chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling; Hot to touch; Black and blue and redness right below injection site/redness had increased; Black and blue and redness right below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Black and blue and redness right below injection site), SWELLING (Swelling), SKIN WARM (Hot to touch) and VACCINATION SITE ERYTHEMA (Black and blue and redness right below injection site/redness had increased) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014121A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Black and blue and redness right below injection site) and VACCINATION SITE ERYTHEMA (Black and blue and redness right below injection site/redness had increased). On 10-Mar-2021, the patient experienced SWELLING (Swelling) and SKIN WARM (Hot to touch). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (Black and blue and redness right below injection site), SWELLING (Swelling), SKIN WARM (Hot to touch) and VACCINATION SITE ERYTHEMA (Black and blue and redness right below injection site/redness had increased) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Day 1: Initially left arm soreness around the site About 4 hours later I developed generalized body aches/felt foggy  Day 2: Left arm soreness
Initial solicited report received on 18 January 2017 from an investigator participating in the below-mentioned study. This is a prospective pregnancy registry case. This case involves a female subject (age not reported) who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was not reported. The mother and father's health status was not reported. The father's age was not reported. The current pregnancy history was not reported. Previous pregnancy details were not reported. The subject's maternal drug exposure details were not reported. The subject received a dose of FLUZONE QIV on an unknown date (route and site of administration and batch number not reported). The subject's treatment for infertility, family history of congenital abnormality details was not reported. The subject had serious adverse event miscarriage. Pregnancy complications were not reported. Prenatal testing details were not reported. The pregnancy outcome was reported as the subject had miscarriage. The outcome of the event miscarriage was not reported. List of documents held by sender: none. Sender's Comments: A pregnant female subject received a dose of study vaccine (information regarding LMP, date of conception, EDD or USG findings were unknown). The subject had a miscarriage (unknown latency) after receiving the study product. Based on limited available information, the sponsor assesses the event as not related to study product or trial procedure.
21MAR95 pt's mom called pt exp fever of 102-103; recently saw PMD for episode of asthma; mom concerned fever may be related to MMR recv on 15MAR95; instructed to call PMD; 22MAR95 tc to mom called MD; poss related to MMR also has coryza;
This spontaneous report was received from a physician refers to a 4 year old patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-AUG-2016, the patient was supposed to be vaccinated with a dose of PROQUAD and KINRIX (lot #, expiry date, dose, strength, dose number, vaccination site, route not provided). However, the nurse grabbed wrong tray of vaccines and the patient was inadvertently administered with a dose of GARDASIL 9 and a third dose of VAQTA on 17-AUG-2016 (lot #, expiry date, dose, strength, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
dizziness, taste in mouth taste like poison or chemical, sensitive to smells and cough with dehydration feeling.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), on 29Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "hyperlipidemia" (unspecified if ongoing); "OSA on CPAP" (unspecified if ongoing), notes: Other medical history: OSA on CPAP; "OSA on CPAP" (unspecified if ongoing), notes: Other medical history: OSA on CPAP; "depression" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: JUNEL; VIIBRYD; BUPROPION; LIOTHYRONINE; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: COVID 19 Treatment; (07Aug2022) negative, notes: symptoms had resolved; (10Aug2022) negative, notes: symptoms returned; (12Aug2022) positive, notes: symptoms worsened. It was reported that the patient completed 5-day course of Paxlovid on 07Aug2022 - symptoms had resolved and tested negative for COVID - Symptoms returned on 10Aug2022 and she tested negative again, symptoms worsened and she tested positive on 12Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
This spontaneous report was received from a licensed vocational nurse and refers to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot number L036831, expiry date 24-SEP-2017; L039092, expiry date 06-OCT-2017 and L044526, expiry date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature between -26 degrees Celsius and -14 degrees Celsius, for 48 hours. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Patient received 2 vaccines at her doctor's office. Later in the day the patient noticed that her right armpit felt swollen. There was some redness around the injection as well. The day after (when patient came in), she still felt some underarm swelling but it had gone down. (Speculated swollen lymph nodes from the vaccine).
Large red hot spot injection site and arm very sore. Slept more, fatigue two days. Syncopal episode and fall 11-11-05 with facial injuries. Had never had episode like this before.
Headache, Diarrhea, NauseaVomiting, General symptoms: Chills, fever, headaches, joint pains, muscle pains, fatigue, nausea, diarrhea, rash swollen glands.  Narrative:
sx: headache the day after vaccination and local pain in the opposite shoulder (right shoulder) from where she was vaccinated (left arm). headache resolved with apap dosing. but rt shoulder pain/tightness has persisted on and off for the last 9days. pt said she is not using apap on regular basis. and also admitted to doing light gardening during this time.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 02 September 2014. A 42 year-old male subject with a past medical history of high blood pressure, chest pain and psychiatric illness was found with cardiomyopathy 22 days after the subject had received an injection of ACAM2000 (lot number and site of administration not reported) on 26 February 2014, concomitantly with the administration of the following vaccines: Anthrax vaccine, Japanese encephalitis vaccine, Typhoid, ViCPs vaccine, "Meningococcal/Diphtheria" vaccine (manufacturers, lot numbers, routes and sites of administration not reported) on the same date. On 20 March 2014, he was diagnosed with cardiomyopathy ("other primary cardiomyopathies"). ECG was performed on 21 March 2014 and results were normal. Troponin I levels were not performed. No other laboratory test results were provided. It was not reported whether the patient had received any corrective treatment. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Additional information will be requested from the investigator.
Starting the evening of 1/11/19 he states he felt extremely tired and took 3 naps on 1/12, "horrendous" upper body joint pain started on 1/11 evening and gone monday, fever of up to 103 F that fluctuated a little bit  and was gone by sunday night, sunday had chin to ankles rash that was eventually all "one pink blanket".
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX, lot number was M006708 and expiration date of 02-JUN-2018 (strength, route of administration and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 10th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that, most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route and administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the case as non-serious.
On 03/18/2021 I had the vaccine and on 3/19/2021 I got very dizzy and passed out and I bruised my ribs on the way down when I fell I felt like I had a stroke because the right side of my face was numb but that may have been from hitting the floor too. I was having breathing problems. I waited a couple of days to see if I could feel better but I was not, so I went to the ER 3 days later. They did a CT scan of my lungs and brain and they found some spots on my lungs, I have to get rechecked in the next couple of days. They also did some blood work and said everything was fine.
I have experienced excruciating pains shooting through my arm where the vaccine was injected for the past 2 days. On the night after the vaccine, I could not sleep because in any way I would lay down the pains would cause my arm to tingle and then the pain was too much. It has been 2 days now and it still hurts to even lift a cup with that arm.
Woke up with severe chilling  and severe muscle aches. Unable to get back to sleep. Also very tired all day.(usually not that tired even with 4 hours sleep.) No appetite. Lasted 24 hours.
Initial unsolicited report received from a consumer on 11-Aug-2017 and additional information received on 14-Aug-2017. This case involves a 70-year-old female patient who was vaccinated with a third intramuscular dose of IMOVAX and intramuscular dose of PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (IMOGAM) on 4-Aug-2017. The patient had a medical history of Bactrim and Psorasis. Concomitant medications was not reported. On 11-Aug-2017, seven days following the vaccination, the patient developed muscle pain in her neck and shoulders, she felt weakness in her legs and arms which is resolved now. The patient was generally exhausted feeling. The patient spoke with her Doctor about if she should take the last 2 vaccines if she is having this discomfort and the bat is now considered to be negative. The patient said her Doctor encouraged her to finish the series but, she is reluctant to take more shots as she has a vacation coming up at the end of the series. Encouraged to have her symptoms physically evaluated by her Doctor. On 11-Aug-2017, seven days following the vaccination, the patient developed redness and swelling of her big toes and she wants us to know she feels much better she decided not to complete the series. She does have some residual stiffness in her neck that is more of a bother than a complaint. The patient required ER visit. Relevant diagnostic tests/laboratory data reported as none. The patient did not received corrective treatment. The patient recovered from event weakness in extremity, had not recovered from event neck stiffness and recovering from other events. List of documents held by sender: none.
Patient experienced a rash which extended greater than three inches.  She also experienced pain in her arm and had trouble moving arm for a few days. Significant improvement was observed by day 5 after vaccine administration.
Patient reported onset of fever, malaise, body aches, fatigue, congestion cough.
Information has been received from a physician concerning an 82 year old female patient living in an assisted living residence who on 1:30PM, 15-AUG-2008 was vaccinated with VARIVAX (Merck) via SC in the left arm (lot# 655065/1142F). The patient had inadvertently received VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to a human error. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Redness, swelling, warm to the touch. Induration measuring 5 cm x 4 cm. Tx cool compress, Motrin and Benadryl as directed.
PERSON WAS ADMITTED TO HOSPITAL ON 12/5/2021 WITH COMPLAINT OF SHORTNESS OF BREATH. DURING HOSPITALIZATION, PERSON HAD ACUTE HYPOXEMIC RESPIRATORY FAILURE WITH PNEUMONIA AS WELL AS NEW ATRIAL FIBRILLATION WITH RVR, SEPTIC SHOCK.
Swelling, itching, pain at injection site for 2 weeks. Has a dark discolored area on posterior left arm at the injection site (Not a bruise). Sterile diluent lot: W032818. Received vaccine due to a negative varicella titer drawn for employee health.
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 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 12:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 12:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.75  Concomitant products were not provided.  On 17-Feb-2021 Excursion time was reported at 09 am with temperature as 22 degrees Fahrenheit respectively , total doses given for the day was unknown, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 05 vials were sent to clinic. Vaccine BUD date was 13-Mar -2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.
sore arm, fatigue, fever (got up to 102.4), headache: sore arm was right away (even with moving arm); fatigue began approximately 3 1/2 hours later; fever noticed at 1:30 am when I was awaken from shivering (12 hours after receiving vaccine) ~ at that time fever was 101.1; by 4 am, fever was at 102.4 and headache started.  Fever stayed at 102.4 for approximately one hour then started coming down.  By 2 pm fever was normal.  Headache continued until I was able to get up and eat something to take Tylenol, went back to sleep right after taking Tylenol; when I woke up, headache was gone (not sure what time this was). FYI: spend most of the day (02/28/2021) sleeping. By Friday morning, felt more normal.  Slight fatigue but nothing to prevent me from doing my normal routine.
Numbness & weakness in arm (left) gave MEDROL & Dosepak and referred to Dr.
Shot was given very high up in arm.  Within 1 hour had severe pain in shoulder and couldn't raise my arm. Can't sleep at night pain is so bad.  Talked to nurse that gave me the shot next morning and she said it would be sore for awhile.  Told her it was pain not sore and I would give it a couple days.  Seen PA on November 12,2019 was still having severe pain and hard time raising my arm. Was put on a Medrol dose. On November 18, 2019 done with steriod and still not better so was referred to and orthopedic doctor. Seen the orthopedic Dr on November 19,2019 and the results were shot was given in the nerve not the muscle! No treatment said it would take time could be weeks or months before pain goes away.  60 days later still have pain and can't raise arm above head.
pt tested positive for COVID on 12/13/21; came to hosp on 12/14/21 in respiratory failure due to COVID; O2 supplementation; given remdesivir, Tocilizumab, Decadron; Pneumonia due to COVID; placed on ECMO, mechanical bilevel ventilation; course of stay was complicated by perforation of ascending aorta with pericardial tamponade requiring repair, shock, seizure, AKI requiring CRRT, hemorrhage; pt's condition worsened; transitioned to comfort care and pt died in the hosp
I had some of the expected side effects: nausea, fatigue, significant muscle pain (it felt like my bones were hurting too), congestion, headache.  I also developed other side effects not listed: the most troublesome that  just recurred with the booster is increased heart rate. For several hours (3-4 hours) I had tachycardia. The other, less bothersome, was pain upon anything touching my skin.
ADVERSE EVENT: POSSIBILITY OF VACCINE STORED IN UNAPPROVED FREEZER. TREATMENT:           NONE OUTCOME:               NO ADVERSE SIGNS OR SYMPTOMS WHATSOEVER
After the first GARDASIL shot, later that night I broke out in cold sweats and experienced heart palpitations. I became extremely fatigued. After the second GARDASIL vaccine given on 7/18/2007, I passed out for the first time in my life in the doctor's office about 10 minutes after receiving the vaccine. I also began feeling even more fatigued and started seeing black upon standing. After the third GARDASIL vaccine administered on 11/27/2007, I felt unable to hold my back up straight and started experiencing terrible G.I. symptoms. I started to have to miss numerous days of school and got sick all of the time.
Vaccination failure; Reports her daughter is "sick as a dog". Really sick; temp as high 100 for couple of days; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue). The patient was treated with IBUPROFEN from 19-Jul-2021 to 22-Jul-2021 at a dose of UNK, as needed. At the time of the report, VACCINATION FAILURE (Vaccination failure), ILLNESS (Reports her daughter is "sick as a dog". Really sick), PYREXIA (temp as high 100 for couple of days) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, Polymerase chain reaction: positive (Positive) source of sample was naso pharyngeal. On 19-Jul-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID on (after being vaccinated). source of sample was naso pharyngeal. On an unknown date, Body temperature: 101.5 (High) duration: 2 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient was symptomatic with allergy like symptoms.  Chills, cough, muscle ache, headache, nasal congestion, loss of taste and loss of smell were reported as symptoms of COVID-19 for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up was received and Patient's race and ethnicity were added. Lab data was updated and the Treatment medication was added.
Woke up about 2:30am with a terrible headache. Her whole body was hot even to touch it. Took 2 Bayer aspirin, which helped. Went to sleep and woke back up with a headache but body was not hot anymore, sleep for several hours. Lost of appetite. Injection sight hard a hard red circle which is hot to the touch and very sore.