chrisvoncsefalvay/vaers-outcomes huggingface dataset:
02/12/2021 at 1031- Patient received 1st dose of Moderna COVID 19 vaccine. At 1047 patient began to experience mild sob. Doctor and Registered Nurse to patient to assess patient. Patient alert, oriented, and awake. GCS=15. Clear speech with full sentences. Pt denied any itchiness in throat or body, n/v/d, or any other complaints. Benadryl 25mg PO given at 1050 by RN. Patient tolerated well. Vitals are as follows bp=140/87 hr=73 pulse ox=98% rr=22. At 1100 patient self administered personal INH. Patient report to feel ?better? at 1110. Patient discharged with discharge instructions by Doctor. Patient with no signs of distress upon discharge at 1115.
Heavy, stiffness in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Heavy, stiffness in injected arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and TRAMADOL for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Heavy, stiffness in injected arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Heavy, stiffness in injected arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products included high blood pressure medications, Diabetes medication, Allegra, Tramadol. Treatment products included Tramadol.   This case was linked to US-MODERNATX, INC.-MOD-2021-076421 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076421:2 dose
Suspected Vaccination Failure; shingles; Hurt; laying still in bed and not moving; couldn't stand to wear clothes/Going to the bathroom was pure agony; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles around her waist).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, pain, mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, mobility decreased and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient got shingles twice, once after the patient received the vaccine. The patient stated that it really hurt both times. First was around my waist, the second time it started tight above and ran all the way down. The couldn't stand to wear clothes, even laying still in bed and not moving, the sheet even hurt over her. It was reported that the going to the bathroom was pure agony. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and as details regarding laboratory confirmation of shingles was not provided.
Patient noticed swelling of his penis following the HPV vaccine. There were 3 separate rings of red, swollen rings around his penis. Did not itch or interfere with urination. Did not look like hives and had no other symptoms with it. These rings cleared up within 48 hours.
I started feeling bad on 11/25/22 and 11/26/22, I was coughing, throat was hurting, fatigue, insomnia for three. I had a fever. I went to the emergency room, and they used a PCR covid-19 that came back positive. The doctor was not comfortable prescribing PAXLOVID because I had just had COVID-19 in September. I went home and called my primary care physician who did prescribe the PAXLOVID for me. I am feeling better, but I am not feeling 100% as I have had COVID-19 three times.
Patient came in to get a Covid Janssen booster. Patient stated being afraid of needles. Patient was given vaccine said he didn't feel a thing. Patient was told to have a seat and wait 15 minutes. After about 5 minutes patient got up to tell an associate of not feeling well and passed out. Patient was pale in the face but came to. Patient was sat up and given water and ice until patient felt better. Patient waited around and even walked around the store and felt better before leaving. Patient declined for us to call someone to bring him home.
Fever, chills, severe body aches and pains and headache. All not relieved with over the counter medications.
I started having tingling of my left lower lip 3/7 that continued to increase to 3/10 and has remained the same since. The numbness/tingling feel is isolated to left lip and chin and slightly feeling occasionally of the left gums. Touching region makes the region feel icy cold. It feels as thought the lip and chin is enlarged and hypo-tone and cold. When a nurse examined lower lip and chin noticed no change in tone or temperature. Symmetrical facial expression.
Started feeling ill a few hours after vaccination. Became increasingly ill over the next few days with nausea and vomiting, severe diarrhea, leg cramps that progressed to where he was not able to ambulate, flushed, confused.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
PATIENT PRESENTED OR REFERS PROBLEMS WITH BALANCE AND COORDINATION, TACHYCARDIA, CHEST PAIN, HEADACHE AND SHORTNESS OF BREATH  BY APROXIMATELY 3 DAYS
Information has been received from a physician concerning a 5 to 7 yr old male who was vaccinated with a dose of varicella virus vaccine live at 1 yr of age. There were no concomitant medication. On approx 19Oct05 the pt broke out with a rash that looks like hives. He had less than 50 lesions. He had no fever. The physician tested the rash, and it was positive for varicella. No treatment was given and the rash resolved on its own. There was no product quality complaint. No additional information is expected.
Rash on arm at the site of the injection. Started off itchy/raised like a mosquito bite. Changed to a wide/red/flat rash.
Right shoulder pain consistent with rotator cuff tendonitis/bursitis. Shoulder Injury Related to Vaccine Administration.
Patient had transient vasovagal response after the injection with light head feeling and tinnitus. Resolved within 30 minutes. Normal vital signs.
Pt came in about 2 months later and said that after the shot they got chills that night and then the next morning  ended up passing out on the bathroom floor for an entire day, woke up and was fine
Headache and developed pustule rash on back that began 3 days post vaccine and lasted 4 days from onset
Tested positive for covid a week later; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid a week later) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid a week later). At the time of the report, COVID-19 (Tested positive for covid a week later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
Mom states upper left arm erythematous and child complains of itching, warm to touch.
Five days post injection, I broke out in significant hives, starting on my forearms, spreading to shoulders, upper chest and back, face with swelling, and thighs. I immediately took two benadryl for the histamine reaction that was occuring, took two more about sixty minutes later.  about an hour after that, the reaction started fading.
injection site rash. rash about 3-4 inches in diameter, swollen, and hot to the touch. mildly itchy. only noticed it late Friday night.   Saturday, rash and swelling persisted. toward the end of the day, whole body was mildly itchy. took 1 benadryl, waited an hour, whole body still itched and get crummy so i checked my temperature. had a 99.1 fever.  took a second Benadryl and acetomenaphin.  Sunday rash and swelling was less noticeable, low grade fever (97.6). less itchy. the area is still warm to the touch but the itchiness had subsided.   expecting symptoms to continue getting gradually better after reading information online about similar reactions to the Moderna vaccine.
Pt. Presented with Nausea, body aches, fever 101F, rash and pain to injection site, general tiredness.
Patient received his first dose of Moderna COVID vaccine at 17:51 and reported at 18:04 that he had a tingling feeling go down his arms to his fingers, then felt light-headed and dizzy.  Nurse noted he appeared pale and diaphoretic and took vital signs at 18:07 BP-105/50, P-85, R-18, O2-99%; 18:13 BP-124/59, P-63, R-18, O2-99%; 18:20 BP-142/62, P-81, R-16; 18:30 BP-137/85, P-81, O2-99%.  At that time he reported feeling much better and was able to leave the vaccine clinic.  RN did suggest f/u with Primary care provider about symptoms
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment medication was reported. Doctor told patient to receive only half a dose as he was doing fine and his laboratory results were good.   This case was linked to MOD-2021-367663 (Patient Link).
Patient was given first dose of COVID vaccine around 4:15 pm and was about 5-10 minutes into their 15 minute waiting period when they got dizzy and passed out to the side of their chair. Patient's father called pharmacy staff over and patient was face down on the floor with a bloody mouth from biting their tongue. Patient was conscious and beginning to move. Immediately called a Code White, got patient an ice pack, water, and a cloth for their bloody mouth. We also called patient an ambulance just to be sure. Stayed with patient while technicians got ice pack, water, and cloth. After a few minutes the patient was able to sit up and said that they were still a little dizzy but remembered everything about falling over and hitting their head and mouth. Patient drank some water and talked with pharmacists until the ambulance got their. EMTs checked patients vitals and then took them out to check them out further. Patient was a little shaky when they left but stated that they had not eaten today and was able to walk themselves out to the ambulance to have their vitals further checked.
Information has been received from a NP concerning a 70 year old white female who on 10/16/00 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent in the right deltoid. On 10/19/00, the pt developed red, hot, painful, swollen right arm. After 2 months, the pt was still experiencing her symptoms. The pt sought medical attention at the doctor's office. The NP considered the pt's experience to be an "Other Medical Event". At the time of the report, the pt's final outcome was unknown. No additional information is expected.
Very high pitched ringing in ears, specifically noticeable in my left ear. I never experienced this prior to the vaccine. This has not stopped since it began and it has gotten worse over the past couple of weeks.
low resistance to diseases; Chronic obstructive pulmonary disease (COPD); Acid Reflux; This is a spontaneous report received from a contactable consumer (patient) based on information received by Pfizer from National Service center (manufacturer control number: 02036017). An unspecified age female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration in 2021 (Lot Number: EN6201; Expiration Date: Jun2021) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration in 2021 (Lot Number: EL9266; Expiration Date: May2021) as single dose for COVID-19 immunization. On 10Aug2021, the patient experienced shoulder surgery. This occurred after receiving 2 shots of the Pfizer covid vaccine. In 2021, the patient had some underlying health conditions, such as low resistance to diseases, chronic obstructive pulmonary disease (COPD) and Acid Reflux. The outcome of events was unknown.  No Follow-up attempts are possible. No Further information expected.
Covid19 breakthrough.  1st vaccine received on 02/25/2021.  2nd vaccine on 03/25/2021. 3rd vaccine on 11/26/2021. 86 y/o female presents to ED with c/o increasing SOB.  Pt had tested + for Covid19 on 04/29/2022 and was sent home on Paxlovid  After 2 doses, pt c/o generalized weakness, daughter took home pulse ox and heart rates 30's so brought to ED.  Pt endorses SOB, diaphoresis and epigastric pain.  Heart rate noted 30-40's, hypothermic, hypotensive, O2sats mid 80's, placed on 15L NRBM-admitted to ICU. CXR with trace right pleural effusion.  Started on IV steroids.
I have broken out in a rash after both covid shots and the rash on arms and thighs and it stayed for a month.  Treated with a prescription steroid Prescribed by Dr.
pt recv vax & 3MAR97 pt devel parotid swelling for 2 days & low grade temp;It was reported that pt MD thought the parotid swelling & fever may have been d/t viral parotitis;
No symptoms after 1st shot - Symptoms started after 2nd shot on 4/20 & some of the symptoms lasted for days - Sore left arm - Massive Headache - Body Aches - Nauseous - Felt like ice cold poison was racing thru my veins - chills like I have never had before, could not warm up - Hives - Bottom lip swelled up - Low Blood Pressure (90/59, 108/65, 115/66, 112/70 - Extreme fatigue
Patient received first Pfizer vaccine and was sitting down for observation for about 3-5 mins before she reported not feeling well and very dizzy.  She said she feels like fainting so I support her arm and upper shoulder  and she fainted in her chair for about 30-40 seconds.  We called emergency number to report the incident.  She came back on her own and was conscious when the ambulance came.  They came and gave her IV and transported her to hospital.
Dose administered after 30-day Use By Date; No adverse event; Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015B22A and 045J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2023, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Initially the vial was stored in the refrigerator on 15Dec2022.  No concomitant medications were reported. No treatment medications were reported.
22 hours after receiving second vaccine started to feel achy. 27 hours after vaccine was extremely achy and very very cold. Cold continued yet was covered in sweat. By about 30 hours after vaccine had terrible headache, chills, sweating, and still body aches. Woke up next morning still with the same symptoms. As the day went on side effects started to subside except the headache and now had no appetite. Still three days after vaccine was taking ibuprofen for headache. By fourth day all symptoms were gone.
CUSTOMER REPORTED FEELING LIGHTHEADED/DIZZY ABOUT 2 MIN AFTER INJECTION. HE SAT DOWN AND PUT HIS HEAD DOWN ON TABLE AND PASSED OUT FOR ABOUT 5 SECONDS,  WOKE UP THEN PUT HEAD DOWN AGAIN AND PASSED OUT AGAIN FOR 5 SECONDS THEN WOKE UP AND SAID HE WAS FEELING NAUSEOUS THEN WE CALLED 911 .   HE LAID ON FLOOR AND RAISED HIS LEGS AND HE WAS OK AFTER AND HE DID NOT WANT TO GO TO THE HOSPITAL
Irritable x 10 days. Raynaud's / Severe loss hand's.
& altered mental status Narrative: Pt reported the following adverse reaction from his covid vaccine dose #1. Taken from the nurses note- "Veteran reports serious altered mental status folowing first vaccination. reports hulicinations felt like he was "very small in size" and, that he was totally "out of it" but could not elaborate. he denies any other preeding event that could have contributed to his mental status. he is alert oriented and in a good mood during our conversation. no signs of distress or confusion. he denies any other symptoms. all symptoms resolved. advised veteran to discuss with pcp before proceeding with 2nd vaccination, and Veteran agrees" He reported this to nurse at his dose #2 covid vaccine appointment. Pt declined vaccine dose #2 at this appointment.
INJECTION SITE PAIN; CHILLS; BODY ACHES; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and cigarette smoker, and other pre-existing medical conditions included does not abuse drug or illicit use. 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 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-APR-2021, was recovering from body aches, and flu like symptoms, and had not recovered from injection site pain. This report was non-serious.
Severe redness swelling (2-5 day onset) around injection site. 2-3.5 inch red circles. 1-1 inch red circle.
This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a 53-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date 24th November 2020) for prophylaxis. On 7th February 2019, the patient received SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was unknown. It was unknown if the reporter considered the blurred vision to be related to SHINGRIX. Additional details were provided as follows: After receiving the SHINGRIX dose, the patient had blurred vision. The reporter gave consent for follow up.
She became infected with COVID19 more than 2 weeks after her 2nd Pfizer vaccination; She became infected with COVID19 more than 2 weeks after her 2nd Pfizer vaccination; This is spontaneous report received from a contactable consumer. A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) (at 50-year-old) at 2nd dose, single in arm left for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) (at 50-year-old) at 1st dose, single for COVID-19 immunisation. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient became infected with COVID19 more than 2 weeks after her 2nd Pfizer vaccination. The event was confirmed (test positive) to have been reported to the (Name withheld) was not hospitalized and appeared to have recovered.  Information on the lot/batch number has been requested.