chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patinent less than 12 years of age received the moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Patient reports that the injection site on her left arm became swollen and hard the day after the vaccination of Boostrix.  She also received a flu vaccination on the same day in the other arm (right arm).  A few days later, she began to experience more systemic symptoms in the Boostrix arm (left arm):  -Tremors/muscle twitches across her shoulders and up neck -Itching  -Pain -Nausea/vomiting -Chills -Sleep interruptions
Has an instant reaction of feeling faint, pounding heart, and numbness in arms and fingers. Being treated for chronic dizziness/lightheadedness and migraine.
Pt came on 4/23/21 for her second dose of COVID vaccine - Moderna.  She reports chest rash after the first dose.  She was give 25 mg of benadryl.  Shot was administered.  Seen by Dr.  Observed for 30 minutes with no additional issues.  Vaccine given at 334pm.
no adverse event; Vaccine administered on the same day as Trumenba; This spontaneous report was received from a doctor's office representative refers to a 11 year old patient of unknown gender. No information regarding the patient's concurrent conditions, concomitant medications and medical history was provided.  On 09-FEB-2022 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1775809, expiration date 18-AUG-2023, intramuscular in the left deltoid (strength and dose not reported) for prophylaxis. Other suspect vaccines administered on the same day included meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) lot # CN8296, expiration date ??-AUG-2022, intramuscular in the right deltoid (strength and dose not reported) (product use for unapproved combination) for prophylaxis and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) lot # U7184AA, expiration date 09-SEP-2023, intramuscular in the right deltoid (strength, dose and indication not reported). No additional adverse events reported. No product quality complaints reported.
admitted for pneumonia with COVID/with possible aspiration pneumonia as well. Treated with antibiotics/and dexamethasone/ resolved, Also rec'd Vit C, Vit D3, Lovenox, Zinc;  maintaining oxygen saturations on room air; noted to have mild-to-moderate oropharyngeal dysphagia; decision for PEG placement/GI was consult consulted/PEG was placed.  Tolerated G-tube feeds/developed intestinal obstruction/which was managed conservatively with bowel rest/and suction, resolved. also had severe left hydronephrosis due to obstruction from cancer/ no intervention at this time; daughter has been advised hospice, is not ready yet to make that choice.
Frequent itchy rash that spontaneously pops up on different parts of my body. Comes and goes. Started 10 days after booster. I thought through and through if I started anything new, ate anything new, tried any new creams or lotions and I have not. I get relief with taking Zyrtec. But when I do not take Zyrtec it comes back within a day or so. I saw my family doctor 2/7/22. She ordered bloodwork and advised me to take Zyrtec every day for the next two or three weeks. Then stop it and we will see if rash comes back.
pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
fine rash beginning on lt arm spreading to rt arm;no SOB or wheezing;no feeling of throat closing up;exp tight throat w/ phlegm, achy, chills, not feeling well x 2wk.
Hospitalized;  COVID-19 positive (9.13.21);  fully vaccinated Admission Date: 9/13/2021 Discharge Date: 9/14/21  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19  HOSPITAL COURSE: 84 year old female who was sent to ED for COVID testing after known exposure at facility. Patient was asymptomatic but tested positive for COVID 19. Due to COVID status facility unable to accommodate patients return so patient was admitted to observation while safe discharge plan was arranged. Patient had a caregiver from the facility who volunteered to take patient to her home and provide care until patient able to return to her AL facility. She confirmed awareness of patients care needs and was able to obtain patients prescriptions from AL facility. Plan was confirmed with patients guardian who was in agreement. CONSULTS / RECOMMENDATION: none INPATIENT PROCEDURES: none Discharge disposition: home or self care
Patient received Prevnar 20 on 6/7/23. Symptoms of bruising, redness, pain, and itching at site of injected started 2 days after on 6/9/23. Patient reached out to provider and provider's office recommended icing site of injection. Patient states to put a frozen water bottle for extended period of time at the site and it has worsen with icing. The icing may  have led to redness around the injection site. Advised patient she needs to wrap towel around ice pack and only apply for 10 min on with rest in between. Recommended ibuprofen for pain and benadryl for itching. If no improvement, contact provider a second time for evaluation. No swelling. No limitation with daily activities. No tingling sensation down arm or restrictions when raising arm. No fever or other systemic symptoms.
Returns to hospital for 2nd vaccine in series. C/o of fever, myalgias, arm with some swelling but lessened.
On my right arm at the injection end it just had a big bruise; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a big bruise on the right arm at the injection end. It was reported that the patient received the Pfizer shot 3 weeks ago and then the patient got the second dose yesterday. After the first injection about 3 or 4 days, about 3 days, the patient was sitting in the wheelchair and noticed in the mirror something on the right arm at the injection end, it just had a big bruise. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Burning up all over; Feet is red and my face is all red and it is blotched; Feet is red and my face is all red and it is blotched; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced burning up all over, feet is red and my face is all red and it is blotched. Patient had no side effects as soon as patient took it. Clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT WAS DIZZY FOR 3 DAYS AFTER SHE RECEIVED 2ND HPV VACCINE
At first I had the achy flu-like symptoms,  After a while, i was Hallucinating and asking or talking to my deceased parents.  I couldn't walk after an hour and had to call my son to help my husband to get me up off the floor.I could not eat due to the smell of the food.  I had a severe headache.
ANXIETY, RAPID HEART RATE, MUSCLE TENDERNESS, JOINT TENDERNESS IN SAME ARM AS VACCINE, HEADACHE
Pt vax /w DTP/OPV on 6NOV90 - on 13NOV began to nod head, became progressively worse.  Examined 23NOV90 @ clinic, no Sx seen, Examed 26Nov by MD.
10 days after I received my first dose (3/24/2021), I noticed a loss of pigment around my neck (collar bone).  This was symmetrical and appeared on both sides of my neck.  After going to the dermatologist, it was initially diagnosed as fungal.  By now May 2021, this had spread to both sides of my face, forehead, chin and hands. 6 weeks of oral and topical fungal treatment with no improvement, the dermatologist did a biopsy.  Results indicate Vitiligo.
vaccine reactions,headache,body ache.  PT presents with bodyaches, HA and chills x 0300. denies n/v/d. reports received JJ vaccine yesterday.
Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on 18Dec2020; This is a spontaneous report from an other hcp.  A 29-year-old female non-pregnant patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration at left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies. No other medical history. Concomitant medication included ibuprofen, alprazolam, ergocalciferol (VIT D), clarithromycin (CLARITIN), cranberry. No other vaccine in four weeks. The patient received first dose (lot number= EK5730) via an unspecified route of administration at Left arm on 18Dec2020 at single dose for COVID-19 immunization. The patient experienced Fever 101.0F, chills, headache, fatigue, arm soreness on 05Jan2021 20:00.  The patient underwent lab tests and procedures which included body temperature: 101.0 fahrenheit on 05Jan2021. No covid prior vaccination, Covid was test post vaccination via Nasal Swab on 22Dec2020 with result of negative. The events Fever 101.0F, chills, headache, fatigue, arm soreness were recovering. Treatment of acetaminophen received for the events Fever 101.0F, chills, headache, fatigue, arm soreness.
Initial misuse report received from a healthcare professional on 16 April 2013. ADACEL vaccine was administered to 21-month-old patient as fourth dose of DTaP. No adverse event was reported. List of documents held by sender: none.
Child very ill on day vaccines given. two days later , mom reports child lethargic, ill appearing, moaning. Temperature 102.8. Child had been saying several words at the time vaccines were given. He totally stopped talking and still does not say words Not even "mama" or "dada". They called ER, but did not go in.
Following immunization pt became very fussy and inconsolable within minutes. He also developed intense erythema and warmth of lower extremities. After giving Tylenol and some formula, he fell asleep (30*-45mins). After 1 hour the erythema faded. The erythema did not involve the area of injection.
vision loss; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or about October 2014, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered vision loss. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of the event was considered as not recovered and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered blindness to be disabling event.  Upon internal review, blindness was determined to be medically significant event.
PT STATED THAT SHE HAD GOOSE-EGG SWELLING AROUND INJECTION SITE THAT HAS NOW TURNED INTO A BRUISE THAT IS ITCHY AND HOT. PT TOLD TO USE COLD COMPRESS, APPLY ANTI-ITCH CREAM IF NEEDED AND USE AN ANTIHISTAMINE.
Double vision started 4 days after receiving flu shot. Symptoms lasted x 3 days and then resolved on own. Did see MD and eye MD after double vision started and they were unsure if flu shot caused double vision. Eye tests and blood work was all WNL.
pt became limp & pale about 20 mins p/shot; less responsive than usual but arousable; pt recovered somewhat over next 15 mis but stil sleepy (color & tone improved); sleepy but arousable for the next 8 hrs;
THROWING UP ALL OVER THE PLACE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced throwing up all over the place. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of throwing up all over the place was not reported. This report was non-serious.
High fever, resulting in fainting and injuries, including a broken nose, forehead gash requiring 17 stitches, and severe bruising all over.
Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experiences (WAES #'s 0610USA04384, 0610USA04386 and 0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patientt who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #'s 0610USA04384, 0610USA04356 and 0610USA03730). Additional information is not expected.
Tubersol and Tenivac vaccines was given to a patient which was stored at lowest temperature of minus16.4 degrees Celsius/No AE; Initial and additional information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 years old female patient who received a dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot number and expiration date not reported via unknown route in unknown administration site on an unknown date and 0.1 ml dose of TUBERSOL (lot - C55698A, expiration date: 08-Apr-2021) for on 07-May-2019 tuberculin test.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage. Tubersol and Tenivac vaccines was given to a patient which was stored at lowest temperature of minus 16.4 degrees Celsius.  No adverse event 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.  Information on the batch number was requested.  List of documents held by sender: none.
on 3/23/21 we discovered the vaccine wasnt  properly diluted  resulting in the patient only  getting a fraction  of the intended  dose.  No adverse reaction  reported to the pharmacy.
Information has been received from a nurse practitioner concerning a 12 year old female who on 11-SEP-2007 at 3:30 PM was vaccinated in the deltoid with the first dose of GARDASIL (lot # 658558/1061U). On 11-SEP-2007, at 3:30, the patient developed immediate swelling and redness at the injection site. The patient was treated with BENADRYL and released. The reaction resolved the same day. Additional information is not expected.
Received initial immunization - within 2 days began SEVERE vaginal bleeding lasting for 6 weeks.Due to extreme blood loss I became severely anemic...I required several visits to the ER and numerous tests for any existing conditions all of which came back negative.
He had no symptoms when he went to bed at 7PM, started crying at 8PM where I found that he vomited and after a bath he vomited 2 more times. No temperature.
Mild overall, but more pronounced than the first vaccination in the series, and definitely the result of the vaccination.  Reporting just as an FYI. Soreness at the site of injection on my right arm starting several hours after, (Friday), and lasting through two days (Sunday).  Took a Tylenol a day. Extreme lethargy/tiredness for several days, and somewhat "off", the first day being the worst. Wasn't really "myself" again until about Tuesday (fourth day). "Off" meaning tired and not 100% clear-thinking. Worst on Saturday and gradually better each day after.
New bivalent booster dose. Woke up with swollen lips . I do have lip filler in this area. Lip filler was placed in  july 2022. Had  lip filler previously  and noreactions with my first 3 vaccines (all of which were moderna)
COVID vaccine reaction/Growth under armpit after COVID vaccine; Pain all over body; Anxiety; Tightness in chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over body), ANXIETY (Anxiety), CHEST DISCOMFORT (Tightness in chest) and AXILLARY MASS (COVID vaccine reaction/Growth under armpit after COVID vaccine) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 13-Jul-2022, the patient experienced PAIN (Pain all over body). In July 2022, the patient experienced ANXIETY (Anxiety) and CHEST DISCOMFORT (Tightness in chest). On an unknown date, the patient experienced AXILLARY MASS (COVID vaccine reaction/Growth under armpit after COVID vaccine). At the time of the report, PAIN (Pain all over body), ANXIETY (Anxiety), CHEST DISCOMFORT (Tightness in chest) and AXILLARY MASS (COVID vaccine reaction/Growth under armpit after COVID vaccine) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. The daily dose for Spikevax was provided as one in one once. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The reporter causality for co-suspect upadacitinib and the events was not provided. No treatment medications were reported.
acute guillain-barre syndrome following a HD fluvax. sxs of lower leg weakness, progressive, occurred about 10 days following a hd fluvax admitted to Med ctr, diagnosis confirmed and received 5 d plex therapy with clinical improvement but still with significant lower leg weakness.
Information has been received from a physician concerning a 7 month old male who on unspecified date was vaccinated with three doses of ROTATEQ oral (lot # not provided). The physician reported that the patient received all three doses and still got rotavirus. The physician also stated that the patient did not receive his first dose at the practice, so it was not sure if the patient received ROTATEQ or ROTARIX. The patient was not hospitalized because the patient's parents did not want him to be hospitalized, however the physician stated that he would have hospitalized him. On unspecified date, the patient recovered from rotavirus. Additional information has been requested.
Sore, swollen arm at injection site (12hrs post injection) Nausea, diarrhea (14hrs post injection) ended 36hrs post injection Chills, sweating, fever (14hrs post injection) ended 48hrs post injection Body and joint aches and inflammation (14hrs post injection) ended 55hrs post injection
Tender, swollen, and enlarged lymph node(s) under left armpit. It hurts to bring arm down. This reaction was not experienced with first and second shots; however, I didn?t start taking methotrexate until after the second shot.   I slept beginning Saturday evening and was not functional all day Sunday. I experienced lethargy, chills, vivid dreams, but no fever.  My lymph node began to feel terribly uncomfortable Monday, but I am not sure if it was evident on Sunday, because I slept the entire day.