chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was administered outside of Facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------------- I21.4 ACUTE NON ST ELEVATION MI 4/27/2022 ACUTE NON ST ELEVATION MI I95.9 HYPOTENSION 4/18/2022 ACUTE NON ST ELEVATION MI R09.02 HYPOXIA 4/18/2022 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 4/27/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 4/18/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R09.02 HYPOXIA 4/18/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
24 days p/vax pt devel ataxia & tingling in legs;dx of transverse myelitis made & pt was hosp;
7 days after the vaccine, itching began on the site of the injection.  On day 8 swelling and redness occurred around the injection shot.  Slight itchiness, warm to the touch.  Red mark the size of a tennis ball.
AT NIGHT AFTER PATIENT EAT ICE CREAM HE VOMIT  AND HAD DIARREHEA PATIENT CONTACTED MD BY PHONE  AND HE TOLD HIM TO USE LIQUID DIET AND IMMODIUM TODAY IS THE FIRST DAY HE CAN EATS 09/21/2020
Case received primary Covid vaccine in August 2021, No booster, then was hospitalized for Covid in February 2022. Hospitalized at Hospital. * Pneumonia due to COVID-19 virus Assessment & Plan Patient was on day 4/5 of her illness when admitted on February 8, here treated with remdesivir and dexamethasone Her hypoxia improved hospital day 1, oral intake improved, no orthostatic symptoms Given mild pulmonary involvement, elected not to continue dexamethasone discharge Patient counseled on isolation recommendation, follow-up if needed for worsening symptoms, development of hypoxia   Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan Due to COVID-19 pneumonia the patient presented with oxygen saturation of 87% on room air requiring 2 L supplemental at time of admission, with in hospital day 1 she was oxygenating well on room air, she was treated with dexamethasone remdesivir At time of discharge she is feeling better with mild shortness of breath with activity and oxygen saturations maintained greater than 90% She will have pulse oximeter to continue to monitor at home
Janssen COVID-19 Vaccine   Woke middle of the night very cold under heavy covers, Hard to walk the next day, had some of the same symptoms I had when I had covid in November.  I can't find the lingering side effect mentioned and why I am sending this: A month later my legs feel like they are in ice water, everything else went away after 3 days.  At the touch they feel normal, this is all day everyday.
Patient was admitted to the hospital on 2/23/2010 with cough and increased green sputum production.  Had had low grade fevers, none higher than 100 degrees.  He states that he has had increased dyspnea on exertion.  He states that he normally requires about 4-1/2 liters of home O2 while at rest and 6 liters while he is up with activity and he states that his saturation is normally about 94-95 percent.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 41-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 14-Feb-2021 at 3:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.48.  Concomitant products were not provided. Treatment medications were not reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 35 degrees Fahrenheit from 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 13-Jan-2021. Product moved to clinic on 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
4 hours after immunization, left deltoid red, hard and egg shaped lump. Told pt to ice and use APAP call if worse. Patient went to ER next day - Dr. said possible cellulitis (WBC count normal). Dr. gave KEFLEX and patient's arm normal next day.
patient called the pharmacy on 4/12/21. she explained that she had a rash on her right arm (above elbow), an itchy knot the size of a tennis ball on the left deltoid (where the vaccine was administered), and a swollen nodule behind her left ear lobe. she also explained she was outside over the weekend, and thought she also had some spring allergies arising. she was counseled to report any further events to her PCP, to take Benadryl in place of Zyrtec, and to apply a cold compress on the right arm rash with some hydrocortisone cream. she was counseled to continue reporting all side effects to v-safe as discussed on 4/12/21.
Case number PHEH2011US01242 is an initial spontaneous report received from a consumer (patient's mother) on 09 Aug 2011. This report refers to a female patient of unknown age. She was vaccinated with Menveo intramuscularly on unspecified date. However, the nurse punctured the rubber cap with needle several times and finally the syringe was shy of recommended 0.5 ml (less than 0.5 ml). There was a potential underdose. No adverse event was reported following this underdose.
Pt stopped by the pharmacy Saturday 7/10/21 and stated he develpoed "pressure" in his R ear - like it feels like water is in it. He saw his PCP and no sign of infection or congestion.
Elevated fever 103.2; sleepiness; continous crying; Seen @ Hosp ER;
Chills, severe shaking, fever >100F for 2-3 days within 3-4 days after flu shot.
This spontaneous case, initially received on 21-Nov-2016, was reported by a health professional and concerns a(n) adult unk patient. Weight: not provided; Height: not provided Concomitant medication: Not reported Administration of company suspect drug(s): The patient received AFLURIA from Oct-2016 to Oct-2016 Dose regimen:0.5 ml, Site: Deltoid area, Route of administration: Intramuscular. Batch number: WT54707. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Range of motion problems (outcome: Not recovered / Not resolved), Significant  pain that lasted 2 weeks or longer at the injection site (outcome: Not recovered / Not resolved). ***Follow-up information received 13-Dec-2016: The patient was recommended to rest arm and use ice or heat if needed for pain and was referred to an orthopaedist for rotator cuff issue (outcome: not recovered / not resolved). The patient experienced no other associated symptoms. The outcome was reported as continuing with orthopaedist. All doses were administered by a RN (registered nurse) or a Certified Medical Assistant who is also a paramedic. Both have been administering flu vaccines for years. A 22 gauge 1 inch or 1.5 inch needle was used. The RN is certain that the dose was administered correctly in the deltoid muscle of the arm as trained. ****Case correction (23-Feb-2017): QA investigation results added and the event 'rotator cuff issue' upgraded to serious. QA investigation results: Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'. The patient did not receive any other concomitant vaccination on the same arm.; Sender's Comments: Listedness: Assessment according to CCSI for CSL's Inactivated Influenza Virus Vaccine, Hereditary rotator cuff syndrome, and Joint range of motion decreased are unlisted. Injection site pain is listed. Causality: Related. Time to event onset not clearly stated but close temporal relationship implied as pain lasted 2 weeks after vaccination. The event severity, associated with impaired range of motion and duration of symptoms lasting weeks following vaccination, is suggestive of Shoulder injury related to vaccine administration (SIRVA). SIRVA is sequelae of immune response to direct (inadvertent) intra-articular vaccine antigens. However there were no examination findings and or investigation results to confirm SIRVA and or exclude other cause of symptoms. Causality is considered related to vaccination due to temporal association most likely due to incorrect technique.
Can the vaccine cause a syndrome reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Can the vaccine cause a syndrome reaction) 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 VACCINATION COMPLICATION (Can the vaccine cause a syndrome reaction). At the time of the report, VACCINATION COMPLICATION (Can the vaccine cause a syndrome reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was provided.  No Treatment medication information was provided.
The same day as receiving an influenza injection, the patient started with fever, cough and body aches that lasted 1 week.  She did not complain of runny nose or sore throat.  All symptoms resolved without medical treatment.  Patient was concerned that there was a live componant to the vaccine and was reassured by myself.
Upon getting the shot, it was extremely painful, so much so that I cried out in pain. I have gotten many shots in my adult life and have never done this. About a week after the vaccine, the normal shot soreness began to turn into extreme stiffness. I experienced weakness and loss of range of motion as well as pain in my left arm.
Persistent flushed and itchy face that lasted close to week.  Some hives.  I used Benadryl cream and elixir, round the clock.  Still have slight redness and reduced itchiness.
Sunday afternoon patient developed a low grade fever. Around 4pm on 9/25 patient said his knees hurt and he couldn't walk. On 9/26 patient's fever continued and he struggled to walk and said his whole body hurt. On 9/27 he broke out in hives all over his body and his feet and knees appeared red and swollen. He struggled to sit up and cried out in pain if we lightly touched his leg. We ended up taking him to the Emergency Room. After bloodwork and urine test he was diagnosed with Serum Sickness and we were prescribed a steroid. He also completed a nasal swab for viruses and it was negative. We continued the steroid (5 day course), Tylonal as needed for fever, and Benadryl as needed for hives. We followed up with the pediatrician and she prescribed a topical steroid for his hives.
Tenderness in his arm for a day for first two shots; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness in his arm for a day for first two shots) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 04R20A and H062E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and DOXAZOSIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE PAIN (Tenderness in his arm for a day for first two shots). At the time of the report, INJECTION SITE PAIN (Tenderness in his arm for a day for first two shots) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment Medications details were provided.   This case was linked to MOD-2021-367613, MOD-2021-367614.
14:00: Vaccines administered.  05/15/2003-05/16/2003 @ 09:30: Left arm red, swollen, hot to touch.  Redness over entire deltoid left arm.  Reports Tylenol given.
My symptoms started with a dry, scratchy throat. I did not feel like my normal self. I took an at home COVID-19 test that was positive. My symptoms progressed to fatigue, fever, cough, slight shortness of breath, and lethargic. I went to an urgent care and got a prescription of Paxlovid.
Started with itching on chest after less than 5 minutes after injection. Nurse did not think that was an issue so she sent me home with no  treatment. Started to get a swollen tongue, tightness in my upper chest, and a spread of the itchy feeling into my torso. Took benedryl at home; symptoms resolved.
RASH ALL OVER , LEFT SIDE OF BODY COMPLETE SORENESS LIKE FLU ARE WORSE, URETHRITIS ARE UTI
Pharmacist accidentally administered two doses, one in each arm (instead of one covid booster and one flu shot)
Uneventful until 9/18/02, two weeks after vaccination, pt noted to have seizure like episode with generalized shaky an jerky activity. He was noted to seem to startle while asleep a week prior to this. He was admitted to epilepsy unit for seizure control. Intractable seizure disorder. Per 60 day follow up: pt has not recovered. Pt being treated for seizure disorder currently controlled. Pt has partial ? of corpus collornea and also possible area of cortical degenerous: developmental delay. Pt  likely be brain abnormality prior to submitted vaccinations.  Follow up on 11/26/03: "Vaccine recipient has not recovered from the adverse events that were reported for this vaccination.  Pt has intradtable seizure disorder/infantile spasms/developmental delay."
Woke up March 9th and had trouble breathing. Fell well short of getting full breaths, chest hurt. Took aspirin and slept for 6 hours. Felt about the same through the evening. Next day, still having trouble getting full breaths but less pain.
Splashed smallpox vaccine in eyes while preparing vaccine for administration to soldiers. Sent to TMV and was given viroptic eye drops and has an ophtho appointment.
This is a 57 year old male, received the Janssen COVID-19 vaccination on 5/4/21, at clinic in Jail, approx 10 minutes post vaccination, patient developed throat tightness, difficulty breathing and swallowing. He was immediately assessed by this writer, EMS activated as code. Given epi-pen to left thigh at 11:23, 50 mg of IM Benadryl to right deltoid at 11:25. Patient reported improvement in his throat tightness, shortness of breath and difficulty swallowing post epi-pen administration. Patient was sent to the ED
Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (chills). On 09-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, CHILLS (chills) had resolved. On 10-Feb-2021, PYREXIA (Fever) had resolved.            No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: The follow up document updated on 22-Apr-2021 states patient has taken second dose.
it was rpt from health care professional concerning pt who was vax w/pneumococcal & devel a localized react described ass a cellulitis-like react;
My arm was very sore about 10 hours after the injection. I took Tylenol to help with the pain and searched online if ice packs or heat would be ok. I put an ice pack on the site over the bandage for about 20-30 minutes. When I removed the ice, I had a large red softball-sized area, it was itchy, and much of it had become a raised welt. The area under where the bandage was was not red. On the morning of April 10, it was dark like a burn/bruise with a clear area where the bandage was. On April 11 it was darker but a bit smaller in size. That afternoon, playing ball, my shirt rubbed off a bit of the darkened skin in a few areas. It looked like a bad burn. Today is April 12 and I have it covered in Aquaphor, it appears to be getting smaller, about half the size it was on April 10. I have photos if those would be helpful for anyone to see.
Hand pain, joint pain, diarrhea, high blood pressure, rash. Prostate cancer we do not receive, never adverse reaction of this vaccine when administered on 2003 at clinic.
I received the SPV about a week ago and it looked normal and now there is a swollen red ring around the vaccination site and a red line on the side.  Yes my armpit hurts too.  No chest pain, no fever.  Yes I have ibuprofen in the home.  Symptoms: Erythema, Edema at injection site 30-50mm, Pain.
optic neuritis; Photophobia; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 54-years-old female patient received BNT162B2 (Pfizer/BioNtech COVID-19 vaccine, formulation solution for injection, lot Number unknown, expiration date unknown) via an unspecified route of administration on an unspecified date, dose number unknown as single dose for covid-19 immunization. The patient medical history was not reported. There was no concomitant medication list. It was reported that after receiving the dose of Pfizer-BioNTech vaccine on an unspecified date the patient suffered from photophobia and optic neuritis. Enquiry received in writing, therefore logged with limited information. There was no product complaint associated with this case. The outcome was not recovered for the events at the time of reporting. The sender noted in their email: As the case reports described in this signal have been transmitted to (withheld) we kindly request you not to resubmit them to the correspondent Regulatory Authority as this is where they originate from.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
w/in 12 hrs p/vax, pt devel a large wheal @ inject site; pt reported that had enlarged ax lymph gland & a fever; pt was not seen in office; reported sx several months later;
Was preparing vaccines for this child and accidently gave her the 12+ Moderna vaccine instead of the 6m-11y. No adverse reactions, Parent's were notified, MD notified. Child is fine.
A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members (demography unk) who were administered a Fluvirin injection by inappropriate route in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. No adverse events were reported. The reporter has assessed the relationship of the vaccines to the event unclassifiable. Update 1 13Dec02: An update report was received received from a health care professional on 13Dec02 concerning a 50 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. No further information was provided. Ref: PJP200200657, PJP200200882, PJP200200890, PJP200200884, PJP200200885, PJP200200889.
35yo vaccinated in OCT89 w/1st dose of Hepatitis B Recombinant experienced one month of malaise;
Patient with ascending sensory deficits consistent with AIDP.  No weakness or respiratory weakness but areflexic. PLEX started on 3/4. Sensory symptoms stable. Still inpatient
On 10/23/21 I had severe vertigo causing severe dizziness & vomiting & was transported by ambulance to the ER.
Whole day in bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Whole day in bed) 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 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 FEELING ABNORMAL (Whole day in bed). At the time of the report, FEELING ABNORMAL (Whole day in bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications included. No treatment information was provided.
01/05/22 presents to ED for "Spinning, nausea, vomiting". PMHx of "left vertebral artery occlusion" "diabetes"
Received vaccine around 7pm on December 18, 2020 and worked the midnight shift.  Went to lay down during the day of December 19 and stated joints and body were severely achy way beyond normal.  Did take a narcotic for pain control with no relief.  December 20th symptoms had resolved.