chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; I had a rash/really big rash on my behind; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry Date: Unknown) via an unspecified route of administration, administered in Left arm on 12May2021 (at the age of 57-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient stated he got his second dose yesterday and stated that "I started experiencing the itching after I got it and when I woke up this morning I had a rash, really big rash on my behind" on an unspecified date in 2021. Outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Injection site swelling, rash, hot to the touch.  Body aches, sore muscles, head ache body chills
Case number PHEH2013US022307, is an initial spontaneous report received from the pharmacist on 22 Oct 2013. This report refers to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with expired seasonal influenza vaccine (unknown manufacturer, batch number: not reported, expiry date: Jun 2013) intramuscularly on an unspecified date. The physician was not sure of the identity of the flu vaccine and the size of the multi dose vial (1 ml vial or 10 ml vial). No adverse event reported following this maladministration (expired vaccine used).
Narrative:  75 yo with PROBLEM LIST: Glaucoma Hypertension Hyperlipidemia Diabetes Type II with neuropathy Tobacco use/smoker COPD Neoplasm of uncertain behavior of adrenal gland H/O prostate cancer died on 9/15/2021. pt received most of his care outside agency so little information available of circumstances of pt death. Pt receive one covid vaccine (J&J) on 3/30/21 from outside agency. Likely this death is not related to the covid vaccine given pt's age, comorbidities & long time span between date of death & covid vaccine.
Sore arm; Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL3247) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 Immunisation. Medical history included hypertension. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included BENICAR, SINGULAIR and multivitamins/multiminerals, these medications were used within two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 at 13:15 as a single dose for COVID-19 Immunisation. The patient experienced sore arm and headache on 17Mar2021 at 18:00. Therapeutic measures were taken as a result of sore arm and headache and included treatment with TYLENOL for headache and used ice on arm. The clinical outcome of the headache and arm in pain was recovering.   No follow-up attempts are needed. No further information is expected.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022 at 5:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Feb-2022 at 5:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 15-Feb-2022 at 17:17:01  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
RASH; This spontaneous report received from a consumer 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210846321.
Mouth rash on inside of cheeks and sometimes tongue. I have not sought treatment for it but appears to be very similar to descriptions/images of oral lichen planus. It is ongoing as of this report.
I had a hard lump in my arm that was very red that spread about 4-5 inches. It itches and burns and is swollen.
Redness, swelling, itching at injection site. Went to an ER where antihistamine was administered.
Information has been received from a nurse practitioner concerning a 71 year old female who on 11-MAR-2008 at 15:30 was vaccinated SC in the arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck). The patient phoned the physician's office stating that on 11-MAR-2008, she developed a large, red, hard area at the injection site on the arm. She was treated with BENADRYL and recovered on an unspecified date. A product quality complaint was not involved. Additional information has been received from the nurse who reported that the redness and firmness at the injection site started on 12-MAR-2008. The area was approximately 12 cm by 7 cm. The redness resolved on its own. The patient recovered on 13-MAR-2008. No further information is expected.
The certified medical assistant (CMA) reported that the following improperly stored doses of vaccines were administered to 4 patients on unspecified dates: 4 doses of RECOMBIVAX HB (dose, route, lot# not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 18Apr2021 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included dysautonomia. The patient was allergic to many antibiotics and metals. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), melatonin (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC), levocetirizine dihydrochloride (XYZAL) and ciclosporin (RESTASIS), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 12:30, the patient experienced uncontrollable bloody nose. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event uncontrollable bloody nose was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
hives/rash @ injection sites and on chest.  Given 25mg BENADRYL po.
Vaccination administered on 3/19 @ 0911 AM. First mention of any issues in the MR was on 3/21 @ 1519 by hospitalist progress note: skin reaction noted to PNEUMOVAX, ID on board starting daptomycin 3/21 @ 0929 - infectious disease - fever, likely from cellulitis of the right shoulder, area of pneumoniac shot. Will DC levofloxacin and start daptomycin. 3/22 @ 1020 (Gen Med) - cellulistis and blister of the right shoulder, area of pneumonia shot, plan will cont. daptomycin. Pt. did not tolerate cold compresses 3/24 @ 1245 - (ID) continue current ATB's, consider kerlix and ace wrap of the right upper extremity. 3/25 @ 1041 - (ID) continue current ATB's, get ultrasound of the right shoulder/arm. 3/26 @ 1637 - (Gen Med) Us 1. no abscess formation at the area of abnormality in the proximal right upper extremity. 2. Diffuse subcutaneous edema and skin thickening is suggestive of cellulitis, continue on daptomycin per ID. Patient readmitted 4/11 from the infusion center getting levaquin and as she was not feeling well. Received dakins packing BID and ATB, improvement noted. 4/15 (ID)- -ready to discharge, continue dakins. FU in 2 weeks and augmentin therapy PO at home. Patient feeling better. 3/22 @ 1653 - (ID) okay with cold compress on the area of right shoulder.
Information was received from a physician regarding a 9 year old female child who was prescribed Pneumovax but received Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) inadvertently. In addition, the child may have received the drug subcutaneously instead of intramuscularly. The child experienced swelling, heat and redness in a 4 inch area at the injection site of the right deltoid. At 9 years of age, the child received a dose on 10/24/2005. The patients concurrent illness includes seasonal allergies. Indication for Prevnar was immunisation. Product was administered on 10/24/2005. Dose regimen was 1 dose. Concomitant therapy included Zyrtec (cetirizine Hydrochloride). On 10/24/2005, the child was prescribed Pneumovax but received Prevnar inadvertently (wrong drug administered) and may have received the drug subcutaneously instead of intramuscularly (incorrect route of drug administration). The child experienced swelling, heat and redness in a 4 inch area at the injection site of the right deltoid (injection site swelling), (injection site warmth), (injection site erythema), beginning the evening of the injection. She did not receive any other injections. The patient was rechecked two days later and the swelling was much improved. The physician reported that the child had recovered.
pt recv vax & returned w/in 30min w/redness in the face & itching all over & cough;
extreme vomiting beginning 25 mar. ending 28 mar. ;extreme pain in abdomen;inability to keep down food and fluids; inability to sleep; fever;chills; severe dehydration; inability to think clearly
Information has been received from a physician concerning a white male who, on an undisclosed date, was vaccinated with a second dose of MMR II, manufactured with HSA.  At the time of the report, 09-MAY-2008, there were no concomitant medications and there was no illness at the time of the second vaccination that was administered in 24-MAR-2008 in the AM.  It was noted that the mother reported that the patient developed (unspecified) sudden behavior problems.  It was noted that the physician was contacted, but it unknown if medical attention was sought.  There was no product quality complaint.  No laboratory/diagnostic studies were performed.  At the time of reporting the patient had not yet recovered.  Follow up information was received from a physician who reported that the behavioral changes were outbursts of rage that began one week after receiving MMR II.  At the time of reporting the patient had not yet recovered.  Follow up information was received from the physician concerning a 20 month old male with no prior medical history, drug reactions or allergies.  It was noted that the patient experienced sudden behavior changes at 20 months of age following vaccination with the first dose of MMR II, manufactured with HSA, and administered on 17-AUG-2004.   Also, an episode of sudden bursts of anger/ rage occurred on approximately 31-MAR-2008, 7 days after the patient received a second dose, subcutaneously into the left arm, of MMR II (lot # 659540/1745U).  It was noted that during that episode the patient was running out of control, sweating, and had no eye contact.  When the mother tried to hold the patient down, the patient fought, would bite, cried hysterically and said vicious words.  It was noted that there were similar reports of rage - at least 8 times.  On 2 MAY 2008 the mother reported that the events were 90% less intense, and that she can talk to the patient and that he calms down sooner.  It was noted that prior to the onset of rage (NOS), the patient complained that he could not move his head, and his arms and legs hurt.  Additional information has been requested.
Immediately following vaccination pt experienced pain in left upper arm. Pain most severe first 3 days after vaccine, then diminished to a chronic ache which is constant since then.  Saw physician 2-5-04, x-ray showed no abnormality.  Took Ibuprofen 400 mg TID with some relief. Saw MD again 2-12-04 and reports pain recurs without Ibuprofen.  Plan physical therapy appt for evaluation.
red, swollen circular area at the injection site. skin hot to touch and currently bruised. it has been like this since the day in injection (7 days now). she has taken Tylenol as needed to help with the pain and swelling
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patient were vaccinated with improperly stored VAQTA lot # L039659 expiry date of 15-MAR-2017 and L015460 expiry date 20-JUL-2017,. On 09-FEB-2016 and 13-FEB-2016 the VAQTA, was exposed to a lowest temperature of +1.0 degree centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, VAQTA, was exposed to a lowest temperature of +1.2 degree centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, VAQTA, was exposed temperature of +1.3 degree centigrade for 21 minutes. On 15-FEB-2016, VAQTA, was exposed to a lowest temperature of +1.1 degree centigrade for 25 minutes. On 17-FEB-2016, VAQTA, was exposed temperature of + 0.0 degree centigrade duration not reported. On 18-FEB-2016 VAQTA, was exposed to a lowest temperature of -1.0 degree centigrade for 12 hours 29 minutes. On 19-FEB-2016 VAQTA, was exposed to a lowest temperature of -1-1 degree centigrade for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored VAQTA, lot # L015460 with an expiry date of 20-JUL-2017. Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Itching , redness and swelling with 8.0 x 6.5 cm round ring with an erythematous bumpy border , right side axillary lymphadenopathy - occurred approx 1/14 (7 days post vaccination) still current and not currently treating
Large Local swelling @ injection site, fever later that day lasting 3 days, chills, muscle spasms 30 hours after injection, lasting 24 hours and no appetite.
COVID-19; cough; fatigue; headache; muscle and body aches; fever of 102.7° F; His arm where he gave shot was a little sore; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021. The most recent information was received on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), COUGH (cough), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle and body aches) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced COUGH (cough), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle and body aches), PYREXIA (fever of 102.7° F) and VACCINATION SITE PAIN (His arm where he gave shot was a little sore). On 02-Jan-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 400 mg and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, COVID-19 (COVID-19), COUGH (cough), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle and body aches), PYREXIA (fever of 102.7° F) and VACCINATION SITE PAIN (His arm where he gave shot was a little sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Body temperature: 102.7 (High) 102.7F temperature. On 02-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-209796 .   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded with the events other than COVID-19 infection.  COVID-19 infection is unlikely related to the product.
at 4am started with nausea, then when got up to vomit, ran into wall with confusion.  Then, went to get nausea medication and next thing woke up on the floor-passed out.  Screamed for help when woke up; husband came in, could not get up, sweating profusely.  After, about 10 mins on the floor, husband helped up. Went to bathroom and had severe diarrhea; then helped to bed and took nausea pill. Then, vomited about 4 times; then had diarrhea on the bathroom floor and had a swollen tongue at this point. Then 8am, gave another nausea pill and had fever and chills till noon. At noon, was able to hold down a cracker and lethargic until Thursday at 3pm.
pt devel chest pains & SOB 24hr p/vax;pt reportedly had no chronic hlth problems, no hx of CHD, no prev hx of chest pains;EKG was non specific;ISO enzymes negative;however a global systolic dysfunction dx via cardiac echo;dx myocarditis
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 1/7/2023 LEFT FOOT BLISTER, W INFECTION, INIT
Developed a DVT related to the administration of the covid-19 vaccine or the ingredients of the vaccine
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 17-JUL-2009, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider at a physician's office 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. 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date the patient was received a booster dose of RECOMBIVAX HB (lot#, expiry date, dose, strength and route unspecified) after presumed exposure to hepatitis B virus from a razor blade cut. The patient with exposure had completed hepatitis B series (name and manufacturer of vaccine unspecified but RECOMBIVAX HB could not be ruled out) on unspecified date in the past. No adverse effects reported. No PQC involved. Additional information is not expected as contact with physician was not allowed.
Nausea, chills, diarrhea, elevated temperature (99 degrees F as opposed to normal basal body temp of 97 degrees F) developed overnight following the vaccine and resolved after 24 hours. Swollen and painful arm at injection site developed a few hours after vaccination and resolved after 3 days. Redness, pain, swelling of vulva developed the day after vaccination and got worse over the next few days. Am treating with prescribed hydrocortisone cream.
Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of the several reports from the same reporter. Additional information has been requested.