chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was fully vaccinated and got COVID after Memorial Day; Patient was fully vaccinated and got COVID after Memorial Day; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 61-year-old female patient received doses 1 and 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified routes of administration on unspecified dates (at the age of 61-years-old) as single doses for COVID-19 immunization. Medical history was unknown. It was unknown if the patient received any other vaccines prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. It was unknown if the patient had any allergies. On 02Jun2021, the patient was fully vaccinated and got COVID-19 after Memorial Day. The event was reported as non-serious. The patient was not hospitalized for the event. It was unknown if the patient received treatment for the event. The outcome of COVID-19 was recovered. It was unknown if the patient was tested for COVID-19 after the vaccination.
Burning sensation on head. Within a few minutes spread all over body. Itchy, red, hot blotches from head to toe and around injection site. Slight swelling of tongue and throat.
Severe arm pain at the site of the injection  which started 24 hours after injection and persisting through today - day 9  postvaccine. The pain is lateral upper right arm and descends inferiorly toward the elbow. No redness or swelling at the site.  I'm having great difficulty with sleep because of the pain.  The pain is aggravated by  motion.  The pain is helped somewhat with ibuprofen 200 mg every 6-8 hours.
pt recvd vax around 11am;mom gave apap about 12; pt fussy & cried 1 1/2 to 2 hrs;high pitched at times;had apap about 4pm;called MD,ordered motrin as needed;on 22nov94, pt smiles, nl mvts; seems ok;
Given HPV#3 on 10/1/14 at clinic on base. Seen in ER that night for reaction to vaccine. Fever 103 with elevated HR.  Severe back pain with spasms. Admitted overnight for observation. No rash or hives.
Shortness of breath and leg numbness began within 1-2 weeks (specific time unknown) of receiving 2nd dose. Leg pain began 9/29/2021, went to ER 10/1/2021 with severe leg pain and swelling. Ultrasound discovered clot in left leg. CT scan discovered multiple pulmonary embolism in both lungs. Admitted to hospital and started on blood thinners. Was released 10/2/2021 with explicit instructions and prescriptions. Still suffering from leg pain and shortness of breath, light headed and dizzy, weak and lethargic.
DIARRHEA; STOMACH ACHE; INCREASED BOWEL MOVEMENT; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa-based allergy, non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient has no known medical history and patient has no history of drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 13-APR-2021, the subject experienced stomach ache. On 13-APR-2021, the subject experienced increased bowel movement. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, and the outcome of increased bowel movement and diarrhea was not reported. This report was non-serious.
Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "mycobacterial colonization of lungs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin"; Penicillin, reaction(s): "Known allergies: Penicillin". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 07Oct2023 to 11Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335759 same reporter/patient, different product/AE;
SIGNIFICANT muscle/joint pain throughout body.  Even my teeth hurt.  I feel just like I have the flu.  NO FEVER, NO RESPERATORY SYMPTOMS, only significant muscle and joint pain.  Difficulty being ambulatory due to pain.  I can still take care of myself and get arond, but I am VERY sore.
Patient was 12 y.o. at time of vaccination and received pediatric dose instead of adult dose.
large hard swelling bump 7 days after injection at the injection site, slight pain in armpit as well.
fever, chills, nausea, abd pain, diarrhea, stopped, then facial rash
Diarrhea; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event diarrhea.  The patient's medical history included Crohn's disease. Concomitant medications reported were vedolizumab, hyoscyamine for Crohn's disease.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A)  in the left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event diarrhea.  Treatment details included imodium, hyoscyamine.  Action taken with mRNA-1273 in response to the events was not reported.   On 5 Mar 2021 the outcome of event diarrhea was unknown.
Adminsitered Tdap in right deltoid, then Menactra in left deltoid.  Patient fainted after second vaccination and had twitchy hand movements.  Had not eaten at all that day before receiving immunizations.
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into database prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and reconciliation o Training on how to enter information into database when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
After vaccine was administered, I felt light-headed and passed out.  Other medical people responded and I am convinced their quick action saved my life.
Information has been received from an occupational health nurse concerning a 31 year old female employee with no known allergies and no pertinent medical history who in 2001 was vaccinated with a first and second dose of varicella vaccine live. A titer was drawn in December 2003 and it was noted that the pt failed to seroconvert. The reporter also indicated that the pt was vaccinated at another facility. Unspecified medical attention was sought and it was unknown if treatment was required. A product quality complaint was not involved. Additional information has been requested.
11/21/2006 Fluzone vaccine, lot U2213AA expiration date 6/30/06 administered 2:10 pm intramuscularly in left deltoid, 11/22/06 11AM (less than 24 hours after flu vaccination) stated he felt unusually tired and very drained. 11/23/06 stated increased tiredness, overall did not feel good, feeling weird, unable to be more specific. 11/24/06 described self as sick, states lethargic, very painful achy muscles and joints, stated difficulty transferring from bed to chair (< 2 feet away), stated warm, had fever (did not check temperature), migraine headache, labored breathing, unable to sleep 11/24/06 (Friday night). 11/25/06 went to hospital, states developed vomiting and diarrhea while in hospital, admitted to hospital for 3 days (11/25/06, 11/26/06, 11/27/06, states IV fluids were given, CAT scan was done (pt stated he did not know results). 12/18/2006 received telephone call from company and spoke with human resource personnel who stated pt said others were ill, but indicated no one else had come forward. Human resource personnel indicated that pt had reported to manufacturer. Spoke with a representative who gave pt my name and number. 12/19/06 telephone call received from pt and VAERS form completed per protocol. Pt indicated that he heard second hand that others were ill with similar, but milder signs and symptoms and a similar time course. Pt was unable to give names of employees who were ill. Requested that pt have other employees who became ill call me.  Hospital MR received for 2 night hospital stay for c/o fatigue, abdominal pain, nausea, vomiting, black diarrhea, increased heartburn, arthralgias, myalgias, and fever.  HPI:  Pt. reports above symptoms started 1 day s/p flu shot.  Weakness and lethargy increased for several days resulting in ER admit. Pt. showed much improvement after 2 days and was d/c home. Assessment: Likely viral syndrome-improved.
Redness over large area of arm, swelling at injection site. Fever for several days. Seen by MD twice.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot, batch # J012772, expiry date 09-OCT-2015, lot, batch # L002216, expiry date 21-JAN-2017, dose, strength, dose number, vaccination site, route of administration unspecified) since 01-SEP-2015. Concomitant medications were not provided. No adverse events were reported. No additional information was provided. The outcome of the reported events was unknown. Product quality complaint (PQC) was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Within 24 hours positive erythema from insertion down to elbow - warm to touch, hardened area 2cm x 2cm.  Lasted 3 days.
This spontaneous report as received from a physician via company representative via  refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details not reported) for prophylaxis. On an unknown date, the patient developed shingles within a week of receiving the vaccine. The patient had a 'bad case' and needed treatment with unspecified steroid. After a couple of month, the patient had developed scars (date not reported). The outcome of the events and causality were not reported. Additional information has been requested.
Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; This is a spontaneous report from a contactable consumer (patient).  This 28 -year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 11Feb2021 (at 15:45) at a single dose on right arm for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history and concomitant medications were provided. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before vaccine. On 11Feb2021 (at 22:00), the patient had soreness at the injection site/tenderness of arm. The events were reported as non-serious. Post vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
within minutes the patient said that his feet and hands felt hot and he was nauseated. I had him sit down, he asked for a glass of water which I provided. (He did not feel short of breath or weak) the nausea continued and he looked more pale, I had him lay down, and observed him as we chatted . After laying down for 15 minutes he felt better and requested another glass of water. I had him sit down in the chair again for a few minutes. He felt well again , reached for his shopping cart and left the pharmacy to continue shopping.
Late on the evening of Feb 18 I started to feel tenderness in my left arm pit (presumably the lymph node).  This persisted throughout Friday and this morning (Feb 20) I awoke to the injection site feeling sore and itchy.  The injection site had previously been sore for the first 24 hours after my vaccine, but then had resolved. Today (Feb 20) it is sore again and very itchy with raised, firm bumps.  It feels like an ant bite. The lymph node is still tender as well.
Beginning Nov 2022, she started decreasing the amount of food she'd eat. On Dec 23rd, she stopped eating altogether. She was seen in ER for fluids on 12/25/22. On 12/27/22, we took her to the Hospital where she was admitted for 3 days. She was diagnosed with ARFID (Avoidant Restrictive Food Intake Disorder). She currently is seeing PCP, speech therapy, psychology, dietitian, peds GI. Upcoming appt with psychiatry and adolescent medicine at hospital.
Report on admission: Patient is a 87 y.o. female presenting from home with c/o She is a 87 y.o. female who presents with a chief complaint of Shortness of Breath and Cough.  Patient states her symptoms started 1 day ago.  Reports generalized fatigue and feeling "like I have the flu."  Reports shortness of breath with lying supine and with exertion.  Patient does not wear home oxygen.  Reports chills and possible fever, did not take her temperature at home.  Also states she has a cough that is intermittent and occasionally productive.  Reports rhinorrhea and occasional sneezing, denies sore throat, sinus pressure, or ear pain.  Reports decreased appetite since yesterday, but can tolerate p.o. intake.  Reports nausea and generalized abdominal pain. Denies vomiting, diarrhea, or urinary symptoms.  Reports headache that started yesterday that is constant in nature and described as dull or aching.  Denies chest pain, visual changes, neck pain/stiffness, or known sick contacts.  Patient has not taken anything prior to arrival for her symptoms.      Hospital course as below.  Patient improved with medical treatment.  Patient will need to be evaluated outpatient for underlying cognitive dysfunction.  Patient discharged in stable condition.   . COVID, +2/16: -Chest x-ray nonacute -DC Decadron in setting of worsening delirium -Home Eliquis DVT prophylaxis -No hypoxia, no indication for remdesivir at this time  2.  Generalized weakness: -PT/OT -Social work for discharge needs  3.  Delirium: -Psychiatry consulted -Delirium precautions -Evaluate for underlying neurocognitive disorder outpatient  4.  Chronic hyponatremia: -Follows with nephrology outpatient -Continue home sodium tablets  5.  Other chronic medical conditions: Arthritis, hyperlipidemia, hypertension, history of DVT
Information has been received from a physician concerning a male patient who was vaccinated with ZOSTAVAX.  The physician reported that she vaccinated the patient and three weeks after the vaccination the patient presented with a severe case of shingles.  The case was severe but the pain was limited.  Additional information has been requested.
Patient had witnessed fall at the facility she resided in on 10/14/2022, approximately 12:30 pm, was transported to a local Hospital emergency department per ambulance in cardiac arrest, arriving at 1:15 pm. Was provided CPR and emergency medications. She expired 10/14/2022 at 1:23 pm in the Hospital ED.
After 2nd dose, I developed left arm soreness, headaches and lateral neck pains, and about after 10 hours developed chills, muscular aches, fatigue, and low grade fever, after 12 hours, had night sweats, then vomiting. Treated with acetaminophen 650 mg twice within 6 - 8 hours apart. Day 2 post 2nd dose still having left arm soreness, headaches, and mild muscle aches.
Mom reported that child started with swelling in (L) arm (upper) and warmth on 8/18/11 con't with same symptoms 8/19/11. Helps with BENADRYL. Will f/u in no improvement.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI
There is normally armpit tenderness; This time my armpit is on fire; moving my arm in any direction HURTS; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Lot number: 30135BA) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation at doctor's office/urgent care. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 14Feb2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL9261, Location of injection: Arm Right), administration date: 24Jan2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 05Jan2022 08:00, outcome "unknown", described as "There is normally armpit tenderness"; BURNING SENSATION (non-serious) with onset 05Jan2022 08:00, outcome "unknown", described as "This time my armpit is on fire"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022 08:00, outcome "unknown", described as "moving my arm in any direction HURTS". Therapeutic measures were not taken as a result of axillary pain, burning sensation, pain in extremity.  Additional information: There is normally armpit tenderness. This time my armpit is on fire. moving my arm in any direction HURTS, not just a little tenderness, but it hurts. My armpit is pulsating as I sit, it isn't a little bit tender, it pulsates and is super painful and I have a pretty high pain tolerance, but it is constant, pulsating pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
ONSET RIGHT AFTER INJECTION OF LEFT SHOULDER P/STIFFNESS RASH DEVELOPED THE NEXT DAY, ANTERIOR TO INJECTION SITE RIGHT HIP PAIN DEVELOPED ON DAY 2 AFTER INJECTION
Woke up 1/1/2019 7AM with itchy, swollen, red skin around both eyes. Went to Urgent Care on 1/2/19.  Rec'd Rxs for Medrol Dose Pack as directed and Triamcinoline 0.1% oint Apply twice a day, filled here and picked up 1/2/19 11:20AM. She said she is not allergic to vaccines and has had the flu vaccine multiple times. She said she does not know if she is allergic to eggs, she doesn't eat them. I suggested FLU-BLOK for next year. I will follow up w/ pt on Friday 1/4/19.
Started experiencing pain during injection and then pain to left arm at 7pm that evening . Shooting pains down to elbow. Also having decreased ROM.
admit for SOB, fever, weakness, chills. had +COVID test 10 days prior, repeat test +. O2 sats 94 on RA, desats to 84-90 with exertion. started on dexamethasone and zinc. Outside window for remdisivir.  passed walk study.
Rt. arm. 3 cm x 3 cm Erythema. BENADRYL