chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired PENTACEL was accidentally administered to a patient with no reported adverse event; Initial information was received on 09-Jul-2021 regarding an unsolicited valid non-serious case from a pharmacist in the United States (GMI Inquiry number: 00676148).  This case involves a patient (age and gender not reported) who was administered with expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was accidentally administered (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on batch number for this case.
Child given PENTACEL, ROTATEQ, and ENGERIX on 1/8/09. Child with apparent SIDS 1/12/09. I am not sure what the final ME report stated.
At 10:13 am, asked client if she was experiencing any side effects and she stated she had some tingling around lips, denied other symptoms. No respiratory distress. At 10:17 am, had tingling of upper and lower lips, no other symptom or respiratory distress. 10:27 am, tingling slightly improved, ears felt clogged. At 10:50, no change in symptoms. BP 148/90, complained of burning feeling to throat and when she received injection, "tasted it". Stated she did not take her allergy nose spray this morning. Cup of water given and swallowed without difficulty. Reviewed case with physician consultant and to observe for another 15 minutes. At 11:05, BP 110/70 and HR 76. Stated she feels ok to leave. Symptoms reviewed and went to call 911/ go to ER. Telephone call to client @1:19 pm- stated she is feeling fine, unsure what happened. Did not eat breakfast and maybe it was her "nerves".
(L) deltoid area, erythema, edema, warm, lumpy, child fussy and uncomfortable.
Received 2nd Menveo shot by error / extra dose of Boostrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640V, expiry date 30th November 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number MR5RK, expiry date 21st September 2023) for prophylaxis.   Previously administered products included Menveo (received 1st dose was on 18th August 2021 at 11 year old of age) and Boostrix (received one dose was on 18th August 2021 at 11 year old of age).   On 11th July 2022, the patient received the 2nd dose of Menveo and the 2nd dose of Boostrix. On 11th July 2022, unknown after receiving Menveo and Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: Medical assistant reported that a patient received a second dose of Menveo by error and an extra dose of Boostrix was administered on the day of reporting by accident. The reporter consented to follow-up by email. Additional supportive information: The patient received an extra dose of Menveo and Boostrix by error, which led to extra dose administered. The case US2022104953 was identified as duplicate of case US2022104945. Case US2022104953 was deleted due to being created in error. All future correspondence will be submitted to case US2022104945.
Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2AJ32, expiry date 2nd September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Pediarix and Pediarix 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 office manager had reported that, a patient had received an expired dose (2 September 2022) of the Pediarix vaccine at Left thigh on 19 January 2023. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Pediarix vaccine, which had led to expired vaccine used.
feels tired; aches & pains; Quite out; breathing troubles; diarrhea; not felt good; sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (sore arm), DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea), FEELING ABNORMAL (not felt good) and FATIGUE (feels tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included medication for blood pressure, medication for COPD, medication for heart, medication for high sugar and pain medication for neck and back pain for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (sore arm). On 31-Mar-2021, the patient experienced DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea) and FEELING ABNORMAL (not felt good). On 04-Apr-2021, the patient experienced DISCOMFORT (Quite out). On 12-Apr-2021, the patient experienced FATIGUE (feels tired) and PAIN (aches & pains). At the time of the report, MYALGIA (sore arm), DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea), FEELING ABNORMAL (not felt good), FATIGUE (feels tired), PAIN (aches & pains) and DISCOMFORT (Quite out) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
30NOV96 pt seen w/non descriptive rash macular w/t itch;2NOV96 seen again w/papular urticaria;9DEC96 itchy welts;7JAN97 T, URI sx, watery eyes, & rash, vesicular lesions;dx mild varicella breakthrough, lesions;lethargic;?immune dysfunction
Blood clots; Still in horrible conditoiin; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria medically significant and life threatening) and FEELING ABNORMAL (Still in horrible conditoiin). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown and FEELING ABNORMAL (Still in horrible conditoiin) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient got blood clots and almost died. The patient was still in horrible condition and also had spent multiple thousands of dollars on tests.  No concomitant medication was provided by the reporter.  No treatment medication was provided.  Company comment: This spontaneous case concerns a patient with limited information, who experienced the unexpected serious (life-threatening, medically significant) AESI Thrombosis, on an unknown date after a dose of mRNA-1273 vaccine (dose unspecified). The patient experienced blood clots and felt like almost died and was feeling abnormal. At the time of reporting, the event had not resolved. No further details were reported. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with limited information, who experienced the unexpected serious (life-threatening, medically significant) AESI Thrombosis, on an unknown date after a dose of mRNA-1273 vaccine (dose unspecified). The patient experienced blood clots and felt like almost died and was feeling abnormal. At the time of reporting, the event had not resolved. No further details were reported. The benefit risk relationship of mRNA-1273 is not affected by this report.
Headache, fatigue, muscle pain (whole body then shoulders), diarrhea first 2days, constipation following week.
No additional AE; a single dose of expired PENUMOVAX 23 was admnistered to a patient; This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.     The medical assistance reported that on 04-OCT-2021, the patient was vaccinated with a single dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number S036495 with expiration date 13-SEP-2021, for prophylaxis (dosage, route of administration and anatomical location were not reported). The vaccine had been stored in recommended range and had never undergone a temperature excursion. No additional adverse event (AE).
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: Vasovagal response
felt pretty rotten for 2 days; had a mild temperature, around 99-100F; sore arm at injection site; pretty strong body aches; felt very run down; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt pretty rotten for 2 days), PYREXIA (had a mild temperature, around 99-100F), VACCINATION SITE PAIN (sore arm at injection site), MYALGIA (pretty strong body aches) and FATIGUE (felt very run down) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced MALAISE (felt pretty rotten for 2 days), PYREXIA (had a mild temperature, around 99-100F), VACCINATION SITE PAIN (sore arm at injection site), MYALGIA (pretty strong body aches) and FATIGUE (felt very run down). In April 2021, MALAISE (felt pretty rotten for 2 days) had resolved. At the time of the report, PYREXIA (had a mild temperature, around 99-100F), VACCINATION SITE PAIN (sore arm at injection site), MYALGIA (pretty strong body aches) and FATIGUE (felt very run down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 99-100 (High) mild temperature, around 99-100F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2022-455755, MOD-2022-455756 (Patient Link).
had heart problems; 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 CARDIAC DISORDER (had heart problems) in a  patient of an unknown age and gender 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 CARDIAC DISORDER (had heart problems). At the time of the report, CARDIAC DISORDER (had heart problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
The patient developed shortness of breath 5 hours after receiving the Covid 19 vaccine on 1/29/21.He had "heavy wheezing " and finally went to the local ER the next day around 6 pm. He was treated with prednisone oral and felt immediate relief.
Wheezing, coughing, shortness of breath at 7:30 AM.  peakflow dropped from 380 to 330 on 12/11/09 at 4:00 AM.  Asthma exacerbation, nausea, headache, sore arm.
Information has been received from a registered nurse (R.N.) concerning a female patient in her late teens who on approximately 24-SEP-2010 (reported as "about 3 weeks ago") was vaccinated with a 0.5 ml dose of GARDASIL (lot # not provided). On approximately 24-SEP-2010 (reported as "about 3 weeks ago") the patient experienced "broke out in hives" after received GARDASIL. At the time of reporting, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
temperature excursion with our Moderna Covid-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The information was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion).    The temperature excursion occurred for both monovalent and bivalent. 27 total doses were administered post excursion.  The concomitant medication was not reported.  The treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
Follow up check and 4x3 cm edema, erythema, tenderness (L) deltoid began day of injection, worsened until seen in clinic on 6-8-08. Tm 102.
Within 1 hour post vax, the pt experienced periodic neuropathy in her feet and hands. She stated that this felt like pins and needles that moved around a bit, then resolved. The reporter also noted that she developed peripheral neuropathy in summer of 2000 while taking Baycol. Baycol was stopped and the symptoms resolved. It was also noted that the pt had taken Mevacor for 10 years and stopped, then restarted in 09/2000 as an alternative to Baycol and experienced a strange dry feeling in her throat. She stopped taking Mevacor and symptoms were resolving as of 01/04/2001.
10 minutes after immunization was given, as the patient was leaving the examining room, she turned around and started seizing and fell down. The seizure lasted less than 30 seconds. The patient recovered completely.
Local reaction - urticaria - pair/pruritic X 4 days, resolved by day 7.
I had minor side effects on January 28, 2021 first dose. My second dose was February 15, 2021. I called an ambulance at about 2:00 am on February 18, 2021, with severe pain on the left side of my face and left neck. The pain in my teeth felt like it was being drilled. I was nauseated and the ambulance people thought I was having a heart attack. My blood pressure is normally 110/65, but it was close to 200/104, I think they said. A few days later I went to another ER because the doctor thought I was having a stroke.
Unexplained and Sustained High Blood Pressure despite yearly lifestyle improvements.  Angiogram in 2013 showed no Atherosclerosis. Currently experiencing Systolic swings of up to 60 points in 24 hours. Unable to adequately control it with Medications
2 weeks after vaccination pt developed red, warm to touch blotch upper right arm ( presumably where received vaccine ) not indurated, tender to touch : pain across lower back and generalized myalgia
A large (4"long x 3"wide x 1.5 depth) welt on my left arm at injection site.  The site is warm to touch, itchy, and painful.
30 minutes after receiving vaccine, I experienced chest pain in the sternum area. Pain came intermittently and each occurrence lasted about 1-3 min. At the time of pain, it was more aggravated with talking, moving or laughing. Went to the ER for further examination but EKG was normal.
Sudden severe pain in Left foot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 07Sep2021 at 08:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing), notes: other medical history: Acid reflux. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: Not available/provided to reporter at the time of report completion,, Time of administration: 08:00 AM,, Anatomical location: Left arm), administration date: 17Aug2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "Severe pain in Left knee". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sudden severe pain in Left foot".  Additional information: It was reported that the patient did not take any other vaccines or medications in four weeks. The patient had sudden severe onset of severe pain in Left knee after the first vaccine. Sudden severe pain in Left foot after the second vaccine. The patient was not tested for COVID prior or post vaccination. Did not have any known allergy  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287298 same patient, different vaccine dose and different event.;US-PFIZER INC-202300287304 same patient, different vaccine dose and different event.;
Patient experienced a significant local reaction: redness (4 inch diameter) swollen, hard center lump at injection site (evaluated 06/14/19) - no previous complication with Td vaccine
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 2022, outcome "not recovered", described as "Terrible ear loss".  Additional information: Since patient got 3rd dose COVID vaccine patient was experiencing terrible ear loss, it has been 3 and half month now, Patient cannot stand it anymore it is like a nightmare, what should patient do?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st dose over a year ago, 2nd not received; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix vaccine over a year ago).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 08-OCT-2022 Reporter's Comment: This case was received from the patient via interactive digital media. The patient wanted to know if he/she could get the second shot of Shingrix vaccine. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Felt tired for one day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired for one day) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 24M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FINASTERIDE, DULOXETINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and AMLODIPINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Felt tired for one day). At the time of the report, FATIGUE (Felt tired for one day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.