chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left thigh swollen, non-tender, no redness. 6.7 cm of induration; otherwise no other sequelae.
C/o pain in muscles, joints.  Felt hot all over, pressure in chest.  Given IV fluids DILAUDID, ZOFRAN in ER.  5/6/09 6 am D/C with VICODIN for pain.
Child complained of burning after putting sunscreen on right arm. Mother noted fine rash extending from DTaP site and raised red (0.5mm) bump at IPV site. Over 2 days a fine bumpy, irregular shaped are with tiny scattered blisters appeared. Non-tender, no heat, no itching reported by child. Area spread to 70 x 40 mm down arm. Mother used Benadryl cream on 6/9/03. Looked better AM of 6/10/03. No other sites present over child. Unusual reaction if attributed to vaccine(s).
A couple of months after my vaccine my finger seemed to have pulled back and locked into an pulled back  position without me being able to control it. I have begun to have clicking in my jaw as well, as well as balance issues as well. I have also been having some memory issues as well, when I went to work I was trying to do my routine work however I just kind of went blank and couldn't figure out what I was supposed to be doing. I have been having some memory with issues and I seem to have to look at the address a few times and my short term memory seems to be decreased significantly. For my finger the symptoms have resolved. I get an occasional cramp in my right leg that is very new. Receiving treatment for cancer at this point as well. I feel that I have been getting better in regards to my symptoms and some have been improving.
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. On or about 09-MAY-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and 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 10-MAR-2016, the patient was treated at a Dermatology facility for the onset of a severe painful rash diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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, pain and suffering, and other damages. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.39 years.  Concomitant products were not provided.  On 30-Mar-2021, the vaccine with batch number 030B21A was moved to fridge. On 03-Apr-2021, vials were moved to the clinic. On 03-Apr-2021 at 9 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. 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 brand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received flu vaccine at 0945 am , left the vaccine clinic, returned at 1220 pm with complains of generalize itching and hives to Left upper extremity (from site of vaccine- deltoid to the hand). Rash also noted on the right upper extremity, behind both knees. No swelling of the mouth,, no wheezing,  no difficulty  breathing or  swallowing difficulties. Patient alert oriented x3. Patient was treated with  Benadryl 50 mg PO x1 and EMS called. Patient was accessed and no indication to transport to ED.  Symptoms resolved an hour after patient received treatment.
Ongoing chronic constipation. Has not been able to poop unassisted for weeks after vaccine.
p/vax pt got dizzy, pale & fell back,losing consciousness for 15 sec. w/few spastic tremors. BP 110/70, HR 120 reg;
Information has been received from a physician concerning a 17 year old female patient with no known drug allergies or pertinent medical history who about two years ago (in approximately 2008) completed the vaccination with the series of GARDASIL (Lot number not provided). On 25-MAR-2010 the patient had a papanicolaou test (PAP) that was positive for human papillomavirus (HPV). At the time of the report the patient's outcome was unknown. The patient sought medical attention by an office visit. Additional information has been requested.
I believe I had a delayed reaction to the COVID-19 vaccine that appeared three weeks after my second dose. My lips swelled up rather severely and were burning and very itchy. When I first went to the doctor, we concluded it was a contact dermatitis reaction to some spicy wings I ate. However, the problem persisted for almost five days and started to get worse, which (I'm told) is very unlikely for a food allergy. I ended up going to another primary doctor the next day and she is the one who ended up prescribing an oral steroid and topical steroid. That finally took care of the issue. I would have reported this through VAERS sooner, but was not aware of it. A few days after I started the steroid, I happened to have a dermatology appointment, and my dermatologist said she was aware of delayed reactions tied to vaccines and believed I had angioedema from the COVID-19 vaccine.
Fever, muscle aches, pain behind right thigh, fatigue, soreness at left arm.
I started to feel very weak around 8:30 pm the night of the shot. I went to bed to wake up at 3 am in  chills and panic. My body was on fire. My husband got up and took my temperature which was 103.9! He gave me Tylenol which i also took right before going to bed. I woke up again at 7 am with 103.3. With another dose of Tylenol and Advil, the whole day my fever would not break. It remained at 102.8. The following night i woke the same way with 102.9. Today is the third day and still woke up with a fever and severe body aches and headache.
Idiopathic Thromocytopenia..... first signs: longer periods, excessive bruising.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with PEDVAXHIB (dose, lot number and frequency was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of the several reports received from the same source. No further information provided. Additional information has been requested.
16 month old was given 2 doses of Hib. He was given ACTHIB when he already got a dose of PENTACEL (with no reported adverse event); Initial information received on 16-May-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 16 months old male patient who was given 2 doses of hib he was given acthib when he already got a dose of pentacel (with no reported adverse event) while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) and hib vaccine conj (tet tox) (Acthib) for prophylactic vaccination.  On 16-May-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] (lot UJ641AA and expiry date 28-Feb-2023 via intramuscular route in the right thigh) (strength, formulation: unknown) for immunization.  On 16-May-2022 the patient developed a non-serious event "16-month-old was given 2 doses of hib. he was given acthib when he already got a dose of pentacel (with no reported adverse event) (extra dose administered) same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel]."  Action taken: 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.
Patient states he got the vaccine and one hour later he felt like someone had hit him in the chest. States he had shortness of breath and heart flutters. He has had them for the last 2 weeks.
11x11 cm swelling w/ erythema and warmth. Itchy but not very sore until after exam. No streaking, no firm edge. Ice, Ibuprofen.
headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient receive first dose of bnt162b2 (lot number: EL3249, Pfizer), via an unspecified route of administration in right arm (shoulder) on 16Jan2021 06:30 at single dose for covid-19 immunization. Medical history included hypertension, gout, BP (blood pressure) abnormal, blood cholesterol abnormal all from an unknown date and unknown if ongoing. Concomitant medication included daily losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced headache, 10 hours later symptoms of fatigue and bell's palsy on 16Jan2021 16:00 about 10 hours after vaccination. Therapeutic measures were taken as a result of events. He was prescribed Prednisone 6 tabs PO (per oral) for 5 days, tapering down 1 tab daily. B12 Shot in 19Jan2021. He had an MRI (magnetic resonance imaging) appointment on 20Jan2021. His BP and cholesterol are both under control. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. No additional vaccines administered on same date of the Pfizer suspect. The adverse event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Family Medical History included: Mother died of cancer in the early 90s. Dad died of heart failure in the early 80s. The outcome of events was not resolved.
Fever (up to 102 F), chills, body aches, weakness, headache
MILD PAIN IN THE ANKLE AND BELOW RIGHT ANKLE ON AND OFF; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety disorder. 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 09-MAY-2021 14:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021, the subject experienced sore arm. On 10-MAY-2021, the subject experienced mild pain in the ankle and below right ankle on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from mild pain in the ankle and below right ankle on and off. This report was non-serious.
Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced COVID-19 (Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.). At the time of the report, COVID-19 (Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.  Company comment: This spontaneous case concerns patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious (AESI) event of COVID-19 (AESI) after mRNA- 1273 vaccine. The event occurred approximately 6 months after the second dose of mRNA- 1273 vaccine. It was reported that the patient was fully vaccinated, but schedule of vaccination was not disclosed, thus vaccination failure is not assessable. Very limited information is available regarding clinical course and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious (AESI) event of COVID-19 (AESI) after mRNA- 1273 vaccine. The event occurred approximately 6 months after the second dose of mRNA- 1273 vaccine. It was reported that the patient was fully vaccinated, but schedule of vaccination was not disclosed, thus vaccination failure is not assessable. Very limited information is available regarding clinical course and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Patient complained about Right arm weakness after HPV injection. Patient completed electronic medical self-triage questionnaire; advice outcome of questionnaire was to call the ambulance. Patient had a video visit with MD on 05/24/2023, then had an in person visit with an MD to follow on 05/24/23, outcome of in person visit was a referral to Neurology.
Patient fainted after receiving the vaccine and regained consciousness after 30 seconds. She was sitting and was laid down in the counseling room with her feet elevated for approximately 10 minutes. She was given food and water and moved to the sitting area where a ride came to pick her up.
Pneumonia; Did not get second dose within 36 days; Tested positive for COVID-19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after 1st dose). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose within 36 days). At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 after 1st dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose within 36 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Based on the mechanism of action of mRNA-1273, a causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. The COVID-19 infection could be a possible confounding factor for the event of Pneumonia. Very limited information regarding the pneumonia event  and hospitalization have been provided. No further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-Jun-2021 and had significant information. Updated event Pneumonia.Case Upgraded to serious.; Sender's Comments: Based on the mechanism of action of mRNA-1273, a causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. The COVID-19 infection could be a possible confounding factor for the event of Pneumonia. Very limited information regarding the pneumonia event  and hospitalization have been provided. No further information is expected.
This spontaneous report as received from a Medical assistant referring to unspecified patients of unknown genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of M-M-R II Lot number reported as "M039202" with expiration date on 05-JUL-2018 (strength and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 22 grades F (Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions for vaccines. The temperature excursion was recorded by a data logger. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006986: US-009507513-1703USA006936: US-009507513-1703USA006983: US-009507513-1703USA006984.
This spontaneous report as received from a consumer refers to an unspecified friend of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced shingles. The outcome of shingles was unknown. The relationship between event was unknown. Additional information is not expected.
Started feeling ill the evening after receiving the seasonal flu shot.  Was sick in bed from Mon.-Fri.  Was too weak to dress until the 22nd of Oct.  Was sick to stomach and had a severe headache.  Said the headache moved around her head.  Stated that one baby aspirin usually would relieve her headaches but that week she took a whole bottle.
Booster; delirious; high fever; shakes; massive joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 09:30 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient did not receive any other medications within two weeks and not receive any other vaccine within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: Unknown. Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2 Batch/Lot No: Unknown.), administration date: 26Apr2021, when the patient was 38 years old, for COVID-19 Immunization, reaction(s): violently sick with high fever, shakes, and delirious. lasted several days. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 09:30, outcome "unknown", described as "Booster"; DELIRIUM (medically significant) with onset Dec2021, outcome "unknown", described as "delirious"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "high fever"; TREMOR (non-serious) with onset Dec2021, outcome "unknown", described as "shakes"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "massive joint pain". The patient underwent the following laboratory tests and procedures: body temperature: (2021) high, notes: After 2nd vaccine; (Dec2021) high. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.