chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child crying vigorously prior to vaccination. Calmed down immediately after given. After sister received immunizations, he began crying again, he complained of sore throat, vomited, he complained of his hands and feet being itchy, no redness or swelling noted at injection sites. At 3:15 PM he complained of itchy hands, feet, and ears. Ears were red and mildly swollen. No respiratory stress noted. Blotchy red area noted on chest. Gave 1/2 teaspoon Benadryl, mom refused full dose. Left the waiting room-walking and talking.
Diarrhea a few hours after the vaccinations were given, that continued for 7 days and required hospitalization. Additionally had some emesis and weight loss. No fevers.
fever; stiff neck; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), the first episode of PYREXIA (fever) and the second episode of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Jun-2021, the patient experienced the first episode of PYREXIA (fever). On 15-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck). On 20-Jun-2021, the patient experienced the second episode of PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Stiff neck, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Fever and Stiff neck, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved and last episode of PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-229873 (Patient Link).
After the vaccination,  patient started experiencing  fatigue, lethargy, malaise, joint pain all over the body (finger joints, hips, knees, and so on).  He also felt down and could not take a long walk.   He has been taking ibuprofen and switched to naproxen to help with the pain since the infection.  At this time, patient reports the malaise has gone but he still needs medications to control his joint pain.  He stopped naproxen on 2/18/21 and started taking tylenol and using voltaren gel instead.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353459USA. A male patient between the ages of 19-24 years, who experienced poisoning by unspecified drug or medicinal substance (Serious, since 21-Mar-2012, until 22-Mar-2012) while enrolled in a Teva study. The patient was an active recruit. Adenovirus vaccine was administered on 20-Mar-2012. At the time of the report the outcome of the AEs were: poisoning by unspecified drug or medicinal substance : recovered/resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included Hep A (since 20-Mar-2012); DTP (since 20-Mar-2012); Meningococcal vaccine (since 20-Mar-2012); IPV (since 20-Apr-2012); Influenza vaccine (since 20-Mar-2012); Hep B (since 20-Mar-2012); Typhoid Vaccine Live Oral (since 20-Apr-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Disability or Permanent Damage). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not assessable to the Adenovirus Vaccine.
Information has been received from a licensed visiting nurse (LVN), via a company representative, concerning a female patient (age not specified), who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). About 15 minutes after the vaccination was administered the patient fainted, and then developed "a big knot on her head." Unspecified blood work was ordered (results not provided). The nurse confirmed that the patient's condition had improved. The patient sought unspecified medical attention. The nurse reported that an additional patient (age and gender not specified) fainted after vaccination with Gardasil (Lot # not provided) (WAES #0707USA05016). Additional information has been requested.
My son was telling me that his eye was itchy but I did not really think much of it. The next day they were still bugging him but they were both red and swollen. I was thinking maybe he had pink eye. We had a virtual visit with his doctor and they said it was a conjunctivitis. We have not gone anywhere and really cautious when we go out. I have not changed anything food, medication, or home product wise (laundry detergent etc.) other than that he had gotten his vaccine recently. The doctor had us to warm compresses on his eyes and eye drops.
Patient has palpitations at 11pm on 10/15/21. She then had visual disturbances at 5:09 pm on 10/17/21 and a headache two hours later.
Initially swelling and redness-difficulty moving arm within 4 hours of vaccine. Pain intensity grew over 2 weeks. Diagnosed with frozen shoulder on 11/3/14.
Pt states 2 days after vaccine (FLUMIST) she contracted viral meningitis. Was hospitalized for 11 days.
PT WAS ADMINISTERED ONLY 1 VIAL (MenCYW-135 LIQUID). MEDICATION WAS NOT MIXED PRIOR TO ADMINISTRATION.  MANUFACTURER WAS CONTACTED AND RPH WAS ADVISED NOT TO REPEAT DOSE OR MIX OTHER VIAL (MenA) WITH ANY OTHER DILUENT. THEY STATED PT IS PROTECTED AGAINST CYW STRAINS AND DOES NOT NEED THE A STRAIN UNLESS HE WILL TRAVEL OUT OF THE COUNTRY.  PT RECEIVED THE VACCINE FOR SCHOOL.
Muscle aches or body aches, fever 100.3, nausea, fatigue /tiredness, chills
Pt received DTAP injection left deltoid region. Swelling and redness developed on same day 12x13 cm but not crossing jnt line. No fever, area tender but arm fully mobile.
On 6/5/00, mom noticed blood on blanket and pt chewing on it. On 6/7/00, the child was crawling instead of walking, like he didn't want to step on right foot. Mom moved all limbs, baby fine. On 6/8/00, the pt seemed to favor right leg and had mouthful of blood. The pt was referred to specialist to rule out internal bleeding. Pt was not taken to physician and symptoms resolved.
patient was administered an expired vaccine/ no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (GMI) (Reference number- 00768466) and transmitted to Sanofi on 14-Sep-2021.   This case involves a 34-year-old female patient who administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Sep-2021, the patient received a 0.5 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Injection) [lot UJ702AA and expiry date 30-Jun-2021] via intramuscular route in right deltoid for prophylactic vaccination.  It was reported, "Caller states that 4 patients in her office on 14SEP2021 received vaccinations of FLUZONE QIV NP that expired on 30JUN2021. Caller asked for information on how to proceed and whether or not these doses should be re-administered".  It was a case of actual medication error due to Expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient said that she couldn't walk starting about 2 days after the shot. She had to go to the hospital and it was discovered that she had 3 blood clots, 2 in her legs and 1 in her lung.
I was rushed to hospital . Needed to be operated on, I had pericarditis. They drained 1 litre of water from around my heart. I am still suffering on a daily basis.  Heart feels squeezed all the time. No breath, no energy. Exhausted. Very stiff neck and lower back.
Pt. presented to EC on 4/29/2021 due to falls at a rehab. facility; pt. w/ chronic Foley, Dx. w/ UTI & bacteremia, AKI; discharged to ECF on 05/21/21 in stable condition.
Arm pain or discomfort on the injection site; Arm pain or discomfort on the injection site; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm pain or discomfort on the injection site. The patient reported it was not severe, he just wanted to know if he can take Tylenol or Advil. Outcome of the events was unknown.  Information of lot/batch number has been requested.
rash in mouth, gums and lips; rash in mouth, gums and lips; lips turned red due to rash; This case was reported by a consumer via call center representative and described the occurrence of rash mouth in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced rash mouth, lip redness and rash lips. On an unknown date, the outcome of the rash mouth, lip redness and rash lips were recovered/resolved.   It was unknown if the reporter considered the rash mouth, lip redness and rash lips to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Sep-2022 Reporter's comment: This case was self reported by patient. The patient received first dose of Shingrix 2 weeks ago.  The patient states that a day or two after the dose, the patient developed a rash in her mouth, which extended into her gums and over her lips.  The patient also stated that lips turned red due to the rash.  The rash resolved on its own after 4 or 5 days. The reporter consent to follow up. Additional supportive information: This case had been linked with US2022133814, reported by same reporter.; Sender's Comments:  US-GSK-US2022133814:Same reporter
This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 11-JUL-2018, the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the right deltoid for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the left deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1807USA007589: US-009507513-1808USA000454: US-009507513-1808USA000455: US-009507513-1808USA000456: US-009507513-1808USA000457: US-009507513-1808USA000458: US-009507513-1808USA000459: US-009507513-1808USA000460: US-009507513-1808USA000461: US-009507513-1808USA000462: US-009507513-1808USA000463: US-009507513-1808USA000464: US-009507513-1808USA000465: US-009507513-1807USA007589:
pt states 12 days later p/recvd #2 vax 18DEC92 exp dizziness denied h/a; further states no effects of vax on 18NOV92;
Throwing up, nausea, diarrhea, chills,heat flashes,tired. Lasted 11 days.
Splitting headache, swollen eyes and lymph nodes in neck, felt beat with a bat (hurt to be touched), injection site 3" in diameter and swollen and red, brain fog, could not lift head or arms for 24 hours, high temperature 102, extreme joint pain.
Re: Shingles Vaccine Side Effects ... 2nd Dose  I had my 2nd shingles vaccine on August 17, 2021. Unlike the first vaccine I had in late May, this second vaccine left my upper arm (left) feeling very sore.   Later that evening and during the following day,  August 18, I felt very fatigued with body aches, much like the same feeling as having the flu. These side effects continued into the next day, albeit at a lower level.   As of this writing I feel much better though the ache in my upper left arm is still present.   G'day.
Pt recvd vax on 19JAN93 & on the same day pt devel red, puffy thigh; pt was not hospitalized; sx resolved w/in 12 hrs; No further details were provided;
Pt stated a couple of hours, post vax, started feeling "dazed", weak, confusion, questionable fever, sweating and can't sleep. Symptoms lasted for a couple of days and resolved on it's own. She didn't see her physician or school medical treatment. Returned to health dept on 11/3/00 for her Depo-Provera shot, declined further Hep-B vaccine and to report the above incident. Telephoned call was not answered.
Patient developed swelling and numbness of tongue.  Angioedema of menal area.  Evaluated in ED. Patient received diphenhydramine and dexamethasone IM, befroe being released home.
Abcess developed under the armpit of the vaccinated arm. Abcess had to be lanced and packed for several days. Clindamycin 300 mg taken 3 times daily for 7 days
This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject's past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject's PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .
Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache,  L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea
Fever of 103, rash over arm and shoulder traveled to back and hot to the touch, Severe Cellulitis, migraine headache, achy all over. Vomiting, dizziness. Had to go to Urgent Care for five days of IV antibiotics.
I woke up that morning with neck pain. I thought I slept wrong. It turned into a headache. It was just on the right side of my head and behind my right eye. I took Tylenol and took a nap. When I woke up I decided to eat something. The headache and the neck pain subsided. However, my left arm was numb. I noticed my balance was off. While I was eating, I noticed that my throat felt swollen. After I ate, I decided to go back to sleep, and when I woke up the pain in my head and my neck was gone so I went to take a shower. When I was in the shower, I noticed my balance was still off. The temperature of the water didn't feel the same on both sides of my body. My face felt numb on the left side. I called my sister and felt like I sounded funny to her when talking. That's when I went to the ER. They didn't think it was a stroke but they did a CT scan and blood work. Everything came back normal. My PCP thought maybe it was MS. They did a CT spine, they did an MRI, and then she sent me to a neurologist. The neurologist believes that it is Bell's Palsy.
About three hours after the vaccination, after eating a light dinner of two pieces of pizza and drinking a beer (to celebrate,  I thought) (an identical dinner to my husband, who was vaccinated minutes after me, and who suffered no adverse effects) I suddenly had extreme nausea and, immediately, projectile vomiting. My entire stomach emptied, but I continued to retch for the entire night and into the next day, weak and nauseated for about 72 hours. I became dehydrated but couldn't keep water down for 48 hours.   That first night, I experienced body temperature swings, whole body pain (not muscle aches, and not localized) and most disturbingly, hallucinations.  I awoke in the middle of the night convinced that my body had stretched in length  and there were two of me.  This was similar to the reaction I had to opiodes, but even worse (I didn't think anything could be worse).
Raised area 30 mm X 15 mm occurred 12 hours after shot given.
Chills, sweats, severe headache, body aches, nausea, fatigue, sleeplessness, loss of appetite. Started during the night of vaccine and continuing, so far, through the first day after vaccine.
During temperature excursion call, customer reports that improperly stored VAXELIS was administered to unknown patient; This spontaneous non-serious safety report was received by partner (Ref: 02169914) on 20-May-2022 and forwarded on 23-May-2022 from a consumer.  Due to the nature of the event, the causality between the event and the product is not applicable.  This case is non-valid due to no patient identifiers.  Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 03-Jun-2022 from a consumer, with reference number: 02169906 (interaction number) and forwarded on 06-Jun-2022. The case was maintained as non-serious.  The case is now considered valid as patient identifiers (initials and age) were provided.  It was reported that there was no adverse event.  Due to the nature of the event, the causality between "During temperature excursion call, customer reports that improperly stored VAXELIS was administered to unknown patient" and Vaxelis is not applicable.  No further information is expected.
within 3 hours right arm at injection site was swollen, red and very itchy. The itching went from neck to below the elbow, redness was around the injection site.  .   No other systemic affects noted.  At 6 hours provider assed and suggested 50 mg po benadryl and ice.   The next day remained itchy redness was reduced but did not want to take any more benedryl.  Took daily antihistamine.
Normally regular menstrual cycle was irregular -  period started 7 days early after 2nd dose
interstitial nephritis; severe headache; Dizziness; whole body ache; high blood pressure; Vitamin-D was 13; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis) (seriousness criterion medically significant), HEADACHE (severe headache), DIZZINESS (Dizziness), MYALGIA (whole body ache), HYPERTENSION (high blood pressure) and VITAMIN D DEFICIENCY (Vitamin-D was 13). At the time of the report, TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis), HEADACHE (severe headache), DIZZINESS (Dizziness), MYALGIA (whole body ache), HYPERTENSION (high blood pressure) and VITAMIN D DEFICIENCY (Vitamin-D was 13) outcome was unknown.      No concomitant medications reported.  Treatment of these events included Tylenol and dexamethasone.   Reporter did not allow further contact
Very bad back and stomach pain beginning 7:30 pm to 7:00 am the next morning when I called advice nurse, told to take Tylenol.  pain got much better.  Continued to take Tylenol every 6 hours, kept pain bearable, slept 12 hours the next night.  Had a slight fever 100.5 the next day, still having some pain in my abdomen.   Thursday night, pain in abdomen was bad again, but not as bad as the first night.  Talked to my doctor on Friday about these effects.  Friday night pain in my abdomen is much better but still there. No fever on Friday or today, Saturday
pt exp syncope soon p/immun given; pupils dilated to 9-10mins; nonresponsive until ammonia salts placed under nostrils several times; ice applied to forehead; pt responsive & able to sit upright w/in approx 5 mins; h/a, P120, lip quivered;