chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported standard sore arm following injection which went away after a couple of days but noticed 4-5 days later that the pain returned and that he had a bump on his arm right around the site of injection.  Patient came into the pharmacy approximately a week and a half later to have it looked at.  Arm still had a small (5-15mm) but noticeable solid bump under the skin which he described as mildly painful.  Recommended tylenol or ibuprofen to help with the pain and to continue to monitor the bump for a few more days. If it doesn't improve.
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 06-MAR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (dose, and frequency were not reported) (lot # M038209 and expiration date 23-APR-2018) orally for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion below 32 degrees Fahrenheit, minimum temperature 31 degrees Fahrenheit for 48 hours. Data logger was not involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA003106.
For the last 4 years that I have gotten the flu shot which was required for nursing school, I have gotten very ill. I have not had an anaphylaxis action yet, but I have had severe nausea & vomiting that lasted for several weeks after the vaccine was given. The public health nurse asked if I wore contacts because she knew thimerosal was an ingredient in both and I am allergic to all contact solutions except one that does not contain that ingredient so she believes i have an allergy to the thimerosal in the flu shot. This has caused me to miss class for several weeks each year after receiving the flu shot so because of all of this I was told to fill out this report. My nausea & vomiting is not just like the normal aches and feeling a little nauseous right after the shot which most people can have. This is more severe and lasts alot longer
24 hour loss of appetite, nausasia, sleepiness and muscle pain for this shot and the one three months later. Given the badness of the disease, these kinds of symptoms far outweigh the discomfort experienced. The next day all this disappeared as if nothing happened.
I started getting hot/sweaty and thought I was either going to pass out or throw up, my heart was racing and both of my hands went completely numb. For about 10 minutes my fingers were cramped in weird positions and I could not move them.  It  was like they were temporarily paralyzed. I seriously thought I was going to have a stroke.  After about 30 minutes I started feeling better and I went to my doctors office.  She checked my blood pressure and it was very low.  I went home and fell asleep.  I woke up a couple hours later and had a fever and felt like I had Covid all over again.  I slept the rest of the day and the next day I felt fine.
1. soreness on my right arm beginning at injection site and expanding to the entire area from the shoulder down to the elbow 2. I am feeling extremely tired 3. sore/stiff muscles
The injection site is very itchy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient had 2nd shingles vaccine this past week from the time of reporting. The patient stated that the injection site was very itchy. The patient asked what was suggested for relief.
Pt received a vaccine for age group 5-11 years. Pt should have received a vaccine for 6 months to 4 years
This non-serious medically confirmed spontaneous report (initial receipt 17-Nov-2014) concerns a female patient who had a right shoulder surgery about 8 years ago. She had received flu vaccines in the past one of which was a quadrivalent vaccine last year. On 02-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T52108) 0.5mL in her left arm. On 02-Nov-2014, approximately 3 hours following the vaccination, the patient experienced extreme pain in the injected arm. The pain was described as "knife grinding into her arm" and felt like the pain she had when she was recovering from the surgery. The pain was constantly there but was worse when she moved her arm side to side or when lifting it up, and felt "really weird". She had limited range of motion. On the night of the administration, she called the 24-hour hotline number which was provided by her insurance company. During this phone call, she spoke to the nurse who stated it may be related to the AFLURIA administration. She went grocery shopping and did not do anything strenuous after the administration. She had not notified her primary care physician because she hoped it would go away soon. She was self-treated with ibuprofen 600mg two or three times daily, which seemed to somewhat helped. Outcome was reported as not yet recovered.
Admitted to the hospital;  COVID-19 positive.  8.24.21 CHIEF COMPLAINT: Fall  Assessment/Plan   ASSESSMENT/PLAN:  1. Acute resp failure with hypoxia- now on HFNC 2. Acute on chronic diastolic heart failure with hemoptysis 3. CAD 4. Elevated ddimer with sudden SOB/hypoxia and tachycardia 5. CKD3 6. DM2-insulin dependent 7. Fall/weakness 8. Anemia- hx iron deficient and chronic disease-  9. Afib 10. HTN 11. HLD 12. GERD 13. Prostate ca-metastatic with right rib lesion  Plan: Admit to ICU-he refused transfer FULL code Oxygen keep sat >88% Lasix 40mg IV bid, first dose now VQ scan in am- >DDimer with covid and clinical status suspect PE Trend Hgb- transfuse <8 Telemetry, frequent VS CM for placement/dc planning- will need placement PT/OT Diabetic diet, and continue basal insulin PPI/heparin sq if hgb stable (hemoptysis)    Subjective   HISTORY OF PRESENT ILLNESS: Patient is a 87 y.o. male who presents today after a fall-though he denies falling.  He was recently here and treated for COVID, hypoxia and CHF- refused SNF and went home.  He has been difficult to care for per his son and needs help with placement. The patient begrudgingly agrees.  In the ER he was completing his workup when he suddenly dropped his 02 satus- thus requiring eventually HFNC- he also had reports of scant blood in his sputum.  With family at bedside and help of the ER doctor- advance care planning was discussed. The patient is guarded and very critically ill- family was in agreement for DNR/comfort care however the patient wishes for FULL code and does not want transfer.  This was discussed in depth with ER doctor, myself, and patient.
Patient developed a golf ball sized lump at the injection site of the BOOSTRIX (right arm); she reported redness, swelling and heat/warmth.
Local reaction to Lt Vastus Lateralis with PENTACEL IM and ROTATEQ PO 6/28/2010. 1.5 cm red area with mild induration. TYLENOL effective for discomfort.
Fever, nausea, diarrhea, headache, dizzy, body and bone ache lasting 2 days
A couple hours after the vaccine I was already feeling groggy and sick, but it went on for a couple days afterward. I even missed a day of work.
chills; body pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (body pain) in a female patient of an unknown age who received mRNA-1273 (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (chills) and MYALGIA (body pain). At the time of the report, CHILLS (chills) and MYALGIA (body pain) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-100421 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100421:Wife case
Received MMR vaccine on 2/28/03, 2 days later, had a headache and photosensitivity. Today on 3/13/03, woke up with a rash from scalp occiput. It spread to face, neck, upper trunk associated with itching. Macular rash. No pustular or vesicle.
2 hours after receiving the vaccine I began to feel hot and cold flashes and a flush feeling as if I was going to faint. I went to the emergency room. The ER doctor did blood work, took my blood pressure (a little high at first) and EKG. Doctor said everything appeared to be fine. After I left the hospital I started feeling mild shortness of breath and tightness in my chest which has not stopped as of this writing. I also have moderate pain in the upper middle part of my back by the vertebrate.
This spontaneous report as received from a pharmacist refers to a 58-year-old female patient (the reporter's mother), smoker with type 2 diabetes mellitus, drug reactions or allergies to sulfur and penicillin. The patient's medical history included pneumonia. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) due to previous history of pneumonia. Concomitant therapies included DEMEROL, NUCYNTA, metformin, trazodone hydrochloride (manufacturer unknown), diclofenac, atorvastatin, FLONASE and tizanidine hydrochloride. It was reported that on approximately 04-NOV-2015, 1 or 2 days after the vaccination the patient began experiencing fatigue and it has been every day since. There were no lab diagnostics studies performed. The patient did not seek medical attention. No treatment was given for the adverse event. The outcome of fatigue was reported as not recovered/not resolved. The reporter considered the event disabling since the patient was unable to do anything from housework to driving. The relatedness between PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
patient were administered the Yellow Fever vaccine with the expired diluent, with no reported adverse event; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from an other healthcare professional via call center via regulatory agency (Reference number- 00893306).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (Vaccine: lot number: UJ372AA and expiry date: 22-Jun-2022 and Diluent: lot number: U6427AA and expiry date: 30-Sep-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Caller stated that the sodium chloride diluent that goes with the vaccine expired and was administered to patients after expiration date. Caller asking if the diluent would still be stable and what should be done. She asks if they were valid doses or if they need to be repeated. She asks if Yellow Fever Vaccine is a live vaccine and how long they need to wait to revaccinate the patients involved."  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 guidelines. 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Underactive thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received Paxlovid from from 27Jan2023 to 01Feb2023 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
pain and numbness in left arm resolved within 3 days / right foot pain continues, pressure headache that resolved within minutes
On  06/12/2022, I had symptoms of sinusitis. It was like a very heavy chest cold. That following morning I had fever of 108. I took at home test and was positive. I had cough and hard time bringing up mucus. I took my oxygen levels which were very low below 90 to 88. My nailbeds were dusty and dark purple.  I had a telehealth with my doctor and received a prescription for Paxlovid.  I rested and having the fever for two days, it was not going lower than 100.0. I did have to use rescue inhalers. After about 24 hours my stats were low when standing. I stayed hydrated and followed with Tylenol. I lost my smell everything smelled like a chemical. My taste became bitter. My smell has not returned. It took two weeks for my pulmonary reading to get back to baseline. I do get a low grade sweat from time to time.  I do have extreme fatigue and I feel very tired. My stats read normal, but It makes me feel very tired. After I eat I still can not get rid of the bitter taste in my mouth. My mucus is very thick and tenacious.
At 9:30 am Saturday morning client got light headed, dizziness, bright lights became bothersome,  and experienced weakness all over body which lasted approximately 30 minutes. Client then became nauseous and threw up within 30 minutes of other symptoms.  Once client got home he slept for approximatley 4-5 hours, woke up feeling 100 % better.
Initially flu-like symptoms including muscle weakness to lower extremities, fatigue and tiredness. These started about 15 hours after the booster was given. After 48 hours I became more weak. Felt like I might fall. I had balance problems, fatigue and a generalized lethargy. I saw a neurologist and he put me on prednisone 60mg and then tapered me. I am now on day 2 of 10mg and again feeling significant feelings of weakness, lethargy, some leg weakness and tiredness.
I flew on Saturday 05/14 so I believe I was exposed while traveling on. I began to feel a slight cough on Tuesday  05/17  and woke up with a bad sore throat and headache, so I tested myself twice that day for Covid and the tests both came back positive. I isolated until I tested negative about 9 days. My doctor prescribed a round of Paxlovid and after starting that medication I began to feel better almost immediately.
Extreme body/muscle ache, fever, fatigue, much worse than symptoms suffered from actual covid disease.
Hyperacusis now in her left ear; ringing in her left ear; pain on the left side of her face on the temple and jaw; Her inside of her ear was on fire; tinnitus in both ears; COVID arm, which she described as a rash and reddish purple color on her arm; COVID arm, which she described as a rash and reddish purple color on her arm; COVID arm, which she described as a rash and reddish purple color on her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (Hyperacusis now in her left ear), TINNITUS (ringing in her left ear), FACIAL PAIN (pain on the left side of her face on the temple and jaw), EAR DISCOMFORT (Her inside of her ear was on fire) and TINNITUS (tinnitus in both ears) in a 48-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.     The patient's past medical history included Tinnitus.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced TINNITUS (ringing in her left ear), FACIAL PAIN (pain on the left side of her face on the temple and jaw), EAR DISCOMFORT (Her inside of her ear was on fire), TINNITUS (tinnitus in both ears), VACCINATION SITE REACTION (COVID arm, which she described as a rash and reddish purple color on her arm), VACCINATION SITE ERYTHEMA (COVID arm, which she described as a rash and reddish purple color on her arm) and VACCINATION SITE RASH (COVID arm, which she described as a rash and reddish purple color on her arm). On 02-Apr-2021, the patient experienced HYPERACUSIS (Hyperacusis now in her left ear). At the time of the report, HYPERACUSIS (Hyperacusis now in her left ear), TINNITUS (ringing in her left ear), FACIAL PAIN (pain on the left side of her face on the temple and jaw), EAR DISCOMFORT (Her inside of her ear was on fire), TINNITUS (tinnitus in both ears), VACCINATION SITE REACTION (COVID arm, which she described as a rash and reddish purple color on her arm), VACCINATION SITE ERYTHEMA (COVID arm, which she described as a rash and reddish purple color on her arm) and VACCINATION SITE RASH (COVID arm, which she described as a rash and reddish purple color on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications provided. no treatment provided.
Pt vomited morning of 25FEB92 around 1PM; started fever of 102 R by 5PM; t013 R mom took pt to ER pt was checked & given dx of throat infection; rx for ATB given 26FEB92 child afebrile but irritable;
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M029919 with expiration date 13-JUN-2018 and lot # M000768 with expiration date 05-JAN-2018 (dose and route of administration were not reported), which were reconstituted with sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007304: US-009507513-1705USA007308: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1704USA014902: US-009507513-1705USA007305.
The day after the vaccine was administered patient woke up feeling "like she had the flu," possible slight fever, and did not want to get out of bed. Rested for the entire day, woke up feeling completely normal the following day, no longer ill whatsoever. Did not look at her arm at all the day that she felt ill, said it was somewhat sore at the injection site, which she knew was to be expected. The following day when she was feeling better (today 6/22/18) looked at her arm in the mirror and noticed redness at the injection site, came into the pharmacy so that we could be aware of the reaction. Injection site was slightly warm to the touch. She is not sure if the redness has spread or reduced over time since she did not look at her arm until today.
Sore arm lasting more than 24 hours,  swollen lymph nodes left armpit and right side neck/ throat,  burning sensation left arm and spine. Pain in left armpit radiating to left breast. Severe hadache and nausea for 12 hours.
Administration of Expired Vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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) 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 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
This is a spontaneous report from a contactable consumer (patient). An 82 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) at age of 81 years old (as reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included Arthritis and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were yes but unspecified. The patient experienced spinal inflammation on 03Jul2021. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized and received treatment. The patient underwent lab tests and procedures which included COVID test nasal swab: negative on 03Jul2021. The outcome was not recovered.    The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Spiked fever of 105 at home on 2/24/10. Parent took child to the ER where he was diagnosed with an ear infection and given ROCEPHIN IM. He was all ready on AUGMENTIN for ear infection diagnosed on 2/16/10.