chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 7 year old female who on 25-AUG-2010 was mistakenly vaccinated with a dose of GARDASIL instead of VARIVAX (Merck). No adverse effects were reported. Follow up information received from the physician concerning a 7 year old female who on 25-AUG-2010 at 1:02 PM was mistakenly vaccinated with a first dose of GARDASIL (lot # 666162/0664Z, IM) in the left deltoid. No adverse effects were reported. The patient tolerated vaccine. Additional information was not expected.
Reports rash / lesions after influenza vaccination few weeks ago. States was not the first episode.
After my third booster dose my period is now 53 days late; After my third booster dose my period is now 53 days late; I believe after the second occurrence the vaccines are too blame for my missed periods and continued lack of menstruation.; I believe after the second occurrence the vaccines are too blame for my missed periods and continued lack of menstruation.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (Pfizer- Covid-19 Vaccine- Solution for injection), administered in arm right, administration date 06Oct2021 10:00 (Lot number: FF8839) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 25Mar2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "After my first two shots, my period was approx. 30 days late."; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 04Mar2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "After my first two shots, my period was approx. 30 days late.". The following information was reported: MENSTRUATION DELAYED (disability) with onset Oct2021, outcome "not recovered", MENSTRUATION IRREGULAR (disability), AMENORRHOEA (disability) all with onset Oct2021, outcome "not recovered" and all described as "I believe after the second occurrence the vaccines are too blame for my missed periods and continued lack of menstruation."; IMMUNISATION (disability) with onset 06Oct2021, outcome "unknown", described as "After my third booster dose my period is now 53 days late". The events "after my third booster dose my period is now 53 days late", "i believe after the second occurrence the vaccines are too blame for my missed periods and continued lack of menstruation." and "i believe after the second occurrence the vaccines are too blame for my missed periods and continued lack of menstruation." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation delayed, menstruation irregular, amenorrhoea.  Additional information: The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that "After my first two shots, my period was approx. 30 days late. My period returned. After my third booster dose my period is now 53 days late. I believe after the second occurrence the vaccines are too blame for my missed periods and continued lack of menstruation. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
fatigue; headache; little bit of fever; chills; body ache; pain in the injection arm/pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache), VACCINATION SITE PAIN (pain in the injection arm/pain in the arm) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache) and VACCINATION SITE PAIN (pain in the injection arm/pain in the arm). On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache), VACCINATION SITE PAIN (pain in the injection arm/pain in the arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified medications for her stomach.
burning sensation; not normal for me; body ache; headaches; fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out; chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), FEELING ABNORMAL (not normal for me), MYALGIA (body ache), HEADACHE (headaches) and FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Drug allergy (codeine, omeprazole, Bactrim) and Basal cell carcinoma. Concomitant products included ESTRADIOL and PROGESTERON for Hormone replacement therapy, THYROID COMPLEX, CHLORTHALIDONE and GABAPENTIN for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (headaches), FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) and CHILLS (chills). On an unknown date, the patient experienced BURNING SENSATION (burning sensation), FEELING ABNORMAL (not normal for me) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation) and FEELING ABNORMAL (not normal for me) outcome was unknown, MYALGIA (body ache) and FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) had not resolved and HEADACHE (headaches) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) unknown blood work done. On an unknown date, SARS-CoV-2 test: no (Negative) negative.         Concomitant products included thyroid supplement, CHLORTHALIDONE, estrogen/progesterone, GABAPENTIN and Imiquimod cream,for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: The patient demographics, medical history, concomitant medications and events details were updated.
Daily Headaches  on sides and top of head.  Headaches have been occurring everyday in the morning and continue throughout the day.  Have taken Tylenol, Sudafed and Aspirin to relieve pain from headaches.  All of the OTC meds have worked to relieve headache.  Headache is mild.  Some days  no pain relief is taken for headaches. Other days pain meds are taken if pain is high. Am able to sleep without pain medication and headaches are not present upon wakening in the morning.  On the 1-10 scale, pain is about  4 or5., will take pain reliver at about 7.
The day after my vaccine my skin became very sensitive. Every morning I inject my Lantus insulin on my stomach but the day after my vaccine I noticed that I felt pain when inserting the needle. This had not happened before.  The pain I felt when injecting disappeared on the  seventh day.  I am back to normal now and have no pain when injecting my insulin.
11 year old female patient received expired dose of ADACEL, no adverse event; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 year old female patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 15-Sep-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5519BA and expiry date: 12-sep-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency on same day).  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.
Information has been received from a physician concerning a 34 year old female with depression, anxiety, iron deficiency, and environmental allergies who on 1/30/03 was vaccinated with a first dose of varicella virus vaccine live. It was reported that the patient told her physician that she was not pregnant. Concomitant therapy included hormonal contraceptives, lithium CO3, lamotrigine, norethindrone and iron. On 2/14/03 the patient developed a blister on her foot. By the next day, on 2/15/03, there were a few more lesions noted. On 2/19/03, the patient was seen in the physician's office with a generalized rash on her face, chest, and back, about 100 lesions overall, some lesions looking pretty angry. It was also reported by a second physician that the patient had some blisters and wide spread herpes lesions. The patient was also noted to have general malaise and a fever of 100.1F. She had no headache or cough. The patient was sent to a dermatologist who confirmed chicken pox. The patient was prescribed valacyclovir HCL 1 G tid which reportedly should have been started on 2/19/03. It was reported that the patient's depression and anxiety acted up considerably as a result of the chicken pox. On 2/21/03 it was reported by a physician that the patent had about 50 lesions with a fever. She reported that the patient was feeling better and that she would not be submitting a specimen for varicella zoster virus analysis. The reporter considered the adverse events to be disabling.  Reported on 04/21/2003: "The patient's chicken pox resolved in 10 to 14 days.  The reported noted that subsequently, a chest x-ray showed mediastinal lymph nodes and a biopsy of a lymph node revealed non-Hodgkin's lymphoma.  The reporter considered the adverse events of chicken pox, depression and anxiety to be disabling.  Non-Hodgkin's lympoma was considered to be an incidental finding.  Additional information has been requested.  Reported on 05/14/2003: "Follow up information from the physician indicated that the patient did not return two phone calls made by the physician, but the patient's oncologist reported that the patient "has been doing very well and seems upbeat".  The reporter considered the adverse events of chicken pox, depression and anxiety to be disabling.  Non-Hodgkin's lymphoma was considered to be an incidental finding.  Additional information is not expected.
Information has been received from a physician concerning a 4 year old male who on 23-JAN-2004 and 29-JAN-2007 was vaccinated with his first and second doses of Varivax (Oka/Merck).  On 11-DEC-2007 the patient developed shingles which was described as a unilateral dermatome on the right side of the abdomen with crusted clusters of papules that stopped at the midline.  It was unspecified whether medical attention was sought.  Subsequently, the patient recovered.  There was no product quality complaint.  Follow-up information from the reporting physician indicated that the 5 year old male with no history or recent exposure of chickenpox was on 29-JAN-2007 at 10:00 was vaccinated with his first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655838/1262F) in the left arm.  On 11-DEC-2007 the patient developed shingles with other symptoms of cough and congestion.  It was noted that on 23-JAN-2004 at 10:00 the patient was vaccinated with his first dose of Varivax (Oka/Merck) (lot# 644558/1156M) in the left arm.  There was no sign of fever and no rash occurred.  The patient had clusters of papules some crusted, located on the right back/side of the abdomen.  A specimen was not collected for PCR, no photos were taken and a direct fluorescent antibody test was performed.  Additional information has been requested.
Pt began with oral typhoid 6/21, on 6/22 began with ringing in her (R) ear x 5 hours saw FMD (exam unremarkable), 6/23 Dose #3 taken 6/25 Dose #4 taken. Remains with intermittent ringing (R) ear. Sometimes sounds like "echoing". Denies any ASA taken. No other symptoms.
Arm slightly sore for 2 days after shot.   4 days after shot arm was itchy in evening and noticed a reddened, swollen, slightly bumpy  area on right arm about 6 inches long and 3.5 inches wide around the injection site.  Continued for about 3 days and then went down.  Never went to doctor.
Upon injection-injection site began to swell and bleeding occurred. Bleeding stopped. Ice was applied-swelling did start to go down. Checked on patient later in afternoon. Was doing fine.
Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2021 09:15 (Lot number: EL8982) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2021, outcome "recovered" (21Jan2021), described as "Arm soreness".  Additional Information: No treatment received, no covid prior to vaccination and no covid test post vaccination. No known allergies and other medical history. No other vaccine in four weeks and no other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
05/26/23 I called and talked with pt.'s mom regarding if there were any reactions to his vaccinations. Pt. has had reactions in the past. Mother said that on 05/23/23 he ran a low grade fever. On 05/26/23, the day I called, she said he had a red rash from his left shoulder to his left elbow. The rash was red, hot to touch and had two hard spots where the shots were given.  He did not c/o the rash itching. She guesstimated the size of was 2 inches by 3 inches.  He was less restful during the first night but other than that, he's been acting totally fine.  You wouldn't know his arm had anything going on with it. On 05/31/23, I followed up on the reaction. Mother said he is still acting just fine and there is just a small hardened area where the shot given closest the his front is (Kinrix).
Called to room 15 minutes after Pfizer 2nd dose.   Patient c/o globus feeling and itching around mouth and inside mouth.  Hx of vaccine reactions to various things.  Had some itching after 1st shot, but did fine after monitoring. Had premedicated with 2 Zyrtec tabs.   VSS, O2 sat 100% RA Gen: 36-year-old female appearing concerned, but in NAD Skin: warm and dry, no visible rashes HEENT: no rashes, no edema or erythema on face or in mouth/throat, Mallampatti 1 Heart: RRR Lungs: CTAB   Approximately 5 min later, patient c/o dizziness described as spinning.  Hx of vertigo.  Laid head of exam table back with some relief.  Other sx unchanged.   VSS, O2sat 100% RA Gen: 36-year-old female appearing concerned, but in NAD Skin: warm and dry, no visible rashes HEENT: no rashes, no edema or erythema on face or in mouth/throat, Mallampatti 1 Heart: RRR Lungs: CTAB   Five minutes later, patient c/o feeling that she was going to pass out and tongue feeling swollen.  Also c/o decreased sensation in B hands and shaking.  Wanting to call coworker, but unable.   VSS, O2 sat 100% RA Gen: 36-year-old female, diaphoretic, rigors Skin: diaphoretic, pink rash R neck HEENT: no rashes on face, no erythema in mouth/throat, edema noted at the base of the tongue, Mallampatti 3 Heart: RRR Lungs: CTAB, breathing more shallow than before Neuro: decreased mentation, unable to tell RN how to unlock her phone to call the coworker she wanted, slow responses, decreased sensation to light touch on BUE compared to BLE, grip strength 4/5, unable to flex B elbows     Code Medic activated Epipen 0.3 mg IM given in R lateral thigh at 0940.   Mentation improved.  Asking for coworker.  Still c/o dizziness and sensation in tongue/throat.  Reporting decreased sensation "from neck down"   VS: HR 112, BP 161/81, O2 sat 100% RA Gen: 36-year-old female, diaphoretic, color improved Skin: diaphoretic, pink rash R neck HEENT: no rashes on face, no erythema in mouth/throat, edema noted at the base of the tongue, Mallampatti 3 Heart: RRR Lungs: CTAB, breathing remained Neuro: mentation improved, rigors resolved, moving all limbs, decreased sensation to light touch throughout   House supervisor and transport arrived.  Report given.  Patient transferred to stretcher.  Patient lost consciousness.  Pulse and shallow breathing remained.    Code blue activated.   Patient regained consciousness spontaneously after ~1 min.     2nd Epipen 0.3 mg IM given in L lateral thigh at 0955.     Patient's color and breathing improved.   Attached to Zole and non-rebreather at 100%.   Code team arrived.  Gave report.    Patient lost consciousness again.  Pulse strong, but no breathing for ~30 sec.  Patient spontaneously began breathing again and regained consciousness.    Code team transferred patient to ER with 3 additional Epipens in hand.  Electronically signed by PA at 08/27/21 1056
Multiple secondary sites -> Quarters restriction sunburn noted, noncompliance with care instructions suspected. Sunburn confirms no shirt. No systemic symptoms.
numbness to right arm following injection that has subsided but has left pain in the deltoid and right wrist. also noted elevated heart rate after leaving the clinic. refuses to go to pcp due to risk of COVID
2-3 days after shot developed progressive headache and neck pain.  progressive and had imaging  almost a month later.  Dural venous sinus thrombosis.  treated with anticoagulation.  Despite anticoagulation, 6 weeks later had submassive PE that had an acute and chronic component.  unresponsive to thrombolytics and thrombectomy attempt.  Required.  Still hospitalized
Information has been received from a pharmacist concerning a male who in 1991 was vaccinated with a dose of PNEUMOVAX 23.  In "1991" the patient experienced unspecified adverse reaction.  It was unknown if the patient sought medical attention.  The patient recovered.  No further information is available.
PATIENT STATES THAT IN THE AREA WHERE HE RECEIVED THE ZOSTAVAX VACCINE THAT HE DEVELOPED A RASH THAT WAS APPROXIMATELY 4 INCHES WIDE AND 3 INCHES LONG.
Day of shot right arm had soreness.  Next day golf ball size welt on right arm.  20 day swelling went down but very large hot red area.  Some fever since shot.  Axillary lymph adenopathy.
No additional adverse events reported; The patient was administered with improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to a 19-month-old patient of unknown gender. Information about the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies was not reported.   On 08-FEB-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot# T033815, expiration date 05-OCT-2022; strength, dose and route were not reported) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion in 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions included 32.9 F for 53 hours 16 minutes, 49.1 F for 5 hours 9 minutes, and 56.3 F for 14 hours 7 minutes. No additional adverse events reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003335: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003310: US-009507513-2203USA003321:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (Refer case US2018219418). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd December 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In December 2018, the patient experienced chills, headache and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, chills, headache and pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, chills, headache and pain to be related to SHINGRIX. Additional details were received as follows: During SHINGRIX vaccination, the vaccine hurt as it was being injected. Three hours later, the patient's arm felt sore at the injection site, even while lifting her arm. There was no bruising. On 4th December 2018, at 4 am, the patient started having bad chills, feeling achy, and having a headache. Till the time of reporting, all symptoms were unresolved. The reporter consented to follow up. The reporter gave permission for physician to be contacted. The reporter unable to obtain additional information.
12x10cm area of redness at site of ZOSTAVAX pain 8/10 - 10/10 at injection site. Flu-like symptoms itching, headache, warmth and lump. PNEUMOVAX 4.5cm area of redness and just "achy".