chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to a 8 week old female patient. No concurrent condition, medical history or concomitant therapy was not reported. On an unspecified date near the end of February 2016, the patient's 1 year old brother was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # L028278, expiration date on 28-JUL-2017, dose and route unknown). No adverse effect with vaccine recipient. Approximately in March 2016 (reported as 16 days later), the patient experienced varicella as possible transmission (in 2016) following (Oka/Merck) VARIVAX vaccination of her brother. On 19-MAR-2016, the patient was seen in urgent care emergency room and treated with acyclovir for 5 days. The physician reported that patient was doing great, lesion all crusted and had no complications. The varicella was determined clinically in patient and isolates were collected and sent to a doctor for genotype determination. The causal relationship between the events of varicella and secondary transmission, and VARIVAX (Oka/Merck) was not reported. Additional information has been requested.
Body itchiness started in March . The itchiness is all over my body and I am unsure if it's related to the vaccine.
c/o hip pain to ankle x 1 week Narrative:  Patient was seen by outside PCP and had MRI to r/o Blood clot-NEG MRI. Was told to apply heat and ice
shingles/herpes zoster; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-JAN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe painful rash across the right side of her back and arm. The patient was diagnosed with shingles/herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles/herpes zoster was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles/herpes zoster to be disability.
right arm is swollen, red, itchy. She states she is using warm compresses and benadryl
This spontaneous report was received from a medical student regarding a 21 year old female patient. The patient was vaccinated with GARDASIL on 07-NOV-2008 (1st dose) with lot number 0572x, 2nd dose in 12-JAN-2009 with lot number 0570x and 3rd dose in 26-MAY-2009 with lot number 1312x. No concomitant medications were reported. On 14-SEP-2012, the patient had a HPV smear result which was positive after 3 doses being administered. The outcome of the event was reported as not recovered. The patient did not seek medical attention. Additional information is expected.
Redness & swelling around site of injection after 24 hours 6 centimeters.  VARICELLA vac only.
Final third dose of Hepatitis B vaccine was administered in the right deltoid and approximately 10 minutes later the individual stated she had a metallic taste in her mouth. Shortly after she reported feeling chest tightness and pressure then developed slur of speech which the individual acknowledged and healthcare providers also found noticeable.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 10:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.  Concomitant products were not provided.  On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 PM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45 and 4 PM: 44.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt experienced abdominal pain, emesis, leukocytosis.  Admitted to hospital on 5/25/2021 and was diagnosed after workup with small bowel obstruction due to a single abdominal adhesion, which was lysed on 5/28/2021.  No prior history of abdominal surgery.  Discharged from hospital on 6/7/21 in stable condition.  On 6/12/2021, pt developed further abdominal pain. Workup revealed SBO with multiple abdominal adhesions that had redeveloped.
That is how they get back at us for killing her daughter with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (That is how they get back at us for killing her daughter with the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Treatment information was not provided. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, fatal outcome of Death. The dates of administration of mRNA-1273 and onset of event were not specified, hence latency could not be assessed. There was no information provided on the dosing regimen, circumstances leading to death, clinical course, concurrent diseases, medical history and autopsy details. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, fatal outcome of Death. The dates of administration of mRNA-1273 and onset of event were not specified, hence latency could not be assessed. There was no information provided on the dosing regimen, circumstances leading to death, clinical course, concurrent diseases, medical history and autopsy details. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
I haven?t had my period in well over a year with absolutely no spotting. I received my vaccine this morning around 6/6:30 am. I have no idea the name of the clinic we were at. When I came back to my room around 12 pm I noticed I had started my period which is highly unlikely it would happen on its own as I?ve had my iud for over a year and it has completely stopped my period until the day I received my vaccine.
Day after administration, right upper anterolateral arm with 80 mm x 110 mm area of erythema, equiv increase in warmth. Non-tender. No palpable mass.
p/vax 6OCT95 pt became confused, could not talk, was sweating & pale sxs lasted 24 hrs;
noticed in the last 5-6 days a very stiff neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "noticed in the last 5-6 days a very stiff neck".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician's assistant concerning a 15 month old female patient, who is "slow to gain weight" and has a history of "borderline" failure to thrive and no allergies, who on 08-Jul-2003 at 15:00 was vaccinated with a first dose of MMR vaccine live (second generation) (lot #639914/0023M) into the left thigh. Concomitant therapy on 08-Jul-2003 at 15:00 included a fourth dose of Streptococcus pneumoniae vaccine (PREVNAR) (lot #484-150) into the left thigh. It was reported that the patient was not ill at the time of vaccination. It was noted that the patient had no adverse symptoms noted with prior vaccinations or previous 3 doses of PREVNAR. On 16-Jul-2003 the patient developed generalized urticaria. According to the reporter there was no lip swelling, angioedema, cough or wheezing. The reporter was "not convinced" that the urticaria was related to the MMR vaccine live (second generation) because it did not occur until 8 days later. The patient was treated with diphenhydramine hydrochloride (Benadryl) and recovered on 20-Jul-2003. It was reported that the patient had not eaten anything on the day of the urticaria that she had not eaten in the past. Additional information is not expected.
fever began to inc on 28MAR94 up to 103 w/APAP & Motrin having been admin q 4 hrs since time of shots; took to MD 29MAR94;
The day after the vaccine I started to have high blood pressure. I was monitored by the OB Triage. I was advised not to work any more. I was having a lot of back pain two weeks later. I delivered five weeks early on 02/11/2021. I went into preterm labor three weeks after I got the second dose of the vaccine. My water broke five weeks early.  After the delivery  I was very sick because it was not evident that I had Placenta Accreta and the Placenta was improperly attached. I had unknowingly retained part of the Placenta. The baby was also born with a heart defect but I got pregnant within  a few weeks before the first dose of the vaccine. I had an infection and needed a blood transfusion. DUE DATE-03/17/2021 Pregnancy -First
Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     It was unknown that whether patient had allergies to medications, food and other products. It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was having acute and Chronic illnesses at the time of vaccination.     On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 28-Apr-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the second booster dose.  No treatment medications were reported.   This case was linked to MOD-2022-554283, MOD-2022-554288 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received included no new information.
Shoulder injury related to vaccine administration. Observed symptoms: Shoulder pain, limited range of motions (painful arc arm abduction 60-120 degrees, limited external rotation (20-30 degrees), limited internal rotation arm abduction). Having trouble with left arm to reach above head, painful while abduction, can't reach active abduction beyond 60 degrees, painful trying to reach back. Shoulder weakness for the left arm after vaccine administration. Symptoms started after the vaccine administration and didn't go away until 12/15/2021 (10 weeks since flu vaccine administration).
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from healthcare professional. This case is linked to cases 2018SA256146 and 2018SA256154 (same reporter). This case involves an elderly female patient (gender was not reported) who was vaccinated with a 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI868AA, expiration date: 03-May-2018, dose in series, and site of administration were not reported) via intramuscular route on 04-Sep-2018 in the left arm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. The patient had no adverse event following the vaccination. 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. Documents held by sender: none.
Sudden burning in nose, ear canals, heavy discharge post nasal and from nose. Body aches, skin sensitivity, chills, sweats. Normal body temp was recorded. Complete stopped up sinuses for several hours.  Used nose drops to get enough air to be able to go to sleep. Felt better but not perfect the following day, by the 2nd day I was back to normal, much faster than a recovery from a normal cold.
Severe left shoulder & arm pain s/p PCV-23 injection 1/5/11. Pt seen at ER for eval with (-) shoulder xray. Believe to have been injected into shoulder joint at time of vaccine. At f/u visit with decreased ROM due to pain (+) ttp shoulder/arm.
Rash, flushing, cough, wheezing, abdominal distention, swelling of arms and legs, vomiting, fever, chills, hive at injection site, left deltoid swelling, diarrhea and constipation, pharangitis, lymphadenopathy, congestion
Pain in arm with decrease in range of motion following flu shot lasting until present. Visit to primary MD, who ordered x ray (neg) and PT. Firt PT appt was 12/19/05, who started a course of exercises. Will see again in 2 weeks.
Hypotension leading to septic shock and DIC.   Started 6 hours after injection.  Discharged from hospital on 2/24/21.   Left with much worse dementia.  Weakness progressed.  Now on hospice
c/o rash, fine raised to chest & back;no temp above 100-fussy & crying mild during the noc;
SWELLING IN LEFT HALF OF THE UPPER AND BOTTOM LIP WHILE SLEEPING; LEFT EYE SWELLING WHILE SLEEPING; SWELLING OF LEFT SIDE OF FACE WHILE SLEEPING; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. Patient had no current medication usage, and no previous known medical conditions. The patient was previously treated with tetanus vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 04-MAY-2021, the patient experienced sore arm at injection site. On JUN-2021, the patient experienced swelling in left half of the upper and bottom lip while sleeping. On JUN-2021, the patient experienced left eye swelling while sleeping. On JUN-2021, the patient experienced swelling of left side of face while sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in left half of the upper and bottom lip while sleeping, left eye swelling while sleeping, and swelling of left side of face while sleeping, and the outcome of sore arm at injection site was not reported. This report was non-serious.
For 60 hours after injection, symptoms included fatigue, nausea, headache, body aches, fever and chills. Treated at home without medical intervention. Menstrual cycle began 4 days after injection and lasted 21 days.
Administered the high dose fluzone instead of fluzone quad.  Discovered immediately.  Patient has not had any adverse reactions
This spontaneous report as received from a dentist refers to a 68 year old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose 0.65ml, lot# and expiration date were unknown) subcutaneous. Concomitant therapy included unspecified blood pressure medications. On an unknown date the patient had gallbladder surgery after receiving ZOSTAVAX. On an unknown date, while the patient was in an unspecified hospital for the gallbladder surgery, the patient developed shingles at an unspecified time after having the surgery. The shingles did not extend the patient's hospital admission and that the patient was prescribed unspecified antiviral medications for treatment while in the hospital. None lab diagnostics studies were performed. The patient had sought for medical attention. The outcome of events was as recovering/resolving. Upon internal review, the event of gallbladder surgery was considered to be medically significant. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 16-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. All available medical records will be provided upon request.
Vomiting, headache, slight swelling of lips and eyelids. 12-15-15 PHENERGAN 25mg IM x 1 at 11.10. Pt tolerated well.
Patient complained of Redness and swelling around injection site with Itching and pain. All symptoms resolved by 9/23/2021
Patient had increased pain that evening and then had red stripe formed below injecttion site- still present 2 days later.  Lips became swollen for 2 days after.  Decrease in lip swelling and pain 2 days later,  Arm was also swollen.  Patient took benadryl and advil.
Shortly after the vaccine was administered, the pt developed a localized reaction. Three days after vaccination, the patient reported her reaction to staff at the Health Department. The pt reported extreme soreness/tenderness/pain in her right arm. The pain was so intense she could not touch her arm, put any pressure on her arm such as trying to sleep on her right side, or lift or raise her arm without pain. She reported swelling around the administration site and a very hard knot approximately the size of a grape where the vaccine was administered. She reported warmth at the site of administration but denied experiencing any fever or other signs of possible infection. The patient had her PCP examine the administration site. The PCP diagnosed the patient with a localized reaction that should resolve over time. A week after the administration, the patient reported an improvement in symptoms. The swelling, knot, tenderness, and pain have resolved on their own.
Soon after dose 5 I was diagnosed with a severe urinary tract infection that showed microscopic blood. Then I began to have problems with my left breast with discharge. It was red and burned. I had a diagnostic mammogram that showed nothing. I then went to my dermatologist and was Paget Disease of the breast. I am scheduled for surgery.