chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Continued to get worse and spread down all the way to her left wrist/Localized rash around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 5th October 2020, 3 days after receiving Shingrix, the patient experienced injection site rash. The patient was treated with triamcinolone (Triamcinolone Cream) and clobetasol propionate (Clobetasol Cream). On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received Shingrix vaccine in the upper part of her left arm and 3 days later she developed a localized rash around the injection site, it continued to get worse and spread down all the way to her left wrist.  The patient tried Triamcinolone cream which did not help, then tried Clobetasol cream for 14 days which did clear up the rash. The reporter did not consent to follow-up.
Had vaccine Zoster 8 days ago, within 24 hours had a red painful rash erupt on right ear which has since spread via small, scattered painful vesicles, to upper right shoulder, back and torso.
Became extremely nauseated and began dry heaving, I got up from bed and my leg gave out. I fell onto my bed and my cell phone was there & I called 911and was taken to Hospital.  I was diagnosed with a bilateral frontal lobe bleed type stroke. I was in ICU from 03/01/21 until 03/11/21 then moved to stroke therapy unit  and discharged to out patient therapy.
patient reports loss of blader control for 3 days after administration, she reports lower back pain for 3 days after administration and increased blood pressure daily since administration , she also admits to stopping her blood pressure medication months before ( bp under control without meds )
After being observed for 15 minutes and then leaving the vaccine site, @ approximately 1140 began to have urticaria on the face and neck. Took 2 tablets of benadryl which she had po and then had complete resolution.
Patient did not experience any adverse effect from immunization. When administering immunization at plunger depression, vaccine poured out through space between syringe & needle connection. Needle(EasyPoint) also did not retract, as per its technology. Fault may have been with connection. Obtained a second FLUZONE HD from an alternative Lot# and new EasyPoint syringe from new box, and administered it successfully to patient without incident.
After hyperventilating during injections stated could not hear well, slumped over, syncope then 45 sec convulsion. No incontinence. Woke and was fine (BP 100/50, HR 57) - has been fine.
Patient was feeling nervous and then had a seizure.  Caregiver that was with her said that she has many seizures and believes it was brought on by her nerves.  Patient was fine after seizure.
Red large spot 3 inch diameter at sight of injection. Sore, itchy, hurts sometimes to move arm.  Red for 3 days went away now has come back on day 10 just as painful if not more.
Patient was hospitalized due to breakthrough infection. Patient received Moderna vaccine (2nd dose in series) on 02/09/21. Patient was hospitalized from 01/25/22 - 01/27/22.  Below is copied from discharge summary:   Hospital Course:  Patient is a 91 y/o M with Hx of chronic CHF, HTN, GERD and DM2 who presents with c/o fatigue x 1 day, found hypoxic at 86% requiring O2 via NC and meeting sepsis criteria in the setting of positive COVID 19. Furthermore with evidence of pleural effusions on Chest Xray and elevated pro bnp indicative of acute on chronic CHF exacerbation. Admitted as inpatient for further management.   Sepsis with acute organ dysfunction/ Acute respiratory failure with hypoxia 2/2 COVID 19 PNA: -meeting sepsis criteria based on fever, tachycardia and source of infection -o2 at 95% on 2L NC -chest Xray showed small bil pleural effusions and atypical infection -elevated nflammatory markers- trending down   -DVT ppx -started Decadron IV -statin started -symptom management with prn meds -Isolation Home exertion test- home oxygen delivered   Acute on chronic CHF with bilateral pleural effusions: -pro BNP> 1.4 K -chest Xray: small bil effusions -start Lasix 20mg IV BID with holding parameters, soft BP -normal EF on ECHO   HTN: -Currently soft BP -Albumin IV ordered -Hold coreg and ACE -IV BP meds prn   Hyperglycemia 2/2 uncontrolled DM2: -Glucose> 190s -Resume metformin in 48 hrs, received contrast -SS and accuchecks   Chronic CVA: -Seen incidentally in CT head -Resume asa -Start statin   Fall: -PT eval -Fall precautions   GERD: -Resume home ppi
Nausea Fever chills Uber arms gland sore Back ache and joint pain Red face No appetite
Patient stated that last night she had chills, and shakes. Also stated she had headaches, insomnia, and high temp. Was also having trouble with balance and walking. Patient has taken Tylenol, Tylenol broke fever and fever is now down to 100.4. Still having headaches.
Red lesion about 1/2 inch round at the injection site,  2 days after my 2nd vaccine.  There is swelling, itching, (which has resolved),  and tenderness at the site. I had no such reaction with the 1st Moderna vaccine.
Patient received Moderna Covid-19 vaccine on 2/1/2021 and 3/1/2021. On 10/18/2021, I accidentally gave the patient a Pfizer Covid-19 vaccine instead of a booster dose of Moderna.  No reaction occurred.  I made patient aware of error and made the medical director for the health department aware.
Screaming & crying began 1 hrs post vax & cont thru 9AM; rx APAP; poss ltm;
Patient noted that approximately 18 hours post vaccination, began to experience "COVID" symptoms, including aches, chills, dizziness, shortness of breath, fatigue, difficulty focusing, some lower limb weakness. Patient did conform past COVID infection and symptoms are consistent, yet milder than when actively infected.
pt recvd vax 6NOV95 815AM;hives appeared 7NOV95 own MD contacted 7NOV95 MD instructed pt to take DPH;9NOV95 pt contacted stating hives were not any better & DPH inc; see MD
The day following vaccination patient developed fairly typical symtpoms of fevers, chills, muscle ache. However also reported diarrhea, nausea and vomiting lasting that day.  Continued to have nausea for 3 more days, and fatigue and headache lasting a week. At time symptoms were reported to me (4/29/21) they had resolved, but they were the reason her clinic appointment was scheduled.
Information has been received from a physician concerning a 14 month old male with no known allergies and no past medical history who on 02/12/2001 was vaccinated with a first dose of varicella vaccine. Concomitant medication included a first dose of MMR vaccine. On 03/03/2001 the pt presented to the doctor's office with ataxia. It was noted that the child had fallen twice prior to the doctor's appointment. The child was hospitalized for a workup on 03/03/2001 and discharged on 03/04/2001 with a diagnosis of "ataxia secondary to varicella vaccine administration." During hospitalization the child had a CAT scan of the brain that was negative and was treated with ceftriaxone sodium. It was noted that on 03/03/2001 or 03/04/2001 the pt also developed a rash. On 03/06/2001 the child was seen in the doctor's office. The rash was described as approximately 10 maculopapular lesions, three of which appeared vesicular. Most of the lesions were on the torso with a few on the neck. The rest of the skin was clear. The child was not bothered by the rash and he was given "symptomatic treatment." It was reported that the ataxia resolved by 03/06/2001. Follow-up info has been received from a registered nurse who reports the child was brought into the doctor's office by his parents who were very upset and concerned about the fact that he apparently had been felling well. No seizures or tremors had been noted. He ate and drank well. There was no diarrhea, but he did have some vomiting on the way to the doctor's office. It was noted that other family members had viral upper respiratory tract infection type symptoms. It was reported that he fell three times. There was no head injury or loss of consciousness with any of the falls. At the office, the doctor put the child on the floor and he appeared to be ataxic. It did not appear to be a problem with pain, but he literally fell back and to the left on both occasions. The parents reported that this is exactly the same ways that he had fallen earlier. The doctor recommended hospitalization for observation. The physical exam at the doctor's office and at the hospital werre benign except for his tympanic membranes were both bright red. He was treated with Rocephin for otitis media. Lab work included ESR 15; a negative throat culture; ASO screen <200. His comprehensive metabolic panel was normal except a Na of 1135; Co2 of 19; ALK Phosphatase of 264; ALT 22. His hemogram and differential was normal except WBC 13; Mono 10.3; MCH 26.1; PLT 440; MPV 6.4; SEG 54; Lymph 34. According to the mother, the ataxia resolved by late Sunday 03/05/2001. By 03/06/2001, he was walking quite well without nay sings of ataxia or any other problems. The pt subsequently recovered.
Reported vomiting 5 or 6 times evening after receiving vaccines. Also, mother of patient reported patient had swelling around eyes. stated no redness or swelling at injection sites.
Asymptomatic; Asymptomatic; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), ASYMPTOMATIC COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Asymptomatic".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective, Asymptomatic Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Began with very painful and swollen injection site the first night. Tuesday during the day I took Tylenol and it helped. Tuesday evening I was hit with extreme chills and body aches. Injection site was very hot, painful, red and swollen. Stayed wrapped in a blanket for hours. Lasted into my sleep. Had a low temp in the morning on Wednesday (99.7) Seemed to have the" sweats " most of the day. Injection site was still hot, red and swollen. Today feeling better but injection site is still painful and has a mounded lump.
Daughter called pharmacy 8/9/16 to report mom was in hospital from flu shot.
While in center-Unresponsive to physical and verbal stimuli lips or dusky nailbeds poor capillary refill respirations 16-36 With 10 to 20 Seconds of apnea unable to obtain SPO2 4 L via nasal cannula was applied. Head a bed was raised a high followers position unable to sustain blood pressure only systolic, 90 Family was at bedside , EMS was called Hospital was called. She was responsive to verbal stimuli overall color has improved, Patient left in stable condition ems stated b/ p was 60 /40. Admitted to hospital with diagnosis: bilateral pulmonary embolism.
Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound;  Severe Diarrhea for 48hrs following 2nd shot.  Pain in arm for about 4 days following both shots
Extremely dry mouth / regularly experiences a dry mouth, but this is more than it typically is.; Extremely dry mouth / regularly experiences a dry mouth, but this is more than it typically is.; loss of taste; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 97-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 07Feb2021 at 14:30 (age at the time of vaccination 97-years-old), as single dose for covid 19 immunisation. The patient medical history included Hypertension, Diabetes. No allergies were reported. The patient concomitant medications included Metformin , Januvia, Enalapril, HCTZ, levothyroxine. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that the patient received her first dose of the COVID vaccine on 07Feb2021. On 15-FEB-2021 13:00 she had experienced a drier than normal mouth since that time; ongoing for the last 18 days and loss of taste. She is scheduled to receive her second dose of the vaccine on 01Mar2021. Her daughter is calling because the dry mouth condition seems to have been exacerbated after her mother received the first dose of the vaccine. she is questioning if this is a possible side effect of the vaccine, and of her mother should receive the scheduled 2nd dose. Her daughter stated that her mother regularly experiences a dry mouth, but this is more than is typically is. The Caller's (Withheld) took her first dose on 07February2021. A week after that, she's still not experiencing any side effects. But now, she is having a really dry mouth. Caller, She, is asking if that is one of the possible side effects of the vaccine Patient did not receive any treatment for the events. The outcome of all events was not resolved.  Follow up #1 (27Feb2021): This is a follow up spontaneous report from a contactable consumer. This 97-year-old female consumer(patient) reported for herself that: New information included: age added, event information added, events onset date and time added  Follow up#2 (27Feb2021): This is a follow up spontaneous report from a Pfizer sponsored program. This consumer (patients daughter) reported for a 97-year-old female patient (reporters mother) includes: Dose administration date was updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
mom stated pt had been shaking on & off all day since 8:30 that AM;stated pt was very sleepy but responded to stimuli-temp didn't go over 100-mom instructed to call amb but child not transported to hosp;tx for kidney infect;
This case was reported by a healthcare professional and described the occurrence of possible latex allergic reaction in a 30-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included latex allergy. Concurrent vaccination included FLULAVAL; GlaxoSmithKline; unknown; left deltoid given on 27 September 2011. There was no concurrent medications. On 27 September 2011 at 15:00 the subject received 1st dose of HAVRIX (.5 ml, unknown, left deltoid). On 27 September 2011, two hours after vaccination with HAVRIX, the subject experienced a local reaction that included possible latex allergic reaction, injection site redness, soreness from injection, knot at injection site, fever and hot feeling injection site. The initial reason for the subject's report was due to the latex content of the HAVRIX syringe (58160-826-48) and when it was noted that a possible latex reaction could occur, due to the tip cap containing dry natural latex rubber the subject was identified. The subject received HAVRIX and FLULAVAL in the left deltoid about two inches apart. The subject has received FLULAVAL annually in years past and had no reaction. HAVRIX immunization series was discontinued. At the time of reporting the possible latex allergic reaction, injection site redness, soreness from injection, nodule injection site, fever and hot feeling injection site were unresolved. The healthcare professional considered the injection site redness was probably related to vaccination with HAVIRX. Follow-up received from the healthcare professional on 20 October 2011: The events resolved on an unspecified date after 3 days duration. The healthcare professional confirmed that the events were not considered serious.
Dizziness, lightheadedness, extreme fatigue, muscle weakness, nausea going in to second week after booster shot, lower left abdomen pain
SUSPECTED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID; This spontaneous report received from a patient who reported via a company representative via social media which concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency one total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021 (first part of September), the patient experienced breakthrough covid with Flu/cold like symptoms that lasted 3 to 4 weeks (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid on SEP-2021 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: 90000195171.; Sender's Comments: V0: 20210957362-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. 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
Covid Arm at vaccine site on left arm. Developed large, raised, red circle about 3 in. in diameter. Swollen lymph nodes in armpit and at base of neck. Developed slight fever, fatique, difficulty concentrating, difficulty sleeping. Had pre-existing tinnitus that increased slightly during this period.
administered ACTHIB that was reconstituted with expired diluent with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 01-Nov-2022, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ604AA and expiry date: 13-Mar-2023) which was reconstituted with diluent (lot U7172AB and expiry date: 29-Oct-2022) via intramuscular route in the right leg for prophylactic vaccination.  On 01-Nov-2022, (latency: same day) the patient was administered acthib that was reconstituted with expired diluent with no reported adverse event (expired product administered).  It was reported, they gave a patient an expired ACT-HIB vaccine. The caller stated the box says 29-Oct-2022 but the diluent part does not expire until 13-Mar-2023. A patient was administered ACTHIB that was reconstituted with expired diluent. The ACTHIB portion of the vaccine was not expired but the diluent was, which expired 29-Oct-2022. This situation is reported as a medication error due to a patient being administered ACTHIB that was reconstituted with expired diluent.   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was 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 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.
The first two was like somebody punched them in the arm for 2,3,4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Back injury, Herniated disc (Ruptured disc), Fragmented intervertebral disc (floating fragments), Pinched nerve and Surgery (Patient had a former back injury which he had surgery for in the past for ruptured disc, floating fragments and pinched nerve). Concurrent medical conditions included Gout and Kidney stones. Concomitant products included ALLOPURINOL for Gout and Kidney stones, GABAPENTIN (GABAPENTIN "PCD") for Shooting pain, LISINOPRIL and SIMVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days). In March 2021, VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) had resolved.            Treatment information was not reported.   This case was linked to MOD-2022-522804, MOD-2022-522968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up recieved. Added batch number and updated date of vaccination.
Patient received Flu and COVID vaccines in clinic today.  Patient waited the appropriate time after immunizations.  As the patient was checking out it appears she had passed out.  By the time this nurse got to the other side of the check out desk, patient was alert and responding. The nurse took the patient back to the exam room and gave juice and crackers.  Patient waited an additional time and left with parents once they felt comfortable.
2 days post vaccine, mother noted quarter size round, raised lump.  Hot to touch, red, tender.  Advised to alternate ice/warm pack, ibuprofen - observe. Left thigh near site of injections.
Some people I know had flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's comment: This case was reported by consumer via interactive digital media. The patients received doses of Shingles vaccine and had flu like symptoms. Additional Supportive Information: This case is linked with case US2022AMR066728 reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066728:Same reporter.