chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little more than 24hr after the vaccine patient developed a red 'rash' at the injection site that spread up and down the arm.  No pain, no itch, no vesicles, no pustules, no swelling.  Just red and warm to the touch.  Mom called the after-hours triage line for advice.  Mom applied hydrocortisone cream.  She reported the occurrence to our office the next day.  The redness was resolved in 2 or 3 days.  No medical care needed.  No other visits needed.
Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine.  However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
The patient presents with BRUE (brief resolved  unexplained event).  The onset was around 11:30pm.  The degree at onset was moderate.  The course of symptom(s) is Improving.  Presently, the degree of symptom(s) is improving .  4 mo old  female born at 37 weeks presents to ED to role out BRUE. Aunt (who is at bedside) reports patient was lying in her arms, not feeding nor crying, and suddenly started to choke/gasp for air. Aunt reports cyanosis in between the eyebrows. She reports patients hands and feet went cold. Aunt reports patient then began to lose muscle tone for about 5-10 minutes. Aunt began CPR on patient and patient was slow to respond, then woke up and was crying and fussy. Mother reports patient is at baseline after episode. She reports that patient got two vaccinations today. She reports intermittent diarrhea and cough for the past few days. Denies vomiting, diarrhea, or rashes. .
This patient presented to the pharmacy for vaccination and led the pharmacy team to believe that this was the first vaccine in an attempt to receive a third shot which would act as a booster. this is less than 6 months after completing the vaccine series. This was discovered after the patient's friend showed up at the pharmacy requesting booster dose
Received flu vaccine on Oct. 5.  Awoke next day with severe neck pains.  Pain worsened making it difficult to lay head down on pillow or raise head.  On Oct. 15 went to Urgent Care.  Received pain med. & muscle relax. and referred to own doctor.  Saw Dr. on Oct 18, who conferred with a neurologist re: possibility of GBS.  Warned to to watch for numbing, tingling or weakness of extremities.  Provided 3 Celebrex.  Awoke Oct 19 soaking wet with sweat, but much less neck pain.  Continued slow improvement after that date.  Fine now.
Pt received Pfizer Bivalent vaccine as dose #3, it should have been a Moderna Booster.
Left leg swollen with hives, 103 temperature.  Mom says child cried for 1 hour, could not walk on leg. Child started vomiting at the Hospital.  Child was given Benadryl, Motrin and phenergan.  Mom reports child developed a cough and diarrhea at ER.  Mom says child still has a little diarrhea today.
Patient was in no harm. Pt was given the liquid suspension only. Pt did NOT receive the lyophilized powder.
Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released from agency until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  Had already received earlier dose of Pfizer mRNA vaccine.
Pain at skull base and vertigo almost immediately after injection. Muscle and joint pain for 36 Hours after injection. Vertigo continued, on and off for 48 hours after injection. Confusion (brain fog) for 48 hours after injection. Low ow grade fever (99.1 with no touch thermometer) for approx. 72 hours after injection.
Patient called pharmacy on 11-7-17 concerned that her arm still hurt from the flu shot she got on 9/26/17.
Wheal and Flare reaction at injection site (L) deltoid after vaccination. Listed below -encompassed both injection site.
8 days after vaccine the injection site is red, itchy, sore and hot to the touch
The patient received a Pfizer Bivalent booster on 12/14/2022, but did not complete a series.  The patient received a monovalent on 10/26/21 but did not receive his second dose.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 10-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and the time of excursion was 0.55 C for 584 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
At 24 hrs, erythema, edema, pain surrounding site. Temp 100.8 oral. Well-appearing child but markedly swollen arm/shoulder.
Received # ANTHRAX vaccines in 1998 and 1999. Developed breast cancer in 2008 and oncologist said he could not be 100% sure that the ANTHRAX vaccine did not cause the cancer so she should avoid it. Has not felt as well since receiving the ANTHRAX vaccines as before she received them.
Increased temp 104.5 - was seen by Dr. in ER. Increased temp because of vaccines or possible ear infection. Alternate TYLENOL and Ibuprofen. Start antibiotic on Monday if needed (3/23/15).
No ADR Patient had no history of COVID-19 vaccination. Was supposed to receive a monovalent dose for his first primary series dose but inadvertently received the bivalent booster dose.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. The nurse reported that since June 2014, on unspecified dates of 2014, unknown dose of (Oka/Merck) VARIVAX (lot#, dose, route and frequency were not provided) were administered after being improperly stored to unknown number of patients. No adverse effects were reported. Additional information has been requested.
Complained of generalized itchiness and rashes at the back and rashes on L anterior leg.  Seen his primary MD and Rx with hydrocortisone
Moderna shot at 5:30 pm on 3/14/2021.  3/15/2021 Body aches started, even nail beds hurt unable to sleep, difficulty breathing, cough.  Took 2 Extra Strength Tylenol at 4 pm, 10 pm and 3/16/21 at 5:30 AM.
Dry cough, extreme sensitivity to chill, sore throat, itchy eyes, fatigue.
Gave my mother A-Fib. Now she's dead.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (death), outcome "fatal", described as "Gave my mother A-Fib. Now she's dead.". The patient date of death was unknown. Reported cause of death: "gave my mother A-Fib. Now she's dead.''  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Gave my mother A-Fib. Now she's dead.
Pt was accompanied by parent.  Parent consented she receive the vaccine.  Patient was 15 years and 3 months old - younger than approved age of 16 yo or older.
Patient developed a Shingles outbreak on the right side of her abdomen on 3/27, one day after receiving her second dose of the Pfizer/BioNTech vaccine.
Left arm got very hot; red; Swollen; Itchy; The circumference is about 2-3 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches). At the time of the report, VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches). At the time of the report, VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Patient was given vaccination at 10:06 she began to get pale and diaphoretic she was lowered to the floor.   She was taken to med obs 2 via wheelchair. 10:15  hr 63 bp 82/39 oxygen 97%.   10:20 hr 76 bp 119/69 oxygen sats 98% room air.   she was given water and she felt better.  10:26 bp 112/ 70 hr 76 pt taken to exit with friend via wheelchair and was released 10:31
Patient came into the pharmacy and asked for her second Moderna shot. We were having a conversation about her broken foot and I did not double check the date of her first  shot then gave her the second shot after 19 days instead of 28
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L006383, expiration date 25-FEB-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information had been requested.
On Friday afternoon patient noticed a rash developing on back right arm it was itchy and swollen. Patient also describes it as "hard" where vaccine was given on right side of face back hip. Patients hives have improved and rash on arm reducing and less swollen.
pneumonia; Sepsis; CMV virus and a lot others; he never got second shot; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia), SEPSIS (Sepsis) and CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization prolonged), SEPSIS (Sepsis) (seriousness criteria hospitalization prolonged and medically significant), CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (he never got second shot). The patient was hospitalized on 04-Mar-2021 due to CYTOMEGALOVIRUS INFECTION, PNEUMONIA and SEPSIS. At the time of the report, PNEUMONIA (pneumonia), SEPSIS (Sepsis) and CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (he never got second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. No treatment information was provided. The patient was coming back home on next Wednesday 2-Jun-2021.The patient was a part of a clinical trial which went completely wrong. The patient had number of diagnose like pneumonia, sepsis, CMV virus and a lot others.  Based on current available information and the temporal association between product use, the start date of the events and the evaluation by HCP's the events of Pneumonia, Sepsis and Cytomegalic virus infection is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use, the start date of the events and the evaluation by HCP's the events of Pneumonia, Sepsis and Cytomegalic virus infection is unlikely.
Blisters outbreak under left arm and left side of trunk. Medication- Acyclovir 800 mg tablets ; Gabapentin 100 mg capsules  5 times daily for 8 days. Tramadol 50 mg tablets take 1 to 2 tablets every 6 hours as needed.
Got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-DEC-2022 This case was reported by a consumer via  interactive digital media. The reporter stated that he/she knew a patient who got the shingles vaccine and then developed shingles shortly thereafter. The follow up would not possible as no contact details were available. The case had been linked to US2022AMR200904, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR200904:Same reporter. Patient 1.
J&J Dose 3/15/21 Covid Positive 1/21/22  1/21/22: An 88-year-old lady presented to the emergency room with history of increasing weakness as noted by daughter.  The patient is a poor historian.  Her daughter said that she has been having difficulty ambulating by herself and had to be helped to get out of the car by the nursing staff and brought to the emergency room by wheelchair.  The patient was just recently treated for UTI.  She denies chest pain. Reports fatigue. She denies fever.  1/25/22: Patient is an 88-year-old female who presented to the emergency department due to worsening weakness, admitted for acute renal failure, UTI, and metabolic encephalopathy.  Patient tested positive for COVID-19 however with no concern of pneumonia, she was saturating well on room air throughout hospitalization with no respiratory distress.  Started on levofloxacin renally dosed which covered for UTI.  She had significantly elevated liver enzymes and alkaline phosphatase for which she underwent HIDA scan which came back negative, she underwent MRCP that showed multiple areas of stenosis in common bile duct dilation, GI consulted who recommended close follow-up in 3 weeks as an outpatient basis.  Kidney function normalized, hyperkalemia resolved, patient was tolerating oral intake and was stable for discharge.  PT/OT evaluation and recommendations were to discharge to skilled nursing facility however family want to take the patient home.
Severe fatigue, upper abdominal pain, back pain, frequent urination, dark colored urine, lightheadedness, weakness.
3SEP97 to ER w/lt arm pain & swelling below the inj site;ER questioned insect bites as cause;pt does not remember Td shot-poor historian d/t alzheimer's dementia;ATB given for cellulitis;rash worsened;c/o itching;20SEP arm red w/warmth
At 6:30 PM on 8-8-18 started to vomit for 4 hrs. Bad sweating, chest pain. I didn't plan on taking part 2, of shingles shot. Was sick for almost 2 weeks. Seen at clinic, and urgent care. I spent more money in Co-Pays to get checked out and to have ZOFRAN. For almost 2 wks. could only drink a little, and eat very little. Had to take ZOFRAN 3 x day to be able to do that.
pt recv vax & does have erythema @ the site today of approx 11cm x 11cm;this is very minimal edema but there is a mild amount of erythema;impression: local site rxn to pneumococcal vax;pt to recv DPH;arm felt swollen 15APR98 evening;
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with M-M-R-II (Lot# M008588, expiry date: 16-FEB-2018, Lot# L041457, expiry date: 22-OCT-2017) (route: subcutaneous) following a temperature excursion of 51F for 24 hours. No adverse effects were reported in any patients. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Persistent daily  itchiness and little bumps on feet,  legs, hands, forearms. Started within 24 hrs of first vaccine dose, and still ongoing 8 wks later. Itchiness and bumps started  on tops of feet, and then  gradually progressed over the next few days to include ankles, lower legs, and  over the next few weeks eventually thighs, and even hands and forearms. No visible redness/rash, just micro bumps. Periods of insatiable itchiness daily.
Fussy through the night and awoke with a 100 degree temperature (taken with digital thermometer underarm).
Severe menstral pain although I was not actively on my menstral cycle.  Ended period on 03/11/2021 and started heavy brown clot like bleeding one day after second dose on 03/19/2021. After second cycle one month later in April, have severe severe cramping and menstral pain.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose (incorrect product storage) of GARDASIL (lot # K010215, expiration date 05-MAY-2017) (dose, frequency, route of administration and anatomical location were not reported). There was no concomitant medication reported. No adverse effect or product quality issue were reported. Additional information has been requested.