chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Claims Supervisor concerning a male who on approximately 30-Sep-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose, route, and lot# not reported). On 01-OCT-2009 the patient experienced a severe infection and pain after receiving an injection of PNEUMOVAX 23 on the deltoid portion of his left arm. The onset of the infection and pain took place within 24 hours of the injection administered by pharmacist. This infection was reported to pharmacy on 06-OCT-2009. At the time of the report, the patient's outcome was not reported. Additional information has been requested.
I first noticed itching around the injection area and swelling. As the day kept going, it got bigger until my whole upper arm had a rash extending even to the back. I took my allergy medication and took some Benadryl as well because I figured I was having an allergic reaction. Every day after that it kept itching and it felt hot to touch. And the mark and swelling stayed on my arm for months but even after that was gone (3 months later) the itching kept persisted still from time to time until around 5 to 6 months after I received the vaccine that all my symptoms finally stopped.
Patient felt dizzy, blurry vision and vomited. Paramedics arrived, and evaluated patient.
THE DAY AFTER THE VACCINATION, PATIENT DEVELOPED HIVES ON HER LEFT ARM NEAR THE SITE OF INJECTION. SHE ALSO REPORTED ONE SINGLE HIVE ON HER RIGHT ARM.  PATIENT CALLED PHARMACY. PHARMACIST INSTRUCTED HER TO TAKE BENADRYL AND DRAW A CIRCLE AROUND THE AREA.  IF THE AREA INCREASED IN SIZE, SHE WAS INSTRUCTED TO SEE MEDICAL ATTENTION.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA281633, 2018SA279965, 2018SA279979, 2018SA281635, 2018SA281638, 2018SA281636, 2018SA279966, 2018SA279967, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA281687 and 2018SA281692, same reporter. This case involves a 3 months old male patient who received vaccine PENTACEL. The patients past medical history, concomitant medication and family history were not provided. On 13-Sep-2018, the patient received injection of suspect PENTACEL VACCINE lot C5507AA, expiry date 05-Sep-2019 via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient received vaccine of which had Temperature on 11 Sep 2018 through 13 Sep 2018 was too low at 30 F, below freezing for 4 hours. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
My child came down with cold/flu symptoms a week after the immunizations then 3-4 weeks later starting having seizures.
Patient is 17 years old and 6 months, not the approved emergency use authorized age of 18 for the Moderna shot.
Around 2/1/19 child became ill, was seen on 2/5/19, had fever x 2 days and fever broke on 2/5/19, on that day rash started all over body which got worse for several days, and finally started improving, today 2/8/19 rash almost all gone. On 2/5 Dx was viral exanthem vs vaccine reaction. Father noted on 2/6/19 child becoming more clumsy, had been walking since 10 MOS old, but now loss of balance "almost like he was drunk" and fell often, he is choosing to crawl like he did 3 MOS ago. Previously he would be grabbing a ball and running with it. Dad describes a lack of eye contact. No fevers since 2/5/19, but today in daycare teachers say he won't play, just sits there. Dad describes him as "zoning out" not engaging and laughing like he used to. He was self-feeding with a spoon, now he won't really eat. He is mostly being carried, not engaged with parents the way he was. He use to point at everything and say this, now he neither points nor says anything at all. He mostly screams and "zones in and out". No treatment or tests have been done.
The first covid vaccination I had symptoms of being flush and a heaviness in my chest.  This lasted 4 3-4 days.  I did seek medical attention at the emergency room day 3 and was hospitalized 1 day.  I was found to have unexplained and unregulated hypoglycemia.       The second shot I had body aches, headache, fever.  I was able to manage my symptoms with Tylenol and Advil.
The patient received the second dose of the series on 1/19/21, earlier than the scheduled date of 1/26/21. Within the first 24 hours of vaccination, the patient experienced soreness at the injection site, headache, body aches and fatigue. The symptoms lasted no longer than 24 hours. The patient states some of the symptoms may be due to her seasonal allergies of mountain cedar and mold.
Got covid...headache, cough, runny nose, temperature of 100.4, extremely sore throat
Tingling in left arn and left leg, on Day 5 1/3/21 perspiration and sweaty, no fever Narrative
Information has been received from a nurse practitioner concerning a 29 year old female patient. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration, dose and route were unknown), at the age of 29 years. After 1 hour of administration, the patient experienced dizziness and fatigue. The outcome of the events was not reported. No product quality complain (PQC) was involved. The causal relationship between the events and GARDASIL 9 was not reported. Additional information has been requested.
Janssen COVID-19 Vaccine EUA; Approximately 8 hrs later started to feel achy; went to bed at 7:30p (about 10hrs after the shot) feeling as though every single nerve ending in my body was tingling with a very mild fever (+1 degree); sleep was very shallow; felt queasy and generally "yucky" for several days later; would feel better and then worse in waves every couple of hours until Saturday (approximately 5 days later)
I received my 5th dose of Pfizer Bivalent on 09/19/2022. My adverse event of COVID-19 Infection started on 12/06/2022 in the morning. I had a sore throat ,cough and fatigue.  I also had diarrhea for 1 day. I did a home COVID-19 test which was positive. The next day on 12/07/2022 I contacted my doctor. They prescribed me cough syrup and Mucinex. I had mild COVID-19 symptoms.
This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were vaccinated with an unspecified number of improperly stored doses of MMR II injection (lot # K011188 with expiration date 12-AUG-2016, albumin status RHA (recombinant human albumin), Lot# K012473 with expiration date 26-AUG-2016 albumin status RHA, and Lot# K020189 with expiration date 11-SEP-2016 albumin status HSA human serum albumin; dose, and route were not provided). There was no concomitant medication. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Patient reported headache and nausea following 1st dose of pfizer covid vaccine. Patient was able to released with no intervention.
Stated after patient received shots child began to run a high fever of 104 - 105 degrees, and developed a cough.  Stated also had decrease in appetite.
Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with nausea, vomiting, and diarrhea for 3 days.  Tested COVID 19 positive. Found to be hyponatremic.  Was treated with IV fluids.  Discharged on 3/6/21. Follow labs on 3/8/21.
pt states 1wk p/getting inj had rash on lt arm where Td given;
Tuesday 10/1 Fever began in the evening sometime reaching up to 102 with decreased appetite.  Lower next morning but returned again that evening again up to 102.  Thursday  10/3 no fever but polka-dot rash all over body persisting until now, 10 AM Saturday 10/5.  White spots present in mouth inside of cheeks with blueish centers.
Right deltoid has 2cm annular red induration - Pt c/o nausea, vomiting, & fever of 101.4 F 2 days after injection was given.  States she has never had reactions to previous tetanus no drainage.  Injection site still tender to touch
Unsettled stomach/diarrhea   Do not know accurately which RSV vaccine was administered.
severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; I had to go to ER to give me some kind of shot but pain still there in my leg/painful in the thighs; This is a spontaneous report from a contactable consumer.   A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Lot Number: ER8732) as SINGLE DOSE (at the age of 59 years old) for covid-19 immunisation .  Medical history included arthritis from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. The patient's concomitant medications included oxycodone hydrochloride, paracetamol (PERCOCET) for pain "I am taking pain killer for it but it's not working".  Historical vaccination included BNT162B2, dose 1, Lot number:  EN6206, on 03Mar2021 for COVID-19 immunization at the age of 59 years old. On unknown date, the patient had severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on. He had to go to emergency room (ER) to give him some kind of shot but pain was still there in his leg. It brought back pain in his shoulder and in back that he had in the past and he was weak. "The reason that I stop and it felt pain went away but the back and the leg pain was still there and it is very very bad." Consumer stated, "Yes but I was not sure it was the vaccine causing it I had arthritis and I thought it might have been arthritis is causing it. It was like 10 hours later when I started to experience the side effect." The patient underwent lab tests and procedures which included complete blood count (CBC) : unknown result on unknown date , Comprehensive metabolic panel: unknown result on unknown date.  Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected
Information has been received from a 76 year old female with chronic obstructive pulmonary disease (COPD), atrial flutter, blood pressure and thyroid disorder and no drug allergies who on 03-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). Concomitant therapy included bisoprolol, levothyroxine Na, PRADAXA, omeprazole, pravastatin Na and ipratropium bromide. On 04-MAR-2011 the patient noticed her arm was red and swollen at the injection site. It had been almost a week since she had ZOSTAVAX (Merck) administered. She also had itchy hands. No lab diagnostics studies were performed. The patient did not seek medical attention. At the time of reporting, the outcomes were unknown. Follow up information has been received from a physician concerning the patient with shellfish allergy who on 03-MAR-2011 at 11:00 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 669259/1360Z, dose not reported) into her left deltoid. Patient experienced redness at inject site, swelling and itchy hands on 04-MAR-2011. It was not sure if S/E (side effect) from vaccine per MD. Additional information is not expected.
Patient received flu vaccine mist on 9/19/2013. Patient noted on screening form NA for possible pregnant status had positive pregnancy test on.
Day after vaccine- arm pain from shoulder to elbow all day,   chills and nausea 6-10 pm day 2-arm pain from shoulder to elbow all day, chills and nausea but less than before 6-10 pm day 3- arm pain from shoulder to elbow all day, chills and nausea (chills were not as bad but nausea was the worst of all three days) 6-10pm
Single round pruritic, urticarial rash on right buttock at site of injection. Recurs at 3 week intervals
Vaccination failure; Breakthrough covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 20Apr2021 as dose 2, single (Lot number: EL3247), in right arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 320308D), in right arm, all intramuscular for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient's relevant medical history and concomitant medications were not reported. The patient had not experienced Covid-19 prior vaccination. The following information was reported: COVID-19 (medically significant) with onset 16Apr2022, outcome "recovered with sequelae", described as "Breakthrough covid-19 infection"; VACCINATION FAILURE (medically significant) with onset 16Apr2022, outcome "recovered with sequelae". The events "vaccination failure" and "breakthrough covid-19 infection" required physician office visit.   Patient's clinical course was the following: Breakthrough COVID-19 infection. Mild headache, runny nose, cough, fever, chills, general fatigue and loss of taste and smell. Most symptoms lasted about 3 days. Cough, runny nose and loss of taste and smell persisted for over a week. Slight recovery of taste and smell about 1.5 weeks post infection.  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive, notes: Clinitest Rapid Ag test; (25Apr2022) Positive, notes: BinaxNOW Rapid Ag test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
(L) arm swelling - redness starting evening of 4/25/11 - date pt received vaccine, temp. 98.8. No tx.
Client had swelling, redness, and skin was warm to touch from deltoid to elbow. Client was encouraged to use warm and cold compresses and to primary doctor if any s/s of shock, or if swelling increases.
2/2/21 Flu like aches:  vomiting and diarrhea, fatigue and headache. 2/3/21 Nausea, disorientation, and headache.  Slept off and on. 2/4/21 Tiredness and headache.  Took Benadryl 2/5/21 Body aches and fatigue.  Foggy brain.  Took Benadryl. 2/6/21 Sore throat, body aches, and fatigue.
Administered vaccine and immediatly his where I injected became like a hard ball.  Swelled, hard nodule.  No treatment.  Monitored pt.
Pain at site muscle aches, body aches, headaches, fever 101,fatigue and chills
No additional AE.; Improperly stored PROQUAD vaccine was administered to a patient.      ?  ?; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 12-AUG-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection(lot number: U026800, which has been to verified to be valid, expiration date reported and validated as 26-FEB-2023) to prevent measles, mumps, rubella and varicella infection (strength, dose, route of administration, and anatomical site of injection were not reported).The administered dose of the vaccine was stored at a temperature of -14 degrees Celsius (C), during a time frame 37 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Redness, swelling, itching, and hives spreading from injection site out about 3 inches all around, beginning one week after vaccine administered.
Aches, malaise, chills, syncope, dizziness, urinary incontinence.
not feeling well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received Shingrix. On 5th March 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and on the day of reporting was not feeling well.  Reporter did not consent to follow-up.
fever; had trouble sleeping; did not feel well; really grumpy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), INSOMNIA (had trouble sleeping), ILLNESS (did not feel well) and ANGER (really grumpy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 20-Oct-2020 to 27-Oct-2020. Concurrent medical conditions included Diabetes and Hypertension.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (fever), INSOMNIA (had trouble sleeping), ILLNESS (did not feel well) and ANGER (really grumpy). At the time of the report, PYREXIA (fever), INSOMNIA (had trouble sleeping), ILLNESS (did not feel well) and ANGER (really grumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Tylenol. No concomitant medications were provided by reporter.
02:42PM 110/50, HR 80, RR 20 appears anxious Reports doesn't routinely take FSB "I goes how I feel" Needs transportation to return home.  Denies eating today.  No family.   03:07PM Left ambulated to car independently
Fluzone HD was administered to patient is not indicated based on age. Patient is 63 years of age. Fluzone is only indicated for 65 and over. No actual adverse side effects reported by patient.
Chronic diarrhea started February 28th and lasted until June 13th. No treatment or dietary change altered the symptoms. It stopped abruptly and has not recurred.
No adverse effect noted, no negative signs or symptoms, patient's parent called reported no negative effect of the vaccine.
expired ACTHIB was administered to a patient with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old female patient who got expired HIB (PRP/T) vaccine [ACT-HIB] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 24-Aug-2023, the patient received (TOTAL) dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot- UJ739ABA and expiration date- 10-Aug-2023) via unknown route in right thigh (dose and strength: not provided) for Immunization (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
pt recvd 2 doses of Engerix-B & became pregnant; now 5 wks pregnant;
The next day after taking the booster dose of the COVID-19 (Pfizer) shot, I woke up around 7:30 am with pain in my abdomen. This then prompted me to go to the bathroom. I had constant loose stools (diarrhea). It made me feel very, very, weak and nauseous. At the same time, my heart rate began to rise rapidly causing me to sweat. I had the sudden urge to throw-up. After fighting this constant feeling for a couple of minutes, I went to my room and notified my sibling I felt like I was about to pass-out. I could not feel the weight of my legs. I began to fall towards my bed.
This is a spontaneous report from a contactable consumer. An 80-year-old female patient received PREVNAR 13, via an unspecified route of administration on 17Dec2014 at single dose for immunization and an influenza vaccine via an unspecified route of administration on 17Dec2014 at single dose. Medical history included hypertension and osteoporosis from unknown dates. Concomitant medication included lisinopril for hypertension. Past vaccination history included flu shot in Sep2013 and pneumococcal 23 in Sep2013. The patient reported that on 17Dec2014: "I went to a local drug store and they gave me a sheet to be filled out and I contacted my local insurance company, they said they would cover my pneumonia 13 shot so I went to local drug store, they gave me a sheet and I filled it out and they went to get the shot but the pharmacist accidentally gave me a Regular seasonal vaccine flu shot." The patient reported that she noticed and asked whether it was PREVNAR 13 and the pharmacist did not realize that was not the one. The patient reported that she had received the "regular flu shot" in September of last year (2013). The pharmacist apologized and gave the patient the PREVNAR 13. The patient went home and experienced a temperature of 102 degrees Fahrenheit, and figured it was a reaction to one of the vaccines, so she stayed home and took TYLENOL. The patient reported that as of 20Dec2014, her fever came down but she still has aches and pains like a chill and I still have a little bit of the symptoms. The patient reported that she had a blood test in 2013 and everything was okay. The clinical outcome of the body temperature increased was reported as recovered and the chills and aches was reported as not recovered.
Chills, loss of taste and smell, weakness, shallow breathing  Narrative: Patient referred to facility ER for COVID- 19 testing and evaluation of symptoms
This spontaneous report was received from a nurse and refers to approximately 25 patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (exact dose and route were not reported, lot # K016314, expiration date: 05-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.