chrisvoncsefalvay/vaers-outcomes huggingface dataset:
noticeable bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (noticeable bruise at the injection site) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical history was provided by the Reporter.  Concomitant products included LORATADINE for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (noticeable bruise at the injection site). At the time of the report, CONTUSION (noticeable bruise at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-229987 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up  received on 30-JUN-2021 and Updated secondary Reporter details and patient initials and updated suspect vaccine Lot number and Updated new Concomitant medication details.
Initial report received on 18Jul06. A neonate was exposed to a dose of Menactra, lot number U1767AA, transplacentally on 21Dec05. The product was administered to the subject's mother, a 15 yr old female, who was enrolled in the study. The baby was delivered via vaginal delivery at 41 1/7 wks gestation, 185 days post exposure to the study product. A prenatal ultrasound performed on 14Mar06 was normal. The baby was born to a mother with a history of sexual abuse. The date of her last menstrual period was on 11Sep05. The baby's mother tested positive for chlamydia in Mar 2006. The baby's mother had gonorrhea in April 2005 and had a abnormal pap smear on 16Mar06. During a routine well baby visit at seven days of age, it was noted that the baby had a bump noted near eye yesterday morning. There was no history of trauma per the baby's mother. The baby was diagnosed with a dermoid/epithelial cyst lateral to the right eyebrow. The physician planned to discuss the case with a dermatologist and consider a dermatology referral. At the time of this report, the baby had not been seen by a dermatologist, but does have an appt for evaluation of the dermoid cyst on 31Jul06. The baby was reported to be well during physician visits on 05Jul06 and 19Jul06. The event of dermoid cyst is considered as ongoing. As per the investigator, the event is not related to the study product. The information for the subject's mother is captured in report 200601346.
Fever, ache bones, soreness on Friday 5-25-12; cotton mouth, raw throat, unable to swallow, elevated temperature on Saturday 5-26-12; 5-30-12 Continues with cough, green phlegm, swollen neck, hoarse voice, soreness of bone.
Large local reaction, burning sensation. Substernal chest pressure and lightheadedness x1 hour. See attached Clinical Summary.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Immediately after vaccination given, patient developed a tingling, numb and warm sensation on the right side of her face. Also felt tingling in her lips and began hyperventilating. She took 50mg of diphenhydramine. After a few minutes, tingling sensation in lips and hyperventilation resolved. After 30 minutes, patient still experiencing some facial numbness. She was still able to move the muscles in her face and no drooping was observed. Followed up 6 hours later and still having same sensation.
Information has been received from a nurse practitioner concerning a 45 year old female pt with hypertension NOS and an allergy to Macrodantin who on 09Jul03 was vaccinated SC into the left arm with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (number of previous doses UNK). It was noted that the pt was well at the time of vaccination and did not have any problems with previous vaccinations. It was unknown if the pt received measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) in the past. Concomitant medications include an "unnamed hypertension medication". On 20Jul03 the pt developed non tender swollen lymph glands of the neck (left anterior cervical node). On 21Jul03 a pruritic macular papular, erythematous rash on the neck, arm, chest and abdomen was noted. A slight fever (99.2 degrees F) was also reported. The only treatment the pt received was acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl) as needed. It was noted that the pt had recovered on 24Jul03. Additional information is not expected.
4 hours post vaccination 5 episodes of dizziness followed by nausea lasting about 2 minutes. Patient noticed reaction on 9-4-09. These episodes continued 9-7-09. Frequency change to 2 times a day with only mild dizziness w/ nausea.
pt recvd vax; 28oct abnormal EEG, neurological sxs of persistent h/a preceding onset of flu vax; devel urinary retention & numbness in legs, unable to ambulate; dx transverse myelitis;
Noticed extra fatigue evening after vaccine adminisrered. Fatigue, dizziness,  tremors when I awoke the next morning and increased with time. By 6 am, felt very dizzy, vertigo and as if limbs and head were filling with lead. Felt like I was going to go down so layer on the floor at work.  Coworkers took me to the emergency department. Symptoms ongoing, lost consciousness multiple times,  through today. Not able to work since emergency room visit.
pt started fevering @ 12:00 MN p/vax; mom had been giving APAP @ 2PM 16SEP called hosp fever 106.2 R x 1hr gave APAP @ 1:00; warm bath recommended called back 20min later temp down to 103.6 pt had no additional high fever
Information has been received from a nurse concerning an 18 year old female patient who on 23-JUL-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included ABILIFY. The nurse reported that the patient developed a benign brain tumor in the fall of 2007 after receiving GARDASIL. She required surgery and was hospitalized. She recovered on an unspecified day. The nurse felt that patient having benign brain neoplasm and requiring surgery was to prevent serious criteria and reported event as Other Medical Event (OME). Additional information has been requested.
Fourteen days post vaccination, the patient developed clusters of vessicles on a raised red base at the injection site. the area was tender.The patient was instructed to keep the area covered with bandaids, to wear long-sleeve shirts and to wash daily.
He has been wetting the bed, sometimes twice a night starting one day after the shots. Normally he only has an accident once a month.
This is a spontaneous case, initially received from a pharmacist and follow up received (combinedly processed) on 09-Oct-2018, concerns a 62-year-old, adult female patient. The patient's medical history and concomitant medications were not available. It was reported that the needle was attached tightly but the hub seemed loose and kept rotating on the syringe and the syringe leaked during the shot. The vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm. The pharmacist also had a drop or two leaked. The needle used was BD safety glide 25 and there were no signs of damage on the needle. On 09-Oct-2018, the patient was administered a partial dose of FLUCELVAX QIV (dose: reported as less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252380 and expiry date: 31-May-2019). No adverse events were reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034035. Based on the QA investigation, it was concluded that very unlikely that a LUER-LOK defect was present throughout the inspection and packaging process. AQL inspection, reclassification results, and Brevetti inspection were all completed per procedure and indicate there were no defects during the inspection and packaging process. There are no relevant deviations to the leaking LUER-LOK. There is no indication that relevant equipment malfunctioned or alarmed during the execution of this batch. There is no indication that the LUER-LOK defect originated during the filling or inspection and packaging processes. Therefore, there is no product impact. No CAPA is required following this complaint. This investigation revealed no evident root cause and batch was manufactured in compliance with all approved internal procedures and GMP requirements. The reporter assessed this case as non-serious. Non-significant follow-up received from the reporter on 07-Nov-2018: It was confirmed that, the patient did not experience any adverse event after the vaccine administration. No changes were made in narrative. Follow up report received from QA department on 20-Nov-2018: Based on the QA investigation report, it was concluded that batch was manufactured in compliance with all approved internal procedures and GMP requirements and no LUER-LOK defect originated during the filling or inspection and packaging processes. Hence, no evidence for the root cause was found. The narrative was amended accordingly. Non-significant case amendment (20-Nov-2018): The statement vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm and the pharmacist also had a drop or two leaked was changed to the vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm. The pharmacist reported a drop or two leaked. The narrative was amended accordingly.
Fever 102.2 plus chills, nausea, headache. Pt self medicated with TYLENOL and finally went away next day. By the 24th felt better.
patient was not able to do Simple thing like brushing hair; my left arm once again lost strength; I still cannot lift my arm over my head or fully extend my arm outward; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 (Lot number: ER8731) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=ER8733, lot unknown=False, administration date=31Mar2021, dose number=1, vaccine location=Left arm), administration date: 31Mar2021, when the patient was 27 years old, for Covid-19 immunization, reaction(s): "Left size of face went numb", "weakness in left arm". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Apr2021, outcome "not recovered", described as "patient was not able to do Simple thing like brushing hair"; MUSCULAR WEAKNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "my left arm once again lost strength"; HYPOKINESIA (non-serious) with onset Apr2021, outcome "not recovered", described as "I still cannot lift my arm over my head or fully extend my arm outward". Therapeutic measures were not taken as a result of loss of personal independence in daily activities, muscular weakness, hypokinesia.  Additional information: After second dose (received in right arm) left arm once again lost strength within 1 hour. After 4 days patient still cannot lift arm over head or fully extend arm outward. Simple thing like brushing hair couldn't do with left arm. The patient not had covid prior vaccination. The patient not tested for covid post vaccination. Patient had no known allergies. Patient did not received any other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
The same night I received my fourth dose of my Moderna vaccine, I ended up with swelling and pain in my left arm at the injection site and around my whole upper arm into my armpit. The next day, it started going down into the lymph nodes and in my armpit. A few days later it had spread to my left breast and caused it to swell. I also ended up with a rash from the injection site to a little bit down below my elbow. That lasted for around 5 days. The swelling in my breast lasted for almost two months. My doctor was concerned about the swelling and wanted some lab work done to ensure there wasn't an infection or anything. They did not find anything of concern and the swelling in my breast subsided around three weeks ago.
Per patient email communication,  pt received the J&J Covid vaccine on April 5, 2021, "a few hours later, my whole body proceeded to start swelling, inflammation and pressure in my joints made it painful to move. Tylenol, Ibuprofen and Aleve did nothing over the next couple of days.  Believing this was just a temporary side effect I continued my daily life/work. After 1.5 weeks I tried to make a Doctors appointment and had to wait another 2 weeks to be seen.    Long story short, I have been diagnosed with Reactive Arthritis, which can be triggered by vaccinations in people with auto immune diseases like hypothyroid. For 4 months now, I have been dealing with uncontrolled swelling, pain and pressure in my joints so bad that it will wake me from sleep crying, a non-stop HA that only dies down to dull and rages when tired, dizziness, and sharp shooting pain down my arms anytime I tried lifting anything, even a gallon of milk. Sometimes causing my hand to release whatever I was attempting to hold. I have been on invisalign braces for the past 1.5 years, and for the past month, have not been able to wear them due to the swelling and ulcers and sores they were creating in my mouth. That's a ton of of money down the drain if the Orthodontist isn't understanding of the circumstances.  Multiple rounds of anti-inflammatorys' and a round of prednisone only gave slight relief before being diagnosed and referred to rheumatology." Patient stated she reported reaction to CDC and she does have an appointment scheduled with a rheumatologist.
This case was reported by a consumer (subject's son) and described the occurrence of flu like symptoms in an adult female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included emphysema and smoker. The subject had none concomitant medications. In February 2012, the subject received unspecified dose of Influenza vaccine (unknown route and injection site; lot number not provided). In February 2012, less than 1 month after vaccination with Influenza vaccine, the subject experienced flu like symptoms, diarrhea, sweating, stomach pain and fever. At the time of reporting the events were resolved. Limited information was provided; during the report the subject's son did not feel comfortable answering any further questions regarding his mother and the report stopped.
foul taste in mouth for about 1/2 hour following injection, extreme fatigue and sleeping approx 4 hours after continuing for 24 hours, sweats, chills, fever, body aches
Day after I received vaccine on my left upper arm, my left arm started hurting in the muscle by my elbow. Each day it continues to hurt and it?s get almost unbearable. Hurts to extend, lift anything, use , etc. Today it started hurting down below my arm. The injection site doesn?t hurt.
When childs mother had sibling in office for Immunizations, she was asked about serious reactions to other vaccines, thats when she related that patient had a seizure after MMRV. She stated that child had been sick day before vaccine, on 01/18/2006 patient was seen by clinic MD and vaccines were given. Mother relates that later that evening child was running fever and she was giving her motrin, she then noted that child was not looking "right" she saw childs eyes rolling back and body jerking with clenched fists, and some drooling was noted. Child was taken to ED where temp was 104.
Nausea, Headache, Chills, Sore Injection Site, Body Aches, Fever, Sleepiness - began that evening and got worse at nighttime and following day was in bed - fever 100.8 - called doctor and took Tylenol to relieve symptoms.  Today I am feeling better - symtoms less but still present- fever at 99.7.  Had to cancel social events.
The sight of the injection is red, spreading, hot, and tender. From yesterday to today, the sight has swollen and doubled in size of turning red.
After I gave the her the vaccine in the passenger seat, she was fine. Then a couple of minutes later we could not distinguish what kind of reaction was occurring and had another patient call 9-1-1. The patient jerked at that moment, but the paramedics arrived within 8 minutes and checked her out, she is fine. It turned out that she has a history of fainting when needles are administered with blood draws or vaccines. She drank some juice and recovered without incident. The paramedics released her home and no other concerns arose.
Around 7 pm child was more fussy, 9-10 pm seemed to be breathing rapidly with abdominal breathing, felt warm, temp 37 axillary. Rapid heart rate. More concerned because mother had a reaction of tachycardia with Tdap vaccine. Gave 1 ml of BENADRYL, child calmed down and went to sleep. Today child is better now, laughing, eating fine.
Nurse reporting an AE for VARIVAX. Caller stated after receiving the vaccine, the patient disclosed she was 5 months pregnant. No symptomatic AE reported. Caller gave permission to contact, did not provide further information during MNSC call. No PQC; No symptomatic AE reported; Caller stated after receiving the vaccine, the patient disclosed she was 5 months pregnant.; This spontaneous prospective report was received from a nurse and refers to a pregnant 24-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown date, the patient became pregnant. The last menstrual period (LMP) was in approximately 2022 and pregnancy gestation date was reported as 5 months.  On 17-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W022605, expiration date 17-JUL-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (immunization). The reported stated that after received the vaccine, the patient disclosed she was 5 months pregnant (vaccine exposure during pregnancy,contraindicated product administered). No symptomatic adverse event reported (no adverse event). The pregnancy outcome was pending and fetal outcome was unknown.
Heavy congestion and wheezing, excessive mucus and phlegm, md inject 1 month infant with Fluzone adult vaccination (0.5 ml) instead of hep B vacination.
Initial unsolicited report received from a consumer (patient's parent) via social media via other company (Merck) (Case Number: 00257660) on 14 November 2016. This case involves a male patient (age not reported) who was vaccinated with first dose of DTap vaccine (Batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient's condition was much worse and also developed a sore arm. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
night sweats; has a lot of allergies /sensitivities; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient got the first Pfizer Covid vaccine and started having night sweats and thinks he is past the time allowed for the second dose. It was believed he was 5 weeks out from the first dose. Wanted to know how much protection he has by the first dose and how that looked to protect him. Had a lot of allergies and does not want this to be another one. Caller stated she spoke with a nurse who said the 1st dose had an 85 percent protection. Due to the night sweats, caller got nervous to get the 2nd shot of the vaccine. Caller had taken her son to the doctor who ran tests wherein the results were fine. Caller had delayed the 2nd shot for her son due to the adverse event and because her son also had allergies and sensitivities. Wanted to know where they can get more information on how much antibodies he had because he had a lot of allergies and does not want this to be another one. This was a concern and knew it was a part of the side effects, but she really wanted to know if it was protecting him and not knowing makes her feel really concerned. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, DECREASED APPETITE (loss of appetite) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
PT HAS EXPERIENCED REDDENING AND ENLARGED VEINS BELOW INITIAL VACCINATION SITE OF LEFT DELTOID.
March 2nd-March 4th: Sore left arm body aches night sweats throat inflammation
Patient was vaccinated with regular pfizer vaccine and not the bivalent vaccine as intended. Regular pfizer no longer approved as a booster dose.
The patient had severe swelling in her right arm about 8 hours after she was given the Pneumovax 23 immunization in her right arm. She also received the Shingrix vaccination the same day but in the left arm. After taking 2 benadryl , the patient started vomiting and went to the ER where she received a cocktail for vomiting/allergic reaction and the ER physician said she was having an allergic reaction. The patient went home and the swelling went down, but her arm felt very hard.
17:45/Vaccine administered , 17:50 patient became pale, diaphoretic, collapsed to ground, while being Assisted by medical staff. Vitals Stable:  HR99, O2 94%, BP 130/77. Able to follow commands and answer questions. 18:05 Vitals Stable: HR83, O2 98%, BP 100/60 18:15 patient able to stand unassisted, vitals remained stable Walked independently to personal vehicle accompanied by mother.
THE PATIENT RECEIVED A DOSE THAT WAS EXPIRED BY 2 DAYS. I CONFIRMED WITH THE MANUFACTURER AND CDC GUIDANCE THAT THE PATIENT WAS IN NO IMMINENT DANGER AND THEY SHOULD REDO THEIR DOSE WITH NO LIMITATIONS ON A WAITING PERIOD FOR THEIR SPECIFIC DEMOGRAPHICS. THE PATIENT HAS BEEN SCHEDULED TO RECEIVE THEIR VACCINE AND IS AWARE OF THE INCIDENT.
tested positive for COVID-19 while in the immunity period after completing a series of COVID vaccine.  2nd dose date was 1/30/21
1.5" x 2.5" Rash (redness, bumps, itchiness) just below site of injection on left arm