown.  Information about lot/batch number has been requested.
FELT WEAK; FELT LIMPED ON BOTH OF HER UPPER ARMS; TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE; WORSENED TREMORS ON BOTH THE LEGS; ELECTRICAL IMPULSE/TINGLING SENSATION; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001EZ1A and 038B21A) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    The patient's past medical history included Ex-smoker from 1976 to 2010, Anemia in 2021, Nervousness and Phlebotomy in December 2020. Previously administered products included for Product used for unknown indication: DILAUDID and ORENCIA. Past adverse reactions to the above products included No adverse event with DILAUDID and ORENCIA. Concurrent medical conditions included Penicillin allergy (Manifested by dry heaves, super sick to stomach but could not vomit) and Drug allergy (Manifested by hives on her back and itchy). Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In May 2021, the patient experienced ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION). At the time of the report, ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Aspartate aminotransferase (9-32): 230 U/L. On 10-May-2021, Serum ferritin: showed high iron with unspecified level..         No treatment medication was reported. The patient had received shingles vaccination on 11May2021.  This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation # QE  019993
The next day left upper arm became very warm, red, swollen  and painful and continued to spread to axilla.
Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)    This is a 86 yr old male with PMHx of CKD-3, gout, persistent Afib, HTN, HLD and BPH who presented for generalized weakness and falls.  CT head was negative.  UA showed evidence of infection and Ucx grew 2 strains of E coli so he was started on ceftriaxone.  He had a CT urogram which showed 2 new bladder masses.  Urology was consulted and said workup can be done outpt.  He follows with Urology at other facility and he will decide if he wants to follow up with them or stay here for the workup.  During his stay he developed a gout flare and was started on a steroid taper along with colchicine.  His heart rate was elevated so Toprol dose was increased.  PT/OT recommended SNF.  Pt was stable on discharge.  He will be discharged.     Sepsis 2/2 UTI - elevated wbc and HR - sepsis resolved - Ucx growing E coli 2 strains - continue cefdinir 300mg BID for 3 more days   New bladder masses Hx of bladder cancer - s/p TURBT - CT urogram showed 2 new bladder masses  - follow up with Urology outpt for workup   Elevated Cr on CKD-3 - baseline Cr 1.4 - likely due to poor perfusion in setting of infection  - resolved    Gout flare - evidence of polyarticular disease with tophi - continue prednisone 40mg for 3 days, then 30mg for 3 days then 20mg for 3 days - start colchicine 0.6mg every other day - start allopurinol 100mg daily on 5/6/23 - referral placed to Rheumatology   Afib with RVR - CHADS-VASc- 3 - continue Eliquis 2.5mg BID - increased Toprol to 100mg daily, monitor HR and may need dose reduced   HTN - continue HCTZ 12.5mg daily, lisinopril 10mg nighlty and Toprol   HLD - continue atorvastatin 20mg daily   BPH - s/p HoLEP   Issues Requiring Follow Up: (Who, what, when, and how communicated?)    Follow up with PCP and Urology.  Referral placed to Rheumatology.  Complete 3 more days of antibiotics.  Complete steroid taper.  Start colchicine and allopurinol.  Toprol dose increased, monitor HR for dose adjustments.
more than a year between doses/Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 03-OCT-2022, 1st dose was received).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: more than a year between doses/Longer than recommended interval).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The pharmacist called in to request information about how to proceed after a patient waited more than a year between doses. Partial information about event, vaccine and patient given. The reporter consented to follow up. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination
Five days after vaccine I developed significant swelling in my left neck; The day of vaccine I was very dizzy; a warm sensation in my chest; a warm sensation in my chest; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:30 (Lot number: EW0169) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ASPIRINE; LOSARTAN; SPIRONOLACTONE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: SWELLING (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Five days after vaccine I developed significant swelling in my left neck"; DIZZINESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "The day of vaccine I was very dizzy"; CHEST DISCOMFORT (non-serious), FEELING HOT (non-serious) all with onset 25Aug2021, outcome "not recovered" and all described as "a warm sensation in my chest". The events "five days after vaccine i developed significant swelling in my left neck", "the day of vaccine i was very dizzy", "a warm sensation in my chest" and "a warm sensation in my chest" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, dizziness, chest discomfort, feeling hot. Additional information: Five days after vaccine I developed significant swelling in my left neck. The day of vaccine I was very dizzy and a warm sensation in my chest. Vaccine facility type was doctor's office/urgent care and facility country was Country. The patient did not receive any other vaccine in four weeks. The treatment included CT scan, blood work and antibiotics. The patient did not have Covid prior to vaccination and not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
After both COVID vaccinations and booster, patient  tested positive for COVID using PCR/symptoms of fatigue, sore throat, low grade fever and cough; After both COVID vaccinations and booster, patient  tested positive for COVID using PCR/symptoms of fatigue, sore throat, low grade fever and cough; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Lot number: FJ1620) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "After both COVID vaccinations and booster, patient tested positive for COVID using PCR/symptoms of fatigue, sore throat, low grade fever and cough"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Additional information: After both COVID vaccinations and booster, patient tested positive for COVID using PCR. Patient has symptoms of fatigue, sore throat, low grade fever and cough. Booster dose was 23Nov2021  The lot number for bnt162b2 was not provided and will be requested during follow up.
Red sore arm,, Fever under 101Degrees,  chills, headache,body aches, about 12 hrs. After injection. Lasted about 24 hours.
My husband and I both had the Moderna Covid-19 Vaccination on February 6.  After the first dose, we both just had sore arms.  Today,  March 9, after having had the 2nd dose on March 6, both of us have swollen  and warm arms with a red rash.  We had both vaccinations in the same arm rather than changing arms.  I am just reporting this information so that it is in your files in relation to the number of people who report this reaction  Perhaps the second dose should be given in alternate arm.  I, not my husband, also experienced 101.7 fever with aches the next day. Husband had headache. Since this is such a new vaccine, I thought this information would be useful.
I got my booster on 12/15/2021, around 12/16/2021 I got a breakthrough period, I went to the ER on 12/18/21 because my period was freaking me out. I do not have periods. They said it was natural. It was triggering suicidal thoughts.
It felt like I had contacted the virus all over again except worse than last time. Body aches, chills, fever, nausea, severe headache, fatigue, slight cough, balance and coordination problems, chest pains. Literally the only things I don?t have are the loss of taste and smell.
Started having neck pain 3 days after first dose.  The pain sometimes hurts in my ear and into my head.  It hurts to move my head or touch my neck.  This is the same side of my body I received the shot.  It hurts to lay on that side because just the pillow touching it hurts.  No other symptoms except soreness at the site of the shot within 24 hours which subsided within 48 hours.  I have been taking tylonal today which seems to help.
Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization peripheral neuropathy left side of body including left testicle burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness