chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (rash at injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    No concomitant product use was reported. Patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided.
Information has been received from a physician concerning a female (age and gender unknown), who, on an unspecified date, was vaccinated with a 0.5mL first dose of GRADASIL.  Subsequently, the day after the vaccination the patient developed a rash and some hives. The patient called the office. The patient went to see a pharmacist and was given an unspecified medications to treat the hives. The medication helped to alleviate the symptoms. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 3/14/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female with no medical history, and no drug allergies, who 18-FEB-2007 was vaccinated IM with a 0.5mL first dose of GARDASIL (Lot# 659180/1758U). Concomitant therapy included ethinyl estradiol (+) norethindrone. On 19-FEB-2007 the patient developed a rash that started on the hands only but by the third day was all over the stomach and the rest of the trunk. It appeared to be more like hives. It was reported that there was no itching. The patient's mother called the office on 20-FEB-2008. The patient took ZYRTEC and by the 4th day the rash and hives went away (previously reported that the patient went to see a pharmacist and was given an unspecified medication to treat the hives and the medication helped to alleviate the symptoms). No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a 80 year old female consumer regarding herself. The patient was not pregnant. The patient's medical history included ovarian cancer surgery and colonoscopy in 18-OCT-2012. On an unknown date in 2008 the patient was vaccinated with ZOSTAVAX dose 1 for prevention of shingles. The patient used unspecified concomitant medications. On an unknown date in November 2013 the patient experienced shingles, feels a burning sensation, blisters on her rib cage and the scabs are slowly falling away. The patient sought medical attention. Her physician thought that the episode was at the end of its course. No treatment was provided for the event. The outcome of the events was unknown. Additional information is not expected.
I was itchy close to the injection site and then developed a red circular rash about 3 inches in diameter. The area also became sore. This lasted for 5 days with the symptoms decreasing on day 4 and day 5. By day 6 it was back to normal.
Immediately had a localized reaction at the injection site that became a autoimmune response. My arm was euthymic, swollen, and hard.  I had fatigue, joint and muscle pain, and low grade temp that went as high as 101 F. I was seen twice in the emergency room and by a telemedicine appointment with my PCP. I was placed on antibiotics and prednisone.  My symptoms lasted 10 days. Monkeypox infection was ruled out.
Pt received Hep-B vaccine at 10:15, while sitting in classroom at 15:00, went into seizure?, yawned, stretched arms, began drooling and eased to the ground. Oxygen given, was red in the face with cyanosis, drooling, arms and legs thrashing. He was sent to ER, intubated, and hospitalized for 4 days. Discharged on Dilantin, driving restrictions for 6 months. Dx: New onset seizure, stupor of unknown origin". Discharge summary also states pt was diagnosed with meningitis.
Cellulitis type rash on right arm, diarrhea, joint swelling, temp of 100.1
patient received dose 1 in AUG 2020 and did not receive 2nd dose..; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable to this report. No other detail of patient or vaccine available. Pharmacist reported that the patient did not receive 2nd dose, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Fever, Diarrhea, NauseaVomiting, night sweats, malaise Narrative:
Caller's mom was really sick and was hospitalized; As per caller's mom's physician, his mom's body is too weak and needs to wait to receive 2nd; She was tested positive for covid in hospital; A spontaneous report was received from a consumer concerning his mother, a 69-year-old, female patient who received Moderna (mRNA-1273) vaccine and was really sick,  and was hospitalized, tested positive for Covid-19 and advised by the patient's physician to wait to receive the second dose as their body is too weak.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021 the patient was really sick and was hospitalized and tested positive for Covid-19. The patient finished their 14 days quarantine period. As per the patient's physician, the patient's body was too weak and needs to wait to receive the second dose of Moderna (mRNA-1273).  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The event of was really sick, and was hospitalized was considered to be serious due to hospitalization.  The outcome of the events was really sick, and was hospitalized, tested positive for Covid-19 and advised by the patient's physician to wait to receive the second dose as their body is too weak were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events Illness and asthenia , a causal relationship cannot be excluded. Based on reporter's causality and the current available information ,the event COVID-19 is assessed as unlikely related to mRNA-1273.
Initial report received from a relative of patient on 02 July 2007. A 40 year old, male patient (with a history of allergy to ASA, doxicillin; herniated discs and Lyme's disease) experienced arm stiffness, numbness, limited mobility and pain to the entire limb within hours after he received IMOVAX (lot number Z0877-2) intramuscularly in the left deltoid on 07 June 2007. He had exposure to a bat bate and received IMOGAM (lot number Z0373-4, gluteal) and a first dose of IMOVAX in the left, lower deltoid (date of administration not reported) without incident. At the time of the third vaccination with IMOVAX, he did not have any illness. At the time of the report, the patient had not recovered.
Immediately after vaccine felt flush and throat felt scrathy then had some mild whistling sound in throat that resolved 24 hours later. Two weeks later, woke up with ear fullness and ringing in ear, face felt swollen and headache
twitching under left eye and cheek; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021320430 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching under left eye and cheek". Additional information: Caller had her first dose of the covid-19 vaccine on 12Mar2021. Caller states that for the last 3 days she has twitching under left eye and cheek, inquiring if this was a side effect. No unaddressed medical questions were referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20a and 038a21a) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included VITAMIN B6, DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 29-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.            Treatment information was not provided. Action taken for Moderna  COVID-19 Vaccine was not applicable. Patient was right now on her 1st trimester.
mins p/inject devel knot @ inj site which went away later that day but returned 21APR accompanied by shoulder & neck discomfort not relieved w/APAP or ice packs; denies fever; seen by MD 25APR95; dx poss herpes zoster;
Heart rate at 180-200 bpm at resting. Chest pain and nausea, abnormal EKG in the ER due to tachycardia . Now being seen my a cardiologist
70 y.o. female received TYPHIM VI for out of country travel. She developed ringing in her ears approximately 8 min after receiving injection followed by sensation in throat resulting in unable to breathe. Received EPI PEN, BENADRYL, paramedics arrived transported to hospital. Developed chest pain, increased troponin in hospital (-) stress echo for ischemia has MVP on COUMADIN (past medical history).
I woke Tuesday morning and felt like I never went to bed the night before which I saw other people say this happened after the booster About 1 pm I decided to try to go fix something to eat   I got the food ready and turned around and felt something funny next thing I knew I was waking up on the floor from passing out I knew not to get up right away so I laid there 30 min then finally got up and got my food ate. then I went back to bed and at about 4:30 I had some paperwork I need to scan and sent so this time luckily I was sitting at a desk. though I felt the same fainting coming so I laid my head down and just sat there and let it happen Wednesday I had an appointment I had to go to so I stopped by local store and grabbed a few things  I got very hot in there and last I felt like I got just a little more sleep mind you I have been sleep 20hrs a day since tuesday
w/in hrs of vax pt was found cyanotic by sitter; w/in 10 mins pt pink but sleepy;
several pt recv vax & inj site swelling & soreness;some of the pt have required ATB tx however not all the pt have returned to the MD office;
No adverse symptoms reported; patient was administered the first dose in the series of GARDASIL 9 on an unspecified date in 2011 and the was administered the second dose in the series of GARDASIL 9 on an unspecified date in January 2020; This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber), referring to a currently 23-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.       On an unspecified date in 2011, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unspecified day in January 2020, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported), and at the time of the report, the patient was at the office to be administered the third dose in the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration).  No adverse symptoms reported.
This is in addition to the episode I described and submitted in my prior report of VAERS E-Report No: 678040. Received my booster vaccination on August 22, 2021. On 9/2/2021, I had increased tinnitus in my right ear with sudden loss of hearing and tinnitus. I was evaluated that day and by the time I reached my ENT's office, my hearing returned. However, the increase in tinnitus followed by complete hearing loss happened three more times but resolved each time. Finally, it occurred again without resolution  and I contacted my ENT's office for full hearing loss in my right ear. I was tested on September 16, 2021 which demonstrated further significant hearing loss in my right ear. I was then put on high dose prednisone again. Upon completion, I was tested again on October 12, 2021 and told there was little change from the prior testing and the loss is permanent (moderate to severe loss) in my right ear.
Immediate reaction of arms tingling and nausea/vomiting.  Basic vaccine symptoms the first week including headache, nausea, fever.  After about a week, COVID fog/fatigue symptoms began.  It is currently 6 weeks later and I have fatigue, shortness of breath, head pressure, double vision, cannot concentrate for any length of time and dizziness/unsteadiness.  I have not been able to go to work since the vaccination and have people helping take care of me.  I cannot take a shower without being short of breath after.  I have been put on 2 different rounds of steroids ? the 2nd more aggressive, which did not make a difference.  I have been to my general doctor several times, an allergist and a neurologist.  I have had extensive bloodwork, an MRI, and an EKG ? all were normal.  My symptoms have not improved at all in the past 3-4 weeks.
On the first day, 07/12/2021, I began to get chest pains around 2 pm. The today, 07/13/2021, the chest pains got worse followed by sudden dizziness and rapid heart rate.
Dizziness, sweating, flushed followed by Syncopal episode, EMS called
19 hours later. Unable to sleep. Chills, fever of 100.5 on and off through the day. Headaches, fatigue, neck achy. Arm swelling with pain and warm to the touch/.
Diarrhea 7 days after receiving 2nd vaccine injection. This is my 4th week of diarrhea and number of stools reach 11 in one day. I have seen 3 doctors, 1st collected stool sample but there was no C-diff. Blood work indicated not dehydrated. one week later office visit different doctor, stool sample indicated no bacteria such as E-coli.  Dr. prescribe Ciprofloxacin 500 Antibiotic, I took 2 pills per day for 7 days. Eight days later 3/23/21 I had office visit with gastroenterologist who took a stool sample, report is not in yet. I was given prescription Cholestyramine to be taken once per day. This is my 4th  day.
While at lunch nausea, disorientation, diaphoresis, emesis, hives on face and difficulty breathing over course of 1 hour. Was taken to Urgent Care, where received Benadryl and medication for nausea.  Went home and slept for 5 hours then felt fine.
Symptoms began with a slight cough on January 23, 2023.  I still had the minor cough the following day and tested positive for COVID-19.  I contacted the doctor on the same day and received prescription for Paxlovid and began taking it on the same day.  I tested negative the following Sunday afternoon.
p/recv vax approx 2 1/2 hr pt c/o soreness, redness, & warmth at inj site w/slight swelling; 11/18 pt seen in clinic; pt placed on therapy w/keflex; swelling dec but area still slightly sore to touch & red;
metallic taste in mouth began within minutes of vaccination, and has not gone away. There is still a strong metallic taste in my mouth over a week after vaccination. No treatment has been received.
The patient refers that his arm "fell off" limiting movement, for which she took 2 Panadol which improved the symptom. According to what he refers to in the afternoon, pain begins in the inner part of the arm and occupies almost the entire upper part of the arm.
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 20-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 20-Jul-2022).    No concomitant medication were reported.   Patient had half dose.  The vial was initially stored in the refrigerator was on 4Jun2022. The vial didn't undergo any temperature excursions.  No treatment information were provided.
When the patient came in today to pick up one of her prescription, I inquired how she is doing on the SHINGRIX vaccine that was administered on 03/17/2018. She said that she had headache, fever, loss of appetite, pain redness, soreness and swelling at the site of injection. She also said that she saw her provider. When I examined her arm this morning, her left arm is still swollen and red at the site of injection.
After 5 mins, pt became pale, nauseated and rolling eyes up. Lied down on exam table and picked up legs due to becoming hypotensive. Place O2 at 2 liters nasal cannula, pt arouseable and opening eyes. Took VS, B/P 80/40, HR 74, Resp. 16. Provider PA evaluated pt and following simple commands. Pt able to drink fluids and drank 12 oz. Pt's mother states pt had been eating snacks prior to event. @ 04:20 Pt more alert and able to ambulate in room and hallway. Drank 6oz more of juice. Instructions given to parents on watching for any serious effects and take to ER immediately and if pt develops fever and given childrens acetaminophen. Event of vagal response lasting 5min. Pt home with parents.
A large hemotoma developed on the patient right arm. Two weeks later the patient developed a blood clot and went to the doctors. The patient was given muscles relaxers for the pain. He came to our clinic today because he was still in pain and he still had a mass under his skin in the same area where he was vaccinated.
Patient was experiencing urine problems and leakage leading up to the vaccine on 9/24/19. No fever was present at time of vaccination.  on 9/23/19 patient had a urine culture but did not get results of culture back until 9/26.  On 9/25/19 patient had a 10 second seizure and his brain was "disorganized".  Mother thought that this may have been because it was the result of having an undiagnosed UTI (which was confirmed on 9/26) and being dehydrated from hot temperatures/travel on the days leading up to the vaccine.  Patient also was experiencing delirium symptoms on 9/26/19.