chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wed March 21, 2007 at 6:55pm. His whole arm around the injection site is swollen. No fever, no streaking. Using cool compresses and Benadryl 12.5 mg 1 tsp q4-6 hours.
Case number PHEH2013US006260, is an initial spontaneous report received from a nurse on 15 Mar 2013. This report refers to a 14 to 15-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with expired MENVEO (batch number: not reported) intramuscularly on 05 Mar 2013. No adverse event was reported following this administration error.
low grade temp, achy feeling, rash on rt arm-last evening noted other sx noted;
reported headache, fever of 103 on night of vaccine administration and lasted for the next 2 days and then was gone
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On 23-AUG-2013, the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose and lot number were not reported). The patient's concomitant therapies were not reported. On 27-FEB-2015, the patient received the second dose of GARDASIL, intramuscular (dose, lot number and indication were not reported) and on 29-APR-2015, the patient received the third dose of GARDASIL, intramuscular (dose, lot number and indication were not reported). No adverse effects and product quality complaints (PQC) were reported. Additional information has been requested.
3 hours after the patient was given his Hepatitis A vaccine he started running a fever. The fever lasted on and off for 3 days. The highest the fever got was 104. He was given Motrin and Tylenol which did not keep the fever down.
A non-serious spontaneous report of administration attempted with a cracked sprayer was received from a health professional concerning a 44-year-old female. She did not realize that the FLUMIST sprayer was cracked at the base. She attempted to administer vaccine to patient however realized after that there was no spray action and the vaccine dribbled out of the base of the sprayer. Therefore, the patient did not receive any vaccine from this sprayer (although the plunger was depressed into each nare before realization that vaccine dribbled out of sprayer base). There was no adverse event associated with this product complaint; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Immediately after receiving shots child w/blotchy macular red rash at site of flu shot (6x5cm LT) and other shots. (3x3cm RT, 5x4cm RA, 3x4cm LA) occurred even after bandaid placed. (3) 1cm blotches on back, blotches on neck within 5min. Attempted to have mother apply ice but not fully compliant. Benadryl 1tsp given 3pm; within 20 min all rash cleared. Child active and playful. No dyspnea/stridor. Observed for 1hr after shots. No sx noted. Sent home; call prn. Dr will d/w CHP ID further course of action with immun.
Infanrix: expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 02-OCT-2023, the patient received Infanrix. On 02-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix: expired dose administered).  The outcome of the expired vaccine used 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: 03-OCT-2023 Nurse reported an expired Infanrix vaccine was administered to a patient on October 2nd 2023, vaccine was expired on September 16th 2023, which led to expired vaccine used. The reporter consented to follow up.
Swelling in both hands, swelling in both ankles, fatigue, muscle and joint pain.
Painful swelling, and redness expanding daily, for the past week. General weakness, severe headaches, pain in abdomen, shivering, feeling cold when room is warm.
Headache, Fever, MUSCLE WEAKNESS, ALL OVER BODY PAIN, INJECTION SITE PAIN Narrative:
herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
BECAME SYMPTOMATIC AND TESTED COVID POSITIVE 8/13/21. DIED 9/7/21
Child came to clinic with rash. Benadryl by mouth. Changed Amoxicillin to Zythromax
Small bumps broke out on the lower part of my back, and I continue to itch to this day.
30 minutes after injection, my throat and base of tongue began to go numb as well as my cheeks began to tingle. I went to swallow a sip of my drink and couldn?t feel anything go down. It progressed till I couldn?t feel myself swallowing my own spit. Went away with no other issues after about 4 hours.
VALTREX 1g 3 times daily x 7 days. Rash over upper rt. buttock area that appeared within the last 24 hrs. after receiving vaccine.
Fever, golf-ball sized knot on the back of the upper Lt arm. It was swollen and red. Mother advised to give BENADRYL q4-6 hrs PRN.
I am a Covid survivor (March 2020) still with antibodies (at least I had them last November when I donated plasm). The morning after I received the Moderna injection (Tuesday), I had a fever of 99 and diarrhea. My fever rose during the day and I had chills. By 9:00 PM my temperature peaked at 102.4. I was taking Tylenol (1000 grams?) every 6 hours. The diarrhea, chills and fever all subsided during the night, so that on Wednesday morning, my fever was back to 99. It  did not rise during the day and was back to normal Wednesday evening. The chills and diarrhea never returned.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-FEB-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion six times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 56, 33 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 24, 48 and R. The total cumulative excursion time (hour), the highest temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 24, 49 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 120, 29 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 24, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the sixth excursion was 36, 34 and R. This is one of several reports received from the same source. Additional information has been requested.
Medication leaked out onto patient's skin; Fluzone Quadrivalent prefilled syringe was administered to a patient estimated that only half the dose was given; Initial information regarding an unsolicited non-valid non serious case was received from other health professional via Regulatory Authority (RA) (Reference number: 00832584) and transmitted on 28-Oct-2021.  This case involves a 24-month-old female patient receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered to a patient estimated that only half the dose was given (underdose) who experienced medication leaked out onto patients skin (exposure via skin contact).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Sodium (not applicable).  On 20-Oct-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ767AA, expiry date 30-Jun-2022] via unknown route in unknown administration site for prophylactic vaccination.  On 20-Oct-2021 the patient developed a non-serious event, medication leaked out onto patients skin (exposure via skin contact) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 20-Oct-2021, INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered to a patient, estimated that only half the dose was given (underdose) same day latency, non serious event.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.
Swelling, redness Lt thigh, 4 1/2" x 4" Benadryl, cool compresses seen in office 4/29/03.
DAY AFTER VACCINATION (1/6/21) AT APPROXIMATELY 12:30PM, DEVELOPED FATIGUE, DIFFICULTY TALKING, NAUSEA, AND MALAISE. SYMPTOMS RESOLVED IN 1 HOUR.
Angioedema, onset began 8 hrs after vaccination. Did not have adequate response to steroids & antihistamines; required nasotracheal intubation, now with our team in the ICU. Unclear if secondary to vaccine or other cause.
Sore arm comes and goes 7 weeks. No treatment. Mentionaed to MD on 2/7/2014.
ZOSTAVAX administered 10/17/11, 10/19 redness itching swelling at site of injection - softball size - doubled overnight in size - tender to touch & warm, able to use extremity with ease/no numbness. No difficulty breathing/systemic reaction.
Around 1:15pm on 4/14/21 about  30 minutes after receiving dose 1 of the Pfizer vaccine, my body started to feel itchy, mainly on my back and arms. I was able to examine my face and body around 1:30pm when I noticed some blotchy, unraised pink rashes on my face near my ears, on my upper back near my shoulders and on my inner thighs near my knees. With it being allergy season in NJ, I would have typically taken Claritin the night before. But because I was getting the vaccine, I did not as per my understanding of CDC guidelines. At around 1:45pm, I took a Claritin Redi-tab. Approximately an hour later, the blotchiness resolved. However, the itchiness continued throughout the rest of the day, albeit less so. Around 4:30pm, I started to experience a headache, a metallic taste in my mouth, as well as a sensation on my lips that felt like sunburn. The headache was on and off and last until the next day. The metallic taste and sunburn sensation lasted a few hours. I treated with Advil and took a Benadryl before bed to deal with the itchiness. I have had some headaches throughout the week. This weekend I experienced some arm discomfort in my left arm.
Within 12 hours after the dose, the lymph node swollen. My arm was sore, my lymph nodes were swelling on both arms, I had a fever of 101. I had flu like symptoms. The symptoms lasted for four days. The nodes stayed swollen. I anticipated that part. About two to three months later, I had a fever and the lymph node on my right groin was palpitating and swelling and fever. I went to urgent care, their were concerned with infection and sent me to the ER. At intake I had temp and my bloodwork was normal for the most part. I had a negative COVID-19 test. A week later I was still the same with fatigue and swelling, I went to my PCP, and she did a Epstein Barr virus test and is was positive. There was no medication, they went down and came back two months after that. I also feel severe fatigue with it all over again. This is happening frequently is happening my swelling of lymph nodes with nausea. I can't even open a bottle of water. It's not the lymph nodes under my arms, but it also in my groin and elbows. I had a ultrasound of my right breast and found a cist. I am now waiting on testing to see if I have chronic Epstein Barr disease using a EBV Antibody Profile Test. At the moment I feel like this permanent damaged, because of this diagnosis.
Headache, Myalgia, NauseaVomiting, Mental fogginess Narrative: Pt reported headache x 3 days. She has fully recovered.
Patient presented to the pharmacy for vaccine as a walk in.  At the time of the vaccine, she was 17 years old.  Vaccine is approved for patient 18+ years old only.
Patient started to experience dizziness and shortness of breath within 10 minutes after the vaccine.  Some rash was observed on her arm and neck area.  She then stated that she couldn't breathe, and started to vomit.  Epipen 0.3 mg was given to her on her right thigh.  Paramedics was called.  They arrived and took her away.  Patient did not loose consciousness during the entire event.
Tachycardia (130-140s), palpitations, chest pain, breathlessness - now on week 3 of symptoms.  Awaiting a Cardiology appointment.  Also with worsening smell and taste compared to prior to vaccination.  Now with paranosmia.
started with chills about 10 hours after receiving vaccine  at 12 hours after receiving vaccine it started with a fever of 100.4 16 hours later the fever was then at 101.4  20 hours later the fever was at 102.2  tylenol was taking starting at hour 12 then switching between that and Motrin did not break the fever fever finally started breaking at hour 36 now has normal body temperature but is switching between sweating and chills.  nausea has been persistent since hour 12  body pain started at 10 hours and has continued to 40 hours  arm pain where shot was injected with some swelling and redness
red rash on my inner thighs; pain in the injection site; couldn't go back to sleep; chills; my throat hurt; tired; muscle pain; my arm hurt; pain in my shoulder is much improved though; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non pregnant female patient received second dose of BNT162B2 (Solution for injection, lot number: EN6199 expiry date: unknown) via an unspecified route of administration in Right arm on 08Mar2021 10:45 as a single dose for Covid-19 immunization. Medical history included high blood pressure and cholesterol, she had diverticulosis, but it was not active at the time of this report. She did not have any known allergies. Concomitant medications in two weeks included Amlodepine, Rosuvastatin and unspecified prescription medicine for high blood pressure and cholesterol. The patient previously received first dose of BNT162B2 (Solution for injection, lot number: EN6201 expiry date: unknown) via an unspecified route of administration in Left arm on 15Feb2021 14:00, as a single dose for Covid-19 immunization. The patient did not receive any other vac-cine in four weeks of suspect vaccine. It was stated that the first shot caused soreness in her arm where the injection was made, which went away after about three days. After about 10 days, she developed a rash on both inner thighs. It cleared up in about three days. The patient also had a rash on the left side of face about the same time. She received second shot two days prior to this report, on 08Mar2021, the day of vaccination, the patient experienced that her arm hurt, and she woke up about 4:30 am and could not go back to sleep because it hurt so. She had chills that day, her throat hurt, she felt so tired, and had muscle pain. On 10Mar2021 the day of this report, two days after the shot, she had the red rash on inner thighs again, but the other symptoms (except for the pain in the injection site) were gone. The pain in her shoulder was much improved though. She did take one acetaminophen a day prior to this report in afternoon. The patient did not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of the events of was resolving.  No follow-up attempts were Possible. No further information was expected.
Patient received Pfizer COVID vaccine on 2/26/21 and 3/26/21. On 1/13/22, patient admitted to our inpatient facility with acute hypoxic respiratory failure secondary to bilateral segmental PE and COVID pneumonia. As of today (1/17/22), patient is still admitted in our med/surg unit.
Information has been received from a certified medical assistant concerning a 17 year old female with a history of penicillin allergy who on 27-FEB-2008 was vaccinated with IM with the first dose of GARDASIL (658556/1060U). On 23-APR-2008 the patient was vaccinated IM in the right deltoid with the second dose of GARDASIL (659962/1740U). The medical assistant reports that the patient developed a "knot" at the injection site at an unspecified time period after receiving the second dose. The patient phoned the physician's office on 10-JUN-2008 to report the adverse symptom. No other symptoms or treatments were reported and no other information is available. The patient's "knot" at the injection site has persisted. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Father called within 2 hours after vaccine was given, complained of the daughter "cant see".  Sent them to ER and I called the father today (the next day) and he said by the time they were seen at the ER, her vision improved and by the time they were home, she was back to normal.   Apparently Dad said no treatment was done in the ER.  I still have to get hold of the ER and get their records.  In the meantime, I got hold of a local Infectious Disease Physician and he have not seen something like this.  I also got hold of GSK medical staff and mentioned one report similar to this and have not known of this kind of event after Bexero.    Talked to the father this morning and he said, the daughther is back to normal and was grateful I checked on her daughter.
Aches and pains low grade fever day after injection 06/14/2003.  On 06/16/2003 midnight-deep muscle pain-very painful-chills, fever 104, lasted 36 hours.
had vax in AM-6PM started an unusual, high screaming/crying episode; lasted 2-3 hrs; also had a staring spell that lasted a few minutes; did not seek medical attention; seems better today;
urticaria began 9MAR98;mom contacted nurse @ home 10MAY98 in AM;told to give DPH;pt improved as long as took med;hives reappeared before dose wore off;seen 11MAY98 large welt legs, back;
Fatigue, stomach upset, diarrhea, & vomiting lasting one day. Arm sore, swollen, & warm to touch for 3-4 days. Clt. requested this be reported. She"never felt this way after receiving a vaccine".
1/18 began to notice that arm is getting warm and became red over the next couple days. Today (1/21) 8 by 10 cm. of redness. referred to agency. placement of shot look appropriate.
Received COVID-19 vaccine the afternoon on 12-18-2020 on 12-19-2020 developed chest pain and "heart racing" intermittently.  Lasted approximately 1 hour .  Patient did take Nitroglycerin  2 times .
Received around 7-8pm on 12/22. Woke up 12/23 feeling okay, just L arm soreness however as day went on progressively worsening chills, myalgias, malaise, headache, and extreme weakness/fatigue. Lasted 24-48 hours, peaking around 24-36 hours. Necessitated sick call out from work. Of note I had Covid in March and had antibodies prior to vaccination.
Got them after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got them after). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient also had the Shingles shot and got them after. The patient had another shot since then and he/she hoped that he/she never had them again. Follow up was not possible, as no contact details were available. As per narrative it seems patient experienced AE after 1st dose only, hence captured conservatively
Severely ill; Body aches; Fever; Chills; Nausea; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CRITICAL ILLNESS (Severely ill), PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRITICAL ILLNESS (Severely ill) (seriousness criteria hospitalization and medically significant), PAIN (Body aches) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). At the time of the report, CRITICAL ILLNESS (Severely ill), PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive. On an unknown date, Oxygen saturation: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's history of COVID  infection just before the vaccination remains a confounder.   Patient had COVID before vaccine.after her isolation was over she received 1st dose; she got severely ill; she had  fever, chills , body aches , nausea , and she was in the hospital on temporally oxygen.   Patient wants to know when she can get the 2nd dose of the vaccine and is it safe to take second vaccine?; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's history of COVID  infection just before the vaccination remains a confounder.
Pt recvd 3 Hep B vax given 26JUL89, 29AUG89 & 23JAN90; 13MAR90 titer=30; 21FEB91 titer=4; Pt was given a 4th Engerix-B dose on 14MAY91 & following this, titer=117;
Child began having seizures, started as twitching of right leg for about 4 minutes, then extended to include right arm and right side of face for another 5 minutes, finally generalized to all of her body for another 10 minutes. EMS arrived during that time and gave Diastat, which immediately stopped seizures. Transported to Hospital ED, where bloodwork, CSF cultures, and head CT performed. Gave patient prescription for Clindamycin because she also had otitis. Patient discharged home from ED.
Patient's wife presented for her 2nd dose of Moderna today. She reported to us that her husband died between his 1st dose of Moderna and now (date not reported). His death was NOT related to COVID.