chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Co-suspect products included AFLURIA (batch number 03044611A, expiry date 30th June 2019) for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd November 2018, the patient received AFLURIA (intramuscular). In November 2018, 5 days after receiving SHINGRIX, the patient experienced joint pain and general body pain. On 3rd December 2018, the patient experienced rash and itchy rash. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the joint pain, general body pain and muscle pain were recovered/resolved and the outcome of the rash and itchy rash were unknown. It was unknown if the reporter considered the joint pain, general body pain, rash, itchy rash and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient began to experience joint pain at the knee five days after receiving her first dose of the SHINGRIX vaccine on left deltoid. Seven days after receiving the vaccine, the patient developed body aches all over her body. On 3rd December 2018, the patient developed a rash across her back consisting of five itchy, annoying bumps. The patient indicated that these were not painful. It took three weeks for the joint and muscle pain to resolve. Unknown the status of the rash. The patient received AFLURIA QUADRIVALENT in right deltoid at the same time she received the SHINGRIX vaccination. The reporter was unable to provide additional information. Because the patient indicated that had not had the symptoms evaluated by her physician, the reporter was trying to determine if the second dose of SHINGRIX should be administered. The reporter did not consent to follow up.
This case was reported by a nurse via call center representative and described the occurrence of fatigue in a male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No further details were provided.
I temporarily lost hearing in my left ear and experienced subsequent "ringing" in both of my ears but predominantly in my left ear. It took several days for the condition to improve but I am still experiencing some low level ringing in my ears.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 76th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
The case was reported by a sales representative (also the wife of the subject) and described the occurrence of injection site hemorrhage in a 45-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject received no concurrent medications. On 11 March 2009 at 16:00 the subject received 1st dose of TWINRIX. Immediately after vaccination with TWINRIX, the subject experienced a significant amount of bleeding. The physician applied pressure and then placed a band-aid on it. On 11 March 2009, the event resolved while the subject was still in the office.
CHILLS, FEVER, FATIGUE Narrative: EMPLOYEE REPORTS THAT HE "FELT OFF" AFTER THE VACCINE. BY EVENING HAD DEVELOPED CHILLS, FATGUE, BODY ACHES, AND FEVER WITH TEMP 101-102.8. CONTINUES THIS MORNING WITH FEVER OF 102. NO HISTORY OF COVID TO HIS KNOWLEDGE. HAD NEGATIVE COVID TEST FIRST WEEK OF DECEMBER.
Arm pain which started immediately and has not resolved in 4 months.  Indentation at site of vaccine injection.
Nurse calling for evaluation on refrigerated products states 3 doses of VAXELIS in PFS involved in this excursion have been administered to patients; This spontaneous safety report, with interaction number 02237963 (case# 02238021), was received by the partner on 01-SEP-2022 and forwarded on 02-SEP-2022, from other health professional.  Due to the nature of the event, the causality between the event "Nurse calling for evaluation on refrigerated products states 3 doses of VAXELIS in PFS involved in this excursion have been administered to patients; VAXELIS :Temperature/Time frame (48.2F) for 40 minutes", and Vaxelis was not applicable.  Further information is expected.  For reference purposes, cases is linked to MCM-003999 and MCM-003974 (same reporter).
After receiving vaccines, patient had a syncopal episode.  He was brought back to an exam room to be assessed and he had two seizure type episodes that lasted lest than 5 seconds each.  He is transported to the hospital by ambulance.  Diagnosed with vasovagal syncope, post syncope convulsions, and dehydration.
Tooth abscess; Hives/broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (Tooth abscess) and URTICARIA (Hives/broke out in hives) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A2(z)1A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORATADINE for Allergy, SUMATRIPTAN for Headache, LEVOTHYROXINE, SERTRALINE, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]), FLUTICASONE, GLUCOSAMINE and MELOXICAM for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTH ABSCESS (Tooth abscess) and URTICARIA (Hives/broke out in hives). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency and AMOXICILLIN for Tooth abscess, at an unspecified dose and frequency. At the time of the report, TOOTH ABSCESS (Tooth abscess) and URTICARIA (Hives/broke out in hives) outcome was unknown.
Pt had IZ's on 8/18 - 4 days later at school pt had a seizure and fainted 3x. Went to ER and had bld wk - nl and then 2 days later saw neurologist. Seizures. Onset was 1 week ago. The problem is isolated. Additional information: Was at school; mom was told she was having a seizure and difficulty with breathing. She had fainted three times during the seizure. She was in PE waiting for roll call and then next thing she knew she woke up with people around her. No head trauma. Normal pregnancy, repeat CS, despite prior 2 children being SVD ND the first was CS. Growth and development normal. Doing very well in school. No EER hospitalizations for other reasons. Patient states she was sad that day - her brother just left for college. She was missing him. No recent illnesses; she just had her vaccinations Thursday prior to day of seizures Monday. She got the HPV and MCV vaccines with routine DT and PPD. Family History: Maternal GF had seizures after brain hemorrhage and passed away. Parent (s) or patient requiring interpreter throughout the encounter.
Eyes and lips swollen. Redness of injection site. Urgent care recommended MEDROL dose pak, Triamcinolone cream and ALLEGRA.
I had ear pain on the right side at 4 am and by  8am my right side of the lip had  gone numb.
The patient began to feel a tightness travel up her arm and into her neck of the arm she received the vaccination.  She began to feel a tightness in her throat too. The patient's blood pressure was checked and it was high 165/80. She reports her blood pressure is normally low. The patient continued to feel a tightness in her throat and reported it being very difficult to swallow. After more than 15 minutes of feeling this way, the patient allowed us to call ems.
Strong increased pain in the arm where injection was received, with loss of mobility.  Stiffness and sharp pain, even during sleep.  The pain has subsided a little, but it remains.  I have sought medical care, and am currently receiving physical therapy.
pt recv vax & devel wheal & flair & was felt to have a hypersensitivity rxn to MMR;
Patient had stroke. 12/15, occlusion L cervical ICA with extension to L MCA. On 12/15 evolving L MCA acute ischemia. On 12/15 cerebral thrombectomy. On 12/17 increase in edema with R midline shift. 12/16 intubated 12/23 extubated
Rash developed two inches below injection site, about 5-6 inches in diameter. Pt given prescription for Keflex and Benadryl.
At 9:30 PM this patient had stiffening of the body, tremulousness of the extremities, stare in eyes, and gray discoloration of face. The whole episode lasted for about 5 minutes. The patient was taken to the ED. His temperature 103.5 (rectal). No focus of infect found on exam. IM of vaciphen given.
Localized reaction. 4" x 5" area of inflammation, edema, warm to touch, painful; warm soaks, Benadryl, Advil and observation.
Nurse was called to check on a patient in the vaccination area. Patient was given his first dose of Covid vaccine . He immediately stated he needed to lay on the floor. Patient was diaphoretic and pale. P. McGrath RN obtained vitals: 112/68, HR 62, pulse ox 97% room air. Patient's wife stated he has these episodes all the time. Patient stated he felt fine and wanted to get up. Patient was assisted up. VS rechecked 112/80, HR 66, 98%. Patient was given water and escorted to the monitoring area. Patient was monitored for an additional 30 minutes without further incident
Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 27-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 31 March 2009, the subject received 1st dose of ENGERIX (1 ml, unknown, right deltoid). On 7 May 2009, the subject received 2nd dose of ENGERIX B (1 ml, unknown, left deltoid). On 27 August 2009 the subject received 3rd dose of ENGERIX B (1 ml, unknown, right deltoid) (drug dose administration interval too short). On an unspecified date, the subject's titer was 0.47, and the subject experienced not responding to therapy. The nurse reported that the first and second dose were from the same lot number. The third dose was from another lot number. Vaccines were given in the deltoid rotating from right with the first vaccine, left with second vaccine, and right with third vaccine. The nurse reported that the titers were showing that the series of ENGERIX-B that she provided to the workers at her assisted living facility did not work. Specifically the report stated that the subject was not immune and needed to restart series. Her titer was less than 0.47. It was determined that the third dose in the series was administered five months from the first vaccine instead of recommended six months. This is one of nine cases reported by the nurse; see cases A0832030A, A0832033A, and A0832035A for female subjects who experienced not responding to therapy and drug dose interval too short; and see cases A0832032A, A0832102A, A0832103A and A0832104A for female subjects who experienced drug dose interval too short.
Pt received FLUVIRIN vaccine and within 10 min pt walked into clinic stating she felt it was harder to breathe/swallow. Pt alert and oriented. She stated she also had severe itching at the site of her injection. NP administered EPIPEN 0.3 mg at 1300 pm and had store management call EMS. Pt stated 1 minute later she was feeling better and easier to breathe after EPIPEN administered. VS -> HR 70s and O2 sat on RA=100%. EMA arrived w/in 5-10 min after EPI-PEN and took over care. They took her to nearby hospital to be observed. Pt walked out of clinic on her own with EMS at her side.
1 of 3 pt vaxed from the same vial who exp edema & redness @ inj site w/in 24hrs p/vax;pt had rxn the size of an apple;no cultures taken;not cellulitis;treated w/cold packs
Chills and body shake for 2 hours, body aches 12 hours, tiredness 2 days, sore arm 2 weeks, lumps in armpit, 1 week.
Initial information was received from a health care professional on 07 August 2008. An 11 year old female patient with no reported past medical history received an injection of ADACEL (lot number C2644AA)0 on 04 May 2007. On 07 May 2007 she experienced swelling, warmth, erythema, tenderness, and some dizziness. The patient's recovery status was not provided. No further information was reported. Follow-up information was received from the health professional on 05 September 2008. The ADACEL was administered in the left arm. On 07 May 2007, the patient was seen by her physician, at which time her left upper arm noted to be erythematous, warm, and tender. She also complained of dizziness. She was treated with KEFLEX, and her mother was instructed to call the office if the event had not recovered within 48 hours. No further contact was made, and the patient did not return for a follow-up visit. No additional information was available. The physician reported another AE for this patient which occurred on 06 June 2008 and is captured in case number 2008-01961.
Vaccine on 8/17/04, red macular papular lesions to torso, arms, upper thighs on 8/28/04-rash faded by 9/5/04.
The patient received the vaccine and when she went to her car she was feeling short of breath.  When the EMT arrived they gave her an epi-pen.  We called and checked on the patient.  She stated that they did not believe it was anaphylaxis but they gave her an Epipen as a precaution.  The patient is doing well.
This spontaneous report as received from a patient's mother refers to her 6 months old son with severe ear infection and fever who had no pertinent medical history and no drug reactions or allergies. On 14-JAN-2013, the patient was vaccinated mistakenly with a dose of GARDASIL (Lot # not reported) when visiting the doctor's office for an unspecified antibiotic shot. No other co-suspects were reported. Concomitant medications included: amoxicillin. The consumer reported that, the patient had been suffering with a severe ear infection and fever at the time of injection, and after receiving the GARDASIL, the patient's fever had worsened and remained at 102.4. The patient's parents had been giving him TYLENOL and ADVIL to attempt to reduce the fever, unsuccessfully. Also it was reported that the patient had been tired and very cranky since receiving the GARDASIL. The patient sought unspecified medical attention. No lab test was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Shot administered 11/2/01, headache soon followed and lasted until 11/3/01 late evening rash broke out on 11/4/01, applied benadryl cream to site of rash and took benadryl allergy pills.
Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, fatigued, body aches, nausea, pain throughout whole body.
Patient noticed fluid/swelling in arm with redness and warmth around site beginning the day after vaccine. 6 days later experiencing pain, swelling in lower arm/tricep area to armpit with redness and itching. Patient reports fever during the past week. Swelling and pain moved from area of immunization to back of arm. Patient to being methylprednisolone treatment.
Patient's mother brought her into the clinic requesting a COVID-19 booster. She attested that she had not received the bivalent booster and had completed the 2 dose primary series only. When making an appointment and checking her in using our system we did not see any previous booster documented in her record. When presenting her CDC card there was a notation of a booster on 11/11/22. We asked the mom about this and she said she did not come to the clinic on that date and wasn't sure why that was on her card- she attributed it to a mistaken notation when receiving her flu vaccine. She asked to proceed with the booster. About 15 minutes after receiving the vaccine the mom remembered that patient had actually already received her booster vaccine at her well-child visit. The vaccine was not documented by alternate location. Patient received 2 boosters. One on 11/11/22 from alternate location and one from our clinic (as documented here) on 12/5/22. She felt fine after her 15 minute observation period and mom will call her pediatrician to let them know what happened.
Received vaccinations right upper arm.  Began to have swelling about six hours later.  Swelling, pain & redness continued to progress.  No fever, or other symptoms.
Numbness of left ear, cheek and jaw, happened suddenly one morning around 8am. This week I've also been experiencing moderate right hip pain making me limp.  Started on prednisone treatment right away outpatient, still no change. Also taking Ibuprofen 800mg with little to no change in pain.
mild numbness above face area upper lip; tingling in cheeks; brain fog for 5 days; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 11:30 (Lot number: FH8027) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: some sulfa" (unspecified if ongoing), notes: Known allergies: some sulfa; "Mold allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Left), administration date: 18May2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No:  EW0175, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 11:30, outcome "unknown", described as "booster"; HYPOAESTHESIA (non-serious) with onset 21Dec2021 11:45, outcome "not recovered", described as "mild numbness above face area upper lip"; PARAESTHESIA (non-serious) with onset 21Dec2021 11:45, outcome "not recovered", described as "tingling in cheeks"; FEELING ABNORMAL (non-serious) with onset 21Dec2021 11:45, outcome "recovered" (26Dec2021), described as "brain fog for 5 days". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia, feeling abnormal.  Additional information: It was reported that patient administer vaccine at Doctor's office/urgent care. The patient did not receive any other vaccine in four weeks and received multi vitamin medications in two weeks. It was also reported that patient did not suffer from covid prior vaccination and did not underwent  covid tested post vaccination. The patient had experienced mild numbness above face area upper lip and tingling in cheeks 20 min after shot on drive home, continued mild for 2 more days, brain fog for 5 days. Face numbness tingling issue reappeared 05Jan2022.  No follow-up attempts are possible. No further information is expected.
SHAKY FEELING; SCARED; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, penicillin allergy, allergic to dairy products, perfume allergy, dust allergy, pollen allergy, mold allergy, allergy to cats, peanuts allergy / cashews allergy, and live vaccines allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had a history of unknown cold medicine caused her to go to the hospital and get a shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced scared. On 13-APR-2021, the subject experienced shaky feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaky feeling, and the outcome of scared was not reported. This report was non-serious.
Itching and slight swelling at injection site 7 days after injection.  Taking Benadryl and itch cream