chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient reports that the patient felt smarter/the patient's mind was more clear; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (patient reports that the patient felt smarter/the patient's mind was more clear) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hallucinations (the patient has a problem with Hallucinations).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (patient reports that the patient felt smarter/the patient's mind was more clear). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (patient reports that the patient felt smarter/the patient's mind was more clear) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided. Concomitant medication was not provided.  The patient received all the three doses of the vaccine in the left arm shoulder deltoid muscle and reported of experiencing no adverse reactions or side effects to the second dose or the booster dose.   Information about the second and the booster doses were captured in this case as there are no dose 2 and dose 3 cases for this patient (no side effects).
w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2-inch by 2-inch welt;pt was improving as of 29OCT;this is 1 of 5 patients, out of 12 patients to exp this event;
Vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Smoker and Alcohol abuse. Concomitant products included METFORMIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.    On 03-Sep-2021 at 11:36 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021 at 11:36 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021). On 03-Sep-2021 at 11:36 AM, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021) to be not related.    No treatment medication were reported.  It was reported that there was no adverse reaction and the lot number expiration date was not extended.   This case was linked to MOD-2021-328706 (Patient Link).
Reaction began with swelling below the right eye on March 15, 3:45pm. Swelling progressed to below the left  eye later that evening around 10:30pm. On March 16th, I woke up around 6 am with moderate to severe swelling of the face, eyes, hands, and feet. My throat was also closing and it was becoming difficult to breathe. I treated with 50mg of Benadryl every 6 hours for the next 3 days. The next day, March 17th, my left eye became red and inflamed. The eye symptoms and face puffiness subsided ~March 19th.
At 12 hours after injection: high fever, chills so bad teeth chattering, aches muscles in in neck, back, ankle (areas that have problems or injured in past, Hourly urination with intense pain and muscle spasm of muscle holding the urination - these stopped at about 5:00 am; Then a fever of 99 and cold clammy feeling for a day - was not able to stand for more than a few minutes without feeling off balance and then just exhausted. For a week I was mentally cloudy and my vision was at times a little blurry. Now...2 weeks later I have developed a UTI and Bacterial Vaginosis. I feel fine otherwise.
terrible chills; fever; This is a spontaneous report from a non-contactable consumer (patient himself). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown), via an unspecified route of administration, on 14Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he got his Covid shot last Thursday 14Jan2021 and everything was good. Then on Jan2021 he started having terrible chills, all kinds of bad things going on, fever, everything, he just suffered it all. The patient called down this morning to ask what to do later on. He added that he has a second shot scheduled for 04Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Extreme sensitivity to sunlight. Patient normally spends many hours a day outside doing various activities exposed to sunlight without getting a sun burn. The day after vaccine and since the patient can be outside for as short as 10-20 minutes and skin becomes visibly red and begins to quickly sun burn severely as if she was outside in direct sunlight for many,many hours. Eyes have also become very sensitive to sunlight requiring the use of sunglasses even indoors in a bright room. Causing great discomfort and unable to focus. Has previously never experienced these issues.
On both events, I had stomach cramps that lasted about a week after both shots. The pain went away on its own. In addition, I currently have pain on the arm I received the shot on. This recently started and occurred several weeks after receiving the second dose. The pain is similar to a burn from a sunburn and itches. It varies throughout the day in pain and stretches sometimes from my hand up to the side of my left check. Also on my upper back and back of neck.
Three days  after vaccination I noticed painful urination and frequent urination. Blood in urine on 01/15/2021. Telehealth consultation antibiotics prescribed Keflex 500mg/ 3X daily for 7 days. Prescription worked quickly. No history of bladder infection previously. Second dose only mild symptoms.
After received my 3rd dose I felt tired and a runny nose. It was a mild case. I did have a fever for 100 for an hour or two. I had these symptoms for only 24 hours.
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. She was due for her second dose of Gardasil on 13-MAR-2007. Subsequently, she developed a urinary tract infection. Unspecified medical attention was sought. Urinary tract infection persisted. Additional information has been requested.
5SEP95 MN t102.7-104; 5SEP95 945Am sz-tremors for 1 1/2 min @ home; T104 in ER: neg CBC; amoxicillin for OM in ER
Neck pain, headache. My arm was painful and swollen for 16 days (iced daily for first three days). Unusual fatigue. Fevers daily, for the first 5 days fevers were about 101 degrees, now they are very mild. Night sweats. Aug. 19th I started to have difficulty holding a toothbrush, I thought I had just over-worked my hand in the studio). Aug. 22 late afternoon I started having excessive pain throughout the body but focused in joints with tingling and muscle weakness. Aug 26th and 27th the pain was so intense that I almost went to the emergency room and it felt like there was movement/pressure under my skin (cried with every movement). Around 10pm on the 27th the intense pain started to release and I had extreme tingling and itching in my hands and feet. The pressure released. Today, I feel very tired, but the intense pain is subsiding. Between the 22nd and last night, I could not touch anything without intense pain.
son who is 16 received the first shot of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna) in a 16-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna) had resolved.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Information has been received from a physician concerning a consumer who on unspecified dates was vaccinated with first and second doses of zoster vaccine live (Oka/Merck). The time of the doses were not specified, but it was reported they were not given on the same day. It was also reported that the patient had increased side effects at the injection site. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a physician concerning a consumer who on unspecified dates was vaccinated with first  and second doses of ZOSTAVAX (Merck).  The time of the doses were not specified, but it was reported they were not given on the same day.  It was also reported that the patient had increased side effects at the injection site.  At the time of the report the patient's status was unknown.  There was no product quality complaint involved.  Additional information is not expected.
Client brought to Health Dept. by parents who reports when client woke up this morning, he had complaints of right leg itching. parents observed red, hard area to (Rt) outer thigh - area warm to the touch, hard, very swollen - approx. 2 inches by 2 inches - Seen by M.D. - diagnosis of cellulitis.
The night I got the shot I had a lot of tenderness in my arm. The next day I felt like I had mono. Extreme malaise and I am an energetic person. I felt achey and tired and cold and didn't want to get off the couch. I couldn't regular my body temperature. On 2/18/2021 the same symptoms persisted but to a lesser degree. Today is 2/19/2021, I feel better than the two days before, but still not myself - tried to workout and had a cold sweat and quit the workout (which I never do), still feel tired but less so than the two days before.
Ran mild fever on Fri 4/15 and Sat 4/16, irritable Sat night 4/16 and Sun 4/17. Rash developed, disappeared Sunday, now has 50-60 spots now on stomach, few on face, ext. No blistered.
I was woken up by a severe headache in the area behind my left ear. I went to brush my teeth and then looked in the mirror and saw my face and that the toothpaste could not stay in my mouth. The entire left side of my face had fallen about an inch. I could tell because my eyebrows were not even. The headache continued for several days but not as severe as the initial event. I could not use the muscles on the left side of my face at all. Initially, I was afraid to go to the hospital because of the level of COVID in my area but I did take pictures throughout the several weeks of my recovery.
"Moderna COVID-19 Vaccine EUA" large reddened area on upper arm, approximately the size of a softball.  warm to touch but does not itch, or hurt
8FEB91 child developed elevated t 105 admitted to hospital for 23 hrs observation. Treated for Rhinitis & Bronchitis.  Child at home now & DR states T elevated again 12FEB91.
Pt reports 2 hours after injection arm became very swollen & tender. Upon examination pt had circumferential edema (L) UE. No erythema very tender to palpation. No dyspnea. Pt refused further exam or tx.
Child had a seizure lasting approximately 25-> 45 minutes required ATIVAN and VERSED. Hospitalized PICU.
Pt deceased on 07/26/08. Currently case remains open at Medical Examiners office. Pt had no positive signs of illness at time of exam, normal PE.  10/20/2008 Autopsy received. COD Sudden Infant Death Syndrome. Infant found by parent cold and unresponsive. Resuscitation efforts were unsuccessful. No significant anatomic, circumstantial or toxicologic findings on Autopsy.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            No concomitant medications were reported. Patient utilized exercise and water to alleviate symptoms from first dose. Patient took second dose on 09-SEP-2021 in upper left arm (053E21A).   This case was linked to MOD-2021-317388 (Patient Link).
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: PATIENT PRESENTED FOR SECOND SHOT, STATING SHE STILL HAS MUSCLE PAIN FROM 1ST SHOT 21 DAYS AGO. IN ADDITION THERE WAS STILL BRUISING, AND SOME UNIDENTIFIED RED SPOTS. I INSTRUCTED HER TO CONSULT HER DOCTORE, WHICH SHE HAD NOT YET, AS THIS COULD BE A SIGN OF SOMETHING THAT REQUIRES MEDICAL TREATMENT
Shingles on her back; This case was reported by a pharmacist and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) (batch number 260385, expiry date 30th April 2020) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD. In September 2019, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and Fluad in the right deltoid. Within less than a week after vaccination, the patient experienced shingles on back. The reporter stated that, the patient was upset and asked explaination to the reporter. The reporter gave permission to follow up. It was unknown if the reporter considered the shingles to be related to Fluad as well.
Headache 24 hours after injections Overall tired and weak 48 hours after injection  Tremor in left thumb at 48 hours and continues currently at about 72 hours post
Pt had an all-over body rash with onset the evening after she had the flu shot. She has previously had the high dose flu shot with no issues. MD recommends getting low dose flu shots in the future.
pt recv vax 11AM & apparently well but not examined;febrile sz 130PM;noted to have t103+ & bilat OM;
After injection pt states a "funny feeling like itchy" on the injection side LD.  Vitals stable pt assess for 30 minutes.  D/C arm feels normal.
fever, headache, body aches, injection site pain, severe pain in the muscles of injection site arm -- did not administer treatment.  continued for 24 hours mild soreness of injection site continued and still in effect as of this report. severe hive reaction at injection site -- used diphenhydramine HCI 2% and zinc acetate .1% continued from day and is almost completely gone as of this report.
Lungs were hurting; The patient was coughing like was going to cough up a lung; Throat soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Lungs were hurting), COUGH (The patient was coughing like was going to cough up a lung) and OROPHARYNGEAL PAIN (Throat soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PULMONARY PAIN (Lungs were hurting), COUGH (The patient was coughing like was going to cough up a lung) and OROPHARYNGEAL PAIN (Throat soreness). On 07-Mar-2021, PULMONARY PAIN (Lungs were hurting), COUGH (The patient was coughing like was going to cough up a lung) and OROPHARYNGEAL PAIN (Throat soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-075528 (Patient Link).
aching, h/a on 20DEC93 (phone call); 22DEC93 afebrile, weak, faitgued, elevated Bp @ home;
I went to Urgent Care after experiencing a sharp chest pain when I woke up in the morning, my heart and respiratory rates were both very high and I was sent to the ER with blood clots in my lungs. I was admitted overnight and discharged about 24 hours later. The nurse recommended that I report it as a possible side effect of the Moderna vaccine since I only got it about three weeks ago, but she said that the birth control I was taking is also a risk factor.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-MAR-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. The pharmacist reported that the patient received ZOSTAVAX that was improperly stored at 27.1F for 30 hours (also reported as stored at 27.1F for 24 hrs). No adverse effects were reported. The outcome of received ZOSTAVAX that was improperly stored at 27.1 F for 30 hrs and no adverse effects were reported as unknown. Additional information has been requested.
Started with redness right deltoid area 2 days ago after receiving MMRV and Flu vaccine and has increased, positive tenderness, no fever.
Runny Nose; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny Nose) and SNEEZING (Sneezing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced RHINORRHOEA (Runny Nose) and SNEEZING (Sneezing). At the time of the report, RHINORRHOEA (Runny Nose) and SNEEZING (Sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Sore knot with pus in it; headache; A spontaneous report was received from a consumer concerning an 88-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced sore knot with pus in it and headache.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 025L20A) on the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced sore knot with pus in it and headache. Treatment for the events included Tylenol and cleansed the injection site with saline solution.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events, sore knot with pus in it and headache resolved is unknown.  Based on Association comment Sore Knot with pus in it (Unlisted in System) and Headache (Listed in System).
A little arm soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had no problem except a little arm soreness. The patient was exercising it and it was better. Follow-up would not possible, as no contact, details were available.
arm was sore around the injection site and turned red; today 10/08 the arm is not so red and not so sore anymore
9 administrations of improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 17-JUL-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, 0.5 ml, lot # T006792, expiration date was reported as 24-AUG-2021 and upon internal validation, established as the same (strength, route of administration and anatomical location were not reported), for prophylaxis. The digital data logger registered the temperature excursion of-13.5 degree Celsius (C) for the 24 minutes, -11.4 (C) for the 27 minutes and -1.8 (C) for the 2 hours and 8 minutes. There was detected previous temperature excursion.  This is one of the 9 linked reports derived from the same reporter.; Sender's Comments:  US-009507513-2007USA010361: US-009507513-2007USA010374: US-009507513-2007USA010419: US-009507513-2007USA010893: US-009507513-2007USA010434: US-009507513-2007USA010252: US-009507513-2007USA010001: US-009507513-2007USA011962: