chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix was not given in a complete dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 21-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 24-APR-2023, the patient received Boostrix. On 24-APR-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: Boostrix was not given in a complete dose). The outcome of the incomplete dose administered 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: 24-APR-2023 The reporter was medical assistant. The reporter reported that a needle cracked and Boostrix was not given in a complete dose. The vaccine administration facility was the same as primary reporter. No additional adverse event details were reported at that time. The reporter consented for safety team follow up.  The vaccine was not given in a complete dose as the needle cracked, which lead to incomplete dose administered.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 07-AUG-2018, the patient was inadvertently vaccinated with an expired dose of ROTATEQ via oral (strength and dose were not reported) lot # M043836 and expiration date: 17-JUN-2018, indicated for prophylaxis. No adverse effects were reported.
Severe chills, severe nausea, dry mouth, joint and muscle pain, particularly lower back and hip, but all over, hot around ears. Heart palpatations, high anxiety. Next day- chills, sinus migrane, vomitting, no appetite. Finally about to eat a little the night of day two. Feeling better by day three. Still nausea, but much better.
After injection left arm was swollen and sore. Right arm was sore but not swollen, I woke up in the middle of the night with nausea, legs got week and fainted hitting head against door jam. Could not get out of bed for two days and slept off and on during both days.Second day left arm was red to the elbow and more swollen. Third day left arm has redness towards left hand an still swollen and sore.  Continue to be nauseous and light headed, dizzy and have a headache.
Received flu vaccine on 11/2/17. On 11/2/17 at 8 PM pt. began having hives to elbows, knees, feet, hands. Took TYLENOL on 11/3/17 AM, ZYRTEC on 11/3/17 noon time.
sinus congestion; cough symptom; joint pain; muscle pain; fever; felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt really sick), SINUS CONGESTION (sinus congestion), COUGH (cough symptom), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM for Anxiety, LEVOTHYROXINE SODIUM (THYROXIN) for Hashimoto's thyroiditis, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (felt really sick), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever ). On 23-Apr-2021, the patient experienced SINUS CONGESTION (sinus congestion) and COUGH (cough symptom). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ILLNESS (felt really sick), SINUS CONGESTION (sinus congestion), COUGH (cough symptom), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 102f (High) Fever 102F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-089488 (E2B Linked Report). This case was linked to MOD-2021-089560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089488:Crossed linked
03/30/2022 vaccination. 05/28/2022 scratchy throat with headache, coughing. I went to my daughters house and she has little ones. They asked to take COVID test. The results were COVID-19 positive. 05/29/2022 contacted my PA. Put on PAXLOVID. I was on 2 of the 3 doses. There was a possibility of a kidney interaction.
Lymph Node under left axillary swelled to size of baseball approximately 24 hours after injection.; This is a spontaneous report from a contactable other HCP. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 2 intramuscular, administered in Arm Left on 23Jan2021 (at the age of 34 year) as dose 2, single for COVID-19 immunisation at clinic. Patient had known allergies. No covid prior vaccination. No covid tested post vaccination. No If other vaccine in four weeks. Patient received other medications in two weeks. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 (at the age of 34 year) for COVID-19 immunisation at clinic. On 24Jan2021, patient experienced Lymph Node under left axillary swelled to size of baseball approximately 24 hours after injection. It was reported that no therapeutic measures were taken for the events experienced. The outcome of event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L029615, the expiration date: 15-MAY-2017, Lot# M012495, the expiration date: 09-OCT-2017 and Lot# M004890, the expiration date: 10-NOV-2017 (dose was not provided) for prophylaxis. No adverse effects reported nor Product Quality Complaint involved (PQC). The call was made due to data logger with a temperature of 35°F during 45 minutes. There was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact. This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # L029615, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. {Additional information has been requested. / Additional information is not expected.}; Sender's Comments: US-009507513-1703USA009966: US-009507513-1704USA001678: US-009507513-1704USA001679:
Red, raised, hard lump in arm, painful and warm,  First noticed on the day after the injection.
Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21.
Patient was sick with a low fever and diarrhea shortly after his 1st birthday. His fever increased and he had a febrile seizure and went to the ER. The next day was his 1 year appointment with his doctor and we discussed the event.  His diarrhea continued and had blood it in so the next day we took him to the weekend drop in at his pediatricians office. They did a stool sample and we found out that he had salmonella. No idea if it's related to the covid vaccine. Also, his pediatricians office gave him his 3rd does of the covid vaccine on the immune compromised schedule by mistake because Patient is not immune compromised. Not sure if that is an important detail.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      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 unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored in cooler 1, on 31-MAR-2021 and the excursion duration at 8 am was 32  taken using a Fisher brand traceable temperature monitor in F.  On  31-MAR-2021, total doses given for the day was 199, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 23-MAR-2021, vial was moved to clinic on  31-MAR-2021. 4 vials were moved to clinic. Vaccine BUD date was 22-APR-2021 for batch number 019B21A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  No treatment information was provided   This case was linked to MOD-2022-566976 (Patient Link).
Generally did not feel good for several days afterward.  Dizziness and balance problem lasted  about a week.  Worst for me was a serious deterioration of my eyesight (estimated 50% reduction) for 7 days and slight improvement to  about 25% eyesight reduction in the second week, gradually improving to near normal in the third week after the first dose. At this point I'll mention that after the second dose, I had almost no adverse reactions, except for, again, an eyesight difficulty, a lesser reduction (about 25%) in my eyesight for four days, improving to normal after about a week.
Mild fever (99.7) (only the day after)  Injection site tenderness and swelling of the lymph nodes (in the same arm of the injection) (fever subsided but pain and swelling of lymph node in armpit of same arm as injection began the following night, increased the next morning)
Shingrix powder vials unmatched adjuvant diluents; Patients may have received the diluent only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's comment: Pharmacist reported that they found in their stock three Shingrix powder vials unmatched with adjuvant diluents.  Three patients might have received the diluent only. The consent to follow up was given. Additional Supportive Information: The patient received Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR099690:Same Reporter, Patient 2 US-GLAXOSMITHKLINE-US2022AMR099689:Same Reporter, Patient 3
Loss of hearing; Blockage in left ear/ Pressure in her ear; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Loss of hearing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Loss of hearing) (seriousness criterion medically significant), EAR DISCOMFORT (Blockage in left ear/ Pressure in her ear) and HEADACHE (Terrible headache). At the time of the report, DEAFNESS (Loss of hearing), EAR DISCOMFORT (Blockage in left ear/ Pressure in her ear) and HEADACHE (Terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication information were not reported.  Patient need Pfizer vaccine because she believed it was the gold standard vaccine but vaccinated with Moderna vaccine.  It was reported that patient already consulted with her health care professional.  This case concerns a 67-year-old female with a serious unexpected event of deafness, and nonserious ear discomfort and headache. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 67-year-old female with a serious unexpected event of deafness, and nonserious ear discomfort and headache. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
One of five pts who recvd DTP/OPV/HIB exp swelling & redness @ DTp inject site & extreme irritability; pt also had inconsolable crying for more than 3 hrs;
patient developed rash, redness, soreness at/around injection site 2 weeks post vaccination event
Pt Received her first dose of SHINGRIX vaccine on 10/19. Pt is reporting that same evening she began feeling: muscle weakness, joint/muscle soreness, swelling and reddening at the injection site, also a "flu" like condition of being cold. She also reported vomiting. Says she was too weak to get out of bed for 3 days.
Breakthrough case admission after three vaccines: Moderna 2/26/2021 batch/lot# 025A21A; Moderna 3/26/2021 batch/lot# 016B21A; Moderna 11/19/2021 batch/lot# 039D21A.
I had a flare up of Herpes on my lip.   Prior to that I did not have any flare ups in the prior 3-5 years.
Felt light headed 2 days bad  fatigue and second day sweaty. Been 1 week today and I still feel very weak.I had the virus July 28th where I had green ruins flushing out of me for 1 week . A little cough and  no appetite .weak for month and confused a little.  Then tested positive for the  antibodies. I heard the second shot can be worst and also if the had the virus so I don't think I want to get the second shot. I have a high immune system  and never had the flu shot or get sick .I only have sinus that effects me in change of weather .I hardly take anything for thatc.
He came to the hospital with a chief complaint of chest pain.  Diffuse all over the chest, 5 to 7/10, nonradiating to the left arm or to the back or to the jaw.  Patient reports some significant cough associated with the chest pain.  He denies any significant shortness of breath.  Denies any fevers but did have some chills.  Denies any abdominal pain, nausea, vomiting, burning or painful urination, diarrhea.  Chest pain has been going on for the last 2 days.  Tested positive on 01/03/2022
rash 12 day post rubella vax JUN93 now AUG93 c/o joint pain & swelling is being worked up as inflammation due to inject or autoimmune disease;
After receiving the vaccine I had a intense flair up of my controlled IBS-D. This included intense abdominal pain and spasms and diarrhea  that lasted days. I had to begin treatment with  Dicyclomine 10mg. I also had a flair up of my eczema not only on my neck where I usually have it, but also along my left bicep and forearm. I treated it with Fluocinolone topical solution.  I have also been having an issue with trembling hands and muscle twitches in my legs. Also for the 2 days after the vaccination I suffered from fatigue.
pt recv vax 11/10/97 & on 11/25/97 pt exp a possible apneic event;for 20 seconds no chest movement was observed;pt began to take breaths w/minimal stimulation;pt was hosp & did fine in hosp;
sore throat; miserable time; Initial information was received on 16-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210219000583).  This case involves an adult patient who experienced sore throat (oropharyngeal pain) and miserable time (feeling abnormal), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore throat (oropharyngeal pain) and miserable time (feeling abnormal) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
no further AE reported; administration of an expired V AQTA vaccine; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 03-NOV-2020, the patient was vaccinated with an expired, pediatric dose of hepatitis a vaccine, inactivated (VAQTA) strength: 25 U/0.5 ml, 1 injection, lot # S025993, expiration date on 17-NOV-2020, for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
severe Axillary swelling and pain over 12 hours worsening over 72 hours started on aspirin and cold compresses
Headache, then chills, then fever reaching 103.7. Lasting 12 hours. Took Tylenol.
slight fever (99.5F), chills, nausea, headache, significant aches and pains all over body (especially in all arm joints in both arms:  wrists, elbows and shoulders), fatigue; duration 12 hours
sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.       This case was linked to MOD-2021-279367 (Patient Link).
The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM; Left at room temperature for more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM) and PRODUCT STORAGE ERROR (Left at room temperature for more than 24 hours) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022 at 10:21 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2022 at 8:12 AM, the patient experienced PRODUCT STORAGE ERROR (Left at room temperature for more than 24 hours). On 15-Feb-2022 at 10:21 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM) and PRODUCT STORAGE ERROR (Left at room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that the patient received Moderna booster dose which was left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12 AM on 14-Feb-2022 and was administered at 10:21 AM.  No treatment information was provided. No symptoms were reported.