chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An adult dose of Engerix-B was administered to a 19 year old; An adult dose of Engerix-B was administered to a 19 year old; States that this is the first dose, but that she received a dose back in 2001; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (Received a dose in 2001).   On an unknown date, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided as follow: The patient previously received a dose of Engerix B. And now, the patient received 1 dose of Engerix B adult at 19 years of age, which led to inappropriate age at vaccine administration, overdose and inappropriate schedule of vaccine administration.  The reporter consented to follow up via email.
Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symptoms started February 1 at 6 PM were intermittent until 6 AM February 4. No symptoms until 6 AM February 6, again they were intermittent. Virtual visit with nurse practitioner at MD office February 6 at 11 AM. No symptoms since 6 AM on February 6.
ADMINISTRATION OF PFIZER-BIONTECH COVID-19 VACCINE DOSE #2 INTO LEFT DELTOID OF PT. PT DENIES PAIN UPON INJECTION. PT COMPLAINS OF SHOULDER PAIN WHEN LIFTING ARM/SHOULDER IN CERTAIN POSITIONS. PAIN DESCRIBED AS SHARP, DEEP, AND RANKED AS 3-4 ON SCALE FROM 0 (NO PAIN) TO 10 (WORST PAIN) UPON ELEVATION OF LEFT ARM AT SHOULDER JOINT. PT DENIES PAIN WITH ARM/SHOULDER IN RELAXED, NEUTRAL POSITION. PT SUSPECTS VACCINE WAS INJECTED TOO HIGH AND/OR TOO DEEP INTO THE SHOULDER JOINT INSTEAD OF PROPERLY INTO THE DELTOID MUSCLE.
Patient felt faint shortly after getting vaccination.  I instructed the patient to put his head between his knees. He still felt like he was going to pass out so I had him lay on the ground with his feet on a chair.  After a few minutes the patient was feeling better.  He drank some water and was able to sit in the chair after about 10 minutes, then left the store.
Discharge Provider:  DO Primary Care Provider: MD Admission Date: 9/23/2022 Discharge Date: 9/28/2022 PRESENTING PROBLEM: Hyperkalemia [E87.5] Hyponatremia [E87.1] Difficulty breathing [R06.89] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73 years old male with history of squamous cell cancer of epiglottis status post total laryngectomy and partial pharyngectomy and bilateral neck dissection with cricophyargeal myotomy, hypothyroidism, chronic bronchitis on 2L oxygen at home, On salt tabs who presented to the hospital with weakness and shortness of breath with URI symptoms. He was found to have covid infection and severe hyponatremia, Na 120. He was treated with antibiotics, steroid and breathing treatment. He was back to baseline on home oxygen at discharge. He was evaluated by PT, and OT, recommended for home with home health services. This was changed to subacute as PT and OT agreed with patient that he was too weak to be discharge home. He was discharged on salt tabs three times per day.
Lump appeared on right side of right ankle. Lumps have continued to appear, some have disappeared over time. One is still on right achilles tendon, under foot on a tendon, and tendon near ankle bone.
After first shot arm got swollen and 4 inches long redness; After first shot arm got swollen and 4 inches long redness; Uncomfortable to move and sensitive skin to the touch; Uncomfortable to move and sensitive skin to the touch; Uncomfortable to move and sensitive skin to the touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 13:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "After first shot arm got swollen and 4 inches long redness"; MOVEMENT DISORDER (non-serious), SENSITIVE SKIN (non-serious), HYPERAESTHESIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Uncomfortable to move and sensitive skin to the touch". Therapeutic measures were taken as a result of peripheral swelling, erythema, movement disorder, sensitive skin, hyperaesthesia.  Additional information: No other vaccine received in four weeks. After first shot arm got swollen and 4 inches long redness which went away within 10 days. Uncomfortable to move and sensitive skin to the touch. The patient received treatment with Alleve 400mg. No covid prior vaccination and not tested for covid post vaccination. No known allergies. The patient did not provide information to HCP regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No loss of function.   7 days after 2nd dose, noticed rash on left wrist, spreading to right wrist, then to right inner thigh, then to left inner thigh, over next 4 days. Right thigh is solid red, skin is thickening, with some cracking, white powdery apprearence.   Wellness check w/PCP in two days (04/20/2021 9:40am).
3 INCH DIAM REDDENED RAISED AREA, SENSITIVE TO TOUCH   OTHERWISE "FEELS FINE"
Started on 12/6/21 - Hives all over body, itchy and inflamed skin, comes and goes, moves over body when inflamed.  Physician follow-up - Put on steroids however rash continues
Muscle aches. Stiffne of the joints. Numbness in injection arm. Aches and pains.
This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of cough (1st dose refer case US2019051652). Concurrent medical conditions included eyebrow loss of (history of eyebrow alopecia, but the condition was improving until she received SHINGRIX.). On 22nd November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash aggravated, blister, facial flushing and drug hypersensitivity. The patient was treated with antihistamine. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the rash aggravated, blister and facial flushing were not recovered/not resolved and the outcome of the drug hypersensitivity was unknown. It was unknown if the reporter considered the rash aggravated, blister, facial flushing and drug hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and the rashes worsened at the time of reporting and has streaky rashes on her legs, patches between her fingers and flushing and blisters on her face. She did not take any other medicine and has been healthy. She was sensitive to chemicals. She has been treated with antihistamines so far but her condition has not improved. The rashes at the time of reporting getting worse. This case linked with US2019051652, reported by same reporter for the same patient.
Child arm had small bruise at Admin's site-and red-itchy patch on arm around and below inject site (Pt said itch started about 24 hr after shot). Mom using BENADRYL cream on site.
injection site sore, tender, achy, fever of 100.5 took ibuprofen itching around  lt arm in injection site, next day walked 3 miles and still felt tender and itchy, went on for 30 hours
Pt was vaccinated with 2 doses of varicella virus vaccine live in approximately 1996. The pt now has a low titer.
received an extra dose, with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 3-year-old and unknown gender patient who received an extra dose, with no reported adverse event of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) and Hepatitis B Vaccine both for Immunisation.  On 22-Jul-2020, 13-Oct-2020, 24-Oct-2019 and 25-Mar-2021 the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at an unknown doses (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.   On 25-Mar-2021 the patient received an extra dose, with no reported adverse event (extra dose administered, same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Action taken: Not applicable.  Outcome: Unknown.   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.
p/vax pt exp pain, achiness & stiffness (no swelling) in the inj arm, which radiated up to neck & down the lt side of back;pt said could not lift arm above shoulder height;pt took some ASA & pain resolved;
About one week after shot.  Fever 101 degrees F 104 degrees F. Unknown rash (was told chickenpox & given Prednisone). Developed food aversions. Loss of milestones & acquired language. Took 3 weeks to recover from physical symptoms.4/2/09-records received-office visitg 5/23/06-No reactions to immunization-well baby exam.6/2/06-seen for C/O fever rash, runny nose, congestion, cough, sore throat and decrease appetite.Assessment:Varicella. 8/21/06-well visit. 10/10/06-cough, runny nose, tugging at ears. Assessment: otitis media. 10/30/06-questionable lactose intolerance. 4/26/07-failed hearing test at school. Low weight on growth curves. 12/04/07-URI. 2/19/08-well baby exam. 3/17/-08-URI, cough, congestion, runny nose, Positive RSV last month. Assessment:URI. 4/1/08-right ear infection. Assessment: Otalgia. 2/17/09-Early childhood intervention, Poor eater, abdominal discomfort every day. parent does not want shots as last time lost ground in speech and eye contact. Assessment:well baby exam. pervasive development disorder, constipation, diarrhea, underweight, abdominal pain.
Pt reported that he was not feeling well over the weekend following vax. Pt began feeling very ill, with fever, chills, body aches, severe headache on Tuesday evening while at work. Pt was unable to work on Wednesday due to fever up to 102.4, chills, severe arthralgia, severe myalgia, headache, weakness, joints were hot, and dizziness. This lasted the entire day. Pt returned to work on Thursday, feeling better, but still with milder symptoms. Pt has had the flu vax the past 3 years without incident.
Initial report received from health care professional on 01 Dec 2009: The reporter stated that a 2 1/2 years old child received FLUVIRIN (batch no: 102042P1) 0.5 ml IM on an unknown date. No adverse event was reported.
This spontaneous report was received from a physician referring to multiple patients of unknown age and gender, The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL (dosage scheduled, route of administration, lot# and expiration date were not provided). There were no concomitant medications reported. On an unspecified dates, the patients experienced unspecified "problems" with GARDASIL. A product quality complaint was not involved. At the time of the reporting the outcome regarding the unspecified "problems" was not reported. The reporter did not provide the causality assessment between the unspecified adverse event and the suspect product. Additional information is not expected as there is not consent to follow-up.
Very itchy rash across abdomen, under breast, on buttocks, upper legs (small red spots w/dark center). Spread to neck, arm pits on 8/25/12. Called local urgent care 8/25/12 -said likely allergic reaction. Has been taking Chlorpheniramine - recommended Diphenhydramine.
pt recv vax;exp desquamation of palms & fingers,bilaterally; A few days later,devel upper resp infect & sinusitis;
The pharmacist reported that her daughter, received her first dose of GARDASIL 9 and then had a syncopal episode (approximately 10 years ago).; This spontaneous report has been received from a pharmacist, referring a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date (also reported as approximately 10 years ago) the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection  (strenght, dose, frequency, administration route, lot number, and expiry date were not provided) indicated as prophylaxis.  On an unknown date, after the first dose, the patient experienced a syncopal episode (syncope).   It was additionally reported that the patient received the second and third doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strenght, dose, frequency, administration route, lot number, and expiry date were not provided) with no adverse effects.  The outcome of the event and the causality assessment were not provided.  Upon internal review, the event syncope was determined to be medically significant.
Husband called Triage hotline and stated that the patient Is Not Feeling Well, She Is Not Able To Write and Her Voice and the Way She Talks Sounds Slurred
Intertrochanteric fx-closed, left, initial encounter. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 53 years, 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: "Obese" (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: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received the vaccine, did not take any other medication in 2 weeks, had no known allergies. Anti-viral details: Product- COVID 19 Treatment, treatment start date-18Oct2022, stop date- 22Oct2022.
mother and client report at this vist (today) that approx. 2 days after the last vaccination (6/4/09), client developed "a bump" with "water" to left arm, posteriorly. this site was site for varicella. Denies "bumps" at other injection sites. Denies other symptoms or problems. now has scar noted to area. soft, nontender today.
Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 4/12/2023 Discharge Date:  4/16/23   DISCHARGE DIAGNOSES 1. Chronic obstructive pulmonary disease infection 2. Acute chronic obstructive pulmonary disease exacerbation-resolved 3. Stage 3 kidney disease 4. History of CVA 5. Coronary artery disease 10. Hypertension 11. Anxiety 12. OSA 13. Tobacco use disorder   HOSPITAL COURSE:   Patient is a 76-year-old female with a past medical history of COPD with poor compliance to inhalers, stage III A CKD, history of CVD, coronary artery disease, hypertension, anxiety, OSA on 1 L nasal cannula at night.  She presented to the emergency department on 04/12 on day 6 of the LEs.  She had a one-week history productive cough, worsening wheezing, shortness of breath, congestion and rhinorrhea.  She notes that she had not been taking inhalers at this time.  She takes her Symbicort as needed and rarely uses albuterol.    Patient to the emergency department she was satting 95% on room air and was placed on 2 L nasal cannula.  3 m her vital signs are stable.  She does have positive for COVID 19.  Labs demonstrated a slightly elevated creatinine at 1.46.  Her D-dimer was elevated at 430. Chest x-ray did not demonstrate an acute infectious process.  She was given 6 mg of Decadron and albuterol inhaler and admitted to internal medicine service for management of COVID and chronic obstructive pulmonary disease.   In the management of her COVID, she received 4 days of Decadron 6 mg. She was not a remdesivir candidate.  She was weaned from 2 L nasal cannula to room air over the course of 4 days.  Treatment also included symptomatic care with cough suppressants and decongestants.  In the management of her chronic obstructive pulmonary disease, she was started on her home Symbicort and albuterol as needed every 2 hours, remained on steroids, and received azithromycin.  She was unable to receive nebulized medications due to COVID status.  During course of her stay, she was weaned to room air, shortness of breath and wheezing resolved, and her AKI resolved.  She was discharged on 4/16 with a prednisone taper, instructions to take care Symbicort daily to use albuterol Q 2 to every 4 hours as needed, and follow-up with her PCP.  She noted that she has been trying to quit smoking and this was encouraged.  Is a 25 pack-year smoking history.  She denied desiring nicotine patches or further management for smoking cessation.  Was encouraged that she follow up with her primary care physician regarding this
This spontaneous report as received from a pharmacist refers to an unspecified number of patients (unknown age and gender). On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, lot number and route of administration were not reported). On an unknown date, the patient experienced injection site reactions. The outcome of injection site reactions was unknown. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Pain, swelling redness at injection site and surrounding (5cm diameter) started after shot. Given KEFLEX.
At 7:00PM (8/6/15) she started feeling off balance when walking only. She c/o pain in her right temple area and felt warmer than usual. She felt very tired on 8/7/15. Denies rash/hives/SOB.
he started to feel heart palpitations -palpitations and now he says they're worse; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (he started to feel heart palpitations -palpitations and now he says they're worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PALPITATIONS (he started to feel heart palpitations -palpitations and now he says they're worse). At the time of the report, PALPITATIONS (he started to feel heart palpitations -palpitations and now he says they're worse) had not resolved.            The concomitant medications was not reported. The treatment history was not provided.
patient stated this morning, after getting his shot last night, he was having typical side effects, fever, body aches and chills. however he then fainted.  States he got up from his bed and "slowly lost consciousness" and his vision went black.  advised patient to follow up with prescriber regarding reaction.
20mins post vaccination, pt reported sweating and her lips & tongue have a tinglie sensation.  Pt also states that breathing is slightly labored. Vitals: 163/100, 79, O2 Sat 98% Pt given 25mg Benadryl @12:05 Pt stable and released from the vaccination site @12:40
Tinnitus for almost entire day Feeling like I?m going into labor Leg cramp  Treatment  baby aspirin-resolved above
Received Pfizer vaccines on 2/17, 3/10/21 COVID-19 positive by PCR on  1/7/22 admitted to hospital on 1/7/22 d/t COVID pneumonia
This spontaneous report was received from the office manager who is also an health care worker and refers to a 13 month female patient with gastroesophageal reflux disease and sensory integration disorder. None known allergies. It was reported that on an 12-MAR-2015 at 16:15 hrs, the patient was vaccinated with the first dose of MMR II HSA (strength, dosage and route were not reported) (lot# K020188, expiration date 22-OCT-2016) Subcutaneous, left arm reported as "high", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. on 12-MAR-2015 at 16:15 hrs, the patient also received as concomitant vaccination the first dose of (Merck) VARIVAX (lot No. K011084. Expiration date was not reported) left arm (high) and the first dose of VAQTA (lot no. K023870, Expiration date was not reported) left arm (high). None illness at the time of the vaccination was reported. No adverse effects were reported. Additional information is not expected because all information required was received.
This spontaneous report was received from a physician refers to a 4 patients of unknown ages who at "varying" dates, on an unknown date, were vaccinated with a dose of ZOSTAVAX (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that "as of the last several weeks of month" on an unknown date, the patients developed shingles. No treatment information was reported. At the time of the report, the patients' outcome was unknown. It was reported that an unspecified number of those 4 patients did see the physician for a follow up visit. The relatedness for 4 patient had developed shingles was unknown for ZOSTAVAX. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.