chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005085: US-009507513-1802USA005090: US-009507513-1802USA005089: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA007559.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (lot # 665215/1172Y, Exp 14-FEB-2011, dose unspecified) on 31-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. Reporter noted that the patient was administered an expired dose of ZOSTAVAX on 31-JUL-2012. No adverse effect reported. It was unspecified the patient had sought medical attention or not. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient had MMRV vaccine and Varicella vaccine administered at the same time. They were administered in separate legs and in the sub q portion.
Mom brought child in to the nurses office today 11/2/2009 at 11:00 am c/o left upper eyelide displayed "slight inflammation referred to pediatrician for evaluation.
Tdap Rt arm - next day - redness, soreness, swelling, knot under site & pain, fever 101, chills - went to ER - gave TYLENOL, ice & told to rest.
Pain in right chest area; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in right chest area) and HERPES ZOSTER (Shingles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHEST PAIN (Pain in right chest area) and HERPES ZOSTER (Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency and IBUPROFEN for Chest pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Pain in right chest area) and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI - FU failed
Patient stated that she had pain, numbness and tingling of fingers and left arm, due to flu shot. Possibly given too high in the deltoid. Denies any redness, fever or chills.
This case was reported by a other health professional and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional information: Physician updated previous AE report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Fever up to 102.8 that is not lowered with Tylenol, significant bilateral knee pain, and redness at vaccine site. Was seen in the ER and advised to "Take ibuprofen ( 3 Advil tablets) 600 mg every 6 hours. In between you can also take acetaminophen (2 Tylenol extra strength) 1000 mg every 4 hours . For example Ibuprofen 600 mg at 8pm. 2am, 8am 2pm regularly Then can take tylenol in between those doses if needed. Drink fluids well." Follow up call to patient on 3/19/21 "States he is feeling better today. Has been taking Ibuprofen which is controlling his fevers. Does not think he has a fever at this time. States I sweat it all out last night. No questions or concerns."
Itchy hives; Rash down both forearms and top and bottom of left foot; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in right arm, administration date 05Jan2022 (Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (unspecified if ongoing), notes: Ehlers danlose syndrome; "Fibromyalgia" (unspecified if ongoing); "Migraine" (unspecified if ongoing), notes: Migraines; "Chronic headaches" (unspecified if ongoing), notes: Chronic daily headache and "Penicillin allergy" (unspecified if ongoing), notes: known allergies; Penicillin. Concomitant medications were not reported. Past drug history included: Amoxicillin, reactions: "Drug allergy"; Erythromycin, reactions: "Drug allergy"; Darvon, reactions: "Drug allergy" and Lyrica, reactions: "Drug allergy".  The following information was reported: URTICARIA (non-serious) with onset 05Jan2022 at 20:00, outcome "not recovered", described as "Itchy hives"; RASH (non-serious) with onset 05Jan2022 at 20:00, outcome "not recovered", described as "Rash down both forearms and top and bottom of left foot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria and rash.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HF9275) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 25Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/Lot Number: EL9266, Anatomical location: Arm Left), administration date: 13Feb2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot Number: FF2590, Anatomical location: Arm Left), administration date: 07Oct2021, for COVID-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot Number: FP4454, Anatomical location: Arm Left), administration date: 02Jun2022, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot Number: GH9702, Anatomical location: Arm Left), administration date: 20Oct2022, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 27Apr2023, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2023 at 00:30, outcome "recovered" (19Oct2023) and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2023) Positive, notes: I developed symptoms the night of 14Oct. I took a home test which was positive; (19Oct2023) Negative, notes: I had no symptoms and tested negative with a home test on thursday, 19Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 14Oct2023 to 19Oct2023. Clinical Course: Patient developed symptoms the night of 14Oct2023. He took a home test which was positive. He then went to urgent care where the diagnosis was confirmed and a prescription for Paxlovid issued. He started it the evening of the 14 and finished it on the morning of 19Oct2023. Known allergies none that he knew of, but he haven't tried them all.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335899 same patient, different drug and event;
Large, hard swelling and redness approx. 10cm in diameter to right deltoid around the injection site.  Axillary swelling/tenderness. Red non-tender area in antecubital space. Pain behind right breast and down right back.
pt recv vax & had severe h/a, ankle/feet/knee pain; ankle swelling & weakness in ankles; almost unable to walk;
Swelling of my throat; Face also looks little bit swollen; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling of my throat on Mar2021, face also looks little bit swollen on Mar2021.Limited information was available over the call. The outcome of the events pharyngeal swelling, swelling face was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
The next day my mom started having a lot of pain on her right arm. Then she got a blister in her index finger. I thought it was a mosquito bite so I gave her Benadryl. She had a flight to visit my sister and the next day she woke up with her hand full of blisters. They took her to urgent care and they said it was an allergic reaction. The next day she was feeling very bad so they took her to the ER. I was on the phone with the doctor and he said she has shingles. He gave her some medications because the pain was very intense.  They sent her home. Today she woke up feeling worse. My sister says she does not want to move, she is dragging her feet when she walks. But she slept fine and ate fine. Now her hand is swollen and has blisters up to her elbow.
Sx onset 7/24 nausea, fatigue, weakness. Tested on 7/26/21 which resulted as positive for COVID-19.
Chills and fever 101, vomiting. Diarrhea, head ache, body aches upset stomach.
Fever day after (Thursday) and felt run down.  Felt a little better by Friday - then by Monday horrible vertigo which I had never had before and feel like my head is in a vice.  Went to dr. to see if it was ear or something else but she found nothing.  I couldn't work barely at all this whole week - today, Friday, my head feels like a watermelon and I am still dizzy - constant dizzy feeling although not falling over.  quite debilitating.
Back of left upper are swollen and red around the site where PROQUAD was given. Mother of child stated she noticed the arm along with fever on 4/21/18. Mother states that the arm does look better today 4/23/18, than it did on 4/21. Swelling and redness has decreased per mom. She came to clinic to ask if she should be concerned. Mother was told to apply cold compresses to arm and follow up with pediatrician. She was counseled to signs and symptoms of infection. The child has a well child visit with his pediatrician today and mother stated she would have the doctor look at child's arm at that time.
Varivax #2 given on 2/15/07; #1 given 5-7-00 at previous PCP on 11-29-09 took to 2 ER's-Both dx shingles on (R) shoulder and (R) wrist. Culture done by CPHs - negative for varicella. This is a delayed FYI.
I received my second dose of Moderna vaccine on 9/17/21 following day I had a clot in my foot
very hot; hard; itchy; highly inflammation of 4x4in at injection site; Painful quite hard; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site) and VACCINATION SITE PAIN (Painful quiet hard) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site), VACCINATION SITE PAIN (Painful quiet hard) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site), VACCINATION SITE PAIN (Painful quiet hard) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        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.   Treatment medication included Zyrtec and Hydrocortisone.  No relevant laboratory details were included.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dx: urticaria 2 hr flu shot-pt had maculopapular rash on body with pruritus-Doctor visit 10/25/07 Decadron 0.5 mL/2 mg
Left axillary lymph node keeps swelling several days after the vaccination. And connected lymphatic vessels are also swelling. I was wondering if I would avoid the second shot when the lymph node still swells.
This spontaneous report as received from Pfizer (Manufacturer Control N. 2015073572) refers to a female adult patient. On an unspecified date in 2007, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot #, dose and route not reported). Subsequently, her arm swelled up with PNEUMOVAX 23 (onset date unspecified). At the time of the report, the patient's outcome was unknown. The original reporting source was a pharmacist. Additional information has been requested.
administrated an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa (Infanrix) (batch number ng5gf, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-JULY-2022 Reporter's Comment: The Medical assistance stated that patient was administrated with an expired dose of Infanrix. No adverse event was reported . The reporter consented to follow up. Additional supportive information The patient administered expired dose of Infanrix, which led to expired vaccine used.
32 weeks pregnant and second dose of Covid vaccine received on 1/21 at 11:00. Flu like symptoms (fever, chills, headache) began 0100 on 1/22 and lasted until about 1300 on 1/23. I had to call out sick from work on 1/22. Worked a 7L shift on 1/24 and at about 2000 noticed a petechial rash on bilateral lower extremities that spread up to lower abdomen. Called on-call L&D Doctor and she advised for me to be assessed at L&D triage. I was then admitted for 4 hours due to my rash and further workup concerning for DIC, thrombocytopenia and/or other possibilities. My petechial rash was very concerning for coagulation disorders and prompted many lab draws to be obtained. My labs showed elevated AST & ALT that were previously normal, low platelet count (thrombocytopenia), protein in urine, elevated alk phos. I was discharged around 0100 for further workup the following day.  On 1/25 I went to clinic to have more labs done per Doctor. 1/26 at about 0830 I was called by my OB Docotor to immediately go back to Labor & Delivery triage to be admitted for what she thought was preeclampsia based on my labs from 1/25 and 1/24. I was again admitted for about 4 hours for monitoring of baby, and myself for preeclampsia. My labs were still elevated and out of range mirroring preeclampsia, but my blood pressure was stable, so I was discharged around 1300. I followed up with labs at clinic on 1/28 and again on 2/2 as well as with home blood pressure monitoring.  My labs on 2/2 showed everything back to normal, causing the doctors involved in my care to believe this was an adverse event due to the moderna covid vaccine.  As a result I missed one day of work, was admitted to the hospital twice, and had 4 days of lab draws which will result in an excess of medical bills.
6 or 7 hours after getting the shot I started to feel a little sore and achy all over my body, it felt like I had the flu for 12 hours. The muscle achiness has persisted and has gotten worse over time. The first day it was my whole body, the next day it was less. Then my legs and arms were really tired. If I lift my arm to get a cup it feels really heavy. I do not feel tired but my legs have gotten worse, it constantly feels like they are really achy and tired. Mainly in my knees. I went to the doctor about 3-4 weeks after my vaccine, so early May and they told me to rest for 6 weeks and come back and if that persisted they recommended me to go to the orthopedic surgeon. He did an x-ray in both knees and prescribed me medication.
pt recvd vax 2OCT91 & w/in 2 wks following vax devel a swollen knee, general malaise & gastrointestinal problems; work-up for the gastrointestinal problems revealed no physical cause; MD felt exp was due to vax;
Several months after the third dose, I had to have a right stint replaced from my ureter. After it was replaced I had to get bilateral nephrostomy tubes put in. I had those in for 3 months. I had a major surgery in mid March on multiple organ systems. I had 3 blot clots in my right calf and had to be put on blood thinners. I bled so much I almost had to have a blood transfusion and went back into the ER. I was put on progesterone and eventually a Depo Lupron shot for temporary Menopause. I am also still on the blood thinner Xarelto.
This case was reported by a nurse and described the occurrence of sore arm in an adult male subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis.   On 10/07/2005 the subject received 3rd dose of Engerix-B in the arm.  At an unspecified time following the 3rd dose of Engerix-B, on or after 10/07/2005 and on or before 10/21/2005, the subject experienced soreness in the arm.  At the time of initial reporting, 10/21/2005, the arm soreness was ongoing.
Almost immediately felt a rush of heat.  Cooled down and felt okay. Within 30 minutes, became tachycardic and short of breath.  Was unable to complete a full sentence.  Facial, lip and tongue swelling noted.  Rapid Response was called.  IV Solumedrol, IV Pepcid, Iv Benadryl and IV Normal Saline bolus given with positive results.  *Patient states previous sensitivity to IV Reglan.*
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 9/11/2021 PALLIATIVE CARE
C/O burning pain & itching with blotchy rash to (R) leg & (R) buttocks. Dx with shingles by primary care MD 11/3/11.
Rash. Looked more like chicken pox or bites.  Most on torso but significant number on legs and few on arms. Mild discomfort and itching.  Ones on legs quite raised with blister on top.  Developed following the third dose. Had been experiencing some headaches and hot flashes but no significant fever. Called health department who advised not taking final capsule.  Called doctor who failed to respond so went to see nurse practitioner who said the spots did not look like regular hives, had no idea what they were or how to treat so sent me home. I was exhibiting about 85 to 100 welts of varying sizes from pin prick to large mosquito bite.  Took Benedryl, cortizone cream and rested.   Once week later,spots have reduced and only a few are still raised.  I am interested in taking Zostavax for Shingles preventions.  Are there any common ingredients in these two live vaccines that I may react to as my spots bear some similarity to chicken pox or shingles except for the lack of itching or pain?
Patient Refers that all the vaccines administered give him the same effect of dizziness 120/80, 76 p, 36.5 temp, 112 dext, 15 resp, is left under observation for 30 min. He is discharged conscious and stable alert.
Indurated erythematous, eczymotic, rash at site of injection,  painful.