chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 1035, client came in to clinic for a scheduled Vaccine- first dose Pfizer (Pfizer Lot # ER8732, exp 07/2021). Patient alert and oriented x4, verbalized a history of migraines. Patient received vaccine in right arm and completed 15 minutes observation. After 15 min observation,  client walked to the exit and complained of headache and verbalized similar to a migraine. Client was placed on gravity chair were she was assessed, vitals taken bp 110/70, HR 64, temp 96.6. After another 15 min of observation she verbalized she felt better, this nurse assessed the headache, client verbalized it had subsided and ready to go home, she refused any further observation and was thankful for the care.
Cellulitis left shoulder following Tdap, 12-24 hours after administration. Admitted and treated with Vancomycin - then changed to ANCEF, discharged on KEFLEX.
The day after pt received the Prevnar vaccination he develop diffuse hives all over his body and lip swelling. Given tx: Benadryl 25 mg every 8 hours PREDNISONE taper starting at 30mg bid x 4 days.  12/10/14 added Zyrtec 10 mg twice daily for continued itching.  Hives   12/10/14 Appt with allergist: 2010 Pneumovax without problems. 12/4/14 Prevnar 13 with initially local swelling surrounding injection site. On the following day developed urticaria (generalized) and upper lip swelling. Hives described as red, raised, pruritic, migratory, however, ongoing flare. No other reactions such as tongue or throat swelling, shortness of breath, wheezing, abdominal cramping, vomiting, diarrhea, or light headeness. Hives/swelling noted on exam by Dr. Improved now with prednisone. In addition taking diphenhydramine (Benadryl) for pruritus, with only mild benefit.  12/12/2014  3:29 PM PST patient reports most of the hives have resolved.
102 fever, chills nausea, headache set in by 9 same day as vaccine  but were gone within 72 hours
fatigued, short of breath, chills, first dose had similar reactions for one to two weeks
The next day post vax, the pt experienced arthralgias, a hive-like rash, cramps in stomach, nausea, and an intermittent fever, with a high of 102.
Patient was given the COVID19 Pfizer Bivalent vaccine prior to two months from the last dose of the previous series. Patient's last dose of 07/16/2022 so booster should have been administered on or after 09/16/2022 but was instead administered on 09/10/2022. No treatment was provided and patient has not reported any adverse reactions.
Case number PHEH2014US014727 is an initial spontaneous report from the nurse on 22 Jul 2014. This report refers to a 17 years old patient of unknown gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: A13061) inadvertently administered subcutaneously on 08 Jul 2014. No adverse event reported after the maladministration (wrong route of administration).
vaccine to a 16 year old patient; A spontaneous report was received from a pharmacist  concerning a 16 year old patient who was administered a COVID vaccine at an inappropriate age.  The pharmacist wants to know how to manage this situation.   The patient's medical history was not provided.  Concomitant medication details were not reported.  On an unreported date, The patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) on 05/Feb/2021 intramuscularly for prophylaxis of COVID-19 infection.   On an unreported date, 16 year old patient who was administered a COVID vaccine at an inappropriate age.  The pharmacist wants to know how to manage this situation. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not applicable.  The event was considered resolved on an unreported date.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age  for mRNA-1273, lot # 030L20A with no associated AEs.
Syncope secondary to vaccinations. Child did not fully recover after 30 minutes of observation. Hypertensive 140/80 and 130/80 after immunizations. Consulted with private MD and referred to ER for evaluation. Released from ER to home.
Patient reports experiencing heart flutter, nerve pain radiating up her legs and hips, and fatigue lasting for several weeks since she received her Janssen immunization. Patient reports no history of these side effects, is not currently taking any medications, and was advised to seek medical care primarily due to the new onset heart flutter.
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 29-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 15 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Became very red-faced and had trouble breathing immediately upon receiving flu vaccine- this lasted approximately 10-15 minutes - BP elevated, HR elevated on admission to E.D. Diaphoretic, felt "tingly" all over.
Narrative:  Patient developed generalized erythematous and itchy rash all over his body but mainly concentrated on his abdomen back and on his legs which was very itchy in nature. Patient received COVID-19 vaccine five days prior. Patient prescribed prednisone taper.
Patient presented to pharmacy with redness at injection site and full body (RPh saw upper torso and abdomen) and upper extremities rash and hives.
patients arm was red, swollen and warm to touch. it had been 3 days since she received the vaccine when she came to report the incident. redness and swelling were spreading.
Fast heart rate; dizziness; Nausea; vomiting; This is a spontaneous report from a contactable other hcp (Patient herself). A 37-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 16:30 (age at the time of vaccination was 37-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included cyclic vomiting syndrome, Peanut allergy, Allergy to nuts from an unknown date and unknown if ongoing. Other medications in two weeks Concomitant medication(s) included nystatin (NYSTATIN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took compazine [prochlorperazine edisylate], reglan [metoclopramide] , betadine [povidone-iodine] and experienced drug hypersensitivity. The patient has no COVID prior to vaccination. The patient has no other vaccine in 4 weeks.The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: 185 on Fast heart rate. 185 BPM when lying  down.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of fast heart rate (heart rate increased), nausea (nausea), dizziness (dizziness), vomiting (vomiting). As a result patient was in [Emergency room/department or urgent care]. Treatment received yes with IV fluids and Phenergan 12.5 mg. On 14Jan2021 18:00 The patient experienced fast heart rate (medically significant), nausea (medically significant) , dizziness (medically significant), vomiting (medically significant). The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination with BNT162B2 played a contributory role in triggering the onset of the events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient presented to the ED and was subsequently admitted within 6 weeks of receiving COVID vaccination. Diagnosis was pneumonia due to COVID 19 infection.
Fever 101; chills, severe muscle aches, headache, weakness. Symptoms lasted almost 24 hrs.  Muscle soreness and fatigue for 2 more days
Patient called on 09/14/10 stating she got weak, chills, short of breath, pain in arms, fatigue after receiving flu shot on 9/10/10. Started feeling bad at 1:30pm on 9/10/10. Felt better 9/11/10 in afternoon. No local reaction (stated).
Entire left arm sore when moved, far less sore the next morning by 5:30 am then fine by the 3rd day.
Stomach ache for over 2 hours; then a bowel movement with some diarrhea 3 times that day. I had a stomach every morning until October 30th accompanied by some diarrhea 2 or 3 a day. I did not eat anything different. I ate what I usually eat. After the 30th, the stomach aches were very mild but, I still have some diarrhea 2 or 3 a day.
1st and 2nd day after vaccine: Low fever, excruciating body pain, site injection itch, suicidal/violent thoughts, head/brain ache, dehydration, persistent migraine, injection site inflammation, and itchiness.  3rd day: Pressure pain on head and eyes, slight tightness when breathing
3/10/03 Imovax given at 8:30 A and at 1:30 P pt became pale, hurt all over, chills. Mother took pt from school to ER for assess. Pt was released at 5pm. 9pm became cold, pale, body hurt all over, teeth chattering. Pt taken to ER-assessed and released at 12mn given Motrin for pain.
cold chain break is reported with no reported adverse event; poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an infant patient of unknown gender and it was reported cold chain break is reported for HIB (PRP/T) vaccine [ACT-HIB] and poor quality vaccine administered with no reported adverse event.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, cold chain break is reported for HIB (PRP/T) vaccine with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (batch/lot number: UJ756AAA, expiry date: 12-08-2023; strength, route: not reported) in unknown administration site for prophylactic vaccination (immunization) (poor quality product administered) (latency: same day).  It was reported that Act-HIB for which cold chain break is reported and excursion vaccine was administered to 30 children were within 2, 4, and 6 months of age. The order contained ActHib (10 boxes or 50 doses) and MenQuadfi (5 boxes or 25 doses). The order was delivered to the facility on 30Mar2023. The facility received email notification on 14Apr2023 at 14:30 that the products should not be used because they were delivered beyond the acceptable shipping time. It was stated that a big frustration is that Sanofi no longer has a cold chain tracker in the boxes. From the information I received, you have a term 'anticipated transaction date' which was 29Mar2023. That term means nothing to the clinical staff as far a cold chain failure. We had no idea this was a broken cold chain until two weeks after the shipment arrived. Because of that, 30 kids received the ActHib and 3 patients received MenQuadfi from this shipment.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: Not applicable.  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 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.
Early next morning feverish and fatigued. Then massive seizures began which lead to hypoxia-ischemic encephalopathy and permanent brain damage.
This case was reported by a physician and described the occurrence of seizure disorder in a female subject of unspecified age who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced seizure disorder. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
11SEP91 had DTP/OPV; 12SEP91 mult frequent myoclonic jerks while sleeping only-mostly exhales-every 20-30 secs; resolved in 48-72 hrs; Had EEG-normal;
Red flat rash on upper chest. Given Ibuprofen 200 mg.  Advised to take Benadryl 25 mg 1-2 as needed if rash persists.  Advised to go to ER if S.O.B.
10/20/05 - Localized reation - red & swollen at injection site 10/22/05 - Fever 10/23/05 - Fever 103.5, headache, fatigue, nausea, low back pain.  Presented to ER and admitted to med-surg unit. Inpatient today 10/24/2005 - IV therapy. Motrin for fever. Per follow up report- Patient died.
Left arm pain onset following vaccination/injection, but persistent for 3 weeks.  States pain to deltoid area with moving arm/shoulders, but no shoulder pain.  Full rom to shoulder joint.  No redness or swelling, no induration or pain to deltoid area with palpation
Pt fainted after receiving the Boostrix (Tdap) immunization, recovered immediately after we laid her on floor, she did not want to call 911, she stated that she had not eaten since noon and had just had an energy drink, watched pt for awhile and called her mother to come pick up.
This spontaneous report as received from a Licensed practical Nurse refers to unspecified number of patients of unknown demographics. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
A rash broke out on my right arm in the crease of my elbow. I received my second dose on Wednesday at around 4 p.m and woke up the next morning at 6 a.m with a full-blown rash that itches and looks like Eczema. It has been 6 days since the injection and the rash is not getting better.
Pt develop swelling, knotted area and bruising at site of injection. Swelling and redness and itching spreaded to lower part of the arms worse on the right. Occur on same day of vaccination on 9/17/22 still red/flushed and itchy to today 9/25/22
pt received the vaccine which had been in the freezer 4 days longer than the max timeframe
Beginning 2nd day, symptoms were sever pain at injection site, fever, chills, body aches, general ill feeling.
June90 pt vax;  devel arthralgia & sinovitis 3 days after vax.
4-8" red rxn on rt arm  got pneumovax twice in 1yr by different hlth care provider;;
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 75 years old male patient who experienced shoulder was hurting and was complaining more up in the shoulder to shoulder blade area, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 23-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ047AA and expiry date: 28-May-2019) via intramuscular route in the left deltoid. On 23-Nov-2018, the patient's shoulder was hurting and was complaining more up in the shoulder to shoulder blade area following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included No Lab data was reported. Patient was given ice pack as a corrective treatment. Final diagnosis was shoulder was hurting and was complaining more up in the shoulder to shoulder blade area. The patient outcome is reported as Unknown for shoulder was hurting and was complaining more up in the shoulder to shoulder blade area. Documents held by the sender: none.
pt experienced severe headache, vomiting, body aches, injection site pain. she was seen by her pcp the following day for something unrelated to the reaction. her pcp was made aware and suggested the pt take tylenol to control symptoms. pt is better as of today, but still complains of pain in her arm.
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, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "cad" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated from 29Apr2023 to 04May2023 with Paxlovid (Batch/lot number: GK2847). Patient had no known allergies  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
administering an expired vaccine to a patient with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old and unknown gender patient who was administering an expired Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jul-2023, the patient received a 0.5 ml dose of Expired suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection (lot number, strength not reported) (Expiry date: 6-Jul 2023) via unknown route at unknown location as immunization (expired product administered) (latency: same day).  Action taken: not applicable.  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 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.
CHILLS; NOT FEELING WELL; MUSCLE ACHES; HEADACHE; FEVER; PAIN AT INJECTION SITE; INJECTION SITE RASH; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergy, and seasonal allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site rash. On 12-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021 17:00, the subject experienced chills. On 12-APR-2021 17:00, the subject experienced not feeling well. On 12-APR-2021 17:00, the subject experienced muscle aches. On 12-APR-2021 17:00, the subject experienced headache. On 12-APR-2021 17:00, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site rash on 13-APR-2021, was recovering from pain at injection site, had not recovered from not feeling well, muscle aches, headache, and chills, and the outcome of fever was not reported. This report was non-serious.
Extreme headache, joint aches (especially hips), nausea, fatigue, fever 102.3, chills
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # N008827 with the expiration date of 16-MAR-2019; exact doses and route of administration were not reported), for prophylaxis. No adverse symptoms were reported.  The administered doses of vaccine experienced a temperature excursion between 6 and 14 Fahrenheit degrees (7.5 F) for 2 hours and between 6 and 14 Fahrenheit degrees (7.3 F) for 13 minutes.  Previous temperature excursion, between 6 and 14 Fahrenheit degrees (10.9 F), occurred for 1 hour. Digital data logger was involved to capture the temperature excursion.