chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received shingrix instead of varicella vaccine; 35 yo patient was administrated shingrix; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 35-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's comment: The physician reported that the patient received a dose of Shingrix instead of varicella vaccine. No adverse event was reported. No patient's identifiers, LOT number, expiration date and vaccination date provided. The reporter consented to follow up. Additional Supportive Information: A 35 years old patient received a dose of Shingrix instead of varicella vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Extreme flare-up of eczema around eyes. The other day when I noticed it began I couldn't open my eyes when I first woke up; since then every morning I've had puffy eyes with a ring of eczema around both eyes. I currently have blurry and foggy vision. The last time I had eczema around my eyes was Fall 2016, but it was nowhere near as painful and prominent as this. I was mandated by my college to get the vaccine, to which I was very much personally against getting, even after my doctor wrote a letter to the college stating I do not need the vaccine, supporting my belief not to get the covid vaccine. The school did not agree with me, I was told to take a sort of leave of absence, or get vaccinated. I am not sure that the vaccine is directly responsible for this recent painful flare-up of eczema on my face, but it is the only thing recently that has been out of the ordinary. I am cautious with products I use, as I often get eczema on my hands. The eczema on my face currently is the worse case of eczema I have ever experienced.
I lifted a 5 gallon bucket with my left arm. There was maybe 2 to 3 gallons of water in the bucket. I was trying to mop the kitchen floor. I felt a pop in my upper left arm as I lifted and a sharp pain directly underneath my smallpox vaccination site. Since then, I've experienced intense pain at times (putting on my coat nearly had me scream) and the area of my upper left arm is puffy. My smallpox vacinnation site is now only a reddish circle on my arm. I can't sleep on my left side. A nurse took a blood pressure yesterday and the inflation of the cuff made me wince with pain. Immobilizing my arm with a sling seems to help as it may allow the muscles time to heal by decreasing the strain. Any strain seems to trigger a continuous pain that becomes more intense with more use.
Itchiness of tongue; Itchiness of throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONGUE PRURITUS (Itchiness of tongue) and THROAT IRRITATION (Itchiness of throat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Medical history reported as asthma), Allergy to nuts (Medical history reported as allergies to peanuts), Allergy NOS (Medical history reported as allergies) and Migraine NOS (Medical history reported as migraines).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jan-2021, the patient experienced TONGUE PRURITUS (Itchiness of tongue) and THROAT IRRITATION (Itchiness of throat). At the time of the report, TONGUE PRURITUS (Itchiness of tongue) and THROAT IRRITATION (Itchiness of throat) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events Benadryl and Zyrtec. No relevant concomitant medications were reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Redness, swelling at injection site, exteding 2 inch diameter.  Mild tenderness
Dry cough occurred prior to vaccine. Cough persisted and worsened with mucus 7 hours after vaccine administration. Nasal congestion and loss of taste and smell began 19 hours after vaccine administration. Took acetaminophen to relieve cough and nasal congestion, it only began relieving cough symptom. Nasal congestion and loss of taste and smell still ongoing.
This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 07May2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included melanoma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included nivolumab (OPDIVO), ibuprofen (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN), hydrocodone bitartrate / paracetamol (NORCO), cyclobenzaprine hydrochloride (FLEXERIL) and colecalciferol (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 16Apr2021 at 09:00 (age at vaccination-unknown) as a single dose for COVID-19 immunisation. On 08May2021 at 04:00, the patient experienced nausea, headache, chills, was feeling very sick and weak. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events nausea, headache, chills, feeling very sick and weak were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with the first dose of GARDASIL (dose, route and indication not reported) in November 2010, the second dose of GARDASIL (dose, route and indication not reported) in May 2011, and the third dose of GARDASIL (dose, route and indication not reported) on 16-FEB-2012. No adverse effects reported. Therapy was not discontinued. It was unknown if the patient sought medical attention. Follow-up information was received from a registered nurse who stated that the 18 female student patient on 22-NOV-2010, was vaccinated intramuscularly (IM) in the left deltoid with the first dose of GARDASIL (lot#666595/0887Z, exp date 14-OCT-2012). On 20-DEC-2010, the patient was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot #666595/0887Z, exp date 14-OCT-2012). On 21-FEB-2011, the patient was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot #667944/1247Z, exp 26-FEB-2013) and on an unspecified date, the patient was vaccinated with the fourth dose of GARDASIL. The patient did not sought medical information. The nurse stated that the patient received the third dose of GARDASIL 1 month too soon for it to be effective. The patient was advised to have the fourth dose of GARDASIL; dose through Health Department based on information provided. No further information is available.
Around 24 hours after Trihibit vaccine given , he developed purpuric/ petechial rash
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Tested positive for COVID-19 after symptoms for four days. Headache, sinus and cough, and fatigue for five days and had on and off congestion for another 5 days. No fever.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 16Jul2021 (Batch/Lot number: unknown) as dose number unknown, single 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), COVID-19 (medically significant) all with onset 22Nov2021, outcome "unknown" and all described as "tested positive for Covid". Patient was given her final shot of the Pfizer Covid vaccine on 16Jul2021 recently tested positive for Covid (22Nov021). Her symptoms were mild, but they existed, and they were not as mild as consumer unvaccinated younger son who had Covid last week. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Very ill for 6 week total onset with fever lethargy weakness flu-like symptoms numbness in both arms from shoulder down to glove-tip three doses of antibiotics reaction to bactrium caused a huge blister on upper lip covering left half of upper lip recovered from flu-like symptoms but daily numbness in both arms still occurs not diabetes no numbness in other extremeties when numbness occurs the pain involved in arms returning to near normal is excruciating like a labor pain I have been living with this for almost 4 years hoping that with time and excercise it would improve; otherwise, I am healthy I walk I had and still have Hashimoto's disease that is treated and a low hypertension that is also treated. My oldest son also took the shot and was hospitized because he could not feel his legs.
Patient received Gardasil vaccine in P.M. during night, nausea, vomited x 1, then fainted. Temperature 100.7
Patient contracted Covid-19 after receiving first dose of Pfizer Vaccine; Patient contracted Covid-19 after receiving first dose of Pfizer Vaccine; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted with COVID-19 after receiving the first dose of Pfizer vaccine. It was unknown whether patient contracted COVID-19 prior to receiving the vaccine or after the vaccine. It was unknown after how many days of first dose of vaccine the patient had COVID 19. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Pt recvd MMR vax early MAR92 & by 23MAR92 c/o h/a, fever, vomiting; On 28MAR92 pt was hospitalized & dx w/meningitis; LP showed 87 white blood cells w/77% segemented neutrophils, 3% lymphocytes & 20% monocytes;
Signs/Symptoms: Macular rash on face, upper arms and chest; "tickling" in throat.  Treatment: Benadryl PO @ 14:10.
t 104 & rash 14 days /p the vax. C/O neck hurt
Disorientation, mental fog, inability to focus, mood swings, numb arm, vision impairment (straight lines became wavy and when he moved his head it took time for his vision to catch up with where he was looking), nausea, loss of some motor function, and nearly blacked out.
developed low grade fever later same evening then going to 102.5 by 4pm next day.
This spontaneous report was received from a physician referring to a 50 year old female patient with recurrent sinus infections. The patient's medical history and historical drugs were not reported. Concomitant therapies included BACTRIM. On 04-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular route, in the left deltoid (dose, dose number, frequency were unknown) with lot number R009162 and expiration date 01-JUL-2020 (also reported as 06-JAN-2020). On the same date of vaccination (reported as "within 1 to 2 hours"), the patient developed severe injection site pain, erythema, and muscle tenderness, and the pain was radiating to the patient's neck, deltoid and tricep. The physician reported that as a result of the pain, the patient could not lift her left arm above 90 degrees and was also having difficulty moving her neck, which physician considers a significant disability. The patient's pain lasted all night and she returned to the physician on 05-SEP-2018 (reported as "today"), the physician reported she did not observe any muscle or joint swelling, and that the events were caused maybe because the injection went in the wrong part of her arm. At the time of the report, the outcome of injection site pain, erythema, myalgia, musculoskeletal discomfort, administration site movement impairment and neck pain was reported as not resolved. The physician did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination.
the patient only received about 90% of the dose/no AE; vaccine leaked between the needle and syringe during injection/no AE; Initial information was received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 21-year-old female patient for whom it was reported that that the RABIES (HDC) VACCINE [IMOVAX RABIES] leaked between the needle and syringe during injection (wrong technique in product usage process) and the patient only received about 90% of the dose (underdose).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 14-Jul-2021, the patient received a 90% of 1 ml dose of suspect RABIES (HDC) VACCINE (lot 768914, expiry date- 26-Aug-2022) via an unknown route in unknown administration site for unknown indication (underdose).  It was a case of actual medication error due to vaccine underdose (latency same day).  It was also a case of wrong technique in product usage process (latency same day).  Pharmacist reported:" While administering a dose of Imovax Rabies to a patient, the vaccine leaked and the patient only received about 90% of the dose. How should I proceed?"  At the time of report, no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There would be no information available on the lot number for this case.
Pain 5/10 at site and enlarged, tender axillary nodes.  Accompanied by mild swelling and erythema of the site and flu-like symptoms.
Patient called and said she had some swelling about the size of a quarter and some itchiness too.
bloody stools; positive for Rotavirus; fever; This spontaneous report has been received from an other health professional (reported as HCP) referring to a 2-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On an unknown date in 2023, the patient was administered with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, dose, lot #, and expiry date were not provided).  On 18-JUN-2023, the patient had 100.2 (unit not provided) fever (pyrexia).  On 19-JUN-2023 (also reported as the day after the child had 100.2 fever), the patient was administered with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, dose, lot #, and expiry date were not provided).  Then the patient was afebrile for 2 days. On 23-JUN-2023, the patient had a 100.4 (unit not provided) fever with bloody stools (haematochezia). On the same date, the patient went to the emergency room (ER). In the ER, the patient performed PCR stool panel test and came back positive for rotavirus (rotavirus test positive).  The patient had sought for medical attention. The outcome of all the events was unknown by reporter.   The causality assessment between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and all the events was not provided.  Upon internal review, the event haematochezia was determined to be medically significant.
After leaving the pharmacy, the patient drove across the street to go to the grocery store. When he got out of his car, he experienced severe pain in both hips, reporting that the pain was more severe in his left hip. He had to sit back down in his car and felt unable to walk due to the pain and he immediately called the pharmacy, which happened about 20 minutes after his vaccine was administered. He denied any difficulty breathing, dizziness, or heart pounding. The pain started to subside and after about 10 minutes the patient said he felt safe to drive home. I called him about 30 minutes later and the pain was gone. He said it lasted 15 to 20 minutes in total. At that point he was not experiencing any symptoms.
Death, unknown cause Narrative: Patient received COVID19 vaccine on 2/23/2021 at 14:27. On 2/24/21, patient's family found patient deceased at 12:08am. The local coroner had called the MC to let us know on 2/24/21 at 12:55am. Coroner did not suspect foul play.
Fatigue, low grade fever to 100, nausea, dizzy, chills, sweats, myalgias.
a history of Parkinson's who presented with generalized weakness as well as urinary frequency. Patient had a history of prior COVID 19 infection in 10/2020, was hospitalized.  He had the first dose of COVID vaccine 1/19 and after that, he developed fever, increasing weakness and was unable to get out of a chair and therefore presented to the ED.
Little red bumps on patients chest and down his left arm. Patient took Benadryl after talking to physician.
Complained of hot to touch, redness, stinging at site of injection left lower injection site. Pain in arm. Red raised itchy rash in patch at vaccine site and now on chest aslo per doctor. Advised DC oral typhoids, use Benadryl and make appointment. Re: rash with PM reveiwed signs anaphylaxis and advised to call 911 if swelling throat area or SOB or different breathing.
Parent states child developed a bump on left thigh on 1/11/06 which then resolved 1/16/06. No other symptoms.
Patient complained of nausea/vomiting, feeling hot and clammy. Vital signs were stable. Patient was observed by onsite provider for 30 minutes before discharge in stable condition.
Within 15 minutes chest became.tight and became very dizzy. I took my meclizine for the dizziness sat my 30 mins and started to drive home. While driving home the left side of my face became numb and stayed that way for an hr still with chest tightness and dizziness went away. My gums started to hurt and right breast. I was very exhausted and very natious so went to bed. The feeling of tightness and numbness went away and woke up the next day still very exhausted unable to eat due to nasea. Still was dizzy and hade a migraine, and had extreme muscle pain and multiple sores in my mouth. I slept the entire day again and until 2 on the following day. Dizziness has not gone away I still have it  and a weird feeling in my neck/ center of my head. Have a low appetite and still have muscle soreness.  I now have 2 cold sores and multiple sores in my mouth including my tongue. My right eye vision has decreased as well.
pt recv vax 2SEp98 1110AM & exp 2 small hives, one mid chest & on lt upper thigh;no other hives or rash noted;c/o itching @ site of hives;BP 82/58;may have had temp & screamed;
Moderna COVID 19 vaccine ADR.  Approximately 24 hours after receiving the vaccine on 02/09/21 the patient lost consciousness and fell. Upon awaking she discovered she vomited and defecated. She also reported joint pain and a low grade fever. These symptoms have now improved. This report was given by her daughter.
Without showing any side effect symtoms, patient suddenly fell unconscious and passed away within an hour. Though 911 was called and Paramedic was trying to revive the patient.
On June 17th early to mid-morning I started to have pressure in my chest. Like someone was sitting on my chest.  I started to have pain go down my arm.  I went to the urgent care and they did an EKG and they determined that I had a heart attack. They transferred me to the hospital, and they did an Echo Cardiogram and other test to confirm that I did have a heart attack. The cardiologist confirmed that I had a heart attack due to SCAD.