chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 13:07, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
TWENTY SECONDS AFTER VACCINE ADMINISTRATION THE GIRL COLLAPSED. SHE APPEARED PALE, FLACID AND COLD TO THE TOUCH. TEN SECONDS LATER SHE WOKE UP AND WAS SENT TO THE EMERGENCY ROOM FOR A CHECK UP.
This spontaneous report as received from a physician refers to a currently 20 year old non-pregnant female patient. On 28-DEC-1993 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 22-JAN-1994 and the third dose was administered on 11-JUL-1994. The reporter stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Severe (L) arm tenderness and swelling without infection occurring < 6 hours after injection of PNEUMOVAX. Unable to move arm in so much pain.
Patient with history of no small cell lung cancer with metastatic disease (T8 lesion). Patient received Moderna COVID vaccine from different facility, two days later complained of bilateral leg numbness, admitted to hospital for T8 laminectomy. Remains admit at current time of VAERS report.
Lymph node(s) in my left armpit are swollen and uncomfortable. Same happened after second vaccine except in my right armpit because injection was in my right arm. This booster shot is less severe, but the person who administered said I should report this.
Pt seen in ED because of an irregular light reddish area at site of injection. Reports receiving yellow fever vaccine about 1 week prior. No information in medical record about who administered it or where.
Patient received a dose of Menveo and a dose of Bexsero at a clinic office visit on 4/5/2022.  Patient was also signed up for a school clinic to receive the vaccines. Patient received a dose of Menveo and Bexsero at the school clinic on 4/21/2022, RN did not know he had been given doses on 4/5/2022. The patient did not mention he had had any vaccines 2 1/2 weeks ago until he had already received the vaccines.  He did not need the dose of Menveo and it was too short of an interval to give the Bexsero.
Right after the shot I felt hot flashes and presure in my chest area and it went away. At 8pm I ate cereal with milk and fell asleep, I was woke up at 100am with vomit in my mouth. I fell asleep again and woke with a cough that continue till I began to have all the systoms of the flu. I took two ibuprofen and fell back to sleep at 3 am. At 535am I got up feeling very sick, it started to pass by 600am.
This spontaneous report as received from a health care professional refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with one dose of improperly stored (Merck) VARIVAX injection (lot # L002217, expiration date: 21-JAN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information is not expected, no contact details were provided.
Redness, swelling, warm/hot to touch, itchy, started < 24 hrs after shot.
Diarrhea nausea belly pain- I fainted briefly- am fine now. Husband was with me. No medical attention needed. 3 am Could have been good poisoning as well but could have been related to vaccination
The day after the second vaccine, I had a high fever, fatigue, and other symptoms of Covid-19. On going events (11/23/21 to present) include my hair falling out, forgetfulness, and extreme itching over my entire body.
Shot taken on Friday October 27. Saturday slept most of the day and several bouts of explosive diarrhea. Sunday felt a little better and more diarrhea. Monday didn't feel good and ended up passing out from dehydration and went to er for fluids.
Developed a very itchy rash at injection site along with pain on lymph node under left arm for 3 days.  Event started a week after injection was placed.
D/w patient after covid vaccine slight headache - elevated bp 143/102  Now symptoms resolved employee feels better and wants to go home.  Encouraged patient to come back if symptoms get worse.
Pt states that their face was swollen on left side, and was burning, states "face was full of fluid", wish rash all over it. Spoke with Physician (distant relative) and told her to not worry. Endorses having severe headaches x 3 days that is now a mild ache, still has a rash all over legs and neck, and now has dark strange bruises on arms, also noticed one to top of breast and inside of arm, no injury  noted, states that they are just appearing. Feels as if face is drooping, not like a stroke, but like there is fluid there.
My daughter was experiencing extreme malaise upon waking this morning for school.  I checked with her after I began not feeling well and around 9:30 AM she reported that she was tired, her stomach was aching, and she felt sick.  She went home from school early as well (11:10).  I gave her some Ibuprofen and she slept for several hours.  She did not have an appetite nor did she want to drink anything.  At about 8:00 pm she woke and was feeling slightly better.
Pt developed flushing/sweating and dizziness. Vitals: 137/94, 67, 16, 99% -- > 138/92, 79, 16, 99% Patient given water for hydration, Pt stable and released from the vaccination site 17:29.
Temporal Scanner: 11:00 PM 02/13/2019 - 99.2; 07:00 AM 02/14/2019 - 99.5; 09:00 AM 02/14/2019 - 100.1 axillary; 10:15 AM 02/14/2019 - 98.8 axillary. Mom reports, "He has been waking up very fussy, hard to settle, and spitting out his pacifier which he never does."
no additional AEs; to report a temperature excursion.  ROTATEQ was administered.; This spontaneous report was received from other and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 time dose, lot #1892784, expiration date: 03-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion. The temperature was reported as 46.4F, time frame was 5 minutes. There was a previous temperature excursion reported as 47.9F for 0 hours 47 minutes and 0 seconds. No additional adverse events (AEs) were reported.
Extrement crying, high pitched screaming and agitation for more than 2 hours.   Temperature (taken under arm) of 98.8 taken after calming. Face swollen and pale.    Extremely sensitive to touch and appeared to be in pain for 4-5 hours after onset of screaming.     Attempted to take him to the emergency room at onset of screaming.  Was advised that it was not necessary.  Cared for him at home by nursing, soothing and offering water from bottle.
Patient caregiver reports large area of swelling which has hot to touch. Red in coloration with pick spots. Patient caregiver contacted primary care provider for advice. PCP advised if not resolved or resolving by 11-10-2017, then patient was to come in to be seen. No follow contact from patient caregiver today, 11/10/2017.
very exhausted after this vaccine; shortness of breath; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiry date not reported) via unspecified route of administration on 17Mar2021 (at age of 74-years-old) as dose 1, single for COVID-19 Immunisation. Medical history included stroke and blood thinner. Concomitant medications included apixaban (ELIQUIS) used for blood thinner. Consumer stated, had my vaccine on the 17Mar2021 and that day I was just very exhausted after this vaccine but then that night I had shortness of breath, a headache and nausea and that lasted for 5 days. Now today was the first day, the patient feel back to normal again after 5 days and was kind of afraid to get my second shot. Patient enquired was that it will okay or what are, will it just dissipate like the other one. The outcome of all events was recovered on 22Mar2021.  No follow-up attempts are possible. No further information is expected.
Guillain-Barre Syndrome (Acute Inflammatory Demyelinating Polyneuropathy); Tingling in toes and difficulty walking with slowly progressive, ascending numbness and weakness evolving to the fingertips over 10 days.  Currently evaluated for treatment with intravenous immunoglobulin.
Pt was seen by physician 3 days post vax. Pt complained of tenderness and redness.  Area hot to touch. Pt was encouraged to call MD and seek treatment for cellulitis, which she did. Pt was treated with antibiotics.
Patient sent to emergency department after being sent from PCP for low platelets. He noted having increased bruising in his right upper extremity for the last week to week and a half (admitted on 4/30/21).  Also notes small red spots developing on his lower extremities. Patient not on anticoagulation. Received Pfizer 2-dose COVID-19 vaccine ~6 weeks prior to 4/30/21.
After giving shots pt wanted a drink. Went to give pt cup and started towards door with pt to water fountain and noticed his face turning white. Brought pt back in room to sit in chair and that's when he passed out & then started to shake all over. Went & got Dr. laid him on floor to prop pt feet up & cool him off. Pt came to & started to feel better.
The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date; Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     It was reported that the patient had no known drug allergies and chronic or long-standing health conditions. The patient had never been diagnosed or tested positive for COVID-19.     On 30-Mar-2022 at 10:40 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 10:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date).    No concomitant medications were reported. The date the vial was initially stored in the refrigerator was on 01-Mar-2022. The nurse (healthcare provider) at a health department that they inadvertently administered the expired Moderna COVID-19 vaccines to 17 patients on 30-Mar-2022 with expiration date was 19-Mar-2022. No patients had reported any adverse events for now. The adverse event had not caused the patient to seek the medical care. The vial had not undergone any temperature excursions. No treatment medications were reported.
Hospitalized 10.28.21 with worsening respiratory failure with dry cough and diffuse interstitial infiltrates on chest imaging. Treated with steroids may have COVID -19 MRNA (Pfizer) vaccine induced interstitial lung disease, significantly improved on steroids, discharged 11.1.21
Within 12-24 hours of 2 m/o immunizations, patient began w/irregular breathing which progressed to apnea. EEG done was abnormal "near seizure activity" noted. Pt now on KEPPRA.
pt devel swelling of arm around inj site;also c/o aching in muscles which devel w/in 2hr of getting the inj; MD ordered med for pt;
Reaction after my 2nd shot on 3/9- I woke up on 3/10 with a swollen right , Big Toe- the swelling worsened day by day, and was painful to walk- on 3/15/2021, I went to Urgent Care- They took an xray, and sent me to a podiatrist, who tried to extract fluid to check for gout crystals- the foot was too swollen, and they were unable to extract fluid. It was then decided that I receive a shot of steroids. I was given that shot in office, and prescribed a medication for gout- Indomethacn- 50MG-  3X's a day.
Was first told I was having a heart attack in the ER, then rushed to another hospital for a heart cath. Once the doctor said I did not have a heart attack, I was diagnosed with Broken Heart Syndrome.  Also had to stay 2 nights in the hospital.
Pt recvd MMR vax 11SEP90 & 13SEP92 exp chills, shaking & joint pain, subsequently devel neuralgia, arthralgia, neuritis & neural damage; It was also noted that pt exp a topical reaction to neomycin pt was hospitalized;
A few days after vaccine 1, I began having chest pain and shortness of breath. I went to the hospital and they saw nothing wrong. A few days after that (1 week from injection) I began having left arm pain, worse shortness of breath and dizziness and left leg numbness. I went back to ER and nothing was found. A few days later the symptoms worsened and I began having joint pain and diarrhea as well. I was getting confused and my heart rate was high.  I would get so fatigued I couldn?t keep my eyes open when it hit - worse than 1st trimester pregnancy fatigue.  I went to my doctor who sent me to urgent care for a CT for possible clots. They sent me to the hospital where I stayed 3 nights for testing. Nothing significant found. I went to a rheumatologist who did a lot of bloodwork, and was diagnosed with mixed connective tissue disease (MCTD).  I now have many common MCTD symptoms and am on Hydroxychloroquine to protect my organs and supplements   Before the vaccine I was fine. I had some strange symptoms like skin itchiness that I took Zyrtec for but was otherwise energetic and normal.
Moderate pain in chest behind sternum when breathing.     Admitted to Hospital on 1 February 2021.    Diagnosed as pericarditis.    Treatment:    Ibuprofen   600 mg  3x/day for 2 weeks, and Colchicine 0.6 mg  2x/day for 3 months.
Pt recvd fluogen vax & devel bell's palsy on lt side & later both sides of face were affected; approx 5-6 wks p/fluogen administration; pt has h/o hypertension; pt went to ER 5 wks p/vax w/poss facial nerve paralysis on lt side of face;
Pt c/o of swelling and pain of 7/10. Upper body aches, sore throat, and swollen hands and feet. Denies fever, breathing problems, and itching.
also has diarrhea and headache which started a couple of months ago with xeljanz,; also has diarrhea and headache which started a couple of months ago with xeljanz; she has been in a lot of pain and sometimes has no energy, not sure if xeljanz is working at it should be.; she has been in a lot of pain and sometimes has no energy, not sure if xeljanz is working at it should be.; This is a spontaneous report from a contactable other hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: 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 for covid-19 immunisation, tofacitinib citrate (XELJANZ XR), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg, daily (once) for psoriatic arthropathy. The patient medical history and concomitant medications were not reported. Historical vaccine BNT162B2 1st dose COVID-19 immunization. On an unspecified date the patient experienced also has diarrhea and headache which started a couple of months ago with xeljanz. she has been in a lot of pain and sometimes has no energy, not sure if xeljanz is working at it should be. Outcome of the event was diarrhoea, pain, asthenia was unknown, headache was recovering. The action taken in response to the for tofacitinib citrate was not applicable.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Tdap-Menactra Hep A given-next day mom called. Chile temp-c/o Dizziness small red raised area at site of all injections, size of 1-2mm. Temp in office 101.3. No appetite. Dr ordered CBC and BI culture.
Fever, very weak, scratchy throat, aches all over body, skin sensitive to touch, light headed. Took Advil- symp. much better by 4/11.  Still some headache, occ. low fever.
fever of 103.8 orally @ 1AM, 2AM, & 3AM occompanied by ? hallucinations; saw people behind parents & wanted them to leave; APAP given; pt was talking funny & not making much sense; had red area size of an egg in DTP site;
Patient received KINRIX too soon, at 10 months. Reported by Medical Assistant after administered. Notified parent, no symptoms or signs of distress at the time of the call reported to RN.
This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported she received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had an ear infection on unspecified date in 2021; with outcome of unknown. Information on the batch/lot number requested.
"Trembling  ,numbness to her upper arm and lower extremities, felt dizzy and near syncopal" vitals 78/55 pulse 58 O2 sat 100% , " patient was pale ,felt uncomfortable reported nausea, was given oral hydration EMS was dispatched and she agreed to be taken to nearest Emergency room repeat BP 100/59 pulse 62
Anaphylactic shock; did not receive her period; terrible period; bleeding is very heavy; cramping; terrible period; bleeding is very heavy; cramping; Headache; Vomiting; This is a spontaneous report received from a contactable nurse (parent). A 15 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left upper arm (Lot number: FD8448, Expiration Date: 21Oct2021) at the age of 15 years 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: ANAPHYLACTIC SHOCK (non-serious), outcome "unknown", described as "Anaphylactic shock"; AMENORRHOEA (non-serious), outcome "unknown", described as "did not receive her period"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "terrible period; bleeding is very heavy; cramping"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; VOMITING (non-serious), outcome "unknown", described as "Vomiting". The action taken for bnt162b2 was unknown. Therapeutic measures were taken as a result of anaphylactic shock, headache, vomiting. Nurse stated she had her 15 year old daughter vaccinated in Oct2021 with her first injection. She went into anaphylactic shock. Treatment for adverse event included 30 ml of liquid diphenhydramine (BENADRYL) for anaphylactic shock. Patient did not receive her period in Oct2021 after the injection. Patient just now received it and it is a terrible period with headache, the bleeding is very heavy, vomiting and cramping. Patient has never experienced periods like that. Therapeutic measures were taken as a result of anaphylactic shock.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
30min p/vax pt had a flu-like feeling 24hr later had a reddened area about 1 1/2" in diameter 48hr later a reddened area the size of the palm of hand, fever of 102 5 days later red raised area from should to elbow;
Swollen armpit on left arm, shakes, headache, sweats, cold, lack of appetite, body pains, severe arm pain around injection site. Most symptoms subsided after 36 hours except armpit is still swollen and arm hurts but not as bad.
Rash over joints, knees, wrist, and over thighs, looks like eczema breakout.
At the time of the vaccination, I felt the burn of the injection. I have been fully vaccinated for COVID with boosters and I have had annual flu shots. This has NEVER burned before. I mentioned to the lady that administered the vaccine that it burned. She seemed puzzled, like this has never happened before. My husband was in the room and he asked if that was normal and she said that she did not know. The burn moved down my arm and over the following weeks I developed a dull pain, muscle weakness and limited mobility in my right arm and hand.
2 hours post vax the pt experienced a 5 cm rash at the injection site. Pt was treated with Benadryl.
Patient came into pharmacy to report an adverse event. He said "left shoulder injection site still very sore, causes on and off immobilization of left arm down. Pain is a 12 out of 10 during episodes". On 11/23/20, he went to ER hospital and doctor referred condition possibly SIRVA. He was prescribed ibuprofen 800mg , cyclobenzaprine 10mg and lidocaine 5% patch by Dr.  Pt picked up all same day.
VACCINE RECEIVED ON 09/15/21 BY CLINIC STAFF AND WASN'T PUT IN THE FRIDGE UNTIL 5 DAYS LATER. THEN OPENED AND GIVEN TO STAFF & PATIENTS. VACCINE WASN'T PROPERLY STORED FOR 4-5 DAYS, LEFT OUT ROOM TEMP.
Patient received a Moderna Covid vaccine at 16 years old.  I follow-ed up with her mother and she reported no side effects day of.
PATIENT RETURNED TO CLINIC AT 1310 STATING SHE FELT SHAKY AND DIZZY AS TIME WENT ON HER THROAT BECAME ITCHY. RAPID RESPONSE WAS CALLED AND PATIENT RECEIVED OXYGEN, BENADRYL, SOLUMEDROL, RELEASED TO FOLLOW UP WITH PROVIDER 19 AUG 2011.
Deep red, hot, painful, hard red mark (size of an average kiwi. Not even where the needle was inserted. It was approximately 1 1/2 to 2 inches from where immunization was given. Today is 9/27/2013 and the mark is still there, & sore, itchy like a healing sore sporadically.