chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after receiving the vaccination the patient began to feel light headed. He stood up and fell back to the floor, landing in a sitting position and not striking his head. He was helped into a chair by a bystander and I was alerted to the situation. He appeared pale and diaphoretic, then he became unresponsive with his eyes up and his arms tensing up. After about 10 seconds he became responsive again. EMS had been called earlier and arrived a few minutes after this and he was evaluated and left with EMS. It was unclear if he had simply passed out or if he had a seizure. He had no previous history of seizure, though the presentation seemed somewhat atypical for just passing out.
Myalgia, Fever & Diarrhea Narrative: Fatigue, Temp 99.5; pain injection site radiating to upper back
I grabbed an expired varivax out of the VFC freezer without noticing. I put the vaccine in the patients chart and did not receive a warning about the vaccine being expired. I drew up the vaccine and administered it.
Redness presenting to the arm where he got the vaccine but it is predominately to the opposite arm; Very minimal itching; This is a spontaneous report from a contactable consumer (parent, reporting for his son). A 14-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175, expiration date: Aug2021) via intramuscularly in left deltoid muscle on 07Jun2021 as 2nd dose single, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 14May2021 as 1st dose, single dose for COVID-19 immunization. Reporter stated, patient had a little bit of redness presenting to the arm where he got the  vaccine but it is predominately to the opposite arm, he does not have any itching or shortness of breath, he does not feel dizzy, he can swallow, there was no other problem except the redness and very minimal itching very minimal but we wanted to know we can give him some Benadryl or do we just leave him alone. The outcome of the events was unknown.   Follow-up attempts are needed. Further information has been requested.
MMR administered left upper arm. Patient experiencing severe herpes flare up at the time. Weakness in arm for weeks; during subsequent flare ups of herpes, arm hurts only in location where shot administered. This has lasted for 22 months. (MMR necessary as prior vaccines received as child had become ineffective per blood drawn).
3 month 4 week female presents for evaluation. Patient was born at 24 weeks, part of a twin, had her 4 month vaccinations yesterday. Mother reports that since vaccinations, the patient has been sleeping a lot more, much more than usual for the patient. Also, just prior to arrival, patient had an episode of moderate amount of vomiting. About a minute or so after the vomiting episode, patient had an apneic episode and turned blue, unresponsive and "floppy". It lasted about 10 seconds or so, unsure, but resolved spontaneously. Patient had one more episode of vomiting upon arrival to the emergency room, but currently awake and alert, mother reports that this is the most awake she's been in the past 2 days. No history of fever. No URI symptoms. No congestion. No cough. No prior history of an apneic episode. Treatment: infant started on formula thickened with rice cereal and had EEG done - epileptiform potential but no seizures.
PT WAS GIVEN PFIZER FOR SECOND DOSE INSTEAD OF MODERNA THAT WAS NEEDED. PT WAS UNSURE WHAT SHE HAD FOR 1ST DOSE.
Following #1 DTP pt devel high-pitch scream type cry x 3 days; sl elevation in temp noted; pt was unconsolable > 3 hrs;
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
SICK; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick on 10-APR-2021. This report was non-serious.
Below the injection site, large egg size swelling and redness all day Saturday and Sunday. Today, swelling has gone down but still has redness and itching
no adverse effects; patient received a dose of a vaccine following temperature excursion; This spontaneous report was received from a physician refers to a patient of unknown demographics.    The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 04-SEP-2019, the patient was vaccinated with improperly stored (also reported as "following a temperature excursion") varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dosage information, route of administration and anatomical locations were unknown) of lot # S005077 and expiry date of 19-FEB-2021 for prophylaxis (product storage error). No adverse effects reported. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) (45F) for a time frame of 1 hour 30 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Genital herpes outbreak. I had been free from any outbreaks for 7+ years.
pt recvd vax 15NOV95 & was found to be pregnant;LMP 06OCT95 & estimated date of delivery was 12JUN96;8DEC95 pt underwent an elective abortion;No further details are expected
Got really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles vaccine and felt really sick hence second dose not received. The patients contact details was not provided hence follow up not possible.
Caller says the the pt started having really bad headache the day after taking the vax that lasted about a week and half.  She had 4 hours of amnesia. Pts husband took her to Hospital ER where she had a brain scan and was diagnosed w/ TGA and then admitted.
Complaint of shortness of breath/difficulty breathing, cough, headache, runny nose/congestion, loss of taste/smell, and myalgia.
I currently have Covid; I currently have Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (179885). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "I currently have Covid". It was reported that patient currently has Covid. The patient reported that vaccines are not really a vaccine or he wouldn't had Covid for the second time this year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A 15-year-old was provided the 5 to 11-year-old Pfizer vaccination. Patient needed the 12 and up Pfizer vaccine based on age screening. Immunizations clinic had the vaccines separated and labeled properly. The failure occurred during screening when the age of the patient was not taken into account properly, and personnel did not double verify the vaccines prior to being administered.
About 6/7 hours after the vaccination, I experienced fairly violent chills/shakes and the beginnings of a headache. I went to bed and woke some hours later with a 101-102-degree fever and muscle/joint aches (at the injection site on my left arm and throughout my body; I especially thought the joint aches in my legs and hands).  Now, about 27 hours after the vaccination, my fever has reduced to 99 degrees, my chills/shakes are gone, and my headache is mostly gone. The primary symptoms I have are the remaining sight fever, continued joint/muscle aches (mostly in my legs) and fatigue.
Severe hypertension with BP 185/105 and new onset atrial fibrillation
Headache, leg pain, stomach pain and diarrhea and fatigue. Loss of appetite  but Cravings for fruit...? So strange. Very thirsty.
Approx 3.5 inches of redness surrounding injection site, pain and swelling to site.
Patient reported receiving his first dose of Jynneos back on August 15th (will be due soon for his second dose) had been taking his maintenance every other week DUPIXENT PFS 300MG/2ML for dermatitis and reports that he injected his Dupixent a week or so before and after the vaccine dose. Patient only reports having had a sore bump at injection site but that he still has a bump there but overall his skin is fine. He gave lot number Lot FDP0018 for the vaccine.
Muscle spasm in the back of the neck Foot pain  Left arm pain/unable to use or lift it Pain in the bottom of my foot and neck pain are still ongoing The pain usually occurs around night time
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was elevated troponin, bilateral pleural effusion, hypertensive urgency.
By examination it was determined that I had multinodular goiter. Ultrasound showed 1 3.3 mostly solid nodule. Then on July 21, 2021 I went back to DR to find it was a 3.3CM nodule.
Pt had just been sent to observation area from vax station and reported that she was feeling "very warm" and that she was experiencing some "heart palpitations".  I was called over to assess her. She was flushed in the face, BP was 134/80 with pulse of 80, regular.  She denied shortness of breath or chest discomfort.  She was wearing a warm sweater and hat, so we removed the hat and transferred her by wheelchair to a cooler area.  She was still feeling weak, so we initiated a 911 call for EMS evaluation.  EMS arrived on site within 4 minutes and performed evaluation.  Pt was less flushed and stated she felt much better. She was not transported. Left clinic with her husband.  I called her today to follow up.  Other than some site tenderness and feeling "a little light headed" this morning, she feels fine.  She stated that she took ibuprofen for the injection site tenderness.  Her entire episode at the clinic last about 12-14 minutes from onset to time she left with her husband.
Chills about 9:30pm. Fever 102.4 at about 1am. Vomiting at about 3am. Symptoms improved slowly by 8am. Had weakness thoughout.
Approximately 5 days after the vaccination the patient's right upper arm became red, her elbow became swollen and both areas became itchy. The patient had tried using hydrocortisone 1% cream and BENADRYL spray to the red area of the arm. Upon consulting with the patient on 12/3, she was advised to try cold compress for a minimum of 15 minutes and to take oral BENADRYL, if  worse or no better in a few days consult with physician.
weakness.; chills; Fever 102°F; itch; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date).   On 29th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced chills, fever, pruritus and weakness. On an unknown date, the outcome of the chills, fever, pruritus and weakness were unknown.   It was unknown if the reporter considered the chills, fever, pruritus and weakness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and presented chills, fever 102°F, itch and weakness.  No symptoms after getting the 1st dose. The reporter did not consent to follow up. No lot number and expiration date provided.  Facility information not provided.
This spontaneous report was received from healthcare worker/vaccine coordinator who refers to a unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. It was reported that on an unspecified date, an unspecified number of patients received unspecified doses of VARIVAX (Merck) (lot # K010339, expiration date: 22-JUL-2016) (Lot # L016126, expiration date: 06-MAY-2017) (dose and route were not reported), that were improperly stored and were part of a immunization series. No concomitant medication was reported. The temperature of storage was reported as 27.9 degrees F as maximum. The time frame was 1008 hours. It was reported that there was cumulative exposures from 16-FEB-2016 through 29-MAR-2016. No PQC involved and no adverse effects were reported. Additional information has been requested.
12/20/22 My stomach hurt real bad. I had a bad cough and I also lost my sense of smell. I threw up, had diarrhea and it was so bad I ended up going to the emergency room.  I had a COVID test that was positive.  I was given medication. Then my back hurt so bad all night long and I was unable to sleep. The doctor said to use Voltron Cream or Diclofenac Cream.  It may have helped, but I still had a backache. They prescribed Paxlovid for the COVID, Benzonatate for my cough, a medication for my diarrhea and to take Gas X for my bloating. I waited a week or two and took an at home COVID test and it was negative. I continued to have a cough,  perhaps long COVID because everything else was gone.   My coughing has gotten less frequent.  I went to the Pulmonology doctor because of my cough. I started using my Albuterol inhaler more frequent. I had a chest x-ray which was normal.  He told me to use my inhaler more.
Fever 1 week after shots - lasted 3 days. Rash 9 days after shots.
Soon after patient had the shots(about 3 minutes), she complained of ear ache and something in the throat.(10:00am) So, she was returned to the Dr.'s examination room.(10:05am) While waiting(about another 4 minutes), patient's corners of of her eyes had hives and soon became swelling. The doctor came in and gave her two teaspoons of Beneydrl. But the swelling of the eyes did not get better, so the doctor gave patient the epipine and the steroids.The doctor noted that there was swelling of patient's lips and tongue. Also, she was coughing and wheezing. So, doctor gave patient some oxygen.At that point, the doctor had dialed 911 and patient was sent to Emergency room.(10:10am) She was stable after the paramedic arrived. She was in the ER for four hours to see if there is any more adverse reaction. She was fine and was discharged (3:00pm).
Vomited twice within 24 hours of Rota vaccine, diarrhea for 72 hours.
(The vaccine was administered greater than 6 hours after the vial was diluted, mix, and drawn up for injection
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    No concomitant medication details was reported. It was reported that patient first dose was a Moderna Monovalent dose. No treatment medication details was reported.  This case was reported for 14 Out of 18(6 Patients-2nd dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Small raised lump in arm more than a week after injection. Lump was warm and itchy. Started Friday and into Saturday. By Sunday it stopped itching. By Monday, no more issue.
Patient here for evaluation of abdominal pain and distention.  Patient states that he routinely needs to have ascites drained.  Patient currently with fullness, abdominal distention, and abdominal pain.
Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021 at 11:21 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.  Total amount of time the vial was exposed to room temperature range  8 degree to 25 degree C, 46degree to 77degree F) 14 hours, Date the vial was initially stored in the refrigerator-29NOV2021
Within 1 hour after administration it started itching at injection site. And then it became swollen and warm surrounding injection site. During night was painful, red, itching and warm. Used hydrocortisone cream, BENADRYL OTC (PO) and ice pack. Throughout next day I had cellulitis that was extending down to elbow and wrapping around the entire upper arm. Was started on cephalexin at end of second day and warm moist cloth.
DULL HEADACHE; This spontaneous case (PVX2019-1631) was received from a consumer on 24-Jun-2019. It describes a 64-year-old female consumer who had dull headache, after the administration of oral Vivotif (one dose every other day; lot number: 3003279 and expiry date: May 2020) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 21-Jun-2019. On the same day, she experienced dull headache. On 23-Jun-2019, she took the second dose. She continued taking Vivotif as her nurse stated that headache was a possible side effect and recommended to continue taking Vivotif. The consumer also stated that she had been under lot of stress and did not want to blame Vivotif for the headaches.  She took Tylenol (paracetamol) for headache.  Action taken with Vivotif was dosage maintained.  The consumer had recovered from the event.  Company's Comment: In this case, it was reported that the consumer had a 64-year-old female consumer had dull headache, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had a 64-year-old female consumer had dull headache, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
4 hours after the vaccine, I started to get body aches and chills and they continued to worsen. I started to develop a low grade fever 8 hours after the shot. 13 hours after the shot, I had a 104.1 fever. Along with the fever, I experienced severe body aches and chills, nausea and a horrible headache. I couldn?t walk as my body was so weak and my vision was blurry. About 15 hours after the vaccine, my fever went down to 102. I was able to get up and walk to my kitchen to take some Advil. My fever broke 20 hours after the vaccine with the medicine. I?m still experiencing severe body aches, headache, nausea and chills and it has been about 30 hours after vaccine. I did have covid 3 months ago, and the symptoms from the vaccine were much worse than the symptoms I had with actual covid.
Patient reorts feeling "funny" while in post vaccination site. Initial VS at 1030 128/80 P80 R18.  Patient denies any shortness of breath or breathing difficulties, no dizziness or lightheadedness.  Monitored at length due to patient being hearing impaired  and communication was by typing (no ASL interpreter available).  By 11am feeling at baseline. Released.
Patient developed sharp midsternal pain in the center of chest. He was diagnosed with Costochondritis. Clear Chest Xray. No hx of fever.
Approximately 30 minutes after receiving the Moderna vaccine, patient complained of feeling itchy on arms and stomach. This then progressed to tingling of lips and tongue. Patient was given 25mg tablet of Benadryl and ambulance called. Patient left in ambulance.