chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 09-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old).    Concomitant drugs were not reported. It was reported that the unvaccinated patient was administered with pink cap bivalent vaccine. Treatment medications were not provided.
painful lymph nodes under left arm, swelling, itching and redness at injection site. Both began about 5-7 days after injection.
Severe numbness in the left side of face , tongue, mouth ,ear neck, arm and foot.
Information has been received from a health professional concerning a 45 year old white female pt with no allergies and no past medical history, who on 10/7/02 at approximately 14:00 was vaccinated with a dose of hep B vaccine recombinant (642095/1536L). Approximately three hours later at 17:00, the pt had a "bad reaction to hep B vaccine recombinant" that started with a severe headache and later included fever, chills, fatigue, body aches, leg pain and vomiting for two days. The pt's daughter had the "flu" at the same time. Subsequently, the pt recovered. The pt did not experience adverse events following prior vaccination. The reporter stated that they will "try to re-vaccinate." Additional info is not expected.
Started feeling tenderness again, the next morning I woke up and had itchiness. By the evening I had seen raised thick lines about 3 inches long below the injection bruise. They are warm, raised, red, sore and itchy.
The mother of this child reported that her child woke up with redness, hard area and clear drainage from injection site. Mother stated the child cried when the site was touched. Mother was instructed to take child to the ER.
pink large oval on arm around area of vaccine, near 20cm long, 12 wide, some firmnss and tenderness but diffuse   Evaluated on 10/25/19 by Dr. in clinic at 9:45 AM.
bullseye rash; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (bullseye rash) and PRURITUS (itching) 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 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (bullseye rash) and PRURITUS (itching). At the time of the report, RASH ERYTHEMATOUS (bullseye rash) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided
Patient stated he felt like he was going to faint. Nurse placed cold bottles of water on both corroded arteries. Client did pass out, pale and a little disoriented when woke up. Client was given a bottle of cold water to drink, which he did.  Laid client on a cot to rest until felt better and able to drive home. After approximately 45 minutes, client stated he was ready to do go home and had someone there to drive him.
According to patient, 4 hrs later after receiving vaccine, patient blacked out, went to ER. Blood pressure dropped severely. Unclear the connection.
Beginning 16-18 hours after receiving the shot: Fever of 100.2 F for 20 hours. Chills, body aches. Significant pain in lymph nodes under the left arm. Fatigue.  Red rash on the surface of the left arm around the injection site. Swelling and heat around the injection site, lasting 2+ days.  Fuzzy thinking, difficulty concentrating. Sore throat. These symptoms subsided about 48 hours after the shot was administered, except the fatigue, which lingers.
Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of GARDASIL, lot # not provided, on 30-NOV-2007.  This vaccination was well tolerated.  It was reported by the physician (who received the information from a patient's mother) that the 14-year-old female patient was vaccinated with a second dose of GARDASIL (lot # not reported) i.m. into the upper arm on 03-JAN-2008.  In the beginning of May-2008, the patient developed paresthesia, migraine and weight loss.  She was hospitalized for diagnostics; no reports on findings were made available to the reporter.  The events were ongoing at the time of reporting.  According to the patient's mother, "the symptoms improve while her daughter listens to loud music via an MP3-player."  The reporting physician does not see a causal relationship to the vaccination (P2).  Other business partner numbers included: E2008-05224.  No further information is available.
I had a UTI and an upper respiratory infection. I took a rapid covid test and pcr test which both came back negative 03/29/2023. I was experiencing a low-grade fever and a lot of fatigue. I experienced a slight cough and a lot of congestion. I took a urinalysis, and it came back positive for a UTI. The Augmentin was prescribed for both the respiratory infection and my uti. I am currently still experiencing a small cough and congestion, the fatigue has subsided and the fever has gone away as well.
Patient received vaccine and began to feel nauseated and lightheaded. Patient began throwing up. EMT responded. Vitals BP 118/98 O2 sat 98%. Patient and mom refused EMT accompany to hospital. Will wait in observation for 30 mins.
01-MAR-2021 and 12-APR-2021, first and second doses of GARDASIL 9; Information has been received from a 28-year-old female patient reporting on herself.  The patient's concurrent conditions and medical history were not reported. Historical therapies included Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  on 01-MAR-2021 and 12-APR-2021, the patient received the first and second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, frequency, route, lot number and expiration date were not reported) as prophylaxis (inapropriate schedule of vaccine administration)  The patient  wanted to know the dosing schedule as she needed the last dose but had not receive it yet.  This is one of two cases from the same patient.; Sender's Comments:  US-009507513-2108USA003871:
Cellulitis in the site of injection (right deltoid). (Inflammation, redness, pain). Went to the urgent care and received prescription for antibiotics. (Right deltoid muscle).
56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Moderna COVID-19 Vaccine EUA   extreme joint pain and muscle pain starting approx 12 hours after injection for duration of next 60 hours.   extreme chills starting approx 12 hours after injection for duration of next 36 hours.   fatigue starting approx 12 hours after injection for duration of next 48 hours.     headache starting approx 12 hours after injection for duration of next 24 hours.    After receiving the second dose of Modera COVID vaccine I experienced all the above side effects most notably extreme joint pain and associated fatigue - it was the worst I have felt in more than 10 years.
I was very tired and slept after vaccination. After I got Covid, I have been having asthma issues at night. The Dr. prescribed an inhaler. I continue to use it nightly.
Began swelling at injection site up to 4" diam. by day 3 with pain into armpit area, unable to lift arm past shoulder height until day 7.
This spontaneous report as received from a pharmacist refers to unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) vial 19400 PFU. On an unknown date, unspecified number of patients developed rashes after receiving ZOSTAVAX. The outcome of the event developed rashes was unknown. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 34 year old female with no pertinent medical history and allergies to penicillin, sulfa, LEVAQUIN and ZITHROMAX who on 04-DEC-2006 was vaccinated SC with the first 0.5 ml dose of VARIVAX (Merck) (lot # 653435/0561F). On 04-JAN-2007 the patient was vaccinated SC with the second 0.5 ml dose of VARIVAX (Merck) (lot # 653435/0561F). There was no concomitant medication. In May 2009, the varicella titer test was done and the result was negative. On 23-MAY-2009 the patient developed rash. It was reported that the rash did not appear to be the varicella lesions. At the time of this report, the patient was recovering from the events. The patient was seen in the office and sought unspecified medical attention. Additional information has been requested.
Day 1- nausea, mild chills, tired, towards the evening mild tingling hands and feet Day 2- more tingling hands and feet, red hands front and back, sharp upper head pain  Day 3- mild tiredness and chills tingling and redness continues Day 4- nausea, tingling continues, at 8:20 pm I start getting a warm burning feeling on both upper part of arms, at 10:00pm in bed, very bad nausea, trembling/jiggerish, very bad chills, heart racing, upper body itching, by 12:00am only itching gone, couldn?t sleep due to other symptoms  Day 5- woke up with same symptoms no itching
22yo female with reported history of covid-19 infection in March 2020 reportedly caused dysautonomia as a result. She was given the vaccine while supine due to syncopal concerns in the past. Pt did have a witnessed syncopal event that she recovered from and was cleared by medical staff and ems after 30min of observation.
fever, body aches, headaches, felt very much like havign the virsu again only stronger
hives in entire body; very itchy; headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in entire body), PRURITUS (very itchy) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 021C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (hives in entire body) and PRURITUS (very itchy). December 2021, the patient experienced HEADACHE (headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and PARACETAMOL (TYLENOL CHILDRENS) for Adverse event, at a dose of Baby tylenol about 30 hours after the booster. In December 2021, HEADACHE (headache) had resolved. At the time of the report, URTICARIA (hives in entire body) and PRURITUS (very itchy) outcome was unknown.            No relevant concomitant medications were reported. .
This report describes hives, itching and swollen eyes in an 11 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis of Hep-B. This report was received from the vaccinee's mother and has not been verified by a physician or other health care professional. The vaccinee had seasonal and animal allergies, but did not have asthma. Her concomitant medications included loratadine (Claritin) and mometasone furoate (Nasonex). On 1/3/00, the vaccinee received her 1st dose of Engerix-B. Two to three hours, post vax, she experienced itching and hives "all over face and neck". The vaccinee was treated with an "itch cream" (NOS) "which helped a little". The hives resolved after approx. 3 weeks. The pt was seen by an allergist, who instructed her to take Claritin and Benadryl prior to the administration of the 2nd dose of Engerix-B. On 6/11/01, the pt received her 2nd dose of Engerix-B at the allergist's office. Per the mother, "within hours" the pt's eyelids turned "blood red" and were "swollen shut". The pt fell asleep and "was not easily aroused". The mother thought that the drowsiness was related to Benadryl. The allergist was called, the pt was taken to his office, where she was treated with epinephrine on 6/11/01. As of 6/12/01, symptoms were slowly resolving. This report is considered "Medically Serious" due to the intervention required.
Swelling daily of hands, arms and fingers. Numbness and tingling in hands, arms and fingers. Hot and cold flashes. Felt like something attacked all my joints with pain two days after the seasonal flu shot. Pain in joints terrible. Trouble breathing and insomnia. Now on many medications for insomnia, pain, depression and anti-inflamnatory. I walk with a cane and have been on short term disablity from my job since 1/20/2010.
This case was reported by a consumer and described the occurrence of stroke in a 70-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect medication included COREG. The subject's medical history included cataract, hearing loss, pacemaker (atrial fibrillation), quadruple heart bypass and vitrectomy. Previous and/or concurrent vaccination included live attenuated oral poliomyelitis vaccine; manufacturer unspecified; oral given on an unspecified date. Concurrent medications included COUMADIN, PRINIVIL, VITAMIN C and TYSHINI (unknown medication). On an unknown date, the subject started CARVEDILOL (oral) at 3.25 mg twice per day. On 23 July 2007 the subject received unspecified dose of TWINRIX (unknown). On 28 July 2007, five days after vaccination with TWINRIX and while on CARVEDILOL, the subject experienced stroke, subdural hematoma, headache, chills and tiredness. The subject was hospitalised. On 08 August 2007, the subject had Computed axial tomography (CAT) scan and was diagnosed subdural hematoma of the brain. The subject died on 10 August 2007 from stroke. It was unknown whether an autopsy was performed. Vaccine AE template documented during the call, after the call I realized that the patient was also taking COREG at the time of death. Customer stated that the patient received the TWINRIX vaccine on July 23, 2007 and on July 28, 2007 he developed a severe headache, chills, and tiredness that continued to worsen over time. The patient consulted his healthcare provider that recommended a CAT scan because the patient was taking COUMADIN. The CAT scan was performed on 8/8/2007 and a diagnosis of subdural hematoma of the brain was made, the patient was then prepped for surgery which was successful but died on 8/10/2007 due to a stroke.  7/28/09 Death certificate received. Final cause of death: Intracerebral hemorrhage.   8/25/09 DC summary outpatient and hospital records received. Service dates 6/28/07 to 08/10/07. Assessment: Subdural hematoma, atrial fibrillation, hypertension, coronary artery disease, hyperlipidemia, status post craniotomy for evaculation of subdural hematoma, status post right basal ganglia hemmorhage / brain herniation.  Patient was complaining of headache. Hematoma evacuated. Brain herniation. Terminal extubation performed and patient expired.
Temperature 103 07/23/2003 Temperature 105-106 07/24/2003 Uncontrollable crying, complained of pain at both injection sites but no localized reaction.  No redness, no swelling.  Vomit x 1.
Almost 24 hrs after shot, I started getting chills then a fever. When I was able to take my temperature, it was 101.8 degrees. I took 2 Tylenol & went to bed. Next time I woke up, my temperature was 99 degrees (which was about 10 hrs after the fever started). Within 2 hrs  of that, temp was back to normal at 97.9 & remained normal.
This case is a part of 2 cluster cases and is linked to case number 2013-09703) (same vaccine lot number and same reporter). Initial report received from a healthcare professional on 11 September 2013. A 05-year-old male patient had received an intramuscular fifth dose of DAPTACEL vaccine (batch number: C4431AA and expiry date: 10/16/2015) in the left deltoid on 21 August 2013. The patient had no illness at the time of vaccination, had no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 23 August 2013, the patient developed vaccination site redness, warmth, hardness and swelling. No laboratory investigations were done and the patient had received MOTRIN and cold compresses to the site so corrective treatment. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
AFIB 1 week later..light headed, immediate care, ambulance to hospital ...NO Previous History of any heart issues, previously walked 5-10 miles daily no issues... , 2 Day Hospital stay, continuing Treatment / cardiologist care
I had a gout-like reaction.  My left foot became very swollen with my ankle, and first three toes affected.
This spontaneous report as received from a nurse practitioner refers to a 13 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 18-DEC-2014, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was pale and nauseous with abdomen pain. patient stated this may have been from her mensural but cycle. Patient put to lye down and left with her guardian to go home and seek medical attention.
08/31/2021  The patient presents with SOB, worsening 3 days ago. Pt tested positive 3 days ago for COVID 19 and note symptoms beginning 1 week ago. He arrived to ED in severe respiratory distress respiratory distress..  The onset was just prior to arrival. Patient is an 83 y/o male admitted to hospital on 8/31 after presenting to ED for evaluation of shortness of breath. He was found to have acute hypoxic respiratory failure secondary to COVID-19 pneumonia, quickly failed BiPAP and was intubated and proned in ED. He had SVT x2 episodes in ED requiring electrical cardioversion each time 100J. Started on levophed gtt after CVC placed in ED. Received bicarb IVP x3 + gtt.
Extreme Dizziness, sweating, ears started ringing, got tunnel vision and then fell down and passed out.