chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/6/99, pt c/o 3" x 3" hot,red area at injection site also had low grade fever.Dvlped severe arm pain & went to ER.Tx w/ cephalexin every 6 hrs & Vicodan for pain.
Headache, Arthralgia, Fever, NauseaVomiting, FEVER 102, SHAKES Narrative:
Around 1pm I started getting increasing pain in my left arm. It caused me concern. I started getting ringing in my ears. The pain started to radiate up to my neck and down my elbow and into the side of my torso. It was experiencing joint and muscle pain. I could  not move my arm or bend forward. The pain seemed to travel to the front of my chest. It wrapped around my back into my scapula down to my forearm. I also felt it in my armpit. I felt my heart beat in my ear and under my armpit on my left side, it was throbbing so bad. It was between stinging pain, burning and throbbing pain . It was a consistently traveling pain it didn't stay in one area. I could not move. I went to sleep, when I woke up this morning everything was gone but I still can not move my arm. When I try to pivot or move my arm in certain ways it causes pain that is still going on right now.
SUSPECTED COVID-19 INFECTION; LITTLE DIZZY FEELING; PRESSURE ON FOREHEAD; HEAD CONGESTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On OCT-2021, the patient experienced suspected covid-19 infection. On OCT-2021, the patient experienced little dizzy feeling. On OCT-2021, the patient experienced pressure on forehead. On OCT-2021, the patient experienced head congestion. On 09-OCT-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on OCT-2021, and the outcome of little dizzy feeling, pressure on forehead and head congestion was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Employee state that event of receiving Flu vaccine, broke out in rash around injection site of right side of body. States she took Benadryl. No respiratory problems per employee.
Legs started hurting, limping, couldn't walk gave him Motrin, next day couldn't walk, pediatrician office said most likely no link to wait it out. 2 days of numbness or soreness making him not able to walk to bathroom, then cleared itself up, not sure if I should get him second dose.
Initial and follow-up information has been received from a physician and medical assistant respectively concerning a 10 week old female who on 27-AUG-2007 was vaccinated po with a 2 ml first dose of Rotateq (lot #657459/0509U). Concomitant vaccination included Pediarix (Lot# AC21B124BA), ActHib (Lot # UF2088A), and Prevnar (lot # B47442K). On 29-AUG-2007 to 30-AUG-2007 the experienced projectile vomiting. On 30-AUG-2007 to 31-AUG-2007 the pateint experienced diarrhea. The patient went to the hospital on 31-AUG-2007 to rule out intussusception. The patient had an ultrasound in the hospital which ruled out intussusception. The patient was watched due to symptoms and released from the hospital on 01-SEP-2007. The patient's outcome was not reported. There was no product quality complaint involved. No further information was reported. The patient's projectile vomiting and diarrhea were considered serious for hospitalization. Additional information has been requested. This is one of several reports from the same source.
Received an HPV and flu shot on 3/29 and broke out in hives all over body. Noticed graffiti around the hospital.
Varicella disease diagnosed 6/2/06 by physician exam. History of varicella vaccine 8/2/01.
Information has been received from a nurse concerning a 27 year old female who on 12-FEB-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # not provided). Subsequently, on 13-FEB-2007 the patient reported that her "face felt hot", she had a fever, nausea and headache. On 23-FEB-2007 the patient reported that she had an additional symptom similar to motion sickness. The patient sought unspecified medical attention. At the time of this report the patient has not recovered from the events. Additional information has been requested.
Eight days following the first vaccine I was admitted with massive blood clots to my lets and lungs. I was hospitalized for 8 days. Four days were in ICU.
After vaccines were given the patient hopped off the exam table (she was sitting on it) & fell to the floor and became rigid and looked blue and unresponsive but not flaccid with then tonic - clonic movements upon awakening after about 1-1 1/2 minutes and felt scared and angry after episode. HR/BP okay X
Patient experienced itching. Patient received 5ml diphenhydramine liquid from pharmacist on duty.
w/in 1wk diarrhea, vomit, convuls, fever, loss of weight;
Fever of 102, body chills, aches, hot,  cold sweats, migraines, (neck stiff - 8 hours).
Report received via the citation. The authors conducted a review of the database from the Vaccine Injury Compensation Program and found 13 patients which suffered from significant shoulder pain and dysfunction after receiving either influenza vaccination (brand unknown, 8 patients), tetanus containing vaccine (4 patients) and Human papillomavirus vaccine (HPV, 1 patient). All patients were adults (mean age 50 years) and 85% were female. The symptoms lasted over 6 months to many years. Onset of pain was reported to occur less than 24 hours after vaccination in 93% and occurred immediately following injection in 54% of the cases. The most common findings on examination were limited and painful range of motion. Skin and local injection site reactions were not reported and sensory symptoms such as tingling and numbness in the affected extremity were uncommon. Weakness was not a common finding and when found was attributed to pain. Deep tendon reflexes, when tested, were noted to be normal. 46% of the patients voiced concerns regarding vaccine administration, specifically that the vaccination had been administered 'too high' in the deltoid. Among the 39% of patients who underwent electrodiagnostic studies, none had findings suggestive of a neurological disorder such as brachial neuritis. MRI findings varied but included fluid collections in the deep deltoid or overlying the rotator cuff tendons (39%), bursitis, fluid 'greater than typically seen' within the bursa, tendonitis, rotator cuff tears, and in one patient, subchondral changes in the humerus with overlying severe tendonitis and fluid accumulation. A complete rotator cuff tear was found in 15% of cases and in one case, associated atrophy of the rotator cuff tendon was noted. More than half of the patients required at least one injection of a corticosteroid over time. Surgical intervention was performed in 31% of cases with half of those cases requiring a second surgical intervention. Patients were also treated with NSAIDs and physical therapy. Outcome of patients is unknown. Less than one third of patients had complete recovery while the majority of patients had continuing symptoms including persistent pain, limited range of motion and pain on range of motion at last follow up.
A legal complaint has been received from an attorney alleging that a female child received a series of Acel-Imune, Hib-Titer, hepatitis B vaccines and one dose of Recombivax-HB vaccine from 2/2/00 through 12/13/00. According to the legal complaint, the child suffers, and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. The reporter indicated that these effects have caused the child to be injured permanently. No further information was available.
Information has been received on 14-JUN-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with  ZOSTAVAX vaccine (lot #, expiration and dose not reported) subcutaneous on or about 21-OCT-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. On or about 05-NOV-2013, the patient was treated at a hospital for a vesicular outbreak that was diagnosed as herpes zoster. The shingles quickly spread throughout the patient's body. The patient was prescribed cortisone injection and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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.
fainted; This spontaneous report was received from a physician via company representative, referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 18-AUG-2020, 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) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  It was reported  that on the same date the patient was vaccinated, he fainted (syncope) in the office. It was unknown how much time had passed once the vaccine was administered and when the patient fainted. Additionally, it was reported the patient recovered from syncope on an unspecified date.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the syncope event was not reported.  Upon internal review, syncope event was determined to be medically significant.
PATIENT FELL SEVERE ARM SORE RADIATING UP THE ARM AND ACROSS BACK AND DOWN THE LOWER BACK
fluzone hd qiv following administration to a patient today 09oct2023, who just received the same vaccine 4 weeks ago with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] following administration today 09oct2023, who just received the same vaccine 4 weeks ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (with an unknown strength and formulation) (lot U8138DA, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization who just received the same vaccine 4 weeks ago with no reported adverse event (inappropriate schedule of product administration) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Symptoms started in 10/98 and gradually increased over time. Had fever, fatigue, joint pain, rash and swollen glands. In 6/00, was very ill with symptoms. Dx'd with fibromyalgia and carpal tunnel. On 2/14/02, dx'd with Epstein-Barr Virus. Immunologist stated it was related to the Hep-B immunization. (First Hep-B given on 1/14/97/1622B/IM/LA and second given on 2/11/97). Annual follow up states : No further contact with vaccine recipient.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 05-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J014851, expiry date 24-OCT-2014) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
Received Pfizer COVID vaccine  12/21/2020.    12/27/2020 developed cough, headache, rhinorrhea, and sore throat.
pt recvd vax; pt exp nausea; w/in 24 hrs pt exp itching & devel small purple-like rash; pt exp also emesis;
dizzy; felt warm; extremely weak; extremely hot; clammy; sore left arm; "typical" side effects; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), ADVERSE DRUG REACTION ("typical" side effects), DIZZINESS (dizzy), FEELING HOT (felt warm) and ASTHENIA (extremely weak) in a 73-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.     Concurrent medical conditions included Hashimoto's disease, Allergy, Allergy, Allergy, Latex allergy and Bee sting. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and ADVERSE DRUG REACTION ("typical" side effects). On 12-Mar-2021, the patient experienced DIZZINESS (dizzy), FEELING HOT (felt warm), ASTHENIA (extremely weak), FEELING HOT (extremely hot) and COLD SWEAT (clammy). At the time of the report, PAIN IN EXTREMITY (sore left arm), ADVERSE DRUG REACTION ("typical" side effects), DIZZINESS (dizzy), FEELING HOT (felt warm), ASTHENIA (extremely weak), FEELING HOT (extremely hot) and COLD SWEAT (clammy) outcome was unknown. Not Provided
STROKE; This spontaneous report received from a consumer via a company representative via social media concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient experienced stroke (at the time of reporting the patient can not use his right hand or speak).  The reporter reported that "Bf - 38 year old heathy male stroke after J and J vaccine. Now can't use his right hand still or speak a year later and has gone form $200 thousand income to no job." and "Bf had a stroke from the JNJ vaccine.. healthy 38 year old male. He can not speak now or use his right hand. Lost his job. Has no income but yet doesn't "qualify" for disability." and "JNJ you reached out to me regarding my contact information about my boyfriends stroke from the #vaccine but you haven't even replied. Seems like a show you me. Lives ruined by vaccine injuries." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220623834-covid-19 vaccine ad26.cov2.s -stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Patient received second dose on day 16, which is less than the minimum required 17 day spacing between dose 1 and dose 2 of Covid vaccine.    Dose one was received on 12/23/2020 Dose two was received on 01/08/2021
Suspected vaccination failure; developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter
Woke at 4am to heart pounding out of chest, elevated heart rate and tightness in left side of chest. Went to ER on 7/11/21, had EKG, chest x-ray, blood work and was released same day. Referred to pulmonologist and cardiologist. Was able to be seen by pulmonologist who ran more labs, came back "clear," but was not able to be seen by cardiologist before moving. Will be following up to schedule an appointment with a cardiologist, as this has been a continued problem for 4 months.
Urticaria, of injection site. Left upper arm, left shoulder, left upper back, subjective itch and burn
Patient's OB-GYN called our vaccination center to report that the patient was 30 weeks 3 days pregnant, had an expected due date of 5/27/21 but delivered a stillborn fetus on 3/21/21 at medical center on 3/21/21.
Pt came in on 7/29/19 and spoke with employee. She had a baseball size (3 inch area) of red + hot to touch skin where injection was given. It protruded (swollen) about 1/4" from skin. Employee recommended Tylenol, ice + call DR!
This spontaneous report as received from a licensed practical nurse refers to an infant patient of unknown gender. No information on his medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, at 0 months of age, the patient received the first dose in the series of three of RECOMBIVAX HB (dose, route of administration, lot # and expiration date not specified). The second dose was received by the patient on an unspecified date at 3 months of age. The third dose of RECOMBIVAX HB was received at 4 months of age, on an unspecified date. There were not adverse effects reported. Additional information has been requested.
35 minutes after vaccine tongue started to swell, subsided after 9 hours Slight diarrhea  Slight dizzy spell Cough Sore throat  Runny nose Nausea next morning Losing voice next morning
five minutes after vaccine developed tingling in left shoulder.  ten minutes after vaccine felt tightness in throat,  fifteen minutes after vaccine had difficulty swallowing
Patient inadvertantly inoculated spouse 4 weeks status post vaccination. Patient admits scratching off scab at week 3 due to pruritis at vaccine site. Spouse reports pustular lesions on erythematous base on neck right arm and right fingers. Denies fever, myalgia, headache.
Approximately 15 minutes after receiving vaccine, patient began complaining of tingly lips.  Vitals assessed, WNL.  Benadryl 25 mg capsule given to patient.  Observed closely.  Patient then began to complain of headache and "slight tightness" in throat.  No signs of respiratory distress, vitals remained WNL.  Approximately 15 minutes after Benadryl administered all symptoms resolved.  Patient asked to leave.  Observed another 10 minutes with no problems.  Patient left site.
soar muscle at injection site; fatigue; This is a spontaneous report from a contactable other hcp. A 48-years-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she contacted initially for questions regarding the vaccine safety while on Dupixent shots for asthma and allergies, not to report side effects. She did not respond to first letter because that was not apply to her. patient clarified to 2nd letter, that she received both vaccines with no side effects at this time other than sore muscle at injection site and fatigue following 2nd vaccine which subside after a day or two. The outcome of events was reported as recovered.  It was notified that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Onset of vertigo in the middle of the night post-vaccine day #3, with gradual improvement and lack of any other notable identifiable precipitating factors.
Blood sugars to be significantly higher than usual for about 3 weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugars to be significantly higher than usual for about 3 weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugars to be significantly higher than usual for about 3 weeks). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugars to be significantly higher than usual for about 3 weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Erythematous, papular/vesicular pruritic lesions started on back and spread over trunk, face, neck and some on arms too.