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 11-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-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117801:Same reporter US-GSK-US2022AMR117816:Same reporter US-GSK-US2022AMR117821:Same reporter
Vasculitis; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to pt's inoculation, the pt was treated for vasculitis. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of vasculitis was unknown. The reporter considered vasculitis to be related to Zoster Vaccine Live (ZOSTAVAX).
Pericarditis. Awoke day after vaccine with chest pain, tachycardia, and arrythmia. Echocardiogram shows thickening of pericardium. Unknown whether this is permanent damage, but I understand it to be. Awaiting an MRI next week for more details. I had no adverse reaction to previous three vaccines.
Stiff neck, burning pain in shoulders, headache. Stiff neck was opposite side of injection site.
THROMBOCYTOPENIA; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 15-JUN-2021 12:00 PM for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-JUN-2021 at 21:30, the patient had a bruise with a radius of 15 centimeters on forearm and not on the site of vaccination. On an unspecified date, the patient had thrombocytopenia. The patient visited emergency room for a blood test, but he was in the category of normal thrombocytopenia and thrombosis-related levels. At the time of this report, the patient's thrombocytopenia trend was being monitored by taking blood tests every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210649091 - Covid-19 vaccine ad26.cov2.s- thrombocytopenia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Twenty-four hours post injection, pt's mom noticed arm to be swollen, red and hot at injection site. Treated for cellulitis by the physician.
Approximately 24 hours after injection (Sept. 26), tenderness in left armpit, upper deltoid above injection site.  Later that day noticed enlarged, rubbery to rigid, painful, lump on upper side of left clavicle.  Lump was somewhat mobile, but movement caused discomfort.  By second day after injection (Sept 27), pain in upper left deltoid less, but not gone.  Left armpit near the pectoral region remained tender, but not painful. Lump (swollen lymph node?) on top side of left clavicle still present and painful.  By evening and that night, noticed growing tenderness around left groin area.  Not actual pain, and no signs of swellings or lumps, but definite soreness and tenderness. Third day after injection (Sept 28), swollen node/lump on left clavicle still swollen and painful, particularly when pressed or moved. Seatbelt in vehicle pressed against it frequently when driving, causing pain.  Left armpit and pectoral areas no longer painful.  Left groin area still ached and tender well into the night.  Fourth day after injection (Sept. 29) lump over left clavicle subsided, no longer painful.  Left groin area no longer tender or sore by end of day/evening. By fifth day after injection (Sept 30) no further signs of side effects, pain or tenderness.
A MENTAL FOG ALMOST LIKE A HANGOVER; FATIGUED; FEVER UPTO 101.4 F; HEADACHE; SOAKING SWEAT OVERNIGHT; BECAME  ACHY; CHILLS; SO COLD WENT TO BED ALL BUNDLED UP; MODERATE ARM PAIN; FELT A BIT NAUSEOUS; This spontaneous report This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. pretty healthy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced soaking sweat overnight. On 12-APR-2021, the subject experienced became achy. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced so cold went to bed all bundled up. On 12-APR-2021, the subject experienced moderate arm pain. On 12-APR-2021, the subject experienced felt a bit nauseous. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 97.0 F. On 13-APR-2021, the subject experienced a mental fog almost like a hangover. On 13-APR-2021, the subject experienced fatigued. On 13-APR-2021, the subject experienced fever upto 101.4 f. Laboratory data included: Body temperature (NR: not provided) 99.7 F, and (NR: not provided) 101.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a bit nauseous, was recovering from moderate arm pain, chills, soaking sweat overnight, headache, and became achy, had not recovered from fever upto 101.4 f, a mental fog almost like a hangover, and fatigued, and the outcome of so cold went to bed all bundled up was not reported. This report was non-serious.
Low grade fever, moderate to severe headache, and swelling under left armpit (swollen lymph node?)  The headache started within hours of the 3rd dose (this lasted about 4 days).   The low grade fever started about 8 hours later and lasted less than 12 hours.  The swollen lymph nodes/pain in armpit began by next morning, November 2nd and lasted until Sat Nov 6th or Sun Nov 7th (don't remember exactly). I emailed my doctor on Nov 2nd and he said to take Tylenol every 6-8 hours.  I only emailed with him, I didn't see him.
sore; fever; chill; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), PYREXIA (fever) and CHILLS (chill) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (sore), PYREXIA (fever) and CHILLS (chill). At the time of the report, PAIN (sore), PYREXIA (fever) and CHILLS (chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Feelings of having a fast-beating, fluttering, or pounding heart. Starting 12/9/2021. Sudden chest pain happen randomly. According to the public information, this could be the symptom of heart inflammation
Redness 4x5cm around the place where Tdap administered (left arm) (no pain). Noted 24 hours after vaccine administrated. Resolved within 72 hours.
Extreme exhaustion, high fever (topped at 105.2). Fever continued at a lower temp through most of May 5. Started taking Tylenol and Ibuprofen on morning of May 5 which helped. Lethargy continued until morning of May 6 after which I felt fine, almost immediately.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 4:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 4:09 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 42.02 for dose administered on 13-Feb-2021. No concomitant medications were reported. On 13-Feb-2021, the vaccine with batch number 031L20A was moved to fridge on 09-Feb-2021, 3 to 30 vials were moved to the clinic on 13-Jan-2021 to 12-Feb-2021 at 09:00 AM to 11:00 AM, vials underwent temperature excursion with temperature of 32 to35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 10-Mar-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old female. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics provided. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Headache and nausea started at 10 pm, 9 hours after injection. Over the next several hours,  headache worsened, chills set in along with low-grade fever (100) and elevated heart rate.  Took Tylenol 500 mg at 4:30 a.m. after not sleeping for hours. Continued taking Tylenol every 6 hours for the next 24 hours for the headache. Fatigue and slight 'brain fog' lasted for 5 days.
bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021; Wrists swell up; itchy red rash; Bubble like bump on the top of the wrist; itchy red rash; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Wrists swell up), RASH PRURITIC (itchy red rash), NODULE (Bubble like bump on the top of the wrist), RASH ERYTHEMATOUS (itchy red rash) and NODULE (bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced JOINT SWELLING (Wrists swell up), RASH PRURITIC (itchy red rash), NODULE (Bubble like bump on the top of the wrist) and RASH ERYTHEMATOUS (itchy red rash). On 09-Jun-2021, the patient experienced NODULE (bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Wrists swell up), RASH PRURITIC (itchy red rash), NODULE (Bubble like bump on the top of the wrist), RASH ERYTHEMATOUS (itchy red rash) and NODULE (bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021) outcome was unknown.            No concomitant medications were provided.
Information has been received from a nurse through the pregnancy registry for GARDASIL concerning a female who on unspecific date was vaccinated with a dose of GARDASIL (Lot # not provided). The nurse reported that a patient received the vaccine when she was pregnant. The patient voluntarily terminated the pregnancy when she learned that she was pregnant. Patient has sought unspecified medical attention. Additional information has been requested.
On the evening of Day 7. I developed a large, red, hard, raised area at the site of the injection.  It is painful, but tolerable.  It is presently  2 inches in diameter . I had a reaction within 24 hours of the injection that was also hard and red, but that started to fade after 3-4 days. This is new, larger and redder. I have taken diphenhydramine, ibuprofen and applied cool compresses. I believe it is ?Moderna Arm? or  ?Vaccine Arm? from what I read on your website.
Patient received Hep A on right arm and HPV on Left arm a few seconds later while nurse in room had dazed look and feeling a heavy feeling lay back some shaking + fainted nurse put her feet up she woke up and said she had a weird feeling + no treatment walked out of clinic given water felt better.
Explosive diarrhea, extreme flu like symptoms, headache, felt like my bones were on fire and I was shivering - these lasted for about 30 hours after the vaccine. I stayed in bed for the duration.
PRODUCT STORAGE ERROR; VACCINE WAS INJECTED DIRECTLY FROM THE FREEZER INTO THE PATIENT WITHOUT THE VACCINE BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2022 for prophylactic vaccination. Age at time of vaccination 25 years old. No concomitant medications were reported.  On 01-APR-2022, the patient experienced vaccine was injected directly from the freezer without the vaccine being stored at recommended storage conditions of 2 to 8 degree celsius.  On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was injected directly from the freezer into the patient without the vaccine being stored at recommended storage conditions of 2 to 8 degree celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505162, 20220505373, 20220505593, 20220504995 and 20220505044.
Migraine, muscle soreness, joint pain, severe body aches on day 3 lasting less than 24 hours.   Took two Imitrex and 400mg Ibuprofen to reduce symptoms. Some residual minor shooting muscle leg pain on day 4  and 5
Vaccine  rash  silver dollar  sized  raised  from  surface  started  itching  not  anymore - began 2-22-21
PATIENT REPORTS THAT HE HAS HAD TINGLING SENSATION AND PAIN RADIATING FROM THE INJECTION EVER SINCE THE FIRST DOSE FROM DECEMBER 2020.  PATIENT STATES THAT IT FEELS LIKE ARTHRITIS AND HAS BEEN APPLYING TOPICAL PAIN RELIVEING CREAM FOR RELIEF,
Shoulder pain 6/10 at it's worst. Inability to raise arm w/out pain. Motrin taken for pain/discomfort.  Patient advised she is afebrile, no swelling and no skin discoloration.
About 13 hours after vaccine, fever to 100.4 F, shivering, chills, muscle aches, headache, nausea, fatigue, slight abdominal cramping.  Throughout the day, fever continued despite Aleve  and aspirin, but muscle aches began to subside with aspirin.  Abdominal cramps lasted about an hour, and nausea went away after chicken soup and sleep.  24 hours after vaccine, fever coming down to 99.2F, muscle aches diminished, no nausea or fatigue, or abdominal cramping.  The next morning, only a slight headache remained, no other symptoms.
I was informed on Monday that the people I was around that previous Saturday were testing positive for COVID-19. I tested that day and Tuesday and those test came back negative.   Wednesday I felt worse and was still testing negative. I went to the local drug store to be tested again and that came back negative. I was told to come back that Friday but I felt bad on Thursday so I tested at home at that came back positive. My first symptom was a sore throat, I started to have a cough. I also had a fever, the highest was 101 degrees. I had a headache, and basically very fatigued. I was taking Tylenol up until the Thursday that I tested positive. On Thursday when I called my doctor she prescribed Paxlovid and also suggested I get an Oximeter. I did start the Paxlovid on Thursday and by Sunday I actually thought I was feeling better on but that night my cough started to get worse. That following Monday I went to walk my dog and started to have shortness of breath. It happened very quickly. I called the doctor and it was suggested I go to a urgent care facility. By the time I got there, My breathing got worse and barely made it into the facility. They called an ambulance for me to take me to the hospital. I spent that day and night in the emergency room. I really could not breath,  I was having difficulty breathing. They did a CT scan and it was discovered I had Pneumonia. They wanted me to go to a larger hospital because they didn't have any rooms available. I was transported by ambulance around midnight to the larger facility. I was there for a week and was discharged the following Monday 9/26. The hospital prescribed me Furosemide, Potassium Chloride, Ferrous Sulfate, and B12. I have a follow up with my primary care in about a week. They did a heart scan and it was discovered that I had damage to one of the valves in my heart. I am going to be seen by a heart specialist in a couple of weeks. I was given Steroids while I was in the hospital and I was on oxygen.
Rash; This is a spontaneous report received from a contactable consumer (mother). This consumer re-ported behalf of female patient (daughter) in response to Non HCP telephonic follow up activity that included.   A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that she took Pfizer covid vaccine and got a rash. Outcome of event was unknown.  Follow-up attempts were completed. No further information is expected; information about lot/batch number could not be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101152710
2min after receiving the vaccines, pt complained of dizziness. Pt was placed in a recumbent position chair. Pt experienced a vasovagal episode and was unconscious for less than 5 seconds. Pt was then A&O x4 with stable vitals. Pt was observed for 30min and released.
Began hearing echos in left ear night of shot date. At first, thought it was the TV. Later, I realized constance ringing in same ear. Later, realized some lost of hearing in same ear, left side.