chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hours of vaccine, patient awoke at 3am with pain in the back of her left arm. Within 30 minutes, that pain had radiated to the inside of her arm, up to her axilla. She visited her primary care physician 2 days later, and was treated.
I was diagnosed with a missed miscarriage on 4/23/2010. The baby was measuring 9 weeks 2 days (should have been 11 weeks 2 days). That means that the baby stopped growing 3 days after the vaccine was administered, on 04/09/2010.
Sinus pressure. Congestion. Runny nose. Body aches. Fatigue. Fever like chills. Sore throat
Celluitis of the L arm. Pt presented with painful, red L arm along with fever and elevated blood glucose.
Pt received vaccine on 3/9/15 - s/sx started occurring on 3/13/15 in (R) arm at injection site 5 x 5 cm area of redness. Erythema 8 x 10 cm and swelling at 3/16/15 appt for follow up.
The day of the shots very fussy and fever, at night broke out with rash, red and blotchy, all over body and legs were swollen. Lasted about 2 days. child ok now, no treatment.
The patient received an expired vaccine (12/31/21) The patient has not reported any adverse events.
Information has been received from a RN concerning a male child who was vaccinated in approximately 07/03 SC with a 0.5mL dose of MMRII (Lot # 645518/0181N).  It was reported on 08/27/03, the within the last month, there had been an increase in adverse events following vaccination with MMRII. The pt developed a bad rash all over his body, fever and injection site swelling of the leg. The child went to the ER, but treatment given was unknown. The pt was not hospitalized. Subsequently, the pt recovered. It was unknown if concomitant medication was taken. The pt's past medical history was unknown. It was unknown if diagnostic tests were performed. The same reporter also noted that 9 other children developed rashes, fever and injection site swelling of leg following vaccination with MMRII (WAES # 0308USA02721).  The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
experienced vaginal spotting started at approximately 12:10 PM and continued until 11PM. Approximately 5 weeks pregnant at time of injection, estimated due date 10/07/2021.
My left arm began to hurt severely about an hour after the first pfizer vaccine shot. The sever pain lasted a few days and turned into a dull ache. An hour after the second shot on April 20th my arm hurt severely for about a week but on the second day i noticed 5 small white pimples forming at and around the injection site. At about the end of the week the pimples were gone and the pain began to dull and currently i still feel a dull ache with intermittent moderate pain spells around the top of my left arm.
Patient was administered a COVID vaccine that was from a vial that was previously punctured and left outside the fridge for 2.5 days
No additional AE reported.; Expired dose of RECOMBIVAX HB ( expiration date: 11/09/2020) was administered to a 2 week old patient today.; This spontaneous report has been received from a medical assistant, referring to a 2-week-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 10-NOV-2020, the patient received an expired dose of vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose reported as 0.5 milliliter (route of administration, vaccine scheme, and anatomical location were not provided; lot number R006746 has been verified to be a valid lot number, expiration date reported as 09-NOV-2020), as prophylaxis. No additional adverse event was reported.
Patient's husband noticed she was turning red. I went to the patient to assess if she was having trouble breathing, which she denied. She looked visibly uncomfortable, physically and mentally. Paramedics were called. Patient's chief complaint was feeling like she was going to pass out, and that her "head felt like it was going to explode." BP was taken and recorded at 170/90. By then paramedics were on the scene and reassessed her BP, which was 160/90 then. Her glucose was measured in the low 80's. Paramedics urged patient to go to the hospital to be assessed more fully, which she agreed to. By that time, her face was back to a normal color, though her chest was still red. Patient's husband was contacted on Sunday, March 14, and he stated that she was in the hospital for 5 hours for a work up and observation, and they told her she had an allergic reaction of some sort but had recovered fully.
Pain in underarm (in the arm vaccine was administered); This is a spontaneous report from a non-contactable consumer, the parent. A 16-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 19Apr2021, as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced pain in underarm (in the arm where the vaccine was administered). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in underarm (in the arm where the vaccine was administered) was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 8NOV93 & pt began unconsolable crying-8PM which lasted until 1130PM; crying stopped spontaneously @ 1130PM & pt slept thru the noc;
Per parent report, very large area of erythema & edema developed involving entire lateral thigh.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, the patients were vaccinated with improperly stored doses RECOMBIVAX HB (lot # L023387, expiration date: 22-JUN-2017, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
The next morning with a 1 inch erythematous, painful area around injection site that progressed by the afternoon to a very tender, very hot  Erythematous area from below shoulder to mid upper arm.  He feels tired, a little bit of a headache and dizzy when tries to run or play.  No fever.  No other rashes on body or abnormal bruising.
Chest tightness, muscle weakness, overall fatigue, dizziness, joint pain, chills, shortness of breath, tingling feeling in hands and feet.   Symptoms kept getting worse for about 3 weeks. Was hospitalized to make sure nothing wrong with heart. Heart checked out OK. Blood tests came back clean for any other diseases. Symptoms lasted for 4 more weeks getting gradually better with time.
Increased heart rate, tachycardia, Pericarditis.  I felt like my heart was pounding out of my chest and fluttering.
Reported BLE swelling after B thigh injections, with deeply red maroon color BLE and child crying for ~15 minutes post shot, and in pain following day. Child with persistent pain, unable to go to sleep easily evening of shots. Day following had improved. Pt provided by parents APAP only. Persistent redness of skin and swelling and skin hypesthesia (appeared painful). No central necrosis/duskiness reported. No localized scale/desquamation. Denied history of sx c/w anaphylaxis (no urticaria, respiratory sx, GI sx, hypotensive sx). Child subsequently able to tolerate dose #3 of above vaccines excepting HiB (not scheduled for 6month appointment. Clinical evaluation by allergist suggesting a mild Arthus reaction given prior sensitization, however pt had no pathognomonic features so diagnosis uncertain.
Moderna COVID-19 Vaccine EUA, on my upper left back and middle front belly, burning- throbbing pain for days, which erupted as rash in defined circles or clusters 5 days later.  Diagnosed as Herpes Zoster (Shingles) on 27-May-21. Still in throes of the rash and pain, currently being treated with valacyclovir 1000 mg po tid, for 7 days.
Pt was mistakenly given pediarix instead of pentacel. Pt received two doses of Hep B. No adverse reactions occured. Pts mother was notified and verbalized understanding. Pt was scheduled to return on Aug. 23 @ 11am for Hib vaccine.
Treatment antibiotic in the hospital and at for 7-10 days. My arm was very red and very hard. My had gotten very large and very painful my body was very sick.
Vomiting reported 1 day post immunizations. Started just after dinner and continued over night.
Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on an unspecified date was vaccinated with PNEUMOVAX (lot # J004242, expiration date 20Jul2014). On 01-OCT-2013, the patient experienced an adverse reaction (not further specified) to the PNEUMOVAX vaccine. Treatment and outcome of the adverse event was unknown. Additional information has been requested.
Symptom onset approximately 5pm on 8/19/23: red/swollen face, mouth, and lips, runny nose, oral dryness and tongue swelling. Treatment: SOLU-Medrol IV push 125 mg, diphenhydramine IV push 50 mg, famotidine IV push 20 mg. Observed 2 hours and symptoms resolved.
Deployed (OCT-03 to JAN 04) Upon leaving within a months time I recieved 4 other vaccines in close proximity (2 influenza,1 smallpox,and 1 Anthrax) Began with Shortness of breath, chest pains and onset of pneumonia,diarrhea,weakness,constant migraine cluster headaches. Proponolol for high-blood presure to try to reduce headaches,CAT scan, and blood work. Symptons started month into my deployment. I got sicker with each series, which led to pneumonia with the 2nd & 3rd series. Shortly after the cluster migraines and shortness of breath started. Scheduling follow up summary narritive.
Patient's left arm is red and inflamed (1 inch diameter, 1 inch below injection site). BAND AID removed today.
Nurse administered FLUZONE QUADRIVALENT in error to a 1 month old with no reported adverse event); Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1 month old patient of an unknown gender whose nurse administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient's nurse administered INFLUENZA QUADRIVAL A-B VACCINE in error (product administered to patient of inappropriate age) (unknown latency) for Suspension for injection (dose, frequency, strength, lot number and expiry date: unknown) via unknown route in unknown administration site for immunization.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a 53 year old female. Initial information was processed along with additional information was received on 29-JUN-2022 The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, and unspecified allergy. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 13-MAR-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. The batch number was not reported and has been requested. Concomitant medications included hydroxyzine for drug used for unknown indication. The patient was prescribed with non-company drug Paxlovid (form of admin and route of admin were not reported, batch number: GA1513 and expiry: unknown) dose was not reported, administered first dose on 10-JUN-2022 and last dose on 14-JUN-2022 for covid-19 treatment. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. On 16-JUN-2022 at 06:00, Paxlovid stopped the symptoms right away but after 2 days of the last dose of Paxlovid, the patient started experiencing dry cough. Treatment medications (dates unspecified) included: benzonatate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000238638.; Sender's Comments: V0:20220657667-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 09-MAY-2016, the patient was vaccinated with an expired dose of VAQTA 50/1.0 U/ML (which had the lot number of K001296 with expiration date of 15-JAN-2016) (dose, route and anatomical site were not reported). Information regarding concomitant medication was not provided. However no adverse effects were reported and there was not product quality complaint involved. Additional information has been requested.
Pt states sever headaches, vision blurred. Dr. visit 06/24/2021 told to contact CDC/VAERS to report.
Patient complained of Headache, Chills and Joint aches, also had a 2 inch diameter red welt at injection site .
Pentacel ordered, but Vaxelis given by staff. Patient without adverse reaction or issues.
Information has been received from a registered nurse concerning a 4 year old male with no known allergies and no past medical history who on 6/26/02 was vaccinated with the second dose of MMR II (641119/1377L), in the left thigh. Concomitant therapy that day included the fifth dose of Infanrix (552) and the fourth dose of IPOL (T1362/2), both in the right thigh. On 6/27/02 the pt had "redness, swelling (10x10cm) of left thigh). The pt sought unspecified medical attention. It was reported that the pt recovered. There were no relevant diagnostic tests or lab performed. It was noted that the pt and pt's sibling did not experience any adverse events following prior vaccinations. No further info is expected.
On the 4th day after getting my second COVID dose (4  weeks after my first COVID dose) I got a very swollen lump (lymph node) on my neck /shoulder area the same side I got the shot on.  Node is noticeably swollen, red, and hot to the touch.
second injection of shingrix vaccine.  arm soreness, chills overnight, nausea overnight, throwing up 3:30 am, headache
Information has been received from a physician referring to an unspecified adult patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date in March 2017 (reported as "sometime in March"), the patient received their first dose of VAQTA (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 04-MAY-2017, the patient received their second dose of VAQTA lot# N002921, expiration date 08-APR-2018, (dose, frequency and route were not reported) for prophylaxis (drug use for unapproved schedule).  No adverse events reported. Additional information is not expected because the reporter does not want to be contacted further.
On Sunday following vaccine my husband noticed that I had a lisp when I spoke and my tongue wanted to protrude out of my mouth sporadically.  As the week has progressed, I now have trouble speaking without jumbling my words - have to stop and speak slowly to make sense
Patient was a 71-year-old Male, fully vaccinated with Moderna on 03/05/2021. Admitted to hospital on 03/21/2021 as he is tested positive for COVID-19 and passed away on 04/09/2021.
66 year old female presents to ED. Patient arrived by ambulance to the ER for left lower limb cellulitis that is worsening. The wound that is circumferential on the left lower leg and extends down to the left foot is reportedly expanding in area and the edema associated with the limb in increasing as well. Patient was hospitalized  on 09/09/21 for same problem however has gotten worse. She is taking augmentin since 9/13/21, doxycycline since 9/12, ciprofloxacin since 9/21.
Seizure at moment of injection. 10:17am B/P = 92/58, P= 52. Previous hx in 6th grade, alert and oriented within 30 seconds. Advised MD for evaluation. Released to father for medical  follow up at 11:10am.
no adverse event; Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.).    No patient details were provided.  Concomitant product use was not provided by the reporter.  It was reported that dose was administered after 30-day Use by Date or after manufacturer Date of Expiry. Individual vial size was reported as 2.5 ml. Dates vial was initially stored was 19-Jun-2023, 22-Jun-2023, and 23-Jun-2023. Vial did not undergo any temperature excursions. Vials were administered on 19-Jun-2023 (1Patient), 22-Jun-2023 (2 patients), and 23-Jun-2023 (2 Patients). Reporter stated that he wanted to wait on the assessment as it was just 1 day after expiration date.  Suspect product dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 2nd out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730746 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730746:Master case ( Patient 1 out of 5)
9-10 hrs after vaccination -- fatigue, sore arm;Events completely wore off overnight, after I slept it off.
headache, chills dizziness, lightheadedness began about 24 hrs after the vaccine.
Onset of fever (101) R arm pain progressing to generalized muscle pain & weakness within 24 of vaccine. Increased pain at site of injection of pneumovax but no visible local reaction. No cellulitis, 1 day later developed hives. Pt has multiple sclerosis & Crohns disease, depression.
pt given APAP prior to & 48hr p/vax;on the fifth day pt had a fever of 102, swollen glands, puffy face & a rash that covered body for several days;
Presented with weakness, mild SOB, hyponatremia; + Covid; CXR wiht trace pleural effusion; Ferritin and CRP slightly elevated; Tx, Merrem, Vit C, Decadron, Lovenox; Remained on room air throughout stay; sodium persistently remain lower side.  Ultimately patient's sodium was up to 130 and she was discharged to home in stable condition.  She was believed to have hyponatremia related to SIADH
Patient has experienced right arm pain and tingling since her Shingrix vaccine in December (roughly two months). It is worth noting that she received the flu shot in the other arm during the same visit. She reports trying acetaminophen/ibuprofen treatment, as well as heat and ice therapy. She reports that the sensation has been fairly constant, and wanted to report it officially. We reached the mutual decision that she will reach out to her doctor for her opinion as well.