chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient received Moderna covid #1 on 3/16/21 and #2 on 4/13/21. On 4/23/21, notes indicate he was recently admitted to a facility due to confusion and difficulty swallowing. On 4/27/21, notes indicate he had transferred to a rehab center for PT/OT. On 5/7/21, notes indicate that he had fallen at the rehab facility x 3 times and sustained a bleed/concussion. On 5/11/21, notes indicate he was re-admitted to the hospital for sepsis. The next day his wife called the clinic to state he is not doing well and was agitated and had to receive haloperidol. Hospice was recommended by provider but they apparently were denied by the local hospice agency. On 5/19/21, his wife reported to the clinic that he had passed away due to three falls, not eating and sepsis. No autopsy report available. Time from second vaccine to date of death was 34 days.
Lt upper arm swollen, red and warm to touch from elbow to shoulder. Saw Dr; has cellulitis and was treated with antibiotic on5/18/06. 5/23/06, phone call to clinic, much better.
Patient received COVID Janssen injection, saw blood and had a vagal response to which he passed out and was lowered to ground. Did not hit head. Laid supine with legs elevated, profuse sweating, ice packs to chest,  water given. After a few minutes assisted to sitting position and then assisted to  standing position with no s/s reported. Assisted to monitoring area for continued monitoring.
Case was vaccinated for Covid in March 2021, then was hospitalized for Covid in March 2022.  Case self-tested at home in January, when had URI symptoms, but did not report it to Health Dept. Came to ER with seizure activity 3/13/22, and tested positive for Covid at that time, withOUT respiratory symptoms. Medical records indicate doctors could not rule out that seizure activity was not due to post-viral inflammatory changes in her brain.
Pt received Moderna booster. Approx 5 min after receiving vaccine Pt felt faint and temporarily lost consciousness. Pt was pale and sweaty. Pt regained consciousness within 1 with stimulation. Pt alert and oriented when she became conscious. Pt remained dizzy, nauseated, and somewhat pale. Pt stated she had not yet eaten today. Pulse 60s, O2 sat >95%. BP within normal limits. EMS called to site for further evaluation. Pt left. Partner stated Pt had same response to 1st dose of Moderna vaccine, but no adverse response to 2nd dose. No medication given.
My goiter shrank. It had been really large during Covid.  My TSH levels normalized and it looks like I am now in permanent remission.
Stiffness; Indigestion; HARD TIME SLEEPING; Pain; COULD NOT EAT FOR A DAY AND HALF; Headache; Tiredness; BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain) and FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis (non-infectious intermediate, posterior and panuveitis).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain), FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain), FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication and treatment information was provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Initial misuse report received from a nurse on 14 October 2013. The patient had received FLUZONE HD. The patient received a dose on 25th September and another dose today. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
About 4-5 mins after administering the vaccine pt passed out slumped over for about 40 seconds he had a mild jerking movement. Once awaking up he was alert oriented x 3 vital signs bp 140/80 heart rate 50 oxygen level 99 percent. EMS called and pt transported to ER in stable condiditon.
Urinary retention, began approximately 27 hours after injection. Additional symptoms: Minor pain at injection site, moderate headache, swollen glands in neck. Urine flow ceased completely at the 32 hour point, and I was in great discomfort at the 40-hour point. Nurse in E.R. inserted foley catheter into my bladder, which provided immediate relief. Urine released:1.2 liters.
arm got very sore; still tender; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles on wrist back in October (before patient was 50)).   On 5th July 2022, the patient received Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and tenderness. On an unknown date, the outcome of the pain in arm and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and tenderness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received a dose Shingles vaccine on Tuesday morning (the day before reporting) and arm got sore and was still tender. The patient never wants them again.  Additional supportive information: This case was linked with US2022AMR104891, reported by same reporter for different patient. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104891:tag at post
CHILDS DATE OF BIRTH WRITTEN ON SIGNED CONSENT. CHILD IDENTIFIED IN DATABASE WITH DIFFERENT DATE OF BIRTH. CHILD IS TOO YOUNG FOR VACCINE.
On 4/14/99, pt recv'd 1st dose of Anthrax.On 5/13/99,pt dvlped iritis & glaucoma.On 7/5/99,pt awoke w/ numbness & tingling of face,fatigue,& slurred speech.Pt was admitted & tx w/probable CVA. On 7/24/99,pt exp a 2nd episode of facial palsy
red circle around the injection site, size necklet; itchy at the injection site; hard to touch; tender; arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt really bad), TENDERNESS (tender), INJECTION SITE PRURITUS (itchy at the injection site), FEELING ABNORMAL (hard to touch) and INJECTION SITE ERYTHEMA (red circle around the injection site, size necklet) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2014) for COVID-19 vaccination.     The patient's past medical history included Guillain-Barre syndrome. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), EZETIMIBE, DOCUSATE SODIUM (STOOL SOFTENER), VITAMIN D3 and MACROGOL 3350 (MIRALAX).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt really bad). On 08-Feb-2021, the patient experienced TENDERNESS (tender). On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchy at the injection site) and FEELING ABNORMAL (hard to touch). On 16-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red circle around the injection site, size necklet). At the time of the report, PAIN IN EXTREMITY (arm hurt really bad), TENDERNESS (tender), INJECTION SITE PRURITUS (itchy at the injection site), FEELING ABNORMAL (hard to touch) and INJECTION SITE ERYTHEMA (red circle around the injection site, size necklet) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment.
3-4 cm area of redness - right thigh cellulitis likely reaction to vaccine.
Swelling, redness, rash, pain on upper arm (left). Seen in Urgent Care. Given Prednisone, Benadryl and an antibiotic. Restricted from work for 2 days. Symptoms resolved after 3 days.
Severe swelling, erythema, induration right deltoid to below elbow. Reaction to IPV
Approximately 4 hours after 2nd dose vaccine my throat had swelling signs and flushing of face, ears and chest.
Immediate severe pain radiating down left side if shoulder, breast, and arm pit. Later severe swelling in arm pit to present day and pain. Swelling has gone down a little. On 4/8/21 woke up about 12:15am difficulty swallowing and breathing It subsided after sitting up 30 min
This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of Human Papillomavirus GARDASIL 9 (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # N000326 with expiration date on 14-OCT-2019, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 216 hours (dates between 15-FEB-2017 and 31-MAR-2017). For the lot # M034780 with expiration date on 15-APR-2019, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours (dates between 30-JAN-2017 and 30-MAY-2017) or 12 hours (on 15-FEB-2017); but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 1044 hours. This lot # was also exposed to a storage temperature of 47 to 77 degrees Fahrenheit (°F) (9 to 25 degrees Celsius (°C)) for a time frame of 12 hours. Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA002362: US-009507513-1706USA011486.
Information has been received from a doctor of pharmacy concerning a 71 year old female patient with no known allergies who on 27-JUL-2010 was vaccinated subcutaneously in the back of her right arm with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 665513/0146Z). The pharmacist reported that "last night" on 27-JUL-2010, the patient noticed a red, round, itchy spot 1/4 inch size, on her right shoulder about 4 inches away from the injection site. The patient told pharmacist that "the spot looks better today" (on 28-JUL-2010). However, the patient told the pharmacist  that she also had a spot on her left arm that was about the size of a half dollar. The patient told pharmacist that she was using triple antibiotic cream. Pharmacist stated that the patient lived in another town, so she did not come in to be seen. But pharmacist stated she did not think this was a chicken pox rash, but possibly bug bites. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Follow up information has been received from the doctor of pharmacy concerning the female patient who on 27-JUL-2010 at 10:00 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot# 665513/0146Z). Diluent (MSD) for ZOSTAVAX (Merck) (Lot# 60764). The onset date of the adverse events was reported as 30-JUL-2010 (previously reported as 27-JUL-2010). The pharmacist reported that the patient was advised to see her primary care provider if symptoms persisted or worsened. The patient's primary care provider was notified of possible reaction to vaccine. At the time of the report, the patient's outcome was reported as unknown (previously reported as recovering). No further information is available.
Had tonic/clonic sz 5.5hrs p/vax; no prior hx of sz; Seen in ER; PE-neg, CT Scan-normal, to have EEG in 2wks;
Information has been received from a nurse concerning a female between 11 and 12 years who in August 2007, "two weeks ago", was vaccinated with a dose of GARDASIL 0.5 ml injection. The nurse reported that the patient had received another dose of GARDASIL 5 days before at another clinic. The patient sought medical attention. The patient also experienced some injection site pain. The outcome of the events was not reported. The nurse felt that the event was an overdose. Additional information has been requested.
Never been in as much pain in muscles and joints to the point where was unable to walk or use hands; Never been in as much pain in muscles and joints to the point where was unable to walk or use hands; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 10:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP), COPD, plantar fasciitis and arthritic knees. The patient had no known allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure meds from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 02Apr2021 at 11:00, the patient reported that he never had been in as much pain in muscles and joints to the point where the patient was unable to walk or use hands, the patient was still feeling the effects of the second shot. Now the patient had headaches, it stops for a day and starts again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events pain in muscles and joints to the point where the patient was unable to walk or use hands and headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had been having allergy symptoms and asthma - coughing and shortness of breath which had been going on prior to vaccine but it got worse enough that I was having to use my inhaler many days a week to help with my symptoms. I had to contact my doctor to get on a daily maintenance inhaler for my daily symptoms I was having. They put me on Pulmicort Inhaler. They did have to escalate the dose a couple of weeks ago because my symptoms were not resolving. I am pretty being treated more aggressively and  I have a referral to a pulmonologist but haven't seen him yet.  I have not been scheduled yet.  This is my first pregnancy; estimated date of delivery is June 4, 2021.
Left side started several hours after injection: pain from below cranium, across shoulder, down the arm to the elbow.  Very tender, painful lateral point between shoulder and elbow lasting for about 10 days; could not lay on left side.  Injection site not especially tender. Extreme fatigue, resting not restful lasting for about 10 days--st.  A lot of trouble sleeping; went on for about 7 nights.  Four nights of low-grade fever, low-grade chills, and low-grade headache.  Felt tipsy when up lasting for 2 weeks; still an issue but much better.  Winded when walking or talking; still an issue but getting much better.  I can still get a 'spin' if talking and walking at the same time; passes quickly if I lean on something.
Begin with sore throat, muscle aches, fever & then sever congestion & sinus headache. At time of reporting all symptoms are still present -day 4.
Injection sight red but did not itch.  Started to itch on chest and realized I am breaking out in little red bumps OB chest and two on face.   No where else so far.
Difficulty breathing for approximately half an hour from 03:30 am - 04:00 am. The day after the vaccine I felt like I'd been hit by a truck. Every muscle in my body very sore including major soreness of left arm. Lasted from morning till evening. Second day after vaccine left arm still sore which improved by third day, but didn't go away completely. Also, about an hour after the vaccine I felt a very weird sensation traveling up my spine and neck. Left arm still somewhat sore and harder to raise that arm than right arm.
Patient started to feel warm at 7:30 pm.  Patient had a generalized tonic seizure at 8:50 pm.  Fever in ER at 2102 was 101.5.
Patient felt light headed. Denies SOPB, chest pain, palpitations, V/V, or visual changes.
Hep B 1 administered 6/28/06. Within 10 minutes began intermittent itching all day. No rash, difficulty breathing, N and V, edema or other symptoms. A 5/6 on a scale of 1-10.
Reporting is for a vaccine administration error where an adult patient was administered the Pfizer-BioTech vaccine  5-11 years   formulation(Orange cap),resulting in a lower than authorized dose for a booster. There is currently no symptoms or adverse event. Patient has been called and correct age appropriate dose of Pfizer-Biotech vaccine has been given as per CDC and vaccine manufacturer guidelines.
There was no adverse reaction. Pt was in office to get covid vaccine #1 and also flu vaccine. Pt decided he wanted the covid shot on left arm and flu shot on right arm. Mom sat on table with pt to video record as I was giving the covid shot. Arm was wiped with alcohol & pt placed his hand over site saying he wasn't ready yet. Mom talked to him for a while and then told me to go ahead. I cleaned site again, pt was still saying he didn't want shot but I went ahead and started the shot, I injection half the dose (0.1 ml) and pt pulled away, I was unable to give full dosage (0.2 ml) I disposed of the remaining dose. Mom wanted to know if half a dose would cover pt I told her I would speak with my manager. I spoke with my nursing manager explained situation. Was told I could not give another shot or half of one. I went back to room, spoke with pt's mom and told her what my manager had said. Mom stated she would like to speak with my manager which manager promptly did.  We were advised to contact the health department, which manager did. We were given COVID-19 Vaccine administration Errors and Deviations and were told to give another half dose to complete dosage for first vaccine. Mom was told about information from health department, she was also given a copy of information provided by health department. She was fine with me giving the other half of the vaccine. She held pt this time, plus a co-worker came in to help as well
Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) at an unspecified dose and frequency; PREDNISONE for COVID-19, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Patient recently got COVID. Patient received the updated bivalent vaccine recently, but still got COVID. Reporter was not sure of the type of COVID-19 vaccine patient have received in the past, but reporter says it could have been Moderna. Reporter does not have the vaccination records for any of the patients.  Patient had to be put on Paxlovid for his symptoms but that helped him a lot. He was still on albuterol, cough medicine, and prednisone for his symptoms. Patient was getting better.   This case was linked to MOD-2023-737195 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2023: Live follow-up received: Patient details, treatment drug and narrative was updated.; Sender's Comments:  MOD-2023-737195:First son case
12/30 vaccination 10 days later, I had itching and noticed a spreading 4" diameter. After 3 days it went away.  1/8/2021 Contacted Dr. office that morning in case it was cellulitis, virtual visit. Monitor and several days later, it was gone.  *Dr stated 'skin reaction seen many times with vaccine'.