chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fever; Throat soreness; Joint pain; Body aches; Body chills; Severe arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Apr2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. It was not reported if the patient had received any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced headache, fever, severe arm soreness, throat soreness, joint pain, body aches and body chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, severe arm soreness, throat soreness, joint pain, body aches and body chills were unknown 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.
administering Adacel instead of Fluzone Quadrivalent / no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA272526 and 2019SA272535.  This case involves a 6 years old male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6378AA, expiry date: 04-Jul-2021 via unknown route in unknown administration site on 28-Sep-2019and was supposed to give the consumers a flu shot vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  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 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.  List of documents held by sender: none.
Developed vulvar aphthous ulcers on second day after vaccine. Initially was unaware of ulcer but noticed pain when urinating and wiping. Went to urgent care and was tested and treated for genital herpes until tests came back negative. Ulcers were not responsive to the anti-viral given nor to the lidocaine gel applied. Ulcers got larger and more painful in the ensuing week, and eventually subsided after 10 or so days.
Burning a week after vaccine after injection side and red raised welts. Rash turned hard and is continuing to burn.
Pt developed a itchy rash on arms, neck, and back of head. Eyes and head were swelling with temp of 99.8.
Information has been received from a registered nurse concerning up to 7-8 children who were intramuscularly vaccinated with RECOMBIVAX HB (Lot no. 654436/1106F) 0.5 ml, during the period of 03-FEB-2009 to 20-MAR-2009. The nurse reported that RECOMBIVAX HB had expired on 02-FEB-2009. No adverse effect was reported. Attempts are being made to obtain additional identifying information
Sore throat, hoarseness progressing to laryngitis, runny nose, raised bumps visible in back of throat all persistent from onset to present time (11 days thus far).  Headache, cough, and fever two degrees above normal have been intermittent for same period of time.
Narrative: COVID infection following COVID vaccine series 12/31/2020 , Moderna , dose #1 administered non-Facility 01/28 , Moderna , dose #2 administered non-Facility 08/10/2020 COVID swab result: not detected 06/25 pt cc: rhinorrhea, sore throat, fatigue, myalgia exposure; unknown 08/03 pt requesting COVD swab 08/04 COVID swab, result: detected 08/04 pt cc: chills, cough, rhinorrhea, fatigue, myalgia clinically resolved
Local pain for 2 days, Headache for 3 hours, Body aches for 24 hours, Fatigue for 2 days.  Symptoms were mitigated using Advil (Iboprufen 200 mg).
This spontaneous report was received from a 32 year old male patient, reporting on himself, as part of a market research. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On an unknown date the patient experienced pneumonia. The outcome of pneumonia was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Hospitalization-planned Narrative:  Patient with planned admission to the hospital for COVID testing and quarantine prior to admission to rehabilitation, strengthening, and social services to establish new home health care services after the previous provider discontinued services.
Urticarial patch (R) forehead & scattered urticaria (R) upper arm & chest. Tends to improve with topical steroid & BENADRYL both OTC.
Little pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little pain in the arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Little pain in the arm). At the time of the report, PAIN IN EXTREMITY (Little pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
CHILLS, TOTAL BODY SHAKES, NAUSEA, DRY COUGH, ACHY BODY, TIRED, SLEEPY, HEADACHE, LASTED ALL OF NEXT DAY. COUGH LASTED SEVERAL DAYS.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (pain at the injection site), vaccination site erythema (redness) and vaccination site swelling in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026L20A) for COVID-19 immunization. No medical history reported. On Jan 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In January 2021, patient experienced vaccination site pain (pain at the injection site), vaccination site erythema (redness) and vaccination site swelling. At the time of the report, vaccination site pain (pain at the injection site), vaccination site erythema (redness) and vaccination site swelling outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-330983 (patient link). Sender's comments: This case concerns a 65 year old female with no reported history, who experienced non-serious events of vaccination site pain, erythema and swelling that required no treatment (at an unknown time) after Moderna COVID-19 vaccine. Re-challenge is not applicable as this was the first dose. Benefit-risk relationship of Moderna COVID-19 vaccine not affected by this report.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 17-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261; US-009507513-1808USA004382:Original Case : 1808USA001261; US-009507513-1808USA004383:Original Case : 1808USA001261; US-009507513-1808USA004384:Original Case : 1808USA001261; US-009507513-1808USA004380:Original Case : 1808USA001261; US-009507513-1808USA004379:Original Case : 1808USA001261; US-009507513-1808USA004376:Original Case : 1808USA001261; US-009507513-1808USA004377:Original Case : 1808USA001261; US-009507513-1808USA004378:Original Case : 1808USA001261; US-009507513-1808USA004362:Original Case : 1808USA001261; US-009507513-1808USA004386:Original Case : 1808USA001261; US-009507513-1808USA004387:Original Case : 1808USA001261; US-009507513-1808USA004388:Original Case : 1808USA001261; US-009507513-1808USA004363:Original Case : 1808USA001261; US-009507513-1808USA004364:Original Case : 1808USA001261; US-009507513-1808USA004389:Original Case : 1808USA001261; US-009507513-1808USA004390:Original Case : 1808USA001261; US-009507513-1808USA004391:Original Case : 1808USA001261; US-009507513-1808USA004392:Original Case : 1808USA001261; US-009507513-1808USA004393:Original Case : 1808USA001261; US-009507513-1808USA004394:Original Case : 1808USA001261; US-009507513-1808USA004395:Original Case : 1808USA001261; US-009507513-1808USA004396:Original Case : 1808USA001261; US-009507513-1808USA004365:Original Case : 1808USA001261; US-009507513-1808USA004366:Original Case : 1808USA001261; US-009507513-1808USA004367:Original Case : 1808USA001261; US-009507513-1808USA004397:Original Case : 1808USA001261; US-009507513-1808USA004398:Original Case : 1808USA001261; US-009507513-1808USA004399:Original Case : 1808USA001261; US-009507513-1808USA004368:Original Case : 1808USA001261; US-009507513-1808USA004369:Original Case : 1808USA001261; US-009507513-1808USA004400:Original Case : 1808USA001261; US-009507513-1808USA004401:Original Case : 1808USA001261; US-009507513-1808USA004370:Original Case : 1808USA00126.
Had injection on the 10th. No sore arm. On the 17th discovered redness, rash, swelling the size of a quarter at injection site. By morning of 18th size of rash $0.50 piece and extremely itchy. Warm to touch and hard.
Sore arm; A little bit of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder NOS (Immune system issues).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications reported.   This case was linked to MOD-2021-406184, MOD-2021-406185 (Patient Link).
2-3 minutes after receiving my 1st Moderna shot I was sitting in my parked car in the observation area. I got super hot, my stomach cramped up, my lungs tightened, my tinnitus was exacerbated, I had an instant headache and a feeling of dread. I left my car and walked to the outdoor drive-through tent to tell the med staff that I was not okay. I was crying and felt like I was going to faint. After 10-15 minutes my symptoms subsided and I drove home alone 45 miles.
Patient received a flu vaccine and a pnuemovax injection to the right deltoid IM. Right deltoid is mottled, red, swollen and extremely painful w/movement and to touch.
Pt was to get 2nd dose of Hep B series. Pt was given Hep B recombivax 0.5ml ped dose instead of and adult 1,0 ml dose. Patient was contacted and informed wrong vaccine and dose was given. Phone call to Merck spoke to representative and per CDC guidelines patient is to be revaccinated with correct vaccine and correct dose. Patient is scheduled for 7/12/22 to get correct vaccine Hep B adult vaccine.
Info reported to our clinic by patient's PCP. 4 hours after receiving vaccines pt reports fever of 102 with rigors and sweats. Later that evening, she developed black papular lesions near vaginal introitus. 3 days later, she continued to report fever of 102F, and arthralgia. Had a localized red area on the arm where vaccines given. Gyn MD unroofed lesion which had a black necrotic center and sent specimen to  pathology. May 26th, pt reported to this RN that she still felt generally weak, but was without fever and lesions were healing.
Discharge Summary (Physician) ? ? Hospitalist Physician Discharge Summary       Age:83 y.o. Admit Date:  7/12/2022 Discharge Date:  7/14/2022      Principal Diagnoses:  Principal Problem:   AKI (acute kidney injury) Active Problems:   Acute cystitis without hematuria   Benign essential HTN   Hypokalemia   Hypomagnesemia   Orthostatic hypotension   Anorexia   COVID-19 virus infection   Generalized weakness     Discharge Diagnosis:  Acute renal failure, Hypotension, Anorexia, UTI, COVID 19, HTN, Debility.    Hospital Course:  The patient was admitted with the above. She was treated with IVF and her renal function improved. The UTI was treated with rocephin. Nothing grew on cultures. She was eating and drinking much better at the time of discharge. She declined SNF placement. She was placed on vantin to complete 3 days for the UTI. She was not hypoxic and did not require acute treatment for the COVID 19. She did have an elevated d.dimer but it was less than 10x normal. She was asked to follow up outpatient.    Consults to: None.    Significant Diagnostic Studies:  None.    Procedure(s): None.    Disposition:  home   Discharge Condition:  fair
Only 1" needles were available for the following 4 MERCE COVID-19 immunization clinics and 1 booster clinic documented on the Navigator site: March 28 at  April 5 at the  April 9 at  April 14 at the  and April 23 at  I estimate that somewhere between 25 to 30% of those vaccinated were over the 200# for women and 260# for men weight guidelines for administering the COVID-19 vacine.
Vial of vaccine was incorrectly reconstituted by LPN with 0.8mL NS instead of 1.8mL NS. A dose of 0.3mL was drawn out of vial after incorrect reconstitution and administered IM. Patient waited 15 minutes after administration and no adverse effects were reported during that time.
Had limited functionality in that arm now/A couple hours after the vaccine she couldn't move it at all; Arm has been messed up; She can pinpoint the exact location, because that is where it hurts the most; It hurts all the time/her whole left arm hurts; This is a spontaneous report from contactable nurse (patient). A 59-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284) via an unspecified route of administration, administered into left arm on 12Jan2021 (at the age of 59-year-old) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685) administered into right arm on 22Dec2020 (at the age of 59-year-old) for COVID-19 immunization. It was reported that patient received the second dose of the vaccine on 12Jan2021 and has had limited functionality in that arm now; it was further reported that a couple hours after the vaccine she couldn't move it at all. It was also reported that her arm has been messed up since 12Jan2021. The patient can show people exactly where her shot was given, she can pinpoint the exact location, because that is where it hurts the most, but now her whole left arm hurts it hurts all the time. The events had limited functionality in that arm now/a couple hours after the vaccine she couldn't move it at all and arm has been messed up was reported as serious, medically significant. The patient received treatment for the events reported, she took Tylenol. Outcome of event arm has been messed up was not recovered while the outcome of all other events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported vaccination site movement impairment and limb discomfort.  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.
Customer went into Anaphylactic reaction after receiving the vaccine, there was shortness of breath. We called 911 and they took the customer to the hospital.
A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 1 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on 20-JAN-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
No additional AE; an expired dose of ROT ATEQ was administered; This spontaneous report was received from a medical assistant and refers to an 8-week-old patient of unknown gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 21-JAN-2022, the patient was vaccinated an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U007860, expiration date: 14-JAN-2022 (exact dose and frequency were not reported) orally for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Patient rec'd VARIVAX on 5/20/13. That evening and though to early a.m. Kept waking up screaming and disoriented seemed to be a night terror. No fever. On 5/21 on exam completely nl.
8am: fatigue, sore arm. 12pm: extreme fatigue, really sore arm, fever. 4pm: extreme fatigue, really sore arm, fever, nausea. 8pm: extreme fatigue, really sore arm, fever, nausea, headache. 8am 1/21: totally fine.
Immediately after Injection I felt my vision blur, and my body started becoming very warm. I broke out in a sweat all over my body. I was told to sit for around 15 minutes, while doing so I blacked out and fell out of my chair onto the floor. I?m not sure how long it was, but when I regained consciousness I was surrounded by the nurses who elevated my feet and ensured that I was sitting up. They kept asking me questions so that I did not fall asleep as I felt very tired. My body felt heavy, my ears were ringing, and I felt nauseated so much so that I leaned forward to vomit, yet nothing came out. It was at this point that they brought me some water and orange juice. I still had to sit for around 20 minutes before I could even move, but I finally started to feel normal other than a terrible ache on the side of my head and disorientation. I still felt very off the rest of the day. And slept for the remainder of the day. I could not go to work
Pt reported a "funny taste" immediately upon receiving the vaccination.  She also reported feeling dizzy and lightheaded.  She has diabetes, A Fib and high BP but reported taking all meds and eating breakfast.  I took BP 3 times over the course of 30 minutes.  She reported a normal systolic between 130-140.  After a little improvement at the end of 30 min. she chose to go to Express Care PA-C for any additional follow up.  Express care reported she felt better and left with spouse.
Approximately 24 hours after administration of vaccine, patient experienced pain, fever and swelling at injection site. MD diagnosed cellulitis and prescribed Azithromycin.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ROTATEQ (lot # 1236AA; exp date 15-OCT-2012) (dose and route not reported) on 19-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
5/23/2022  I attended a wedding the week-end before where there was a COVID outbreak. I began getting a sore throat and head ache. My wife tested positive and I tested negative. I scheduled a PCR test. On 5/25/2022 I tested positive. I had chills, low grade fever and pressure on my chest. The next day I spoke with my PCP. He prescribed Paxlovid. I took that for 5 days. After the first day, the pressure in my chest went away. After 3 days I started feeling better. Then 2 days later I had lack of energy, my sore throat came back and by 06/04/2022 I had congestion, runny nose, fever, chills and a tremendously bad head cold.  I felt crappy. 06/05/2022 I started taking Sudafed in the daytime and Alka Seltzer Cold relief at night that helped me sleep for the first time in weeks. Then I started feeling better.  Yesterday, I felt better. The runny nose has stopped.  Today my voice is affected, have fever and feel crappy.  I tested positive on 06/07/2022 I tested positive.