chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Muscle ache; elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and BODY TEMPERATURE INCREASED (elevated temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information 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 DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and BODY TEMPERATURE INCREASED (elevated temperature). At the time of the report, DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and BODY TEMPERATURE INCREASED (elevated temperature) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 21-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L043702 with expiration date 03-NOV-2017, status albumin: RHA) . Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Pt recvd vax fourth dose of vax & exp petechiae on bridge of nose that spread to face, neck & chest;
This case was reported by a healthcare professional and described the occurrence of arm weakness in a 39-year-old male subject who was vaccinated with ENGERIX B, GlaxoSmithKline.  Previous vaccination included TETANUS TOXOID vaccine; unknown; left deltoid given on 04 September 2008.  On 16 September 2008 at 19:00, the subject received the 3rd dose of ENGERIX B (20 mcg, unknown, right deltoid).  On 16 September 2008, less than one day after vaccination with ENGERIX B, the subject experienced arm weakness, pulling sensation and arm fatigue.  The events were reported to be systemic.  On 06 October 2008, the subject reported to a nurse that his symptoms had improved over time, but when he played ball with his daughter over the weekend, the symptoms were noticeable again.  The subject treated his symptoms with IBUPROFEN.  Follow-up information was received on 17 November 2008, via healthcare professional who reported the subject's events were localized to his right arm.  The healthcare professional associated the events to medical history of the subject receiving the TETANUS vaccine on 04 September 2008 in the left arm.  Also on 04 September 2008, the subject was treated with decongestants for a right ear infection.  On 11 October 2008, the events were resolved.  The healthcare professional considered the events were possibly related to vaccination with ENGERIX B.
4:00pm - stomach ache & nausea 6:00pm - hives - no respiratory problems - talked with ER - took BENADRYL - symptoms resolved after approx 1/2 hour - never any reaction or discomfort at injection site.
When I received the vaccine, the technician administering the vaccine had a difficult time pushing in the syringe.  He moved it around a little bit and pushed hard again.  After he pulled the syringe out, he kept tapping it, I guess to make sure all of it went into my arm.  When he was administering it, I had a burning sensation as it went in.  No one I know had this occur during their vaccine.  Due to working environment, I need to know that I received the vaccine, and that something did not go wrong and it failed.  Can you let me know if I still received the vaccine after experiencing this during the administration of the vaccine?  I am very nervous that it failed and I am not protected.  I had a slightly sore arm the evening of the vaccine, but it was gone the next day.
Left arm: deltoid area with 2.5x2" red, raised and tender area. No axilla involvement. No lymphadenopathy. Pink, raised sandpaper like rash on trunk associated with urticaria.
passed out on the floor; uncontrollable chills (for which he could not get warm); too weak to get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:30 as dose 5 (booster), single (Lot number: GJ5342) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "prostrate cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JARDIANCE; ALPHA LIPOIC ACID; CETIRIZINE; ATORVASTATIN; VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (DOSE 4; SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11May2022, for COVID-19 immunization; BNT162b2 (DOSE 3; SINGLE, Batch/Lot No: FC3184, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 17Sep2021, for COVID-19 immunization; BNT162b2 (DOSE 2; SINGLE, Batch/Lot No: EN6102, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 1; SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Feb2021, for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 05Oct2022 at 21:30, outcome "recovered with sequelae", described as "passed out on the floor"; ASTHENIA (non-serious) with onset 05Oct2022 at 21:30, outcome "recovered with sequelae", described as "too weak to get up"; CHILLS (non-serious) with onset 05Oct2022 at 21:30, outcome "recovered with sequelae", described as "uncontrollable chills (for which he could not get warm)". Therapeutic measures were not taken as a result of loss of consciousness, chills, asthenia.  Clinical course: After receiving the last vaccine on 05Oct2022, reporter father went home, experienced uncontrollable chills (for which he could not get warm), and passed out on the floor. He was too weak to get up and his wife was unable to assist with lifting him, so he remained on the floor and slept for 12 hours. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks.Other medications in two weeks were Metformin, prebiotic/probiotic, Jardiance, r alpha lipoic acid, Cetirizine, Atorvastatin, Vitamin D. No covid prior vaccination. Covid tested post vaccination was unknown. No Known allergies.
devel fever of 104 & generalized rash worse on back & chest;runny nose;tx w/antipyretics & tepid baths;saw MD 14JAN99;
Information has been received from a medical assistant concerning a female who was vaccinated with the first dose of Gardasil. Subsequently, the patient fainted on the exam table after vaccination. The patient will discontinue further series of the vaccine. Patient outcome was unknown. Additional information has been requested. It was reported that another female fainted after Gardasil vaccination (WAES0703USA03189).
From the site of the injection pain began to spread evenly across my shoulder, down my back and left arm arm immediately. From their the feeling was as though I was infected. It was instant. A burning sensation with sharp pain whenever I began to move. The level of pain was off the chart, before I made it to the Emergency Department. The pain remains. I am unable to lift my arm more than 4 inches. My fingers remain numb. Treatment: Emergency room Evaluation, Medication Management, Steroids x 2, MRI, referrals.
temperature excursion and reported PROQUAD that was stored improperly was administered to a patient; There was no adverse event; This spontaneous report was received from a medical assistant and referred to a currently 4-year-old female patient. Information about historical conditions, concurrent conditions, drug allergies/reactions and concomitant medications was not reported.  On an unknown date, there was a temperature excursion and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (lot #W004029, expiration date: 02-AUG-2023, indication: prophylaxis; anatomical location, strength, dose, and route were not reported) that was stored improperly was administered to the patient (product storage error). There was no adverse event reported.
Patient tested positive for COVID after receiving 3 COVID 19 Vaccines; Patient tested positive for COVID after receiving 3 COVID 19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Physician).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (caused and prolonged hospitalization, medically significant), COVID-19 (caused and prolonged hospitalization, medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "Patient tested positive for COVID after receiving 3 COVID 19 Vaccines". The patient was hospitalized and prolonged hospitalization for drug ineffective, covid-19 (start date: 21Jun2022). The event "patient tested positive for covid after receiving 3 covid 19 vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: Unit: Not Provided; (04Jun2022) Negative, notes: had taken a rapid test and the patient was negative on 04Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She was a Pfizer Field Representative calling in regards to Paxlovid. The patient was on the late end of getting Paxlovid prescribed. It was on 10Jun2022 that the patient came in and had a positive PCR test and was prescribed Paxlovid. Previously the patient had been ill for about a week prior to 10Jun2022 and had taken a rapid test and the patient was negative on 04Jun2022 but then came to the doctor on 10Jun2022. The patient took Paxlovid for 5 days, felt better, then on day 10 roughly, Tuesday 21Jun2022 the patient came in and was in terrible shape. The patient was getting nebulizer in office, getting shortness of breath, wheezing, and coughing. The patient was referred for hospitalization. She does know that the doctor did say the patient did receive 3 COVID Vaccines and they were Pfizer Vaccines. She did not know the NDC/LOT/EXPIRY or dates of the previous vaccinations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Pt experienced increase temperature, right arm swollen and red/purple all the way to elbow.
A spontaneous report was received from a consumer concerning a 54-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events arm were sore/pain in extremity, flu-like symptoms/influenza like illness, body felt itchy/tops of his hands felt itchy/pruritus, roof of his mouth hurt and was red in color/oral pain, felt like it was burning/oral discomfort, bumps on his thighs/urticaria and little bumps all from within a red ring of where his injection site was/vaccination site abscess.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On 25 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot/batch: unknown) in the anatomical location for prophylaxis of COVID-19 infection. The route of administration was unknown.    On an unknown date, after receiving the vaccine, the patient experienced arm sore and flu-like symptoms. He started to feel better on the 29 Jan 2021. On 02 Feb 2021, the patient felt body itchy, top of the hands felt itchy. On the same day, patient reported that, roof of his mouth hurts and it was red in color, felt like burning and a burning itchiness, bumps on his hands, bumps on his thighs and there was little bumps within red rings on the injection site.  Treatment details included some sort of creams and benadryl.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events arm sore, flu like symptoms, felt body itchy, tops of the hands itchy, roof of his mouth hurt and was red in color, felt like burning, burning itchiness, bumps on his hands, bumps on his thighs and little bumps all from within a red ring of where his injection site was, were not recovered/not resolved.
Patient received incorrect COVID-19 dose #2 vaccination. Dose #1 was Pfizer, administered 1/7/2021. On 3/18/21, patient presented late for dose #2. Patient involved in serious car accident prior to dose #2 due date of 1/28/21. Upon presentation to clinic for dose #2, patient. Standard process followed for check in, including Pfizer dose preparation. Vaccine doses labeled with corresponding 2D barcodes.  Other scheduled dose #2 for 3/18/21 were Moderna. Administering RN reports she was aware patient was to receive Pfizer dose #2 as indicated on screening and consent form, but mistakenly administered Moderna as dose #2. Error was immediately realized following administration of incorrect vaccine and reported. Patient made aware, additional information collected, and this VAERS report entered. Considering mistake and extended interval following initial Pfizer dose 70 days prior to dose #2 (Moderna), will seek advice from CDC/ACIP and chief hospital infectious disease physician as to whether patient could benefit from receiving a second Moderna dose in 28 days (i.e. 3rd COVID-19 vaccine).
No adverse effect reported; PROQUAD that underwent a temperature excursion were administered to an unspecified number of patients; Information has been received from a medical assistant, referring to an unspecified number of patients. Information about medical histories, concurrent conditions and concomitant therapies was unknown.   From 19-OCT-2019, unspecified doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S024054 which is invalid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), expiration date: 01-DEC-2020; route and strength were unknown) that underwent a temperature excursion were administered to the patients for prophylaxis.  Temperature excursion was reported as range -0.52 Celsius degrees(C) for time frame 10 hours and 34 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.  This is a non-valid case due to no patients identifiers.  Follow up information was received from a medical assistant referring to female patient of 4-year-old on 27-MAY-2020: On 09-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009271:
Shingrix to patients under 50; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in an unspecified number of patients 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 drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.  Additional details were provided as follows: Age at vaccination was not applicable to this report. The pharmacist reported that the doctors had been prescribing Shingrix to patients under the age of 50, which led to drug prescribing error. The HCP did not have patients information, she was looking for general information about Shingrix in patients under 50. The reporter consented to follow up. This case has been linked with case US2021209477, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209477:Same reporter
Chronic  cough x 4 weeks. No wheezing or sputum production.
BLOOD CLOT; This spontaneous report received from a consumer concerned an adult male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot. The reporter stated that as per news report, the agency was investigating this case of blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210454446.; Sender's Comments: V0:20210454646-covid-19 vaccine ad26.cov2.s -blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Vaccine administered was not diluted resulting in a higher concentration. Patient is being monitored and has not reported symptoms as of now.
Neck started hurting on one side; This is a spontaneous report from a contactable consumer or other non hcp.   A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 12:00 (at the age of 12-Years-old) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy. Vaccine was not administered at a hospital facility. No additional vaccines were administered on same date of the Pfizer suspect. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). The patient experienced neck started hurting on one side on 17May2021 15:00. When he turns his head it hurts more, but if not moving it does not hurt as much. RA was not resulted to require a visit of emergency room or physician office. Relevant tests were none. The outcome of the event was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Patient visited the vaccine clinic today which she received her first dose of Moderna vaccine lot# 020B21A to her right deltoid. While the patient sitting in the observation area , she complaining of huge to vomit. However, no vomiting noted at this time. Patient said; she has been vomiting since last night which she took medication to help stop the vomiting . As per patient and her granddaughter who currently present in the facility, the patient went to medical hospital two weeks ago where she was diagnosed with gastritis, Gallstones, she did not have any surgical procedure done. She was only prescribed medication for nausea and vomiting . Initial vital signs: Bp148/80, pulse 76, resp 18, o2 sat 99% on room air. Patient has medical history of diabetes, hypertension . As per patient, she has not been checking her blood glucose level lately nor taking her insulin. She also said that she was instructed by her doctor to be off of her medication but she still taking her metformin 500 mg twice daily, medication for vomiting and gastritis. Patient denied any known allergy. Patient was closely monitored and her condition improved. At 12:17 vs: PB 110/80, resp 18, pulse 75, o2 sa98 on room air. Patient went home accompanied her granddaughter. Patient instructed to follow up with her medical doctor or to go the nearest hospital if the condition continue. Granddaughter states" I will take her back to the hospital this evening.
The patient received a Pfizer Monovalent vaccine that was used 171 days past the beyond use by date.
Information has been received from a physician concerning a male pt who in 1999 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in 1999, the pt developed an injection site reaction with redness and induration after vaccination. Unspecified medical attention was sought. Subsequently, the pt recovered. No other information was provided. There was no product quality complaint. Additional information has been requested.
Nausea after 2 minutes, lasted about 5 minutes.  Light headedness after 2 minutes very pronounced for about 15 minutes then eased up but lasted all day. Fatigue  after 2 minutes,  still ongoing today. Muscle aches, within an hour and still continuing though gradually improving. Odd taste and sensations in mouth after a minute lasting about 20 minutes.  Slight fever (99.8) in afternoon but gone next morning. Headache within a minute, still ongoing ar this time
Information has been received from a Doctor of Pharmacy concerning an 18 year old male who on unspecified date reported as "many years ago" was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  The reporter mentioned that the patient had an allergic reaction; he had hives and difficulty breathing.  It was unknown if the patient sought medical attention.  At the time of reporting the patient's outcome was unspecified.  Additional information has been requested.
I have a Mirena IUD and typically do not have a period. After my first shot, I had a period almost immediately and it was heavier than just the very light spotting that happens occasionally with an IUD.  I have since had intermittent bleeding, including 7 days after my second shot.  The bleeding comes with migraines, which I normally have once a month around ovulation. They have occurred three times since my first shot.  Other than the sudden onset of the menstrual cycle, I had elevated temp of 99.5 - 99.8 plus chills and upset bowel for 24 hours after the second shot. I did not have these side effects after the first shot. After these symptoms subsided, I had intermittent dizzy spells for another 24 hour period, but nothing else other than irregular menstrual bleeding.
On 2/5/01, pt awoke with heart pounding, chest discomfort, SOB and pale. At 07:15, saw MD for signs and symptoms above. Pulse Oximetry-96%, P-114. Physician told pt that the cause of symptoms were likely, viral infection.
Within 24 hours after receiving the SHINGRIX first dose, the pt had a hard area develop under the skin and then a very large red area appeared in the skin surrounding the vaccine site over that day and the next day (5/16-5/17/18).