chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inching all over and i cant stop; This case was reported by a consumer and described the occurrence of generalized pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient. The patient had taken Shingrix vaccine and experiencing itching all over and patient cannot stop. The patient asked what should they do.
Itchiness in the head; This case was reported by a nurse via sales rep and described the occurrence of pruritus in a 33-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 3A929, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season .5 ml. On an unknown date, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   The reporter considered the pruritus to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. In the morning, 12 to 16 hours after vaccination, the patient experienced itchiness in the head and next area. The itchiness lasted about 2 days and was intense. This case has been linked with US2019AMR199245, reported by the same reporter.
Received 3 vaccines in Rt thigh on 10/13. Swelling noted that was increasing in size. Treated with Clindamycin.
UNEXPECTED THERAPEUTIC BENEFIT (NO LONGER A DIABETIC); IT FELT LIKE MY ARM GOT HIT WITH A MALLET; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diabetes, and concurrent conditions included do not exercise. The patient was previously treated with metformin for diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included liraglutide for diabetes. On JUN-2021, Laboratory data included: HbA1C decreased (NR: not provided) 5.1. On an unspecified date, the subject experienced unexpected therapeutic benefit (no longer a diabetic), and it felt like my arm got hit with a mallet. Laboratory data (dates unspecified) included: HbA1C increased (NR: not provided) 7.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the it felt like my arm got hit with a mallet and unexpected therapeutic benefit (no longer a diabetic) was not reported. This report was non-serious.
A cut on her finger that she saw when she removed her gloves; She felt the rim crack and a piece fell on the floor; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00324227) and transmitted to Sanofi on 20-Oct-2020.   This case involves female patient (unknown demography) who felt the rim crack and a piece fell on the floor (syringe issue) and got a cut on her finger that she saw when she removed her gloves (limb injury), while administering a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ512AA and expiration date: 30-Jun-2021) to the patient (unknown demography) via unknown route at an unknown administration site for prophylactic vaccination on 20-Oct-2020.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Oct-2020, the pharmacist got a non-serious cut on her finger that she saw when she removed her gloves (limb injury), on same day following the administration of INFLUENZA SPLIT TRITON THIOMERSAL FREE VACCINE - CN.  Reporter reported that the syringe was fully intact prior to administering and was not difficult to push. Flange, glass rim broke during administration. There was no damage to the carton upon receipt and no product residue in the carton and no signs of damage to any other vial in the carton.  Laboratory test was not reported.  It was not reported if the pharmacist received any corrective treatment or not.  It was also the case of product technical complaint due to syringe issue (on same day).  The outcome of the event got cut on her finger that she saw when she removed her gloves was 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 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.
17 mo pt immunized 11APR90, developed 2X4 inch area of swelling, center had small pustule, scant drainage, severe discomfort.
Starting about four hours after receiving the injection I formed a large, hard, hot, painful and itchy lump under the skin.  By 8:00 PM that same night it measured 4.5 inches across and 3 inches tall.  As of two days later it is still just as large and is extremely hard and has formed a rash on the skin.  It's very painful, itchy, and is radiating heat.
Patient for 2 days had severe erythema not just around the vaccination site but all down his left arm in a circumferential manner; was hot to touch and tender as well per report.
Right arm swollen at upper arm, bright red, hot to the touch. Pt stated arm hurt, but moving/using arm fine. Mom called PCP - waiting to hear what she needed to do. Had called Hosp - advised to take to urgent care.
After the immunizations were received had to go to ER w/eye, face swelling. Received DECADRON and BENADRYL.
That night I started with fatigue and I was probably spacey but I think It was just me trying to be stay awake.
8/31/05 Child visiting aunt in Atlanta, arrived 3 days ago woke this AM with 15+ vesicles on face, back, legs and arms. Also has 10+ bug bites (unrelated). Aunt does not know of any exposure history. Dx: mild varicella.
After two weeks my arm started to hurt, it hurts until this day. I use hot and cold compresses but it is still the same.
Sore arm & mild rash after injection, headache, fever, tinnitus, aches. All resolved within 36 hours, except tinnitus, which has persisted.
Can not raise the left arm after 2nd dose; Tingly Injection site after 2nd dose; Muscle Weakness after 2nd dose; Heart pounding; Itching bottom of feet, left ear; Red Injection site after 2nd dose; Pounding Head; Left arm injection site after 2nd shot; Muscle soreness after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose), PALPITATIONS (Heart pounding) and PRURITUS (Itching bottom of feet, left ear) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Tetanus (Reaction to Tetanus shot.). Past adverse reactions to the above products included Reaction to previous exposure to any vaccine with Tetanus.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose), PALPITATIONS (Heart pounding), PRURITUS (Itching bottom of feet, left ear), VACCINATION SITE ERYTHEMA (Red Injection site after 2nd dose), HEADACHE (Pounding Head), VACCINATION SITE PRURITUS (Left arm injection site after 2nd shot) and MYALGIA (Muscle soreness after 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 3 pills. At the time of the report, INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose) and VACCINATION SITE ERYTHEMA (Red Injection site after 2nd dose) had not resolved, PALPITATIONS (Heart pounding) and HEADACHE (Pounding Head) outcome was unknown and PRURITUS (Itching bottom of feet, left ear), VACCINATION SITE PRURITUS (Left arm injection site after 2nd shot) and MYALGIA (Muscle soreness after 2nd dose) was resolving.            No concomitant medications were provided.   This case was linked to MOD-2021-360548 (Patient Link).
Symptom:  Dizziness with certain head movements. Diagnosis:  Benign paroxysmal positional vertigo, bilateral. Treatment: Physical Therapy (Vestibular Rehab) - resolved within 5 days.
Lower back pain beginning day after vaccine. Vertigo & nausea beginning days after vaccine, lasting 2-3 days. Fatigue beginning day after vaccine and is improved, but still present. Leg muscle pain and slight swelling beginning 5 days post-vaccine.
Pt recv vax on 11/4/98; 7 hr post vax pt exp tingling; swollen eyes
Blurry vision; Loss of balance; Dizziness; Strange feeling of pressure in the head; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), BALANCE DISORDER (Loss of balance), DIZZINESS (Dizziness), HEAD DISCOMFORT (Strange feeling of pressure in the head) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VISION BLURRED (Blurry vision), BALANCE DISORDER (Loss of balance), DIZZINESS (Dizziness), HEAD DISCOMFORT (Strange feeling of pressure in the head) and NAUSEA (Nausea). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 1 dosage form. At the time of the report, VISION BLURRED (Blurry vision), BALANCE DISORDER (Loss of balance), DIZZINESS (Dizziness), HEAD DISCOMFORT (Strange feeling of pressure in the head) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sore left arm, Headach, Nausea, Vomiting....Patient said there was a little blood in the vomit. He only vomited once.
Information has been received from a registered nurse concerning a 22 year female health worker with no pertinent medical history who, on 16-Sep-1986, was vaccinated with MMR II . There was no concomitant medication. On 14-Nov-1991, the patient was vaccinated with her second dose of MMR II. On 28-Mar-2008, the patient had an MMR titer drawn with the following results: negative measles titer, just adequate mumps titer, and rubella titer adequate. No problems were reported. The product quality complaint was not involved. Additional information has been requested.
Information has been received on 05-FEB-2019 from a lawyer and a male patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 20-JUN-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a hospital for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The patient stated he experienced arm soreness, tingling, sweating, and redness at the injection site the day after receiving the immunization. The patient stated he was feeling better two days following the immunization. Redness and heat was isolated to the deltoid area of the left arm. The patient was advised to follow up with his primary care doctor if he had any further symptoms or felt more comfortable seeing the physician.
Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     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. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-378412 (Patient Link).; Sender's Comments: This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient called office on 12-23-19 @ 1620 to report that since his flu vaccine on 11-21-19 he had been having intermittent cramping to (L) upper arm at injection site. Denied any redness, or swelling at site. Provider called patient back on 12-24-19 and he described a "pinching", "achy" "Charlie Horse" feeling to (L) upper arm that started the day after he received the vaccination, worsens with increased ROM of (L) arm and subsides when arm still. (continued)
Pt recvd a series of 3 Engerix-B on 24AUG90 & 15NOV90 & 27FEB91 & was a poss non-responder;
Started feeling congested and was coughing. Took home COVID-19 test and was positive. Contacted doctors clinic and was prescribed PAXLOVID. Started feeling better by the next day, then was completely back to normal 4 days later.
Fever 102.6, soreness @ site, redness & swelling 24 hrs p/vax given; rt deltoid area CT given APAP;
Patient had erythematous macules to face and torso after 4-year old vaccines, she was also upset and nervous after vaccines, no hives present, no facial swelling, vomiting or difficulty breathing.
in bed all day; A Spontaneous  report was received through a phone call, that the patient is a female who received the first dose of Moderna's COVID-19  vaccine mRNA-1273 she was experienced bed all day.  The patient medical history was not reported by the reporter.There is no concomitant list.   A patient called in to report that her friends mom got the first dose of the vaccine and she was in bed all day. The patient did not want to talk to the Med info team. Treatment information is not provided by reporter.  The action taken with mRNA-1273 in response to the dose is unknown.  The outcome of event experienced  bed all day is unknown.
Pt deceased of suspected SIDS on the day following administration of routine 6 month vaccines as well as flu shot.
12 days after the vaccine the injection site is starting to get red, swollen and sore to the touch
Missed to receive the 2nd dose of Moderna vaccine D64; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine D64) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine D64). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine D64) had resolved.            NO Concomitant products used by the patient included.  Treatment information was not provided.  Patient missed the due date in order to receive the 2nd dose on 13-May-2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Live followed up received on 17-Jun-2021: addition of patient details, addition of batch number, event updated to Missed to receive the 2nd dose of Moderna vaccine D64.
Within 24 hours I broke out in Shingles.  Symptoms lasted for 2 weeks.
Within three weeks of having the Moderna Covid 19 vaccine the patient had a very stiff right shoulder.  She went to the doctor and the doctor diagnosed her with a frozen shoulder and had her do physical therapy for several weeks.  Later in the year, the frozen shoulder returned and in October (8 months after the injection) patient began to have a tremor in the same arm.  She was diagnosed with Parkinson's in June 2022, 9 months after the tremor began.
Low grade fever, chills, fatigue.  Lasted about 18 hours but improved significantly while taking Advil.  Was able to stay at home and rest.
On morning after shot, awoke with a low fever of 99 degrees, felt nauseous, and vomited. Slept through the afternoon and then had no further adverse affects.
Immediately within minutes after the Pfizer vaccination I got quite painful tingling in the injection arm and hand that shot to the face on the same side. Dizziness and bad headache followed. At home a couple of hours later I began to get tingling in the leg on the same side as the injection side was. A day later I had the typical fever symptoms that were not of worry to me. About 7 days later I got neuropathic pain in the arm, hand and leg on the opposite side of the body also. Until this day peripheral neuropathy on both body sides continues.
As per what the hospital leaflets said about 4 wks after operation my upper arms both left & right sides got very very sore could not even lift them above my chest, still to this day (Oct 30, 2012).
7x8cm firm swelling at site of PENTACEL injection, (R) lateral-ant thigh. No treatment.
itching and redness at injection site, started 2wks s/p injection and lasted ~1.5wks Narrative:
I woke up with a scratchy throat on 07/12/2022 but thought that it was due to my CPAP machine. On 07/13/2022 around 5AM I woke up feeling worse and that is when I tested positive for COVID-19 with an at home test. I called my insurance nurse's line who advised that I return home as I was staying in a hotel room since my husband was in hospital. I went to a local clinic and was prescribed PAXLOVID and something for my cough. I began the medication the night of 07/15/2022. I felt really sick with a sore throat, headache, bad coughing, and brain fog. I felt badly all weekend. The following Monday, I started to feel a bit better and by 07/22/2022 I felt pretty good but I stayed home for the full 10 days. I still have a cough and some nasal symptoms but am feeling better overall.
Rash fading but continuous Chills, aches, fatigue, lethargy, poor appetite for about 60 hours No fever
Achy; Hot at injection site; Went to bed he covered himself with blankets and when he woke up all sweaty; Really bad headache; Fatigued; Hot at inject site and red color; Cold chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache) and FATIGUE (Fatigued) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Hot at inject site and red color), CHILLS (Cold chills) and PYREXIA (Fever). At the time of the report, PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Hot at inject site and red color), CHILLS (Cold chills) and PYREXIA (Fever) outcome was unknown.            No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-560588 (Patient Link).   Reporter did not allow further contact
Menveo - Reconstitution with a different diluent.; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA956A, expiry date 31-JUL-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo - Reconstitution with a different diluent.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 20-OCT-2023 A nurse called to report the administration of Menveo vaccines that were reconstituted with a different diluent other than the supplied meningococcal CYW-135 (MenCYW-135) liquid conjugate vaccine component. The vaccines were probably reconstituted with a diluent from MERCK, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The patients who received the improperly reconstituted vaccine have not been identified. The reporter consented to follow up.