chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second dose of Moderna on 3/20/21 I experienced the expected low grade fever, body aches and chills on Saturday 3/21. The entire week following I had felt exhausted and had GI upset. Thurs day afternoon 3/25 I started to experience some dizziness which was out of the norm for me. On Friday 3/26 I woke up, unable to sit up or stand up without falling over and getting extremely nauseated. Everything was spinning and the only thing I could do was lay down. I took .5mg Ativan and 25mg Meclazine with no effect. After 4 hours of laying down, crawling to the bathroom and kitchen to get some food in, I ended up throwing up. My doctor suggested I go to the ER which I did around 2:45-3pm. I was admitted, an EKG was administered and a CAT scan. I was given IV fluids and 1mg Ativan and more Meclazine. My Vitals were WNL and no issues found iht EKG or CAT scan. I was d/c home around 8pm. I have not experienced any vertigo since but severe anxiety around it.  I believe this was caused by the vaccine as I have never experienced anything this severe before.
After getting the vaccine I had soreness in my arm. Then I had caught Covid 2 days later. I had body aches, was super tired, and I felt like I had the flu. It took about 3 or 4 days before I got over it. I had slept for 3 days. Right after Covid symptoms went away I have been really fatigued. My body is just tired all the time. My left eye is always in a fog. My joints hurt. I think I may have a little arthritis, but my joints hurt in places they never hurt before. Sometimes I took some TYLENOL. I think I have a high tolerance for medication so if I get something it has to be kind of strong to work. I feel like I can't get as much done as I used to. I'm still having issues with my joints and vision that is ongoing.
Pt was given 0.3mL of Moderna (second dose) instead of the recommended dosage of 0.5mL for Moderna.
persistent, irritating runny nose; soreness in the arm; A spontaneous report was received from a consumer concerning a  Years-old male female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, persistent, irritating runny nose and soreness in the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: or unknown) intramuscularly in the location for prophylaxis of COVID-19 infection.  On 16-JAN-2021, the patient experienced event, soreness in the arm and on  17-JAN-2021, the patient experienced event, persistent, irritating runny nose.  Treatment medications included neosynephrine and an antihistamine.  Action taken with mRNA-1273 in response to the events, persistent, irritating runny nose and soreness in the arm was not reported.   On 18-JAN-2021 the outcome of event, persistent, irritating runny nose was recovered and on an unknown date, the outcome of event, soreness in the arm was not recovered.
Light headed, nausea/vomiting upon arrival at home. 10/29/2002 after vaccine given in office- family called "911"- Pt's daughter called later next day and said pt did not have to be transported to ER- felt better when paramedics arrived. No further symptoms.
loose stools starting a few hours after vaccine administration, vomiting starting 4 days after vaccination
SHORTNESS OF BREATH; FELT LIKE I WAS GOING TO DIE; ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no pertinent medical history. the patient was a healthy person and had not been to an emergency room in years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A 21A, and expiry: 05-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced felt like i was going to die. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, felt like i was going to die and allergic reaction was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pt states had large knot size of an orange on site were Pneumovax was given. Site was red and hot associated with malaise
Patient reported that she has huge brush up to elbow after she has received Pneumovax23 . So she went to Dr and gave her Zyrtec and Benadryl and asked her to watch for it. Patient doesn't have any systemic symptoms.
broken out in a rash on her neck and chin; broken out in a rash on her neck and chin; This is a spontaneous report from a contactable consumer (patient) received through Regulatory Agency. A female patient of an unspecified age received BNT162B2 (, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2 SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunizations. The patient medical history and concomitant medications were not reported.  The patient experienced broken out in a rash on her neck and chin on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient received vaccine on a Monday. On Sunday patient started experiencing redness, warmness, and itchiness at injection site.  Still an issue 2 days later.
After 2nd dose MMR, patient developed stomach upset, high fevers up to 105 for 6 days requiring fever reducers. He also had Inflammation of lymph nodes in neck, inflammation of throat, and sinuses. On 3rd day of fever, took him to the doctor. Doctor there sent us home. 4th day of fever, took him to for 2nd opinion. That doctor prescribed antibiotics, and took a throat culture which was negative. Eventually on the 6th day his fever disappeared.
sinus infection; running out of her temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (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: SINUSITIS (non-serious), outcome "recovering", described as "sinus infection"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "running out of her temperature". The patient underwent the following laboratory tests and procedures: body temperature: running out of her temperature.  Additional information: Reported that she received the 1st dose of vaccine on 03Mar2021. But she missed her 2nd shot that was scheduled on 24Mar2021. She had a sinus infection and running out of her temperature. Her doctor advised her not to take her 2nd shot until her sinus infection had been cleared up. She mentioned her doctor was recommending to take her 2nd dose now since she was recovering from the sinus infection. Wanted to know how she can sign up again for the 2nd shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache, nausea, tongue tingly, EMS evaluated, self resolved, pt. refused transport
Pt recv vax on 4/5/99; on same day pt exp feeling bad, vomiting, fever, malaise, sleepy, irritable
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (ectopic) in May 2019, Alcohol use (very minimal) in May 2019 and Miscarriage (blighted ovum) in October 2019. Concurrent medical conditions included Drug hypersensitivity, Hypothyroidism since April 2010, Food allergy and Penicillin allergy. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Jul-2020 and the estimated date of delivery was 05-May-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2020, Pregnancy test: positive (Positive) Positive. On 04-Nov-2020, Prenatal screening test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Ultrasound was done at 5, 7, 10 and 20 weeks. Glucose screening was scheduled on 03-Feb-2021. Estimated date of conception was on 12-Aug-2020.   Treatment medications were not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient reports localized redness around injection site that resolved within 12 hours. He then developed localized redness and minor swelling expanding around injection site (6cm at widest diameter) 8 days following injection (19 Jan 2021) with warmth over erythematous area, consistent with local delayed type reaction. No hives, drainage, pain or any associated systemic symptoms. Rash has persisted unchanged for 36h at the time of initial evaluation.
I WAS SUPPOSED TO GIVE HER A COVID JANNSEN IMMUNIZATION BUT I GAVE HER THE PFIZER BY MISTAKE. WHEN I DISCOVERED MY ERROR, I CONTACTED MY REGIONAL MANAGER, WHO HAD ME CONTACT OUR CLINICAL PEOPLE TO SEE WHAT TO DO. THEY INFORMED ME THAT I COULD HAVE HER COME IN FOR THE CORRECT  IMMUNIZATION WITH NO WAITING PERIOD, I CONTACTED HER AND SHE WAS FINE, NO ISSUES, NO SIDE EFFECTS, AND AGREED TO COME IN AT HER CONVENIENCE TO GET THE CORRECT ONE.
h/a, fevers, myalgias x 3 days p/vax;on 3rd day altered MS, slurred speech, tonic-clonic sz x 2 then paralyzed & sedated & loaded w/dilantin;
Violent shaking relived by hot bath Migraine Chest spasms all night-little sleep Frequent urination Muscle soreness everywhere especially upper back
The patient had received a flu vaccine previously on 01/13/2017 and another on 04/03/2017. Followed up with parent of patient and no adverse reactions noted.
Violent shivering/ague, intense muscle/joint aches, like flu or maybe mono but but much worse, feeling freezing cold, couldn't get warm enough. (Temperatures were in the 80's)  a feeling of nerve irritation under  the skin that moved from place to place.  unsteadiness on my feet, lack of focus, a basic, total shut down. I curled up in fetal position under a pile of covers for 24 hours. Didn't fully recovery for 3 days  All simptoms hit me more or less simultaneously within 5 minutes, about 12 hours after 2nd covid shot.  Didn't seek medical attention, just plowed through it.  I imagined a biological warfare agent would have felt like that. "I thought I was gunna DIE!"
During our 3rd clinic, the facility registered this patient to receive their second dose of the Pfizer COVID-19 Vaccine, and they did not produce the record card. We administered the dose as requested. Upon returning to the Pharmacy to process the VAR, our records indicated that this patient had already received 2 doses of the vaccine at previous clinics.
INJECTION SITE SWELLING, REDNESS, SORENESS FOR A FEW DAYS
The patient reports soreness and in the injection  at the site as well as becoming progressively more ill with flu like symptoms.
Shingrix and COVID booster (Moderna) taken at same time. Within 6 hours mild soreness in both arms. Within 18 hours left arm (Shingrix injection site) noticeably more sore.  Within 24 hours began experiencing flu-like (non-respiratory) symptoms: weakness, fatigue, joint pain, chills. Symptoms worse day by day for. next consecutive 6 days. Oral temperature recorded on day 7 following injection (May 11, 2023) 100.5 consistently throughout the day. Day 8 temperature 100.2 recorded at 10 AM. Flue-like symptions slightly improved, but still significant. Patient's exposure to sources of infection were limited to only spouse for over 1 week prior to date of Shingrix injection. Symptoms still extant as of date of this report.
Swelled up the size of an egg, red, and very itchy. The itching drove me nuts because it hurt to touch it so I didn't want to scratch it. The swelling, redness and pain have gone away but it still itches.
Asked nurse if daughter could recieve nasal with type 1 diabetes, nurse said yes. Nasal h1n1 admin. Swelling of right sinus 2 days after recieving nasal h1n1, fever for 3 weeks now, hospitalized twice with hyperglycemia, elevated liver enzymes, viral type infection, elevated Wbc with elevated lymph, along with other out of range labs, continues to be ill.  11/18 and 11/30/09 Medical records received for DOS  11/9/09 Final DX: hyperglycemia, influenza-like illness, leukocytosis, borderline neutropenia, resolving hepatitis. DOS 11/12-11/14. Final DX: Type 1 Diabetes, Viral syndrome, Epstein Barr Virus.  Intermittent fever and hyperglycemia s/p vaccine. Watery puffy eyes, nasal congestion, clear nasal discharge. leukocytosis. LFTs increased. Mild abd pain. + monospot, Epstein Barr.   12/03/09 Discharge  summary and medical records received for DOS 11/9- 11/10.  Final DX: Elevated blood sugar related to viral infection, mild dehydration Improving LFTs, WBC still elevated. D/C to home.
My Hgb is normally above 14 gm/dL. On02/22/21at 5:00 pm I began to pass a large amount of bright red blood rectally. On 05/23/21 I called my Dr. & went to the ER that same morning. They  CT scan & I was admitted. The rectal bleeding continued until 02/26/21. On 02/25/21 after doing a prep, I had a colonoscopy. Results showed bright red blood I colon which made visualization difficult. Conclusion was that bleeding was thought to be result of bleeding from diverticulitis in the sigmoid colon. I never had a rectal bleed before or since. Several meds were discontinued. Asa, ibuprofen, guaifenesin, & tapered off oral budesonide. Hgb was 7.1 on discharge on 02/26/21.
o Patient experienced a moderate reaction to the vaccine. Nausea 3d-today, vomiting 2-3d ago, diarrhea few times/d past 3d, abdominal pain 8/10 3d, headache today 5/14/2021. Stated she has lost her appetite since the vaccine 3d ago, and has had only water to drink. o Symptoms were not relieved with over the counter medications. She took tylenol 5/11/2021. She also took motion sickness medication 5/12/2021, which did not provide relief. She tried loperamide anti-diarrheal on 5/13/2021, which did not provide any relief. She took pepto bismal today 5/14/2021, which has not improved symptoms.
Patient started having decreased appetite, and diarrhea starting 2 days after patient receiving vaccinations.  Diarrhea described as "mushy" and having mucous in it.  Patient not wanting to eat as he normally would.  Patient didn't have fever or any other symptoms.
Chills, fatigue, headache,nausea , vomiting all after 8 hrs; then 2nd day; abdominal pain and loose watery bloody stool for 10 + hrs
2 days post vax fine petechiae rash appeared, also aching of joints; this aching lasted for 1 month; required splints for wrists; pt reported taking analgesics & antinflamatory rx;
Patient received her second dose Pfizer COVID vaccine (Lot#FL3209 exp: 06/30/2022) on 1/23/22. Patient alerted RNs and stated she felt tightness in her throat and was shaking a lot. Patient was accompanied by her Grandma. Grandma stated that patient had finished her 15 minute observation and as soon as they got in the car patient stated that her throat "felt weird." Grandma then decided to bring patient back to vaccination site from their car. RN took patients vital signs at 1222. BP: 146/84, HR: 84, O2: 98%. Patient stated her "throat felt weird." RN retook patients vital signs and reassessed patient at 1227. BP: 137/82, HR: 105, 02: 99%, RR: 16. Patient was shaking and there was noticeable hives around the injection site on left arm and on the left side of her neck. Patient stated that she felt her "throat was tight." RN assessed patients respiration rate at 1231 RR: 16. RN called EMS at 1227. RN called Vaccine Operation Lead asked if it was okay to give minor Benadryl without parent present. RN asked RN to get parent verbal consent for approval of Benadryl IM administration. Verbal consent to give Benadryl IM was given by Father for patient over facetime to RN at 1233. Patient stated she weighed 48 kilograms (105 lbs). With client's assent, RN gave patient IM Benadryl (LOT#: 041020 exp: 04/23) in the right deltoid at 1233 (1mL (50mg) as directed in emergency protocol for patients >45 kilograms). RN retook patients vital signs at 1234. BP: 135/93, HR: 98, O2: 98%, RR:16. EMS arrived at 1235 and assumed care. EMS assessed patient and recommended that patient go to hospital since parent guardian wasn't on site. Grandma called patients father via facetime and he stated he did not want his daughter going to the ED. EMS had to receive Physician approval for AMA. Paramedics educated father on worsening signs and symptoms of allergic reaction and recommended that patient go to ED as soon as possible. Father of patient verbalized understanding and stated he would take daughter to ED. Physician from local hospital gave consent to release patient to grandmas care. EMS left vaccination site at 1246. RN retook patients vital signs at 1302. BP: 134/83, HR: 123, O2: 99%, RR:16. Patient stated she had not eaten anything all day. Patient was given a juice, water and crackers. Patient finished her snack. Patient stated that she was feeling a lot better and that symptoms had subsided. Patient completed 30 minutes of extra observation at 1303. Patient stated that she was feeling "a lot better" and symptoms had completely subsided. RN educated patient and her Grandma on worsening sign and symptoms of COVID vaccine and when to seek EMS. RN educated patient and her Grandma on worsening signs and symptoms of an allergic reaction and recommended patient go to ED as soon as possible. Patient and Grandma verbalized understanding. Grandma stated that she "was going to take her granddaughter to her Dad's and then he was going to take patient to the ED." Patient left vaccination site with a steady gait and unassisted with her Grandma at 1305.
This spontaneous report was received from a registered nurse, concerning a 61 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not provided. On 22-OCT-2018, the patient was vaccinated with the first dose of VARIVAX subcutaneously for prophylaxis, lot #N030406 and expiration date 30-OCT-2019 (strength, dose and frequency was not provided). On 26-OCT-2018, the patient developed varicella-like rash on her hands, legs and bottoms of her feet. The patient called her physician and did not receive any treatment for the event. The nurse could not confirm if the rash was a post-vaccination rash caused by the vaccine virus or whether the rash was indicative of disseminated varicella caused by wild-type virus, therefore a VZVIP was faxed. At the time of reporting, the patient recovered from varicella-like rash on her hands, legs and bottoms of her feet. The causal relationship between the vaccination with VARIVAX and the event was not provided by the reporting nurse.
Unable to discern drugs by their name at job, anxiety, cognitive disruptions, suicidal ideation
Pain in R leg with limping.  No redness or swelling noted.  No fever.
the vaccines were exposed to freezing temperatures and administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 08-NOV-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: the vaccines were exposed to freezing temperatures and administered). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Nov-2023 A health care professional contacted GlaxoSmithKline via phone inquiring about Havrix and what information was available about the administration of Havrix after the vaccines were exposed to freezing temperatures and administered.  The reporter gave partial information about vaccines, patient and event.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received a dose of Havrix after temperature excursion, which led to incorrect storage of drug.
left wrist was swollen but got better; left wrist was swollen but got better/Right wrist is also swollen; Right knee is still swollen/Right knee was so messed up; Could not walk/Can barely walk; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right knee is still swollen/Right knee was so messed up), GAIT DISTURBANCE (Could not walk/Can barely walk), JOINT SWELLING (left wrist was swollen but got better) and JOINT SWELLING (left wrist was swollen but got better/Right wrist is also swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced GAIT DISTURBANCE (Could not walk/Can barely walk). On an unknown date, the patient experienced JOINT SWELLING (Right knee is still swollen/Right knee was so messed up), JOINT SWELLING (left wrist was swollen but got better) and JOINT SWELLING (left wrist was swollen but got better/Right wrist is also swollen). The patient was treated with MELOXICAM for Inflammation, at an unspecified dose and frequency and HYDROCODONE for Pain, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Right knee is still swollen/Right knee was so messed up) had not resolved, GAIT DISTURBANCE (Could not walk/Can barely walk) and JOINT SWELLING (left wrist was swollen but got better/Right wrist is also swollen) outcome was unknown and JOINT SWELLING (left wrist was swollen but got better) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was very active people. Patient consulted with several doctors and were prescribed medication for the inflammation and pain, that helped a little.   This case was linked to MOD-2021-367126 (Patient Link).