chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mid size leg vasculitis; Livedo reticularis; rash on both legs; This case was reported by a pharmacist via call center representative and described the occurrence of vasculitis legs in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number E9y5M, expiry date unknown) for prophylaxis.   On 17th August 2021, the patient received the 1st dose of Shingrix. On 19th August 2021, 2 days after receiving Shingrix, the patient experienced vasculitis legs, livedo reticularis and rash. On an unknown date, the outcome of the vasculitis legs, livedo reticularis and rash were unknown.   It was unknown if the reporter considered the vasculitis legs, livedo reticularis and rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had new onset rash on both legs, which appeared to be a vasculitis type of rash.  The patient consulted dermatology and rheumatology.  ANA, RF and Cyclic Citrullinated antibodies were ordered and results were pending.  As per the rheumatologist notes, livedo reticularis rash suggesting a mid-size leg vasculitis.  No signs of systemic vasculitis were present. The patient reported experience to pharmacist on 18th October 2021. The pharmacist stated that, till the time of reporting, the patient had not received the second dose of Shingrix.  The pharmacist was unable to provide expiration date of vaccine.  The reporter did not consent to follow-up
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccine with an associated reaction of pyrexia (see link case US2018GSK111713 for the same patient). On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, chills, fever and injection site pain. On 12th June 2018, the patient experienced tiredness. In June 2018, the patient experienced influenza. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the tiredness, injection site pain and influenza were recovering/resolving and the outcome of the chills and fever were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, tiredness, chills, fever, injection site pain and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient received SHINGRIX this past Monday. That evening she had soreness and pink coloring at the injection site. She also noted fever and chills on Monday evening but those had resolved till the time of reporting. Tuesday was the worst day she stated, noting she slept in her car at lunch due to being tired, the redness and soreness were worse. She stated the soreness and redness and warmth of the area were now below the actual injection site, she describes like a streak that is 3 to 4 inches long and about an inch wide. The redness had gotten more red and the soreness was less. She noted she called and reported this to her physician office, but they did not seem to be concerned. She also noted a history of fever, chills and soreness at the injection site with flu vaccine from unknown manufacturer. She noted her last flu vaccine was a couple of years ago when they combined with the swine flu. That was the worst of her reactions and she had not gotten one since. This case has been linked with US2018GSK111713, reported for the same patient.
I don't know that I got the complete dose. The syringe popped when he took it out, it appeared to be some left in between the plunger and the needle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 (DOSE 1 (unknown manufacturer)), for COVID-19 immunisation. The following information was reported: SYRINGE ISSUE (non-serious) with onset 20Mar2021, outcome "unknown", described as "I don't know that I got the complete dose. The syringe popped when he took it out, it appeared to be some left in between the plunger and the needle".  Question: DSU: E-transmitting - Potential AE/PQC  The reporter question was the provider that gave him the shot, the patient noticed after he gave the shot there was a droplet that he smudged away, and the patient noticed in the syringe that there were droplets in the syringe. The patient did not know that he got the complete dose. The syringe popped when he took it out, it appeared to be some left in between the plunger and the needle.  No follow-up attempts are possible. No further information is expected.
Headache, ErythemaMultiform, UrticariaPruritus, 1/10-1/12 erythema, swelling, firm, warm to touch, itchy, looks like a bug bite at injection site, headache 1/10-1/12 erythema, swelling, bug bite, firm, warm to touch, itchy, headache. employee reports prone to migraines. Taking prescribed migraine meds. Applying ice compress. Pain spasms. Instructed to take antihistamine, apply cold compress, apply hydrocortisone. will continue to monitor.
pt recvd vax & arm swollen, red & sore for 3rd day; severe h/a upon awakining, lasted all day; severe diarrhea until 21:15; severe arthritic sx in hips, could not walk; all joints hurt bad, elbows esp swollen, red, & warm;
Systemic: Rash (other than injection site)-Mild, Systemic: Other- Shortness of breath, itching, throat tightening; symptoms lasted 1 day
Severe rash covering pubic area not arm; Patient had second Moderna Covid-19 Vaccine booster shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Severe rash covering pubic area not arm) and EXTRA DOSE ADMINISTERED (Patient had second Moderna Covid-19 Vaccine booster shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient had second Moderna Covid-19 Vaccine booster shot). On an unknown date, the patient experienced RASH (Severe rash covering pubic area not arm). At the time of the report, RASH (Severe rash covering pubic area not arm) and EXTRA DOSE ADMINISTERED (Patient had second Moderna Covid-19 Vaccine booster shot) outcome was unknown.            Patient had no known allergies. Patient not had any concomitant medications and did not take any treatment medications.
SYNCOPE (PASSED OUT) TWICE; MUSCLE SPASMS; VOMIT ONCE; SHAKING; SHIVERING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043821A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, in APR-2021, the patient experienced shaking, shivering, muscle spasms, syncope (passed out) twice and threw up (vomit) one time about 8 hours ago.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, shivering, muscle spasms, passed out twice, and vomit once. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210410013--COVID-19 VACCINE AD26.COV2.S-Syncope (passed out)twice. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CLOPIDOGREL for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Extreme chills and low body temperature for 5 hours, beginning 9 hours post injection. Unable to warm my body, felt cold to touch, with chills so extreme I would have chipped teeth without my mouth guard. I felt like I was going to have a seizure - woke my husband up to monitor me. Ongoing headache for a week and tinnitus intermittent for 2 months.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender who on 30-APR-2013, was vaccinated with an expired dose of GARDASIL (lot # 1397AA, expiration date, 09-APR-2013) this was the 2nd. The first dose was administered on 19-MAR-2013. No adverse effect reported. Additional information has been requested.
Patient showed lethargy and a low grade fever. It then progressed to him refusing to move or babble. And all he did was glare into space. I am filing this because although the pediatricians and doctors were unsure of what caused this, I believe it was a reaction and it needs documented and added to statistics of other children who encountered this "event".
(1) Headache (frontal) progressed to migraine several hrs after immunization. (2) watery diarrhea (10+ episodes in 24 hours)-Began 5/31/16. (3) Blisters- inside mouth (both sides) and on tongue Began 5/31/16. (4) "Knot" and warmth at site of vaccination (began 6/2/16) (upper right arm).
This case was reported by a lawyer and described the occurrence of mercury poisoning in a 6 year old male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and pertussis absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified this report. At an unknown time after receiving Hepatitis B vaccine, DTP/DTaP vaccine, Haemophilus vaccine and/or MMR II vaccine, the patient experienced neurotoxic effects resulting in severe neurodevelopmental injuries. The events were attributed to mercury overdose and poisoning resulting from the thimerosal component of the vaccines. The multiple symptoms of the patient's injuries occurred and were first manifest no later than 01/01/2001. According to the attorney, the patient incurred medical expenses and will continue to incur medical expenses in the future as a result of his injuries. The attorney also alleged that the patient suffered significant impairments in his ability to enjoy life, faces significant obstacles to performing the tasks and activities of every day living, and suffers ongoing physical and mental distress. The case was assessed as medically serious (OMIC).
Patient was inadvertently given the second dose of Pfizer earlier than the recommended interval.  Dose #1 was given 1/30/22 and dose #2 was given 2/12/22.  Per the CDCs Administration Errors Revaccination Guidance, patient should be re-vaccinated with dose #2 on 2/20/22; patient was informed via phone call.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: Tested positive at home rapid antigen test for covid 8 days after the stop of paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication was not taken in 2 weeks by the patient. From 22Jun2022 he received COVID 19 Treatment, he used Pfizer Paxlovid, till 26Jun2022. Rebound: Tested positive at-home rapid antigen test for covid 8 days after the stop of paxlovid treatment. No known allergies. Other medical history was none.  No follow-up attempts are Possible. No further information is expected.
Patient under 18 was accidently given the Moderna Dose instead of the Pfizer one indicated
Called on 1/24/01, eyes swollen, took Sudafed and are still puffy. Called client on 1/25/01 and left eyelid better, right eyelid worse. On 1/30/01, some puffiness on eyelids but much better. Plans to get #2 Hep-B shot.
Headache fever fatigue severe pain cough earache sore throat  sore arm. Sore arm day after shot for 3 days. Fatigue day after for 5 days all other sxs started day 5 and still continue
COMPLETE EDEMA OF THE LEFT BICEP/TRICEP FROM SHOULDER TO ELBOW. ZERO ERYTHEMA, CIRCUMFRENCIAL EDEMA, ZERO SYSTEMIC SIGNS OR SYMPTOMS
upset stomach; sore arm; queasy; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced upset stomach, pain in arm and queasy. On an unknown date, the outcome of the upset stomach, pain in arm and queasy were recovering/resolving.   It was unknown if the reporter considered the upset stomach, pain in arm and queasy to be related to Shingrix.  Additional details were received as follows: The patient experienced upset stomach, he was queasy and had a sore arm. The patient did not consent to follow up.
Face became very red/hot: temp of 99.7.  Felt bad/fatigued.  Nauseated, no vomiting.  Had 2 diarrhea stools and abd cramping.  Felt better am 9/25/09-Then abd cramping and sweating started at 0830 9-25-09.  Also was lightheaded/weak.  Sent home.
Pfizer 12/30/20 and 1/20. Positive on 12/22
Swelling site of injection 72hrs after immunizations. No itching, no resp. problems.
Typical side effect symptoms experienced and cleared within 24 hours. Same symptoms returned (chills, low fever, heavy sweating, tense breathing) approx. 60 hours later along with severe aching chest pain. All symptoms resolved by next morning besides chest pain, which was severe enough to warrant emergency room admission about 72 hours after vaccination. Admitted to hospital overnight with an episode of palpitations around 6pm on the first night, being given motrin and colchicine throughout stay. Pain somewhat resolved and was discharged aprox. 100 hours after vaccination. Continued use of ibuprofen and colchicine in weeks following as pain slowly resolves.
No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX  x006983   3/7/2025 Temperature and Time frame: -9.2C; This spontaneous report was received from a registered nurse and refers to a. patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #x006983, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine udnerwent temperature excursion in -9.2 degree Ceslius fo 1 hour 7 minutes and in -11.2 degree Celsius for 31 minutes (Product storage error). No additional adverse event was reported.
Information has been received from a physician concerning a female patient over 60 years of age who in October 2008 was vaccinated with (Lot #662599/1076X, therapy date, route, site unknown).  "In the last 10 days", approximately 19-OCT-2008,  this patient developed severe local reactions in the injection arm.  The patient experienced welts and swelling on the arm.  A lot check is requested for PNEUMOVAX Lot #662599/1076X.  Unspecified medical attention was sought.  The patient's outcome was unknown.  This is one of several reports received from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Patient received Janssen vaccine and within 3 minutes felt faint, slouched and was assisted to a position laying on the floor, 911 was called..  Patient had a seizure lasting approximately one - two minutes and slowly revived to nearly full attentiveness.  EMT arrived within 5 minutes and assumed patient care.  Within the next 10 minutes patient had another seizure.  Patient was taken to the Emergency Room by EMT staff.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of VAQTA (lot # L022259 and expiration date 06-APR-2017, lot # J011385 and expiration date 10-MAR-2016; exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
As needle was being pressed, the vaccine started to leak from the joint of the needle and syringe, most running down the arm. I removed the needle. I thought there must have been a defect with the needle, as I had no issues in two vaccinations earlier that morning with the same syringe/needle combination. I got a second prepared syringe, and as I started to administer, the issue began to repeat. I withdrew the needle, found the connection slightly loose and tightened it. At that point, I suspected the patient had gotten small part of dose in the first syringe, and so I administered the remainder of the second syringe (~0.4 mL).
Symptoms for 6 hours after the vaccine. Fever and chills, fever, sweats
DEVELOPED INDURATION AT INJECTION SITE (5cm X 5cm), WARM, RED RASH CHEST TO NECK. EMESIS x3. DECREASED OXYGEN SATURATION, FATIGUE, NAUSEA, AND DIARRHEA LASTING 12 HOURS.
pt recvd 2 doses of fluogen on 4OCT93 & 14OCT93;
temperature of 102 F and felt achy and feverish.; flu like symptoms; 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 INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (temperature of 102 F and felt achy and feverish.) 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.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced PYREXIA (temperature of 102 F and felt achy and feverish.). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (temperature of 102 F and felt achy and feverish.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021 04:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
PFIZER COVID VACCINE FOR (5-11) WAS ADMINISTERED IN STEAD OF PFIZER COVID VACCINE FOR 6MONTH-4YEAR TO THIS PATIENT.  SHE IS FEELING WELL AND THERE'S NO OTHER SIGN AND SYMPTOMS.
Information has been received from a physician concerning her 13 year old daughter who on approx 8/16/06, (also reported as within the past 2-3 weeks) was vaccinated with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast. the physician reported that her daughter experienced soreness at injection site for a couple of days after receiving HPV vaccine. The pt sought unspecified medical attention. At the time of this report, the outcome of the event was unk. Additional information has been requested.
no immediate reaction upon discovery of medication error; Reports dose of PROQUAD given at the same time as VARIVAX.; This spontaneous report was received from a physician via a field representative referring to a 12 months old male patient. The patient had eczema and was otherwise health and had a normal delivery, no hospitalization. He was recommended weight-based dose of ibuprofen. Information about drug reactions/allergies was not reported.  On 11-SEP-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dosage form, lot # was reported as SO30211, expiration date not reported, upon internal evaluation changed to the valid lot# S030211 (therapy type: rHA) with expiration date 25-MAR-2021, route was not reported) for prophylaxis. On the same date, at the same time, the patient was also vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form, lot # was reported as SO15463, expiration date not reported, upon internal evaluation changed to the valid lot# S015463 with expiration date 20-MAY-2021, route was not reported) for prophylaxis (inappropriate schedule of product administration) and the patient was also given a dose of hepatitis a vaccine, inactivated (VAQTA) (1 dosage form, lot # was reported as SO25993, expiration date not reported, upon internal evaluation changed to the valid lot# S025993 with expiration date 17-OCT-2020, route was not reported) for prophylaxis. The patient had no immediate reaction upon discovery of the medication error (no adverse event).
we call the patient next day and she with no any side effect, we explain to the parent if she had any reaction or any new symptome she had to call us or call EMS