chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my arm is a little sore; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 16Feb2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced arm is a little sore. The patient received 2nd dose and she was experiencing no side effects. The patient stated that she is at the 23rd hour. In fact, the patient felt better than she usually does, her arm is a little sore. The patient said it is about the same as the first time. The patient asked if the shot was good or that he gave me enough. The patient asked if the vaccine was working because she was not experiencing side effects like other people. The reporter asked about a test for antibodies to see if the vaccine is working, referred further about antibody testing. The outcome of the event is unknown.   Follow-up attempts are completed. No further information is expected.
Fever onset at 12 am (approx 12 hours after vaccine) 103.6 restless night, unable to sleep and did not want to be put down. Had fever next day all day. 2nd day fever ended but she was still crying and unsettled. Saw DR 3/23 to Discuss SXS. No treatment.
Upon returning home after receiving vaccine injections at approximately 2 pm on 5/14/07, pt. began experiencing severe headache, tinnitus, and respiratory distress. Pt. self treated with 50 mg Benadryl and 3-4 puffs from her sisters Albuterol inhaler. She also received a prescription at the emergency room for Vicodin.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (606 doses given after expiration date/received expired dose beyond expiry date: Oct 3, 2021) and product storage error in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 043B21A) for COVID-19 immunization. No medical history reported. On Dec 3, 2021, patient received the 3rd dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 3, 2021, patient administered expired product (606 doses given after expiration date/received expired dose beyond expiry date: Oct 3, 2021). On an unknown date, patient experienced product storage error. At the time of the report, administered expired product (606 doses given after expiration date/received expired dose beyond expiry date: Oct 3, 2021) and product storage error outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial placed in the refrigerator on Dec 28, 2021, did not undergo any temperature excursion. The patient did not experience any adverse event.
2 months after second COVID vaccination, patient developed the worst headache of her life.  She mis-took it for a migraine headache.  She sought evaluation by an ophthalmologist when her "migraine" visual symptoms persisted.  She also noted that the headache was extremely positional being much worse when she was bending over which was atypical.  Examination showed bilateral papilledema.  I suspected dural venous sinus thrombosis and sent her for immediate admission and evaluation.  She was found to have dural venous sinus thrombosis (extensive - see below).  There is absolutely no reason for this patient to suffer extensive dural venous sinus thrombosis. She has been admitted for anticoagulation and may need venous. and may need venous sinus stenting.  And she could go blind.  Your form is extremely stupid.  I would think that you would want to know the lot number and date of administration of BOTH COVID vaccines as well as boosters but evidently not.  They were given more than one month apart so item 22 doesn't work.  How can I possibly know which shot triggered the coagulation cascade?  It might be a cumulative effect, or it might be the batch from the first vaccination - which you know nothing about based on the documentation options above - thereby preventing you from actually performing batch-specific surveillance for an extremely severe AE.  Go CDC.  Since I am a better doctor than you are a form-maker:  1st COVID vaccine: Pfizer lot EW0173 date 9/1/2021 left arm
Information has been received from a nurse concerning a 16 year old female who on an unknown date was vaccinated with the second dose of VARIVAX (lot# 662582/0059Y) 0.5mL. Subsequently the patient experienced warmth, redness and severe swelling at the injection site. Subsequently, the patient recovered from warmth, redness and severe swelling at the injection site. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
pt recv vax & 24hr later pt devel an inj site rxn characterized by: redness, warmth, swelling & pain;rxn resolved on it's own w/in 2-3 days;this is one of three patients, from the same site, reporting a similar rxn;
1 hour after inj. c/o itching all over. 24 hours after inj., mild, slightly raised rash to chest only.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose strength, Dose number, route unspecified). No adverse events were reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1506USA004940, 1506USA004987, 1506USA004985 via same reporter link. Additional information has been requested.
6-7 days post injection developed rash that progressed and was diagnosed immediately as Shingles.  Was not immunocompromised, ill, or on immunosuppressants at time of vaccination.  Three days after start of shingles outbreak developed severe headache and back pain when walking near shingles dermatome nerve root.   Received and have just as of 10/15 started vancyclovir treatment.
In early 02/2023, I went to the local store to update my cell phone. They were having a promotion for a free Galaxy Watch 5. I asked them to put it on and enable the cardiac function. As soon as they did, it read that I was in atrial fibrillation, although I was asymptomatic. I am still experiencing that and am going in for a procedure tomorrow to try to correct that. In that same month on 02/15/2023, I experienced severe abdominal pain, to the point where I thought I might have a urinary tract infection. I didn't want to wait for an appointment with a urologist, so I went to my local emergency room. There was no evidence of bacterial infection and the urine itself was clear. They gave me pain medication and sent me home without further evaluation. The pain kind of went in and out over the next few days. on 02/19/2023, I experienced severe enough pain to return to the emergency room. The same treatment was given to me. They did a urinalysis and a sonar of my testicle area. They couldn't find anything, gave me pain medication and sent me home again. 24 hours later on 02/20/2023, the pain came back, and I suspected that they needed to do a CAT Scan of the area. I insisted that they perform one and when the results came back, I had an enlarged prostate. They inserted a catheter, and I voided a liter of urine. It turned out that my urinary bladder was enlarged. Once I voided, the pain dissipated and they advised that I see a urologist, which I did. Last week, I had a cystoscopy to locate the cause of pain. I am scheduled for a laser surgery in mid-May to adjust the size of my prostate, he said that mine was doubled in size. I am currently on a catheter at all times and was also prescribed Tamsulosin HCL and Finasteride to reduce the size of my prostate. He also prescribed Tramadol for pain as needed.
Pt received covid vaccine BUD. Vaccine expired 7/7/22 and was given to pt on 7/19/2022
Increased redness, pain and heat radiating down from deltoid area of arm to lower arm.  Discomfort with bending elbow.  Treated with Motrin and prednisone.
leg cramps; 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 MUSCLE SPASMS (leg cramps) 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 MUSCLE SPASMS (leg cramps). At the time of the report, MUSCLE SPASMS (leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
mom states 5 days p/vax pt devel fever of 101 w/redness on arm;also pt ear is red;mom told to give pt APAP for fever & to ice site of redness;mom advised to see MD;
The symptoms began as pain in the clavicular area, which over 12 hours eventually developed into shingles involving left sided dermatomes C2-C4.
I suddenly passed out 3 times when I arrived at the gym (before exercising) and had extreme shortness of breath for a week post-incident.
fever; Sore arm; tired; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a 14-year-old female patient in response to Non-HCP letter sent in cross referenced case that included:  A 14-years-old female patient received bnt162b2 (BNT162B2 Solution for injection, Batch/Lot Number: EW0179) via an unspecified route of administration, administered in Arm Left on 03Jun2021 at 16:15 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine bnt162b2 (BNT162B2, Batch/Lot Number: EW0173) via an unspecified route of administration, administered in Arm Left on 14May2021 at 4pm as dose 1 single for covid-19 immunisation, the patient experienced chills, fever and sore arm. The patient experienced, the same fever but it tasted 2 days. Overall tolerance of second dose was not better. Sore arm, tired, fever for 2days, on an unspecified date in 2021. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
The evening after getting the vaccines I left arm started to hurt and get red. By the next day it has swelled up. After about a week the swelling went down yet I am no longer able to raise My left arm up two my shoulder like doing a jumping jack nor can I rose it behind that. I can slowly raise it forward over my head
Hypotonic-hyporesponsive collapse immediately p/inject w/DTP (w/in one minute); pt limp & non responsive, cyanosis from nose to below chin, required aggressive stimulation & 02 via mask to recover pt;
Patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration reported as 19-AUG-2021.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-365046 (Patient Link).
felt mild weakness about 10min p/vax;pulse feels nl 60;23NOV98 reported weakness subsided that day of report;
Patient arrived to the ED on 11/7/2021 Complaints of: headache and photosensitivity x 2 days, chilld, congestion, cough
No adverse event, however, monovalent vaccine was inadvertently given instead of bivalent.
Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves an 11-month patient (gender not reported)who was vaccinated with a dose of 0.5 ml IMOVAX POLIO via intramuscular in right thigh on 23-Jul-2018 and it was reported that the vaccine underwent a temperature excursion (opened vial 51.9F for 1 hour 45 min). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL, INFANRIX, ACTHIB, and PREVNAR all for Immunization. It was an actual medication error due to product storage error. It was reported that the patient had no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot# M019708, 25-OCT-2017, lot # L033549, 05-JUN-2017. No adverse effects were reported. Data logger was yes, Vaccines went to 35F for 30 hours. Vaccines were back in range. This is one of the two reports received from the same reporter. Additional information has been requested.
Sore, red, raised, hot reaction at site of injection placed 2/18/03. Began on dx for ? cellulitis on 2/21/02.
I received the first dose of the vaccine (lot number 004M20A) on 01/22/2021, and I received the second does of the vaccine (lot number 023M20AA) on 02/19/2021. After the second dose I worked until 04/12/2021, at that point I couldn't get out of bed, I was nauseated, dizzy, completely unable to walk, stumbling, falling down, I have had four surgeries to date and still am going to have more. now i have serious heart issues. The issues with being dizzy is due to lack of blld flow to heart and brain and I am having several surgeries to correct. I never had these issues before the vaccine.
EMG: Demyelinating neuropathy, possible AIDP vs developing CIDP
About 15 minutes after the vaccine, I experienced tingling down both my arms into my hand and fingers. It then felt like needles were pricking my fingers. My hands started to shake, too. The nurse checked my blood pressure. It was high, but she said it could have been anxiety, although I didn't really feel anxious. The symptoms were very similar to food allergy symptoms I have experienced before. It did not progress into anaphylaxis, though. The symptoms abated after about an hour. But then I experienced a ocular migraine that lasted about 30 minutes.
received a dose of an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided    This case was linked to MOD-2021-211358 (Patient Link).
Information has been received from a pharmacist concerning a 63 year old female with hypertension who on 02-JUL-2008 was vaccinated with ZOSTAVAX (Merck) subcutaneously.  Concomitant therapy included ACUPRIL, ACTONEL, vitamins (unspecified) and calcium (unspecified).  On 15-JUL-2008 the patient experienced Sweet's syndrome.  The patient was treated by an unspecified dermatologist with CELEBREX and TYLENOL.  On 30-SEP-2008, the patient completely recovered from sweet's syndrome.  The patient sought medical attention.  Additional information has been requested.
Pt had marked swelling with wheal and 8cm circle and warm to touch. Refusing to walk and cries when area is touched.
Fatigue, Headache, Brain fog, Body Aches, Nausea, Malaise, Fevers, Exhaustion, SOB
Patient and Mother came to a covid vaccination event at the clinic where flu vaccines are offered. Patient Mother wanted daughter to get the Flu Vaccine and signed consent for patient to get the Flu vaccine. Medical staff at the Covid vaccination event requested a staff member upstairs on a separate medical Team come give the patient a Flu vaccine. A Nurse went down with a vaccine identified the patient reviewed the consent form and administered the vaccine. Upon charting the vaccine in patient chart it became evident the patient already received Flu Vaccine on 9/19/22 Fluzone U7684B
After 24 hours of receiving vaccine, I started getting numbness in my left arm (arm that received injection). Numbness felt like it was beginning from my elbow and going down to my fingertips. My left hand was noticeably colder than my right hand. 48 hours after injection, I started getting numbness in my left leg. Starting from my knee, down to my toes. My left foot was noticeably colder than my right foot. Both my elbow and knee feel swollen even though they don't look swollen. I tend to lay on my right side at night so I don't think I slept on it wrong. I get the numbness and tingling feeling randomly regardless of standing, sitting or laying down. It doesn't hurt but feels very uncomfortable. 48 hours after injection I felt nauseated, and felt like I had muscle weakness in both arms. I was extremely tired. I did have to take a child to the ER on the same day I received the vaccine (for a gastrointestinal virus that lead to dehydration). My 14 month old ended up with the same virus (uncontrolled nausea) two days later. I may have been fighting that virus even though I never threw up. No fever or redness at injection site. The numbness and tingling on my left side (including random spasms in my ribs) has continued for 96 hours since vaccine.
About 2 minutes after vaccine given pt began to pass out with possible seizure. another 3 or 4  minutes later the same thing happened, pass out/ seizure.
rash to face, neck & ears;immun given 12JUN98 reported 27JUN98 pt still has rash to face, neck & ears;
PT had heart racing, visited ER.  released after receiving fluids. had elevated D-dimer
Symptoms began on 07/03/2022 with a slight scratchy throat. I woke up tired, achy and had a scratchy throat. At that point I took a COVID-19 test and had a positive test result from a home test on 07/04/2022. I had a fever of about 101 and headache so I called the doctor's office and the triage nurse I spoke to said I should rest and if things get worse to visit a test and treat center at a local pharmacy. I was told I may be eligible for antiviral that I could take. I am scheduled for this visit in a few hours. Last night I had a fever of 102.5 which broke in the middle of the night, I am coughing with a productive cough, and I feel like something is in my throat.
Left arm and left eye is bloodshot; Left arm and left eye is bloodshot; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Left arm and left eye is bloodshot) and ERYTHEMA (Left arm and left eye is bloodshot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced OCULAR HYPERAEMIA (Left arm and left eye is bloodshot) and ERYTHEMA (Left arm and left eye is bloodshot). At the time of the report, OCULAR HYPERAEMIA (Left arm and left eye is bloodshot) and ERYTHEMA (Left arm and left eye is bloodshot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
She developed a lump around the area of the injection site; She also experienced injection site tenderness and pain; This spontaneous report was received from a physician refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent condition and concomitant medications was not reported.   On 25-APR-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  dose 1, 0.5 milliliter, for human papilloma virus prevention, lot # R027577, expiration date  23-JUN-2021 (route of administration was not reported).  On an unspecified date in 2019 (reported as around the time she got the first shot) the patient developed a lump around the area of injection (injection site mass) and she also experienced injection site tenderness and pain. The physician advised the patient to take ibuprofen (MOTRIN) and ice the area around he injection site.   The outcome of injection site mass and injection site pain was unknown.      The causality between  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not reported.